Electrical applicator for applying energy to a tissue surface or a superficial region of the surface

Abstract

Treatment applicators, including treatment applicators, and methods for delivering electrical energy to target tissue are configured to reduce or eliminate arcing and enhance targeting to areas at or just below the tissue surface.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to U.S. Provisional Patent Application No. 63 / 231,698, entitled "ELECTRICAL APPLICATORS FOR APPLYING ENERGY TO TISSUE SURFACES OR REGIONS SUPERFICIAL TO THE SURFACE," filed August 10, 2021, which is incorporated herein by reference in its entirety.

[0002] Incorporation by Reference All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was 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, e.g., 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. The devices and methods described herein may be particularly useful for improving targeting and positioning, as well as avoiding or minimizing undesired electrical changes in tissue, including preventing or limiting electrical arcing. [Background technology]

[0004] Electrical energy may be applied into tissue for a variety of purposes, including for the treatment of medical conditions. The electrical energy may be provided through electrodes of a treatment applicator that is placed on and / or inserted into the tissue. In some cases, the application of electrical energy through the electrodes can result in undesirable changes to the tissue at or around the electrodes. Poor or inconsistent contact between the treatment applicator, including the electrodes, and the tissue can result in such undesirable changes, resulting in uncontrolled electrical discharges, such as arcing, especially when applying high voltage or high power energy.

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

[0006] Because the treatment voltages are so high and the pulse times so fast, applicators for the delivery of such sub-microsecond pulsed devices should ideally be configured to avoid, or at least minimize, arcing between the 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 penetrated or pressed against by one or more electrodes on the applicator and / or treatment tip stretches around the electrodes, leaving gaps. Tenting can cause problems with targeting and control of the applied energy, including arcing, which can result in less favorable electrical therapy outcomes.

[0007] The methods and devices described herein may address various issues raised above, including improved targeting of treatment areas. Summary of the Invention

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

[0009] The methods and devices described herein may address the arcing and tenting and targeting problems discussed above. For example, these methods and devices may improve targeting of the lesion area by allowing a user to clearly view the target lesion when placing the treatment applicator on tissue and to maintain vision of the lesion throughout treatment.

[0010] Thus, energy can be applied directly to the skin surface using one or more electrodes, which can reduce the physical trauma caused by inserting every individual needle into the skin. These methods and devices can also reduce the amount of arcing between electrodes along the surface of the skin through any air gaps around the electrodes. This gap / air path between the electrodes is one cause of arcing. Various designs of the treatment applicator devices of the present application provide a vacuum between the electrodes that forms a seal between the tip of the treatment applicator and the tissue, blocking the gap / air between the electrodes. These methods and devices can further reduce the holding force required to maintain constant contact with tissue throughout treatment. Eliminating air gaps (e.g., tenting) and / or reducing the force required to apply the treatment applicator can improve overall usability or ease of use when treating tissue.

[0011] In some embodiments, the electrodes are biased such that contact with tissue drives the electrodes (individually or collectively) to slightly retract, thereby applying a counterforce to the tissue. In some embodiments, the electrodes are non-penetrating pin electrodes configured with a biasing portion (e.g., spring) on ​​the interior and / or exterior of the pin electrode. In some embodiments, these electrodes may be configured with a biasing portion (e.g., spring) within the pin electrode, similar to a pogo pin. Spring-loaded electrodes may apply a spring force to ensure continuous contact with tissue (e.g., skin). Non-penetrating electrodes may have smooth and / or rounded distal ends (e.g., tips) and other smooth exterior surfaces, thus reducing the likelihood of arcing. When using high-voltage pulses, such as nanosecond pulsed electrical therapy, sharp tips are typically more susceptible to arcing. Because the electrodes do not penetrate the skin, they may be used in sensitive areas of the body, such as around the eyes or elsewhere on 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 under and around each of the electrodes and may help eliminate any air gaps around the electrodes to achieve better or more complete contact with the tissue. Eliminating air gaps around the electrodes may also reduce treatment delays due to arcing, resulting in better or more consistent treatment results. When using penetrating electrodes (e.g., needle electrodes), these vacuum ports may also assist in the insertion of the needle electrodes into the tissue and reduce the force the user needs to apply to the treatment applicator to initiate treatment and / or during ongoing treatment. The use of suction ports around each of the needles may generate sufficient suction around the treatment area to hold the treatment applicator in place without the need to apply significant force before and during treatment. The suction may hold the electrodes against the tissue surface throughout treatment, thereby reducing the likelihood of arcing and thereby improving treatment results.

[0013] Generally, described herein are devices for delivering electrical therapy, specifically including treatment applicators (including those configured as removable / disposable treatment tips) for delivering electrical therapy. The electrical therapy can be pulsed (e.g., sub-microsecond, nanosecond, etc.) pulsed electrical energy. These tips can generally apply suction before and / or during application of the electrical therapy. In some examples, each electrode (e.g., tissue-penetrating or non-penetrating electrode) can be surrounded by and / or extend from a suction port through which suction can be applied.

[0014] Also described herein is a device for delivering electrical therapy, the device including an electrode housing extending from a distal end of a treatment applicator, a first electrode or set of electrodes extending from or configured to extend from the electrode housing and disposed along 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 disposed along a second length of the electrode housing parallel to the first length, and a suction port opening through the electrode housing and extending continuously between the first electrode or set of electrodes and the second electrode or set of electrodes, the suction port extending further through the electrode housing than the first length and the second length so as to prevent arcing between the first electrode or set of electrodes and the second electrode or set of electrodes.

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

[0016] Also described herein are methods of operating and / or using any of these apparatus (e.g., devices, systems, etc.). For example, the method may include applying a distal end of a treatment applicator against tissue, contacting the tissue with a first electrode or set of electrodes and a second electrode or set of electrodes on an electrode housing of the treatment applicator, and preventing arcing between the first electrode or set of electrodes and the second electrode or set of electrodes by applying suction through a continuous suction port on the electrode housing extending between the first electrode or set of electrodes and the second electrode or set of electrodes such that the tissue contacts the continuous suction ports extending beyond either side of the first electrode or set of electrodes and the second electrode or set of electrodes. The method further includes applying pulsed electrical therapy to the tissue from the first electrode or set of first electrodes and the second electrode or set of second electrodes.

[0017] Any of the devices for delivering electrical therapy to tissue described herein (e.g., applicators and devices and systems including applicators configured as disposable / detachable treatment tips) can include a viewing window for viewing the target tissue within the suction chamber of the device. For example, the device can include a suction chamber having an open bottom, a top surface, and one or more sides, the suction chamber including 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 a negative pressure within the suction chamber.

[0018] For example, a therapy applicator device for delivering electrical therapy 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 in fluid communication with the suction chamber, the suction chamber including an optically transparent viewing window that allows a user to view the target tissue through the open bottom; one or more electrical connectors configured to electrically couple the one or more electrodes to a source of electrical energy; a controller coupled to the one or more electrodes and configured to extend and retract the 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 (devices and systems including a tip) may include a control for controlling the application of suction through the device, specifically suction may include drawing tissue through the tip or suction chamber for treatment or holding the device against the skin for treatment. In any of these devices, the control may include a bleed valve, allowing a 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 bleed valve. For example, any of these devices may include a bleed valve, e.g., on the handle of the device, that may divert suction from the suction port and / or suction chamber until the user blocks it (e.g., by covering it), and suction may be applied through the suction port and / or suction chamber. The bleed port may be part of the handle. Suction may be applied continuously, but may only be directed to the suction chamber and / or suction port at the treatment tip when activated by the user closing the bleed valve.

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

[0021] For example, the method may include applying a suction chamber of a therapy applicator against tissue such that an open end of the suction chamber is held against the tissue and a target region of the tissue is visible through a viewing window in the suction chamber, applying negative pressure within the suction chamber from a suction port in fluid communication with the suction chamber to draw the target tissue into the suction chamber, and extending one or more tissue-penetrating electrodes laterally across the suction chamber from one or more sides such that the one or more tissue-penetrating electrodes penetrate the tissue within the suction chamber. The method may further include applying pulsed electrical therapy to the target tissue through the one or more electrodes.

[0022] Also described herein are methods of treating conditions, diseases, or disorders using any of these devices. Specifically, described herein are methods of treating syringoma. For example, a method of treating syringoma may include applying a suction chamber of a treatment applicator over a target syringoma on a subject's skin such that the target syringoma is visible through a viewing window in the suction chamber; applying negative pressure in the suction chamber from a suction port in fluid communication with the suction chamber to draw the syringoma into the suction port and out of the plane of the subject's skin; contacting one or more electrodes in the suction chamber with the target syringoma; and applying sub-microsecond pulsed electrical energy to the syringoma through the one or more electrodes.

[0023] For example, also described herein is a device for delivering electrical treatment or therapy to a tissue surface, the device comprising: an electrode housing extending from a distal end of a treatment applicator; one or more (e.g., multiple) suction ports opening into the electrode housing; a plurality of non-penetrating electrodes (in some embodiments, spring-loaded electrodes) extending from the electrode housing and configured not to penetrate tissue, the non-penetrating electrodes extending from the suction port in an extended configuration, each non-penetrating electrode further configured to retract into the electrode housing when actuated against tissue; and a plurality of biasing members coupled with a biasing member of the plurality of biasing members such that each non-penetrating electrode presses against tissue when actuated to return the non-penetrating electrode to the extended configuration.

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

[0025] For example, described herein is a device including a device for delivering electrical therapy to a tissue surface, the device including: an electrode housing extending from a distal end of a treatment applicator; one or more (e.g., multiple) suction ports opening into the electrode housing; one or more peripheral seals around the one or more (e.g., multiple) suction ports configured to seal the distal end of the treatment applicator against tissue when suction is applied through the multiple suction ports; a plurality of non-penetrating electrodes extending from the electrode housing and configured not to penetrate tissue, the plurality of non-penetrating electrodes extending from the suction port(s) beyond the one or more peripheral seals in an extended configuration, each of the non-penetrating electrodes further configured to retract into the electrode housing when actuated against tissue; and a plurality of biasing members coupled with a biasing member of the plurality of biasing members such that each non-penetrating electrode presses against tissue when actuated to return the non-penetrating electrode to the extended configuration.

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

[0027] The distal end of the treatment applicator can be angled, for example, relative to the longitudinal axis of the treatment applicator, such that the tissue-engaging surface from which the electrodes extend is angled. For example, the distal end of the treatment applicator can be angled at an angle of about 5 degrees to about 90 degrees relative to the longitudinal axis of the electrode housing.

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

[0029] Any of the devices described herein can be configured so that the application of negative pressure (suction) from the suction port is coordinated with the non-penetrating electrode. For example, the device can be configured so that a vacuum is applied through the suction port when the non-penetrating electrode is pressed against tissue, which can deflect the non-penetrating electrode proximally into the electrode housing, opening the suction channel and applying negative pressure (suction) from the suction port.

[0030] The non-penetrating electrodes may generally be configured as spring-loaded pins. For example, each of the plurality of non-penetrating electrodes may comprise a blunt pin having an internal chamber that houses a spring with a biasing portion coupled to the non-penetrating electrode. Thus, in some embodiments, each of the plurality of non-penetrating electrodes comprises a pogo pin structure (e.g., having an internal spring element). Alternatively or additionally, each of the plurality of non-penetrating electrodes may comprise a wire electrode that extends 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 portion (e.g., a spring) that may enable the electrode to be pressed into the housing and may exert a force against tissue. Typically, the biasing portion includes a spring (e.g., a coil spring, a leaf spring, etc.). The biasing portion may be configured to apply a constant force against tissue when actuated to return the non-penetrating electrode to the 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 configured to removably couple the treatment tip to the handpiece (e.g., to form a treatment applicator assembly). The mechanical and electrical connectors may be integrated. In some examples, 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 previously mentioned, the non-penetrating electrode may have a smooth, rounded, blunt tissue-contacting surface. In some embodiments, the non-penetrating electrode has an enlarged distal end region that is larger in diameter than a more proximal region. The non-penetrating electrode may have a flat or flattened distal tip.

[0033] Any of these devices (treatment applicators, treatment tips, etc.) can be part of a system that includes a pulse generator and / or a negative pressure source. For example, described herein is a system that includes a reusable handpiece with one or more electrical and vacuum connectors at the distal end of the handpiece and any of the devices described herein. The treatment applicator (configured as a treatment tip) can be configured to releasably couple to the handpiece through one or more electrical and vacuum connectors. Any of these systems can 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 apparatus (devices, systems, e.g., treatment applicators). For example, the method may include applying a distal end of the treatment tip against tissue, drawing negative pressure at the distal end of the treatment tip such that each of a plurality of non-penetrating electrodes is actuated against tissue and at least partially retracted into an electrode housing of the treatment tip, wherein a biasing member coupled to each of the non-penetrating electrodes applies a constant force against the tissue, and applying pulsed electrical therapy to the tissue through the plurality of non-penetrating electrodes.

[0035] In particular, any of these methods may be used for cosmetic treatments such as reducing or eliminating wrinkles, skin blemishes, and the like.

[0036] Any of these methods can include sealing the distal end of the treatment tip against tissue. In some examples, drawing negative pressure can include drawing negative pressure at the distal end of the treatment tip such that each of the multiple non-penetrating electrodes is driven against tissue and partially independently retracts into the electrode housing.

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

[0038] In addition to methods and devices including treatment applicators with non-penetrating electrodes that self-bias against the surface of tissue, also described herein are treatment applicators with laterally deployed needle electrodes (e.g., tissue-penetrating electrodes) configured to penetrate laterally into shallow regions of tissue just below the surface of the tissue. These treatment applicators may include a suction chamber that may have an open bottom through which tissue can be drawn by suction, such that one or more needle electrodes may exit the side of the suction chamber and extend into the tissue (e.g., skin) parallel to the open bottom of the treatment 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, laterally deployed 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 (rather than substantially parallel) to the tissue surface. Thus, these treatment applicators may cause less mechanical trauma to the tissue (e.g., skin tissue or epidermis) and may allow overall treatment to occur below the skin. Additionally, these treatment applicators may improve the targeting capabilities of the treatment applicator by allowing the user to clearly view the target lesion when placing the treatment tip on the tissue and to maintain visibility of the lesion throughout treatment.

[0040] In general, any of the devices or methods described herein that include deployable electrodes (such as, but not limited to, laterally deployed needle electrodes or non-penetrating electrodes) can be deployed and / or retracted automatically, manually, or semi-automatically. For example, any of these devices can include one or more solenoids for deploying and / or retracting the electrodes. In some examples, the device can also, or instead, include one or more biasing members (e.g., springs) for deploying and / or retracting the needles. In some examples, a biased solenoid can be used to deploy (e.g., extend) and retract one or more electrodes. Controls for triggering the solenoid, e.g., to deploy or retract the electrodes, can be included on the device, e.g., on a handle portion of the device, and / or on a pedal (e.g., foot pedal), switch, button, etc.

[0041] For example, described herein is a treatment 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 therebetween, 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 the top surface.

[0042] Any of these treatment applicators may be configured with a removable and / or replaceable tip region for use with a reusable handpiece, and the suction chamber and electrodes may be part of a tip that may be removably coupled to the handpiece. For example, described herein is a device for delivering electrical therapy to tissue, the device including: an applicator housing forming a suction chamber having an open bottom, a top surface, and one or more side surfaces therebetween; one or more needle electrodes configured to extend through one of the one or more side surfaces and traverse the suction chamber parallel to the open bottom; a suction port adjacent to the top surface, the top surface including a viewing window that is optically transparent and includes one or more markings indicating the path of the one or more needle electrodes into the suction chamber; one or more electrical connectors configured to electrically couple the 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 markings (e.g., crosshairs, etc.) that indicate the path of the one or more needle electrodes into the suction chamber. The viewing window may be configured to provide a magnified view.

[0044] The one or more needle electrodes may be configured to completely traverse the suction chamber, with the tip of each of the one or more needle electrodes extending to or into one or more side surfaces at the end of the suction chamber opposite the one or more needle electrodes extending from the suction chamber. Alternatively, the one or more needle electrodes may be configured to partially traverse the suction chamber. The needle electrodes may be configured such 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, the 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 that is configured to be within the intermediate portion of the suction chamber when the one or more needle electrodes are fully extended. Alternatively or additionally, the needle electrodes may be configured such 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 can have any suitable shape, including square, rectangular, circular, etc. In some embodiments, the suction chamber is shallow, e.g., the top surface can extend across the suction chamber for a length three or more 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 include an electrode. The electrode may be central and / or peripheral about the top surface. In some variations, a majority of the top surface (all or 90%, 85%, 80%, 75%, etc. of the top surface) is an electrode (e.g., a return electrode).

[0048] Any of the suction chambers 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, etc.).

[0049] As previously mentioned, any of these treatment applicator devices may include a reusable handpiece and a detachable tip, where the detachable tip includes a suction chamber, one or more needle electrodes, and a suction port. For example, the treatment applicator may include controls on the reusable handpiece for extending and retracting the one or more needle electrodes.

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

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

[0052] For example, the method may include applying a suction chamber of a treatment applicator against tissue so that the open bottom of the suction chamber is held against the tissue; applying negative pressure within the suction chamber from a suction port adjacent a 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 so that the one or more needle electrodes extend parallel to the open bottom of the suction chamber; and applying pulsed electrical therapy to the tissue through the 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) in the suction chamber to position the suction chamber over the target area of ​​the tissue. Applying pulsed electrical therapy may include applying pulsed electrical therapy between the 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 coupling a detachable tip comprising the suction chamber and one or more needle electrodes to a reusable handpiece of a pulse generator to form the treatment applicator prior to applying the treatment applicator against the tissue.

[0054] As previously mentioned, 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 electrode or multiple electrodes. The electrode may be, for example, an array of electrodes. The electrodes described herein are generally tissue-penetrating electrodes.

[0055] The treatment applicators described herein, including the treatment tip portion of the treatment applicator, can also include an electrical connector for connecting to a source of electrical energy. For example, the power connector can be configured to electrically connect one or more needle electrodes to a power source configured to apply high-voltage power to the one or more needle electrodes, the high-voltage power 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, greater than about 0.1 kV / cm, greater than about 0.5 kV / cm, greater than about 1 kV / cm, etc.).

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

[0057] As described above, any suitable electrical energy may be applied while moving the electrode relative to the tissue. For example, applying energy may include applying high-voltage nanosecond electrical pulses, such as applying a sub-microsecond electrical pulse train having a pulse width of 0.1 nanoseconds (ns) to 1000 nanoseconds (ns). Applying high-voltage nanosecond electrical pulses may include applying a sub-microsecond electrical pulse train having a peak voltage of 10 kilovolts per centimeter (kV / cm) to 500 kV / cm. Applying high-voltage nanosecond electrical pulses may include applying a sub-microsecond electrical pulse train at a frequency of 0.01 Hz to 10,000 Hz. Applying energy may include applying microsecond electrical pulses or picosecond electrical pulses.

[0058] The methods and devices described herein can be used as part of any suitable electrical treatment or therapy in which electrical energy is applied within tissue (or possibly at the surface of tissue). Various embodiments of the present disclosure are useful for applying electrical treatment 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 penetrating and non-penetrating electrodes of various embodiments can be used to treat the surface of tissue, including the epidermis of the skin. Similarly, various embodiments of the present disclosure, including those with both penetrating and non-penetrating electrodes, can be used to apply electrical treatment to sub-surface 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 organ tissue cancer (e.g., lung cancer, kidney cancer, pancreatic cancer, colon cancer, breast cancer, etc.), skin cancer, cherry angiomas, warts, keloids / scars, aging skin, skin conditions and / or diseases, molluscum angiomas, necrolysis lipoidica (NBL), melisma, epidermolipoma / sebaceous cyst, basal cell carcinoma, any type of tumor or abnormal tissue growth (e.g., benign tumor, precancerous tumor). Alternatively, or in addition, these methods may be of any other body tissue, including non-skin tissue (respiratory tissue, soft tissue, lung tissue, breast tissue, liver tissue, etc.).

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

[0060] For example, described herein are apparatus for delivering electrical treatment or therapy (e.g., devices including a treatment applicator device) in which some or all of the individual electrodes can be independently extended or retracted relative to one another and / or relative to the electrode housing. These devices can include an electrode housing extending from the distal end of a treatment tip, one or more suction ports opening into the electrode housing, multiple electrodes extending from the electrode housing, each configured to independently retract into or extend from the electrode housing when actuated against tissue, and multiple biasing members, each independently coupled to a biasing member of the multiple biasing members to press against tissue when actuated to return the electrode to the 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 portion that applies a force to return the electrode housing to the extended configuration relative to the distal end of the treatment tip.

[0062] Any suitable electrodes may be used in any of these treatment applicator devices. For example, the electrodes may be non-penetrating or penetrating, and the same treatment 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-contacting surface.

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

[0064] As mentioned above, the distal end of the treatment tip may be flat or angled, for example, angled at 5 to 90 degrees relative to the longitudinal axis of the electrode housing. Any of these devices may include a suction channel in fluid communication with one or more suction ports in the electrode housing.

[0065] In some embodiments, each individually biased electrode can include an internal chamber including a biasing member (e.g., a spring) coupled to the electrode. For example, each electrode of the plurality of electrodes can include a non-piercing pogo pin.

[0066] Any of these devices may include a mechanical and / or electrical connector at the proximal end of the treatment tip configured to removably couple the treatment tip to the handpiece.

[0067] Any of these devices described herein can be configured as an interchangeable 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 apparatuses (e.g., devices) may include a pulse generator coupled to a handpiece, such as a reusable handpiece. Any of these apparatuses (e.g., devices) may include a negative pressure source within the reusable handpiece.

[0069] Also described herein are methods of using a treatment applicator device including individually biased tips. For example, the method (e.g., a method of treating tissue) may include applying a distal end of the treatment tip against tissue; drawing negative pressure through an electrode housing at the distal end of the treatment tip such that each of multiple electrodes of the treatment applicator device is independently actuated against the tissue and at least partially retracted within the electrode housing, where each electrode is independently actuated against the tissue by one of the multiple biasing members; and applying pulsed electrical therapy to the tissue through the multiple electrodes. As described above, acting on the distal end of the treatment tip against the tissue may include retracting the electrode housing into the treatment tip against a housing biasing force, where the electrode housing is actuated distally relative to the treatment tip by the housing biasing member.

[0070] Any of these methods may include sealing the distal end of the treatment tip against tissue. The disclosed methods also include methods of 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 against tissue. The electrodes may extend from one or more suction ports in the electrode housing. The multiple electrodes independently driven against tissue may be non-penetrating electrodes.

[0071] Also described herein is a treatment applicator device for delivering electrical treatment or therapy to tissue that includes one or more windows for viewing (and targeting) the tissue to be treated. For example, the device may include a suction chamber having an open bottom, a top surface, and one or more sides, the suction chamber including 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 a negative pressure within the suction chamber.

[0072] The one or more electrodes can be configured to extend out from one or more sides and traverse the suction chamber in a path parallel to the open bottom. In some embodiments, the one or more electrodes are configured to extend from the top and traverse the suction chamber. In some embodiments, the one or more electrodes are configured to extend in a curved path across the suction chamber. In some embodiments, the one or more electrodes are configured to traverse the suction chamber completely such that a 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 formed of a polymeric material, a transparent material such as glass, etc.). The viewing window may be formed on any portion of the chamber, such as on one or more of the top surface and / or one or more side surfaces. As noted above, the viewing window may generally include one or more markings indicating the path of one or more electrodes into the suction chamber. The viewing window may be configured to provide a magnified view.

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

[0075] As previously mentioned, any of these therapy applicator devices may include 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 accordance with another aspect of the present disclosure, also described herein is a therapy applicator device for delivering electrical therapy 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 in fluid communication with the suction chamber, the suction chamber including an optically transparent viewing window that allows a user to view the target tissue through the open bottom; one or more electrical connectors configured to electrically couple the one or more electrodes to a source of electrical energy; an electrode movement control input coupled to the one or more electrodes and configured to extend and retract the 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 a suction chamber of a treatment applicator against tissue such that an open end of the suction chamber is held against the tissue, thereby allowing a target area of ​​the tissue to be viewed through a viewing window in the suction chamber; applying negative pressure within the suction chamber from a suction port in fluid communication with the suction chamber; extending one or more electrodes within the suction chamber such that the one or more electrodes contact the target tissue within the suction chamber; and applying pulsed electrical therapy to the target tissue through the one or more electrodes. Applying negative pressure may include applying negative pressure from a suction port adjacent a second end opposite the open end of the suction chamber. Any of the methods described herein, with reference to different examples and embodiments, may include visualizing the tissue through the viewing window.

[0078] Applying the pulsed electrical therapy can include applying the pulsed electrical therapy between the one or more electrodes and a second electrode on the surface of the suction chamber.

[0079] Generally, these devices and methods may allow for improved targeting of the target tissue (e.g., lesion) area by allowing the user to clearly view the target region when placing the treatment tip on the tissue. These methods and devices may also allow the user to maintain vision of the lesion throughout treatment. Thus, any of these devices and methods may allow visualization. As mentioned above and described in further detail 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 penetrating and non-penetrating electrodes. These devices and methods may preferably (but not necessarily) be used with suction.

[0080] In some embodiments, the apparatus (and methods of using the apparatus) may be configured as a laterally deployable treatment device with penetrating electrodes that may provide subsurface application of treatment energy, which may help minimize or prevent damage or injury to surface areas above the treatment region, including but not limited to the skin / epidermis.

[0081] For example, a therapy applicator device for delivering electrical therapy to tissue may include a suction chamber having an open bottom, a top surface, and one or more sides therebetween, a plurality of suction ports in fluid communication with the suction chamber, and one or more needle electrodes, each extending at a fixed height from a respective suction port of the plurality of suction ports such that when suction is applied when the device is held against tissue, the one or more needle electrodes are driven into the tissue to a predetermined depth.

[0082] A treatment applicator device for delivering electrical treatment 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; a first electrode or electrodes within the applicator housing and configured to move within the suction chamber; a second electrode disposed on a periphery of the open bottom, the suction chamber including an optically transparent viewing window; a control on the applicator housing configured to adjust the position of the first electrode or electrodes to move within the suction chamber 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 therapy applicator device for delivering electrical therapy 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 above 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 controller configured to cause the 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. The 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. The one or more tissue-penetrating electrodes may be configured to extend in a curved path across the suction chamber. The one or more tissue-penetrating electrodes may be configured to completely traverse the suction chamber such that a 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 previously mentioned, the viewing window may be in (or may extend through) any portion of the chamber, such as in the top surface and / or one or more sides of the suction chamber.

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

[0086] As mentioned above and described in more detail herein, any of these treatment applicator devices may be configured with suction ports on the tip (e.g., on the electrode housing) between and 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 therapy applicator device for delivering electrical therapy to tissue may include an electrode housing extending from the distal end of a therapy tip, a first tissue-penetrating electrode or set of tissue-penetrating electrodes, a second tissue-penetrating electrode or set of tissue-penetrating electrodes, wherein the first tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-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 tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-penetrating electrodes, the one or more suction ports adjacent to the first tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-penetrating electrodes.

[0087] The one or more suction ports may include a single suction port centrally located on the outer surface of the electrode housing. The one or more suction ports may be located on either side of the first tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-penetrating electrodes. The one or more suction ports may each comprise two or more suction ports arranged in parallel across the outer surface of the electrode housing between and separating the first tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-penetrating electrodes. As described above, each of the electrodes of the first tissue-penetrating electrode or set of tissue-penetrating electrodes and the second tissue-penetrating electrode or set of tissue-penetrating electrodes may be independently biased so that they can be independently retracted relative to the electrode housing. Alternatively or in addition, the electrode housing may be biased so that it can be retracted relative to the body of the treatment tip.

[0088] The various exemplary devices and methods described herein can be used to treat relatively large treatment areas, for example, by using multiple surface electrodes arranged as described herein. Additional devices and methods of the present disclosure can be used to treat a variety of specific conditions, as described herein. Other features and advantages of the devices and methods of the present disclosure will become apparent from the following detailed description of one or more implementations, when read in light of the accompanying figures. [Brief explanation of the drawings]

[0089] The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes and angles of various elements are not drawn to scale, and some of these elements have been enlarged and positioned to improve drawing legibility. The novel features of the invention described herein are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the method and apparatus of the present invention can be obtained by reference to the following detailed description that sets forth exemplary embodiments, and the accompanying drawings, in which:

[0090] [Figure 1]FIG. 1 illustrates an example of a system for delivering high-voltage, high-rate pulsed electrical energy that includes a treatment applicator as described herein and a pulse generator to which the treatment applicator is coupled. [Figure 2] Figures 2A-2C show the operation of an example of a treatment applicator including a tip region that includes a spring-loaded non-penetrating electrode that is biased to retract when driven against tissue, where Figure 2A is a cross-sectional view showing the distal end of the treatment applicator separated from the target tissue, Figure 2B is a similar cross-sectional view showing the tip of the treatment applicator of Figure 2A placed against tissue before suction is applied, and Figure 2C is a cross-sectional view showing the tip pressed against tissue with suction being applied from the suction port. [Figure 3] 3A-3B are diagrams illustrating an example of a tip of a treatment applicator as described herein showing an array of four (2x2) spring-loaded non-penetrating electrodes, where FIG. 3A is a diagram illustrating the distal end of the treatment applicator (an example of a treatment tip that is removable and / or disposable) and FIG. 3B is a side view. [Figure 4] 4A-4B illustrate another example of an applicator tip as described herein, showing an array of eight (4x4) spring-loaded non-penetrating electrodes, where FIG. 4A is a side perspective view of the distal end (e.g., detachable treatment tip) of the treatment applicator, and FIG. 4B is a view of the distal end of the same treatment applicator. [Figure 5] 5A-5C show another example of a treatment applicator as described herein, where FIG. 5A is a side view of a treatment applicator including a spring-loaded non-penetrating electrode (configured as a detachable treatment tip), FIG. 5B is a distal end view of the treatment tip of FIG. 5A, and FIG. 5C is a side perspective view of the treatment tip. [Figure 6] 6A-6C show another example of a treatment applicator as described herein, where FIG. 6A is a side view of a treatment tip (treatment applicator) including pin (and spring-loaded) electrodes, FIG. 6B is a distal perspective view of the treatment tip of FIG. 6A, and FIG. 6C is a side perspective view of the treatment tip. [Figure 7]7A-7C illustrate another example of a treatment applicator as described herein, in which the non-penetrating electrode is a wire electrode representing a flattened loop of wire forming a spring-loaded electrode as described herein, with FIG. 7A being a side view of a treatment tip including a spring-loaded non-penetrating electrode, FIG. 7B being a distal perspective view of the treatment tip of FIG. 7A, and FIG. 7C being a side perspective view of the treatment tip. [Figure 8] FIG. 8 shows another example of a portion (distal end portion) of a vacuum-assisted treatment tip including a bar or wire non-penetrating electrode and a suction port. [Figure 9] FIG. 9 shows another example of a portion (distal end portion) of a treatment tip including a spring-loaded non-penetrating electrode and a suction port. [Figure 10] 10A-10F illustrate examples of treatment applicators (e.g., shown as treatment tips) with differently angled distal surfaces to aid in accessibility and visibility of tissue contact in hard to reach target areas. [Figure 11] 11A-11C show another example of a treatment applicator configured as a treatment tip as described herein, having a relatively large array of surface electrodes (which may be spring-loaded) and including multiple suction ports. [Figure 12] 12A-12E show different examples of treatment tips with wire or bar electrodes, where FIG. 12A is an exemplary side view, FIGS. 12B-12D show treatment tips with different sizes and numbers of rows of electrodes each surrounded by a suction port / channel, and FIG. 12E is a top perspective view showing three examples of such treatment tips. [Figure 13] 13A-13B are diagrams showing another example of a treatment tip portion including a plurality of non-penetrating electrodes configured as coil electrodes, and FIG. 13B is an enlarged view of the treatment tip portion of FIG. 13A. [Figure 14]14A-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 chamber of the tip and the electrodes may contact tissue that is drawn into the tip; FIG. 14B is a perspective cross-sectional view through the treatment tip of FIG. 14A; and FIG. 14C is a side view of the treatment tip of FIG. 14A. [Figure 15] Figure 15A shows an example of a treatment tip (e.g., treatment applicator) with a central vacuum port between tissue-penetrating electrodes to ensure contact between the electrode housing and tissue. Figure 15B shows the treatment tip of Figure 15A with the tissue-penetrating (e.g., needle) electrodes extended. Figure 15C shows a distal end view of the treatment tip of Figures 15A-15B. Figure 15D shows the impingement distance for the electrodes in the treatment tips of Figures 15A-15C. [Figure 16] Figure 16A shows an example of a treatment tip having multiple (e.g., two) vacuum ports adjacent to and between two sets of tissue-penetrating electrodes. Figure 16B shows the treatment tip of Figure 16A with tissue-penetrating (e.g., needle) electrodes extended. Figure 16C shows a distal end view of the treatment tip of Figures 16A-16B. Figure 16D shows the impingement distance for electrodes within the treatment tip of Figures 16A-16C. [Figure 17] Figure 17A shows an example of a treating tip with a central vacuum port between non-penetrating electrodes (e.g., wire electrodes) and outer vacuum ports, with a vacuum port located on either side of each set of non-penetrating electrodes. Figure 17B shows the treating tip of Figure 17A with the electrodes extended. Figure 17C shows a distal end view of the treating tip of Figures 17A-17B. Figure 17D shows the impingement distance for the electrodes in the treating tip of Figures 17A-17C. [Figure 18]Figure 18A shows an example of a treatment tip with two C-shaped vacuum ports between two sets of tissue-penetrating electrodes (e.g., needle electrodes), with the vacuum port between and partially surrounding the sets of tissue-penetrating electrodes. Figure 18B shows the treatment tip of Figure 18A with the electrodes extended. Figure 18C shows a distal end view of the treatment tip of Figures 18A-18B. Figure 18D shows the impingement distance for the electrodes in the treatment tip of Figures 18A-18C. [Figure 19] Figure 19A shows an example of a treatment tip with an I-shaped vacuum port between two sets of tissue-penetrating electrodes (e.g., needle electrodes), with the vacuum port between and partially surrounding the sets of tissue-penetrating electrodes. Figure 19B shows the treatment tip of Figure 19A with the electrodes extended. Figure 19C shows a distal end view of the treatment tip of Figures 19A-19B. Figure 19D shows the impingement distance for the electrodes in the treatment tip of Figures 19A-19C. [Figure 20] FIG. 20 illustrates an example of a treatment applicator that includes a suction chamber with a transparent top surface that allows for targeting of lateral needle electrodes through the target tissue. [Figure 21] FIG. 21 illustrates another example of a treatment applicator that includes a suction chamber with a transparent top surface that allows for targeting of lateral needle electrodes through the 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 shows a cross-sectional view through the distal tip region of the treatment tip shown in Figure 22A, where the needle electrodes are recessed into the sidewall of the suction chamber. Figure 22C shows a cross-sectional view through the distal tip region of the treatment tip shown in Figure 22A, where the needle electrodes extend laterally into the suction chamber, parallel to the open bottom of the suction chamber. [Figure 23]23A-23C show another example of a treatment tip similar to that shown in FIGS. 22A-22C, showing a suction chamber with a transparent surface that allows for tissue targeting; FIG. 23A shows the treatment tip with three needle electrodes extending partially across the suction chamber parallel to the open bottom of the suction chamber; FIG. 23B shows the three needle electrodes extending fully across the suction chamber so that they extend to the opposite side wall of the chamber; and FIG. 23C is a bottom view of the treatment tip of the example of FIGS. 23A-23B, looking up through the open bottom into a transparent top (e.g., a viewing window including a concentric targeting ring). [Figure 24] Figures 24A-24D illustrate the operation of an example treatment tip including a suction chamber and multiple needle electrodes, and Figure 24E illustrates an example treatment tip configured to treat superficial tissue using a suction chamber and surface electrodes. [Figure 25] Figure 25A is a top perspective view of another example of a treatment applicator including a distal tip portion including a suction chamber, the top of which is configured as a return electrode. Figure 25B is a cross-section through the suction chamber of the treatment tip of Figure 25A. [Figure 26] Figures 26A-26C illustrate the operation of another example of a treatment applicator including a tip having a suction chamber and multiple electrodes, where a viewing window allows visualization of tissue through the tip, and Figure 26D is an enlarged view showing the distal end of the tip region. [Figure 27] 27A-27B are exploded views illustrating examples of treatment applicators including vacuum treatment tips with either tissue-penetrating electrodes (FIG. 27A) or non-penetrating electrodes (FIG. 27B) similar to those shown in FIGS. 26A-26D. [Figure 28] 28A-28B illustrate the operation of another example treatment tip including a suction chamber as described herein, with FIG. 28A showing the tip prior to engaging tissue and FIG. 28B showing the tip engaged with tissue. FIG. 28C is an enlarged view of the distal end of the treatment tip of FIG. 28B. FIG. 28D is a view of the distal end of the treatment tip of FIG. 28A-28C. [Figure 29] 29A-29B are exploded views illustrating examples of treatment applicators including vacuum treatment tips with either tissue-penetrating electrodes (FIG. 29A) or non-penetrating electrodes (FIG. 29B) similar to those shown in FIGS. 28A-28D. [Figure 30] FIG. 30 illustrates an example of a treatment tip as described herein. [Figure 31] Figures 31A-31D show another example of a treatment tip having a suction chamber with a transparent window for viewing the target tissue and an example of a cylindrical electrode, where Figure 31A shows the transparent window with the electrode advanced to contact tissue in the suction chamber, Figure 31B is the same as Figure 31A but with the electrode retracted, Figure 31C is a cross section through the treatment tip shown in Figure 31A, and Figure 31D is a cross section 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 where the controller is configured to apply negative pressure to the suction chamber. [Figure 32] Figure 32A shows an example of a distal end region of a treating tip having multiple electrodes (in this example, non-penetrating electrodes) with adjacent suction regions. Figure 32B shows the electrode holder and main body of the treating tip shown in Figure 32A. Figure 32C shows a cross-sectional view of the treating tip of Figures 32A-B with the electrodes extended. Figure 32D shows a cross-sectional view of the treating tip of Figures 32A-B with the electrodes retracted. Figures 32E-32F show another example of a treating tip with the electrodes retracted (Figure 32E) and extended (Figure 32F), respectively. DETAILED DESCRIPTION OF THE INVENTION

[0091] For the purposes of clarity and brevity, certain aspects of components or steps of particular embodiments are presented without unnecessary detail where such detail would be apparent to those skilled in the art in light of the teachings herein and / or where such detail would obscure an understanding of the more relevant aspects of the embodiments.

[0092] Described herein are apparatus (eg, devices, systems, etc., including treatment applicators) adapted for use in applying electrical energy into target tissue.

[0093] As used herein, a treatment applicator includes one or more electrodes for applying pulsed electrical energy, and particularly sub-microsecond pulsed electrical energy, to tissue. A treatment applicator may be simply referred to as an "applicator," or equivalently, an applicator device. The treatment applicators described herein may be configured as disposable or detachable treatment tips. Thus, detachable and disposable treatment tips are a subset of treatment applicators that may be attached to and / or detached from handpieces, particularly including reusable handpieces. When a disposable / detachable treatment tip is coupled to a handpiece, the assembly may be referred to as a treatment applicator assembly. In some examples, a treatment applicator includes a treatment tip (treatment tip region) that is integrated into a handpiece.

[0094] Any of the treatment applicators described herein may include one or more electrodes or groups of electrodes. An electrode may generally be a conductive portion of a treatment applicator configured to contact tissue and deliver pulsed energy to the tissue. As used herein, a group of electrodes may be multiplexed together to contact tissue at multiple discrete and / or different locations but apply energy together and act as if they were a single electrode. For example, in some cases, a treatment applicator may be configured to apply suction between different electrodes (e.g., needle electrodes, pin electrodes, etc.), which may be multiplexed together (or may be separately addressable). In some examples, a treatment applicator may be configured to apply a vacuum between multiple groups of electrodes (e.g., a first set of electrodes that may be multiplexed together and act as "positive" electrodes, and a second set of electrodes that may be multiplexed together and act as "negative" electrodes).

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

[0096] The treatment applicators described herein can be configured to use suction. In some of the treatment applicators described herein, the electrodes can be biased (e.g., spring-loaded), non-penetrating, or tissue-penetrating (e.g., sharp-pointed) electrodes that can be slightly displaced by contact with the tissue and apply a force against the tissue surface. Suction can be used to hold the tissue and electrode in contact. The treatment applicators described herein can apply electrical therapy (e.g., pulsed, sub-microsecond, including nanosecond, electrical therapy) to the tissue surface.

[0097] Some embodiments of the treatment applicators described herein can be adapted to apply electrical therapy in a region of tissue that is just below (e.g., superficial to) the surface of the tissue. For example, described herein are treatment applicators that include a suction chamber with one or more electrodes, including, but not limited to, tissue-penetrating electrodes that can extend laterally into the tissue. In some embodiments, the treatment applicators described herein include a suction chamber with one or more non-penetrating electrodes that can be held securely against the tissue. In some embodiments, the electrodes can each be independently energized against the tissue.

[0098] Any of these devices may include a pulse generator as part of a system that includes a treatment applicator (e.g., tip, handpiece, etc.). For example, FIG. 1 shows an example of a system 100 that may be used with or incorporate any of the treatment applicators described herein. The system shown in FIG. 1 for delivering high-voltage, high-velocity pulses of electrical energy (also referred to herein as a high-voltage system or sub-microsecond generation system) may include an elongated treatment 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) through a cable and connector 106. The treatment applicator 102 may include an electrode (e.g., as part of an electrode tip) and may be connected to the housing 105 and electronic components therein through a cable 137 and a high-voltage connector 112. Examples of treatment applicators are described in more detail below. The high-voltage system 100 may also include a handle 110 and a storage drawer 108. The system 100 may also include a holder (eg, a holster, a carrier, etc.) (not shown) that 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 a treatment applicator handpiece. In some variations, the treatment tip can be adapted to make electrical, mechanical, and pressure connections, as described in more detail below. In some embodiments, the system can include or be configured to operate with a negative pressure (e.g., suction, vacuum, etc.) source. In some embodiments, the treatment applicator handpiece can include a built-in source of suction that can be used to apply suction at the tip.

[0100] A human operator may select the number of pulses, amplitude, pulse duration, and / or frequency information, for example, by entering such parameters into a numeric keypad or touch screen of interface 104. In some embodiments, the pulse width may be varied. Controller 144 (e.g., a microcontroller) may send signals to pulse control elements within system 100. In FIG. 1, the controller (which may include one or more processors and other control circuitry, including memory) is shown within housing 105, but may 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 processor may include multiple processors. In some embodiments, fiber optic cabling is used to enable control signal transmission and electrically isolate the contents of sub-microsecond pulse generation system 100, e.g., a metal cabinet containing high-voltage circuitry, from the outside. To further isolate the system electrically, system 100 may be battery-powered instead of being powered by a wall outlet.

[0101] The elongated treatment applicator tool can be handheld (e.g., by a user) or can be affixed to a movable arm of a robotic system, and its operation can be at least partially or fully automated, including computer-controlled. In some implementations, a solenoid (not shown) can be used to deploy and / or retract electrodes of the treatment applicator. For example, a foot pedal, button, or any other control mechanism that applies an electric current to the solenoid can be used, which can force the electrodes to deploy and / or retract. Any other type of actuator device can be used in place of a solenoid. The solenoid can be used in conjunction with a bias (e.g., a spring). For example, any of these devices can include a biased solenoid that deploys an electrode, such as a tissue-penetrating electrode, into tissue when power is applied to the solenoid. When a user activates the solenoid, the electrode can be driven into tissue, and driving the electrode into tissue can also apply a load to the bias. When power to the solenoid is removed (e.g., after application of a treatment), the power to the solenoid can be removed and the bias can withdraw the electrodes from the tissue, or the solenoid can be configured to withdraw one or more electrodes and the bias can be configured to deploy the electrodes out of the tissue (responding to the bias).

[0102] As mentioned above, the methods and devices described herein include a treatment applicator including one or more sets of electrodes for applying electrical energy to tissue. The treatment applicator may include a tip portion and a handpiece portion. The tip portion and handpiece may be separate or may be a single, integrated treatment 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 source of negative pressure (e.g., suction or vacuum) that can be applied through the electrodes to modify contact between the tip portion, particularly the electrodes on the tip portion, and tissue. In particular, the handpiece may include a built-in vacuum source.

[0103] In any of the methods and devices described herein, suction may be controlled by one or more controls on the tip and / or handpiece portion of the treatment applicator. In some examples, suction may be controlled manually by a user-actuated bleed valve. When the valve is opened, suction is applied through the valve, and very little suction may be applied at the tissue contact area of ​​the tip, but closing or obstructing the bleed valve, for example, by covering the bleed valve with a finger or hand, may increase suction through the suction port at the tip.

[0104] Surface Treatment Applicator Treatment applicators as described herein can be configured to deliver electrical treatment or therapy to the surface of tissue. These treatment applicators can include either penetrating or non-penetrating electrodes, or both. In some examples, treatment applicators of the present disclosure can include an electrode housing extending from the distal end of the treatment tip and one or more (e.g., multiple) suction ports opening into the electrode housing. Generally, these treatment applicators can include multiple non-penetrating electrodes extending from the electrode housing. Non-penetrating electrodes are configured not to penetrate tissue and not extend from the treatment applicator housing. In some examples, the electrodes extend from suction ports in the electrode housing. In some examples, the electrodes extend adjacent to one or more suction ports in the electrode housing; for example, an electrode or set of electrodes can extend from an opening in the electrode housing adjacent to (including being surrounded or partially surrounded by) one or more suction ports. In the extended configuration, the non-penetrating electrodes can extend away from the treatment applicator distal face. The non-penetrating electrode can be configured to retract into the electrode housing when actuated against tissue, and can be, for example, spring-loaded. For example, the non-penetrating electrode can be connected to (or include) a bias that presses against the tissue when actuated against tissue, causing the non-penetrating electrode to return to the extended configuration. Examples of non-penetrating electrodes can include surface or plate electrodes, blunt needle electrodes, cylindrical electrodes, wires, bars, coils, or blunt pin or needle electrodes.

[0105] An example of a treatment applicator including multiple spring-loaded electrodes with suction ports is shown in FIG. 2A. In this example, the treatment applicator 200 is shown in cross section above the target tissue 203. The treatment applicator includes three spring-loaded non-penetrating electrodes 205. Each electrode in this example is configured similar 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, which may be electrically isolated from the electrode's conductors. In this example, the outer body 211 is held fixed within the electrode housing 201, but the pin body 209 may be retracted when actuated against tissue, as shown in FIG. 2B.

[0106] As shown in FIG. 2B, the distal face (e.g., treatment tip) of the treatment applicator can be pressed against the tissue (e.g., skin) surface. The non-penetrating electrodes in this example are shown as rounded and relatively large diameter so as not to penetrate the tissue. In some examples, the non-penetrating electrodes can be blunt and / or flat. The treatment applicator also includes a seal 213 around all or a portion of the electrode. In FIGS. 2A-2C, the seal is formed by a flange or rim, which can be formed of a silicone material, that surrounds the electrode. The seal can press against the skin. In FIG. 2B, each electrode is individually (and independently) displaced proximally as the device contacts the skin surface.

[0107] Negative pressure (e.g., vacuum, suction, etc.) may be applied through one or more suction ports 215, which are fluidly connected to a negative pressure source through suction channel 217. In some embodiments, suction may be applied prior to contacting tissue. Alternatively, in some embodiments, suction may be applied after contacting tissue and may be triggered by displacing one or more of the electrodes. FIG. 2C shows the tip shown in contact with tissue, with the tissue being 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 against the tissue.

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

[0109] For example, Figures 3A-3B show a first example of a treatment tip including retractable non-penetrating electrodes for applying energy to the surface of tissue. In Figures 3A-3B, a treatment applicator 300 includes an electrode housing 301, which also extends (in this embodiment) from a treatment applicator housing 302. In this embodiment, four non-penetrating electrodes 305 are included at the tip, and each of these four electrodes is individually biased so that it can retract slightly when driven against tissue. For example, each electrode can be internally biased (as shown in Figures 2A-2C above). Each electrode can extend from a suction port 315 (as shown, multiple electrodes can extend from the same suction port). In this embodiment, the electrodes are blunt, smooth pins that are less likely to arc and do not require the protective retractable feature of a needle housing to shield against unintentional protrusion.

[0110] 4A-4B show another example of a treatment tip 400 including an array (4x2) of non-penetrating electrodes 405 that are spring loaded to retract into an electrode housing 401 similar to that described above in FIGS. 2A-2C and 3A-4B. The electrode housing may be electrically insulating in whole or in part (e.g., an outer coating) and / or may be formed of a soft or deformable material. The array of non-penetrating electrodes shown in FIGS. 4A-4B may cover, for example, an approximately 5 mm x 5 mm square. The electrodes in this example 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] 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., spring-loaded, retractable, pogo pin-type electrodes). The spring-loaded, retractable electrodes can contact and apply pressure to the tissue surface. The outer surface of the electrode housing 501 can be made of a soft (e.g., low durometer) material that can help seal the tip against the tissue during treatment. In any of these examples, the distal surface of the electrode housing can include a seal configured to contact and seal against the tissue when a vacuum is applied. The seal can surround each electrode or set of electrodes separately, or can surround all of the electrodes (e.g., the distal end face of the treatment tip). Suction can be applied through suction ports 515. In the example shown in FIGS. 5A-5C, each of the two sets of electrodes extends from a suction port 515 so that suction can be applied around the electrodes.

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

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

[0114] Any suitable electrode may be used. For example, FIGS. 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 at either end within the electrode housing 701, and one or both ends may be coupled to a bias (e.g., a spring) that allows the electrode to be extended and pushed (retracted) into the electrode housing against the bias when actuated against tissue (as shown in FIG. 7C). For example, the wire electrode shown in FIGS. 7A-7C may incorporate an internal spring that allows the electrode to be retractable and function like the pogo-style electrode shown in FIGS. 3A-3B, and may apply a constant force to the tissue during energy application. Suction may be applied around the wire loop electrode.

[0115] 7A-7C, two non-through-wire electrodes are shown, in some embodiments, fewer (e.g., one) or more (e.g., three, four, five, etc.) non-through-wire electrodes may be included.

[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 support continuous contact with tissue. Figures 8 and 9 show example tips (with the treatment applicator housing removed) that include multiple suction ports and a sealing ring. Figures 8 and 9 each show a treatment tip with a wire (or "bar") electrode, where the distal face of the treatment tip includes a sealing area (seal) around the electrode and suction port. While these examples show a single seal, in some embodiments, multiple and / or different seals may be used around a subset of the electrodes and suction ports.

[0117] In FIG. 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-like structure for securely fastening to tissue. Two wire (e.g., bar) electrodes 805 are included, and multiple suction ports 815, including one or more suction ports down the length of the wire electrodes, are shown parallel to the distal face. The multiple suction ports can help eliminate air gaps between the electrode and tissue, allowing for better contact with the tissue and reducing or avoiding arcing. In FIG. 8, a 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 variations, suction from the tip may be controlled by one or more suction controls that the user may operate. In some embodiments, the suction control may include a bleed valve. For example, when suction is turned on and the bleed valve (suction control) is opened, the suction port 815 may provide only minimal suction (or no suction). However, the user may occlude (or otherwise close) the bleed valve with a finger or hand so that suction is preferentially applied from the suction port 815 on the tip. In some embodiments, application of suction may draw tissue into contact with the electrodes. Suction may be released by releasing or removing the cover from the bleed valve.

[0119] The exemplary treatment tip 900 shown in FIG. 9 is similar to that shown in FIG. 8 and includes an electrode housing 901 and a soft silicone seal 913 formed around the distal face of the treatment tip, enclosing a wire electrode 905 and a suction port 915. As in FIG. 8, the seal forms a suction chamber. In FIG. 9, three bar electrodes are shown, rather than the two shown in FIG. 8. In some embodiments, the tip can be configured to include both an anodic and cathodic electrode, or can be monopolar, and a return electrode (e.g., a ground pad) can be used. For example, the center electrode can be an anode and the two outer electrodes are cathodes.

[0120] 10A-10F show examples of treatment tips 1000 that include a curved or angled distal surface on which non-penetrating electrodes and suction ports are disposed. The angled surface of the distal tip can aid in the accessibility and visualization of some lesions (especially difficult to reach lesions), and electrode tips can be configured at various angles relative to the treatment tip. For example, FIG. 10A shows an example of a distal tip in which the curved or angled distal surface 1022 is angled at approximately 20 degrees relative to the vertical plane shown in FIGS. 8 and 9 (e.g., 80 degrees relative to the long axis 1025 of the tip). Similarly, FIG. 10B shows a treatment tip 1000 in which the distal surface 1022 of the tip is angled at approximately 45 degrees relative to the long axis 1025. In FIGS. 10C and 10D, the distal surface 1022 is angled at approximately 70 degrees relative to the vertical plane (e.g., 20 degrees relative to the long axis 1025 of the treatment tip). Finally, in Figures 10E and 10F, the distal surface 1022 of the treating tip 1000 is parallel to the long axis of the treating tip (and angled at approximately 90 degrees relative to the vertical plane of the treating tip).

[0121] Various configurations of non-penetrating electrodes, such as wire (e.g., bar) electrodes, pin electrodes, etc., can be used with suction ports and can include multiple rows and / or multiple poles (e.g., configured as anode / cathode pairs). For example, FIGS. 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 can be used with suction through one or more suction ports 1115 of a larger surface electrode, which can include multiple rows and / or multiple poles extending from the electrode housing 1101, as shown. Dimensions can be, for example, 10-30 mm (e.g., forming a 25 mm x 25 mm square, a 30 mm x 30 mm square, or any rectangular shape, etc.). The spring-loaded electrodes described herein can be particularly useful for large arrays, as individually biased electrodes can more easily adjust to variations in depth or height of tissue surfaces, which can be curved and / or irregular.

[0122] As shown in Figure 11B, vacuum or suction applied under and / or around the wire or bar electrode 1105 through multiple suction ports 1115 can help eliminate any air gaps and allow for a better 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 suction channels 1117 formed through the electrode housing. The suction channels can be continuous with the suction ports 1115 and a negative pressure source.

[0123] In any of these treatment tips of the present disclosure, suction can be applied to assist the tissue in contacting the electrode. Thus, suction can be applied after or before contacting the tissue. In some embodiments, suction can be applied only for a period just prior to and during the application of energy from the electrode. Figures 12A-12E show other examples of suction port configurations that are particularly beneficial for reducing arcing, as described below. Figures 12B-12C demonstrate three different sizes of treatment tips, each with a non-penetrating electrode and suction configured in accordance with one or more aspects of the present disclosure. Figure 12A shows a side perspective view of the treatment tip, showing the connection to a suction line (e.g., a negative pressure source) 1208 extending from the treatment applicator body (e.g., treatment applicator housing 1202). An electrical connector 1223 extends from the proximal end of the tip, and a mechanical connector (release 1221) can releasably couple the tip to a handpiece. The distal end of the treatment tip includes an electrode housing 1201 from which extend multiple non-penetrating (e.g., spring-loaded) electrodes. FIGS. 12B-12D show different tip sizes, each shown with a wire or bar electrode that can be biased to extend and retract upon contact with tissue, as described above. In this example, the tips of FIGS. 12B-12E each include a suction port 1215 around the electrode 1205, each configured as a continuous channel extending beyond the respective electrode 1205 visible within the channel or port 1215. The individual suction ports can include individual seals around the electrode. In the example of FIGS. 12A-12E, each electrode can be individually sealed to tissue by a seal formed on the tip around each electrode and suction port. FIG. 12E shows example tips of different sizes, but all similarly configured with suction ports that extend far enough beyond the electrode to reduce / avoid arcing, each of which can be used with the same handpiece to form a complete treatment applicator. This novel configuration of suction ports located between the electrodes and extending beyond the two ends of each electrode may be incorporated into any of the embodiments and figures of the present disclosure, including but not limited to, the treatment applicator designs of Figures 13A-13B and 14A-14C below.

[0124] In any of the devices and methods described herein, suction may be applied continuously but may not be activated at the tip until suction is focused at one or more suction ports at the tip by actuating a suction control, which may include a bleed valve. Suction may be provided from a pump (such as a vacuum pump, suction pump, etc.) or from a suction chamber or other device such as a syringe.

[0125] FIGS. 13A-13B show another example of a treatment tip 1300 similar to that shown in FIGS. 12A-12B, but with a spring or coil electrode as the non-penetrating electrode 1305. This electrode also extends from the housing 1301 and can be spring-biased (e.g., biased to extend from the electrode housing and can be pushed back into the housing by the force of contact with tissue). Suction ports 1315 can be used to draw tissue against the non-penetrating electrodes. FIG. 13B shows a close-up view of the distal end of the treatment tip shown in FIG. 13B. Each non-penetrating (spring) electrode resides within a suction chamber that is bounded on 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 positioned between the three electrodes shown. Alternatively or additionally, in some embodiments, a vacuum is provided for each non-penetrating electrode.

[0126] In the treatment applicator shown in Figures 13A-13B, the electrodes are separated by continuous suction ports 1355, which may extend further than the length of each electrode, thereby reducing or preventing arcing. As described in more detail below with reference to Figures 15A-15D through 19A-19D, the shortest distance between electrodes (or sets of electrodes) that passes around a continuous suction barrier between the electrodes (or sets of electrodes) may be 5% or more (e.g., 10% or more, 12% or more, 15% or more, 17% or more, 20% or more, 25% or more, 30% or more, etc.) of the minimum distance between the electrodes (or sets of electrodes) disregarding the continuous suction barrier. The shortest distance between electrodes (or sets of electrodes) that passes around a continuous suction barrier between the electrodes may be referred to as the collision distance.

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

[0128] In any of the embodiments described herein, the electrodes can be tissue-penetrating electrodes. For example, in FIGS. 14A-14C, the electrodes can be tissue-penetrating needle electrodes. Suction ports 1415 are shown positioned around and below each row of needle electrode sets. Each suction port can surround all of the electrodes in its respective row and extend at least slightly further than the row to achieve the benefits discussed with reference to FIG. 12. In this embodiment, the needles can be fixed in place relative to the tip so that when suction is applied, the needles are inserted into the tissue as it is drawn into the vacuum cavity. Alternatively or additionally, in some embodiments, the needles can be extendable / retractable. In some embodiments, the needles can be individually actuated and / or individually extendable or retractable.

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

[0130] Any of the treatment applicators described herein can be configured to prevent or reduce arcing by including a region of continuous attraction 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 the electrodes. Thus, the continuous attraction barrier region can increase the impact distance between the active electrodes or sets of electrodes. For voltage ranges typically used by the methods and devices described herein (e.g., about 0.1 kV / cm to about 500 kV / cm), the treatment applicators described herein can have an impact distance that is 10% or more (12% or more, 15% or more, 17% or more, 20% or more, 22% or more, 25% or more, 27% or more, 30% or more, etc.) longer than the minimum distance between the electrodes or sets of electrodes (ignoring the continuous attraction barrier), where the impact distance is the shortest distance between the electrodes or sets of electrodes around the continuous attraction barrier. In effect, the impact distance is the shortest path along which voltage can flashover or arc between the electrodes or sets of electrodes. The operating voltage of the tip can vary the impingement distance (e.g., with a higher operating voltage, a longer impingement distance can be used). In treatment tips such as those shown in Figures 2A-2C, 3A-3B, 4A-4B, 5A-5C, 6A-6C, and 7A-7C, the electrode or set of electrodes that delivers treatment can each be surrounded by suction, thereby reducing or eliminating arcing. Alternatively or additionally, continuous suction ports can separate and extend beyond the electrodes or set of electrodes to prevent or reduce arcing in addition to firmly securing the tissue during energy application.

[0131] For example, Figures 15A-15D, 16A-16D, 17A-17D, 18A-18D, and 19A-19D all show examples of treatment applicators (configured as treatment tips) in which the continuous suction port extends between the set of electrodes that deliver the 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) that deliver the treatment such that the continuous suction port extends further than the length of the electrodes or set of electrodes.

[0132] 15A-15C show another example of a treatment applicator configured as, for example, a removable / replaceable treatment tip 1500 including multiple tissue-penetrating electrodes 1505, 1505′ on either side of a suction port 1515. In this example, 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 multiplexed together. A second set of electrodes 1505′ to the right of the suction port are also multiplexed together. For example, the first set of electrodes can act as a cathode and the second set of electrodes can act as an anode. FIG. 15A shows the treatment tip with the needle electrodes retracted into the electrode housing 1501, while in FIG. 15B, the electrodes 1505, 1505′ extend distally from the electrode housing 1501 on either side of the suction port 1515. The suction ports 1515 extend in a continuous line between the set of electrodes 1505 such that the electrodes (which may be combined or multiplexed together, as described above) forming the anode electrodes are continuously separated from the cathode electrodes and extend beyond the end of the electrode or set of electrodes. The electrode housings are shown extending distally from the applicator housing 1503; in some embodiments, the electrode housings may retract into the applicator housing; a bias (e.g., a spring) may tend to keep the electrode housing extended; however, a user may drive the electrodes into the tissue by driving the applicator housing distally when tissue is held 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 within a channel 1518. The electrodes are separated from the central suction port 1515 by a sidewall 1522 that may seal against tissue when suction is applied. Each electrode in a set of electrodes may be electrically coupled such that energy may be applied between the set of electrodes.

[0133] As mentioned above, the example shown in FIGS. 15A-15C includes a single suction port 1515 (e.g., vacuum port) between the sets of electrodes, which can help ensure tissue contact with the electrode housing. This continuous suction port, which extends between the electrodes and beyond the ends of the electrodes, can also help prevent arcing during use. FIG. 15D illustrates the relative positions of the first set of electrodes, the second set of electrodes, and the suction port 1515. In this example, the suction port 1515 forms a continuous suction barrier that increases the impingement distance 1557 between the active electrodes or sets of electrodes to be 5-10% or more longer than the minimum distance 1555 between the sets of electrodes ignoring the continuous suction barrier. As mentioned above, the impingement distance 1557 is the shortest distance between the electrodes or sets of electrodes around the continuous suction port and is shown in FIG. 15D by the longer dashed line. In these examples, the impingement distance, and the minimum distance not including the suction port, can be measured along the surface of the electrode housing 1501, as shown in FIG. 15D.

[0134] FIGS. 16A-16C show an example of a treatment tip 1600 in which dual suction ports 1615 each form a continuous suction port between two sets of electrodes 1605. Each set of electrodes is adjacent to an inner suction port (as indicated by 1622). The two sets of electrodes each reside within a channel 1618 in the electrode housing 1601, which extends relative to the applicator housing 1603. In FIG. 16A, the electrodes are shown retracted into the applicator housing, while in FIG. 16B, the electrodes are shown extending from the applicator housing. As in FIGS. 15A-15C, the electrodes are sharp, tissue-piercing electrodes. In FIG. 16C, a distal end view of the tip shows that each elongated suction port 1615 draws tissue between the sets of electrodes, preventing arcing and securing the tissue against the tip so that the electrodes can penetrate into the tissue. As in FIGS. 15A-15C, the suction ports are not connected to the channels (slots) through which the electrodes extend and retract. Each suction port forms a continuous suction port (barrier) between the sets of electrodes through which therapy is delivered, extending over the length of each set of electrodes.

[0135] 16D shows an increase in the collision distance 1657 between the first set 1605 and the second set 1605′ of electrodes due to the continuous suction barrier 1515 such that the collision distance 1657 is more than 5% (in this example, more than 15%) longer than the minimum distance 1655 between the sets of electrodes ignoring the continuous suction barrier. The collision distance 1657 is shown in FIG. 16D as the longer dashed line, and the minimum distance 1655 without the suction ports is shown as the shorter solid line, both of which may be measured along the surface of the electrode housing 1601 as shown in FIG. 16D.

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

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

[0138] 18A-18D show another example of a treatment applicator (e.g., treatment tip) including a pair of C-shaped suction ports that extend partially around electrodes 1805, 1805′. The treatment applicator 1800, in this example, includes an electrode housing 1801 extending from an applicator housing 1803 and includes two sets of tissue-piercing (e.g., needle) electrodes 1805, 1805′ that can 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 can be coupled to the same suction source or can be coupled to separate suction sources. The electrodes can move relative to the applicator housing, or the applicator housing can move relative to the electrodes, or both. Figure 18A shows the treatment applicator with the electrodes retracted into the applicator housing. Figure 18B shows the treatment applicator with the electrodes extending from the applicator housing. Figure 18C shows a front view of the treatment applicator. The electrodes shown in Figures 18A-18D are tissue-penetrating (e.g., needle) electrodes, although this configuration can also be used with non-penetrating electrodes.

[0139] The treatment applicator shown in FIGS. 18A-18D is configured to reduce arcing between a first set 1805 of electrodes and a second set 1805′ of electrodes when operated at a relatively high voltage (e.g., from about 0.1 kV / cm to about 500 kV / cm, including from about 1 kV / cm to about 500 kV / cm, from about 5 kV / cm to about 500 kV / cm, from about 10 kV / cm to about 500 kV / cm, etc.). For example, as shown by dashed line 1857 and solid line 1855 in FIG. 18D, the collision distance 1857 between the first set 1805 of electrodes and the second set 1805′ of electrodes is more than 5% (in this example, more than 25%) longer than the minimum distance 1855 between the sets of electrodes disregarding the continuous suction barrier. Each C-shaped suction port is continuous and extends the length of the set of electrodes.

[0140] 19A-19C show another example of a treatment applicator in which electrodes 1905, 1905' are separated by a continuous suction port 1915 that extends over the length of each set of electrodes 1905, 1905'. In this example, the suction port 1915 has an I-shape that extends partially around each set of electrodes 1905, 1905'. Like the examples shown in FIGS. 15A-15D, 16A-16D, 17A-17D, and 18A-18D, the treatment applicator 1900 of FIGS. 19A-19D also includes an electrode housing 1901 that extends from an applicator housing 1903.

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

[0142] The treatment 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 show examples of treatment applicators configured as treatment tips. These treatment tips may be attached or otherwise coupled to a pulse generator handpiece to form a treatment applicator assembly. Alternatively, any of these treatment applicators may be configured to include an integrated handpiece / handle.

[0143] Superficial Treatment Applicator Further described herein are treatment applicators configured to be particularly useful as superficial treatment applicators, in which the entire treatment occurs below the tissue surface, e.g., below the epidermis in the case of skin treatment. While many of the embodiments disclosed below are shown having penetrating electrodes, it should be understood that some of these embodiments can be implemented using non-penetrating electrodes, e.g., by adjusting the energy level. Treatment applicators with non-penetrating (e.g., superficial) electrodes can deliver electrical energy, such as nanosecond pulses, below the surface, e.g., to a depth of 1 mm to 5 mm. Any of these treatment applicators can include a suction chamber adapted to be held against the tissue surface (e.g., the skin surface) and draw the tissue into the suction chamber. Once in the chamber, one or more electrodes can then extend across the suction chamber into or against the tissue. In some embodiments, the electrodes can be tissue-penetrating electrodes (e.g., needle electrodes) inserted substantially parallel to the tissue surface. The top of the suction chamber can be transparent so that the tissue (e.g., skin) can be viewed therethrough and can include one or more markings to guide the user. In some embodiments, the one or more markings may indicate the path of one or more electrodes. Thus, the upper surface may be a viewing window. In some embodiments, the viewing window may include magnification to enhance the view of the tissue. The one or more markings may include crosshairs, a bull's-eye, or the like. Such a configuration may allow the target lesion or treatment area to be viewed, improving proper positioning and targeting both during positioning of the treatment applicator and throughout treatment.

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

[0145] For example, Figures 20, 21, 22A-22C, 23A-23C, 24A-24D, and 25A-25B show examples of treatment applicators that include a suction chamber and one or more needle electrodes adapted to extend across and penetrate parallel to the open bottom surface of the suction chamber. Such treatment applicators with penetrating electrodes are particularly useful for various subsurface applications of tissue, including, but not limited to, for subsurface skin treatments where it is desirable to avoid the epidermal layer of the skin.

[0146] Generally, the suction chamber can be adapted to receive tissue, which can be drawn into the chamber and retained by suction applied from at or near the top of the chamber. The chamber can be sized to allow it to substantially fill with tissue (e.g., skin) when suction is applied. The chamber can include a top surface, which can be flat or curved (and in some variations, can include a window comprising an optically transparent material). The sides of the chamber can be angled or curved, wider at the open bottom or base and narrower near the top. The chamber can be rounded (e.g., circular or oval). In some embodiments, the chamber is longer in length (diameter) than it is deep. The bottom of the chamber is open and can be placed on tissue so that suction (negative pressure) applied to the chamber can draw the tissue into the suction chamber. The bottom, which opens into the suction chamber, can include a seal, such as a flexible and / or compressible material (e.g., silicone), that can seal against the tissue when suction is applied, drawing the tissue into the chamber.

[0147] As mentioned above, any of these devices, including those having a suction chamber such as those shown in FIGS. 20, 21, 22A-22C, 23A-23C, 24A-24D, and 25A-25B, may include a suction control that may allow suction to be turned on and off within the suction chamber. In any of these devices, suction (negative pressure) may be turned on but diverted from the suction chamber by one or more bleed valves that may be occluded by the user to turn suction on or off within the suction chamber. For example, manual occlusion (e.g., using a finger, thumb, palm, etc.) may cause suction to be preferentially applied to the suction chamber. Releasing the occlusion of the bleed valve may redirect suction through the bleed valve, releasing suction from the suction chamber. Alternatively, suction for the device may be turned off entirely.

[0148] Figure 20 shows an example of a treatment applicator 2000 including a hand piece 2002 that may be removably attached to a tip 2001 that includes a suction chamber 2035. In some embodiments, the tip may be integrated with the hand piece, as shown in Figure 20. The hand piece may include one or more controls 2031 that may be used, for example, to trigger the application of a 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 treatment applicator may also include a viewing window 2033 through which the target tissue may be viewed. As mentioned above, the window may be transparent.

[0149] FIG. 21 shows another example of a treatment applicator 2100 that can 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 FIG. 21, the suction chamber 2135 includes a transparent upper surface configured as a viewing window 2133 and including guides (shown as concentric bull's-eye rings) that can assist the user in targeting the portion of tissue to be treated. The handpiece also includes one or more controls 2131, such as a slider that extends / retracts the needle electrodes into the suction chamber. Suction can be applied to draw at least a superficial portion of the tissue (e.g., skin) into the suction chamber. In some embodiments, the electrode tip can be detachable from the handpiece and replaced with a different tip.

[0150] FIG. 22A shows an example of a top view of a treatment tip including a suction chamber. In FIG. 22A, the suction chamber includes an optically transparent upper surface (e.g., viewing window 2233). In FIG. 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., LED, light pipe, etc.) that illuminates tissue, including the target tissue. In some embodiments, the viewing window may include a filter. FIGS. 22B and 22C show cross-sectional views through the suction chamber portion of the tip. As shown in FIG. 22B, the needle electrode 2205 can be housed within the tip and fully retracted into the side of the suction chamber 2235. The bottom 2236 of the suction chamber is open, and the suction chamber includes only one continuous conical wall. The wall includes an opening into the applicator housing 2240 through which the needle electrode can 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 region between the top surface and the wall). In FIG. 22B, the needle electrode is shown fully retracted into the wall of the suction chamber. In FIG. 22C, the needle electrode is fully extended across the suction chamber, thereby extending parallel to the bottom open end of the suction chamber, with the tip of the needle electrode engaged with the wall opposite the opening where the needle extends into the receiving opening 2248. In this example, the needle is configured such that the distal end region (tip region) 2250 is insulated, as is the more proximal end region 2251, so that energy is delivered only from the lateral, uninsulated portions. In some examples, multiple regions along the length of the needle are insulated and exposed, allowing for targeting of different regions.

[0151] Any of the suction chambers disclosed herein may be configured so that the depth of the suction chamber can be adjusted, thereby allowing for adjustment of the depth of treatment. The longer the distance between the lens and the electrode, the deeper the treatment will occur 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 FIGS. 22A-22C, the expandable region may be a threaded region that can be screwed tighter (to shorten the chamber) or loosened (to expand the chamber). In some embodiments, the suction chamber may have a fixed depth.

[0152] FIGS. 23A-23C show an example of a treatment tip showing three needle electrodes. In this example, the top surface is a transparent viewing window through which tissue can be viewed. When no tissue is in the suction chamber, the three needle electrodes can be seen partially extended in FIG. 23A and fully extended in FIG. 23B. As mentioned above, the needle electrodes 2305 can be insulated at the distal tip 2350 and at a more proximal region 2351, leaving an uninsulated region 2352 where energy can be applied. Energy can be applied between two or more of the needle electrodes (in a bipolar or tripolar configuration), or a ground pad or other return electrode can be used (in a monopolar configuration). The electrical insulation can be any suitable electrically insulating material, such as polyimide or equivalent. This insulation pattern can limit the treatment area to the center of the targeted location shown through the transparent viewing window.

[0153] In FIG. 23A, the control 2331 on the handpiece can be driven distally (as shown in FIG. 23B) to extend the needle electrodes across the suction chamber. The same control or a second control can be used to trigger the application of energy (e.g., nanosecond pulsed 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 can be larger or smaller, e.g., the diameter of the suction chamber can be, e.g., 4 mm to 60 mm (e.g., 5 mm to 30 mm, 5 mm to 25 mm, etc.). The depth can be, e.g., 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 can be adjustable. FIG. 23C shows a bottom view of the suction chamber of the device of FIG. 23B, including tissue within the suction chamber and fully deployed needle electrodes.

[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 (eg, may be the active area).

[0155] Figures 24A-24D show the operation of one example of a treatment tip configured to treat superficial tissue using a suction chamber and needle electrodes that move parallel to an open bottom surface. In Figure 24A, a cross section through the suction chamber shows the device applied onto tissue (such as skin tissue) 2445 before any suction is applied. The open bottom side of the suction chamber can 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 in the suction chamber to draw tissue into the suction port 2415. The open bottom surface can include a peripheral seal material (e.g., silicone) that seals against the tissue. The needle electrodes 2405 are fully retracted to the side of the suction chamber, as shown in Figures 24A-24B. In FIG. 24C, as tissue is drawn into the suction chamber, the needle electrode can be driven into the tissue 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. FIG. 24D shows the needle electrode fully extended, exposing the central active area 2452. Energy can then be applied from the uninsulated middle region of the needle electrode. In some embodiments, treatment can occur between the active areas. To increase the treatment area, the number of active areas (e.g., the number of needles with active areas) can be increased. In some embodiments, the number of needles and / or active areas can be increased to increase the treatment area. Portions or regions of the needle can be insulated to form inactive regions 2462, such as regions proximal and distal to the active region, as shown in FIG. 24D.

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

[0157] In some embodiments, the return electrode can be part of the suction chamber, such as a portion of the top surface. For example, FIGS. 25A-25B show an example configuration in which the suction chamber includes a plate (one electrode) 2566 that will contact tissue, such as skin, at the top of the suction chamber. A needle electrode 2505 can be inserted into tissue held within the suction chamber and inserted below the top of the tissue or skin. A needle electrode can be positioned opposite this top electrode (e.g., a plate electrode or mesh electrode) 2566, which can act as a return electrode when extended across or partially across the suction chamber. In the exemplary treatment applicator 2500 shown in FIG. 25B, the top surface of the suction chamber can include a viewing window as described above or can be replaced with a solid plate electrode. In this embodiment, energy can be conducted between the needles, which are just below the surface of the tissue, and the plate electrode, which is at the skin surface on top of the suction chamber. The treatment tip can be placed on tissue, the vacuum can pull the tissue or skin flush flushed ...

[0158] 25B, a vacuum can be applied from above the plate electrode through suction port 2515 coupled to the suction channel. An open suction chamber 2536 can draw tissue up into contact with the return electrode. The various examples of treatment applicators with vacuum-assisted laterally deployed electrodes disclosed herein not only provide the benefits and advantages of improved targeting, but also reduce the pressure required to administer the treatment and reduce the number of electrodes (e.g., needles) required to administer the treatment, which in turn minimizes any tissue trauma or pain that may be associated with the insertion of needle electrodes.

[0159] Further described herein are treatment applicators that may be particularly well adapted for treating skin tissue by isolating the area of ​​skin to be treated within the treatment applicator prior to applying pulsed electrical therapy. Some of the devices described herein may use suction to draw the tissue area to be treated into a chamber to isolate it for treatment. Treatment may be applied to a portion of tissue (e.g., skin) drawn into the chamber by a tissue-penetrating or non-penetrating electrode. The chamber may accommodate 0.2 cubic cm or more (e.g., 0.3 cm) of tissue. 3 More than 0.4cm 3 More than 0.5cm 3 Over 0.6cm 3 More than 0.7cm 3 Over 0.8cm 3 Over 0.9cm 3 More than 1cm 3 The tissue may be drawn into the chamber of the treatment applicator and pulled over the surface of the tissue, away from other tissue, nearby sensitive areas such as the eye, mucous membranes, etc. These devices may include visualization, such as one or more windows into the chamber of the treatment applicator.

[0160] Any of the devices and methods described herein may be used to treat conditions, lesions, or diseases, such as syringoma, seborrheic keratosis, keloid, molluscum contagiosum, sebaceous hyperplasia, congenital capillary malformation (port wine stain), melasma, actinic keratosis, dermatosis papulosus nigricans, angiofibroma, skin tumors, basal cell carcinoma (BCC), and warts. In some embodiments, devices and methods configured to draw the tissue to be treated into a chamber of a treatment applicator by suction, isolating it from nearby tissue areas that may be sensitive, before applying treatment, may be particularly useful in treating these conditions, including, but not limited to, syringoma.

[0161] For example, described herein are treatment application designs and corresponding methods that use suction to isolate tissue to be treated with pulsed electrical therapy from nearby non-treatment areas within the treatment applicator to improve safety. For example, facial areas, including particularly the areas around the eyes or intraorbital areas, and / or nearby mucous membranes, may be beneficially isolated using these methods and devices. In some of the treatment tips described herein, the suction chamber may be oriented so that its optical axis relative to the tissue extends through the treatment tip in the same direction as the electrode advances. For example, FIGS. 26A-26D show an example of a treatment applicator that includes a chamber that draws in the tissue to be treated and allows visualization through the treatment applicator. In the device shown in FIGS. 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, a wire electrode, a loop electrode, etc.).

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

[0163] In operation, the user may view the tissue through the treatment applicator and may 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 may be coupled to an external suction source. The user may then advance the retractable tip (within the body of the applicator housing) distally to position the electrode in contact with the tissue. If a tissue-penetrating electrode is used, the needle may be inserted distally into the tissue rather than parallel, as shown in the example above.

[0164] For example, in FIG. 26A, the treatment applicator 2600 includes a main body portion 2601 (configured as the applicator housing 2601 in FIGS. 26A-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 by applying suction. The electrode housing 2613 is internal to the applicator housing in FIG. 26A and includes two or more (e.g., two sets) electrodes 2605 that may extend distally of the electrode housing. In FIG. 26A, the treatment applicator includes a bias (compression spring or simple spring 2609) that is releasably locked in a non-deployed state. The bias holds the retractable tip together with the proximal electrode (e.g., needle electrode) until the controller 2607 releases the electrode housing to drive the electrode distally.

[0165] FIG. 26B illustrates operation of the device 2600 of FIG. 26A to draw tissue 2611 into the suction chamber. For example, a vacuum pump can draw tissue 2611 into the treatment tip, as shown. The user can then advance the electrode distally from the electrode housing to engage the tissue held within the suction chamber, as shown in FIG. 26C. In some instances, the user can actuate a control (e.g., a release control, an electrode advancement control, etc.) 2607 to drive the electrode distally. In some embodiments, the control can allow the user to manually advance the electrode distally (at a controlled rate) until the end of the electrode housing firmly contacts the tissue within the suction chamber (for non-penetrating electrodes) or is inserted (for tissue-penetrating electrodes). For example, the user can slide a control (e.g., a button, knob, slider, etc.) distally to drive the tissue-penetrating electrode into the tissue or until the non-penetrating electrode firmly contacts the tissue. Once the electrode is in or on the tissue within the suction chamber, treatment can 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 eye or within the orbit. The treatment applicator may be simple to use and may include visual guidance.

[0166] For example, FIG. 26D shows a close-up view of the distal end of the treatment applicator of FIGS. 26A-26C , showing the applicator housing 2601 with tissue 2611 drawn into it. The interior of the applicator housing forms a suction chamber that holds the tissue. In FIG. 26D , the electrode 2605 is a needle electrode that protrudes from the electrode housing 2613 within the applicator housing. For example, in use, the treatment applicator may retract into the suction chamber more than about 2 mm (e.g., more than 3 mm, more than 4 mm, more than 5 mm, etc.). In FIG. 26D , the retractable / extendable electrode housing is advanced distally until it firmly contacts the target tissue distally. The tissue-penetrating electrode protrudes from the electrode housing by about 1 mm in this example, so the device can insert the electrode up to this length (e.g., 1 mm).

[0167] FIGS. 27A and 27B show examples of exploded views of devices similar to those shown in FIGS. 26A-26D. In FIG. 27A, the treatment applicator (treatment tip 2700) includes, in the example, two tissue-penetrating electrodes 2703. In contrast, FIG. 27B shows a similar treatment device with two non-penetrating electrodes 2703′. Both variations comprise an elongated treatment applicator 2700 including 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 FIGS. 26A-26C. An electrode housing 2704 is held within the interior of the main body by, in part, a bias (e.g., a compression spring) 2702. The electrode housing 2704 holds an electrode 2703 (FIG. 27A) or 2703′ (FIG. 27B) and an internal electrical connection via an electrode holder 2705. In some embodiments, the electrode housing may be adapted or configured to allow the user to see into the treatment applicator and out 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 treatment applicator that includes a suction chamber within the applicator housing and a distally biased electrode. Like Figures 26A-26D, the example shown in Figures 28A-28D also includes multiple electrodes (either tissue-penetrating or non-penetrating).

[0169] 28A shows the distal end of a treatment applicator 2800, including an 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 bias (e.g., a compression spring 2807). The electrode housing 2801 may be driven all the way to an opening 2813 in the applicator housing, or just proximal thereof; generally, space around the electrode housing within the opening allows suction to draw tissue into the suction chamber and drive the electrode housing proximally against the bias (compression spring). This may drive the electrode 2805 distally on the electrode housing against the tissue.

[0170] As shown in FIGS. 28A-28B, there is an optical channel 2815 through the treatment applicator that extends from the proximal end of the treatment applicator to the distal end opening 2813, which passes through the electrode housing and then through the applicator housing. FIG. 28B shows the treatment applicator with tissue drawn into a suction chamber 2811 formed in the end of the applicator housing. As suction draws tissue into the suction chamber, it compresses the bias 2807 proximally, driving the electrode on the electrode housing into the tissue while driving the electrode housing proximally. FIG. 28C shows an enlarged view of region C from FIG. 28B. In FIG. 28C, the suction chamber portion 2811 that holds the tissue drives against the non-penetrating (loop) electrode 2805 on the electrode housing 2801 as it is displaced proximally. In this example, tissue can be drawn into the suction chamber by about 2 mm or more (eg, 3 mm or more, 4 mm or more, 4.5 mm or more, 5 mm or more, etc.).

[0171] 28D shows an example of a window 2831 that includes magnifying optics for viewing through the treatment applicator and positioning it on tissue. A user can position the distal end of the treatment tip and optimally locate the treatment location 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] In use, a user can position the distal end of the treatment tip of the treatment applicator on 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 to illuminate the magnifying optics and assist in targeting. Once the distal end of the treatment tip is positioned on tissue, the user can apply suction to a suction chamber within the applicator housing. In some embodiments, the user can activate a vacuum pump or move a control on the handpiece portion of the treatment applicator to create suction within the treatment tip. The tissue is then drawn into the interior of the applicator housing (e.g., the suction chamber portion) as far as the tissue's elasticity allows. As the tissue is drawn in, a compression spring can compress to maintain a constant pressure against the distal end of the electrode housing and the tissue drawn into the applicator housing (e.g., the suction chamber). This can seal the tissue within the suction housing against 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 against the tissue. Once the tissue is fully within the suction chamber, treatment can be applied. For example, a foot pedal or manual control (e.g., a finger switch) can be used to actuate the application of pulsed electromagnetic energy (e.g., sub-microsecond pulsed, nanosecond pulsed, etc.).

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

[0174] In any of the embodiments described herein, one or more electrodes may be present in or near the suction chamber, and a second electrode (or set of electrodes) may be on the inner electrode housing. For example, FIG. 30 shows another example of a treatment applicator including an internal suction chamber in which one or more electrodes may be applied against tissue drawn into the suction chamber. In FIG. 30, the applicator housing 3001 is a tubular enclosure whose outer periphery contains the electrodes 3005. One or more central electrodes (shown 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 may be drawn into the interior of the applicator housing by applying suction through the space between the distal end opening of the applicator housing 3009 and the cylindrical central electrode 3005'. As tissue is drawn into the suction chamber at the distal end of the treatment applicator, the tissue seals between the outer electrode 3005 and the inner cylindrical electrode 3005'.

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

[0176] Figures 31C and 31D show cross-sectional views through the device of Figures 31A and 31B, respectively. In Figure 31C, the electrode 3105 is centered within the field of view and, when suction is applied, may contact 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 been moved proximally, moving the electrode 3105 out of the field of view through the window 3106, as shown in Figure 31B. As mentioned, the device may include a light source (e.g., LED, light pipe, etc.) 3129.

[0177] In the example shown in FIGS. 31A-31D, the controller 3130 is attached to a cylindrical electrode, allowing the user to control the position of the electrode relative to the tissue. For example, the electrode can be moved out toward the viewing window so that the view is unobstructed. In some embodiments, the controller can also, or instead, move the electrode closer to or into contact with the tissue. Once targeting is complete, the controller can move the electrode distally to lock it into a treatment position. In some embodiments, the viewing window is plastic or glass and can be lensed (e.g., magnified). Once positioned, negative pressure (e.g., vacuum) can be applied. Suction can be applied after moving the electrode into position.

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

[0179] FIGS. 32A-32F show another example of a treatment applicator. In this embodiment, multiple electrodes can be positioned within an applicator housing that 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 electrode 3205 before applying suction and / or pulsed electrical therapy. In FIG. 32A, a portion of the treatment applicator is shown showing the distal end opening 3216. Two electrodes are coupled to an electrode housing 3241 that includes a gap (space) to allow airflow (airway 3235). FIG. 32B shows the controller 3230, applicator housing body 3201, viewing window 3211, and light pipe 3229. FIG. 32C shows a side view through the treatment applicator showing control of the electrode housing 3222 by the controller 3230 to adjust the position of the electrodes over 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 electrode when it is deployed.

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

[0181] As mentioned 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 one or more of a suction chamber, tissue-penetrating or non-penetrating electrodes, and visualization, that may be particularly well-adapted for treating skin conditions such as syringomas, benign tumors of sweat glands, which typically occur around the eyes or neck, or other sensitive areas. In general, the use of penetrating and / or non-penetrating electrodes, vacuum chambers, and viewing windows as described herein may be particularly beneficial for protecting such potentially sensitive areas, including around the eyes. The treatment applicators described herein may use a viewing window to improve targeting and proper placement of even very small (e.g., 1-3 mm) syringoma growths, while the use of a vacuum chamber may reduce or eliminate impacts to nearby sensitive skin (including protection from arcing). This may beneficially avoid damage to the area around the eyes, for example.

[0182] In one example, an area of ​​tissue containing a syringoma may be treated by applying a treatment applicator (such as any of the treatment applicators of Figures 26A-26D, 27A-27B, 28A-28D, 29A-29B, 30, 31A-31E, and 32A-32F) against the skin so that the lesion (e.g., syringoma) is visible within a viewing area (e.g., a window) of the treatment applicator. A window into the treatment applicator may provide a view into the suction chamber. The suction chamber may be positioned over the lesion. In some embodiments, the suction chamber and treatment applicator may be used adjacent to a patient's eye. Suction may then be applied to draw the tissue containing the lesion into the suction chamber. The positioning of the lesion within the chamber may be visually confirmed through the window. The tissue can be drawn into the suction chamber so that it is pulled out of the plane of the adjacent tissue by 1 mm or more (e.g., 1.5 mm or more, 2 mm or more, 3 mm or more, 4 mm or more, 5 mm or more, 6 mm or more, 7 mm or more, 8 mm or more, 9 mm or more, 1 cm or more, etc.). The tissue can be held in the suction chamber by suction while pulsed electrical energy is applied, as described herein. For example, the pulse energy can be sub-microsecond pulse energy, including relatively high voltage pulse 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, greater than about 0.1 kV / cm, greater than about 0.5 kV / cm, greater than about 1 kV / cm, etc.). One or more treatments (e.g., pulse trains) can 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 variations, positive pressure may be applied to release the suction, and therefore 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 devices described herein can be used to treat tissue where deployment of electrodes and / or application of suction at the tip can be controlled manually and / or automatically. In some examples, the devices described herein can include a foot switch to activate (turn on / off) the vacuum, but even when the vacuum is "on," suction from the tip, e.g., into the suction chamber, can be diverted from the suction chamber and / or tip by a bleed valve, and a user can apply suction at the suction chamber and / or tip by closing the bleed valve. For convenience, the bleed valve can be on the handle of the device.

[0184] Similarly, any of the devices described herein may automatically or semi-automatically deploy and / or retract the electrodes using one or more of a bias, a solenoid, or any other suitable actuator. For example, the electrodes may be coupled to a moving shaft of a solenoid, which may be controlled, for example, by a user, to deploy the electrodes through or into tissue upon actuation of a trigger.

[0185] For example, a user may initiate a vacuum by triggering a foot switch, and the user may position and reposition the treatment tip using a suction control that includes a bleed valve. Once the tip is positioned, the bleed valve may be covered (e.g., closed) and suction may be applied, and in some embodiments, the suction may draw tissue into the suction chamber for treatment. For example, once tissue is drawn into the suction chamber, the user may trigger deployment of one or more electrodes by energizing a solenoid to drive the electrodes into or against the tissue. Once treatment is complete, the solenoid may be de-energized, and the microneedles may be retracted, for example, manually or by triggering the solenoid or releasing a bias (e.g., a spring). The user may then open the bleed valve (e.g., by uncovering the bleed valve opening), releasing the suction in the suction chamber or tip, allowing the user to remove or move the tip.

[0186] Alternatively, in some examples, the user may turn on suction, causing tissue to be drawn into the suction chamber and / or tip, and the user may then manually deploy one or more spring-loaded electrodes, such as, but not limited to, needle electrodes. Once treatment is complete, the user may reset the electrodes to their original or saved configuration and terminate the vacuum (e.g., by activating a foot switch).

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

[0188] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it will be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. In contrast, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Additionally, those skilled in the art will recognize that a reference to a structure or feature being disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0189] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly dictates otherwise. Furthermore, it will be understood that the terms "comprises" and / or "comprising," as used herein, specify the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ."

[0190] Spatially relative terms such as "below," "belower," "lower side," "above," and "upper" may be used herein for ease of description to describe the relationship of one element or feature to another as shown in the figures. It will be understood that spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the figures. For example, if the device in the figures were inverted, elements described as being "below" or "below" other elements or features would now be oriented "above" the other elements or features. Thus, the exemplary term "below" can encompass both an above and below orientation. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes only, unless specifically indicated otherwise.

[0191] Terms such as "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 the context dictates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element discussed below could be referred to as a second feature / element, and similarly, a second feature / element discussed below could be referred to as a first feature / element, without departing from the teachings of the present disclosure.

[0192] As used in this specification and claims, including those used in the examples, and unless specifically expressed otherwise, all numbers may be read as preceded by the word "about" or "approximately," even if such terms do not explicitly state otherwise. The phrase "about" or "approximately" may be used when describing a size and / or location to indicate that the stated value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value may have a value of ±0.1% of the stated value (or range of values), ±1% of the stated value (or range of values), ±2% of the stated value (or range of values), ±5% of the stated value (or range of values), ±10% of the stated value (or range of values), etc. Any numerical value given herein should also be understood to include about or approximately that value, unless the context dictates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical value recited herein is intended to include all subranges subsumed therein. It is also understood that when a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between the values ​​are also disclosed, as would be appropriately understood by one of ordinary skill in the art. For example, if a value "X" is disclosed, "less than or equal to X" as well as "greater than or equal to X" (e.g., X is a numeric value) are also disclosed. It is also understood that throughout this application, data is provided in a number of different formats, and this data represents endpoints and starting points, and ranges for any combination of the data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it is understood that greater than, greater than, less than, less than, less than, and equal to, 10 and 15 are considered disclosed, as are values ​​between 10 and 15. It is also understood that each unit between two specified units is 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 numerous modifications may be made to the various embodiments without departing from the scope of the present disclosure. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped altogether. Optional features of the various device and system embodiments may be included in some embodiments and not included in other embodiments. Furthermore, various features described in some embodiments may be included in other embodiments and may be combined with other features of various examples. Accordingly, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the present invention as set forth in the claims.

[0194] Various embodiments of the inventive subject matter may be referred to herein individually or collectively by the term "invention" merely for convenience, without any intention to intentionally limit the scope of this application to any single invention or inventive concept when, in fact, more than one invention or inventive concept is disclosed. Thus, while specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any adaptations or modifications of the various embodiments. Combinations of the above-described embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

Claims

1. 1. A device for delivering electrical therapy, comprising: an electrode housing extending from a distal end of the device; a first electrode or set of electrodes configured to extend on or from a distal outer surface of the electrode housing and disposed generally along a first length along the distal outer surface of the electrode housing; a second electrode or set of electrodes configured to extend on or from the distal outer surface of the electrode housing, having a different polarity than the first electrode or set of electrodes, and disposed generally along a second length along the distal outer surface of the electrode housing parallel to the first length; a suction port extending through the electrode housing and continuously along a distal outer surface of the electrode housing between the first electrode or set of electrodes and the second electrode or set of electrodes, the suction port extending further along the distal outer surface of the electrode housing than the first length and the second length to increase a collision distance between electrodes of opposite polarity and prevent arcing between the first electrode or set of electrodes and the second electrode or set of electrodes.

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

3. 1. A device for delivering electrical therapy, comprising: an electrode housing extending from a distal end of the device; a first electrode or set of electrodes configured to extend on or from a distal outer surface of the electrode housing; a second electrode or set of electrodes configured to extend on or from a distal outer surface of the electrode housing, the second electrode or set of electrodes having a different polarity than the first electrode or set of electrodes; a suction port extending through the electrode housing and continuously along the distal outer surface of the electrode housing between the first electrode or set of electrodes and the second electrode or set of electrodes, wherein a collision distance between the first electrode or set of electrodes and the second electrode or set of electrodes, including a minimum path length around the suction port, is 10% or more longer than a 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 arcing between the first electrode or set of electrodes and the second electrode or set of electrodes.

4. The device of claim 1 , wherein the suction port at least partially surrounds the first electrode or set of electrodes.

5. 4. The device of claim 1, further comprising a second suction port extending through the electrode housing and continuously between the first electrode or set of electrodes and the second electrode or set of electrodes.

6. 4. The device of claim 1, further comprising: a first outer suction port disposed along the distal outer surface on a side of the first electrode or set of electrodes opposite the suction port; and a second outer suction port disposed along the distal outer surface on a side of the second electrode or set of electrodes opposite the suction port.

7. The device of claim 1 , wherein the suction port comprises a C-shaped opening through a distal outer surface of the electrode housing.

8. The device of claim 1 , wherein the suction port comprises an I-shaped opening through the distal outer surface of the electrode housing.

9. The device of claim 1 , wherein the electrode housing is configured to extend and retract relative to a distal end of the device.

10. The device of claim 1 , wherein the first electrode or set of electrodes and the second electrode or set of electrodes comprise non-penetrating electrodes.

11. The device of claim 1 , wherein the first electrode or set of electrodes and the second electrode or set of electrodes comprise tissue-penetrating electrodes.

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

13. The device of claim 1 , further comprising a suction channel within the electrode housing in fluid communication with the suction port.

14. 4. The device of claim 1, wherein the device is configured as a treatment tip, and further wherein the device comprises a mechanical and / or electrical connector at a proximal end of the treatment tip configured to removably couple to a handpiece.

15. 4. The device of claim 1, wherein the device comprises a reusable hand piece and a replaceable treatment tip configured to releasably couple to the reusable hand piece through one or more electrical and vacuum connectors.

16. The device of claim 1 , further comprising a pulse generator.

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

18. 4. The device of claim 1, wherein the suction port is configured to help remove air gaps around any electrodes.

19. The device of claim 1 , wherein the electrical treatment is a treatment using sub-microsecond pulses.

20. 4. The device of claim 1, further comprising a plurality of suction ports disposed adjacent to or between the first electrode or set of electrodes and / or the second electrode or set of electrodes.

Images