WO2022271469A1 - Treatment tips with suction feature - Google Patents
Treatment tips with suction feature Download PDFInfo
- Publication number
- WO2022271469A1 WO2022271469A1 PCT/US2022/033169 US2022033169W WO2022271469A1 WO 2022271469 A1 WO2022271469 A1 WO 2022271469A1 US 2022033169 W US2022033169 W US 2022033169W WO 2022271469 A1 WO2022271469 A1 WO 2022271469A1
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- WIPO (PCT)
- Prior art keywords
- electrodes
- suction
- tissue
- handpiece
- negative pressure
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0502—Skin piercing electrodes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1402—Probes for open surgery
Definitions
- the methods and apparatuses described herein may be related to electrodes for the application of electrical energy to a subject, for example, a patient. More specifically, the methods and apparatuses described herein relate to the electrodes that may apply suction. These methods and apparatuses may include electrode treatment tips and/or handpieces that may include or be used with these treatment tips for electrical treatment of tissue. These apparatuses and methods may be particularly useful for avoiding or minimizing undesirable electrical modification of the tissues, including preventing or limiting electrical arcing.
- Electrical energy may be applied within the tissue for a variety of purposes, including for the treatment of medical conditions. Electrical energy may be provided through an electrode that is inserted into the tissue. For example, energy, and particularly high-voltage or high-power energy, applied to the tissue may progressively change the impedance of the surrounding tissue in some regions near the electrode; at some point, the change in tissue impedance may result in an uncontrolled electrical discharge, such as an arc.
- This problem may be particularly acute when applying rapid, high-energy pulses, e.g., to treat patients.
- rapid, high-energy pulses e.g., to treat patients.
- nanosecond high voltage pulse generators have been described for biological and medical applications. See, e.g., U.S. Patent Application No. 2010/0038971, which is herein incorporated herein by reference in its entirety.
- applicators for delivery of such sub-microsecond pulsing devices must be configured so as to avoid or at least minimize arcing between the applicators.
- the applicator may be configured to penetrate into the tissue and may include multiple needle-type electrodes.
- Such applicators may be particularly difficult to use with high-voltage systems while avoiding undesirable arcing.
- a small corona discharge can occur at locations of high current density on the needle (i.e., the very tip of the sharpened needle, or a sharpened needle edge on a trocar-shaped needle, or the transition between exposed needle/metal and insulation on the needle/metal).
- the corona discharge during each pulse may start to break down the tissue.
- FIG. 1 Another issue referred to as “tenting” may occur when electrodes, and particularly needle electrodes, are inserted into the tissue; the tissue that is being penetrated by the electrode may stretch around the electrode(s) as pressure is applied. This may form an air gap (shaped like a tent) around the electrode. This issue may be exacerbated with multiple needle electrodes adjacent to each other, in which the tissue gap (tent) around one needle can overlap with the tissue gap (tent) of neighboring needle electrodes, forming a larger gap than with a single needle electrode. This tenting effect can also lead to arcing, particularly at the surface of the tissue. [0008]
- the methods and apparatuses described herein may address various issues raised above and also improve usability of the devices and instrument that apply electrical energy, especially with high therapeutic voltages.
- Described herein are apparatuses and methods for applying electrical energy to a subject’s tissue using one or more electrodes such as to prevent or limit unintended modification of the tissue adjacent to the electrode, such as by arcing.
- any of these apparatuses may be configured as a device or a system, including, for example, a hand-held or hand-operated device, a computer-controlled, and/or a robotically operated, or remotely operated device.
- the term “handpiece” as used herein refers to any structure to support, hold or attach to the electrode portion of the device, whether it is intended to be hand-held, or attached to the robotic arm, or for percutaneous or other minimally invasive applications.
- the handpiece may be configured to be hand-held, and may include a manual grip.
- the handpiece may be configured to be held by a robotic manipulator (e.g., arm, etc.).
- the apparatuses described herein may be configured with one electrode or more than one electrode.
- the electrode may be, e.g., an array of electrodes.
- any of the apparatuses described herein may include penetrating (e.g., tissue penetrating) or non-penetrating electrodes.
- the electrodes are illustrated as tissue penetrating electrodes.
- the electrodes may be one or more needle, wire, plate, blade, etc. electrodes.
- non-penetrating electrodes may be used.
- the electrodes may be configured for acute treatment (e.g., insertion into or placing in contact with the tissue for the duration of a treatment or thereabouts).
- a penetrating electrode may be any electrode that is configured or adapted for insertion into the tissue.
- Penetrating electrodes may be configured to penetrate into and/or through the tissue. Penetrating electrodes may be sharp and/or cutting and may include a leading tissue-penetrating edge. Examples of penetrating electrodes include but are not limited to needle electrodes. In general, a penetrating electrode may be configured to deliver energy (electrical energy) from all or a portion of the electrode. The penetrating electrode may be electrically insulated over one or more regions or portions. The non-insulated portions may be referred to uninsulated and may be configured as energy delivery regions of the electrode. Although in some variations the penetrating electrode may include a single energy delivery region, in some variations a penetrating electrode may include multiple energy delivery regions.
- the electrodes may be non-penetrating electrodes, such as plate or surface electrodes, blunt (including blunted needle, pins, etc.) electrodes or other configurations having non-penetrating tips.
- Non-penetrating electrodes may be configured to be biased against the surface of a tissue, and may advance and/or retract slightly (against a biasing force, such as a spring) to conform to tissues of different heights relative to the applicator.
- a biasing force such as a spring
- an applicator may include a handpiece and/or a tip.
- the tip may be removable and/or replaceable (e.g., disposable), while the handpiece may be reusable.
- the tips also referred to herein as treatment tips
- the tips may include two or more non-penetrating electrodes and may include localized suction ports for the application of suction (negative pressure) at or near the base of the electrodes as they are applied (or after they have been applied) against the tissue.
- the electrodes may be configured to deploy out of the suction ports.
- Suction ports may also be referred to herein as vacuum ports.
- the treatment tips may include one or more electrodes (e.g., needle electrodes) that may be held by a frame (e.g., electrode frame) configured to allow the electrodes to move when driven by a driver.
- a frame e.g., electrode frame
- the same or a different housing (e.g. tip housing) or frame may be moved relative to the one or more electrodes.
- the electrodes may be coupled to a linkage directly or through the frame (or an electrode block that is configured to move with the electrodes).
- the treatment tip may also include an electrical connector for connecting to a source of electrical energy.
- the power connector may be configured to electrically connect the one or more electrodes to a power source configured to apply high voltage power to the one or more electrodes having a peak voltage of between about 100 volts per centimeter (e.g., 0.1 kV/cm) and about 500 kV/cm (e.g., between about 0.5 kV/cm and about 500 kV/cm, between about lkV/cm and 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.).
- a treatment tip may include any number of electrodes, including needle electrodes.
- the electrodes may be configured as positive (cathode) and/or negative (anode), and/or as return (ground) electrodes.
- the electrodes may include groups or sets of electrodes that are electrically coupled so that they share a common source.
- the electrodes may be arranged to apply pulsed energy (e.g., sub-microsecond pulses) between two electrodes or two groups of electrodes.
- the electrodes may be configured for monopolar application of energy and a separate return electrode (e.g., pad, mat, etc.) may be used.
- any of the methods and apparatuses described herein may include an internal source of negative pressure within the handpiece. This negative pressure may be used to apply suction through one or more suction ports of the tip.
- any of these handpieces may include a vacuum chamber (also referred to herein as a negative pressure chamber or a suction chamber), that may be in fluid communication with the suction port(s) at the tip, for example through a suction connector and suction channel or suction tube.
- the vacuum chamber may be charged with negative pressure by withdrawing a piston (or piston-like member) within the vacuum chamber.
- the piston may be manually withdrawn by the user from outside of the handpiece and may be held in place by a lock.
- a ratcheting lock mechanism may be used to allow stepwise drawing of negative pressure.
- the use of such a vacuum chamber within the handpiece may enhance and improve usability of the handpiece.
- Such embodiments may be operated without requiring an external source of vacuum and may be reusable.
- the methods and apparatuses described herein may be operated with relatively low vacuum level and may further be operated over a relatively short duration (e.g., as one or more pulses of suction from the suction port) immediately before and/or during the application of energy. Thus, a small, manually charged vacuum chamber may be sufficient.
- Any of the methods and apparatuses described herein may be configured to deploy the electrodes, for example, by activating of a control on the handpiece. In some examples the deployment may be driven by negative pressure.
- any of these apparatuses may be configured to deploy (e.g., extend) electrodes (e.g., pneumatically) by activation of a control (e.g., latch, switch, etc.) so that a negative pressure may drive movement of the electrodes distally (and/or in some cases proximally).
- a control e.g., latch, switch, etc.
- any of these methods may include: inserting one or more electrodes into the subject’s tissue; and applying suction at the base of the tissue-penetrating electrodes to remove air from around the electrode(s) to prevent arcing.
- the energy therapy may refer to the applied electrical energy.
- energy is applied by the electrode(s) during the application of energy therapy.
- the energy therapy may be continuous or pulsed.
- the energy therapy may be pulsed at a single frequency or a range of frequencies, including at a modulated frequency (e.g., having a carrier frequency).
- applying energy may comprise applying electrical pulses, for example, high-voltage nanosecond electrical pulses, such as applying a train of sub microsecond electrical pulses having a pulse width of between 0.1 nanoseconds (ns) and 1000 nanoseconds (ns).
- Applying high-voltage nanosecond electrical pulses may comprise applying a train of sub-microsecond electrical pulses having peak electric fields, for example, of between 5 kilovolts per centimeter (kV/cm) and 500 kV/cm.
- Applying high-voltage nanosecond electrical pulses may comprise applying a train of sub-microsecond electrical pulses at a frequency of between 0.01 (Hz) to 10,000 Hz.
- Applying energy may comprise applying microsecond electrical pulses, or picosecond electrical pulses.
- the methods and apparatuses described herein may be used as part of any appropriate electrical therapy, including cosmetic procedure or therapy, in which electrical energy is applied within the tissue (or in some cases on the tissue).
- the method of applying energy described herein may be used to treat one or more of the following: organ tissue cancer (e.g., lung cancer, kidney cancer, pancreatic cancer, colon cancer, breast cancer, etc.), skin cancer, cherry angioma, warts, keloids/scars, aging skin, dermatological conditions and/or disease, molluscum angioma, necrobiosis lipoidica (NBL), melisma, lipoma epidermal/sebaceous cyst, basal cell carcinoma, any type of lesions, tumors or abnormal tissue growth on or in various body organs (e.g., benign tumors, precancerous tumors).
- organ tissue cancer e.g., lung cancer, kidney cancer, pancreatic cancer, colon cancer, breast cancer, etc.
- NBL necrobiosis lip
- any power connector may be configured to electrically connect the one or more electrodes to a power source configured to apply high voltage power to the one or more electrodes, such as (but not limited to) power having a peak electric field of between 10 kilovolts per centimeter (kV/cm) and 500 kV/cm.
- treatment tip devices for delivery of electrical therapy.
- These devices may include: an electrode housing extending from a distal end of the treatment tip device; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes at least partially within the electrode housing; wherein at least some of the electrodes of the plurality of electrodes are configured to extend out of the plurality of suction ports; further wherein the treatment tip device has an un-deploy ed configuration in which distal ends of the plurality of electrodes do not extend beyond a distal end face of the electrode housing and a deployed configuration in which the distal ends of the plurality of electrodes extend beyond the distal end face of the electrode housing, and wherein at least one of the electrode housing and the plurality of electrodes is configured to move relative to the other to convert between the un-deployed and the deployed configurations.
- a treatment tip device for delivery of electrical therapy may include: an electrode housing extending from a distal end of the treatment tip device; a plurality of suction ports opening into the electrode housing; a plurality of electrodes at least partially within the electrode housing and configured to extend out of the suction ports; wherein the treatment tip device has an un-deployed configuration in which distal ends of the plurality of electrodes do not extend beyond a distal end face of the electrode housing and a deployed configuration in which the distal ends of the plurality of electrodes extend beyond the distal end face of the electrode housing, and wherein at least one of the electrode housing and the plurality of electrodes is configured to move relative to the other to convert between the un-deployed and the deployed configurations; and a suction connector extending from a proximal end of the treatment tip device configured to mate with a quick connect latch on a handpiece, wherein the suction connector is in fluid connection with the plurality of suction ports.
- any of the treatment tip devices may include a suction connector extending from a proximal end of the treatment tip device and in fluid connection with the plurality of suction ports.
- the suction connector may be configured to remain stationary while the electrode housing (and the suction ports) moves relative to the rest of the treatment tip.
- the suction connector may make a sealing connection with the suction ports that allows relative movement between the suction ports (e.g., the electrode housing) and the suction connector.
- the suction connector may move with either the electrode housing or with the electrodes.
- any of the treatment tip devices may include one or more (e.g., a pair of) electrical pins extending from a proximal end of the treatment tip device that are configured to mate with electrical connectors on a handpiece.
- the tip may be mechanically secured to the handpiece by the one or more electrical connectors (e.g., pins) and/or by a suction connector.
- the treatment tips described herein may include a vacuum manifold within the treatment tip configured to distribute negative pressure between the plurality of suction ports, from the suction connector.
- the plurality of electrodes may be slidably disposed within the plurality of suction ports.
- the plurality of electrodes are tissue-penetrating electrodes.
- the plurality of electrodes are non-penetrating electrodes.
- Any of these devices may include a bias exerting a bias return force to oppose conversion from the un-deployed to the deployed configuration or from the deployed to un deployed configuration.
- a handpiece particularly a handpiece that may include a vacuum chamber (e.g., negative pressure chamber).
- the handpiece may include a manual control for generating negative pressure within the applicator.
- apparatuses or applicator systems comprising: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes configured to extend out of the plurality of suction ports, wherein the electrode housing and the plurality of electrodes are configured to move relative to each other to convert between an un deployed configuration, in which the plurality of electrodes do not extend beyond a distal end face of the electrode housing, and a deployed configuration, in which the plurality of electrodes extend beyond the distal end face of the electrode housing; and a handpiece comprising: a body having one or more electrical connectors at a distal end configured to couple with the treatment tip to apply electrical energy to the plurality of electrodes; a vacuum chamber within the body in fluid communication with the suction connector; a vacuum plate within the vacuum chamber, configured to generate a negative pressure within the vacuum chamber; and a suction control on the handpiece configured to apply negative pressure from the vacuum
- Any of these systems may also include a suction connector, for example, extending from the treatment tip, and a suction connector receiver on a handpiece that is configured to engage with the suction connector to apply suction to the suction ports.
- the suction connector receiver may be configured to latch the treatment tip to the handpiece.
- the suction connector may be a push-to-connect connector.
- Any of these systems may include a release control on the handpiece to release the treatment tip from the handpiece by releasing the suction connector from the suction connector receiver.
- the suction control on the handpiece may be configured to apply a pulse of negative pressure from the vacuum chamber out of the plurality of suction ports.
- any of these systems may include a lock on the handpiece configured to secure a relative position of the vacuum plate and the vacuum chamber to maintain the negative pressure.
- any of the apparatuses described herein may include a manual vacuum control on the handpiece configured to be moved to generate the negative pressure within the vacuum chamber.
- the vacuum plate comprises part of a piston, further wherein a shaft of the piston is coupled to an electrode interface on the treatment tip so that movement of the vacuum plate drives linear movement of the piston and extends the plurality of electrodes to the deployed configuration, beyond the distal end face of the electrode housing.
- any of these apparatuses may include a trigger control, wherein the trigger control is configured to be actuated to release the vacuum plate so that the plurality of electrodes moves to a deployed configuration.
- the applicators may be configured to provide a relatively low level of negative pressure for a short duration (e.g., a burst).
- a short duration e.g., a burst
- any of these apparatuses may include a vacuum chamber that is be configured to provide less than 10 kPa of negative pressure through the suction ports.
- the system may be configured to apply pressure for less than 60 seconds through the suction ports after deploying the electrode housing.
- the system may be configured to apply negative pressure through the suction ports only after deploying the electrode housing.
- an apparatus may include: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; and a plurality of electrodes disposed within the electrode housing; and a handpiece comprising: a body; a vacuum chamber within the body; a piston having a vacuum plate within the vacuum chamber, wherein the piston is operably connected to the plurality of electrodes; and a trigger, wherein the trigger is configured so that activation of the trigger releases the vacuum plate to move within the vacuum chamber when there is a negative pressure within the vacuum chamber, driving the plurality of electrodes distally out of the electrode housing.
- the handpiece may include a suction port in fluid communication with the vacuum chamber and configured to couple to a source of negative pressure.
- Any of these apparatuses may include a latch on the handpiece coupled to the trigger and configured to retain the piston in a fixed position until released by actuation of the trigger.
- the latch may be further configured to retain the piston in both a deployed configuration with the piston extended distally and in an undeployed configuration with the piston retracted proximally.
- the treatment tip may be removably coupled to the applicator via an electrical connection and a pressure connection.
- the apparatus e.g., an applicator
- the apparatus may include a plurality of suction ports on the treatment tip, wherein the suction ports are configured to apply suction at a base of the plurality of electrodes.
- a method may include: contacting a tissue with a tip of an applicator; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing of the tip of the applicator so that the plurality of electrodes are in contact with the tissue; applying a negative pressure (e.g., a pulse of a negative pressure) through the suction ports to remove or at least reduce air from between the electrodes of the plurality of electrodes and the tissue; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes.
- a negative pressure e.g., a pulse of a negative pressure
- Deploying the plurality of electrodes may include deploying a plurality of tissue- penetrating electrodes out of the plurality of suction ports and into the tissue.
- deploying the plurality of electrodes comprises deploying a plurality of non-penetrating electrodes so that they are in contact with the tissue.
- deploying the plurality of electrodes may include releasing a latch on a handpiece so that a negative pressure within the handpiece moves a piston in the handpiece and drives the plurality of electrodes distally out of the electrode housing.
- the pulse of negative pressure may be applied immediately prior to or concurrent with the application of the pulsed electrical treatment.
- applying the pulse of negative pressure comprises applying the pulse of negative pressure for less than 1 minute.
- Applying the pulsed electrical treatment may comprise stopping application of the pulse of negative pressure before applying the pulsed electrical treatment.
- applying the pulse of negative pressure may comprise applying less than 100 kPa of negative pressure.
- Any of these methods may include manually generating a negative pressure within a vacuum chamber of the applicator, further wherein applying the pulse of negative pressure comprises applying the negative pressure from the vacuum chamber.
- manually generating may comprise pulling a vacuum plate within the applicator to generate negative pressure within the vacuum chamber.
- a method of operating an apparatus comprising a plurality of electrodes within an electrode housing and a handpiece including a vacuum chamber and a piston within the vacuum chamber.
- the method may comprise: causing application of a negative pressure within the vacuum chamber of the handpiece of the apparatus; and actuating a control to cause the piston within the vacuum chamber of the handpiece to move within the vacuum chamber, thereby driving the plurality of electrodes operatively connected to the piston out of the electrode housing into a deployed configuration.
- the method may further comprise regulating an amount of negative pressure applied (e.g., around the electrodes).
- the method may further comprise using vacuum to retract the plurality of electrodes into undeployed configuration.
- the method of operating of an apparatus may comprise: applying a negative pressure within a vacuum chamber of an applicator, wherein the applicator includes a tip comprising a plurality of electrodes housed within an electrode housing; actuating a trigger on the applicator to cause a piston on the applicator to be drawn distally by the negative pressure within the vacuum chamber; and translating movement of the piston into a movement of the plurality of electrodes to deploy the plurality of electrodes out of the electrode housing.
- a method may include: contacting a tissue with an applicator including a tip; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing and in contact with the tissue by negative pressure; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes.
- the methods described herein may include applying negative pressure through the suction ports to remove air from between the electrodes and the tissue before applying the pulsed electrical treatment.
- Deploying the plurality of electrodes by negative pressure may include applying the negative pressure from a vacuum chamber within the applicator.
- Any of these methods may include manually generating the negative pressure within a vacuum chamber in the applicator.
- Deploying the plurality of electrodes may comprise deploying a plurality of tissue-penetrating electrodes into the tissue.
- Deploying the plurality of electrodes may comprise deploying a plurality of non-penetrating electrodes so that they are in contact with the tissue.
- deploying comprises actuating a trigger on the applicator to release a latch, wherein releasing the latch allows a piston within the applicator to be drawn distally by the negative pressure within a vacuum chamber of the applicator.
- FIG. 1 illustrates one example of a system, including an applicator as described herein and a pulse generator to which the applicator is coupled, for delivery of high voltage, fast pulsed electrical energy.
- FIGS. 2A-2B illustrate one example of an applicator including a tip (shown here as a disposable treatment tip) that removably couples with a handpiece.
- FIG. 2A shows the treatment tip coupled to the handpiece.
- the handpiece includes a source of negative pressure within the body of the handpiece.
- FIG. 2B shows the tip decoupled from the handpiece.
- FIGS. 3 A and 3B illustrate another example of an applicator including a tip, also shown as a removable tip.
- FIG 3A shows a longitudinal section through the body applicator, showing the internal (self-contained) vacuum source within the handpiece body.
- FIG. 3B shows another longitudinal section through the applicator of FIG. 3A, with the internal vacuum source actuated to apply suction around the electrodes of the attached tip.
- FIG. 4 illustrates another example of an applicator with a reusable handpiece including an internal vacuum source and a removable tip.
- FIG. 5A illustrate one example of a cut-away portion of an applicator illustrating engagement between a removable tip and a handpiece, including a vacuum connector making connection between the suction ports on the tip and the vacuum source within the handpiece.
- FIG. 5B shows one example of a vacuum connector for a handpiece as described herein.
- FIGS. 6A-6B illustrate examples of a distal end of a treatment tip including suction ports through which a vacuum may be applied and out of which electrodes may extend.
- FIGS. 7A-7B illustrate another example of a portion of a treatment tip including suction ports in an electrode housing out of which the tissue-penetrating electrodes may extend.
- FIG. 7A the perspective view shows the distal end of the housing and the plurality of tissue penetrating electrodes within the housing.
- FIG. 7B shows a section through the electrode housing showing the tissue-penetrating electrodes, suction ports and suction lines.
- FIGS. 8A-8B illustrate another example of a portion of a treatment tip including suction ports in an electrode housing out of which the tissue-penetrating electrodes (or blunt needle electrodes) may extend.
- FIGS. 8A-8B demonstrate an example where multiple rows of needles could be incorporated.
- FIG. 8A the perspective view shows the distal end of the housing and the plurality of tissue penetrating electrodes in multiple rows within the housing.
- FIG. 8B shows a section through the electrode housing showing the tissue-penetrating electrodes, suction ports and suction lines.
- FIGS. 9A-9B illustrate another example of a portion of a treatment tip including suction ports in a movable (e.g., retractable) electrode housing out of which the tissue- penetrating electrodes may extend.
- FIG. 9A the perspective view shows the distal end of the retractable electrode housing extending from a tip housing and including a plurality of suction ports; one or more tissue penetrating electrodes may be extended from within each of the suction ports of the retractable housing.
- FIG. 9B shows the tip shown in FIG. 9A with the tissue- penetrating electrodes, suction ports and suction lines, extending at least partially out of the suction ports.
- FIG. 10A illustrates another example of an applicator tip including suction ports out of which electrodes may extend when the electrode housing is retracted.
- FIGS. 10B-10G illustrate the operation of one example of an applicator including an applicator tip similar to that shown in FIG. 10A in which suction is applied during deployment of the tissue-penetrating electrodes into the tissue.
- FIGS. 1 lA-11C illustrate another method of operation of an applicator including an applicator tip similar to that shown in FIG. 10A, in which the suction is applied after deploying the tissue-penetrating electrodes to reduce or prevent tenting of the electrodes in the tissue.
- FIG. 12 shows another example of an applicator, including a treatment tip, in which negative pressure in the handpiece may be used to deploy the tissue-penetrating electrodes from out of the tip housing.
- an external vacuum source may also or alternatively be used.
- FIGS. 13A-13C illustrate another example of an applicator, including a treatment tip, with a latch trigger.
- the outer housing has been made transparent.
- the applicator is configured so that a control on the handpiece (e.g., a trigger) may rapidly deploy the plurality of electrodes out of the tip.
- FIG. 13A shows the electrodes in an undeployed state.
- FIG. 13B shows the electrodes deployed.
- FIG. 13C shows a section through the device of FIG. 13B with the electrodes deployed.
- FIGS. 14A-14B illustrate another example of an applicator without a latch trigger, with an internal vacuum source that may be triggered to deploy the electrodes and/or to retract the electrodes.
- FIG. 14A shows the applicator with the electrodes undeployed.
- FIG. 14B shows the applicator with the electrodes deployed.
- the applicators described herein may include an electrode tip and a handpiece.
- the electrode tip may be removable and disposable and may be attached to a reusable handpiece.
- the tip may be integrated into the handpiece.
- the applicators described herein may be configured to use suction specifically to prevent air gaps between the tissue and the electrode that may negatively impact the applied electrical therapy, including allowing arcing.
- the disclosed designs improve the overall usability and the ease of use of these devices.
- electrical applicators may include a handpiece with a source of suction (or vacuum) to apply a negative pressure through one or more suction ports on a tip attached or integral with the handpiece.
- the tip may be configured so that the suction, which may be applied during or immediately after the electrodes have penetrated or contacted the tissue (but before applying therapeutic energy from the electrodes), is applied at the base of the electrode, including to just the region around the electrode(s).
- the suction exits an electrode housing of the tip, so as to remove or minimize any air gaps between individual electrodes and the tissue.
- suction may be used to deploy the electrodes from the applicator, so that a negative pressure with the handpiece may be used to drive extension of the electrodes when a trigger is activated.
- FIG. 1 illustrates one example of a system 100 that may be used with or may incorporate, any of the applicators described herein.
- the system shown in FIG. 1 (also referred to herein as a high voltage system or a sub-microsecond generation system) for delivering high voltage, fast pulses of electrical energy that may include an elongate applicator tool 102, a pulse generator 107, footswitch 103, and user interface 104.
- Footswitch 103 is connected to housing 105 (which may enclose the electronic components) through a cable and connector 106.
- the elongate applicator 102 may include electrodes (e.g., as part of an electrode tip) and may be connected to housing 105 and the electronic components therein through a cable 137 and high voltage connector 112. Examples of applicators are described in greater detail below.
- the high voltage system 100 may also include a handle 110 and storage drawer 108.
- the system 100 may also include a holder (e.g., holster, carrier, etc.) (not shown) which may be configured to hold the elongate applicator tool 102.
- the applicator tip includes one or more disposable tips that may releasably couple to the handpiece of the applicator.
- the applicator tip may be adapted to make an electrical, mechanical and a pressure connection, as will be described in greater detail below.
- the handpiece of the applicator may include a self-contained source for generating suction that may be used to apply suction at the tissue-penetrating electrodes, e.g., as the base of the tissue-penetrating electrodes, where the electrodes extend from the tip.
- a human operator may select a number of pulses, amplitude, pulse duration, and frequency information, for example by inputting such parameters into a numeric keypad or a touch screen of interface 104.
- the pulse width can be varied.
- a controller 144 may send signals to pulse control elements within system 100.
- the controller (which may include one or more processors and other control circuitry, including memory) is shown within the housing 105, but it may be positioned 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 may be a separate processing unit or may be incorporated with the controller.
- the controller and/or a processor may trigger and/or control application of a negative pressure within a vacuum chamber of the handpiece as discussed below.
- fiber optic cables are used which allow control signaling while also electrically isolating the contents of the metal cabinet with sub-microsecond pulse generation system 100, e.g., the high voltage circuit, from the outside.
- system 100 may be battery powered instead of being powered from a wall outlet.
- the elongate applicator tool may be hand-held (e.g., by a user), configured for percutaneous or other minimally-invasive applications, or it can be affixed to a movable arm of a robotic system, and its operation may be at least partially automated or fully automated, including computer controlled.
- the methods and apparatuses described herein may include applicators that include one or more sets of electrodes (e.g., needle electrodes, surface or plate electrodes, wire electrodes, bar electrodes, etc.) for applying electrical energy to a tissue.
- the electrodes may be configured for monopolar application of energy and a separate return electrode 133 (e.g., pad, mat, etc.) may be used.
- the applicator may include a tip portion and a handpiece portion.
- the tip and handpiece may be separate, or they may be a single, unitary applicator.
- the tip is removable from the handpiece so that the multiple different tips, including different types of tips, can be coupled to the handpiece.
- the handpiece may include a source of negative pressure (e.g., suction or vacuum) that may be applied through the electrode in order to modify the contact between the tip, and in particular the electrode(s) of the tip, and the tissue.
- a source of negative pressure e.g., suction or vacuum
- the handpiece may include a self-contained source of vacuum.
- the apparatuses e.g., tips, handpieces, etc.
- the apparatus may be configured to reduce the forces required to drive contact or insertion of the electrodes relative to the tissue and/or to reduce the holding forces required to maintain constant contact with the tissue throughout a treatment, such as in particular a nanosecond pulsed electrical treatment.
- a treatment such as in particular a nanosecond pulsed electrical treatment.
- Any of the handpieces described herein may be configured to eliminate or reduce the air gap or “tenting” that may otherwise occur as well as reduce the forces the user needs to apply, which will improve the overall usability when applying the electrode tips to the tissue.
- Applicator tips including retractable/extendable electrodes may produce arcing between the electrodes when an air gap forms around the electrodes during application to the tissue, both with tissue-penetrating electrodes and with non-penetrating electrodes.
- arcing may result when a portion of one or more electrodes (e.g., tissue-penetrating or non penetrating electrodes) are exposed to air, e.g., forming air-gaps around or between the electrode(s).
- tissue-penetrating or non penetrating electrodes e.g., tissue-penetrating or non penetrating electrodes
- air gaps near the electrode(s) are large enough, they can create an electrical path where a corona may build up until an electrical arc occurs, stopping or delaying the procedure when using a pulse generator, such as a nanosecond pulsing system.
- the applicators described herein may apply a negative pressure (e.g., suction, vacuum, etc.) to remove or reduces such air gaps.
- a negative pressure e.g., suction, vacuum, etc.
- the apparatuses and methods described herein particularly useful and effective because they may provide very low suction and apply this suction only in a limited manner, such as around the base region of the electrode, such as near the point of contact with the tissue and the electrode, in order to prevent or reduce tenting around this base region.
- the suction applied is not required to pull the tissue (e.g., skin) onto the electrodes, or to secure it into position, may be significantly lower in magnitude, and directed to regions that may otherwise not be effective to hold the tissue in position relative to the tip.
- the tips described herein may be adapted to apply a relatively low level of suction (e.g., about 1 kPa or less, about 0.5 kPa or less, about 0.1 kPa or less, about 0.05 kPa or less, about 0.01 kPa or less, etc.). Suction may be applied to just a region around the base of all or some of the electrodes, such as just around the region of the cathodic electrode(s), to prevent or reduce tenting where the electrode engages the tissue.
- a relatively low level of suction e.g., about 1 kPa or less, about 0.5 kPa or less, about 0.1 kPa or less, about 0.05 kPa or less, about 0.01 kPa or less, etc.
- these methods and apparatuses may be configured to include one or more ports around some or all of the electrodes (e.g., needle electrodes, surface electrodes, etc.), which may be specifically configured to evacuate and reduce or eliminate air gaps around the electrodes, allowing the electrodes to achieve a better or more complete contact with the tissue.
- the methods and apparatuses may reduce or eliminate air gaps from around the electrode following penetration of the electrode(s) into the tissue. By removing or reducing the air gaps around the electrodes, the likelihood of delays during a procedure using these tips due to arcing may be reduced, which may in turn lead to better and/or more consistent procedural outcomes.
- the suction may be applied at or from just the base of some or all of the electrodes.
- the suction may be applied during and/or after inserting or placing the electrodes into a contact with the tissue.
- the suction may be applied during insertion of the electrodes into the tissue and/or after insertion of the electrodes into the tissue but not before inserting the electrodes into the tissue.
- suction may be applied during application of the electrodes to the tissue; e.g., with tissue penetrating electrodes, once the electrode has begun penetrating the tissue, and with non-penetrating electrodes once the electrode has contacted the tissue surface. This may improve electrode contact. With tissue penetrating electrodes, the application of even low-levels of negative pressure (suction) around the base of the electrode(s) may reduce the force needed to insert the electrode into the tissue.
- any of the tips or applicators described herein may include a housing portion that is retracted and/or deflected from over and/or adjacent to the one or more electrodes (e.g., needle electrodes, plate electrodes, or other tissue-penetrating electrodes) as the electrode is inserted into or contacted with the tissue.
- these suction ports also referred to herein as vacuum ports
- these suction ports may also assist with the insertion of the needles into the tissue as well and may reduce the forces the user needs to apply to the electrode tips to start the procedure as well as during the procedure.
- the use of low level of negative pressure may help maintain contact between the tissue and the electrodes, particularly when the tip is configured to allow extension/retraction of the electrodes and/or of the housing from which the electrodes extend.
- a user applying the tip to the tissue may otherwise have to apply a relatively large amount of force to penetrate the tissue (e.g., to break the skin, in some examples) and/or to maintain a consistent pressure to sustain contact with the tissue during a procedure.
- the use of a suction port at least partially around all or some of the electrode(s) may create sufficient suction around the engagement site of the tissue to hold the electrode in place and/or to reducing the force needed to penetrate the tissue.
- the vacuum suction feature may also hold the tip flush to the surface of the tissue throughout the procedure, which will, in turn, reduce the likelihood of the arcs occurring.
- FIGS. 2A-2B illustrate a first example of an applicator as described herein.
- the applicator 200, 200’ includes a reusable handpiece 203, and a disposable tip 205, 205’.
- the disposable tips may be removably connected to the handpiece; in FIG. 2A the tip 205 is shown connected to the handpiece.
- This example shows a 2.5 mm x 2.5 mm tip, wherein 2.5 mm x 2.5 mm represents a surface area between the electrodes at the distal end of the tip.
- the tip 205’ is shown detached; this example shows a 5 mm x 5 mm tip.
- the tip may couple to the handpiece through two or more electrical connectors (e.g., connector pins 207) which may also function as mechanical connectors.
- electrical connectors e.g., connector pins 207
- FIG. 2B two high-voltage connector pins are shown.
- the tip also includes a suction connector 209 that makes a sealed connection to transfer negative pressure from a suction source within the handpiece.
- the connector receiver 211 including a suction line latch
- the tip is releasably coupled with the handpiece.
- a tip detachment control (shown in FIGS. 2A-2B) as a tip detachment knob 213 may also be included.
- the tip may be mechanically latched onto the handpiece and secured in place to maintain a seal via the suction line latch and suction connector.
- the tip detachment control may disengage the pressure (e.g., suction) interface and/or a mechanical connection between the tip and the handpiece.
- the handpiece may include a body housing 215 that encloses the internal structures within the housing, such as the source of suction within the handpiece.
- the suction may include a hand-actuated source of suction.
- a slider may be accessible on or through housing to drive (or pull) a plunger within a vacuum chamber 221 to generate a negative pressure within the internal vacuum chamber before locking in place to hold the vacuum.
- the actuation of the source of suction may be controlled by a controller or a processor, for example, in response to the user instructions.
- FIGS. 2A-2B also shows a suction push slider 223 that may be gripped to generate the negative pressure within the handpiece, and a suction line 219.
- the handpiece may couple with a separate source of negative pressure, e.g., vacuum.
- FIGS. 3A-3B show an example of a handpiece including internal structures that may generate, maintain and deliver the suction through the tip so that it may be applied at the base of the electrodes on the tip.
- the applicator 300 includes both the handpiece and a tip, shown attached. The tip is secured to the handpiece, including both electrical contacts and a sealed suction path.
- a suction chamber 306 (seen in FIG. 3B) is included that may increase in size by moving a cylindrical drive piece 308 proximally (e.g., pulling it away from the distal tip).
- the cylindrical drive piece is fully distal; it may be biased in this position by a return bias (e.g., return spring 312, not shown in FIG. 3B for clarity).
- the return bias may be lockable (e.g., by a latch, lock, or other mechanism) to prevent driving return of the piston until application of the therapy is complete.
- a piston-like member including a suction plate 314 may form one end (the fixed end) of the suction chamber and may be held fixed in position relative to the outside of the handpiece as the drive piece is driven proximally.
- FIG. 3B the cylindrical drive piece is shown driven proximally (to the left in this example), by pushing on a suction push plate 316, as shown by the arrows in FIG. 3A.
- the suction plate 314 may be sealed (suction seal 320) against the inner walls of the vacuum chamber. As the cylindrical drive piece is driven proximally, enlarging the vacuum chamber, a negative pressure is generated that may be transferred through the center tube (suction tube 322) all the way through the attached tip, and out of suction port(s) on the electrode housing of the tip, as described in greater detail below.
- the suction tube may include a seal formed with the connector on the tip, as described above. Thus, the suction may remove any air gaps around the electrodes (e.g., needles, wires, or plate electrodes) of the tip that are in contact with the tissue.
- FIG. 3 A and 3B illustrate the suction applied through the device, from the distal tip suction ports 318 back into the suction chamber.
- the return spring may be compressed in FIG. 3B; the device may lock the cylindrical drive piece in place to prevent applying positive pressure through the suction ports of the tip.
- a one-way (e.g., check) valve may be included in the handpiece and/or tip to prevent positive pressure.
- the amount of negative pressure applied through the tip may be regulated by one or more pressure regulators within the handpiece and/or tip.
- the amount of pressure may be regulated by adjusting a bleed valve on the handpiece and/or tip, that is in communication with the suction channel, such as center tube (suction tube 322) or a suction chamber, that is in fluid communication with the suction channel and the tip.
- the suction channel between the tip and the suction chamber within the handpiece and/or tip may include one or more valves, e.g., check valves, to prevent or limit positive pressure from around the electrodes.
- the handpiece and/or tip may be configured to apply positive pressure out of the suction channel(s) and/or port(s) to aid in disengaging the tip following treatment.
- a control e.g., switch, toggle, etc.
- the negative pressure may be formed and retained in the handpiece but one or more valves may prevent the suction from being applied though the suction lines until activated by a suction control (e.g., button, switch, lever, etc.).
- a suction control e.g., button, switch, lever, etc.
- the negative pressure may be applied on demand, either while inserting the tissue-penetrating electrodes or contacting the tissue with non-penetrating electrodes, and/or after the electrodes have already contacted the tissue or have been inserted into tissue.
- FIG. 4 illustrates another example of an applicator 400 including a handpiece 403 and an attachable/removable (e.g., disposable) tip 405.
- the reusable handpiece may have multiple different tip options for attaching different tips, including differently shaped and/or dimensioned tips that are adapted to apply suction by including one or more suction ports on the tip and a suction connector that allows the air to be removed from around the electrodes of the tip.
- the tips may include a plurality of electrodes that may be configured as needles, wire, plates, bar electrodes, etc.
- the handpiece includes a “push-to -connect” connector receiver 411 for coupling the suction line 422 with the suction connector 409 on the tip.
- This connector receiver 411 may also act as a latch for holding the tips on the handpiece using a quick connector.
- the handpiece may also include electrical connectors 437 for coupling with electrical pins 407 on the tip.
- FIG. 5A illustrates another example of a latch for securing the tip 505 to the handpiece 503 and making a secure suction connection.
- the handpiece includes a tip detachment knob 513 that may couple to an internal collet for secure engaging with a suction connector 509 on the tip 505.
- a tip detachment knob When pressure is applied to the tip detachment knob, it may transfer this pressure to an outer connector ring 533 on a push-to-connect tubing connector 511, releasing a grip on the tube as well as the overall disposable tip, so that the tip may be removed.
- FIG. 5B shows an example of the push-to-connect connector 511.
- This example includes an outer connector ring 533 that allows the suction connector 509 on the tip to be easily inserted into the connector, however the push-to-connect tubing connector may hold tight until pressure is applied to the ring (e.g., by the tip detachment knob or other control), releasing the grip on the tube.
- FIGS. 2A-2B and 4A-4B show examples in which the suction connector 209, 409 extends proud of the tip and engages into a connector receiver 211, 411 (e.g., a latching, push-to- connect connector) in the handpiece, the locations of the suction connector and the connector receiver may be switched.
- the connector receiver that receives the extending suction connector may be on the tip and the section connector may be on the handpiece.
- FIGS. 6A-6B, 7A-7B, 8A-8B and 9A-B all illustrate examples of tips including a suction connector and suction port(s) that may be used as part of the applicators described above to apply suction to remove air from around the one or more electrodes.
- the tips include one or more (e.g., two or more, three or more, etc.) suction ports on a face of the tip, such as on the distal face. These suction ports may be configured so that they apply suction at the base of the electrode.
- the electrodes may be configured to extend out of the suction port. Multiple electrodes may extend from the same suction port.
- each electrode may extend from each separate suction port, or a subset of the electrodes may extend from a shared suction port. In case of the penetrating electrodes, as the electrodes penetrate the tissue the suction applied though the suction port may remove air from around the electrode.
- the amount of suction required may be quite low, as discussed above.
- the duration of the application of suction may be brief, e.g., during and/or after inserting the electrodes into the tissue.
- the suction may be applied for 60 seconds or less (e.g., about 50 seconds or less, about 45 second or less, about 40 seconds or less, about 35 seconds or less, about 30 seconds or less, about 25 seconds or less, about 20 seconds or less, about 15 seconds or less, about 10 seconds or less, about 5 seconds or less, about 2 seconds or less, etc.).
- the suction may be applied as one or more pulses during or after application of the electrodes to the tissue.
- the tips described herein may include one or more suction or vacuum manifolds within the apparatus that may distribute the negative pressure from the suction connector; the vacuum manifold may distribute the negative pressure between multiple suction ports, each associated with one or more electrodes.
- FIGS. 6A and 6B illustrate examples of a distal face of two different tips, each configured to include two plate or surface electrodes 671, 671’ out of a different suction port. Suction is applied in the space 680 around each electrode to allow the suction to remove any air gaps. Suction may be applied on around the entire perimeter or circumference of the electrode as is extends out of the electrode housing 678 in the tip, or it may extend just partially around the electrode. In FIG. 6A the tip has a smaller overall surface area coverage (e.g., 2.5 mm x 2.5 mm) as compared to the tip in FIG. 6B (e.g., 5 mm x 5 mm).
- FIGS. 7A-7B illustrate another example of a treatment tip including suction ports 780, 780’ that are adapted to remove air form around the electrodes as described herein.
- the tissue-penetrating electrodes are needle electrodes 744 that are shown housed within an electrode housing 778.
- the electrodes may be exposed out of the electrode housing 778.
- the electrodes are positioned just below the distal surface of the tip and are not movable, but rather the suction would pull the tissue into the needles.
- the electrode housing may move relative to an outer tip housing, e.g., retracting proximally to expose the electrodes.
- the electrodes may move distally or proximally into or out of the electrodes housing.
- the electrodes may extend distally out of the suction ports 780, 780’ of the electrode housing.
- the suction port is in communication with the suction connector that couples to a suction line latch on the handpiece through a suction channel 782 (seen in FIG.
- FIG. 7B shows a section through the tip shown in FIG. 7A, showing the tissue-penetrating electrodes within the suction port and suction channels 782 passing through the electrode housing.
- tissue-penetrating electrodes or the tip housing may be moved relative to each other to penetrate the tissue.
- a tip such as the one shown in FIGS. 7A-7B may be configured for use with non-penetrating electrodes.
- the electrodes 744 may be blunted and configured to ride on the surface of the tissue to be treated, rather than penetrating into the tissue.
- the tip is configured so that individual electrodes or sets of electrodes have a pogo pin like structure in which the distal ends of the electrodes are rounded, flattened, or otherwise blunted so as not to penetrate the tissue.
- the tip and electrode may otherwise function as described above for FIG. 7A-7B, but without penetrating the tissue.
- the non penetrating electrodes may be extended relative to the housing of the tip so that the distal ends of the electrode may be held against the surface of the tissue. Either the electrodes may be biased distally relative to the housing or the housing may be driven proximally (exposing the tips). Suction may be applied, e.g., to seal the tip (and in particular a soft, insulating distal tip region) against the tissue and/or to hold the tip against the tissue during treatment.
- a pulse of negative pressure may be applied during or after applying the electrode(s) to the tissue in order to remove any air from around and/or between the tissue and electrode interface prior to treating the tissue.
- the same activation (control) that applies the energy may first apply the negative pressure.
- the negative pressure may be sustained during the treatment (e.g., continuously applied) or it may be applied prior to or at the start of treatment.
- the pressure may be released, e.g., by manually or automatically activating a pressure release control on the handpiece and/or tip which may, e.g., open the suction channel and/or suction port(s) to atmosphere to release suction, rather than (or in addition to) allow the suction to leak from the tip.
- a pressure release control on the handpiece and/or tip which may, e.g., open the suction channel and/or suction port(s) to atmosphere to release suction, rather than (or in addition to) allow the suction to leak from the tip.
- FIGS. 8A and 8B illustrate another example, similar to that shown in FIG. 7A and 7B, but showing three suction ports 880, 880’, 880” (which also may be three rows of suction ports) out of which three rows of electrodes 844, shown in this example as needle electrodes, may extend.
- the suction ports are in communication with a suction connector (not shown) that couples a suction line latch on the handpiece through a suction channel 882 within the electrode housing 878, and within which the electrodes extend, as shown in FIG. 8B. While this example shows three rows, any multiple number of rows may be used.
- each row may have one shared suction port for all or a portion of the electrodes in the row, or each electrode in each row may have its individual suction port.
- the needles may be advanced distally out of the electrode housing 878, or needle housing may be retracted proximally (e.g., into a tip housing) to expose the needles, or both.
- FIGS. 9A-9B illustrate an example of a tip in which the electrode housing may retract proximally (e.g., by pushing against the tissue, driving the tissue penetrating electrodes 944 out of the suction ports 980 on the distal face of the electrode housing 978 and into the tip housing 979, exposing the tissue-penetrating electrodes.
- each electrode includes a separate suction port out of which it may extend; in some examples sets of electrodes may share a suction port, as shown above in FIGS. 7A-7B and 8A-8B.
- FIG. 10A shows another example of a tip for an applicator that includes suction ports through which one or more tissue-penetrating electrodes may extend.
- FIG. 10A three rows of seven tissue-penetrating (e.g., needle) electrodes 1044 are shown, each within (and configured to extend from) a suction port 1080.
- the tips described herein can be configured with different electrode configurations.
- suction ports are connected to suction channels that may each communicate with a single suction chamber within the tip, as shown in FIGS. 10B-10G.
- the suction chamber may be coupled with the suction connector that couples with a handpiece providing the connection to the source of negative pressure.
- FIGS. 10B-10G illustrate one example of a method of operating an applicator as described herein.
- a tip such as the one shown in FIG. 10A may be coupled to a handpiece that includes a source of suction, such as a handpiece as described herein (including but not limited to the handpiece shown in FIGS. 2A-2B, 3A-3B and 4.
- the suction may be applied while advancing the tissue penetrating electrodes into the tissue, to prevent air gaps from forming.
- FIG. 10B a sectional view through the tip (of
- FIG. 10A is shown, before the tip is in contact with the tissue.
- FIG. 10B shows a row of tissue- penetrating electrodes 1044 (e.g., needle electrodes) within suction channels 1082 of the tip 1078; the suction channel 1082 is connected to a suction chamber 1086 that is in fluid contact with the source of negative pressure (suction/vacuum) in the handpiece, as described above.
- the tissue-penetrating electrodes are retracted into the tip housing.
- FIG. IOC the same tip is paced into contact with the target tissue 1092 to be treated.
- the needles may be advanced while (or immediately after) suction has been applied.
- FIG. 10D shows the tip after applying suction through the suction ports; the tissue 1092 is drawn up into the suction ports 1080.
- the suction may be applied continuously while then driving the tissue-penetrating electrodes out of the suction ports and into the tissue, as shown in FIG. 10E.
- the suction is applied only after driving the tissue-penetrating electrodes into the tissue (e.g. at the stage shown in FIG. 10E); this may both remove air between the electrodes and the tissue and may also help drive the electrodes into the tissue.
- FIG. 10F shows the electrodes fully inserted into the tissue. In FIG. 10F the use of suction immediately before or during insertion may prevent air gaps from forming.
- FIG. 10G illustrates an example of undesirable results, in which suction was not applied through the suction ports, and insertion of the electrodes into the target tissue resulted in the ‘tenting’ and forming of air gaps 1095 between the electrodes and the tissue.
- FIGS. 1 lA-11C illustrate an alternative method in which suction may be applied after the tissue-penetrating electrodes are driven into the tissue, to remove any air gap between the electrodes and the tissue.
- FIG. 11A shows the tip housing 1178 contacting the tissue 1192 at the target site.
- the plurality of tissue-penetrating electrodes 1144 may then be extended into the tissue and out through suction ports 1180 on the tip housing.
- no suction is applied while inserting the electrodes into the tissue, which may result in air gaps 1195 forming between the tissue and the electrodes, as shown in FIG. 1 IB. These air gaps may be removed as described above, by applying suction from the suction ports 1180.
- the suction ports are present at the base of each electrode where it enters the tissue (and where the tenting and formation of the air gap occurs.
- the negative pressure may be applied quickly and locally for a brief duration to remove the air gap; air is drawn into the suction ports 1180 around the electrodes 1144 and into the suction channels 1182 that are connected to a suction chamber 1186 that is in fluid communication with the source of negative pressure in the handpiece.
- the air gaps may be removed and pulsed, e.g., sub-microsecond pulsed energy, may be applied through the electrodes and into the tissue more efficiently.
- pulsed e.g., sub-microsecond pulsed energy
- apparatuses in which the electrodes may be deployed (e.g., advanced distally into the tissue) using negative pressure to drive the electrodes distally into contact with the tissue.
- Any of the apparatuses and methods described herein may be used in combination with the methods and apparatuses described above for the local use of suction to remove air gaps from the tissue.
- the same suction source or separate sources may be used.
- the apparatuses described herein may be configured to apply negative pressure to assist in deploying electrodes from the tip of the applicator.
- the apparatus may be configured to deploy tissue-penetrating electrodes by the application of negative pressure within the handpiece and/or tip.
- the system may include a vacuum source (e.g., source of negative pressure) that may assist with the deployment and/or insertion of the tissue-penetrating electrodes to the tissue.
- a vacuum source e.g., source of negative pressure
- a vacuum chamber e.g., a deployment/holding vacuum chamber
- the electrode holder If the electrode holder is latched, the electrodes will remain in place until the trigger button is pressed. Once the trigger is pressed, the holder and electrodes will move very quickly towards the tissue, and in those implementations involving penetrating electrodes, thrusting these electrodes against and/or into the tissue (e.g., to a correct depth).
- the rate of insertion may be configured to help the penetrating electrodes penetrate the surface of the tissue easier and may help eliminate or reduce tenting or the introduction of air gaps around the electrodes.
- the same vacuum may also or additionally be applied as described above, from around the electrodes as they contact the tissue.
- the vacuum may be applied even after the electrodes are inserted into the tissue (or, in case of the non-penetrating electrodes, after the electrodes contact the tissue), and vacuum may continue to be applied through suction ports at the base of the electrode(s) to evacuate any air around the electrodes from the deployment which may further reduce the likelihood of arcing and/or may held hold the tip to the tissue and maintain the electrodes in the correct location on or in the tissue.
- FIG. 12 illustrates one example of an applicator 1200 including a handpiece 1203 having a body 1238, the applicator also includes a tip 1205.
- the tip may be removably coupled to the handpiece.
- the handpiece in this example is coupled to an external vacuum source (e.g., source of negative pressure) through a vacuum tube 1249.
- This external vacuum source may be supplemental and may be used to apply vacuum into the vacuum chamber and/or directly into the suction ports as described above).
- the handpiece may be coupled to a pulse generator (see, e.g., FIG. 1, above) via a power cable 1252, which may be coupled to the proximal end of the handpiece via a strain relief connection 1254.
- the treatment tip includes three rows of tissue-penetrating electrodes (e.g., needles) 1244.
- the applicator 1200 shown in FIG. 12 may be configured so that the needles may be driven out of the tip housing 1278 by actuating a control (e.g. an electrode deployment control), such as a trigger, release, latch, switch, etc. 1263 on the handpiece.
- a control e.g. an electrode deployment control
- release of the trigger causes the negative pressure within the body of the handpiece (e.g., within a vacuum chamber of the handpiece) to drive a shaft within the tip to drive the electrodes distally.
- releasing the control may drive the electrode against or into the tissue, but residual negative pressure may remain in the vacuum chamber even after deploying against and/or into the tissue.
- This residual pressure may be applied out of the suction port(s) at the tip of the electrode as described above.
- engaging the electrode deployment control may also open the suction channel to allow suction from the vacuum chamber to be drawn through the suction ports around the electrodes at the tip.
- suction from the vacuum tube may be applied out of the suction ports.
- the vacuum chamber may be evacuated prior to use by manually drawing the vacuum, e.g., by pulling back on the piston within the handpiece similar to that shown in FIGS. 2-4, above, or by applying an external source of vacuum into the vacuum chamber.
- FIG. 13A illustrates an applicator 1300 similar to that shown in FIG. 12 but showing the outer housing 1338 of the handpiece 1303 portion of the actuator as transparent.
- the handpiece includes a body (formed by the outer housing 1338) enclosing a vacuum chamber 1381 and the applicator also includes tip 1305 having tip housing 1378.
- a piston 1383 includes a vacuum plate 1385 that is slidably held within the vacuum chamber and a shaft that is coupled to the tissue penetrating electrodes within the tip. This coupling may be via a mechanical coupling between the tip and the handpiece so that movement of the shaft distally drives the electrodes distally.
- a piston retainer 1387 is coupled to the piston and engages the trigger 1363.
- a vacuum input port 1388 receives negative pressure (e.g., from an external source).
- the handpiece may include an internal negative pressure source, as described above.
- the trigger may secure the piston (via the piston retainer) so that the vacuum chamber is held under negative pressure, while the electrodes are retracted within the tip.
- the trigger is actuated, so that the trigger releases the piston retainer, the vacuum plate of the piston is drawn distally to reduce the volume of the vacuum chamber, since the piston is free to slide distally and proximally when unconstrained by the piston retainer.
- the movement of the vacuum plate distally drives the shaft of the piston distally, therefore driving the electrodes distally and out of the electrode housing of the tip. This is illustrated in FIG. 13B-13C.
- FIG. 13B shows the applicator of FIG. 13A after release of the trigger 1363 has been actuated to release the piston retainer 1387 (e.g., by disengaging the retainer from a holder on the piston retainer.
- the trigger includes a latch region 1399 that may engage with the piston retainer in both the undeployed configuration (e.g., with the piston held proximally), or the deployed configuration (after release of the trigger, with the piston allowed to advance distally).
- the negative pressure within the vacuum chamber 1381 causes the vacuum plate to move distally, as shown in FIG. 13B, extending the electrodes 1344.
- the trigger latch shown in FIG. 13B (and FIG. 13C) also includes an interference surface that engages with the piston retainer when the piston is advanced fully (or partially) distally, so that the electrodes are deployed.
- the interference surface may prevent the piston from sliding back proximally (retracting the electrodes) until sufficient force is applied, e.g., force above a threshold for resetting the piston.
- the residual negative pressure within the vacuum chamber 1381 may be applied through a suction channel (e.g., within piston 1383) and out of one or more suction ports in the tip, as described above.
- suction may be applied from the vacuum port 1388.
- FIG. 13C shows a section through the applicator of FIG. 13B, showing some of the internal features.
- the piston may form a seal, e.g., a vacuum seal 1376, with the wall(s) of the internal chamber forming a portion of the vacuum chamber inside of the housing of the handpiece.
- the vacuum chamber may be held under negative pressure during operation of the applicator. Additional negative pressure (vacuum) may be applied through the tip to a suction port the region at the base of the tissue-penetrating electrodes, as discussed above.
- the handpiece may also include a mechanical bias such as a spring or lever to reset or help reset the piston and withdrawn the electrodes.
- FIGS. 14A-14B illustrate another example of an applicator including a tip with deployable tissue-penetrating electrodes, in which the handpiece is configured to deploy (and in this example, retract) the electrodes from the tip using negative pressure.
- the handpiece 1403 is coupled to the electrode tip 1405 and a piston member 1483 may be driven distally by the piston once a control is actuated to release the piston, allowing it to advance and deploy the electrodes.
- FIG. 14A shows the device with the electrodes 1444 retracted and un deployed.
- the control may be released to drive the piston distally and deploy the electrodes, as shown in FIG. 14B.
- a second vacuum chamber 1492 retract vacuum chamber
- the apparatus may use the vacuum to extend the electrodes as well as retract the electrodes from the tissue.
- the extension and retraction of the electrodes onto/into the tissue may also be achieved without the use of the latch feature.
- vacuum chamber When the vacuum is applied to the vacuum chamber, and the tip is in contact with the tissue, vacuum chamber may collapse as the piston is driven distally, causing the electrodes to move forward.
- the suction ports around the electrodes may hold the tissue in place as the forward moving electrodes contact (e.g., in some examples, pierce) the tissue and continue to advance until full deployment is achieved.
- This method of deploying the needles shown in FIGS. 14A-14B may be slightly smoother than the concept with the latch.
- the user may switch a valve that reconnects the vacuum supply to the retraction vacuum chamber 1492.
- the electrodes 1444 will be retracted from the tissue and pulled back into the tip housing in preparation for the next treatment.
- the user may again activate the control (e.g., a trigger button) and the electrodes may be deployed onto/into the tissue to treat the next lesion.
- the electrodes may be driven distally by the application of a mechanical (rather than pneumatic) force, such as by a spring.
- a mechanical force such as by a spring.
- the apparatus may be configured so that advancing the electrodes distally generates a negative pressure within a chamber of the handpiece (e.g., within a vacuum chamber), and this resulting negative pressure may be applied through one or more suction port(s) out of the distal tip during and/or after deploying the electrodes (e.g., activating an electrode deployment control).
- any of the features described herein may be combined or used with any of the apparatuses and methods described herein.
- any of these devices and methods may be used with either tissue-penetrating or non-penetrating electrodes.
- the tips described herein may be configured to apply suction from the suction port(s).
- the apparatuses and methods configured to apply suction (including a suction pulse) to remove air from around the electrode may be used with any of the vacuum deployment features described with reference to FIGS. 10-14.
- Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control performance or perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), causing application of a negative pressure within the vacuum chamber of the handpiece, determining, alerting, or the like.
- a processor e.g., computer, tablet, smartphone, etc.
- Certain embodiments relate to a machine-readable medium (e.g., computer readable media) or computer program products that include program instructions and/or data (including data structures) for performing various computer-implemented operations.
- a machine-readable medium may be used to store software and data which causes the system to perform methods of the present disclosure.
- the above-mentioned machine-readable medium may include any suitable medium capable of storing and transmitting information in a form accessible by processing device, for example, a computer.
- Some examples of the machine-readable medium include, but not limited to, magnetic disc storage such as hard disks, floppy disks, magnetic tapes. It may also include a flash memory device, optical storage, random access memory, etc.
- the data and program instructions may also be embodied on a carrier wave or other transport medium. Examples of program instructions include both machine code, such as produced by a compiler, and files containing higher level code that may be executed using an interpreter.
- the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
- the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
- first and second may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
- a numeric value may have a value that is +/- 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 values given herein should also be understood to include about or approximately that value unless the context indicates otherwise. For example, if the value "10" is disclosed, then “about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
- inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed.
- inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed.
- inventive subject matter merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed.
- inventive subject matter merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed.
- This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above
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Abstract
Applicators and methods including electrodes that are configured to apply energy within the tissue while selectively applying vacuum to prevent arcing and/or to enhance deployment of the electrodes into the tissue are provided. The applicators may comprise vacuum ports around the electrodes of the applicators and may be also comprise an internal vacuum source.
Description
TREATMENT TIPS WITH SUCTION FEATURE
CROSS REFERENCE TO RELATED APPLICATIONS [0001] This patent application claims priority to U.S. provisional patent application No. 63/213,677, titled “REUSABLE HANDPIECES AND TREATMENT TIPS WITH SUCTION FEATURE,” filed on June 22, 2021, which is herein incorporated by reference in its entirety.
INCORPORATION BY REFERENCE
[0002] 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.
FIELD
[0003] The methods and apparatuses described herein may be related to electrodes for the application of electrical energy to a subject, for example, a patient. More specifically, the methods and apparatuses described herein relate to the electrodes that may apply suction. These methods and apparatuses may include electrode treatment tips and/or handpieces that may include or be used with these treatment tips for electrical treatment of tissue. These apparatuses and methods may be particularly useful for avoiding or minimizing undesirable electrical modification of the tissues, including preventing or limiting electrical arcing.
BACKGROUND
[0004] Electrical energy may be applied within the tissue for a variety of purposes, including for the treatment of medical conditions. Electrical energy may be provided through an electrode that is inserted into the tissue. For example, energy, and particularly high-voltage or high-power energy, applied to the tissue may progressively change the impedance of the surrounding tissue in some regions near the electrode; at some point, the change in tissue impedance may result in an uncontrolled electrical discharge, such as an arc.
[0005] This problem may be particularly acute when applying rapid, high-energy pulses, e.g., to treat patients. For example, nanosecond high voltage pulse generators have been described for biological and medical applications. See, e.g., U.S. Patent Application No. 2010/0038971, which is herein incorporated herein by reference in its entirety.
[0006] Because of the very high therapeutic voltages, as well as the very fast pulse times, applicators for delivery of such sub-microsecond pulsing devices must be configured so as to avoid or at least minimize arcing between the applicators. In some cases, the applicator may be
configured to penetrate into the tissue and may include multiple needle-type electrodes. Such applicators may be particularly difficult to use with high-voltage systems while avoiding undesirable arcing. For example, when using a needle electrode, a small corona discharge can occur at locations of high current density on the needle (i.e., the very tip of the sharpened needle, or a sharpened needle edge on a trocar-shaped needle, or the transition between exposed needle/metal and insulation on the needle/metal). As the treatment progresses, the corona discharge during each pulse may start to break down the tissue.
[0007] Another issue referred to as “tenting” may occur when electrodes, and particularly needle electrodes, are inserted into the tissue; the tissue that is being penetrated by the electrode may stretch around the electrode(s) as pressure is applied. This may form an air gap (shaped like a tent) around the electrode. This issue may be exacerbated with multiple needle electrodes adjacent to each other, in which the tissue gap (tent) around one needle can overlap with the tissue gap (tent) of neighboring needle electrodes, forming a larger gap than with a single needle electrode. This tenting effect can also lead to arcing, particularly at the surface of the tissue. [0008] The methods and apparatuses described herein may address various issues raised above and also improve usability of the devices and instrument that apply electrical energy, especially with high therapeutic voltages.
SUMMARY OF THE DISCLOSURE
[0009] Described herein are apparatuses and methods for applying electrical energy to a subject’s tissue using one or more electrodes such as to prevent or limit unintended modification of the tissue adjacent to the electrode, such as by arcing.
[0010] Any of these apparatuses may be configured as a device or a system, including, for example, a hand-held or hand-operated device, a computer-controlled, and/or a robotically operated, or remotely operated device. For clarity and avoidance of any doubt, the term “handpiece” as used herein refers to any structure to support, hold or attach to the electrode portion of the device, whether it is intended to be hand-held, or attached to the robotic arm, or for percutaneous or other minimally invasive applications. In some examples the handpiece may be configured to be hand-held, and may include a manual grip. In some examples, the handpiece may be configured to be held by a robotic manipulator (e.g., arm, etc.). The apparatuses described herein (devices, systems, etc.) may be configured with one electrode or more than one electrode. The electrode may be, e.g., an array of electrodes.
[0011] Any of the apparatuses described herein may include penetrating (e.g., tissue penetrating) or non-penetrating electrodes. In some examples of the apparatuses shown herein, the electrodes are illustrated as tissue penetrating electrodes. For example, the electrodes may be
one or more needle, wire, plate, blade, etc. electrodes. Alternatively, except where the context makes clear otherwise, non-penetrating electrodes may be used. The electrodes may be configured for acute treatment (e.g., insertion into or placing in contact with the tissue for the duration of a treatment or thereabouts). In general a penetrating electrode may be any electrode that is configured or adapted for insertion into the tissue. Penetrating electrodes may be configured to penetrate into and/or through the tissue. Penetrating electrodes may be sharp and/or cutting and may include a leading tissue-penetrating edge. Examples of penetrating electrodes include but are not limited to needle electrodes. In general, a penetrating electrode may be configured to deliver energy (electrical energy) from all or a portion of the electrode. The penetrating electrode may be electrically insulated over one or more regions or portions. The non-insulated portions may be referred to uninsulated and may be configured as energy delivery regions of the electrode. Although in some variations the penetrating electrode may include a single energy delivery region, in some variations a penetrating electrode may include multiple energy delivery regions.
[0012] In some examples the electrodes may be non-penetrating electrodes, such as plate or surface electrodes, blunt (including blunted needle, pins, etc.) electrodes or other configurations having non-penetrating tips. Non-penetrating electrodes may be configured to be biased against the surface of a tissue, and may advance and/or retract slightly (against a biasing force, such as a spring) to conform to tissues of different heights relative to the applicator. Unless the context makes clear otherwise, any of the examples described herein including non-penetrating electrodes may instead be configured to include tissue penetrating electrodes.
[0013] In any of the apparatuses described herein, an applicator may include a handpiece and/or a tip. The tip may be removable and/or replaceable (e.g., disposable), while the handpiece may be reusable. In some examples, the tips (also referred to herein as treatment tips) may include two or more tissue penetrating electrodes and may include localized suction ports for the application of suction (negative pressure) at or near the base of the electrodes as they are inserted (or after they have been inserted) into the tissue. In some examples, the tips (e.g., treatment tips) may include two or more non-penetrating electrodes and may include localized suction ports for the application of suction (negative pressure) at or near the base of the electrodes as they are applied (or after they have been applied) against the tissue. In general, the electrodes may be configured to deploy out of the suction ports. Suction ports may also be referred to herein as vacuum ports.
[0014] Thus the treatment tips (e.g., treatment tip devices) described herein may include one or more electrodes (e.g., needle electrodes) that may be held by a frame (e.g., electrode frame) configured to allow the electrodes to move when driven by a driver. In some embodiments, the
same or a different housing (e.g. tip housing) or frame may be moved relative to the one or more electrodes. The electrodes may be coupled to a linkage directly or through the frame (or an electrode block that is configured to move with the electrodes).
[0015] The treatment tip may also include an electrical connector for connecting to a source of electrical energy. For example, the power connector may be configured to electrically connect the one or more electrodes to a power source configured to apply high voltage power to the one or more electrodes having a peak voltage of between about 100 volts per centimeter (e.g., 0.1 kV/cm) and about 500 kV/cm (e.g., between about 0.5 kV/cm and about 500 kV/cm, between about lkV/cm and 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.).
[0016] In general, a treatment tip may include any number of electrodes, including needle electrodes. The electrodes may be configured as positive (cathode) and/or negative (anode), and/or as return (ground) electrodes. In some examples the electrodes may include groups or sets of electrodes that are electrically coupled so that they share a common source. The electrodes may be arranged to apply pulsed energy (e.g., sub-microsecond pulses) between two electrodes or two groups of electrodes. Alternatively, in some examples the electrodes may be configured for monopolar application of energy and a separate return electrode (e.g., pad, mat, etc.) may be used.
[0017] Any of the methods and apparatuses described herein may include an internal source of negative pressure within the handpiece. This negative pressure may be used to apply suction through one or more suction ports of the tip. Thus, any of these handpieces may include a vacuum chamber (also referred to herein as a negative pressure chamber or a suction chamber), that may be in fluid communication with the suction port(s) at the tip, for example through a suction connector and suction channel or suction tube. The vacuum chamber may be charged with negative pressure by withdrawing a piston (or piston-like member) within the vacuum chamber. In some examples the piston may be manually withdrawn by the user from outside of the handpiece and may be held in place by a lock. In some examples a ratcheting lock mechanism may be used to allow stepwise drawing of negative pressure. The use of such a vacuum chamber within the handpiece may enhance and improve usability of the handpiece. Such embodiments may be operated without requiring an external source of vacuum and may be reusable. The methods and apparatuses described herein may be operated with relatively low vacuum level and may further be operated over a relatively short duration (e.g., as one or more pulses of suction from the suction port) immediately before and/or during the application of energy. Thus, a small, manually charged vacuum chamber may be sufficient.
[0018] Any of the methods and apparatuses described herein may be configured to deploy the electrodes, for example, by activating of a control on the handpiece. In some examples the deployment may be driven by negative pressure. For example, any of these apparatuses may be configured to deploy (e.g., extend) electrodes (e.g., pneumatically) by activation of a control (e.g., latch, switch, etc.) so that a negative pressure may drive movement of the electrodes distally (and/or in some cases proximally).
[0019] Also described herein are methods of applying electrical therapy to a subject. For example, any of these methods may include: inserting one or more electrodes into the subject’s tissue; and applying suction at the base of the tissue-penetrating electrodes to remove air from around the electrode(s) to prevent arcing. In general, the energy therapy may refer to the applied electrical energy. As used herein energy is applied by the electrode(s) during the application of energy therapy. The energy therapy may be continuous or pulsed. The energy therapy may be pulsed at a single frequency or a range of frequencies, including at a modulated frequency (e.g., having a carrier frequency).
[0020] As mentioned, any appropriate electrical energy may be applied while moving the electrodes relative to the tissue. For example, applying energy may comprise applying electrical pulses, for example, high-voltage nanosecond electrical pulses, such as applying a train of sub microsecond electrical pulses having a pulse width of between 0.1 nanoseconds (ns) and 1000 nanoseconds (ns). Applying high-voltage nanosecond electrical pulses may comprise applying a train of sub-microsecond electrical pulses having peak electric fields, for example, of between 5 kilovolts per centimeter (kV/cm) and 500 kV/cm. Applying high-voltage nanosecond electrical pulses may comprise applying a train of sub-microsecond electrical pulses at a frequency of between 0.01 (Hz) to 10,000 Hz. Applying energy may comprise applying microsecond electrical pulses, or picosecond electrical pulses.
[0021] The methods and apparatuses described herein may be used as part of any appropriate electrical therapy, including cosmetic procedure or therapy, in which electrical energy is applied within the tissue (or in some cases on the tissue). For example, the method of applying energy described herein may be used to treat one or more of the following: organ tissue cancer (e.g., lung cancer, kidney cancer, pancreatic cancer, colon cancer, breast cancer, etc.), skin cancer, cherry angioma, warts, keloids/scars, aging skin, dermatological conditions and/or disease, molluscum angioma, necrobiosis lipoidica (NBL), melisma, lipoma epidermal/sebaceous cyst, basal cell carcinoma, any type of lesions, tumors or abnormal tissue growth on or in various body organs (e.g., benign tumors, precancerous tumors). Alternatively, or additionally, these methods may be methods of any other body tissue, including non-skin tissue (respiratory tissue, lung tissue, breast tissue, liver tissue, etc.).
[0022] Any power connector may be configured to electrically connect the one or more electrodes to a power source configured to apply high voltage power to the one or more electrodes, such as (but not limited to) power having a peak electric field of between 10 kilovolts per centimeter (kV/cm) and 500 kV/cm.
[0023] For example, described herein are treatment tip devices (or apparatuses) for delivery of electrical therapy. These devices may include: an electrode housing extending from a distal end of the treatment tip device; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes at least partially within the electrode housing; wherein at least some of the electrodes of the plurality of electrodes are configured to extend out of the plurality of suction ports; further wherein the treatment tip device has an un-deploy ed configuration in which distal ends of the plurality of electrodes do not extend beyond a distal end face of the electrode housing and a deployed configuration in which the distal ends of the plurality of electrodes extend beyond the distal end face of the electrode housing, and wherein at least one of the electrode housing and the plurality of electrodes is configured to move relative to the other to convert between the un-deployed and the deployed configurations.
[0024] A treatment tip device for delivery of electrical therapy may include: an electrode housing extending from a distal end of the treatment tip device; a plurality of suction ports opening into the electrode housing; a plurality of electrodes at least partially within the electrode housing and configured to extend out of the suction ports; wherein the treatment tip device has an un-deployed configuration in which distal ends of the plurality of electrodes do not extend beyond a distal end face of the electrode housing and a deployed configuration in which the distal ends of the plurality of electrodes extend beyond the distal end face of the electrode housing, and wherein at least one of the electrode housing and the plurality of electrodes is configured to move relative to the other to convert between the un-deployed and the deployed configurations; and a suction connector extending from a proximal end of the treatment tip device configured to mate with a quick connect latch on a handpiece, wherein the suction connector is in fluid connection with the plurality of suction ports.
[0025] Any of the treatment tip devices may include a suction connector extending from a proximal end of the treatment tip device and in fluid connection with the plurality of suction ports. In some examples, the suction connector may be configured to remain stationary while the electrode housing (and the suction ports) moves relative to the rest of the treatment tip. For example, the suction connector may make a sealing connection with the suction ports that allows relative movement between the suction ports (e.g., the electrode housing) and the suction connector. Alternatively in some examples the suction connector may move with either the electrode housing or with the electrodes.
[0026] Any of the treatment tip devices may include one or more (e.g., a pair of) electrical pins extending from a proximal end of the treatment tip device that are configured to mate with electrical connectors on a handpiece. The tip may be mechanically secured to the handpiece by the one or more electrical connectors (e.g., pins) and/or by a suction connector.
[0027] The treatment tips described herein may include a vacuum manifold within the treatment tip configured to distribute negative pressure between the plurality of suction ports, from the suction connector.
[0028] In any of these examples, the plurality of electrodes may be slidably disposed within the plurality of suction ports. In some examples, the plurality of electrodes are tissue-penetrating electrodes. Alternatively, in some examples the plurality of electrodes are non-penetrating electrodes.
[0029] Any of these devices may include a bias exerting a bias return force to oppose conversion from the un-deployed to the deployed configuration or from the deployed to un deployed configuration.
[0030] Also described herein are systems including any of the tips described herein and a handpiece, particularly a handpiece that may include a vacuum chamber (e.g., negative pressure chamber). The handpiece may include a manual control for generating negative pressure within the applicator.
[0031] For example, described herein are apparatuses or applicator systems comprising: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes configured to extend out of the plurality of suction ports, wherein the electrode housing and the plurality of electrodes are configured to move relative to each other to convert between an un deployed configuration, in which the plurality of electrodes do not extend beyond a distal end face of the electrode housing, and a deployed configuration, in which the plurality of electrodes extend beyond the distal end face of the electrode housing; and a handpiece comprising: a body having one or more electrical connectors at a distal end configured to couple with the treatment tip to apply electrical energy to the plurality of electrodes; a vacuum chamber within the body in fluid communication with the suction connector; a vacuum plate within the vacuum chamber, configured to generate a negative pressure within the vacuum chamber; and a suction control on the handpiece configured to apply negative pressure from the vacuum chamber out of the plurality of suction ports.
[0032] Any of these systems may also include a suction connector, for example, extending from the treatment tip, and a suction connector receiver on a handpiece that is configured to engage with the suction connector to apply suction to the suction ports. The suction connector
receiver may be configured to latch the treatment tip to the handpiece. The suction connector may be a push-to-connect connector. Any of these systems may include a release control on the handpiece to release the treatment tip from the handpiece by releasing the suction connector from the suction connector receiver.
[0033] The suction control on the handpiece may be configured to apply a pulse of negative pressure from the vacuum chamber out of the plurality of suction ports.
[0034] Any of these systems may include a lock on the handpiece configured to secure a relative position of the vacuum plate and the vacuum chamber to maintain the negative pressure. A mentioned, any of the apparatuses described herein may include a manual vacuum control on the handpiece configured to be moved to generate the negative pressure within the vacuum chamber. In some examples the vacuum plate comprises part of a piston, further wherein a shaft of the piston is coupled to an electrode interface on the treatment tip so that movement of the vacuum plate drives linear movement of the piston and extends the plurality of electrodes to the deployed configuration, beyond the distal end face of the electrode housing.
[0035] Any of these apparatuses may include a trigger control, wherein the trigger control is configured to be actuated to release the vacuum plate so that the plurality of electrodes moves to a deployed configuration.
[0036] As mentioned above, the applicators (e.g., the tip and handpiece) may be configured to provide a relatively low level of negative pressure for a short duration (e.g., a burst). For example, any of these apparatuses may include a vacuum chamber that is be configured to provide less than 10 kPa of negative pressure through the suction ports. The system may be configured to apply pressure for less than 60 seconds through the suction ports after deploying the electrode housing. The system may be configured to apply negative pressure through the suction ports only after deploying the electrode housing.
[0037] According to further examples, an apparatus (e.g., an applicator, system, etc.) may include: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; and a plurality of electrodes disposed within the electrode housing; and a handpiece comprising: a body; a vacuum chamber within the body; a piston having a vacuum plate within the vacuum chamber, wherein the piston is operably connected to the plurality of electrodes; and a trigger, wherein the trigger is configured so that activation of the trigger releases the vacuum plate to move within the vacuum chamber when there is a negative pressure within the vacuum chamber, driving the plurality of electrodes distally out of the electrode housing.
[0038] In some examples, the handpiece may include a suction port in fluid communication with the vacuum chamber and configured to couple to a source of negative pressure. Any of
these apparatuses may include a latch on the handpiece coupled to the trigger and configured to retain the piston in a fixed position until released by actuation of the trigger. The latch may be further configured to retain the piston in both a deployed configuration with the piston extended distally and in an undeployed configuration with the piston retracted proximally. The treatment tip may be removably coupled to the applicator via an electrical connection and a pressure connection. The apparatus (e.g., an applicator) may include a plurality of suction ports on the treatment tip, wherein the suction ports are configured to apply suction at a base of the plurality of electrodes.
[0039] Also described herein are methods, including methods of treating a tissue in a manner that prevents arcing. For example, a method may include: contacting a tissue with a tip of an applicator; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing of the tip of the applicator so that the plurality of electrodes are in contact with the tissue; applying a negative pressure (e.g., a pulse of a negative pressure) through the suction ports to remove or at least reduce air from between the electrodes of the plurality of electrodes and the tissue; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes.
[0040] Deploying the plurality of electrodes may include deploying a plurality of tissue- penetrating electrodes out of the plurality of suction ports and into the tissue. In some examples deploying the plurality of electrodes comprises deploying a plurality of non-penetrating electrodes so that they are in contact with the tissue. For example, deploying the plurality of electrodes may include releasing a latch on a handpiece so that a negative pressure within the handpiece moves a piston in the handpiece and drives the plurality of electrodes distally out of the electrode housing. The pulse of negative pressure may be applied immediately prior to or concurrent with the application of the pulsed electrical treatment. In some examples applying the pulse of negative pressure comprises applying the pulse of negative pressure for less than 1 minute. Applying the pulsed electrical treatment may comprise stopping application of the pulse of negative pressure before applying the pulsed electrical treatment. In some examples applying the pulse of negative pressure may comprise applying less than 100 kPa of negative pressure. [0041] Any of these methods may include manually generating a negative pressure within a vacuum chamber of the applicator, further wherein applying the pulse of negative pressure comprises applying the negative pressure from the vacuum chamber. For example, manually generating may comprise pulling a vacuum plate within the applicator to generate negative pressure within the vacuum chamber.
[0042] Also described herein are methods, including methods of using and/or operating these apparatuses. For example, a method of operating an apparatus comprising a plurality of
electrodes within an electrode housing and a handpiece including a vacuum chamber and a piston within the vacuum chamber is provided. The method may comprise: causing application of a negative pressure within the vacuum chamber of the handpiece of the apparatus; and actuating a control to cause the piston within the vacuum chamber of the handpiece to move within the vacuum chamber, thereby driving the plurality of electrodes operatively connected to the piston out of the electrode housing into a deployed configuration. The method may further comprise regulating an amount of negative pressure applied (e.g., around the electrodes). The method may further comprise using vacuum to retract the plurality of electrodes into undeployed configuration. In some implementations, the method of operating of an apparatus may comprise: applying a negative pressure within a vacuum chamber of an applicator, wherein the applicator includes a tip comprising a plurality of electrodes housed within an electrode housing; actuating a trigger on the applicator to cause a piston on the applicator to be drawn distally by the negative pressure within the vacuum chamber; and translating movement of the piston into a movement of the plurality of electrodes to deploy the plurality of electrodes out of the electrode housing.
[0043] According to further examples, a method may include: contacting a tissue with an applicator including a tip; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing and in contact with the tissue by negative pressure; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes. The methods described herein may include applying negative pressure through the suction ports to remove air from between the electrodes and the tissue before applying the pulsed electrical treatment. Deploying the plurality of electrodes by negative pressure may include applying the negative pressure from a vacuum chamber within the applicator.
[0044] Any of these methods may include manually generating the negative pressure within a vacuum chamber in the applicator. Deploying the plurality of electrodes may comprise deploying a plurality of tissue-penetrating electrodes into the tissue. Deploying the plurality of electrodes may comprise deploying a plurality of non-penetrating electrodes so that they are in contact with the tissue. In some examples deploying comprises actuating a trigger on the applicator to release a latch, wherein releasing the latch allows a piston within the applicator to be drawn distally by the negative pressure within a vacuum chamber of the applicator.
[0045] 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 view of the accompanying figures.
BRIEF DESCRIPTION OF THE DRAWINGS [0046] It should be noted that the drawings are not to scale and are intended only as an aid in conjunction with the explanations in the following detailed description. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. The novel features of the inventions described herein are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present methods and apparatuses will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
[0047] FIG. 1 illustrates one example of a system, including an applicator as described herein and a pulse generator to which the applicator is coupled, for delivery of high voltage, fast pulsed electrical energy.
[0048] FIGS. 2A-2B illustrate one example of an applicator including a tip (shown here as a disposable treatment tip) that removably couples with a handpiece. FIG. 2A shows the treatment tip coupled to the handpiece. The handpiece includes a source of negative pressure within the body of the handpiece. FIG. 2B shows the tip decoupled from the handpiece.
[0049] FIGS. 3 A and 3B illustrate another example of an applicator including a tip, also shown as a removable tip. FIG 3A shows a longitudinal section through the body applicator, showing the internal (self-contained) vacuum source within the handpiece body. FIG. 3B shows another longitudinal section through the applicator of FIG. 3A, with the internal vacuum source actuated to apply suction around the electrodes of the attached tip.
[0050] FIG. 4 illustrates another example of an applicator with a reusable handpiece including an internal vacuum source and a removable tip.
[0051] FIG. 5A illustrate one example of a cut-away portion of an applicator illustrating engagement between a removable tip and a handpiece, including a vacuum connector making connection between the suction ports on the tip and the vacuum source within the handpiece. [0052] FIG. 5B shows one example of a vacuum connector for a handpiece as described herein.
[0053] FIGS. 6A-6B illustrate examples of a distal end of a treatment tip including suction ports through which a vacuum may be applied and out of which electrodes may extend.
[0054] FIGS. 7A-7B illustrate another example of a portion of a treatment tip including suction ports in an electrode housing out of which the tissue-penetrating electrodes may extend. In FIG. 7A the perspective view shows the distal end of the housing and the plurality of tissue
penetrating electrodes within the housing. FIG. 7B shows a section through the electrode housing showing the tissue-penetrating electrodes, suction ports and suction lines.
[0055] FIGS. 8A-8B illustrate another example of a portion of a treatment tip including suction ports in an electrode housing out of which the tissue-penetrating electrodes (or blunt needle electrodes) may extend. FIGS. 8A-8B demonstrate an example where multiple rows of needles could be incorporated. In FIG. 8A the perspective view shows the distal end of the housing and the plurality of tissue penetrating electrodes in multiple rows within the housing. FIG. 8B shows a section through the electrode housing showing the tissue-penetrating electrodes, suction ports and suction lines.
[0056] FIGS. 9A-9B illustrate another example of a portion of a treatment tip including suction ports in a movable (e.g., retractable) electrode housing out of which the tissue- penetrating electrodes may extend. In FIG. 9A the perspective view shows the distal end of the retractable electrode housing extending from a tip housing and including a plurality of suction ports; one or more tissue penetrating electrodes may be extended from within each of the suction ports of the retractable housing. FIG. 9B shows the tip shown in FIG. 9A with the tissue- penetrating electrodes, suction ports and suction lines, extending at least partially out of the suction ports.
[0057] FIG. 10A illustrates another example of an applicator tip including suction ports out of which electrodes may extend when the electrode housing is retracted.
[0058] FIGS. 10B-10G illustrate the operation of one example of an applicator including an applicator tip similar to that shown in FIG. 10A in which suction is applied during deployment of the tissue-penetrating electrodes into the tissue.
[0059] FIGS. 1 lA-11C illustrate another method of operation of an applicator including an applicator tip similar to that shown in FIG. 10A, in which the suction is applied after deploying the tissue-penetrating electrodes to reduce or prevent tenting of the electrodes in the tissue.
[0060] FIG. 12 shows another example of an applicator, including a treatment tip, in which negative pressure in the handpiece may be used to deploy the tissue-penetrating electrodes from out of the tip housing. In FIG. 12, an external vacuum source may also or alternatively be used. [0061] FIGS. 13A-13C illustrate another example of an applicator, including a treatment tip, with a latch trigger. In FIGS. 13A-13B the outer housing has been made transparent. The applicator is configured so that a control on the handpiece (e.g., a trigger) may rapidly deploy the plurality of electrodes out of the tip. FIG. 13A shows the electrodes in an undeployed state. FIG. 13B shows the electrodes deployed. FIG. 13C shows a section through the device of FIG. 13B with the electrodes deployed.
[0062] FIGS. 14A-14B illustrate another example of an applicator without a latch trigger, with an internal vacuum source that may be triggered to deploy the electrodes and/or to retract the electrodes. FIG. 14A shows the applicator with the electrodes undeployed. FIG. 14B shows the applicator with the electrodes deployed.
DETAILED DESCRIPTION
[0063] For the sake of clarity and conciseness, certain aspects of components or steps of certain embodiments are presented without undue detail where such detail would be apparent to skilled persons in light of the teachings herein and/or where such detail would obfuscate an understanding of more pertinent aspects of the embodiments.
[0064] Described herein are applicators adapted to be used for the application of electrical energy into a target tissue. In particular, the applicators described herein may include an electrode tip and a handpiece. In some examples the electrode tip may be removable and disposable and may be attached to a reusable handpiece. In some variations the tip may be integrated into the handpiece. The applicators described herein may be configured to use suction specifically to prevent air gaps between the tissue and the electrode that may negatively impact the applied electrical therapy, including allowing arcing. Moreover, the disclosed designs improve the overall usability and the ease of use of these devices. Thus, described herein are electrical applicators that may include a handpiece with a source of suction (or vacuum) to apply a negative pressure through one or more suction ports on a tip attached or integral with the handpiece. The tip may be configured so that the suction, which may be applied during or immediately after the electrodes have penetrated or contacted the tissue (but before applying therapeutic energy from the electrodes), is applied at the base of the electrode, including to just the region around the electrode(s). The suction exits an electrode housing of the tip, so as to remove or minimize any air gaps between individual electrodes and the tissue.
[0065] Also described herein are apparatuses in which the suction may be used to deploy the electrodes from the applicator, so that a negative pressure with the handpiece may be used to drive extension of the electrodes when a trigger is activated.
[0066] FIG. 1 illustrates one example of a system 100 that may be used with or may incorporate, any of the applicators described herein. The system shown in FIG. 1 (also referred to herein as a high voltage system or a sub-microsecond generation system) for delivering high voltage, fast pulses of electrical energy that may include an elongate applicator tool 102, a pulse generator 107, footswitch 103, and user interface 104. Footswitch 103 is connected to housing 105 (which may enclose the electronic components) through a cable and connector 106. The elongate applicator 102 may include electrodes (e.g., as part of an electrode tip) and may be
connected to housing 105 and the electronic components therein through a cable 137 and high voltage connector 112. Examples of applicators are described in greater detail below. The high voltage system 100 may also include a handle 110 and storage drawer 108. The system 100 may also include a holder (e.g., holster, carrier, etc.) (not shown) which may be configured to hold the elongate applicator tool 102.
[0067] In some cases, the applicator tip includes one or more disposable tips that may releasably couple to the handpiece of the applicator. In some variations the applicator tip may be adapted to make an electrical, mechanical and a pressure connection, as will be described in greater detail below. The handpiece of the applicator may include a self-contained source for generating suction that may be used to apply suction at the tissue-penetrating electrodes, e.g., as the base of the tissue-penetrating electrodes, where the electrodes extend from the tip.
[0068] A human operator may select a number of pulses, amplitude, pulse duration, and frequency information, for example by inputting such parameters into a numeric keypad or a touch screen of interface 104. In some embodiments, the pulse width can be varied. A controller 144 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 the housing 105, but it may be positioned 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 a separate processing unit or may be incorporated with the controller. In some examples and implementations, the controller and/or a processor may trigger and/or control application of a negative pressure within a vacuum chamber of the handpiece as discussed below. In some embodiments, fiber optic cables are used which allow control signaling while also electrically isolating the contents of the metal cabinet with sub-microsecond pulse generation system 100, e.g., the high voltage circuit, from the outside. In order to further electrically isolate the system, system 100 may be battery powered instead of being powered from a wall outlet.
[0069] The elongate applicator tool may be hand-held (e.g., by a user), configured for percutaneous or other minimally-invasive applications, or it can be affixed to a movable arm of a robotic system, and its operation may be at least partially automated or fully automated, including computer controlled.
[0070] As mentioned, the methods and apparatuses described herein may include applicators that include one or more sets of electrodes (e.g., needle electrodes, surface or plate electrodes, wire electrodes, bar electrodes, etc.) for applying electrical energy to a tissue. In some examples the electrodes may be configured for monopolar application of energy and a separate return electrode 133 (e.g., pad, mat, etc.) may be used. The applicator may include a tip portion and a
handpiece portion. The tip and handpiece may be separate, or they may be a single, unitary applicator. In some examples the tip is removable from the handpiece so that the multiple different tips, including different types of tips, can be coupled to the handpiece. The handpiece may include a source of negative pressure (e.g., suction or vacuum) that may be applied through the electrode in order to modify the contact between the tip, and in particular the electrode(s) of the tip, and the tissue. In particular, the handpiece may include a self-contained source of vacuum. Alternatively or additionally, in some examples the apparatuses (e.g., tips, handpieces, etc.) may be used with an external source of suction.
[0071] The apparatus may be configured to reduce the forces required to drive contact or insertion of the electrodes relative to the tissue and/or to reduce the holding forces required to maintain constant contact with the tissue throughout a treatment, such as in particular a nanosecond pulsed electrical treatment. Any of the handpieces described herein may be configured to eliminate or reduce the air gap or “tenting” that may otherwise occur as well as reduce the forces the user needs to apply, which will improve the overall usability when applying the electrode tips to the tissue.
[0072] Applicator tips including retractable/extendable electrodes may produce arcing between the electrodes when an air gap forms around the electrodes during application to the tissue, both with tissue-penetrating electrodes and with non-penetrating electrodes. For example, arcing may result when a portion of one or more electrodes (e.g., tissue-penetrating or non penetrating electrodes) are exposed to air, e.g., forming air-gaps around or between the electrode(s). When air gaps near the electrode(s) are large enough, they can create an electrical path where a corona may build up until an electrical arc occurs, stopping or delaying the procedure when using a pulse generator, such as a nanosecond pulsing system.
[0073] The applicators described herein (e.g., tips and/or handpieces) may apply a negative pressure (e.g., suction, vacuum, etc.) to remove or reduces such air gaps. The apparatuses and methods described herein particularly useful and effective because they may provide very low suction and apply this suction only in a limited manner, such as around the base region of the electrode, such as near the point of contact with the tissue and the electrode, in order to prevent or reduce tenting around this base region. In some examples, the suction applied is not required to pull the tissue (e.g., skin) onto the electrodes, or to secure it into position, may be significantly lower in magnitude, and directed to regions that may otherwise not be effective to hold the tissue in position relative to the tip.
[0074] Thus, the tips described herein may be adapted to apply a relatively low level of suction (e.g., about 1 kPa or less, about 0.5 kPa or less, about 0.1 kPa or less, about 0.05 kPa or less, about 0.01 kPa or less, etc.). Suction may be applied to just a region around the base of all
or some of the electrodes, such as just around the region of the cathodic electrode(s), to prevent or reduce tenting where the electrode engages the tissue.
[0075] For example, in general, these methods and apparatuses may be configured to include one or more ports around some or all of the electrodes (e.g., needle electrodes, surface electrodes, etc.), which may be specifically configured to evacuate and reduce or eliminate air gaps around the electrodes, allowing the electrodes to achieve a better or more complete contact with the tissue. In examples including tissue-penetrating electrodes these methods and apparatuses may reduce or eliminate air gaps from around the electrode following penetration of the electrode(s) into the tissue. By removing or reducing the air gaps around the electrodes, the likelihood of delays during a procedure using these tips due to arcing may be reduced, which may in turn lead to better and/or more consistent procedural outcomes.
[0076] Thus, the suction may be applied at or from just the base of some or all of the electrodes. In some cases, the suction may be applied during and/or after inserting or placing the electrodes into a contact with the tissue. For example, the suction may be applied during insertion of the electrodes into the tissue and/or after insertion of the electrodes into the tissue but not before inserting the electrodes into the tissue.
[0077] For example, suction may be applied during application of the electrodes to the tissue; e.g., with tissue penetrating electrodes, once the electrode has begun penetrating the tissue, and with non-penetrating electrodes once the electrode has contacted the tissue surface. This may improve electrode contact. With tissue penetrating electrodes, the application of even low-levels of negative pressure (suction) around the base of the electrode(s) may reduce the force needed to insert the electrode into the tissue. Any of the tips or applicators described herein may include a housing portion that is retracted and/or deflected from over and/or adjacent to the one or more electrodes (e.g., needle electrodes, plate electrodes, or other tissue-penetrating electrodes) as the electrode is inserted into or contacted with the tissue. For example, in addition to removing the air gaps around the tissue-penetrating electrodes, these suction ports (also referred to herein as vacuum ports) at or near the base of the tissue-penetrating electrodes may also assist with the insertion of the needles into the tissue as well and may reduce the forces the user needs to apply to the electrode tips to start the procedure as well as during the procedure.
For non-penetrating electrodes, the use of low level of negative pressure may help maintain contact between the tissue and the electrodes, particularly when the tip is configured to allow extension/retraction of the electrodes and/or of the housing from which the electrodes extend. [0078] Without the use of additional suction, a user applying the tip to the tissue may otherwise have to apply a relatively large amount of force to penetrate the tissue (e.g., to break the skin, in some examples) and/or to maintain a consistent pressure to sustain contact with the
tissue during a procedure. As described herein, the use of a suction port at least partially around all or some of the electrode(s) may create sufficient suction around the engagement site of the tissue to hold the electrode in place and/or to reducing the force needed to penetrate the tissue. The vacuum suction feature may also hold the tip flush to the surface of the tissue throughout the procedure, which will, in turn, reduce the likelihood of the arcs occurring.
[0079] FIGS. 2A-2B illustrate a first example of an applicator as described herein. In this example the applicator 200, 200’ includes a reusable handpiece 203, and a disposable tip 205, 205’. The disposable tips may be removably connected to the handpiece; in FIG. 2A the tip 205 is shown connected to the handpiece. This example shows a 2.5 mm x 2.5 mm tip, wherein 2.5 mm x 2.5 mm represents a surface area between the electrodes at the distal end of the tip. In FIG. 2B, the tip 205’ is shown detached; this example shows a 5 mm x 5 mm tip. Thus, different tips (e.g., with different sizes and/or different numbers of electrodes and their position) may be used with the same handpiece. The tip may couple to the handpiece through two or more electrical connectors (e.g., connector pins 207) which may also function as mechanical connectors. In FIG. 2B two high-voltage connector pins are shown. The tip also includes a suction connector 209 that makes a sealed connection to transfer negative pressure from a suction source within the handpiece. In FIG. 2B the connector receiver 211 (including a suction line latch) is shown.
[0080] As mentioned, in this example the tip is releasably coupled with the handpiece. A tip detachment control (shown in FIGS. 2A-2B) as a tip detachment knob 213 may also be included. Thus, the tip may be mechanically latched onto the handpiece and secured in place to maintain a seal via the suction line latch and suction connector. The tip detachment control may disengage the pressure (e.g., suction) interface and/or a mechanical connection between the tip and the handpiece. In FIGS. 2A and 2B the handpiece may include a body housing 215 that encloses the internal structures within the housing, such as the source of suction within the handpiece. In FIGS. 2A and 2B the suction may include a hand-actuated source of suction. For example, a slider may be accessible on or through housing to drive (or pull) a plunger within a vacuum chamber 221 to generate a negative pressure within the internal vacuum chamber before locking in place to hold the vacuum. In some implementations, the actuation of the source of suction may be controlled by a controller or a processor, for example, in response to the user instructions. FIGS. 2A-2B also shows a suction push slider 223 that may be gripped to generate the negative pressure within the handpiece, and a suction line 219. In some (as described below in other handpiece examples, such as shown in FIGS. 12-13C) the handpiece may couple with a separate source of negative pressure, e.g., vacuum.
[0081] FIGS. 3A-3B show an example of a handpiece including internal structures that may generate, maintain and deliver the suction through the tip so that it may be applied at the base of
the electrodes on the tip. For example, in FIG. 3A, the applicator 300 includes both the handpiece and a tip, shown attached. The tip is secured to the handpiece, including both electrical contacts and a sealed suction path. Within the handpiece, a suction chamber 306 (seen in FIG. 3B) is included that may increase in size by moving a cylindrical drive piece 308 proximally (e.g., pulling it away from the distal tip). In FIG. 3A the cylindrical drive piece is fully distal; it may be biased in this position by a return bias (e.g., return spring 312, not shown in FIG. 3B for clarity). The return bias may be lockable (e.g., by a latch, lock, or other mechanism) to prevent driving return of the piston until application of the therapy is complete. A piston-like member including a suction plate 314 may form one end (the fixed end) of the suction chamber and may be held fixed in position relative to the outside of the handpiece as the drive piece is driven proximally. For example, in FIG. 3B the cylindrical drive piece is shown driven proximally (to the left in this example), by pushing on a suction push plate 316, as shown by the arrows in FIG. 3A. The suction plate 314 may be sealed (suction seal 320) against the inner walls of the vacuum chamber. As the cylindrical drive piece is driven proximally, enlarging the vacuum chamber, a negative pressure is generated that may be transferred through the center tube (suction tube 322) all the way through the attached tip, and out of suction port(s) on the electrode housing of the tip, as described in greater detail below. The suction tube may include a seal formed with the connector on the tip, as described above. Thus, the suction may remove any air gaps around the electrodes (e.g., needles, wires, or plate electrodes) of the tip that are in contact with the tissue. The solid arrows in FIGS. 3 A and 3B illustrate the suction applied through the device, from the distal tip suction ports 318 back into the suction chamber. The return spring may be compressed in FIG. 3B; the device may lock the cylindrical drive piece in place to prevent applying positive pressure through the suction ports of the tip. Alternatively or additionally, a one-way (e.g., check) valve may be included in the handpiece and/or tip to prevent positive pressure.
[0082] In any of these examples, the amount of negative pressure applied through the tip (e.g., around the electrodes) may be regulated by one or more pressure regulators within the handpiece and/or tip. For example, the amount of pressure may be regulated by adjusting a bleed valve on the handpiece and/or tip, that is in communication with the suction channel, such as center tube (suction tube 322) or a suction chamber, that is in fluid communication with the suction channel and the tip.
[0083] The suction channel between the tip and the suction chamber within the handpiece and/or tip may include one or more valves, e.g., check valves, to prevent or limit positive pressure from around the electrodes. Alternatively in some examples the handpiece and/or tip may be configured to apply positive pressure out of the suction channel(s) and/or port(s) to aid in
disengaging the tip following treatment. A control (e.g., switch, toggle, etc.) may be included to allow or prevent positive pressure through the suction channel(s) and/or port(s). In some examples, the negative pressure may be formed and retained in the handpiece but one or more valves may prevent the suction from being applied though the suction lines until activated by a suction control (e.g., button, switch, lever, etc.). Alternatively, the negative pressure may be applied on demand, either while inserting the tissue-penetrating electrodes or contacting the tissue with non-penetrating electrodes, and/or after the electrodes have already contacted the tissue or have been inserted into tissue.
[0084] FIG. 4 illustrates another example of an applicator 400 including a handpiece 403 and an attachable/removable (e.g., disposable) tip 405. In FIG. 4, which is similar to the example shown in FIG. 3A-3B, the reusable handpiece may have multiple different tip options for attaching different tips, including differently shaped and/or dimensioned tips that are adapted to apply suction by including one or more suction ports on the tip and a suction connector that allows the air to be removed from around the electrodes of the tip. As mentioned above, the tips may include a plurality of electrodes that may be configured as needles, wire, plates, bar electrodes, etc. In this example, the handpiece includes a “push-to -connect” connector receiver 411 for coupling the suction line 422 with the suction connector 409 on the tip. This connector receiver 411 may also act as a latch for holding the tips on the handpiece using a quick connector. The handpiece may also include electrical connectors 437 for coupling with electrical pins 407 on the tip.
[0085] FIG. 5A illustrates another example of a latch for securing the tip 505 to the handpiece 503 and making a secure suction connection. In FIG. 5A the handpiece includes a tip detachment knob 513 that may couple to an internal collet for secure engaging with a suction connector 509 on the tip 505. When pressure is applied to the tip detachment knob, it may transfer this pressure to an outer connector ring 533 on a push-to-connect tubing connector 511, releasing a grip on the tube as well as the overall disposable tip, so that the tip may be removed. FIG. 5B shows an example of the push-to-connect connector 511. This example includes an outer connector ring 533 that allows the suction connector 509 on the tip to be easily inserted into the connector, however the push-to-connect tubing connector may hold tight until pressure is applied to the ring (e.g., by the tip detachment knob or other control), releasing the grip on the tube. Although FIGS. 2A-2B and 4A-4B show examples in which the suction connector 209, 409 extends proud of the tip and engages into a connector receiver 211, 411 (e.g., a latching, push-to- connect connector) in the handpiece, the locations of the suction connector and the connector receiver may be switched. For example, the connector receiver that receives the extending suction connector may be on the tip and the section connector may be on the handpiece.
[0086] FIGS. 6A-6B, 7A-7B, 8A-8B and 9A-B all illustrate examples of tips including a suction connector and suction port(s) that may be used as part of the applicators described above to apply suction to remove air from around the one or more electrodes. In these examples the tips include one or more (e.g., two or more, three or more, etc.) suction ports on a face of the tip, such as on the distal face. These suction ports may be configured so that they apply suction at the base of the electrode. For example, the electrodes may be configured to extend out of the suction port. Multiple electrodes may extend from the same suction port. In some examples each electrode may extend from each separate suction port, or a subset of the electrodes may extend from a shared suction port. In case of the penetrating electrodes, as the electrodes penetrate the tissue the suction applied though the suction port may remove air from around the electrode.
This may improve the contact and may prevent or limit arcing. The amount of suction required may be quite low, as discussed above. In addition, the duration of the application of suction may be brief, e.g., during and/or after inserting the electrodes into the tissue. For example, the suction may be applied for 60 seconds or less (e.g., about 50 seconds or less, about 45 second or less, about 40 seconds or less, about 35 seconds or less, about 30 seconds or less, about 25 seconds or less, about 20 seconds or less, about 15 seconds or less, about 10 seconds or less, about 5 seconds or less, about 2 seconds or less, etc.). Thus, the suction may be applied as one or more pulses during or after application of the electrodes to the tissue.
[0087] The tips described herein may include one or more suction or vacuum manifolds within the apparatus that may distribute the negative pressure from the suction connector; the vacuum manifold may distribute the negative pressure between multiple suction ports, each associated with one or more electrodes.
[0088] FIGS. 6A and 6B illustrate examples of a distal face of two different tips, each configured to include two plate or surface electrodes 671, 671’ out of a different suction port. Suction is applied in the space 680 around each electrode to allow the suction to remove any air gaps. Suction may be applied on around the entire perimeter or circumference of the electrode as is extends out of the electrode housing 678 in the tip, or it may extend just partially around the electrode. In FIG. 6A the tip has a smaller overall surface area coverage (e.g., 2.5 mm x 2.5 mm) as compared to the tip in FIG. 6B (e.g., 5 mm x 5 mm). In some implementations the location of the electrodes 671, 671’ inside of the space 680 may be biased to those sides of the respective spaces 680 that are further apart from each other instead of being centered in each space 680, as shown by example in FIGS. 6A and 6B. In such configuration, the suction ports may efficiently remove or reduce any air gaps on the sides of the spaces 680 that are closer together, and therefore, between the electrodes 671 and 671’.
[0089] FIGS. 7A-7B illustrate another example of a treatment tip including suction ports 780, 780’ that are adapted to remove air form around the electrodes as described herein. In FIG. 7A the tissue-penetrating electrodes are needle electrodes 744 that are shown housed within an electrode housing 778. The electrodes may be exposed out of the electrode housing 778. In this example, the electrodes are positioned just below the distal surface of the tip and are not movable, but rather the suction would pull the tissue into the needles. However, as discussed, in some examples the electrode housing may move relative to an outer tip housing, e.g., retracting proximally to expose the electrodes. In some examples the electrodes may move distally or proximally into or out of the electrodes housing. In general, the electrodes may extend distally out of the suction ports 780, 780’ of the electrode housing. The suction port is in communication with the suction connector that couples to a suction line latch on the handpiece through a suction channel 782 (seen in FIG. 7B) within the electrode housing and within which the electrodes are positioned in this example. FIG. 7B shows a section through the tip shown in FIG. 7A, showing the tissue-penetrating electrodes within the suction port and suction channels 782 passing through the electrode housing. As mentioned, either the tissue-penetrating electrodes or the tip housing may be moved relative to each other to penetrate the tissue.
[0090] In some examples, a tip such as the one shown in FIGS. 7A-7B may be configured for use with non-penetrating electrodes. For example, the electrodes 744 may be blunted and configured to ride on the surface of the tissue to be treated, rather than penetrating into the tissue. In some examples the tip is configured so that individual electrodes or sets of electrodes have a pogo pin like structure in which the distal ends of the electrodes are rounded, flattened, or otherwise blunted so as not to penetrate the tissue. The tip and electrode may otherwise function as described above for FIG. 7A-7B, but without penetrating the tissue. For example, the non penetrating electrodes may be extended relative to the housing of the tip so that the distal ends of the electrode may be held against the surface of the tissue. Either the electrodes may be biased distally relative to the housing or the housing may be driven proximally (exposing the tips). Suction may be applied, e.g., to seal the tip (and in particular a soft, insulating distal tip region) against the tissue and/or to hold the tip against the tissue during treatment.
[0091] In any of these variations a pulse of negative pressure (suction) may be applied during or after applying the electrode(s) to the tissue in order to remove any air from around and/or between the tissue and electrode interface prior to treating the tissue. In some examples the same activation (control) that applies the energy may first apply the negative pressure. In some examples the negative pressure may be sustained during the treatment (e.g., continuously applied) or it may be applied prior to or at the start of treatment. In some examples following treatment the pressure may be released, e.g., by manually or automatically activating a pressure
release control on the handpiece and/or tip which may, e.g., open the suction channel and/or suction port(s) to atmosphere to release suction, rather than (or in addition to) allow the suction to leak from the tip.
[0092] FIGS. 8A and 8B illustrate another example, similar to that shown in FIG. 7A and 7B, but showing three suction ports 880, 880’, 880” (which also may be three rows of suction ports) out of which three rows of electrodes 844, shown in this example as needle electrodes, may extend. The suction ports are in communication with a suction connector (not shown) that couples a suction line latch on the handpiece through a suction channel 882 within the electrode housing 878, and within which the electrodes extend, as shown in FIG. 8B. While this example shows three rows, any multiple number of rows may be used. Also, each row may have one shared suction port for all or a portion of the electrodes in the row, or each electrode in each row may have its individual suction port. As mentioned above, either the needles may be advanced distally out of the electrode housing 878, or needle housing may be retracted proximally (e.g., into a tip housing) to expose the needles, or both.
[0093] For example, FIGS. 9A-9B illustrate an example of a tip in which the electrode housing may retract proximally (e.g., by pushing against the tissue, driving the tissue penetrating electrodes 944 out of the suction ports 980 on the distal face of the electrode housing 978 and into the tip housing 979, exposing the tissue-penetrating electrodes. In this example, each electrode includes a separate suction port out of which it may extend; in some examples sets of electrodes may share a suction port, as shown above in FIGS. 7A-7B and 8A-8B.
[0094] FIG. 10A shows another example of a tip for an applicator that includes suction ports through which one or more tissue-penetrating electrodes may extend. In FIG. 10A, three rows of seven tissue-penetrating (e.g., needle) electrodes 1044 are shown, each within (and configured to extend from) a suction port 1080. The tips described herein can be configured with different electrode configurations. In FIG. 10A, suction ports are connected to suction channels that may each communicate with a single suction chamber within the tip, as shown in FIGS. 10B-10G. The suction chamber may be coupled with the suction connector that couples with a handpiece providing the connection to the source of negative pressure.
[0095] FIGS. 10B-10G illustrate one example of a method of operating an applicator as described herein. In this example, a tip such as the one shown in FIG. 10A may be coupled to a handpiece that includes a source of suction, such as a handpiece as described herein (including but not limited to the handpiece shown in FIGS. 2A-2B, 3A-3B and 4. In this example the suction may be applied while advancing the tissue penetrating electrodes into the tissue, to prevent air gaps from forming. For example, in FIG. 10B a sectional view through the tip (of
FIG. 10A) is shown, before the tip is in contact with the tissue. FIG. 10B shows a row of tissue-
penetrating electrodes 1044 (e.g., needle electrodes) within suction channels 1082 of the tip 1078; the suction channel 1082 is connected to a suction chamber 1086 that is in fluid contact with the source of negative pressure (suction/vacuum) in the handpiece, as described above. The tissue-penetrating electrodes are retracted into the tip housing. In FIG. IOC, the same tip is paced into contact with the target tissue 1092 to be treated. In this example, once in contact with the tissue the needles may be advanced while (or immediately after) suction has been applied. For example, FIG. 10D shows the tip after applying suction through the suction ports; the tissue 1092 is drawn up into the suction ports 1080. The suction may be applied continuously while then driving the tissue-penetrating electrodes out of the suction ports and into the tissue, as shown in FIG. 10E. In some examples the suction is applied only after driving the tissue-penetrating electrodes into the tissue (e.g. at the stage shown in FIG. 10E); this may both remove air between the electrodes and the tissue and may also help drive the electrodes into the tissue. FIG. 10F shows the electrodes fully inserted into the tissue. In FIG. 10F the use of suction immediately before or during insertion may prevent air gaps from forming.
[0096] FIG. 10G illustrates an example of undesirable results, in which suction was not applied through the suction ports, and insertion of the electrodes into the target tissue resulted in the ‘tenting’ and forming of air gaps 1095 between the electrodes and the tissue.
[0097] FIGS. 1 lA-11C illustrate an alternative method in which suction may be applied after the tissue-penetrating electrodes are driven into the tissue, to remove any air gap between the electrodes and the tissue. FIG. 11A shows the tip housing 1178 contacting the tissue 1192 at the target site. The plurality of tissue-penetrating electrodes 1144 may then be extended into the tissue and out through suction ports 1180 on the tip housing. In this example, no suction is applied while inserting the electrodes into the tissue, which may result in air gaps 1195 forming between the tissue and the electrodes, as shown in FIG. 1 IB. These air gaps may be removed as described above, by applying suction from the suction ports 1180. The suction ports are present at the base of each electrode where it enters the tissue (and where the tenting and formation of the air gap occurs. The negative pressure may be applied quickly and locally for a brief duration to remove the air gap; air is drawn into the suction ports 1180 around the electrodes 1144 and into the suction channels 1182 that are connected to a suction chamber 1186 that is in fluid communication with the source of negative pressure in the handpiece. Thus, as shown in FIG.
11C, the air gaps may be removed and pulsed, e.g., sub-microsecond pulsed energy, may be applied through the electrodes and into the tissue more efficiently.
Vacuum Deployment of Electrodes
[0098] Also described herein are apparatuses in which the electrodes may be deployed (e.g., advanced distally into the tissue) using negative pressure to drive the electrodes distally into contact with the tissue. Any of the apparatuses and methods described herein may be used in combination with the methods and apparatuses described above for the local use of suction to remove air gaps from the tissue. The same suction source or separate sources may be used.
[0099] Thus, the apparatuses described herein may be configured to apply negative pressure to assist in deploying electrodes from the tip of the applicator. In some examples the apparatus may be configured to deploy tissue-penetrating electrodes by the application of negative pressure within the handpiece and/or tip. The system may include a vacuum source (e.g., source of negative pressure) that may assist with the deployment and/or insertion of the tissue-penetrating electrodes to the tissue. For example, when the tip of the applicator is in contact with the tissue, negative pressure may be applied to a vacuum chamber (e.g., a deployment/holding vacuum chamber), the negative pressure builds up in the vacuum chamber causing a force to be applied to the electrode holder. If the electrode holder is latched, the electrodes will remain in place until the trigger button is pressed. Once the trigger is pressed, the holder and electrodes will move very quickly towards the tissue, and in those implementations involving penetrating electrodes, thrusting these electrodes against and/or into the tissue (e.g., to a correct depth). In the case of tissue-penetrating electrodes, the rate of insertion may be configured to help the penetrating electrodes penetrate the surface of the tissue easier and may help eliminate or reduce tenting or the introduction of air gaps around the electrodes.
[0100] In some examples, the same vacuum (or a supplemental vacuum) may also or additionally be applied as described above, from around the electrodes as they contact the tissue. For example, the vacuum may be applied even after the electrodes are inserted into the tissue (or, in case of the non-penetrating electrodes, after the electrodes contact the tissue), and vacuum may continue to be applied through suction ports at the base of the electrode(s) to evacuate any air around the electrodes from the deployment which may further reduce the likelihood of arcing and/or may held hold the tip to the tissue and maintain the electrodes in the correct location on or in the tissue.
[0101] FIG. 12 illustrates one example of an applicator 1200 including a handpiece 1203 having a body 1238, the applicator also includes a tip 1205. The tip may be removably coupled to the handpiece. The handpiece in this example is coupled to an external vacuum source (e.g., source of negative pressure) through a vacuum tube 1249. This external vacuum source may be supplemental and may be used to apply vacuum into the vacuum chamber and/or directly into the suction ports as described above). As with any of the handpieces described herein, the handpiece
may be coupled to a pulse generator (see, e.g., FIG. 1, above) via a power cable 1252, which may be coupled to the proximal end of the handpiece via a strain relief connection 1254. The treatment tip includes three rows of tissue-penetrating electrodes (e.g., needles) 1244.
[0102] The applicator 1200 shown in FIG. 12 may be configured so that the needles may be driven out of the tip housing 1278 by actuating a control (e.g. an electrode deployment control), such as a trigger, release, latch, switch, etc. 1263 on the handpiece. Release of the trigger causes the negative pressure within the body of the handpiece (e.g., within a vacuum chamber of the handpiece) to drive a shaft within the tip to drive the electrodes distally. When the tip is placed against the tissue before actuating the electrode deployment control, releasing the control may drive the electrode against or into the tissue, but residual negative pressure may remain in the vacuum chamber even after deploying against and/or into the tissue. This residual pressure may be applied out of the suction port(s) at the tip of the electrode as described above. Thus, engaging the electrode deployment control may also open the suction channel to allow suction from the vacuum chamber to be drawn through the suction ports around the electrodes at the tip. Alternatively, in some examples, suction from the vacuum tube may be applied out of the suction ports.
[0103] The vacuum chamber may be evacuated prior to use by manually drawing the vacuum, e.g., by pulling back on the piston within the handpiece similar to that shown in FIGS. 2-4, above, or by applying an external source of vacuum into the vacuum chamber.
[0104] FIG. 13A illustrates an applicator 1300 similar to that shown in FIG. 12 but showing the outer housing 1338 of the handpiece 1303 portion of the actuator as transparent. In FIG. 13 A the handpiece includes a body (formed by the outer housing 1338) enclosing a vacuum chamber 1381 and the applicator also includes tip 1305 having tip housing 1378. A piston 1383 includes a vacuum plate 1385 that is slidably held within the vacuum chamber and a shaft that is coupled to the tissue penetrating electrodes within the tip. This coupling may be via a mechanical coupling between the tip and the handpiece so that movement of the shaft distally drives the electrodes distally. A piston retainer 1387 is coupled to the piston and engages the trigger 1363. In FIG 13A, a vacuum input port 1388 receives negative pressure (e.g., from an external source). In some variations the handpiece may include an internal negative pressure source, as described above. In operation, the trigger may secure the piston (via the piston retainer) so that the vacuum chamber is held under negative pressure, while the electrodes are retracted within the tip. When the trigger is actuated, so that the trigger releases the piston retainer, the vacuum plate of the piston is drawn distally to reduce the volume of the vacuum chamber, since the piston is free to slide distally and proximally when unconstrained by the piston retainer. The movement of the
vacuum plate distally drives the shaft of the piston distally, therefore driving the electrodes distally and out of the electrode housing of the tip. This is illustrated in FIG. 13B-13C.
[0105] FIG. 13B shows the applicator of FIG. 13A after release of the trigger 1363 has been actuated to release the piston retainer 1387 (e.g., by disengaging the retainer from a holder on the piston retainer. The trigger includes a latch region 1399 that may engage with the piston retainer in both the undeployed configuration (e.g., with the piston held proximally), or the deployed configuration (after release of the trigger, with the piston allowed to advance distally). When deployed following actuation of the trigger, allowing release of the latch from a holder 1398 of the piston retainer 1387, the negative pressure within the vacuum chamber 1381 causes the vacuum plate to move distally, as shown in FIG. 13B, extending the electrodes 1344. The trigger latch shown in FIG. 13B (and FIG. 13C) also includes an interference surface that engages with the piston retainer when the piston is advanced fully (or partially) distally, so that the electrodes are deployed. The interference surface may prevent the piston from sliding back proximally (retracting the electrodes) until sufficient force is applied, e.g., force above a threshold for resetting the piston.
[0106] In this example, as described above, with the electrodes fully deployed distally against (or in some examples, into) the tissue, the residual negative pressure within the vacuum chamber 1381 may be applied through a suction channel (e.g., within piston 1383) and out of one or more suction ports in the tip, as described above. Alternatively, suction may be applied from the vacuum port 1388.
[0107] FIG. 13C shows a section through the applicator of FIG. 13B, showing some of the internal features. The piston may form a seal, e.g., a vacuum seal 1376, with the wall(s) of the internal chamber forming a portion of the vacuum chamber inside of the housing of the handpiece. The vacuum chamber may be held under negative pressure during operation of the applicator. Additional negative pressure (vacuum) may be applied through the tip to a suction port the region at the base of the tissue-penetrating electrodes, as discussed above. The handpiece may also include a mechanical bias such as a spring or lever to reset or help reset the piston and withdrawn the electrodes.
[0108] FIGS. 14A-14B illustrate another example of an applicator including a tip with deployable tissue-penetrating electrodes, in which the handpiece is configured to deploy (and in this example, retract) the electrodes from the tip using negative pressure. In FIG. 14A, the handpiece 1403 is coupled to the electrode tip 1405 and a piston member 1483 may be driven distally by the piston once a control is actuated to release the piston, allowing it to advance and deploy the electrodes. FIG. 14A shows the device with the electrodes 1444 retracted and un deployed. Once the vacuum chamber 1481 is held under negative pressure, the control may be
released to drive the piston distally and deploy the electrodes, as shown in FIG. 14B. In some variations a second vacuum chamber 1492 (retraction vacuum chamber) may be used to apply a vacuum to retract the electrodes as well.
[0109] In FIGS. 14A-14B, the apparatus may use the vacuum to extend the electrodes as well as retract the electrodes from the tissue. The extension and retraction of the electrodes onto/into the tissue may also be achieved without the use of the latch feature. When the vacuum is applied to the vacuum chamber, and the tip is in contact with the tissue, vacuum chamber may collapse as the piston is driven distally, causing the electrodes to move forward. The suction ports around the electrodes may hold the tissue in place as the forward moving electrodes contact (e.g., in some examples, pierce) the tissue and continue to advance until full deployment is achieved. This method of deploying the needles shown in FIGS. 14A-14B may be slightly smoother than the concept with the latch.
[0110] In some examples, at the conclusion of the treatment, the user (e.g., doctor, nurse, technician, etc.) may switch a valve that reconnects the vacuum supply to the retraction vacuum chamber 1492. As the air is removed from the retraction vacuum chamber 1492, the electrodes 1444 will be retracted from the tissue and pulled back into the tip housing in preparation for the next treatment. When the user places the tip on a new lesion, the user may again activate the control (e.g., a trigger button) and the electrodes may be deployed onto/into the tissue to treat the next lesion.
[0111] Although the examples shown in FIGS. 12-14B, above illustrate examples in which the electrodes are advanced distally using an internal vacuum chamber, alternatively or additionally the electrodes may be driven distally by the application of a mechanical (rather than pneumatic) force, such as by a spring. In some cases, however, the apparatus may be configured so that advancing the electrodes distally generates a negative pressure within a chamber of the handpiece (e.g., within a vacuum chamber), and this resulting negative pressure may be applied through one or more suction port(s) out of the distal tip during and/or after deploying the electrodes (e.g., activating an electrode deployment control).
[0112] In general, any of the features described herein may be combined or used with any of the apparatuses and methods described herein. For example, any of these devices and methods may be used with either tissue-penetrating or non-penetrating electrodes. In some examples the tips described herein may be configured to apply suction from the suction port(s). In some examples, the apparatuses and methods configured to apply suction (including a suction pulse) to remove air from around the electrode may be used with any of the vacuum deployment features described with reference to FIGS. 10-14.
[0113] Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control performance or perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), causing application of a negative pressure within the vacuum chamber of the handpiece, determining, alerting, or the like.
[0114] Certain embodiments relate to a machine-readable medium (e.g., computer readable media) or computer program products that include program instructions and/or data (including data structures) for performing various computer-implemented operations. A machine-readable medium may be used to store software and data which causes the system to perform methods of the present disclosure. The above-mentioned machine-readable medium may include any suitable medium capable of storing and transmitting information in a form accessible by processing device, for example, a computer. Some examples of the machine-readable medium include, but not limited to, magnetic disc storage such as hard disks, floppy disks, magnetic tapes. It may also include a flash memory device, optical storage, random access memory, etc. The data and program instructions may also be embodied on a carrier wave or other transport medium. Examples of program instructions include both machine code, such as produced by a compiler, and files containing higher level code that may be executed using an interpreter.
[0115] When a feature or element is herein referred to 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. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be 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 shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
[0116] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular
forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude 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 "/".
[0117] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
[0118] Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
[0119] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 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 values given herein should also be understood to include about or approximately that value unless the context indicates otherwise. For example, if the value "10" is
disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
[0120] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the 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 various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
[0121] Various embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above 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. A treatment tip device for delivery of electrical therapy, the device comprising: an electrode housing extending from a distal end of the treatment tip device; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes at least partially within the electrode housing; wherein at least some of the electrodes of the plurality of electrodes are configured to extend out of the plurality of suction ports; further wherein the treatment tip device has an un-deployed configuration in which distal ends of the plurality of electrodes do not extend beyond a distal end face of the electrode housing and a deployed configuration in which the distal ends of the plurality of electrodes extend beyond the distal end face of the electrode housing, and wherein the electrode housing or the plurality of electrodes, or both are configured to move relative to each other to convert between the un-deployed and the deployed configurations.
2. The device of claim 1, wherein the treatment tip device comprises a suction connector extending from a proximal end of the treatment tip device and in fluid connection with the suction ports.
3. The device of claims 1 or 2, further comprising a plurality of electrical pins extending from a proximal end of the treatment tip device that are configured to mate with electrical connectors on a handpiece.
4. The device of any one of claims 1 to 3, further comprising a vacuum manifold within the treatment tip device configured to distribute a negative pressure between the plurality of suction ports.
5. The device of any one of claims 1 to 4, wherein the plurality of electrodes is slidably disposed within the plurality of suction ports.
6. The device of any one of claims 1 to 5, wherein the plurality of electrodes is tissue- penetrating electrodes.
7. The device of any one of claims 1 to 5, wherein the plurality of electrodes is non penetrating electrodes.
8. The device of any one of claims 1 to 7, further comprising a bias exerting a bias return force to oppose conversion from the un-deploy ed to the deployed configuration or from the deployed to the un-deployed configuration.
9. An applicator system, the system comprising: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; a plurality of suction ports opening into the electrode housing; and a plurality of electrodes configured to extend out of the plurality of suction ports, wherein the electrode housing and the plurality of electrodes are configured to move relative to each other to convert between an un-deployed configuration, in which the plurality of electrodes do not extend beyond a distal end face of the electrode housing, and a deployed configuration, in which the plurality of electrodes extend beyond the distal end face of the electrode housing; and a handpiece comprising: a body having one or more electrical connectors at a distal end configured to couple with the treatment tip to apply electrical energy to the plurality of electrodes; a vacuum chamber within the body; a vacuum plate within the vacuum chamber, configured to generate a negative pressure within the vacuum chamber; and a suction control on the handpiece configured to apply the negative pressure from the vacuum chamber out of the plurality of suction ports.
10. The system of claim 9, further comprising a suction connector extending from the treatment tip and a suction connector receiver on the handpiece configured to engage with the suction connector to apply suction to the suction ports.
11. The system of claim 10, wherein the suction connector is a push-to-connect connector.
12. The system of claims 10 or 11, wherein the suction connector receiver is configured to latch the treatment tip to the handpiece, the system further comprising a release control on the handpiece to release the treatment tip from the handpiece by releasing the suction connector from the suction connector receiver.
13. The system of any one of claims 9-12, wherein the suction control on the handpiece is configured to apply a pulse of negative pressure from the vacuum chamber out of the plurality of suction ports.
14. The system of any one of claims 9-13, further comprising a lock on the handpiece configured to secure a relative position of the vacuum plate and the vacuum chamber to maintain the negative pressure.
15. The system of any one of claims 9-14, further comprising a manual vacuum control on the handpiece configured to be moved to generate the negative pressure within the vacuum chamber.
16. The system of any one of claims 9-15, wherein the vacuum plate comprises part of a piston, further wherein a shaft of the piston is coupled to an electrode interface on the treatment tip so that movement of the vacuum plate drives linear movement of the piston and extends the plurality of electrodes to the deployed configuration, beyond the distal end face of the electrode housing.
17. The system of any one of claims 9-16, further comprising a trigger control, wherein the trigger control is configured to be actuated to release the vacuum plate so that the plurality of electrodes moves to the deployed configuration.
18. The system of claim 10, wherein the vacuum chamber is configured to provide less than 10 kPa of negative pressure through the plurality of suction ports.
19. The system of any one of claims 9-18, wherein the system is configured to apply the negative pressure: 1) through the plurality of suction ports only after deploying the electrode housing and/or 2) for less than 60 seconds through the plurality of suction ports after deploying the electrode housing.
20. .An apparatus comprising: a treatment tip comprising: an electrode housing extending from a distal end of the treatment tip; and a plurality of electrodes disposed within the electrode housing; and a handpiece comprising: a body; a vacuum chamber within the body;
a piston having a vacuum plate within the vacuum chamber, wherein the piston is operably connected to the plurality of electrodes; and a trigger, wherein the trigger is configured so that activation of the trigger releases the vacuum plate to move within the vacuum chamber when there is a negative pressure within the vacuum chamber, driving the plurality of electrodes distally out of the electrode housing.
21. The apparatus of claim 20, wherein the handpiece further comprises a suction port in fluid communication with the vacuum chamber and configured to couple to a source of negative pressure.
22. The apparatus of claims 20 or 21, further comprising a latch on the handpiece coupled to the trigger and configured to retain the piston in a fixed position until released by actuation of the trigger.
23. The apparatus of claim 22, wherein the latch is further configured to retain the piston in both a deployed configuration with the piston extended distally and in an undeployed configuration with the piston retracted proximally.
24. The apparatus of any one of claims 20 to 23, wherein the treatment tip is removably coupled to the apparatus via an electrical connection and a pressure connection.
25. The apparatus of any one of claims 20-24, further comprising a plurality of suction ports on the treatment tip, wherein the plurality of suction ports are configured to apply suction at a base of the plurality of electrodes.
26. The apparatus of any one of claims 20 to 25, the apparatus configured to be attached to a robotic arm.
27. A method of operating an apparatus comprising a plurality of electrodes within an electrode housing and a handpiece including a vacuum chamber and a piston within the vacuum chamber, the method comprising: causing application of a negative pressure within the vacuum chamber of the handpiece of the apparatus; and actuating a control to cause the piston within the vacuum chamber of the handpiece to move within the vacuum chamber, thereby driving the plurality of electrodes operatively connected to the piston out of the electrode housing into a deployed configuration.
28. The method of claim 27, the method comprising regulating an amount of negative pressure applied.
29. A method, the method comprising: contacting a tissue with a tip of an applicator; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing of the tip of the applicator so that the plurality of electrodes is in contact with the tissue; applying a negative pressure through the plurality of suction ports to remove or at least reduce air from between the electrodes of the plurality of electrodes and the tissue; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes.
30. A method, the method comprising: contacting a tissue with an applicator including a tip; deploying a plurality of electrodes out of a plurality of suction ports in an electrode housing and in contact with the tissue by a negative pressure; and applying a pulsed electrical treatment to the tissue through the plurality of electrodes.
31. The method of claim 29, further comprising applying the negative pressure through the plurality of suction ports to remove air from between the electrodes of the plurality of electrodes and the tissue before applying the pulsed electrical treatment.
32. The method of any one of claims 29-31, wherein deploying the plurality of electrodes comprises deploying a plurality of tissue-penetrating electrodes out of the plurality of suction ports and into the tissue.
33. The method of any one of claims 29-31, wherein deploying the plurality of electrodes comprises deploying a plurality of non-penetrating electrodes so that they are in contact with the tissue.
34. The method of any one of claims 29-33, wherein deploying the plurality of electrodes comprises releasing a latch on a handpiece so that the negative pressure within the handpiece moves a piston in the handpiece and drives the plurality of electrodes distally out of the electrode housing.
35. The method of any one of claims 29-33, wherein the negative pressure is applied immediately prior to or concurrent with the application of the pulsed electrical treatment.
36. The method of any one of claims 29-33 and 35, wherein applying the pulsed electrical treatment comprises stopping application of the negative pressure before applying the pulsed electrical treatment.
37. The method of any one of claims 27-29, wherein causing application of the negative pressure or applying the negative pressure comprises applying less than 100 kPa of negative pressure.
38. The method of any one of claims 29-33, further comprising manually generating the negative pressure within a vacuum chamber of the applicator.
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US202163213677P | 2021-06-22 | 2021-06-22 | |
US63/213,677 | 2021-06-22 |
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WO2022271469A1 true WO2022271469A1 (en) | 2022-12-29 |
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PCT/US2022/033169 WO2022271469A1 (en) | 2021-06-22 | 2022-06-13 | Treatment tips with suction feature |
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