Electrical applicator for applying energy to the surface of a tissue or the shallow layer of that surface.

Abstract

The present invention provides an apparatus and method for applying electrical energy to target tissue using a therapeutic applicator equipped with one or more electrodes. [Solution] The therapeutic applicator for delivering electrical energy to target tissue has a therapeutic tip in which dual suction ports 1615 each form a continuous suction port between two sets of electrodes 1605, and each elongated suction port pulls the tissue between the sets of electrodes to prevent arc discharge and firmly fixes the tissue in contact with the tip so that the electrodes can penetrate into the tissue.

Description

Technical Field

[0001] Cross - Reference to Related Applications This patent application claims the priority of U.S. Provisional Patent Application No. 63 / 231,698, filed on August 10, 2021, entitled "ELECTRICAL APPLICATORS FOR APPLYING ENERGY TO TISSUE SURFACES OR REGIONS SUPERFICIAL TO THE SURFACE", the entire content of which is incorporated herein by reference.

[0002] Incorporation by Reference All publications and patent applications described in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference.

[0003] Technical Field The methods and devices described herein may relate to electrodes for applying electrical energy to a subject, such as a patient. More specifically, the methods and devices described herein relate to electrodes that can apply pulsed electrical energy (e.g., nanosecond pulsed electrical energy) to the surface of a patient's tissue, such as the skin, or to regions superficial to the tissue surface. These devices and methods described herein may be particularly useful for avoiding or minimizing undesirable electrical changes in tissue, including improved targeting and positioning, and preventing or limiting electrical arcs.

Background Art

[0004] Electrical energy can be applied within tissues for a variety of purposes, including the treatment of medical conditions. Electrical energy can be delivered through electrodes of therapeutic applicators placed on and / or inserted into tissues. In some cases, the application of electrical energy through electrodes can cause undesirable changes in the tissue at or around the electrodes. Such undesirable changes can occur, particularly when applying high voltage or high-power energy, if the contact between the therapeutic applicator, including the electrodes, and the tissue is inadequate or inconsistent, potentially leading to uncontrolled discharges such as arcs.

[0005] These problems can become particularly serious when applying high-speed, high-energy pulses, for example, to treat patients. For example, nanosecond high-voltage pulse generators have been described for biological and medical applications. See, for example, U.S. Patent Application Publication No. 2010 / 0038971. The entire contents of these publications are incorporated herein by reference.

[0006] Because the treatment voltage is very high and the pulse time is very fast, applicators for the delivery of such sub-microsecond pulsed devices should ideally be configured to avoid, or at least minimize, arc discharge between electrodes. Furthermore, it would be beneficial to improve contact between the tissue and the applicator and electrodes, including preventing tissue tenting around and / or between the electrodes of the applicator. Tenting can occur when tissue that is penetrated or pressed by one or more electrodes on the applicator and / or treatment tip stretches around the electrodes, leaving a gap. Tenting can cause problems with the targeting and control of the applied energy, including arc discharge, and as a result, the outcome of the electrotherapy may be less favorable.

[0007] The methods and apparatus described herein can address the various problems raised above, including improved targeting of the treatment area. [Overview of the project]

[0008] Described herein are apparatuses and methods for applying electrical energy to target tissue using a therapeutic applicator (hereinafter also simply referred to herein as “applicator” or “applicator device”) having one or more electrodes. These electrodes may be configured to be used in conjunction with suction which may be applied locally to assist in establishing or maintaining contact with the tissue surface and / or superficial regions of the tissue. For example, described herein is a therapeutic applicator having an array of electrodes, each which may be biased to apply a predetermined force in contact with the tissue. These electrodes may have extended positions, but may be blunted or otherwise configured not to penetrate the tissue in some embodiments, so that contact with the tissue surface can drive the electrodes to retract at least partially into the therapeutic applicator while the electrodes are driven in contact with the tissue with a constant force. In some embodiments, these electrodes may be used in conjunction with suction applied around the electrodes, so that contact with the target tissue can be stabilized. Suction may be coupled with the electrodes so that contact with the tissue (detected by retracting the electrodes) can trigger the application of suction.

[0009] The methods and apparatus described herein can address arc discharge and tenting, as well as the targeting problems described above. For example, these methods and apparatus can improve targeting of the lesion area by allowing the user to clearly see the target lesion when placing the treatment applicator on the tissue and to continue to see the lesion throughout the treatment.

[0010] Therefore, energy can be applied directly to the skin surface using one or more electrodes, thereby reducing the physical trauma caused by inserting each individual needle into the skin. These methods and apparatus can also reduce the amount of arc discharge between electrodes along the skin surface through any gaps around the electrodes. This gap / air path between electrodes is one of the causes of arc discharge. Various designs of the therapeutic applicator devices of this application form a seal between the tip of the therapeutic applicator and the tissue and provide a vacuum between the electrodes that blocks the gap / air between the electrodes. These methods and apparatus can further reduce the retaining force required to maintain constant contact with the tissue throughout the treatment. By eliminating gaps (e.g., tenting) and / or reducing the force required to apply the therapeutic applicator, the overall usability or ease of use when treating tissue can be improved.

[0011] In some embodiments, electrodes are biased such that contact with tissue drives the electrodes to retract slightly (individually or collectively), thereby applying a reaction force against the tissue due to the bias associated with the electrodes. In some embodiments, the electrodes are non-penetrating pin electrodes configured with biasing elements (e.g., springs) inside and / or outside the pin electrode. In some embodiments, these electrodes may be configured with biasing elements (e.g., springs) within the pin electrode, similar to pogo pins. Spring electrodes can apply spring force to ensure continuous contact with tissue (e.g., skin). Non-penetrating electrodes may have a smooth and / or rounded distal end (e.g., tip) and other smooth outer surfaces, thus reducing the likelihood of arc discharge. When using high-voltage pulses, such as nanosecond pulsed electrotherapy, sharp tips are typically more susceptible to arc discharge. Because the electrodes do not penetrate the skin, they can be used in sensitive areas of the body, such as around the eyes or other parts of the face, minimizing potential tissue damage from the electrodes.

[0012] Any of the treatment applicators described herein may include non-penetrating (e.g., spring-loaded) electrodes integrated with vacuum or suction ports. These suction ports may be located beneath and around each electrode and may help eliminate any air gaps around the electrode to achieve better or more complete contact with the tissue. Eliminating air gaps around the electrode may also reduce delays in treatment due to arc discharge, which would consequently lead to better or more consistent treatment outcomes. When using penetrating electrodes (e.g., needle electrodes), these vacuum ports may also assist in the insertion of the needle electrode into the tissue and may reduce the force that the user needs to apply to the treatment applicator to initiate and / or during the treatment. Using suction ports around each needle may generate sufficient suction force around the treatment area to hold the treatment applicator in place, without requiring the application of large forces before and during the treatment. Suction may keep the electrode in contact with the tissue surface throughout the treatment, consequently reducing the likelihood of arcing and thereby improving treatment outcomes.

[0013] In general, what is described herein is a device for delivering electrotherapy, specifically including a therapeutic applicator (including those configured as removable / disposable therapeutic tips) for delivering electrotherapy. Electrotherapy may be pulsed (e.g., submicrosecond, nanosecond, etc.) pulsed electrical energy. These tips can generally be used to apply suction before and / or during the application of electrotherapy. In some embodiments, each electrode (e.g., a tissue-penetrating electrode or a non-penetrating electrode) may be surrounded by and / or extend from a suction port to which suction can be applied.

[0014] Also described herein is a device for delivering electrotherapy, the device comprising: an electrode housing extending from the distal end of a therapeutic applicator; a first electrode or set of electrodes extending from or configured to extend from the electrode housing and positioned over a first length of the electrode housing; a second electrode or set of electrodes extending from or configured to extend from the electrode housing and positioned over a second length of the electrode housing parallel to the first length; and a suction port opening penetrating the electrode housing and extending continuously between the first electrode or set of electrodes and the second electrode or set of electrodes, wherein the suction port opening extends further across the electrode housing than the first and second lengths to prevent arc discharge between the first electrode or set of electrodes and the second electrode or set of electrodes.

[0015] A device for delivering electrotherapy may include an electrode housing extending from the distal end of a therapeutic applicator; a first electrode or set of electrodes extending from or configured to extend from the electrode housing; a second electrode or set of electrodes extending from or configured to extend from the electrode housing; and a suction port opening penetrating the electrode housing and extending continuously between the first electrode or set of electrodes and the second electrode or set of electrodes, wherein the collision distance between the first electrode or set of electrodes and the second electrode or set of electrodes, including the minimum path length around the first suction port, is 5% or more longer than the minimum distance between the first electrode or set of electrodes and the second electrode or set of electrodes extending across the suction port to prevent arc discharge between the first electrode or set of electrodes and the second electrode or set of electrodes.

[0016] Also described herein are methods for operating and / or using any of these devices (e.g., devices, systems, etc.). For example, a method may include applying the distal end of a therapeutic applicator in contact with tissue; bringing the tissue into contact with a first electrode or set of first electrodes and a second electrode or set of second electrodes on the electrode housing of the therapeutic applicator; and preventing arc discharge between the first electrode or set of first electrodes and the second electrode or set of second electrodes by applying suction through a continuous suction port on the electrode housing that extends between the first electrode or set of first electrodes and the second electrode or set of second electrodes, such that the tissue comes into contact with the continuous suction port that extends beyond either side of the first electrode or set of first electrodes and the second electrode or set of second electrodes. The method further includes applying pulsed electrotherapy to tissue using a first electrode or set of first electrodes and a second electrode or set of second electrodes.

[0017] Any of the devices for delivering electrotherapy to tissue described herein (e.g., devices and systems including an applicator and an applicator configured as a disposable / removable treatment tip) may include a viewing window for viewing the target tissue within the suction chamber of the device. For example, a device may include a suction chamber having an open bottom, top, and one or more sides, and comprising a viewing window; one or more electrodes configured to extend into the suction chamber and at least partially visible through the viewing window; and a suction port in fluid communication with the suction chamber to apply negative pressure into the suction chamber.

[0018] For example, a therapeutic applicator device for delivering electrotherapy to tissue may include a housing forming a suction chamber, the suction chamber having an open bottom, a top surface, and one or more sides; one or more electrodes configured to move within the suction chamber; a suction port fluidly communicating with the suction chamber, the suction chamber having an optically transparent viewing window that allows a user to view target tissue through the open bottom; one or more electrical connectors configured to electrically couple one or more electrodes to an electrical energy source; a control unit coupled to one or more electrodes and configured to extend and retract one or more electrodes within the suction chamber; and a vacuum connector configured to fluidly couple the suction port to a negative pressure source.

[0019] Any of the devices (including the tip and system) may include a control unit for controlling the application of suction through the device, and suction specifically includes the ability to draw tissue through the tip or suction chamber for treatment, or to hold the device in contact with the skin for treatment. In any of these devices, the control unit may include an extraction valve, thereby allowing the user to quickly and easily manually turn on / off suction from the suction port or suction chamber at the tip of the device and suction from the extraction valve. For example, any of these devices may include an extraction valve, for example, on the handle of the device, which may bypass suction from the suction port and / or suction chamber until the user closes it (e.g., by covering it), and suction may be applied through the suction port and / or suction chamber. The extraction port may be part of the handle. Suction may be applied continuously, but may be directed only to the suction chamber and / or suction port at the treatment tip when activated by the user closing the extraction valve.

[0020] A method of using such a device may include: applying the suction chamber of a treatment applicator in contact with the tissue such that the open end of the suction chamber is held in contact with the tissue and the target area of ​​the tissue is visible through the viewing window of the suction chamber; applying negative pressure into the suction chamber from a suction port that is in fluid communication with the suction chamber; and extending one or more electrodes into the suction chamber such that one or more electrodes are in contact with the target tissue inside the suction chamber. The method may further include applying pulsed electrotherapy to the target tissue through one or more electrodes.

[0021] For example, the method may include: applying the suction chamber of a treatment applicator in contact with the tissue such that the open end of the suction chamber is held in contact with the tissue and a target area of ​​the tissue is visible through a viewing window of the suction chamber; applying negative pressure into the suction chamber from a suction port that is in fluid communication with the suction chamber to draw the target tissue into the suction chamber; and extending one or more tissue-penetrating electrodes from one or more sides, traversing the suction chamber laterally, so that one or more tissue-penetrating electrodes penetrate the tissue within the suction chamber. The method may further include applying pulsed electrotherapy to the target tissue through one or more electrodes.

[0022] Also described herein are methods for treating a condition, disease, or disorder using any of these devices. Specifically, described herein are methods for treating syringomas. For example, a method for treating a syringoma may include: applying the suction chamber of a treatment applicator over a target syringoma on the skin of a subject so that the target syringoma is visible through a viewing window of the suction chamber; applying negative pressure within the suction chamber from a suction port that is in fluid communication with the suction chamber to draw the syringoma into the suction port and pull it out from the plane of the skin of a subject; bringing one or more electrodes within the suction chamber into contact with the target syringoma; and applying sub-microsecond pulsed electrical energy to the syringoma through one or more electrodes.

[0023] For example, this specification also describes a device for delivering electrotherapy or therapy to the surface of tissue, the device comprising an electrode housing extending from a distal end of a treatment applicator, one or more (e.g., plural) suction ports opening into the electrode housing, and a plurality of non-penetrating electrodes (in some embodiments, spring electrodes) extending from the electrode housing and configured not to penetrate the tissue, the non-penetrating electrodes extending in an extended configuration from the suction ports, and each non-penetrating electrode being configured to retract into the electrode housing when driven in contact with the tissue, and a plurality of biasing portions, each non-penetrating electrode being coupled to a biasing portion of the plurality of biasing portions such that when the non-penetrating electrode is driven to return to the extended configuration, it presses against the tissue.

[0024] These devices can be treatment applicators that include the electrode housing and electrodes described above. In some embodiments, these treatment applicators are configured as removable and / or replaceable treatment tips that include the electrode housing and non-penetrating electrodes. The removable / replaceable tip can be used with a reusable handpiece coupled to a pulse generator. To avoid any ambiguity for clarity, terms such as "handpiece" are intended to describe the proximal portion of a treatment applicator assembly when used herein, but are not limited thereto. This term refers to any structure for supporting, holding, or attaching the electrode portion of the device, whether the device is intended to be handheld, attached to a robotic arm, or for percutaneous or other minimally invasive applications and whether catheter-based delivery is intended. In some embodiments, the handpiece can be configured to be handheld and can include a manual grip. In some embodiments, the handpiece can be configured to be held by a robotic manipulator (e.g., an arm, etc.). In some embodiments, the handpiece can be configured to be introduced through a scope or catheter.

[0025] For example, described herein is a device including a device for delivering electrotherapy to the surface of a tissue. The device includes an electrode housing extending from the distal end of a treatment applicator, one or more (e.g., a plurality of) suction ports opening into the electrode housing, and one or more (e.g., a plurality of) peripheral seals around the one or more (e.g., a plurality of) suction ports configured to seal the distal end of the treatment applicator against the tissue when suction is applied through the plurality of suction ports. The device further includes a plurality of non-penetrating electrodes extending from the electrode housing and configured not to penetrate the tissue, with each non-penetrating electrode extending beyond one or more peripheral seals from the suction ports in an extended configuration. Each non-penetrating electrode is further configured to retract into the electrode housing when driven in contact with the tissue, and a plurality of biasing portions, with each non-penetrating electrode coupled to a biasing portion of the plurality of biasing portions such that when the non-penetrating electrode is driven to return to the extended configuration, it presses against the tissue.

[0026] Any of these devices may include one or more peripheral seals around one or more suction ports and configured to seal the distal end of the treatment applicator against the tissue when suction is applied through the plurality of suction ports. In some embodiments, the electrode housing may include an insulating distal end forming one or more seals configured to seal the distal end of the treatment applicator against the tissue when suction is applied through the plurality of suction ports around the one or more suction ports.

[0027] The distal end of the treatment applicator may be angled, for example, with respect to the long axis of the treatment applicator such that the tissue engagement surface from which the electrodes extend is angled. For example, the distal end of the treatment applicator may be angled at an angle of about 5 degrees to about 90 degrees with respect to the long axis of the electrode housing.

[0028] The suction channel within the electrode housing may be in fluid communication with multiple suction ports. Any of these devices may include a suction connector at the proximal end of the electrode housing, configured to connect to a negative pressure source when, for example, the treatment tip of the treatment applicator is coupled to the handpiece. The connector may seal and engage with a connection on the handpiece.

[0029] Any of the devices described herein may be configured such that the application of negative pressure (suction) from the suction port is coordinated with the non-penetrating electrode. For example, the device may be configured such that a vacuum is applied through the suction port when the non-penetrating electrode is pressed against tissue (which may cause the non-penetrating electrode to be deflected proximal in the electrode housing, opening the suction channel and allowing negative pressure (suction) to be applied from the suction port).

[0030] Non-penetrating electrodes can generally be configured as spring-loaded pins. For example, each of a group of non-penetrating electrodes may comprise a blunt pin having an internal chamber that houses a spring with a biasing element coupled to the non-penetrating electrode. Thus, in some embodiments, each of the group of non-penetrating electrodes comprises a pogo pin structure (e.g., having an internal spring element). Alternatively or in addition, each of the group of non-penetrating electrodes may comprise a wire electrode extending laterally across the distal end of the treatment applicator (e.g., the tip portion of the applicator). A portion of the electrode within the electrode housing may be coupled to a biasing element (e.g., a spring) that can push the electrode into the housing and exert force on the tissue. Generally, the biasing element includes a spring (e.g., a coil spring, a leaf spring, etc.). The biasing element may be configured to apply a constant force to the tissue when driven to return the non-penetrating electrode to an extended configuration.

[0031] Any of these devices may include one or more mechanical and / or electrical connectors at the proximal end of the treatment tip, which is configured to be detachably coupled to a handpiece (e.g., forming a treatment applicator assembly). The mechanical and electrical connectors may be integrated. In some embodiments, the treatment applicator (e.g., the treatment tip) may include a separate suction connector, and / or the suction connector may be integrated with the mechanical and / or electrical connector.

[0032] As mentioned above, non-penetrating electrodes may have a smooth, rounded, blunt tissue contact surface. In some embodiments, non-penetrating electrodes have an enlarged distal end region with a larger diameter than the more proximal region. Non-penetrating electrodes may have a flat or flattened distal end tip.

[0033] Any of these devices (such as a treatment applicator or treatment tip) may be part of a system including a pulse generator and / or a negative pressure source. For example, described herein is a reusable handpiece having one or more electrical and vacuum connectors at the distal end of the handpiece, and a system including any of the devices described herein. The treatment applicator (configured as a treatment tip) may be configured to be releasably coupled to the handpiece through one or more electrical and vacuum connectors. Any of these systems may include a pulse generator coupled to the reusable handpiece and / or a negative pressure source within the reusable handpiece.

[0034] Also described herein are methods of using any of these devices, systems, or, for example, therapeutic applicators. For example, a method may include applying the distal end of a therapeutic tip in contact with tissue, drawing in negative pressure at the distal end of the therapeutic tip such that each of a plurality of non-penetrating electrodes is driven in contact with tissue and retracts at least partially into the electrode housing of the therapeutic tip, thereby applying a constant force to the tissue via biasing units coupled to each of the non-penetrating electrodes, and applying pulsed electrotherapy to the tissue through the plurality of non-penetrating electrodes.

[0035] Specifically, any of these methods can be used in cosmetic treatments such as reducing or removing wrinkles, skin blemishes, and other skin imperfections.

[0036] Any of these methods may involve sealing the distal end of the treatment tip to the tissue. In some embodiments, drawing in negative pressure may involve drawing in negative pressure at the distal end of the treatment tip such that each of the multiple non-penetrating electrodes is driven in contact with the tissue and retracts partially and independently into the electrode housing.

[0037] Any of these methods may involve coupling the treatment tip to a reusable handpiece of a pulse generator before applying the distal end of the treatment tip to the tissue.

[0038] In addition to methods and apparatus comprising therapeutic applicators having non-penetrating electrodes that self-bias toward the surface of tissue, also described herein are therapeutic applicators having laterally deploying needle electrodes (e.g., tissue-penetrating electrodes) configured to penetrate laterally into the superficial region of tissue just below the surface of the tissue. These therapeutic applicators may include a suction chamber, which may have an open bottom into which tissue can be drawn by suction, so that one or more needle electrodes can exit from the side of the suction chamber and extend into the tissue (e.g., skin) parallel to the open bottom of the therapeutic applicator. The top of the suction chamber may be optically transparent so that a user can view the tissue (and identify the target area to be treated) through the top. In some embodiments, the top may magnify the image through the tissue. A vacuum port may be located in or adjacent to the top surface of the suction chamber.

[0039] These vacuum-assisted lateral dispensing treatment applicators may enable treatment of near-surface tissue with fewer electrodes and / or less trauma to the tissue than other treatment applicators that penetrate tissue laterally (substantially, not parallel) to the tissue surface. Therefore, these treatment applicators may reduce mechanical trauma to the tissue (e.g., skin tissue or epidermis) and may allow the entire treatment to be performed subcutaneously. In addition, these treatment applicators may improve the targeting capabilities of the treatment applicator by allowing the user to clearly see the target lesion when positioning the treatment tip on the tissue and to continue to see the lesion throughout the treatment.

[0040] In general, any apparatus or method described herein that includes deployable electrodes (such as, but not limited to, lateral deployable needle electrodes or non-penetrating electrodes) can be deployed and / or retracted automatically, manually, or semi-automatically. For example, any of these apparatuses may include one or more solenoids for deploying and / or retracting the electrodes. In some embodiments, the apparatus may also include, or instead, one or more biasing parts (e.g., springs) for deploying and / or retracting the needles. In some embodiments, biased solenoids may be used to deploy (e.g., extend) and retract one or more electrodes. A control unit for triggering the solenoids, for example, for deploying or retracting the electrodes, may be included on the apparatus, for example, on the handle portion of the apparatus, and / or on a pedal (e.g., a foot pedal), switch, button, etc.

[0041] For example, the Specified herein describes a therapeutic applicator device for delivering electrical treatment or therapy to tissue, the device comprising: a suction chamber having an open bottom, a top surface, and one or more sides between them; one or more needle electrodes extending from one or more sides and configured to traverse the suction chamber in a path parallel to the open bottom; and a suction port adjacent to the top surface.

[0042] Any of these therapeutic applicators may be configured as a removable and / or replaceable tip region for use with a reusable handpiece, and the suction chamber and electrodes may be part of the tip that can be detachably coupled to the handpiece. For example, described herein is a device for delivering electrotherapy to tissue, the device comprising: an applicator housing forming a suction chamber having an open bottom, a top surface, and one or more sides between them; one or more needle electrodes extending from one of the one or more sides and configured to traverse the suction chamber parallel to the open bottom; a suction port adjacent to the top surface, the top surface having a viewing window that is optically transparent and has one or more marks indicating the path of one or more needle electrodes into the suction chamber; one or more electrical connectors configured to electrically couple one or more needle electrodes to a handpiece of an electrical energy source; and a vacuum connector configured to fluidly couple the suction port to a negative pressure source.

[0043] The top surface may include an optically transparent viewing window. The viewing window may include one or more marks (e.g., crosshairs) indicating the path of one or more needle electrodes into the suction chamber. The viewing window may be configured for magnification.

[0044] One or more needle electrodes may be configured to traverse the entire suction chamber so that the tip of each of the needle electrodes extends to or into one or more sides of the suction chamber opposite to the end of the suction chamber from which the one or more needle electrodes extend. Alternatively, one or more needle electrodes may be configured to traverse the suction chamber partially. The needle electrodes may be configured so that electrical energy is delivered from the body of the needle (e.g., from a region proximal to the tip of the needle electrode). For example, one or more needle electrodes may be electrically insulated along the tip region and its length, except for a region proximal to the tip region, so that when one or more needle electrodes are fully extended, they are located within the middle portion of the suction chamber. Alternatively or in addition, the needle electrodes may be configured so that electrical energy is delivered from the tip of the needle electrode.

[0045] In any of these devices, one or more sides of the suction chamber may be configured to be adjustable to adjust the height of the suction chamber. For example, one or more sides may be inflatable and / or expandable.

[0046] The suction chamber may have any suitable shape, including square, rectangular, or circular. In some embodiments, the suction chamber is shallow, for example, the top surface may extend across the suction chamber for a length of more than three times the height of one or more sides. In some variations, the suction chamber has a length of 5 mm to 80 mm (e.g., 5 mm to 70 mm, 5 mm to 60 mm, 5 mm to 50 mm, 5 mm to 40 mm, etc.) and a depth of 1 mm to 30 mm (e.g., 1 mm to 25 mm, 1 mm to 20 mm, 1 mm to 15 mm, 1 mm to 10 mm, etc.).

[0047] In any of these suction chambers, the top surface may be equipped with electrodes. The electrodes may be located at the center and / or periphery of the top surface. In some variations, a large portion of the top surface (all of the top surface or 90%, 85%, 80%, 75%, etc.) is occupied by electrodes (e.g., return electrodes).

[0048] Any suction chamber may include a seal (e.g., a seal ring) around the open bottom of the suction chamber. The seal ring may be formed of a flexible sealing material (e.g., silicone).

[0049] As described above, each of these therapeutic applicator devices may include a reusable handpiece and a removable tip, the removable tip including a suction chamber, one or more needle electrodes, and a suction port. For example, the therapeutic applicator may include a control unit on the reusable handpiece for extending and retracting one or more needle electrodes.

[0050] As described above, any of these therapeutic applicators may be configured as a system. The system may include any of the therapeutic applicator devices described herein and a pulse generator electrically coupled to one or more needle electrodes.

[0051] Also described herein are methods for operating these devices. These methods may include methods for cosmetic purposes, including methods for treating wrinkles, blemishes, and the like.

[0052] For example, the method may include: applying the suction chamber of a treatment applicator to tissue such that the open bottom of the suction chamber is held in contact with the tissue; applying negative pressure into the suction chamber from a suction port adjacent to the top surface of the suction chamber; extending one or more needle electrodes laterally from the side of the suction chamber and into the tissue within the suction chamber such that one or more needle electrodes extend parallel to the open bottom of the suction chamber; and applying pulsed electrotherapy to the tissue through one or more needle electrodes.

[0053] Any of these methods may include visualizing the tissue through a viewing window (sometimes referred to herein as a targeting window) within the suction chamber in order to position the suction chamber over a target area of ​​the tissue. Applying pulsed electrotherapy may include applying pulsed electrotherapy between one or more needle electrodes and an electrode on the top surface. The method may include adjusting the height of the suction chamber. For example, the method may include forming a treatment applicator by coupling a removable tip, which includes the suction chamber and one or more needle electrodes, to a reusable handpiece of a pulse generator before applying the treatment applicator in contact with the tissue.

[0054] As described above, any of these devices may be configured as a device or system including, for example, a handheld or manually operated device, a computer-controlled and / or robotically operated device, or a remotely operated device. These devices may be configured with one or more electrodes. The electrodes may be, for example, an array of electrodes. The electrodes described herein are generally tissue-penetrating electrodes.

[0055] The therapeutic applicator described herein, including the therapeutic tip portion of the therapeutic applicator, may also include an electrical connector for connection to an electrical energy source. For example, the power connector may be configured to electrically connect one or more needle electrodes to a power source configured to apply high-voltage power to one or more needle electrodes, having a peak voltage of about 100 volts per centimeter (e.g., 0.1 kV / cm) to about 500 kV / cm (e.g., about 0.5 kV / cm to about 500 kV / cm, about 1 kV / cm to about 500 kV / cm, above about 0.1 kV / cm, above about 0.5 kV / cm, above about 1 kV / cm, etc.).

[0056] In general, the energy delivered by any of these therapeutic applicators may refer to the applied electrical energy. As used herein, energy is applied by electrodes during the application of energy therapy or treatment. Energy therapy may be continuous or pulsed. Energy therapy may be pulsed at a single frequency or a range of frequencies, including modulated frequencies (e.g., having a carrier frequency).

[0057] As mentioned above, any appropriate electrical energy can be applied while moving the electrodes against the tissue. For example, applying energy may include applying high-voltage nanosecond electrical pulses, such as applying a train of submicrosecond electrical pulses with pulse widths of 0.1 nanoseconds (ns) to 1000 nanoseconds (ns). Applying high-voltage nanosecond electrical pulses may include applying a train of submicrosecond electrical pulses with peak voltages of 10 kilovolts (kV / cm) to 500 kV / cm per centimeter. Applying high-voltage nanosecond electrical pulses may include applying a train of submicrosecond electrical pulses with frequencies of 0.01 Hz to 10,000 Hz. Applying energy may include applying microsecond electrical pulses or picosecond electrical pulses.

[0058] The methods and apparatus described herein may be used as part of any appropriate electrotherapy or treatment in which electrical energy is applied within (or, optionally, on the surface of) tissue. Various embodiments of this disclosure are useful for applying electrotherapy to the surface of tissue, for example, the surface of the skin for the treatment of various skin conditions, lesions, tumors, growths, or abnormalities. Both through-electrodes and non-through-electrodes of various embodiments may be used for the treatment of the surface of tissue, including the epidermis of the skin. Similarly, various embodiments of this disclosure, including those with both through-electrodes and non-through-electrodes, may be used for applying electrotherapy to subsurface areas of tissue, including superficial treatment areas below the epidermis. For example, the methods of applying energy described herein may be used to treat one or more of the following: organ tissue cancers (e.g., lung cancer, kidney cancer, pancreatic cancer, colon cancer, breast cancer, etc.), skin cancers, cherry hemangiomas, warts, keloids / scars, aging skin, skin conditions and / or diseases, molluscum hemangiomas, lipoid necrosis (NBL), melisma, epidermal lipomas / sebaceous cysts, basal cell carcinomas, and any type of tumor or abnormal tissue proliferation (e.g., benign tumors, precancerous tumors). Alternatively, these methods may also be used on any other body tissue, including non-cutaneous tissues (e.g., respiratory tissues, soft tissues, lung tissues, breast tissues, liver tissues, etc.).

[0059] Any power connector may be configured to electrically connect one or more therapeutic applicators to a power supply configured to apply high-voltage power, for example, power having a peak voltage of 10 kilovolts (kV / cm) to 500 kV / cm per centimeter (but not limited to these), to one or more electrodes.

[0060] For example, described herein are devices for delivering electrotherapy or therapy (e.g., devices including a therapeutic applicator device) in which some or all of the individual electrodes can extend or retract independently relative to each other and / or relative to the electrode housing. These devices may include an electrode housing extending from the distal end of a therapeutic tip, one or more suction ports opening into the electrode housing, a plurality of electrodes extending from the electrode housing, each electrode configured to independently retract into or extend from the electrode housing when driven in contact with tissue, and a plurality of biasing parts, each electrode being independently coupled to a biasing part of a plurality of biasing parts so as to press against tissue when driven to return the electrode to an extended configuration.

[0061] In some embodiments, it may also be advantageous to make the electrode housing extendable and retractable relative to the treatment tip body and / or electrode. For example, in any of these treatment applicator devices, the electrode housing may be configured to extend and retract relative to the distal end of the treatment tip. For example, any of these treatment applicator devices (including the tip region) may include a biasing section that applies a force to return the electrode housing to an extended configuration relative to the distal end of the treatment tip.

[0062] Any suitable electrode can be used in any of these therapeutic applicator devices. For example, the electrode may be non-penetrating or penetrating, and the same therapeutic applicator device may include a combination of penetrating (tissue-penetrating) and non-penetrating electrodes. For example, each electrode of a plurality of electrodes may have a smooth, rounded, and / or blunt tissue contact surface.

[0063] Any of these devices may include one or more peripheral seals located around one or more suction ports and configured to seal the distal end of the treatment tip to tissue when suction is applied through the suction ports. The electrode housing may include an insulating distal end located around one or more suction ports and configured to form one or more seals that seal the distal end of the electrode housing to tissue when suction is applied through the suction ports.

[0064] As described above, the distal end of the treatment tip may be flat or angled, for example, at an angle of 5 to 90 degrees with respect to the long axis of the electrode housing. Any of these devices may include one or more suction ports within the electrode housing and a suction channel that is in fluid communication with them.

[0065] In some embodiments, each individually biased electrode may comprise an internal chamber containing a biasing element (e.g., a spring) coupled to the electrode. For example, each of the multiple electrodes may comprise a non-through pogo pin.

[0066] Any of these devices may include a mechanical connector and / or an electrical connector at the proximal end of the treatment tip, which is configured to be detachably coupled to the handpiece.

[0067] Any of these devices described herein may be configured as a replaceable treatment tip (e.g., disposable, single-patient use) that can be releasably coupled to a reusable handpiece through one or more electrical and vacuum connectors.

[0068] Any of these devices may include a pulse generator coupled to a handpiece, such as a reusable handpiece. Any of these devices may include a negative pressure source within the reusable handpiece.

[0069] Also described herein are methods of using a therapeutic applicator device including individually biased tips. For example, a method (e.g., a method of treating tissue) may include applying the distal end of the therapeutic tip in contact with the tissue, drawing negative pressure through the electrode housing at the distal end of the therapeutic tip such that each of the plurality of electrodes of the therapeutic applicator device is driven independently in contact with the tissue and retracts at least partially into the electrode housing, each electrode being driven independently in contact with the tissue by one of the plurality of biasing parts, and applying pulsed electrotherapy to the tissue through the plurality of electrodes. As previously stated, driving the distal end of the therapeutic tip in contact with the tissue may include retracting the electrode housing into the therapeutic tip against a housing biasing force, the electrode housing being driven distally to the therapeutic tip by the housing biasing part.

[0070] Any of these methods may include sealing the distal end of the treatment tip to the tissue. The methods of this disclosure also include methods for operating the various devices described herein. The methods described herein may include coupling the treatment tip to a reusable handpiece of a pulse generator before applying the distal end of the treatment tip to the tissue. Electrodes may extend from one or more suction ports within the electrode housing. Multiple electrodes, independently driven in contact with the tissue, may be non-penetrating electrodes.

[0071] Also described herein are therapeutic applicator devices for delivering electrotherapy or therapy to tissue, which include one or more windows for visualizing (and targeting) the tissue to be treated. For example, the device may include a suction chamber having an open bottom, top, and one or more sides, and comprising a viewing window; one or more electrodes configured to extend across the suction chamber so as to be at least partially visible within the viewing window; and a suction port in fluid communication with the suction chamber to apply negative pressure within the suction chamber.

[0072] One or more electrodes may be configured to extend from outside one or more sides and traverse the suction chamber in a path parallel to the open bottom. In some embodiments, one or more electrodes are configured to extend from the top and traverse the suction chamber. In some embodiments, one or more electrodes are configured to extend in a curved path across the suction chamber. In some embodiments, one or more electrodes are configured to traverse the suction chamber completely, such that the tip of each of the one or more electrodes extends to or into one or more sides of the suction chamber.

[0073] The viewing window may generally be optically transparent (including being formed from a polymer material, a transparent material such as glass, etc.). The viewing window may be formed on any part of the chamber, such as the top surface and / or one or more of one or more sides. As described above, the viewing window may generally include one or more marks indicating the path of one or more electrodes into the suction chamber. The viewing window may be configured for magnification.

[0074] In any of these devices (e.g., a device, a treatment tip, etc.), one or more electrodes may be electrically insulated along the tip region and its length, but not in the region proximal to the tip region, where one or more electrodes are configured to be located within the middle portion of the suction chamber when fully extended.

[0075] As mentioned above, any of these therapeutic applicator devices may have a detachable tip configured to be detachably coupled to a handpiece. Any of these devices may be part of a system that includes a pulse generator electrically coupled to one or more electrodes.

[0076] In another aspect of the present disclosure, also described herein is a therapeutic applicator device for delivering electrotherapy to tissue, the device comprising: a housing forming a suction chamber, the suction chamber having an open bottom, a top surface, and one or more sides; one or more electrodes configured to move within the suction chamber; a suction port fluidly communicating with the suction chamber, the suction chamber having an optically transparent viewing window that allows a user to view target tissue through the open bottom; one or more electrical connectors configured to electrically couple one or more electrodes to an electrical energy source; electrode movement control inputs coupled to one or more electrodes and configured to extend and retract one or more electrodes within the suction chamber; and a vacuum connector configured to fluidly couple the suction port to a negative pressure source.

[0077] A method (e.g., a treatment method) may include: applying the suction chamber of a treatment applicator in contact with tissue such that the open end of the suction chamber is held in contact with the tissue, thereby making a target area of ​​the tissue visible through a viewing window of the suction chamber; applying negative pressure into the suction chamber from a suction port that is in fluid communication with the suction chamber; extending one or more electrodes into the suction chamber so that one or more electrodes are in contact with the target tissue within the suction chamber; and applying pulsed electrotherapy to the target tissue through one or more electrodes. Applying negative pressure may include applying negative pressure from a suction port adjacent to a second end opposite the open end of the suction chamber. Any of the methods described herein may include visualizing the tissue through a viewing window, with reference to different embodiments and models.

[0078] Applying pulsed electrotherapy may involve applying pulsed electrotherapy between one or more electrodes and a second electrode on the surface of the suction chamber.

[0079] In general, these devices and methods may enable improved targeting of the target tissue (e.g., lesion) area by allowing the user to clearly see the target area when positioning the treatment tip on the tissue. These methods and devices may also allow the user to continue viewing the lesion throughout the treatment. Thus, any of these devices and methods may enable visualization. As described above and further described herein, any of these devices may include a window (e.g., a viewing window or visualization window). Such devices may be used with either or both a through-electrode and a non-through-electrode. These devices and methods may preferably (but not necessarily) be used with suction.

[0080] In some embodiments, the apparatus (and method of using the apparatus) may be configured as a laterally deployable therapeutic device equipped with a penetrating electrode capable of providing subsurface application of therapeutic energy. This may help minimize or prevent damage or injury to surface areas above the treatment area, including but not limited to skin / epidermis.

[0081] For example, a therapeutic applicator device for delivering electrotherapy to tissue may include a suction chamber having an open bottom, a top surface, and one or more sides between them; a plurality of suction ports in fluid communication with the suction chamber; and one or more needle electrodes, each needle electrode extending at a certain height from each of the plurality of suction ports such that when suction is applied while the device is held in contact with tissue, one or more needle electrodes are driven into the tissue to a predetermined depth.

[0082] A therapeutic applicator device for delivering electrotherapy or therapy to tissue may include: an applicator housing forming a suction chamber having an open bottom, a top surface, and one or more sides; one or more first electrodes located within the applicator housing and configured to move within the suction chamber; a second electrode disposed on the periphery of the open bottom, wherein the suction chamber has an optically transparent viewing window; a control unit on the applicator housing configured to adjust the position of the first one or more electrodes within the suction chamber so as to move the first one or more electrodes relative to the field of view of the viewing window; and a vacuum connector configured to fluidly couple the suction chamber to a negative pressure source.

[0083] A therapeutic applicator device for delivering electrotherapy to tissue may include an applicator housing forming a suction chamber having an open bottom and one or more sides; one or more tissue-penetrating electrodes configured to extend across the suction chamber over the open bottom of the suction chamber; an optically transparent viewing window into the suction chamber providing visibility of the open bottom of the suction chamber; a control unit configured to cause one or more tissue-penetrating electrodes to extend across the suction chamber; and a vacuum connector configured to fluidly couple the suction chamber to a negative pressure source. One or more tissue-penetrating electrodes may be configured to extend from one or more sides and traverse the suction chamber in a path parallel to the open bottom. One or more tissue-penetrating electrodes may be configured to extend in a curved path across the suction chamber. One or more tissue-penetrating electrodes may be configured to completely traverse the suction chamber such that the tip of each of the one or more tissue-penetrating electrodes extends to or into one or more sides of the suction chamber.

[0084] As mentioned above, the viewing window may be located on any part of the chamber, such as the top surface and / or one or more sides of the suction chamber (or may penetrate part of it).

[0085] According to further aspects of the present disclosure, a method of treatment using these devices may include: applying the suction chamber of a treatment applicator in contact with tissue such that the open end of the suction chamber is held in contact with the tissue and a target area of ​​tissue is visible through a viewing window of the suction chamber; applying negative pressure into the suction chamber from a suction port that is in fluid communication with the suction chamber; extending one or more tissue-penetrating electrodes from one or more sides such that one or more tissue-penetrating electrodes penetrate the tissue in the suction chamber parallel to the open end of the suction chamber; and applying pulsed electrotherapy to the target tissue through one or more electrodes.

[0086] As described above and as will be described in more detail herein, any of these therapeutic applicator devices may be configured to have suction ports on the tip (e.g., on the electrode housing) separating the electrodes or groups (sets) of electrodes. One or more suction ports may be positioned to form a suction barrier between the electrodes or groups of electrodes. For example, a therapeutic applicator device for delivering electrotherapy to tissue may include an electrode housing extending from the distal end of the therapeutic tip; a first penetrating electrode or set of penetrating electrodes; a second penetrating electrode or set of penetrating electrodes, wherein the first penetrating electrode or set of penetrating electrodes and the second penetrating electrode or set of penetrating electrodes are configured to extend from a first position within the electrode housing to a second position raised from the electrode housing; and one or more suction ports separating the first penetrating electrode or set of penetrating electrodes and the second penetrating electrode or set of penetrating electrodes, adjacent to the first penetrating electrode or set of penetrating electrodes and the second penetrating electrode or set of penetrating electrodes.

[0087] One or more suction ports may include a single suction port located at the center of the outer surface of the electrode housing. One or more suction ports may be located on either the side of the first penetrating electrode or set of penetrating electrodes, or the side of the second penetrating electrode or set of penetrating electrodes. Each of the one or more suction ports may comprise two or more suction ports arranged parallel to each other across the outer surface of the electrode housing separating the first penetrating electrode or set of penetrating electrodes and the second penetrating electrode or set of penetrating electrodes. As described above, each electrode of the first penetrating electrode or set of penetrating electrodes and the second penetrating electrode or set of penetrating electrodes may be independently biased so as to be able to retract independently relative to the electrode housing. Alternatively or in addition, the electrode housing may be biased so as to be able to retract relative to the body of the treatment tip.

[0088] The various exemplary devices and methods described herein may be used to treat relatively large treatment areas, for example, by using multiple surface electrodes arranged as described herein. Further devices and methods of this disclosure may be used to treat various specific conditions, as described herein. Other features and advantages of the devices and methods of this disclosure will become apparent from the following detailed descriptions of one or more implementations, when read in consideration of the accompanying figures. [Brief explanation of the drawing]

[0089] The size and relative position of elements in the drawings are not necessarily proportional to the actual size. For example, the shapes and angles of various elements are not drawn proportionally to the actual size, and some of these elements are enlarged and positioned to improve the readability of the drawings. Novel features of the present invention described herein are described in detail in the subsequent claims. A better understanding of the features and advantages of the method and apparatus of the present invention can be obtained by referring to the following detailed description illustrating exemplary embodiments, as well as the accompanying drawings.

[0090] [Figure 1]Figure 1 shows an example of a system for delivering high-voltage, high-speed pulsed electrical energy, including a therapeutic applicator as described herein and a pulse generator to which the therapeutic applicator is coupled. [Figure 2] Figures 2A to 2C illustrate the operation of an example of a therapeutic applicator including a tip region that includes a spring-loaded non-penetrating electrode that is biased to retract when driven in contact with tissue, where Figure 2A is a cross-sectional view showing the distal end of the therapeutic applicator separated from the target tissue, Figure 2B is a similar cross-sectional view showing the tip of the therapeutic applicator in Figure 2A positioned in contact with the tissue before suction is applied, and Figure 2C is a cross-sectional view showing the tip pressed against the tissue with suction being applied from the suction port. [Figure 3] Figures 3A and 3B illustrate an example of the tip of a therapeutic applicator as described herein, showing an array of four (2x2) spring-loaded non-penetrating electrodes, where Figure 3A shows the distal end of the therapeutic applicator (an example of a removable and / or disposable therapeutic tip), and Figure 3B is a side view. [Figure 4] Figures 4A and 4B illustrate another example of the tip of an applicator as described herein, showing an array of eight (4x4) spring-loaded non-penetrating electrodes, where Figure 4A is a side perspective view showing the distal end of the treatment applicator (e.g., a removable treatment tip), and Figure 4B shows the distal end of the same treatment applicator. [Figure 5] Figures 5A to 5C illustrate another example of a treatment applicator as described herein, where Figure 5A is a side view showing a treatment applicator including a spring-loaded non-penetrating electrode (configured as a removable treatment tip), Figure 5B is a distal end view showing the treatment tip of Figure 5A, and Figure 5C is a side perspective view showing the treatment tip. [Figure 6] Figures 6A to 6C illustrate another example of a treatment applicator as described herein, where Figure 6A is a side view showing the treatment tip (treatment applicator) including pin (and spring-loaded) electrodes, Figure 6B is a distal oblique view showing the treatment tip of Figure 6A, and Figure 6C is a side perspective view showing the treatment tip. [Figure 7]Figures 7A to 7C illustrate another example of a treatment applicator as described herein, in which the non-penetrating electrode is a wire electrode showing a flattened loop of wire forming a spring-loaded electrode as described herein, Figure 7A is a side view showing the treatment tip including the spring-loaded non-penetrating electrode, Figure 7B is a distal oblique view showing the treatment tip of Figure 7A, and Figure 7C is a side perspective view showing the treatment tip. [Figure 8] Figure 8 shows another example of a portion (distal end portion) of the vacuum-assisted treatment tip, including a bar or wire-non-penetrating electrode and a suction port. [Figure 9] Figure 9 shows another example of a portion of the treatment tip (distal end portion) including a spring-loaded non-penetrating electrode and a suction port. [Figure 10] Figures 10A to 10F show examples of therapeutic applicators (indicated as, for example, therapeutic tips) having distal surfaces angled differently to facilitate accessibility and visibility of tissues that are difficult to reach in the target area. [Figure 11] Figures 11A to 11C show another example of a therapeutic applicator configured as a therapeutic tip as described herein, having a relatively large array of surface electrodes (which may be spring-biased) and including multiple suction ports. [Figure 12] Figures 12A to 12E illustrate different examples of treatment tips having wire or bar electrodes, where Figure 12A is an exemplary side view, Figures 12B to 12D illustrate treatment tips with different dimensions and numbers of electrode rows, each surrounded by a suction port / channel, and Figure 12E is a top perspective view illustrating three examples of treatment tips as described. [Figure 13] Figures 13A and 13B show another example of a treatment tip including multiple non-penetrating electrodes configured as coil electrodes, with Figure 13B being an enlarged view of the treatment tip shown in Figure 13A. [Figure 14]Figures 14A to 14C show an example of a treatment tip including multiple electrodes configured as elongated electrodes (which may be tissue-penetrating or non-penetrating), where suction may be applied within the distal end chamber of the tip, and the electrodes may be in contact with the tissue being drawn into the tip. Figure 14B is a perspective cross-sectional view passing through the treatment tip of Figure 14A, and Figure 14C is a side view showing the treatment tip of Figure 14A. [Figure 15] Figure 15A shows an example of a treatment tip (e.g., a treatment applicator) having a central vacuum port between tissue-penetrating electrodes that can ensure contact between the electrode housing and the tissue. Figure 15B shows the treatment tip of Figure 15A with the tissue-penetrating (e.g., needle) electrode extended. Figure 15C is a distal end view showing the treatment tips of Figures 15A to 15B. Figure 15D shows the collision distance with the electrode within the treatment tip of Figures 15A to 15C. [Figure 16] Figure 16A shows an example of a treatment tip having multiple (e.g., two) vacuum ports adjacent to two sets of tissue-penetrating electrodes. Figure 16B shows the treatment tip of Figure 16A with the tissue-penetrating (e.g., needle) electrode extended. Figure 16C is a distal end view showing the treatment tips of Figures 16A to 16B. Figure 16D shows the collision distance to the electrodes within the treatment tips of Figures 16A to 16C. [Figure 17] Figure 17A shows an example of a treatment tip having a central vacuum port and an outer vacuum port between non-penetrating electrodes (e.g., wire electrodes) such that the vacuum port is located on either side of each set of non-penetrating electrodes. Figure 17B shows the treatment tip of Figure 17A with the electrodes extended. Figure 17C is a distal end view showing the treatment tips of Figures 17A to 17B. Figure 17D shows the collision distance to the electrodes within the treatment tips of Figures 17A to 17C. [Figure 18]Figure 18A shows an example of a treatment tip having two C-shaped vacuum ports between two sets of tissue-penetrating electrodes (e.g., needle electrodes), where the vacuum ports are between the sets of tissue-penetrating electrodes and partially surround them. Figure 18B shows the treatment tip of Figure 18A with the electrodes extended. Figure 18C is a distal end view showing the treatment tips of Figures 18A to 18B. Figure 18D shows the collision distance to the electrodes within the treatment tips of Figures 18A to 18C. [Figure 19] Figure 19A shows an example of a treatment tip having an I-shaped vacuum port between two sets of tissue-penetrating electrodes (e.g., needle electrodes), where the vacuum port is between the sets of tissue-penetrating electrodes and partially surrounds them. Figure 19B shows the treatment tip of Figure 19A with the electrodes extended. Figure 19C is a distal end view showing the treatment tips of Figures 19A to 19B. Figure 19D shows the collision distance to the electrodes within the treatment tips of Figures 19A to 19C. [Figure 20] Figure 20 shows an example of a therapeutic applicator that includes a suction chamber with a transparent top surface, which allows for targeting of a lateral needle electrode through target tissue. [Figure 21] Figure 21 shows another example of a therapeutic applicator that includes a suction chamber with a transparent top surface, which allows for targeting of a lateral needle electrode through target tissue. [Figure 22] Figure 22A shows a further example of a treatment tip having a vacuum chamber and a window (including a targeting lens). Figure 22B is a cross-sectional view through the distal tip region of the treatment tip shown in Figure 22A, where the needle electrode is retracted into the side wall of the suction chamber. Figure 22C is a cross-sectional view through the distal tip region of the treatment tip shown in Figure 22A, where the needle electrode extends laterally into the suction chamber parallel to the open bottom of the suction chamber. [Figure 23]Figures 23A–23C show another example of a treatment tip similar to those shown in Figures 22A–22C, which shows a suction chamber with a transparent surface that allows tissue targeting, where Figure 23A shows a treatment tip in which three needle electrodes partially extend across the suction chamber parallel to the open bottom of the suction chamber, Figure 23B shows three needle electrodes fully extending across the suction chamber so as to extend to the opposite side wall of the chamber, and Figure 23C is a bottom view showing the treatment tip of the example in Figures 23A–23B, looking up through the open bottom to a transparent top (e.g., a viewing window containing a concentric targeting ring). [Figure 24] Figures 24A to 24D show the operation of an example of a treatment tip including a suction chamber and multiple needle electrodes. Figure 24E shows an example of a treatment tip configured to treat superficial tissue using a suction chamber and surface electrodes. [Figure 25] Figure 25A is a top perspective view showing another example of a treatment applicator, including a distal tip portion that includes a suction chamber with the top of the suction chamber configured as a return electrode. Figure 25B is a cross-section of the treatment tip portion through the suction chamber in Figure 25A. [Figure 26] Figures 26A–26C show the operation of another example of a therapeutic applicator, which includes a tip with a suction chamber and multiple electrodes, with a viewing window allowing tissue to be viewed through the tip. Figure 26D is a magnified view showing the distal end of the tip region. [Figure 27] Figures 27A to 27B are exploded view diagrams showing examples of treatment applicators that include a vacuum treatment tip having either a tissue-penetrating electrode (Figure 27A) or a non-penetrating electrode (Figure 27B), similar to those shown in Figures 26A to 26D. [Figure 28] Figures 28A and 28B illustrate the operation of another example of a treatment tip including a suction chamber as described herein, where Figure 28A shows the tip before engagement with tissue, and Figure 28B shows the tip engaged with tissue. Figure 28C is a magnified view showing the distal end of the treatment tip of Figure 28B. Figure 28D shows the distal end of the treatment tip of Figures 28A to 28C. [Figure 29] Figures 29A to 29B are exploded view diagrams showing examples of treatment applicators that include a vacuum treatment tip having either a tissue-penetrating electrode (Figure 29A) or a non-penetrating electrode (Figure 29B), similar to those shown in Figures 28A to 28D. [Figure 30] Figure 30 shows an example of a treatment tip as described herein. [Figure 31] Figures 31A to 31D illustrate another example of a treatment tip having a suction chamber with a transparent window for viewing target tissue and an example of a cylindrical electrode, where Figure 31A shows the transparent window with the electrode advanced and in contact with the tissue in the suction chamber, Figure 31B is the same as Figure 31A but with the electrode retracted, Figure 31C is a cross-sectional view through the treatment tip shown in Figure 31A, and Figure 31D is a transverse cross-sectional view through the treatment tip shown in Figure 31B. Figure 31E shows an alternative example of a treatment tip similar to that shown in Figure 31A, but with a control unit configured to apply negative pressure to the suction chamber. [Figure 32] Figure 32A shows an example of the distal end region of a treatment tip having multiple electrodes (non-penetrating electrodes in this example) including adjacent suction areas. Figure 32B shows the electrode holder and main body of the treatment tip shown in Figure 32A. Figure 32C is a cross-sectional view showing the treatment tip of Figures 32A to 32B with the electrodes extended. Figure 32D is a cross-sectional view showing the treatment tip of Figures 32A to 32B with the electrodes retracted. Figures 32E to 32F show examples of other treatment tips with the electrodes retracted (Figure 32E) and extended (Figure 32F), respectively. [Modes for carrying out the invention]

[0091] For clarity and brevity, specific aspects of components or steps of a particular embodiment are presented without such unnecessary details if those details would be obvious to a person skilled in the art in light of the teachings herein, and / or if such details would obscure the understanding of more relevant aspects of the embodiment.

[0092] This specification describes devices, systems, etc., including therapeutic applicators, that are adapted for use in applying electrical energy into target tissue.

[0093] As used herein, a therapeutic applicator comprises one or more electrodes for applying pulsed electrical energy, and in particular sub-microsecond pulsed electrical energy, to tissue. A therapeutic applicator may be simply referred to as an “applicator,” or equivalent to an applicator device. The therapeutic applicators described herein may be configured as disposable or removable therapeutic tips. Thus, removable and disposable therapeutic tips are a subset of therapeutic applicators that can be attached to and / or removed from a handpiece, particularly a reusable handpiece. When disposable / removable therapeutic tips are coupled to a handpiece, the assembly may be referred to as a therapeutic applicator assembly. In some examples, a therapeutic applicator comprises a therapeutic tip (therapeutic tip region) that is integrated into a handpiece.

[0094] Any of the therapeutic applicators described herein may include one or more electrodes or groups of electrodes. Electrodes are generally conductive portions of a therapeutic applicator configured to contact tissue and deliver pulsed energy to it. When used herein, groups of electrodes may be multiplexed together so that they contact tissue at multiple discrete and / or different locations but act together as a single electrode by applying energy. For example, in some cases, a therapeutic applicator may be configured to apply suction between different electrodes (e.g., needle electrodes, pin electrodes, etc.), and the different electrodes may be multiplexed together (or may be independently addressable). In some embodiments, a therapeutic applicator may be configured to apply vacuum between groups of electrodes (e.g., a first set of electrodes that can be multiplexed together and act as "positive" electrodes, and a second set of electrodes that can be multiplexed together and act as "negative" electrodes).

[0095] Any suitable type of electrode may be used, including tissue-penetrating electrodes (e.g., needle electrodes, knife electrodes, etc.) and non-penetrating electrodes (e.g., surface electrodes, wire electrodes, coil electrodes, etc.).

[0096] The therapeutic applicators described herein may be configured to use suction. In some of the therapeutic applicators described herein, the electrodes may be non-penetrating or tissue-penetrating (e.g., pointed) electrodes that are biased (e.g., spring-loaded) to be slightly displaced by contact with tissue and to apply force to the surface of the tissue. Suction may be used to bring the tissue and electrodes into contact and hold them together. The therapeutic applicators described herein may apply electrotherapy (e.g., pulsed, sub-microsecond electrotherapy including nanoseconds) to the surface of the tissue.

[0097] Some embodiments of the therapeutic applicators described herein may be adapted to apply electrotherapy to a region of tissue that is directly below the surface of the tissue (e.g., its superficial layer). For example, described herein is a therapeutic applicator comprising a suction chamber having one or more electrodes, including but not limited to a tissue-penetrating electrode that can extend laterally into the tissue. In some embodiments, the therapeutic applicator described herein comprises a suction chamber having one or more non-penetrating electrodes that can be held firmly in contact with the tissue. In some embodiments, each electrode can be biased independently in contact with the tissue.

[0098] Any of these devices may include a pulse generator as part of a system that includes a therapeutic applicator (e.g., tip, handpiece, etc.). For example, Figure 1 shows an example of a system 100 that may be used with or incorporated with any of the therapeutic applicators described herein. The system shown in Figure 1 (also referred herein as a high-voltage system or sub-microsecond generating system), which delivers high-voltage, high-speed pulses of electrical energy, may include an elongated therapeutic applicator tool 102, a pulse generator 107, a foot switch 103, and a user interface 104. The foot switch 103 is connected to a housing 105 (which may enclose electronic components) via a cable and connector 106. The therapeutic applicator 102 may include an electrode (e.g., as part of an electrode tip) and may be connected to the housing 105 and the electronic components therein via a cable 137 and a high-voltage connector 112. Examples of therapeutic applicators will be described in more detail later. The high-voltage system 100 may also include a handle 110 and a storage drawer 108. System 100 may also include a holder (e.g., a holster, carrier, etc.) (not shown) which may be configured to hold the treatment applicator 102.

[0099] In some cases, the treatment applicator includes a disposable treatment tip that can be releasably coupled to the treatment applicator handpiece. In some modifications, the treatment tip may be adapted to make electrical, mechanical, and pressure connections, as will be described in more detail later. In some embodiments, the system may include or be configured to operate by a negative pressure source (e.g., suction, vacuum, etc.). In some embodiments, the treatment applicator handpiece may include a built-in source that generates suction which can be used to apply suction at the tip.

[0100] A human operator can select the number of pulses, amplitude, pulse duration, and / or frequency information, for example, by inputting such parameters into a numeric keypad or touch screen on interface 104. In some embodiments, the pulse width can be varied. A controller 144 (e.g., a microcontroller) can send signals to pulse control elements in system 100. In Figure 1, the controller (which may include one or more processors and other control circuits including memory) is shown in housing 105, but can be located anywhere in the system. The controller may be coupled to the pulse generator and / or power supply and may receive input from any of the input components. One or more processors (not shown) may be separate processing units or may be combined with the controller. The controller may include multiple controllers, and the processors may include multiple processors. In some embodiments, fiber optic cables are used to enable control signal transmission and to electrically isolate the contents of the sub-microsecond pulse generation system 100, for example, a metal cabinet with high-voltage circuits, from the outside. To further electrically isolate the system, system 100 may be battery-powered instead of being powered from a wall outlet.

[0101] Elongated therapeutic applicator tools may be handheld (e.g., by the user) or fixed to a movable arm of a robotic system, and their operation may be at least partially or fully automated, including computer control. In some implementations, a solenoid (not shown) may be used for deploying and / or retracting the electrodes of the therapeutic applicator. For example, a foot pedal, button, or any other control mechanism may be used that applies an electric current to the solenoid, which can forcibly deploy and / or retract the electrodes. Any other type of actuator device may be used instead of a solenoid. The solenoid may be used in conjunction with a bias (e.g., a spring). For example, one of these devices may include a biased solenoid that, when power is applied to the solenoid, deploys an electrode, such as a tissue-penetrating electrode, into the tissue. When the user activates the solenoid, the electrode may be driven into the tissue, and a load may also be applied to the bias by driving the electrode into the tissue. When power to the solenoid is released (for example, after the application of treatment), the power to the solenoid may be released, and the bias may pull the electrode out of the tissue. Alternatively, the solenoid may be configured to pull out one or more electrodes, and the bias may be configured to deploy the electrodes outside the tissue (and thus load the bias).

[0102] As described above, the methods and apparatus described herein include a therapeutic applicator comprising one or more sets of electrodes for applying electrical energy to tissue. The therapeutic applicator may include a tip portion and a handpiece portion. The tip portion and the handpiece may be separate or may be a single integrated therapeutic applicator. In some embodiments, the tip portion is detachable from the handpiece so that multiple different tips, including different types of tips, can be coupled to the handpiece. The handpiece and / or tip portion may include a negative pressure (e.g., suction or vacuum) source that can be applied through the electrodes to correct contact between the tip portion, particularly the electrodes of the tip portion, and the tissue. In particular, the handpiece may include a built-in vacuum source.

[0103] In any of the methods and apparatus described herein, suction may be controlled by one or more control units on the tip and / or handpiece portion of the treatment applicator. In some embodiments, suction may be manually controlled by a user-operated suction valve. When the valve is open, suction is performed through the valve, and very slight suction may be applied to the tissue contact area of ​​the tip, but suction through the suction port of the tip can be increased by closing or blocking the suction valve, for example by covering the suction valve with a finger or hand.

[0104] Surface treatment applicator Therapeutic applicators as described herein may be configured to deliver electrotherapy or therapy to a tissue surface. These therapy applicators may include either through electrodes or non-through electrodes, or both. In some embodiments, the therapy applicators of the Disclosure may include an electrode housing extending from the distal end of a therapy tip and one or more (e.g., multiple) suction ports opening toward the electrode housing. Generally, these therapy applicators may include multiple non-through electrodes extending from the electrode housing. Non-through electrodes are configured not to penetrate tissue and not to extend from the therapy applicator housing. In some embodiments, the electrodes extend from the suction ports of the electrode housing. In some embodiments, the electrodes extend adjacent to one or more suction ports of the electrode housing, for example, an electrode or set of electrodes may extend from an opening in the electrode housing adjacent to (including being surrounded by or partially surrounded by) one or more suction ports. In extended configurations, non-through electrodes may extend away from the distal surface of the therapy applicator. Non-penetrating electrodes may be configured to retract into the electrode housing when driven in contact with tissue, for example, by a spring mechanism. For example, non-penetrating electrodes may be connected to (or include) a bias that presses against tissue when driven in contact with tissue, thereby restoring the non-penetrating electrode to an extended configuration. Examples of non-penetrating electrodes include surface or plate electrodes, blunt needle electrodes, cylindrical electrodes, wires, bars, coils, or blunt pin or blunt needle electrodes.

[0105] An example of a therapeutic applicator including multiple spring-loaded electrodes with suction ports is shown in Figure 2A. In this embodiment, the therapeutic applicator 200 is shown in cross-section above the target tissue 203. The therapeutic applicator includes three spring-loaded non-penetrating electrodes 205. Each electrode in this embodiment is configured similarly to a pogo pin, with an internal bias (e.g., a coil spring) 207 held within a conductive (e.g., gold-coated) pin body 209, where the spring may be electrically insulated from the conductor of the electrode. In this embodiment, the outer body 211 is fixed and held within the electrode housing 201, but the pin body 209 may be retracted when driven in contact with tissue, as shown in Figure 2B.

[0106] As shown in Figure 2B, the distal surface of the treatment applicator (e.g., the treatment tip) can be pressed against a tissue (e.g., skin) surface. The non-penetrating electrodes in this embodiment are shown as having a relatively large diameter with rounded edges so as not to penetrate the tissue. In some embodiments, the non-penetrating electrodes may be blunt and / or flat. The treatment applicator also includes a seal 213 around all or part of the electrodes. In Figures 2A–2C, the seal is formed by a flange or rim which may be formed of a silicone material surrounding the electrodes. The seal can be pressed against the skin. In Figure 2B, when the device is in contact with the skin surface, each electrode is displaced proximal to the surface individually (and independently).

[0107] Negative pressure (e.g., vacuum, suction) can be applied through one or more suction ports 215, which are fluidly connected to a negative pressure source through a suction channel 217. In some embodiments, suction can be applied before contact with tissue. Alternatively, in some embodiments, suction can be applied after contact with tissue and can be triggered by displacing one or more of the electrodes. Figure 2C shows the tip in contact with tissue, where the tissue is pulled up and held in contact with each electrode by a combination of suction applied through the suction ports and a biasing force driving the electrodes in contact with the tissue.

[0108] Any embodiment including those shown in Figures 3A-3B, 4A-4B, 5A-5C, 6A-6C, 7A-7C, 8, 9, 10A-10F, 11A-11E, 12A-12C, and 14A-14B may be realized as a treatment tip similar to those described above, having a non-penetrating electrode (e.g., spring-loaded) that is biased to apply force in contact with tissue in conjunction with suction.

[0109] For example, Figures 3A–3B show a first example of a treatment tip that includes retractable non-penetrating electrodes for applying energy to the surface of tissue. In Figures 3A–3B, the treatment applicator 300 includes an electrode housing 301, which (in this embodiment) also extends from a treatment applicator housing 302. In this embodiment, four non-penetrating electrodes 305 are included in the tip, and each of these four electrodes is individually biased so that it can retract slightly when driven in contact with tissue. For example, each electrode can be biased internally (as shown in Figures 2A–2C above). Each electrode can extend from a suction port 315 (multiple electrodes can extend from the same suction port, as illustrated). In this embodiment, since the electrodes are blunt, smooth pins, there is a low probability of arc discharge and no retractable configuration for protecting the needle housing to shield against unintended protrusion is required.

[0110] Figures 4A–4B show another example of a treatment tip 400 including an array (4 × 2) of non-penetrating electrodes 405 that are spring-loaded and retract into an electrode housing 401, similar to those described in Figures 2A–2C and 3A–4B above. The electrode housing may be electrically insulated in whole or in part (e.g., by an outer coating) and / or may be formed from a soft or deformable material. The array of non-penetrating electrodes shown in Figures 4A–4B may cover, for example, an area of ​​about 5 mm × 5 mm square. The electrodes in this embodiment may extend from a suction port, each electrode may be surrounded by a suction port, or two sets of electrodes may each extend from the same suction port 415.

[0111] Figures 5A–5C show another example of a treatment tip 500 including non-penetrating electrodes for delivering surface treatment. Each of these electrodes 505 is configured as described above (e.g., a spring-loaded retractable pogo pin type electrode). The spring-loaded retractable electrode can contact the tissue surface and apply pressure to the tissue surface. The outer surface of the electrode housing 501 may be made of a soft (e.g., low-hardness) material that can help seal the tip against the tissue during treatment. In any of these embodiments, the distal surface of the electrode housing may include a seal configured to contact and seal with the tissue when a vacuum is applied. The seal may surround each electrode or set of electrodes separately, or surround all of the electrodes (e.g., the distal end face of the treatment tip). Suction may be applied from the suction port 515. In the example shown in Figures 5A–5C, each of the two sets of electrodes extends from the suction port 515 so that suction can be applied around the electrodes.

[0112] The smooth, rounded tip of a non-penetrating electrode may be less likely to arc discharge between tips than an electrode with a sharp tip. As shown in Figure 5A, the treatment tip may be configured to be detachably attached to a handpiece (not shown). In Figure 5A, the tip includes one or more electrical connectors 523 at its proximal end, which can engage with a connector on the handpiece. In this embodiment, the tip also includes a mechanical connector and release 521 which can be used to reliably connect the tip to the handpiece.

[0113] Figures 6A–6C show another example of a treatment tip 600 similar to that shown in Figures 5A–5C. In Figures 6A–6C, the electrode 605 extends from the electrode housing 601 in a 4-electrode, 3-row array. As described above, each electrode can be biased separately and independently. In some embodiments, groups of electrodes can be biased together (all or some, such as each row of electrodes). In the example shown in Figures 6A–6C, each electrode extends from (and is surrounded by) the suction port 615.

[0114] Any suitable electrode may be used. For example, Figures 7A–7C show an example of a treatment tip 700 having a non-penetrating wire electrode 705. The wire electrode (also referred to herein as a wire loop electrode) is configured as a loop of wire attached to either end within the electrode housing 701, and one or both ends may be coupled to a bias (e.g., a spring) that, when driven in contact with tissue (as shown in Figure 7C), allows the electrode to extend and be pushed (retracted) into the electrode housing against a biasing force. For example, the wire electrode shown in Figures 7A–7C may incorporate an internal spring that allows the electrode to be retractable and function like the pogo-style electrode shown in Figures 3A–3B, and can also apply a constant force to the tissue while energy is being applied. Suction may be applied around the wire loop electrode.

[0115] Figures 7A to 7C show two non-penetrating wire electrodes. Some embodiments may include fewer than two (e.g., one) or more (e.g., three, four, five, etc.) non-penetrating wire electrodes.

[0116] In general, any of these treatment tips may also be configured to apply suction, as described above. For example, suction may be applied to assist in continuous contact with tissue. Figures 8 and 9 show examples of tips (treatment applicator housing removed) that include multiple suction ports and sealing rings. Figures 8 and 9 each show treatment tips having wire (or "bar") electrodes, where the distal surface of the treatment tip includes a sealing area (seal) around the electrode and suction ports. While these embodiments show a single seal, in some embodiments, multiple and / or different seals may be used around a subset of electrodes and suction ports.

[0117] In Figure 8, the treatment tip 800 includes a soft silicone material that forms a seal 813 on the electrode housing 801, which can form a suction cup-shaped structure for secure fixation to tissue. Two wire (e.g., bar) electrodes 805 are included, and multiple suction ports 815, including one or more suction ports below the length of the wire electrodes, are shown parallel to the distal surface. Multiple suction ports can help eliminate gaps between the electrode and tissue, resulting in better contact with the tissue and reducing or avoiding arc discharge. In Figure 8, the suction chamber is formed by the seal 813 (e.g., the lip of the seal), into which tissue (e.g., skin) can be drawn by applying negative pressure (suction).

[0118] As mentioned, in some modifications, suction from the tip may be controlled by one or more suction control units that can be operated by the user. In some embodiments, the suction control unit may include an extraction valve. For example, when suction is turned on and the extraction valve (suction control unit) is open, the suction port 815 may provide only minimal suction (or no suction at all). However, the user may close the extraction valve with their finger or hand (or in another way) so that suction is preferentially applied from the suction port 815 at the tip. In some embodiments, the application of suction may draw tissue into contact with the electrode. Suction may be released by releasing the extraction valve or removing the cover.

[0119] The illustrative treatment tip 900 shown in Figure 9 is similar to that shown in Figure 8 and includes an electrode housing 901 and a soft silicone seal 913 formed around the distal surface of the treatment tip and surrounding the wire electrode 905 and the suction port 915. As in Figure 8, the seal forms a suction chamber. In Figure 9, three bar electrodes are shown instead of the two shown in Figure 8. In some embodiments, the tip may be configured to include both an anode and a cathode electrode, or it may be unipolar, and a return electrode (e.g., a grounding pad) may be used. For example, the central electrode may be the anode and the two outer electrodes are cathodes.

[0120] Figures 10A–10F show examples of treatment tip 1000, including a curved or angled distal surface on which a non-penetrating electrode and suction port are positioned. The angled surface of the distal tip can aid in accessibility and visibility of certain lesions (particularly difficult to reach), and the electrode tip can be configured at various angles to the treatment tip. For example, Figure 10A shows an example of a distal tip where the curved or angled distal surface 1022 is angled at approximately 20 degrees to the vertical plane shown in Figures 8 and 9 (e.g., 80 degrees to the long axis 1025 of the tip). Similarly, Figure 10B shows a treatment tip 1000 where the distal surface 1022 of the tip is angled at approximately 45 degrees to the long axis 1025. In Figures 10C and 10D, the distal surface 1022 is angled at approximately 70 degrees to the vertical plane (e.g., 20 degrees to the long axis 1025 of the treatment tip). Finally, in Figures 10E and 10F, the distal surface 1022 of the treatment tip 1000 is parallel to the long axis of the treatment tip (and at an angle of approximately 90 degrees with respect to the vertical plane of the treatment tip).

[0121] Various configurations of non-penetrating electrodes, such as wire (e.g., bar) electrodes and pin electrodes, may be used with suction ports and may include multiple rows and / or multiple poles (e.g., configured as anode / cathode pairs). For example, Figures 11A–12C show another example of a treatment tip 1100 having multiple non-penetrating electrodes formed as elongated wires. For example, a non-penetrating wire (or bar) electrode 1105 may be used with suction through one or more suction ports 1115 of larger surface electrodes, which may include multiple rows and / or multiple poles extending from the electrode housing 1101, as shown. Dimensions may be, for example, 10–30 mm (e.g., forming a 25 mm × 25 mm square, a 30 mm × 30 mm square, or any rectangle, etc.). The spring-loaded electrodes described herein may be particularly useful in large arrays because the individually biased electrodes can be more easily adjusted for variations in the depth or height of the tissue surface, which may be curved and / or irregular.

[0122] As shown in Figure 11B, vacuum or suction applied through multiple suction ports 1115 beneath and / or around the wire or bar electrode 1105 can help to eliminate any gaps and improve the electrical connection between the electrode and the tissue. Figure 11C shows a cross-sectional view through the distal tip region of the treatment tip, showing a suction channel 1117 formed through the electrode housing. The suction channel may be continuous with the suction ports 1115 and a negative pressure source.

[0123] In any of these therapeutic tips of the present disclosure, suction may be applied to assist tissue in contact with the electrode. Thus, suction may be applied after or before contact with tissue. In some embodiments, suction may be applied only during the period immediately before and while energy is being applied from the electrode. Figures 12A–12E show other examples of suction port configurations that are particularly beneficial for reducing arc discharge, as will be discussed later. Figures 12B–12C demonstrate three different sizes of therapeutic tips, each with a non-penetrating electrode and suction configured according to one or more embodiments of the present disclosure. Figure 12A shows a side perspective view of a therapeutic tip showing the connection to a suction line (e.g., negative pressure source) 1208 extending from the therapeutic applicator body (e.g., therapeutic applicator housing 1202). An electrical connector 1223 extends from the proximal end of the tip, and a mechanical connector (release 1221) may releasably connect the tip to the handpiece. The distal end of the treatment tip includes an electrode housing 1201 from which multiple non-penetrating (e.g., spring-loaded) electrodes extend. Figures 12B–12D show different dimensions of the tip, each shown with a wire or bar electrode that is biased to extend and retract upon contact with tissue, as described above. In this embodiment, the tips in Figures 12B–12E each include a suction port 1215 around the electrode 1205, each configured as a continuous channel that extends longer than the respective electrode 1205 visible within the channel or port 1215. Each suction port may include individual seals around the electrode. In the examples in Figures 12A–12E, each electrode may be individually sealed to the tissue by seals formed on the tip around each electrode and suction port. Figure 12E shows an example of a tip where suction ports of different sizes but all similarly configured, extending long enough beyond the electrode to reduce / avoid arc discharge, each of these tips can be used with the same handpiece to form a complete treatment applicator. This novel configuration of the suction port, located between electrodes and extending beyond the two ends of each electrode, can be incorporated, without limitation, into any of the embodiments and drawings of the present disclosure in the design of the therapeutic applicator shown in Figures 13A–13B and 14A–14C below.

[0124] In any of the apparatuses and methods described herein, suction may be applied continuously, but it does not need to be actuated at the tip until a suction control unit, which may include an extraction valve, is activated and the suction is concentrated at one or more suction ports at the tip. Suction may be provided from a pump (such as a vacuum pump or suction pump), or from a suction chamber or other device such as a syringe.

[0125] Figures 13A–13B show another example of the treatment tip 1300, similar to those shown in Figures 12A–12B, but with a spring or coil electrode as a non-penetrating electrode 1305. This electrode may also extend from the housing 1301 and be biased to be spring-loaded (for example, biased to extend from the electrode housing and be pushed back into the housing by the force of contact with tissue). A suction port 1315 may be used to draw tissue into contact with the non-penetrating electrode. Figure 13B shows a magnified view of the distal end of the treatment tip shown in Figure 13B. Each non-penetrating (spring) electrode is located within a suction chamber, which is bounded by its sides but open at the top to allow tissue to be drawn into the suction chamber. In one example, two suction ports 1355 are located between the three electrodes shown. Alternatively, or in addition, in some embodiments, a vacuum underlies each of the non-penetrating electrodes.

[0126] In the treatment applicators shown in Figures 13A and 13B, the electrodes are separated by continuous suction ports 1355 that may extend beyond the length of each electrode, thereby reducing or preventing arc discharge. As will be described in more detail with reference to Figures 15A to 15D through 19A to 19D, the shortest distance between electrodes (or sets of electrodes) passing around the continuous suction barrier between electrodes (or sets of electrodes) may be 5% or more of the minimum distance between electrodes (or sets of electrodes) ignoring the continuous suction barrier (e.g., 10%, 12%, 15%, 17%, 20%, 25%, 30%, etc.). The shortest distance between electrodes (or sets of electrodes) passing around the continuous suction barrier between electrodes may be called the collision distance.

[0127] Figures 14A–14C show another example of a treatment tip that may be configured with through- or non-through electrodes. In Figure 14A, the treatment tip 1400 includes mechanical and electrical attachments (for mounting a handpiece, not shown) and includes four rows of elongated electrodes 1405 extending into the electrode housing 1401. Each row in this embodiment comprises a set of electrodes. The individual electrodes in each set may be electrically coupled or individually addressable. In Figures 14A–14C, each set of electrodes is shown extending from a suction port 1415. Figure 14A shows four suction ports. The entire distal tip region of the electrode housing may form a suction chamber, and the outer circumference 1407 may form a seal, so that when suction is applied, tissue may be drawn into the suction chamber.

[0128] In any of the embodiments described herein, the electrodes may be tissue-penetrating electrodes. For example, in Figures 14A–14C, the electrodes may be tissue-penetrating needle electrodes. Suction ports 1415 are shown located around and below each row of needle electrodes. Each suction port may extend at least slightly longer than the row, surrounding all the electrodes in its respective row, to achieve the benefit discussed with reference to Figure 12. In this embodiment, the needle may be firmly fixed in place relative to its tip so that, when suction is applied, the needle is inserted into the tissue as the tissue is drawn into the vacuum cavity. Alternatively or in addition, in some embodiments, the needle may be extendable / retractable. In some embodiments, the needle may be individually biased and / or individually extendable or retractable.

[0129] In the therapeutic applicator of this embodiment shown in Figures 14A to 14C, each electrode of the electrode pair (or, in this embodiment, the set of electrodes) that is activated to deliver the treatment is surrounded by suction. This can reduce arc discharge between the electrode pair (or the pair of electrode sets). Alternatively, a continuous suction barrier may be applied between the pair of electrodes or the set of electrodes.

[0130] Any therapeutic applicator described herein may be configured to prevent or reduce arc discharge by including a region of continuous suction between a pair of active electrodes (or a pair of sets of electrodes electrically coupled to one another) that extends beyond the length of the electrodes between them. Thus, the continuous suction barrier region may increase the collision distance between the active electrodes or sets of electrodes. In the voltage range commonly used by the methods and apparatus described herein (e.g., about 0.1 kV / cm to about 500 kV / cm), the therapeutic applicators described herein may have a collision distance that is 10% or more (12%, 15%, 17%, 20%, 22%, 25%, 27%, 30%, etc.) longer than the minimum distance between electrodes or sets of electrodes (ignoring the continuous suction barrier), where the collision distance is the shortest distance between electrodes or sets of electrodes around the continuous suction barrier. In practice, the collision distance is the shortest path through which the voltage can flashover or arc discharge between electrodes or sets of electrodes. The operating voltage of the tip can vary the impact distance (for example, a higher operating voltage may result in a longer impact distance). In therapeutic tips such as those shown in Figures 2A-2C, 3A-3B, 4A-4B, 5A-5C, 6A-6C, and 7A-7C, the electrodes or sets of electrodes delivering the treatment may each be surrounded by suction, thereby reducing or eliminating arc discharge. Alternatively or in addition, continuous suction ports may separate the electrodes or sets of electrodes and extend beyond them to prevent or reduce arc discharge, in addition to firmly fixing the tissue while applying energy.

[0131] For example, Figures 15A–15D, 16A–16D, 17A–17D, 18A–18D, and 19A–19D all illustrate examples of treatment applicators (configured as treatment tips) in which a continuous suction port extends between the set of electrodes delivering treatment, instead of (or in addition to) surrounding the electrodes with suction. The continuous suction port may extend between the electrodes (or set of electrodes) delivering treatment, such that the continuous suction port extends further than the length of the electrode or set of electrodes.

[0132] Figures 15A–15C show another example of a treatment applicator configured as a removable / replaceable treatment tip 1500, which includes, for example, multiple tissue-penetrating electrodes 1505, 1505' on either side of the suction port 1515. In this embodiment, the suction port 1515 is centrally located within the electrode housing. A first set of electrodes 1505 to the left of the central suction port includes multiple individual needle electrodes, which are multiplexed together. A second set of electrodes 1505' to the right of the suction port is also multiplexed together. For example, the first set of electrodes may act as cathodes and the second set of electrodes may act as anodes. Figure 15A shows the treatment tip with the needle electrodes retracted into the electrode housing 1501, while Figure 15B shows electrodes 1505, 1505' extending distally from the electrode housing 1501 on either side of the suction port 1515. The suction port 1515 extends in a continuous line between the set of electrodes 1505 so as to extend beyond the end of the electrode or set of electrodes, with the electrodes forming the anode electrode (which may be coupled or multiplexed together as described above) continuously separated from the cathode electrode. The electrode housing is shown extending distally from the applicator housing 1503, and in some embodiments, the electrode housing may retract into the applicator housing, and a bias (e.g., a spring) may tend to keep the electrode housing extended, but the user may drive the electrodes into the tissue by driving the applicator housing distally when the tissue is held in place on the applicator housing by suction, allowing the electrodes to penetrate into the tissue to a predetermined depth. In this embodiment, the electrodes are in two separate sets, each located in a channel 1518. The electrodes are separated from the central suction port 1515 by side walls 1522 that can contact and seal with the tissue when suction is applied. Each electrode in the set of electrodes may be electrically coupled so that energy can be applied between the set of electrodes.

[0133] As described above, the examples shown in Figures 15A–15C include a single suction port 1515 (e.g., a vacuum port) between the sets of electrodes, which can help ensure that tissue does not come into contact with the electrode housing. This continuous suction port, extending further between the electrodes beyond the ends of the electrodes, can also help prevent arc discharge during use. Figure 15D shows the relative positions of the first set of electrodes, the second set of electrodes, and the suction port 1515. In this embodiment, the suction port 1515 forms a continuous suction barrier that increases the collision distance 1557 between the active electrodes or sets of electrodes so that it is 5–10% longer than the minimum distance 1555 between the sets of electrodes ignoring the continuous suction barrier. As described above, the collision distance 1557 is the shortest distance between the electrodes or sets of electrodes around the continuous suction port and is shown by a longer dashed line in Figure 15D. In these embodiments, the collision distance and the minimum distance excluding the suction port can be measured along the surface of the electrode housing 1501, as shown in Figure 15D.

[0134] Figures 16A–16C show an example of a treatment tip 1600 in which two suction ports 1615 each form a continuous suction port between two sets of electrodes 1605. Each set of electrodes is adjacent to an internal suction port (as indicated by 1622). Each of the two sets of electrodes is located within a channel 1618 in an electrode housing 1601, which extends toward an applicator housing 1603. In Figure 16A, the electrodes are shown retracted into the applicator housing, and in Figure 16B, the electrodes are shown extending from the applicator housing. As shown in Figures 15A–15C, the electrodes are sharp tissue-penetrating electrodes. In Figure 16C, a distal end view of the tip shows that the elongated suction ports 1615 each pull tissue between the sets of electrodes to prevent arc discharge and firmly secure the tissue in contact with the tip so that the electrodes can penetrate into the tissue. As shown in Figures 15A–15C, the suction ports are not connected to a channel (slot) from which the electrodes extend and retract. Each suction port forms a continuous suction port (barrier) between the electrode sets, through which the treatment is delivered, extending beyond the length of each electrode set.

[0135] Figure 16D shows the increase in collision distance 1657 between the first set of electrodes 1605 and the second set of electrodes 1605' due to the continuous suction barrier 1515, such that the collision distance 1657 is more than 5% (more than 15% in this embodiment) longer than the minimum distance 1655 between the sets of electrodes ignoring the continuous suction barrier. The collision distance 1657 is shown in Figure 16D as a longer dashed line, and the minimum distance 1655 excluding the suction port is shown as a shorter solid line; both can be measured along the surface of the electrode housing 1601, as shown in Figure 16D.

[0136] Any number of suction ports may be positioned adjacent to (or between) the set of electrodes. In some embodiments, suction ports may also be present on the opposite side of the set of electrodes and / or around the set of electrodes. For example, Figures 17A–17C show a treatment tip 1700 where two electrodes (or sets of electrodes) are bounded on two sides by suction ports 1715. In Figures 17A–17C, the electrodes are shown as non-penetrating plate electrodes 1705. The suction port 1715 includes a central suction port 1715' which is larger than the two lateral suction ports 1715'' and longer than the length of electrodes 1705, 1705'. The electrode housing 1701 extends from the applicator housing 1703.

[0137] Figure 17D shows that this modification also includes a continuous suction port 1715' between electrodes 1705, 1705' that extends beyond the length of the electrodes, thereby the collision distance 1757 between the first set of electrodes 1705 and the second set of electrodes 1705' is more than 10% longer in this embodiment than the minimum distance 1755 between sets of electrodes ignoring the continuous suction barrier, thereby eliminating or reducing arc discharge between electrodes, especially when operating at relatively high voltages (e.g., about 0.1kV / cm to about 500kV / cm, including about 1kV / cm to 500kV / cm, about 5kV / cm to 500kV / cm, about 10kV / cm to 500kV / cm, etc.).

[0138] Figures 18A–18D show another example of a therapeutic applicator (e.g., a therapeutic tip) including a pair of C-shaped suction ports partially extending around electrodes 1805, 1805'. In this embodiment, the therapeutic applicator 1800 includes an electrode housing 1801 extending from an applicator housing 1803, and includes two sets 1805, 1805' of tissue-penetrating (e.g., needle) electrodes that may extend from or retract into the electrode housing 1801. The first set of electrodes 1805 is partially surrounded by a C-shaped suction port 1815. The second set of electrodes 1805' is also partially surrounded by a C-shaped suction port 1815'. Both suction ports may be coupled to the same suction source or to separate suctions. The electrodes may move relative to the applicator housing, or the applicator housing may move relative to the electrodes, or both. Figure 18A shows a treatment applicator with the electrode retracted into the applicator housing. Figure 18B shows a treatment applicator with the electrode extending from the applicator housing. Figure 18C shows a front view of the treatment applicator. The electrodes shown in Figures 18A to 18D are tissue-penetrating (e.g., needle) electrodes, but this configuration can also be used with non-penetrating electrodes.

[0139] The treatment applicators shown in Figures 18A to 18D are configured to reduce arc discharge between the first set of electrodes 1805 and the second set of electrodes 1805' when operating at relatively high voltages (e.g., approximately 0.1kV / cm to approximately 500kV / cm, including approximately 1kV / cm to 500kV / cm, approximately 5kV / cm to 500kV / cm, approximately 10kV / cm to 500kV / cm, etc.). For example, as shown by the dashed line 1857 and the solid line 1855 in Figure 18D, the collision distance 1857 between the first set of electrodes 1805 and the second set of electrodes 1805' is more than 5% (more than 25% in this embodiment) longer than the minimum distance 1855 between sets of electrodes neglecting the continuous suction barrier. Each C-shaped suction port is continuous and extends beyond the length of the set of electrodes.

[0140] Figures 19A–19C show another example of a therapeutic applicator separated by a continuous suction port 1915 extending beyond the length of electrodes 1905, 1905'. In this embodiment, the suction port 1915 has an I-shape that partially extends around each of the electrode sets 1905, 1905'. The therapeutic applicator 1900 in Figures 19A–19D also includes an electrode housing 1901 extending from the applicator housing 1903, as in the examples shown in Figures 15A–15D, 16A–16D, 17A–17D, and 18A–18D.

[0141] The treatment applicator 1900 shown in Figures 19A to 19D is also configured to reduce arc discharge between the first set of electrodes 1905 and the second set of electrodes 1905' when operating at relatively high voltages (e.g., approximately 0.1kV / cm to approximately 500kV / cm, including approximately 1kV / cm to 500kV / cm, approximately 5kV / cm to 500kV / cm, approximately 10kV / cm to 500kV / cm, etc.). In Figure 19D, the collision distance 1957 (shown by the dashed line) between the first set of electrodes 1905 and the second set of electrodes 1905' is more than 10% (more than 25% in this embodiment) longer than the minimum distance 1955 between sets of electrodes neglecting the continuous suction barrier of the suction port 1915, as shown in Figure 19D.

[0142] The therapeutic applicators shown in Figures 3A-3B, 4A-4B, 5A-5C, 6A-6C, 7A-7C, 8, 9, 10A-10F, 11A-11C, 12A-12E, 13A-13B, 14A-14C, 15A-15D, 16A-16D, 17A-17D, 18A-18D, and 19A-19D all represent examples of therapeutic applicators configured as therapeutic tips. These therapeutic tips can be attached to the handpiece of a pulse generator or otherwise coupled to form a therapeutic applicator assembly. Alternatively, any of these therapeutic applicators may be configured to include an integrated handpiece / handle.

[0143] Superficial treatment applicator Further described herein are therapeutic applicators configured to be particularly useful as superficial therapeutic applicators, where the entire treatment takes place beneath the surface of the tissue, for example, beneath the epidermis in the case of skin treatment. While many of the embodiments disclosed below are shown to have penetrating electrodes, it should be understood that some of these embodiments can be realized using non-penetrating electrodes, for example, by adjusting the energy level. Therapeutic applicators with non-penetrating (e.g., surface) electrodes can deliver electrical energy, such as nanosecond pulses, to a depth below the surface, for example, 1 mm to 5 mm. Any of these therapeutic applicators may include a suction chamber that is held in contact with a tissue surface (e.g., skin surface) and adapted to draw tissue into the suction chamber, and once entered the chamber, one or more electrodes may then extend into or in contact with the tissue across the suction chamber. In some embodiments, the electrodes may be tissue-penetrating electrodes (e.g., needle electrodes) inserted substantially parallel to the tissue surface. The top of the suction chamber may be transparent so that tissue (e.g., skin) can be seen through it and may include one or more markings that can guide the user. In some embodiments, one or more markings may indicate the paths of one or more electrodes. Thus, the upper surface may be a viewing window. In some embodiments, the viewing window may include magnification to enlarge the view of the tissue. One or more markings may include crosshairs, targets, etc. Such a configuration improves proper positioning and targeting, both during the positioning of the treatment applicator and throughout the treatment, by making the target lesion or treatment area visible.

[0144] The electrode may extend entirely or partially across the suction chamber. In some embodiments, the electrode may extend only partially across the chamber, while in other embodiments, the electrode may extend entirely across the chamber.

[0145] For example, Figures 20, 21, 22A–22C, 23A–23C, 24A–24D, and 25A–25B illustrate an example of a therapeutic applicator comprising a suction chamber and one or more needle electrodes extending across the suction chamber and fitted to penetrate parallel to the open bottom surface of the suction chamber. Such therapeutic applicators with penetrating electrodes are particularly useful for various subcutaneous applications of tissues, including, but not limited to, subcutaneous treatment of the skin where it is desirable to avoid the epidermal layer of the skin.

[0146] Generally, a suction chamber can be adapted to receive tissue that is drawn into the chamber and can be retained by suction applied from the top or near the top of the chamber. The chamber can be sized to allow it to be substantially filled with tissue (e.g., skin) when suction is applied. The chamber can have a top surface that is flat or curved (in some modifications, it may include a window made of optically transparent material). The sides of the chamber can be angled or curved, being wider at the open bottom or base and narrower near the top. The chamber can be rounded (e.g., circular or elliptical). In some embodiments, the chamber is longer (diameter) than it is deep. The bottom of the chamber is open and can be positioned over tissue so that suction (negative pressure) applied to the chamber can draw the tissue into the suction chamber. The bottom that is open into the suction chamber may include a seal, such as a flexible and / or compressible material (e.g., silicone), that seals into the tissue when suction is applied, drawing the tissue into the chamber.

[0147] As described above, any of these devices, including those having a suction chamber as shown in Figures 20, 21, 22A-22C, 23A-23C, 24A-24D, and 25A-25B, may include a suction control unit that can enable suction to be turned on / off within the suction chamber. In any of these devices, suction (negative pressure) can be turned on but may be bypassed from the suction chamber by one or more suction valves that can be blocked by the user to turn suction on or off within the suction chamber. For example, by manually blocking (e.g., using a finger, thumb, palm, etc.), suction may be preferentially applied to the suction chamber. Releasing the blockage of the suction valve can redirect suction through the suction valve and release suction from the suction chamber. Alternatively, suction to the device may be turned off completely.

[0148] Figure 20 shows an example of a therapeutic applicator 2000, which includes a handpiece 2002 that can be detachably attached to a tip 2001 containing a suction chamber 2035. In some embodiments, the tip may be integrated with the handpiece, as shown in Figure 20. The handpiece may include one or more control units 2031 that can be used, for example, to trigger the application of vacuum and / or to extend or retract a needle electrode 2005 across the suction chamber 2035 and / or to apply electrical energy to the needle electrode. In Figure 20, the therapeutic applicator may also include a viewing window 2033 through which target tissue can be seen. As mentioned above, the window may be transparent.

[0149] Figure 21 shows another example of the treatment applicator 2100, which may be used for larger lesions or treatment areas. In this embodiment, the treatment applicator 2100 includes a handpiece 2105 and a tip 2101 having three or more needle electrodes. In Figure 21, the suction chamber 2135 includes a transparent upper surface configured as a viewing window 2133 and containing a guide (shown as a concentric target ring) that can assist the user in targeting the portion of tissue to be treated. The handpiece also includes one or more control units 2131, such as sliders that extend / retract the needle electrodes into / out of the suction chamber. Suction may be applied to draw at least a superficial portion of the tissue (e.g., skin) into the suction chamber. In some embodiments, the electrode tips are removable from the handpiece and can be replaced with other tips.

[0150] Figure 22A shows an example of a top view of the treatment tip including the suction chamber. In Figure 22A, the suction chamber includes an optically transparent upper surface (e.g., a viewing window 2233). In Figure 22A, the viewing window includes multiple concentric targeting rings 2241. The viewing window may include or be configured as a magnifying lens to help the user see and target very small, hard-to-see lesions. The treatment applicator may include a light source (e.g., an LED, a light pipe, etc.) to illuminate the tissue containing the target tissue. In some embodiments, the viewing window may include a filter. Figures 22B and 22C show cross-sectional views through the suction chamber portion of the tip. As shown in Figure 22B, the needle electrode 2205 is housed within the tip and can be fully retracted into the side of the suction chamber 2235. The bottom 2236 of the suction chamber is open, and the suction chamber includes a single continuous conical wall. The wall includes an opening into the applicator housing 2240 from which a needle electrode may extend or retract into it. The top surface is a transparent viewing window 2233. One or more suction ports 2215 may also open into the suction chamber through the wall or from the top surface (or from the area between the top surface and the wall). In Figure 22B, the needle electrode is shown fully retracted into the wall of the suction chamber. In Figure 22C, the needle electrode extends fully across the suction chamber, thereby extending parallel to the open end at the bottom of the suction chamber, and the tip of the needle electrode engages with the wall opposite the opening from which the needle extends into the receiving opening 2248. In this embodiment, the needle is configured such that the distal end region (tip region) 2250 is insulated, such as the more proximal end region 2251, so that energy is delivered only from the lateral uninsulated portion. In some embodiments, multiple regions along the length of the needle are insulated and exposed to allow targeting of different regions.

[0151] Any of the suction chambers disclosed herein may be configured such that the depth of the suction chamber can be adjusted, thereby allowing adjustment of the depth of treatment. The greater the distance between the lens and the electrode, the deeper the treatment is performed below the surface of the tissue (e.g., below the epidermal layer of the skin). For example, distance adjustment may be provided by an expandable region 2260 which may be included between the top surface and the opening through which the needle electrode retracts or extends. In Figures 22A–22C, the expandable region may be a threaded region through which a screw can be tightened (to shorten the chamber) or loosened (to expand the chamber). In some embodiments, the suction chamber may have a fixed depth.

[0152] Figures 23A–23C show an example of a treatment tip with three needle electrodes. In this embodiment, the top surface is a transparent viewing window through which tissue can be seen. If no tissue is in the suction chamber, the three needle electrodes can be seen as partially extended in Figure 23A and fully extended in Figure 23B. As described above, the needle electrode 2305 may be insulated at the distal tip 2350 and the more proximal region 2351, leaving a non-insulated region 2352 to which energy can be applied. Energy may be applied between two or more of the needle electrodes (in a two-pole or three-pole configuration), or (in a single-pole configuration) a grounding pad or other return electrode may be used. Electrical insulation may be any suitable electrical insulating material, such as polyimide or an equivalent. This insulating pattern may restrict the treatment area to the center of the targeting position shown through the transparent viewing window.

[0153] In Figure 23A, the control unit 2331 on the handpiece can be driven distally (as shown in Figure 23B) to extend the needle electrode across the suction chamber. The same control unit or a second control unit may be used to trigger the application of energy (e.g., nanosecond pulse energy) to treat the tissue. These devices can be used to treat multiple sizes and shapes of lesions. The dimensions of the suction chamber and the number of needle electrodes may be larger or smaller; for example, the diameter of the suction chamber may be, for example, 4 mm to 60 mm (e.g., 5 mm to 30 mm, 5 mm to 25 mm, etc.). The depth may be, for example, 0.5 mm to 10 mm (e.g., 1 mm to 5 mm, 1 mm to 4 mm, 1 mm to 3 mm, etc.). As mentioned above, in some embodiments, the depth may be adjustable. Figure 23C shows a bottom view of the suction chamber of the device in Figure 23B, including the tissue in the suction chamber and the fully extended needle electrode.

[0154] In some variations, the needle electrode may extend only partially across the suction chamber, and the distal end of the needle electrode may be configured to apply electrical energy (for example, it may be an active region).

[0155] Figures 24A–24D illustrate the operation of an example of a treatment tip configured to treat superficial tissue using a suction chamber and needle electrode that move parallel to the open bottom surface. In Figure 24A, a cross-section through the suction chamber shows the device applied to tissue (such as skin tissue) 2445 before any suction is applied. The open bottom side of the suction chamber may contact the tissue (skin) to form a seal. In Figure 24B, negative pressure (e.g., vacuum or suction) 2463 is applied from one or more vacuum ports of the suction chamber to draw the tissue into the suction port 2415. The open bottom surface may include a peripheral sealing material (e.g., silicone) that contacts and seals the tissue. The needle electrode 2405 is fully retracted to the side of the suction chamber, as shown in Figures 24A–24B. In Figure 24C, as the tissue is drawn into the suction chamber, the needle electrode may be driven into the tissue so as to extend below the surface of the tissue, parallel to the bottom opening of the suction chamber and thus substantially parallel within the superficial region of the tissue. Figure 24D shows the needle electrode fully extended, exposing the central active region 2452. Energy may then be applied from the uninsulated intermediate region of the needle electrode. In some embodiments, treatment may be performed between the active regions. To increase the treatment area, the number of active regions (e.g., the number of needles having active regions) may be increased. In some embodiments, to increase the treatment area, the number of needles and / or active regions may be increased. A portion or region of the needle may be insulated to form an inactive region 2462, such as the proximal and distal regions of the active region, as shown in Figure 24D.

[0156] Figure 24E shows another example of a treatment tip configured to treat superficial tissue using a suction chamber that provides a surface electrode (rather than a needle electrode) which can be used, for example, to pinch tissue. In the example of Figure 24E, a static surface electrode 2494 (e.g., a wire electrode) is loaded in the distal region of the treatment tip, and a dynamic surface electrode 2495 (e.g., a wire electrode) is loaded on a slide shaft 2492 coupled to a slide button 2491. The control unit can draw in a vacuum either manually or using an extraction valve as described above. In some embodiments, the control unit (e.g., an opening that can be covered by the user's finger) may be on the slide button 2491. Once tissue is drawn into the tip, for example by applying a vacuum, the user may slide the slide button 2491 forward. The slide button and / or slide shaft may be biased toward the rear of the assembly by one or more biases (e.g., compression springs). As the user slides the slide button 2491 forward, the vacuum draws the tissue into the tip, allowing the tissue to be grasped between the static surface electrode 2494 and the dynamic surface electrode 2495, which can be observed through the transparent viewing window 2493. Such a therapeutic applicator with surface electrodes is particularly useful for various surface applications of tissue, including, but not limited to, surface skin treatment. The static and dynamic surface electrodes may be of the type of wire, bar, spring, etc., and any appropriate number of surface electrodes, e.g., two, three, four, etc., may be used.

[0157] In some embodiments, the return electrode may be part of the suction chamber, such as a portion of the top surface. For example, Figures 25A–25B show an example configuration in which the suction chamber includes a plate (one electrode) 2566 that will come into contact with tissue such as skin at the top surface of the suction chamber. A needle electrode 2505 may be inserted into the tissue held within the suction chamber and may be positioned below the top of the tissue or skin. The needle electrode may be positioned opposite this upper electrode (e.g., a plate electrode or mesh electrode) 2566, which may act as a return electrode when extended across or partially across the suction chamber. In the exemplary therapeutic applicator 2500 shown in Figure 25B, the top surface of the suction chamber may include a viewing window as described above, or may be replaced by a solid plate electrode. In this embodiment, energy may be conducted between the needle just below the surface of the tissue and the plate electrode on the skin surface above the top of the suction chamber. The treatment tip may be positioned on the tissue, and the vacuum may pull the tissue or skin flushing co-facing with the top of the suction chamber, including the return electrode (e.g., plate or mesh), and then, as shown in Figures 24A to 24D, the needle electrode may be inserted through the tissue.

[0158] In Figure 25B, vacuum can be applied from above the plate electrode through a suction port 2515 coupled to a suction channel. The open suction chamber 2536 can lift the tissue and bring it into contact with the return electrode. Various examples of therapeutic applicators having vacuum-assisted lateral deployment electrodes disclosed herein not only provide the benefits and advantages of improved targeting, but also reduce the pressure required to perform the treatment and the number of electrodes (e.g., needles) required to perform the treatment, thereby minimizing any tissue trauma or pain that may be associated with the insertion of needle electrodes.

[0159] Further described herein are therapeutic applicators that can be particularly well adapted for the treatment of skin tissue by isolating the area of ​​skin to be treated within the therapeutic applicator before applying pulsed electrotherapy. Some of the devices described herein may use suction to draw the area of ​​tissue to be treated into the chamber and isolate it for treatment. The treatment may be applied to a portion of tissue (e.g., skin) drawn into the chamber by a penetrating electrode or a non-penetrating electrode. The chamber contains at least 0.2 cubic cm (e.g., 0.3 cm) of tissue. 3 More than 0.4cm 3 More than 0.5cm 3 Above, 0.6cm 3 More than 0.7cm 3 Above, 0.8cm 3 Above, 0.9cm 3 More than 1cm 3 The device may be configured to hold (the above, etc.). The tissue may be drawn into the chamber of the treatment applicator and pulled away from other tissues, sensitive areas near the eyes, mucous membranes, etc., on the surface of the tissue. These devices may include visualization, such as one or more windows, into the chamber of the treatment applicator.

[0160] Any of the apparatus and methods described herein may be used to treat symptoms, lesions, or diseases such as syringoma, seborrheic keratosis, keloids, molluscum contagiosum, sebaceous hyperplasia, congenital capillary malformations (port-wine stains), melasma, actinic keratosis, melanopapular dermatosis, angiofibroma, skin tumors, basal cell carcinoma (BCC), and warts. In some embodiments, apparatus and methods configured to draw the tissue to be treated into the chamber of a treatment applicator by suction, thereby isolating it from potentially sensitive nearby tissue areas before applying the treatment, may be particularly beneficial for treating these symptoms (including, but not limited to, syringoma).

[0161] For example, described herein are therapeutic application designs and corresponding methods for improving safety by isolating the tissue to be treated by pulsed electrotherapy from nearby non-treatment areas within the treatment applicator by suction. For example, facial areas, particularly those around the eyes or intraorbital areas, and / or areas near mucous membranes, can be beneficially isolated using these methods and apparatus. In some of the treatment tips described herein, the suction chamber may be oriented such that its optical axis extends through the treatment tip in the same direction as the electrode advances relative to the tissue. For example, Figures 26A–26D show an example of a treatment applicator that includes a chamber that allows the tissue to be treated to be drawn in and visualized through the treatment applicator. In the apparatus shown in Figures 26A–26D, the treatment tip includes a deployable electrode that may be configured as a tissue-penetrating electrode (e.g., a needle or microneedle electrode) or a non-penetrating electrode (e.g., a plate electrode, wire electrode, loop electrode, etc.).

[0162] In this embodiment, the user can position the distal end (treatment tip) of the treatment applicator over the treatment area and activate suction within the suction chamber at the tip. Suction may be applied by a suction pump to which the treatment applicator is connected, or, in some embodiments, by a vacuum or suction chamber within the treatment applicator, and negative pressure may be generated within the treatment applicator itself (e.g., by moving a plunger or other mechanism) to draw tissue into the suction chamber at the treatment tip. Tissue may be drawn into the treatment tip as long as the elasticity of the tissue to be treated allows. In some embodiments, the midline of the treatment applicator may form a visual channel through which tissue can be seen. For example, the electrode housing may include a central passage between the electrodes through which tissue can be seen. Alternatively, the electrodes may move in / out of the line of sight through the treatment applicator. In some cases, the suction path through the electrode housing may also allow imaging through the electrode housing. Any of the devices described herein may also include a light source for illuminating the tissue and / or a magnifying optical system for viewing the tissue.

[0163] During operation, the user may view the tissue through the treatment applicator and apply suction to draw the tissue into the suction chamber during, after, or before applying suction. The treatment applicator may include an internal suction source or be coupled to an external suction source. The user may then advance the retractable tip (within the body of the applicator housing) distally so that the electrode is in contact with the tissue. When a tissue-penetrating electrode is used, the needle may be inserted distally into the tissue rather than parallel, as shown in the embodiments described above.

[0164] For example, in Figure 26A, the therapeutic applicator 2600 includes a main body portion 2601 (configured as the applicator housing 2601 in Figures 26A to 26D) that forms a tip region 2603. The applicator housing forms an internal chamber (suction chamber) within the open distal end of the applicator housing into which tissue is drawn in by applying suction. The electrode housing 2613, located inside the applicator housing in Figure 26A, includes two or more (e.g., two sets) electrodes 2605 that can extend distally to the electrode housing. In Figure 26A, the therapeutic applicator includes a bias (compression spring or simple spring 2609) that is releasably locked in the unextended state. The bias holds the retractable tip together with the proximal electrode (e.g., needle electrode) until the control unit 2607 releases the electrode housing and drives the electrode distally.

[0165] Figure 26B shows the operation of the apparatus 2600 of Figure 26A in drawing tissue 2611 into the suction chamber. For example, a vacuum pump may draw tissue 2611 into the treatment tip, as shown. The user may then advance the electrode distally from the electrode housing and engage it with the tissue held in the suction chamber, as shown in Figure 26C. In some cases, the user may drive the electrode distally by operating a control unit (e.g., a release control unit, an electrode advance control unit, etc.) 2607. In some embodiments, the control unit may allow the user to manually advance the electrode distally (at a controlled speed) until the end of the electrode housing is firmly in contact with the tissue in the suction chamber (for non-penetrating electrodes) or until it is inserted (for penetrating electrodes). For example, the user may slide a control unit (e.g., a button, knob, slider, etc.) distally to drive a penetrating electrode into the tissue or to ensure that a non-penetrating electrode is firmly in contact with the tissue. Once the electrode is in or over the tissue in the suction chamber, treatment may be applied. For example, treatment may be applied from one or more electrodes using a finger switch or foot pedal. This configuration may allow treatment of the target tissue from as far away as possible for the safety of both the user and the patient. As mentioned above, this may be particularly useful when the target treatment tissue is on the face, such as around the eyes or inside the orbit. The treatment applicator may be easy to use and may include visual guidance.

[0166] For example, Figure 26D shows a magnified view of the distal end of the treatment applicator in Figures 26A-26C, showing the applicator housing 2601 into which the tissue 2611 is drawn. The interior of the applicator housing forms a suction chamber that holds the tissue. In Figure 26D, the electrode 2605 is a needle electrode that protrudes from the electrode housing 2613 within the applicator housing. For example, during use, the treatment applicator can retract into the suction chamber by approximately 2 mm (e.g., 3 mm, 4 mm, 5 mm, etc.). In Figure 26D, the retractable / extendable electrode housing is advanced distally until it makes firm contact with the target tissue distally. In this embodiment, the tissue-penetrating electrode protrudes approximately 1 mm from the electrode housing, so the device can insert the electrode to this length (e.g., 1 mm).

[0167] Figures 27A and 27B show examples of exploded assembly diagrams of a device similar to those shown in Figures 26A–26D. In Figure 27A, the treatment applicator (treatment tip 2700) includes, in this example, two tissue-penetrating electrodes 2703. In contrast, Figure 27B shows a similar treatment device having two non-penetrating electrodes 2703'. Both variations include an elongated treatment applicator 2700, which includes a main body 2701. The interior of the distal end of the main body 2701 (also referred to herein as the applicator housing) may form a suction chamber, as shown in Figures 26A–26C. The electrode housing 2704 is held within the main body, partly by a biasing force (e.g., a compression spring) 2702. The electrode housing 2704 holds the electrodes 2703 (Figure 27A) or 2703' (Figure 27B) and internal electrical connections via the electrode holder 2705. In some embodiments, the electrode housing may be fitted or configured to allow the user to look down into the treatment applicator and out of the distal end so that the target tissue can be identified, as described above. The rear of the device may include a cap or cover 2706.

[0168] Figures 28A–28D show another example of a therapeutic applicator, including a suction chamber within the applicator housing and electrodes biased distally. As with Figures 26A–26D, the examples shown in Figures 28A–28D also include multiple electrodes (either tissue-penetrating or non-penetrating).

[0169] Figure 28A shows the distal end of the treatment applicator 2800, including the applicator housing 2803. The interior of the applicator housing at the distal end may form a suction chamber 2811. The internal electrode housing 2801 may be axially biased by a biasing force (e.g., a compression spring 2807). The electrode housing 2801 may be driven all the way to the opening 2813 of the applicator housing, or just proximal thereto, and generally, the space around the electrode housing within the opening allows suction to draw tissue into the suction chamber and drive the electrode housing proximal against the biasing force (compression spring). This may drive the electrode 2805 distally on the electrode housing in contact with the tissue.

[0170] As shown in Figures 28A and 28B, there is an optical channel 2815 that passes through the treatment applicator, extending from the proximal end to the distal end opening 2813, passing through the electrode housing and through the applicator housing. Figure 28B shows the treatment applicator with tissue drawn into a suction chamber 2811 formed within the end of the applicator housing. As suction draws the tissue into the suction chamber, the biasing force 2807 compresses proximal to drive the electrode on the electrode housing into the tissue, while also driving the electrode housing proximal. Figure 28C shows a magnified view of region C from Figure 28B. In Figure 28C, the suction chamber portion 2811 that holds the tissue is driven in opposition to the proximal displacement of the non-penetrating (loop) electrode 2805 on the electrode housing 2801. In this embodiment, tissue can be drawn into the suction chamber to a length of approximately 2 mm or more (for example, 3 mm or more, 4 mm or more, 4.5 mm or more, 5 mm or more, etc.).

[0171] Figure 28D shows an example of a window 2831 that includes a magnifying optical system for positioning on tissue through the treatment applicator. The user can position the treatment area by aligning the distal end of the treatment tip and, optimally, by viewing the treatment area through the illuminated window. The window may include a magnifying lens at the proximal end of the treatment applicator.

[0172] During use, the user can position the distal end of the treatment tip of the treatment applicator in a fixed position on the tissue by viewing the treatment area through the proximal end of the device. In this embodiment, the proximal end includes a viewing window and an LED that illuminates the magnifying optical system to assist in targeting. Once the distal end of the treatment tip is positioned on the tissue, the user can apply suction to the suction chamber within the applicator housing. In some embodiments, the user can operate a vacuum pump, or the user can move a control unit on the handpiece portion of the treatment applicator to generate suction within the treatment tip. The tissue is then drawn into the applicator housing (e.g., the suction chamber portion) as far as the elasticity of the tissue allows. As the tissue is drawn in, a compression spring compresses to maintain constant pressure on the distal end of the electrode housing and on the tissue drawn into the applicator housing (e.g., the suction chamber). This can seal the tissue within the suction housing, in contact with the electrode on the electrode housing. If the electrode is a tissue-penetrating electrode, it can be driven completely into the tissue. If the electrode is a non-penetrating electrode, it can be fixed in contact with the tissue. Once the tissue is completely inside the suction chamber, treatment can be applied. For example, a foot pedal or manual control unit (e.g., a finger switch) may be used to activate the application of pulsed electromagnetic energy (e.g., sub-microsecond pulsed, nanosecond pulsed, etc.).

[0173] Figures 29A and 29B show exploded assembly diagrams of a treatment applicator similar to those shown in Figures 28A to 28D. Figure 29A shows an exploded assembly diagram of a device including a tissue-penetrating electrode 2902, and Figure 29B shows an exploded assembly diagram of a device having a non-penetrating electrode 2902'. Both exploded assembly diagrams include an outer applicator housing 2901, an inner electrode housing 2903, a biasing element (e.g., a compression spring 2904), a proximal cover 2905, and a magnifying window 2906.

[0174] In any of the embodiments described herein, one or more electrodes may be located inside or near the suction chamber, and a second electrode (or set of electrodes) may be located on the inner electrode housing. For example, Figure 30 shows another example of a therapeutic applicator that includes an inner suction chamber in which one or more electrodes can be applied in contact with tissue drawn into the suction chamber. In Figure 30, the applicator housing 3001 is a tubular enclosure whose outer edge includes electrodes 3005. One or more central electrodes (indicated in this embodiment as non-penetrating cylindrical electrodes) 3005' may be positioned at different relative positions within the applicator housing 3001, allowing suction to be applied around the inner electrodes. Tissue can be drawn into the applicator housing by applying suction through the space between the distal end opening of the applicator housing 3009 and the cylindrical central electrodes 3005'. As the tissue is drawn into the suction chamber at the distal end of the treatment applicator, the tissue seals the space between the outer electrode 3005 and the inner cylindrical electrode 3005'.

[0175] Figures 31A–31D show another example in which the treatment applicator is configured to allow viewing through the tissue to be treated and to allow positioning of the electrodes. Figure 31A shows a treatment applicator including an outer applicator housing 3101 and a window 3106 that passes through the applicator housing and exits through a distal opening into the applicator housing. This example also includes a light source and light pipe 3129 for illuminating the tissue to be treated. One or more electrodes 3105 may be positioned within the applicator housing. In this embodiment, the electrodes 3105 are configured as non-penetrating, for example, cylindrical electrodes. A second electrode or set of electrodes 3105' may be positioned around the periphery of the distal end opening into the applicator housing, as shown in Figure 31C. The second electrode or set of electrodes 3105' may be attached to an electrode housing or other structure of the device within the device that allows the second electrode or set of electrodes 3105' to be moved. For example, as shown in Figures 31B to 31D, the control unit 3130 (shown in this embodiment as a button or slider) can slide distally to advance the electrodes more centrally into the inner chamber of the applicator housing (e.g., the vacuum chamber 3111). Thus, one electrode or set of electrodes can be moved relative to the distal end opening, including entering / exiting the field of view.

[0176] Figures 31C and 31D show cross-sectional views through the respective apparatuses in Figures 31A and 31B. In Figure 31C, the electrode 3105 is centrally positioned in the field of view and, when suction is applied, may come into contact with the tissue drawn into the suction chamber. A second electrode or set of electrodes 3105'' is positioned around the distal opening 3113' into the applicator housing 3101. In Figure 31D, the control unit 3130 has moved proximal, moving the electrode 3105 out of the field of view through the window 3106, as shown in Figure 31B. As mentioned, the apparatus may include a light source (e.g., an LED, light pipe, etc.) 3129.

[0177] In the examples shown in Figures 31A to 31D, the control unit 3130 is attached to the cylindrical electrode and allows the user to control the electrode's position relative to the tissue. For example, the electrode may be moved out of the direction of the viewing window so as not to obstruct the view. In some embodiments, the control unit may also, or instead, move the electrode closer to or into contact with the tissue. Once targeting is complete, the control unit may allow the electrode to be moved distally and locked into the treatment position. In some embodiments, the viewing window is made of plastic or glass and may be a lens (e.g., it may be magnifying). Once positioned, negative pressure (e.g., vacuum) may be applied. Suction may be applied after the electrode has been moved into its fixed position.

[0178] Figure 31E shows another example of a treatment applicator similar to those shown in Figures 31A to 31D. In this embodiment, the control unit (button 3130') may instead function as a control unit for an internal negative pressure source, such as a plunger. The viewing window may be used for targeting, and the second control unit may be used to move and / or position the central electrode 3105, or to maintain it in a fixed position.

[0179] Figures 32A–32F show another example of a therapeutic applicator. In this embodiment, multiple electrodes are positionable within an applicator housing, which also includes a suction chamber at the distal opening. A window in the device's applicator housing 3201 allows the user to view the tissue and electrodes 3205 before applying suction and / or pulsed electrotherapy. Figure 32A shows a portion of the therapeutic applicator showing the distal end opening 3216. Two electrodes are coupled to an electrode housing 3241 which includes a gap (space) that allows airflow (airway 3235). Figure 32B shows the control unit 3230, the applicator housing body 3201, the viewing window 3211, and the light pipe 3229. Figure 32C shows a side view through the therapeutic applicator showing the control unit 3230 controlling the electrode housing 3222 to adjust the position of the electrodes above the distal end opening of the applicator housing 3201. The two or more non-penetrating electrodes shown may be configured as cylindrical electrodes, and the electrode holder (electrode housing 3222) may be surrounded by one or more means to provide a seal. As shown in Figure 32A, three or more openings for air (suction) are provided around the electrodes when they are deployed.

[0180] Figure 32D shows a side view of the device of Figure 32C with the electrode moved proximal to the outside of the viewing window, and Figure 32E shows a front view of the viewing window 3211 with the electrode moved proximal to the outside of the viewing window. Figure 32F shows an alternative embodiment in which the control unit 3230 can control an internal suction source (e.g., a plunger), and the electrode may be in a fixed position or may be controlled by a separate control unit.

[0181] As described above, the treatment applicators shown in Figures 26A–26D, 27A–27B, 28A–28D, 29A–29B, 30, 31A–31E, and 32A–32F all include features including a suction chamber, a tissue-penetrating or non-penetrating electrode, and visualization, which may be particularly well suited to treating skin conditions such as syringomas, benign tumors of sweat glands, which commonly occur around the eyes, neck, or other sensitive areas. In general, the use of tissue-penetrating and / or non-penetrating electrodes, vacuum chambers, and visualization windows, as described herein, may be particularly beneficial for protecting such potentially sensitive areas, including around the eyes. The treatment applicators described herein, by using a visualization window, may improve targeting and proper placement even for very small (e.g., 1–3 mm) syringoma growths, while the use of a vacuum chamber may reduce or eliminate the impact on nearby sensitive skin (including protection from arc discharge). This can, for example, beneficially avoid damage to the area around the eyes.

[0182] In one example, a tissue area containing a syringoma may be treated by applying a treatment applicator (e.g., any of the treatment applicators shown in Figures 26A-26D, 27A-27B, 28A-28D, 29A-29B, 30, 31A-31E, and 32A-32F) in contact with the skin so that the lesion (e.g., the syringoma) is visible within the viewing area (e.g., window) of the treatment applicator. The window into the treatment applicator may allow viewing into a suction chamber. The suction chamber may be positioned above the lesion. In some embodiments, the suction chamber and treatment applicator may be used adjacent to the patient's eyes. Suction may then be applied to draw the tissue containing the lesion into the suction chamber. The position of the lesion within the chamber can be visually confirmed through the window. Tissue can be drawn into the suction chamber as if being pulled out of the plane of adjacent tissue, by an amount of 1 mm or more (e.g., 1.5 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 1 cm, etc.). The tissue can be held in the suction chamber by suction while pulsed electrical energy is applied, as described herein. For example, the pulsed energy may be sub-microsecond pulsed energy, including relatively high voltage pulsed energy such as about 100 volts per centimeter (e.g., 0.1 kV / cm) to about 500 kV / cm (e.g., about 0.5 kV / cm to about 500 kV / cm, about 1 kV / cm to about 500 kV / cm, about 0.1 kV / cm, about 0.5 kV / cm, about 1 kV / cm, etc.). One or more treatments (e.g., pulse trains) may be applied. After application, the tissue can be released from the suction chamber. In some embodiments, suction may be turned off to release the tissue. In some modifications, positive pressure may be applied to release the suction and thus the tissue from the suction chamber. Optionally, the same treatment applicator may then be moved to another lesion to be treated.

[0183] For example, the apparatus described herein may be used to treat tissue, wherein the deployment of electrodes at the tip and / or the application of suction can be controlled manually and / or automatically. In some embodiments, the apparatus described herein may include a foot switch to activate (turn on / off) the vacuum, but even when the vacuum is "on," suction from the tip, for example into the suction chamber, may be bypassed from the suction chamber and / or tip by an extraction valve, and the user can apply suction at the suction chamber and / or tip by closing the extraction valve. For convenience, the extraction valve may be located on the handle of the apparatus.

[0184] Similarly, any of these devices described herein may automatically or semi-automatically deploy and / or retract electrodes using one or more of a biaser, a solenoid, or any other suitable actuator. For example, an electrode may be coupled to a moving shaft of a solenoid, which may be controlled, for example by the user, so that when a trigger is activated, the electrode can be deployed through or into the tissue.

[0185] For example, the user may initiate vacuum by triggering a foot switch, and the user may position and reposition the treatment tip using a suction control unit including an extraction valve. Once the tip is positioned, the extraction valve may be covered (e.g., blocked) and suction may be applied, and in some embodiments, suction may draw tissue into the suction chamber for treatment. For example, once tissue is drawn into the suction chamber, the user may trigger the deployment of one or more electrodes by applying voltage to a solenoid to drive the electrodes into or into the tissue. Once treatment is complete, the solenoid may be de-energized, and the microneedle may be retracted, for example, manually or by triggering the solenoid or releasing its bias (e.g., a spring). The user may then open the extraction valve (e.g., remove the cover over the extraction valve opening) to release suction from the suction chamber or tip, allowing the user to remove or move the tip.

[0186] Alternatively, in some embodiments, the user may turn on suction to draw tissue into the suction chamber and / or tip, and the user may then manually deploy one or more spring electrodes, such as but not limited to needle electrodes. Once treatment is complete, the user may reset the electrodes to their original or storage configuration and terminate the vacuum (for example, by activating a foot switch).

[0187] Any of these methods, including those described above, may be used to treat various cosmetic ailments, as well as seborrheic keratosis, keloids, molluscum contagiosum, sebaceous hyperplasia, congenital capillary malformations (port-wine stains), melasma, actinic keratosis, melanopapular dermatosis, angiofibroma, skin tumors, basal cell carcinoma (BCC), and warts, in place of or in addition to syringomas.

[0188] When a feature or element is referred to herein as being "on top of" another feature or element, there may also be features and / or elements that are directly on top of or interposing to that other feature or element. In contrast, when a feature or element is referred to as being "directly on top of" another feature or element, there are no interposing features or elements. Also, when a feature or element is referred to as being "connected," "attached," or "combined" to another feature or element, it will be understood that there may be features or elements that are directly connected to, attached to, or combined with that other feature or element, or that are interposing to it. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly combined" to another feature or element, there are no interposing features or elements. Features and elements described or illustrated in reference to one embodiment may be applicable to other embodiments. Furthermore, it will be recognized by those skilled in the art that references to structures or features positioned "adjacent" to another feature may have portions that overlap or lie beneath the adjacent feature.

[0189] The technical terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the invention. For example, as used herein, the singular forms "a," "an," and "the" also include the plural form unless otherwise specified by the context. Furthermore, as used herein, the terms "equipped with" and / or "equipped with" specify the presence of the presented features, steps, actions, elements, and / or components, but it will be understood that this does not exclude the presence or addition of one or more other features, steps, actions, elements, components, and / or groups thereof. As used herein, the terms "and / or" include any combination of one or more of the items listed in relation and may be abbreviated as " / ".

[0190] Spatial relative terms such as “below,” “downward,” “below,” “up,” and “upper” may be used herein to simplify descriptions of the relationship between one element or feature and another, as shown in the drawings. It will be understood that spatial relative terms encompass different orientations of the device during use or operation, in addition to the orientation shown in the drawings. For example, if the device in the drawing is inverted, an element described as being “below” or “below” another element or feature will now be oriented “above” the other element or feature. Thus, the exemplary term “below” can encompass both up and down orientations. The device may be oriented in a different way (rotated by 90 degrees or in other orientations), and the spatial relative descriptors used herein will be interpreted accordingly. Similarly, terms such as “upward,” “downward,” “vertical,” and “horizontal” are used herein for descriptive purposes only, unless otherwise specifically indicated.

[0191] The terms “first” and “second” may be used herein to describe various features / elements (including steps), but these features / elements should not be limited by these terms unless otherwise indicated by the context. These terms may be used to distinguish one feature / element from another. Thus, without departing from the teachings of this disclosure, the first feature / element discussed below may be referred to as the second feature / element, and similarly, the second feature / element discussed below may be referred to as the first feature / element.

[0192] When used herein and in the claims, including in the examples, and unless otherwise specifically indicated, all numbers may be read as being preceded by the words “about” or “approximately,” even if the term is not expressly stated. The words “about” or “approximately” may be used when describing the magnitude and / or location to indicate that the value and / or location described is within a reasonable expected range of the value and / or location. For example, a number may have values ​​of ±0.1% of the presented value (or range of values), ±1% of the presented value (or range of values), ±2% of the presented value (or range of values), ±5% of the presented value (or range of values), ±10% of the presented value (or range of values), and so on. Any number given herein should also be understood to include its value approximately or approximate unless otherwise indicated by the context. For example, if the value “10” is disclosed, “about 10” is also disclosed. Any number listed herein shall include all subranges incorporated therein. Furthermore, when a value is disclosed, it is understood that, in a manner appropriate to those skilled in the art, the possible ranges between that value, such as "less than or equal to," "greater than or equal to," and between that value are also disclosed. For example, if the value "X" is disclosed, then "less than or equal to X" and "greater than or equal to X" (for example, X is a number) are also disclosed. Also, throughout this application, it is understood that data is provided in numerous different formats, and this data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that the range between 10 and 15, as well as greater than and greater than, less than, less than or equal to, and equal to 10 and 15, are disclosed. It is also understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0193] While various exemplary embodiments have been described above, any of the numerous modifications can be made to various embodiments without departing from the scope of this disclosure. For example, the order in which various described method steps are performed can often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps can be skipped together. Any features of various device and system embodiments may be included in some embodiments and not in others. Furthermore, various features described in some embodiments may be included in other embodiments and combined with other features of various embodiments. Therefore, the foregoing descriptions are provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention to what is described in the claims.

[0194] Various embodiments of the subject matter of the present invention may be referred to individually or collectively by the term "invention" for convenience only, when two or more inventions or inventive concepts are actually disclosed herein, without intending to arbitrarily limit the scope of this application to any single invention or inventive concept. Accordingly, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same objective may be substituted for the specific embodiment illustrated. This disclosure shall cover all adaptations or variations of the various embodiments. Combinations of the embodiments described herein and other embodiments not specifically described herein will be obvious to those skilled in the art by reviewing the above description.

Claims

1. A device for delivering electrotherapy, An electrode housing extending from the distal end of the device, A first electrode or set of electrodes extending from or configured to extend from the electrode housing and arranged over a first length of the electrode housing, A second electrode or set of electrodes extending from or configured to extend from the electrode housing and positioned over a second length of the electrode housing parallel to the first length, A device comprising: a suction port that penetrates the electrode housing and extends continuously between the first electrode or set of electrodes and the second electrode or set of electrodes, the suction port extending further across the electrode housing than the first and second lengths to prevent arc discharge between the first electrode or set of electrodes and the second electrode or set of electrodes.

2. The device according to claim 1, wherein the collision distance, including the minimum path length between the first electrode or set of electrodes and the second electrode or set of electrodes around the suction port, is 5% or more longer than the minimum distance between the first electrode or set of electrodes and the second electrode or set of electrodes extending across the suction port.

3. A device for delivering electrotherapy, An electrode housing extending from the distal end of the device, A first electrode or set of electrodes extending from or configured to extend from the electrode housing, A second electrode or set of electrodes extending from or configured to extend from the electrode housing, A device comprising: an suction port that penetrates the electrode housing and extends continuously between the first electrode or set of electrodes and the second electrode or set of electrodes, wherein the collision distance between the first electrode or set of electrodes and the second electrode or set of electrodes, including the minimum path length around the first suction port, is 10% or more longer than the minimum distance extending across the suction port between the first electrode or set of electrodes and the second electrode or set of electrodes, so as to prevent arc discharge between the first electrode or set of electrodes and the second electrode or set of electrodes.

4. The device according to any one of claims 1 to 3, wherein the suction port at least partially surrounds the first electrode or set of electrodes.

5. The device according to any one of claims 1 to 4, further comprising a second suction port that penetrates the electrode housing and extends continuously between the first electrode or set of electrodes and the second electrode or set of electrodes.

6. The device according to any one of claims 1 to 5, further comprising: a first external suction port disposed on the side of the first electrode or set of electrodes opposite the suction port; and a second external suction port disposed on the side of the second electrode or set of electrodes opposite the suction port.

7. The device according to any one of claims 1 to 6, wherein the suction port has a C-shaped opening that penetrates the electrode housing.

8. The device according to any one of claims 1 to 7, wherein the suction port has an I-shaped opening that penetrates the electrode housing.

9. The device according to any one of claims 1 to 8, wherein the electrode housing is configured to extend and retract relative to the distal end of the applicator housing.

10. The device according to any one of claims 1 to 9, wherein the first electrode or set of electrodes and the second electrode or set of electrodes each comprise a non-penetrating electrode.

11. The device according to any one of claims 1 to 9, wherein the first electrode or set of electrodes and the second electrode or set of electrodes each comprise a tissue-penetrating electrode.

12. The device according to any one of claims 1 to 11, further comprising one or more peripheral seals around the suction port, configured to seal the distal end of the device to target tissue when suction is applied through the suction port.

13. The device according to any one of claims 1 to 12, further comprising a suction channel having fluid communication with the suction port within the electrode housing.

14. The device according to any one of claims 1 to 13, wherein the device is configured as a treatment tip, and the device further comprises a mechanical and / or electrical connector at the proximal end of the treatment tip, which is configured to be detachably coupled to a handpiece.

15. The device according to any one of claims 1 to 13, comprising a reusable handpiece and a replaceable treatment tip, wherein the replaceable treatment tip is configured to be releasably coupled to the reusable handpiece through one or more electrical connectors and vacuum connectors.

16. The device according to claim 15, further comprising a pulse generator coupled to the handpiece.

17. The device according to claim 15, further comprising a negative pressure source within the reusable handpiece.

18. Applying the distal end of the treatment applicator in contact with the tissue, The tissue is brought into contact with the first electrode or set of first electrodes and the second electrode or set of second electrodes on the electrode housing of the treatment applicator. To prevent arc discharge between the first electrode or set of first electrodes and the second electrode or set of second electrodes by applying suction through the continuous suction port on the electrode housing that extends between the first electrode or set of first electrodes and the second electrode or set of second electrodes, so that the tissue comes into contact with the continuous suction port that extends beyond either side of the first electrode or set of first electrodes and the second electrode or set of second electrodes, A method comprising applying pulsed electrotherapy to the tissue using a first electrode or a set of first electrodes and a second electrode or a set of second electrodes.

19. The method according to claim 18, wherein preventing arc discharge involves applying suction through the suction port such that the collision distance between the first electrode or set of electrodes and the second electrode or set of electrodes, including the minimum path length around the first suction port, is 5% or more longer than the minimum distance extending across the suction port between the first electrode or set of electrodes and the second electrode or set of electrodes.

20. The method according to any one of claims 18 to 19, wherein contact with the tissue includes penetrating the tissue using the first electrode or set of first electrodes and the second electrode or set of second electrodes.

21. The method according to any one of claims 18 to 19, wherein contact with the tissue includes applying the first electrode or set of first electrodes and the second electrode or set of second electrodes without penetrating the tissue.

22. The method according to any one of claims 18 to 21, comprising driving the distal end of the device into contact with the tissue such that contact with the tissue causes the electrode housing to retract into the applicator housing against a housing biasing force.

23. The method according to any one of claims 18 to 22, further comprising sealing the distal end of the device to the tissue.

24. The method according to any one of claims 18 to 23, further comprising coupling the treatment tip to a reusable handpiece of a pulse generator in order to assemble the treatment applicator before applying the distal end of the treatment applicator to the tissue.

25. The method according to any one of claims 18 to 24, wherein the electrode extends from one or more suction ports within the electrode housing.

26. The method according to any one of claims 18 to 25, wherein applying suction through the continuous suction port includes applying suction at least partially around the first electrode or set of first electrodes and the second electrode or set of second electrodes.

27. A therapeutic applicator device for delivering electrotherapy to tissue, A suction chamber having an open bottom, a top surface, and one or more sides, and equipped with a viewing window, One or more electrodes configured to extend into the suction chamber and at least partially visible within the viewing window, A therapeutic applicator device comprising a suction port that is in fluid communication with the suction chamber so as to apply negative pressure within the suction chamber.

28. The device according to claim 27, wherein one or more electrodes are configured to extend from one or more sides and traverse the suction chamber in a path parallel to the open bottom.

29. The device according to claim 27, wherein one or more electrodes are configured to extend from the top and traverse the suction chamber.

30. The device according to any one of claims 27 to 29, wherein one or more electrodes are configured to extend in a curved path across the suction chamber.

31. The device according to any one of claims 27 to 29, wherein the one or more electrodes are configured to completely traverse the suction chamber such that the tip of each of the one or more electrodes extends to or within the one or more sides of the suction chamber.

32. The device according to any one of claims 27 to 31, wherein the viewing window is optically transparent.

33. The device according to any one of claims 27 to 32, wherein the viewing window is formed within the top surface.

34. The device according to any one of claims 27 to 32, wherein the viewing window is formed within one or more sides.

35. The device according to any one of claims 27 to 34, wherein the viewing window is provided with one or more marks indicating the path of the one or more electrodes into the suction chamber.

36. The device according to any one of claims 27 to 35, wherein the viewing window is configured to display an enlarged view.

37. The device according to any one of claims 27 to 36, wherein one or more electrodes comprises non-penetrating electrodes.

38. The device according to any one of claims 27 to 36, wherein one or more electrodes comprises a tissue-penetrating electrode.

39. The device according to claim 38, wherein the tissue-penetrating electrode extends from the suction port to a certain height such that when suction is applied while the device is held in contact with the tissue, the tissue-penetrating electrode is driven into the tissue to a predetermined depth.

40. The device according to any one of claims 27 to 36, wherein the one or more electrodes are electrically insulated along the tip region and its length, but are not insulated in a region proximal to the tip region, which is configured to be located within the middle portion of the suction chamber when the one or more electrodes are fully extended.

41. The device according to any one of claims 27 to 40, wherein one or more of the aforementioned sides are configured to be adjustable to adjust the height of the suction chamber.

42. The device according to claim 41, wherein one or more of the aforementioned sides are inflatable.

43. The device according to any one of claims 27 to 42, wherein the top surface is provided with an electrode.

44. The device according to any one of claims 27 to 43, further comprising a sealing ring around the open bottom of the suction chamber.

45. Any of the therapeutic applicator devices described in claims 27 to 44, A system comprising a pulse generator electrically coupled to one or more electrodes.

46. One or more electrical connectors configured to electrically couple one or more electrodes to an electrical energy source, A control unit coupled to one or more electrodes and configured to extend and retract one or more electrodes within the suction chamber, The device according to any one of claims 27 to 45, further comprising a vacuum connector configured to fluidly couple the suction port to a negative pressure source.

47. The device according to any one of claims 27 to 46, wherein each electrode of the one or more electrodes comprises a pogo pin.

48. The device according to claim 47, wherein the one or more tissue-penetrating electrodes are configured to extend from the one or more sides and traverse the suction chamber in a path parallel to the open bottom.

49. A therapeutic applicator device for delivering electrotherapy to tissue, An applicator housing forming a suction chamber having an open bottom, a top surface, and one or more sides, One or more first electrodes located within the applicator housing and configured to move within the suction chamber, A second electrode disposed on the periphery of the open bottom, The suction chamber includes a second electrode with an optically transparent viewing window, A control unit on the applicator housing is configured to adjust the position of the first one or more electrodes within the suction chamber so that the first one or more electrodes are moved relative to the field of view of the viewing window, A therapeutic applicator device comprising a vacuum connector configured to fluidly couple the suction chamber to a negative pressure source.

50. The suction chamber of the treatment applicator is applied in contact with the tissue such that the open end of the suction chamber is held in contact with the tissue and the target area of ​​the tissue is visible through the viewing window of the suction chamber. A negative pressure is applied into the suction chamber from a suction port that is in fluid communication with the suction chamber, Extending one or more electrodes within the suction chamber such that one or more electrodes contact the target tissue within the suction chamber, A method comprising applying pulsed electrotherapy to the target tissue through one or more electrodes.

51. The method according to claim 50, further comprising adjusting the height of one or more sides of the suction chamber.

52. The method according to claim 51, wherein adjusting the height includes inflating one or more of the sides.

53. The method according to any one of claims 50 to 52, further comprising sealing the open bottom of the suction chamber against the tissue with respect to the sealing ring.

54. The method according to any one of claims 50 to 53, further comprising detachably coupling the treatment tip to the handpiece.

55. The method according to any one of claims 50 to 54, wherein applying the negative pressure includes applying the negative pressure from the suction port adjacent to the second end of the suction chamber opposite to the open end.

56. The method according to any one of claims 50 to 55, further comprising visualizing the tissue through the viewing window.

57. The method according to any one of claims 50 to 56, wherein the application of the pulsed electrotherapy includes applying the pulsed electrotherapy between the one or more electrodes and a second electrode on the surface of the suction chamber.

58. The method according to any one of claims 50 to 57, wherein the one or more electrodes comprises the one or more tissue-penetrating electrodes that traverse the suction chamber laterally from one or more sides, such that the one or more tissue-penetrating electrodes penetrate the tissue in the suction chamber.

59. The method according to claim 58, wherein extending one or more tissue-penetrating electrodes includes extending them parallel to the open end of the suction chamber.

60. A method for treating syringomas, The suction chamber of the treatment applicator is applied over the target syringoma on the target skin so that the target syringoma in the tissue is visible through the viewing window of the suction chamber. Applying negative pressure into the suction chamber from the suction port, which is in fluid communication with the suction chamber, in order to draw the syringoma into the suction port and pull it out from the plane of the target skin, The target syringoma is brought into contact with one or more electrodes in the suction chamber. A method comprising applying sub-microsecond pulsed electrical energy to the syringoma through one or more electrodes.

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