Conductive spacers in electrode assemblies of electrotherapy devices

Abstract

To provide an electric treatment device, an operation method of thereof, and a delivery method of electric treatment to a patient, in order to distribute electric treatment to a treatment region of a patient.SOLUTION: In some embodiments, an electric treatment device includes: at least two electrodes; and an electrode assembly including a conductive spacer arranged between the electrodes. A selection method and an operation method of the electric treatment device are also provided.SELECTED DRAWING: Figure 9A

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims priority to U.S. Provisional Application No. 63 / 174,210, filed on April 13, 2021, entitled "CONDUCTIVE SPACER IN AN ELECTRODE ASSEMBLY OF AN ELECTRICAL TREATMENT APPARATUS", which is hereby incorporated by reference in its entirety for all purposes.

[0002] [Field of the Invention] This specification describes an electrode assembly (e.g., an electrical applicator tip) that can be preferentially used to apply high - voltage ultrashort electrical pulses, such as nanosecond pulses, to treat a patient. More specifically, this specification describes an electrode assembly having a conductive spacer and methods of using them for electrical treatment to more evenly distribute electrical treatment across a treatment area.

Background Art

[0003] Electrical treatment therapies, particularly ultrashort high - electric - field - strength electrical pulses, sometimes described as nanosecond pulsed electric field (nsPEF) therapy, can be used for the electrical manipulation of living cells. For example, electrical pulses can be used to treat human or animal cells and tissues, including tumor cells such as basal cell carcinoma, squamous cell carcinoma, and melanoma.

[0004] These electrical treatment therapies are often performed using an electrode assembly (e.g., a treatment tip) that incorporates either surface electrodes placed on the treatment area without penetrating the tissue or needle electrodes that penetrate the tissue. A voltage is applied between the electrodes to induce an electric field in the treatment area and damage the cells in the treatment area. Current electrode assemblies incorporating surface electrodes do not effectively distribute electrical treatment across the treatment area between the electrodes. Needle electrodes distribute electrical treatment more effectively. However, needle electrodes are more uncomfortable for the patient.

Summary of the Invention

[0005] To distribute electrotherapy to a patient's treatment area, one common embodiment includes an assembly for the delivery of electrotherapy. The electrode assembly may include a conductive spacer and at least two electrodes. Each electrode may include a conductive treatment surface configured to apply electrotherapy to the treatment area and a conductive non-treatment surface. The conductive non-treatment surface may be configured to contact the conductive spacer. The conductive spacer is positioned between at least two electrodes and is configured to electrically contact the surface of the treatment area between the electrodes.

[0006] The electrode assemblies of this disclosure may be implemented as a handheld device, as a catheter, or as other percutaneously delivered devices. Embodiments may include various combinations of the following features. In some embodiments, the conductive spacer may be a hydrogel, a conductive adhesive, a conductive gel, a conductive silicone, a urethane rubber, a conductive thermosetting resin, a thermoplastic resin, any other biocompatible material having the desired conductivity, any semiconductor material, or any combination thereof.

[0007] In some embodiments, the conductivity of the conductive spacer is substantially equal to 10 times (10x) the conductivity of the tissue in the treatment area.

[0008] In some embodiments, the conductivity of the conductive spacer is greater than or equal to the conductivity of the tissue in the treatment area, and less than or equal to 100 times (100x) the conductivity of the tissue in the treatment area.

[0009] In some embodiments, the height of the conductive spacer is based on the distance between the electrodes.

[0010] In some embodiments, the height of the conductive spacer is 20 percent or more of the distance between the electrodes and 50 percent or less of the distance between the electrodes. In some embodiments, the height of the conductive spacer is up to 70% of the distance between at least two electrodes. In some embodiments, the optimal height may be 20% to 60% of the distance, for example, including 30% to 50% of the distance between at least two electrodes.

[0011] In some embodiments, the conductive therapeutic surface of each electrode electrically contacts the treatment area indirectly, for example, via a gel that helps ensure electrical contact between the treatment area and the electrode. In some embodiments, the conductive therapeutic surface of each electrode directly contacts the treatment area, for example, with a surface electrode in contact with the surface of the treatment area, or with a penetrating electrode puncturing and entering the treatment area.

[0012] In some embodiments, the electrodes are bipolar or unipolar electrodes.

[0013] In some embodiments, at least one of the electrodes is a surface electrode. In some embodiments, at least one of the electrodes is a through electrode, such as a needle electrode, blade electrode, or knife electrode. In some embodiments, at least one of the electrodes comprises a combination of a non-through (e.g., surface) electrode and a through electrode.

[0014] In some embodiments, the length of the conductive spacer is substantially equal to the length of at least one of the electrodes.

[0015] In some embodiments, the electrodes may include two rows of needle electrodes, and the length of the conductive spacer is substantially equal to the length of one or both of the two rows.

[0016] In some embodiments, the conductive spacer includes at least two conductive zones. Each of the conductive zones may have a different conductivity.

[0017] In some embodiments, the conductive spacer may include recesses, such as geometric notches. In further implementations and embodiments, the conductive spacer may include a semiconductor material and be configured to act / function as both a conductive spacer and a resistor. In various embodiments, the conductive spacer may have conductivity or geometric shape, or both, configured to allow the conductive spacer to also function as a resistor. For example, in any embodiment or example of the electrode assembly, treatment tip, electrotherapy device, and / or method of the present disclosure, the conductive spacer may be configured to act as a parallel resistor, for example, to match the impedance of the electrode assembly to the impedance of a pulse generator that generates and applies electrical energy through the electrode assembly. The conductive spacer may be configured, for example, to reduce the impedance of the electrode assembly.

[0018] According to one general aspect of the present disclosure, an electrotherapy device is provided. The device may comprise a plurality of interchangeable electrode assemblies and a therapy applicator configured to be coupled to one of the plurality of interchangeable electrode assemblies. Each of the plurality of electrode assemblies may include at least two electrodes, each electrode having a conductive therapy surface configured to apply electrotherapy to a treatment area of ​​interest and a conductive non-therapy surface configured to contact a conductive spacer. The conductive spacer may be positioned between at least two electrodes, where the conductive spacer is configured to electrically contact the surface of the treatment area of ​​interest between the at least two electrodes. In some examples and implementations, the conductive spacer may be configured to serve a dual role as both a conductive spacer and a resistor. Such a conductive spacer / resistor may include a semiconductor material that is conductive to achieve both of these two functions.

[0019] Another common embodiment includes a method of administering, for example, electrotherapy to a patient. In some implementations, the method of administering electrotherapy may include arranging an electrode assembly, which includes at least two electrodes and a conductive spacer positioned between two of the electrodes, on a treatment area such that the conductive treatment surface of each electrode is in electrical contact with the treatment area and the conductive spacer is in electrical contact with the surface of the treatment area between the electrodes. The treatment also includes applying a voltage to the treatment area through the electrodes. In some examples, the electrotherapy may be administered for cosmetic purposes, for example, to improve the appearance of the treatment area.

[0020] Some embodiments of this model may include one or more of the following features. In some embodiments, the method may include selecting an electrode assembly. In some embodiments, the selection of the electrode assembly may be based on a conductive spacer having a conductivity substantially equal to 10 times (10x) the conductivity of the tissue in the treatment area (e.g., the surface of the treatment area in some applications).

[0021] In some embodiments, the selection of the electrode assembly may be based on a conductive spacer having a conductivity less than, greater than, or equal to the conductivity of the tissue in the treatment area. In some embodiments, the conductivity may be greater than or equal to the conductivity of the tissue in the treatment area and less than or equal to 100 times (100x) the conductivity of the tissue in the treatment area.

[0022] In some embodiments, the selection of the electrode assembly is further based at least partially on the size of the electrode assembly and / or the size of the treatment area.

[0023] In some embodiments, the method may include placing a conductive gel on the surface of the treatment area to facilitate contact between the conductive treatment surfaces of at least two electrodes and the surface of the treatment area, between the conductive spacer and the surface of the treatment area, or both.

[0024] In some embodiments, the method may include selecting a voltage applied to a treatment area based at least partially on the conductivity of the conductive spacer. In some embodiments, the method may include selecting an electrode assembly based at least partially on the conductivity of the conductive spacer. In various examples, the method may include using a conductive spacer as a resistor to match the impedance of the electrode assembly to the impedance of a pulse generator that generates and applies electrical energy through a replaceable electrode assembly. In some examples, the method may include using a conductive spacer to reduce the impedance of the electrode assembly. In some examples, the method may include selecting an electrode assembly and / or conductive spacer based on the conductivity of the material of the conductive spacer, or its shape, or both the conductivity of the material and its shape. The conductivity of the material and / or shape of the conductive spacer may also be selected to improve treatment depth, or resistance, or both. In various examples, the method may include selecting the shape of the conductive spacer to change the shape of a treatment zone or area. The method may also include using the shape of the conductive material to change the value of parallel resistance.

[0025] Yet another general aspect of the present disclosure includes an electrotherapy device. According to some examples, the electrotherapy device includes a treatment applicator configured to be coupled to a replaceable electrode assembly (such a replaceable electrode assembly may also be referred to as a treatment tip, for example), and in some examples, may further include a display device. Each replaceable electrode assembly is configured to be coupled to and removed from the treatment applicator. Each replaceable electrode assembly includes at least two electrodes and a conductive spacer disposed between the electrodes for applying electrotherapy to a treatment area of a subject (e.g., a patient). The electrotherapy device also includes a controller configured to execute instructions that, when executed, cause the controller to determine or receive an indication of a replaceable electrode assembly coupled to the treatment applicator, and in some examples, optionally cause configuration information to be displayed on the display device based on the conductive spacer of the replaceable electrode assembly. Other modes of notifying the user of the configuration information may be used instead of or in addition to the display. In some examples, the controller may be further configured to provide electrotherapy parameters for the treatment area based at least in part on an indication of one of the plurality of replaceable electrode assemblies.

[0026] In some embodiments of the electrotherapy device, the configuration information includes the type of tissue suitable for treatment by the replaceable electrode assembly.

[0027] Another general aspect includes a method of selecting an electrotherapy device. The method can include selecting an electrode assembly based at least in part on the conductive spacer of the electrode assembly, where the electrode assembly includes at least two electrodes, two of which are conductively in contact with the conductive spacer. The method may further include placing the electrode assembly within the treatment area such that each conductive portion of the electrodes and the conductive surface of the conductive spacer contact the treatment area.

[0028] A method for operating an electrotherapy device is provided according to another general aspect of the present disclosure. The method comprises determining or receiving instructions for an electrode assembly coupled to a therapy applicator, the electrode assembly comprising at least two electrodes conductively in contact with a conductive spacer, and at least in part on the instructions for the electrode assembly, determining the properties of the conductive spacer, and at least in part on the properties of the electrode assembly and the conductive spacer, selecting therapy configuration information. In some implementations, selecting therapy configuration may include selecting therapy parameters, and the method may include selecting one or more of the type of tissue to be treated with the electrode assembly, therapy duration, therapy depth, voltage field, pulse duration, pulse frequency, and number of pulses. In some examples, the indication of the electrode assembly may include at least one of the size of the electrode assembly, the type of electrode assembly, the number of electrodes, or the model number of the electrode assembly. In some examples, the method may further include using the conductive spacer as a resistor based on either the conductivity of the material of the conductive spacer or the geometric shape of the conductive spacer, or both conductivity and geometric shape. In further examples, the method may include displaying therapy configuration information on a display device.

[0029] In various examples, the method may include using a conductive spacer as a resistor to match the impedance of the electrode assembly to the impedance of a pulse generator that generates and applies electrical energy through the electrode assembly. In some examples, the method can include using a conductive spacer to reduce the impedance of the electrode assembly. In some examples, the method can include selecting the electrode assembly and / or the conductive spacer based on the conductivity, or shape, or both the conductivity and shape of the material of the conductive spacer. Also, the conductivity of the material and / or shape of the conductive spacer may be selected to improve the depth of treatment, or the resistance value, or both. In some examples, the method may include selecting the shape of the conductive spacer to change the shape of the treatment zone or area. In some examples, the method may also include using the shape of the conductive material to change the value of the parallel resistance. In any of the methods of the present disclosure, the method may also include using the conductive spacer as a resistor by selecting the electrode assembly and / or the conductive spacer to optimize both the desired resistance value and the depth of treatment.

[0030] Other features and advantages of the devices and methods of the present disclosure will become apparent from the following detailed description of various implementations.

Brief Description of the Drawings

[0031] [Figure 1] FIG. 1 shows a nanosecond pulse generation device according to some embodiments. [Figure 2] FIG. 2 shows an electrode assembly having surface electrodes according to some embodiments. [Figure 3A] FIG. 3A shows a partial exposed view of some examples of the configuration of the electrode assembly of FIG. 2. [Figure 3B] FIG. 3B shows a partial exposed view of some examples of the configuration of the electrode assembly of FIG. 2. [Figure 4A] FIG. 4A shows a replaceable electrode assembly according to some embodiments. [Figure 4B]Figure 4B shows an electrode assembly having a needle electrode according to several embodiments. [Figure 4C] Figure 4C shows a proximal end view of an interchangeable electrode assembly according to several embodiments. [Figure 5A] Figure 5A shows a replaceable electrode assembly before it is coupled to the handle portion of the treatment applicator, according to several embodiments. [Figure 5B] Figure 5B shows the replaceable electrode assembly from Figure 5A after it has been coupled with the handle portion. [Figure 6A] Figure 6A shows exemplary balloon catheter electrode assemblies according to several embodiments. [Figure 6B] Figure 6B illustrates an example of a transdermal needle electrode assembly. [Figure 6C] Figure 6C shows an example of a transcutaneous needle electrode assembly. [Figure 7A] Figure 7A shows a cross-sectional view of an example of an electrode assembly having a surface electrode according to several embodiments. [Figure 7B] Figure 7B shows a cross-sectional view of an example of an electrode assembly having a surface electrode according to several embodiments. [Figure 8A] Figure 8A shows a cross-sectional view of an example of an electrode assembly having a needle electrode, according to several embodiments. [Figure 8B] Figure 8B shows a cross-sectional view of an example of an electrode assembly having a needle electrode, according to several embodiments. [Figure 9A] Figure 9A shows a cross-sectional view of an example of an electrode assembly having a needle electrode and a central surface electrode, according to several embodiments. [Figure 9B] Figure 9B shows a cross-sectional view of an example of an electrode assembly having a needle electrode and a central surface electrode, according to several embodiments. [Figure 9C] Figure 9C shows a perspective view of an exemplary electrode assembly having a needle electrode and a central surface electrode according to several embodiments. [Figure 10A] Figure 10A shows a method for performing electrotherapy according to several embodiments. [Figure 10B] Figure 10B shows a method for selecting electrode assemblies and parameters for electrotherapy according to several embodiments. [Figure 11] Figure 11 shows methods for configuring a pulse generator to perform electrotherapy according to several embodiments. [Figure 12A] Figure 12A shows an exemplary model of a treatment area of ​​a surface electrode assembly with an insulating spacer. [Figure 12B] Figure 12B shows exemplary models of the treatment area of ​​a surface electrode assembly with conductive spacers according to several embodiments. [Figure 13A] Figure 13A shows an exemplary model of a treatment area of ​​another surface electrode assembly with an insulating spacer. [Figure 13B] Figure 13B shows an exemplary model of a therapeutic area of ​​another surface electrode assembly with a conductive spacer, according to several embodiments. [Figure 14A] Figure 14A shows an exemplary model of a therapeutic area for a surface electrode assembly, having a conductive spacer with a height of 10% of its width, according to several embodiments. [Figure 14B] Figure 14B shows an exemplary model of a therapeutic area for a surface electrode assembly, having a conductive spacer with a height of 20% of its width, according to several embodiments. [Figure 14C] Figure 14C shows an exemplary model of a therapeutic area for a surface electrode assembly, having a conductive spacer with a height of 30% of its width, according to several embodiments. [Figure 14D] Figure 14D shows an exemplary model of a therapeutic area for a surface electrode assembly, having a conductive spacer with a height of 40% of its width, according to several embodiments. [Figure 14E] Figure 14E shows an exemplary model of a therapeutic area for a surface electrode assembly, according to several embodiments, having a conductive spacer with a height that is 50% of the width. [Figure 15]Figure 15 shows graphs of the change in values ​​as the height of the conductive spacer increases in several embodiments. [Figure 16A] Figure 16A shows a model of a treatment area for a surface electrode assembly having a conductive spacer with conductivity similar to that of the treatment area, according to several embodiments. [Figure 16B] Figure 16B shows a model of a treatment area for a surface electrode assembly, in several embodiments, which has a conductive spacer with a conductivity approximately 10 times that of the treatment area. [Figure 16C] Figure 16C shows a model of a treatment area for a surface electrode assembly, which has a conductive spacer with a conductivity approximately 100 times that of the treatment area, according to several embodiments. [Figure 16D] Figure 16D shows a model of a treatment area for a surface electrode assembly, in several embodiments, which has a conductive spacer with a conductivity approximately 1000 times that of the treatment area. [Figure 17] Figure 17 shows a graph of the change in value as the conductivity of the conductive spacer increases, according to several embodiments. [Figure 18A] Figure 18A shows a model of the treatment area for a three-row needle electrode assembly with insulating spacers. [Figure 18B] Figure 18B shows a model of a therapeutic area for a three-row needle electrode assembly with conductive spacers, according to several embodiments. [Figure 18C] Figure 18C shows a model of a treatment area for an electrode assembly, which includes two rows of needle electrodes and a central surface electrode, and has an insulating spacer. [Figure 18D] Figure 18D shows a model of a therapeutic area for an electrode assembly having conductive spacers, with two rows of needle electrodes and a central surface electrode, according to several embodiments. [Figure 19A] Figure 19A shows a model of a therapeutic area for an electrode assembly with a surface electrode, having a conductive spacer with two conductive zones, one of which is 10 times larger than the other, according to several embodiments. [Figure 19B]Figure 19B shows a model of a therapeutic area for an electrode assembly with a surface electrode having a conductive spacer with two conductive zones, according to several embodiments, one of which is insulating. [Figure 19C] Figure 19C shows a model of a therapeutic area for an electrode assembly with a surface electrode having a conductive spacer with two different conductive zones, according to several embodiments. [Figure 20A] Figure 20A shows a model of a therapeutic area for an electrode assembly with three surface electrodes, each having a conductive spacer with different conductive zones between the electrodes, according to several embodiments. [Figure 20B] Figure 20B shows a model of a therapeutic area for an electrode assembly with a needle and surface electrode, having a conductive spacer with different conductive zones, according to several embodiments. [Figure 21A] Figure 21A shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21B] Figure 21B shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21C] Figure 21C shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21D] Figure 21D shows a model of the treatment area of ​​an electrode assembly with recesses of various shapes in the conductive spacer. [Figure 21E] Figure 21E shows a model of the treatment area of ​​an electrode assembly with recesses of various shapes in the conductive spacer. [Figure 22A] Figure 22A shows a model of a therapeutic area of ​​an electrode assembly having strip electrodes placed on a conductive spacer, according to several embodiments. [Figure 22B] Figure 22B shows a model of a treatment area of ​​an electrode assembly having strip electrodes placed on a conductive spacer, according to several embodiments. [Figure 23A]Figure 23A shows a model of a therapeutic area for an electrode assembly with a unipolar electrode. [Figure 23B] Figure 23B illustrates a model of a therapeutic area for an electrode assembly having a unipolar electrode with a conductive spacer, according to several embodiments. [Figure 24] Figure 24 shows a model of a therapeutic area for an electrode assembly having two electrodes with conductive spacers, according to several embodiments. [Figure 25] Figure 25 shows exemplary cross-sectional views of the electrode assembly portion of a treatment applicator according to several embodiments, in which the conductive spacer within the electrode assembly is configured to function as both a conductive spacer and a parallel resistor. [Modes for carrying out the invention]

[0032] Electrotherapy, such as nsPEF therapy, has been shown to be useful in inducing apoptosis, or programmed cell death, in unwanted cells, particularly tumor cells and lesions. Studies have shown that such lesions and tumors can shrink to the point of disappearing after treatment. Drugs may not be necessary. It has also been shown that the target immune system can be stimulated to attack all similar unwanted cells, including tumor cells, including tumor cells that are not present in the nsPEF-treated tumor.

[0033] "Tumor" includes any neoplasm or abnormal, undesirable growth of tissue on or within a subject. A tumor may consist of a collection of one or more cells exhibiting abnormal proliferation. Many types of tumors exist. Malignant tumors are cancerous, pre-malignant tumors are precancerous, and benign tumors are noncancerous. Examples of tumors, though only a few, include benign prostatic hyperplasia (BPH), uterine fibroids, psoriasis, seborrheic keratosis, warts, seborrheic hyperplasia, pancreatic carcinoma, liver carcinoma, kidney carcinoma, colon carcinoma, prebasal cell carcinoma, melanoma, and Barrett's esophagus-related tissue.

[0034] Submicrosecond electrical pulses, such as nanosecond pulses, may be used to treat a variety of conditions, disorders, and diseases, including, but not limited to, lesions, mucosal epithelium, gastrointestinal tract, esophagus, skin tumors and diseases, aging skin, abnormal tissue growth, cardiac conditions such as atrial fibrillation, and otolaryngological conditions.

[0035] The apparatus, systems, and methods of this disclosure include the application of short, high-field-intensity electrical pulses for improved treatment of various conditions, disorders, and diseases, while minimizing or avoiding the risk of harming non-target tissue.

[0036] Pulse lengths of less than 1000 nanoseconds have been particularly studied for their effectiveness in stimulating immune responses. Pulse lengths of approximately 10 to 1000 nanoseconds are particularly interesting because they are long enough to deliver sufficient energy to be effective with a low number of pulses, but short enough to be effective in the desired way.

[0037] In general, applying a treatment may involve applying submicrosecond electrical pulses. For example, applying submicrosecond electrical pulses may involve applying a series of electrical pulses having pulse widths of 0.1 nanoseconds (ns) to 1,000 nanoseconds (ns). In some variations, applying submicrosecond electrical pulses may involve applying a series of nanosecond electrical pulses having peak voltages of, for example, less than 1 kilovolt / centimeter (kV / cm), 1 kV / cm to 500 kV / cm, 1 kV / cm to 100 kV / cm, or 5 kV / cm to 50 kV / cm. Applying submicrosecond electrical pulses may involve applying a series of submicrosecond electrical pulses at frequencies of 0.1 Hz to 10,000 Hz. Other pulse frequencies and widths may be used in other applications. For example, microsecond or slower electrical pulses may be used. Furthermore, the use of conductive spacers as described herein may be used in any electrotherapy treatment where improvement of the electric field between electrodes is desired. Therefore, this disclosure is not limited to pulse technology, but can also be applied to, for example, radio frequency technology.

[0038] Various therapeutic devices containing electrodes are known. In some of these devices, multiple spaced electrodes are used. In other embodiments, insulating spacers are placed between the electrodes. Insulating spacers may be used to avoid arc discharge and other problems that may arise from current flowing in areas other than the tissue to be treated. Surface electrodes offer improved safety and a lower risk of infection and are preferred by both physicians and patients over penetrating electrodes (e.g., needle electrodes, blade electrodes, knife electrodes) which must puncture the skin or other tissue to be treated. However, surface electrodes with insulating spacers cannot provide sufficient therapeutic value at the desired depth within the treatment area between electrodes. Therefore, needle electrodes are often more effective. However, for larger treatment areas, larger electrode assemblies are generally required to treat the appropriate area. As the size of the electrode assembly increases, the number of needle electrodes in the electrode assembly increases. This increases the complexity and cost of manufacturing the electrode assembly. Another problem associated with increasing the number of needle electrodes is the increased insertion force required to drive all needles into the skin. As a result, it may become difficult to push the needles in, and a "nail bed" phenomenon may occur, where the needle does not penetrate the skin or the needle penetration is insufficient. Furthermore, even with the use of needle electrodes, it is difficult to effectively distribute electrotherapy to the treatment area.

[0039] To address these issues and provide a distributed and effective treatment in the treatment area that can reach sufficient depth and offer a safer alternative with fewer penetrating electrodes, a novel electrode assembly is disclosed herein that includes conductive spacers instead of insulating spacers between electrodes. The use of such conductive spacers allows for a more consistent treatment depth in the treatment area and limits the need for needle electrodes. Furthermore, even when needle electrodes are used, conductive spacers can be used to reduce the need for additional rows of needles and / or some needles within a row. Conductive spacers in these treatments effectively prevent arc discharge between electrodes, which does not interfere with treatment but rather improves it.

[0040] Figure 1 shows a nanosecond pulse generator system according to one embodiment. Any of the pulse generators described in U.S. Patent No. 10 / 548,665, filed on May 6, 2016, titled "HIGH-VOLTAGE ANALOG CIRCUIT PULSER WITH FEEDBACK CONTROL" and incorporated herein by reference, may be used with the therapeutic apparatus of the present disclosure. The NsPEF system 100 includes a therapeutic instrument or therapeutic applicator 102, a foot switch 103, and an interface 104. The foot switch 103 is connected to the housing 105 and internal electronic components via a connector 106. The therapeutic applicator 102 is connected to the housing 105 and internal electronic components via a connector 112. The NsPEF system 100 also includes a handle 110 and a storage drawer 108. As shown in detail section A of Figure 1, the nsPEF system 100 also includes a holster 116 configured to hold the therapeutic applicator 102 by its handle portion 114. The therapeutic applicator 102 includes an electrode assembly at its distal end, which will be described in more detail throughout this disclosure.

[0041] A human operator may input pulse count, amplitude, pulse duration, and frequency information, for example, into a numeric keypad or touchscreen on interface 104. Interface 104 may provide the operator with therapeutic information, including configuration information for the user to view and adjust, as well as therapeutic values ​​and information during the administration of the treatment. In some embodiments, the pulse width can be varied. A controller 107 in housing 105 transmits signals to pulse control elements in the nsPEF system 100. The controller may be any suitable computing device, including memory for storing instructions and a processor for executing instructions. In some embodiments, a fiber optic cable enables the transmission of control signals while simultaneously electrically isolating the contents of the metal cabinet containing the nsPEF generating system 100, which is a high-voltage circuit, from the outside. To further isolate the system, the system 100 may be battery-powered rather than from a wall outlet.

[0042] Figure 2 shows some of the electrode assembly 200 according to several embodiments. In some embodiments, the electrode assembly 200 may be coupled to the handle of a treatment applicator, such as a treatment applicator 102. In some embodiments, the electrode assembly (electrode assembly / treatment applicator 102, etc.) may be interchangeable so that different electrode assemblies can be detachably coupled to the handle. The interchangeable electrode assemblies may be disposable (e.g., through electrodes may be discarded after use) or reusable (e.g., surface electrodes may be reusable). In further embodiments, the treatment applicator does not have a separate handle, and the electrode assembly itself forms the treatment applicator or electrotherapy device. The electrode assembly 200 may include an insulating housing 205 that can be coupled to a housing 210. In some embodiments, the insulating housing 205 and housing 210 are single parts, for example, molded plastic. The insulating housing 205 may be made from any suitable insulating material, such as plastic. The electrode assembly 200 also includes two surface electrodes 215 (indicated as 215a and 215b) and a conductive spacer 220.

[0043] Although two electrodes 215 are shown, the electrode assembly 200 may include any number of electrodes. For example, as shown in Figure 18A, it may include three rows of through electrodes, and in other examples, various numbers of electrodes may be provided. In some embodiments, the electrodes 215 are bipolar, with one negatively charged and the other positively charged, so that current flows between the two electrodes 215. The bipolar configuration may be used with additional electrodes. Furthermore, although Figure 2 shows two electrodes 215 enclosed within the same insulating housing 205 and housing 210, each electrode 215 may have its own housing. In some embodiments, the electrodes 215 may be unipolar electrodes so that current flows between the electrode and a return pad placed on the patient. The electrodes 215 may be, for example, about 1 millimeter wide (or thick) (width of electrode 215a or 215b) measured on the side 225, and, for example, 5 millimeters long (length of electrode 215a or 215b) measured on the side 230. The electrodes 215 may be made from any suitable conductive material, such as stainless steel, graphite, precious metals (e.g., gold, silver, platinum), copper, titanium, brass, or any other suitable material. The electrodes 215 are not visible in this figure because they extend within the insulating housing 205, but may have a height that will be shown in more detail in later figures. The electrodes 215 are arranged substantially parallel to each other at a certain distance apart. For example, in a 5 mm × 10 mm (5 mm × 10 mm) electrode assembly, the electrodes 215 are arranged 10 mm apart and have a length of 5 mm. In a 5 mm × 5 mm electrode assembly, the electrodes 215 are arranged 5 mm apart and have a length of 5 mm. The dimensions of the electrodes may vary depending on the therapeutic application, including 1.5 mm × 1.5 mm, 10 mm × 10 mm, 10 mm × 1.5 mm, 20 mm × 1 mm, etc. Furthermore, other components of the electrode 215 may include a ring electrode surrounding the central electrode, electrodes that are not uniformly distributed, an array of electrodes, etc. In addition, although surface electrodes are depicted in Figure 2, any type of electrode may be used, including, for example, through electrodes, catheter electrodes, clamp electrodes (e.g., parallel cardiac clamps or laparoscopic clamps), Barrett esophageal devices, percutaneous needle electrodes, balloon electrodes, balloon catheter electrodes, etc.

[0044] The conductive spacer 220 is placed between electrodes 215a and 215b. The conductive spacer 220 can be made from any suitable conductive material having a desirable conductivity for the conductive spacer 220. For example, the conductive spacer 220 may be made from a hydrogel, conductive adhesive, conductive gel, conductive silicone, urethane rubber, carbon nanotube, thermoplastic resin, thermosetting resin, or any combination thereof. The desired conductivity of the conductive spacer 220 may be selected based on the conductivity of the skin or tissue being treated. For example, the conductivity of the conductive spacer 220 may be substantially the same as the conductivity of the treated area of ​​the skin or tissue being treated, or it may be up to about 100 times (100x) the conductivity of the treated area or tissue being treated. In some embodiments, the conductivity of the conductive spacer 220 may vary throughout the conductive spacer 220. For example, the conductive spacer 220 may have zones with different conductivity, as shown in the examples in Figures 19A, 19B, 19C, 20A, and 20B, and / or a conductivity gradient within the conductive spacer 220. Various conductivity results are described with respect to Figures 12A to 20B. The viscosity of the conductive spacer 220 may be solid, compressible, or gelatinous, but it may be firm enough to maintain its shape and position within the electrode assembly 200. The conductive spacer 220 may be in contact with the electrodes 215 such that it has a width equal to the distance between the two electrodes 215, or, in some embodiments, the width equal to the distance between two rows of electrodes (e.g., needle electrode rows). For example, if the spacing between the electrodes 215 is 10 mm, the width of the conductive spacer 220 is 10 mm. The length of the conductive spacer may be substantially the same as the length of the electrodes 215. For example, if the length of electrode 215 is 5 mm (measured on the side surface 230), the length of conductive spacer 220 may also be 5 mm. The bottom of conductive spacer 220 may be substantially coplanar with the bottom of surface electrode 215 so that both conductive spacer 220 and surface electrode 215 are in contact with the treatment area. In some embodiments, conductive spacer 220 may extend into the insulating housing 205.In other words, the conductive spacer 220 and electrode 215 can have conductive portions within the insulating housing 205 such that only a portion of the conductive spacer 220 and electrode 215 is exposed.

[0045] In some embodiments, the exposed surfaces of the conductive spacer 220 and the electrode 215 are substantially coplanar with the opening of the insulating housing 205. The portion of the electrode 215 that is not in contact with the conductive spacer 220 may be in contact with the insulating housing 205.

[0046] Figures 3A and 3B show exposed views of the electrodes 215 (215a and 215b) and conductive spacer 220 of the electrode assembly 200. It has been found that varying the shape or geometric shape of conductive materials, such as conductive spacers between electrodes, can help increase electric field penetration and also make the treatment zone more uniform. As shown in Figure 3A, the conductive spacer 220a is substantially the same height as the electrode 215. In Figure 3B, an alternative embodiment of the conductive spacer 220b includes a recess or notch so that the height of the conductive spacer 220b varies with respect to the recess. In Figure 3B, the recess is a triangular shape with an angle, and the angle can vary in various embodiments. The recess of the conductive spacer may be modified in shape and size in some embodiments to affect a more uniformly distributed treatment, as will be described in more detail herein (and in some examples may be formed as notches of various geometric shapes). However, the shape of the recess is not limited to any geometric shape and can be formed in any suitable way, and it is not necessary to cut out any part of the spacer material. In some embodiments, the electrode 215 may extend further into an insulating housing, such as an insulating housing 205, such that the conductive exposed portion of the electrode 215 is at the same height as the conductive spacer 220 in contact with the electrode 215, or it may have insulating material wound around the electrode 215. In some embodiments, the electrode 215 may be coupled to a conductor in the insulating housing 205 or to another location in the electrode assembly 200. The height of the conductive spacer 220 can be selected, for example, based on the distance between the electrodes 215. For example, a height of the conductive spacer 220 that is about 10% to 50% of the distance between the electrodes 215 may be used. The distance between the electrodes 215 is substantially the same as the width of the conductive spacer 220, and therefore the height of the conductive spacer 220 may be about 10% to 50% of the width of the conductive spacer 220. A height of the conductive spacer 220 up to about 40 percent (40%) of the distance between the electrodes 215 can be used.For example, if the electrodes 215 are 10 mm apart such that the conductive spacer 220 has a width of 10 mm, the height of the conductive spacer 220 may be, for example, 4 mm. The conductive exposed portion of the electrode 215 in contact with the conductive spacer may also be 4 mm high. The treatment surfaces of the conductive spacer 220 and the electrode 215 may be placed on the surface of a treatment area 300 which may include skin or other tissues containing the heart, liver, or any other cell or tissue type to which the treatment is applied.

[0047] Figure 4A shows a side view of an example of a replaceable / removable coupled electrode assembly 400. The electrode assembly 400 includes a housing 410 and an insulating housing 405. The electrode assembly housing 410 may have a slightly elongated tapered shape. Protruding from the distal end of the housing 410 is the insulating housing 405, which may contain an electrode (not shown in this figure). Protruding from the proximal end of the electrode assembly 400 is a connector 415, which electrically connects the electrode (not shown in this figure) to a pulse generator to apply electrotherapy to the patient via the electrode. In this example, a mechanical connector 420 is used to mechanically attach the electrode assembly 400 on the proximal end to the handle of a treatment applicator.

[0048] Figure 4B shows an electrode assembly 400 having a needle electrode 425 and a conductive spacer 430. The electrode assembly 400 may have a rectangular or square cross-section as shown, or it may have a cross-section of any shape, such as circular or elliptical. The needle electrode 425 extends from an end facing distally (e.g., facing tissue). The needle electrode 425 may penetrate the patient's skin or tissue to apply electrotherapy to the treatment area. The needle electrode 425 may have a sharp, angled distal end, and in some embodiments, it may be a cylindrical needle. The conductive spacer 430 may be substantially the same as the conductive spacer 220. The conductive spacer 430 is in contact with the needle electrode 425. The conductive spacer 430 may have a height that extends into the insulating housing 405 and / or housing 410 such that the height of the conductive spacer 430 is in contact with the exposed conductive surface of the needle electrode 425. The needle electrode 425 may penetrate the tissue until the conductive spacer 220 contacts the surface of the treatment area (e.g., skin or tissue). The replaceable electrode assembly 400 describes the needle electrode 425, but as described throughout this disclosure, plates or surface electrodes such as the surface electrode 215, or a combination of surface and needle electrodes, may be used within the replaceable electrode assembly 400.

[0049] Figure 4C shows the proximal end of the replaceable electrode assembly 400. The mechanical connector 420 may snap or latch onto the handle (e.g., handle 114 in Figure 1) of a treatment applicator (e.g., treatment applicator 102). The mechanical connector 420 may be part of the housing 410. Two electrical connectors 415 (shown as 415a and 415b) may be electrically coupled to the electrical connector in the handle. This proximal end can be coupled to the handle to provide both mechanical and electrical connections between the replaceable electrode assembly 400 and the handle.

[0050] In some embodiments, within the replaceable electrode assembly housing 410, the electrodes may form part of an electrode assembly that is coupled to the electrode assembly housing 410, thereby locking the electrodes in place relative to the insulating housing 405 and the electrode assembly housing 410.

[0051] The electrode assemblies described herein may be of various different sizes and configurations, and may be used in multiple indications. For example, the size (e.g., diameter) of the treatment area on the distal surface of the device may vary (e.g., from about 1 mm to 150 mm or more) and may be of any suitable shape (e.g., rectangular, circular, triangular, elliptical, etc.). The electrodes used may be through electrodes, surface electrodes, or a combination thereof. The conductive surface of the electrode in contact with the treatment area may be of any suitable size, which will be described in more detail with respect to Figures 6-8. Part of the electrode may be surrounded by insulating material, and part of the electrode may be in contact with a conductive spacer. All portions of the electrode in contact with a conductive spacer extending from an insulating housing, etc., may be adjusted as necessary to apply the treatments described herein.

[0052] A replaceable electrode assembly (e.g., a disposable or reusable electrode assembly) is generally configured to be coupled with a disposable or reusable handle. Figures 5A and 5B show the mechanical and electrical coupling between a replaceable electrode assembly 500 and a portion of the handle 505. A connector 510 (shown as a clip-mechanical connector 420 in Figures 4A and 4B) can mechanically and releasably secure the replaceable electrode assembly 500 and the handle 505 together.

[0053] Figure 6A shows another embodiment of the implementation of an electrode assembly with a conductive space for transcutaneous application. In this example, the electrode assembly 600 has a balloon catheter configuration. The electrode assembly 600 includes a catheter body 605, an inflatable balloon 610, a positive electrode 625, a negative electrode 630, and a conductive spacer 635 having a first zone 615 and a second zone 620. In the electrode assembly 600, the positive electrodes 625 alternate with the negative electrodes 630 such that every other electrode is positive and the remaining electrodes are negative. Between the positive electrodes 625 and the negative electrodes 630 is a conductive spacer 635 including a first zone 615, a second zone 620, and another first zone 615. The first zones 615 may have a first conductivity, and the second zones 620 may have a second conductivity. In some embodiments, the second zones 620 may be an insulating zone.

[0054] Figure 6B shows a further embodiment useful for transdermal applications, such as a transdermal needle electrode assembly 650. The transdermal needle electrode assembly 650 may include a first electrode 670, a second electrode 660, a conductive spacer 665, and an insulator 655.

[0055] Figure 6C shows a cross-sectional view 675 of the percutaneous needle electrode assembly 650. The cross-sectional view 675 shows that there is an additional insulator 680 within the percutaneous needle electrode assembly 650. The first electrode 670 extends through the center of the percutaneous needle electrode assembly 650 to the tip and is directed to puncture tissue. Above the first electrode 670 along the shaft of the percutaneous needle electrode assembly 650, a conductive spacer 665 is located between the first electrode 670 and the second electrode 660. The second electrode 660 is exposed above the conductive spacer 665 along the shaft of the percutaneous needle electrode assembly 650. The second electrode 660 also extends through the percutaneous needle electrode assembly 650 but is buffered by an insulator 655 from the treatment area above the exposed portion and by an insulator 680 from the first electrode 670 through the shaft of the percutaneous needle electrode assembly 650.

[0056] Figure 7A shows a cross-sectional view 700 of a surface electrode assembly 705 that applies treatment to a treatment area 710. The treatment area 710 may be any suitable treatment area, including, for example, a skin or tissue surface containing a tumor.

[0057] The surface electrode assembly 705 may be similar to the electrode assembly 200. The surface electrode assembly 705 may include a surface electrode 715 (shown as 715a and 715b, for example), a conductive spacer 720, and an insulating housing 725. The surface electrode 715 may be substantially the same as the surface electrode 215. The conductive spacer 720 may be substantially the same as the conductive spacer 220. The insulating housing 725 may be substantially the same as the insulating housing 205. In some embodiments, the surface electrode 715 and the conductive spacer 720 may extend outward from the housing 725. In some embodiments, the surface electrode 715 and the conductive spacer 720 may be embedded within the housing 725 so that contact with the treatment area 710 is achieved by drawing tissue from the treatment area 710 into the housing 725. Such configurations may be used through any of the electrode assemblies described herein.

[0058] As shown in cross-sectional view 700, the first surfaces 730a and 730b of each surface electrode 715a and 715b are in contact with the treatment area 710. The first surface 730 is the conductive treatment surface or portion of electrode 715. The second surfaces 735a and 715b of each surface electrode 735 are in contact with the conductive spacer 720. The second surface 735 is the conductive non-treatment surface or portion of electrode 715. The third surfaces 740a and 715b of each surface electrode 740 are in contact with an insulating material such as the insulating housing 725. The surface 745 of the conductive spacer 720 between the two electrodes 715 is in contact with the surface of the treatment area 710.

[0059] As shown, when a voltage is applied across the surface electrodes 715 (for example, electrode 715a may have a positive charge and electrode 715b may have a negative charge), an energy pulse is applied to the treatment area 710. The conductive spacer 720 can conduct a portion of the current from the energy pulse based on the second surface 735 of the surface electrodes 715 that is in contact with the conductive spacer 720. The conductivity of the material allows the energy pulse to be directed between the surface electrodes 715 into the treatment area 710 and further into the treatment area 710. Such results are shown with respect to the model shown by the examples in Figures 12A to 18D.

[0060] Figure 7B shows an alternative cross-sectional view 750 of a surface electrode assembly 755 that applies treatment to a treatment area 710. In the cross-sectional view 750, the conductive spacer 760 includes a recess 780. The surface 745 of the conductive spacer 760, located between the two electrodes 715, is in contact with the surface of the treatment area 710. The conductive spacer 760 includes a first portion 765, as shown. The first portion 765a is located between the surface 735a of electrode 715a and the dashed line "A", and the first portion 765b is located between the surface 735b of electrode 715b and the dashed line "D". The first portion 765a has a first height such that the edge of the conductive spacer 760 having a first height is in contact with the conductive surface of electrode 715. The conductive spacer 760 includes a second portion 775 between the dashed lines "B" and "C". The second portion 775 has a second height that is lower than the first height. The second portion 775 may have a radial edge as shown in Figure 7B, a flat edge as depicted in Figure 21D, or a tip as depicted in Figure 21A. The conductive spacer 760 includes a third portion 770, each of which includes an angled edge 785 extending from a first height in the first portion 765 to a second height in the second portion 775, defining a recess 780 (e.g., a “rounded V” notch). As shown, the third portion 770a has an angled edge 785a extending from a first height in the first portion 765a to a second height in the second portion 775, and the third portion 770b has an angled edge 785b extending from a first height in the first portion 765b to a second height in the second portion 775. The illustrated recess 780 is illustrative, and any shape or size can be used to modify the shape of the conductive spacer 760.

[0061] Figure 8A shows a cross-sectional view 800 of an example of a needle electrode assembly 705 having a through electrode for applying electrotherapy to a patient's treatment area 810. The treatment area 810 may be any suitable treatment area, including, for example, a skin or tissue surface having a tumor, lesion, or other undesirable condition.

[0062] The needle electrode assembly 805 may be the same as the electrode assembly 400. The needle electrode assembly 805 may include a needle electrode 815, a conductive spacer 820, and an insulating housing 825. The needle electrode 815 may be substantially the same as the needle electrode 425. The conductive spacer 820 may be substantially the same as the conductive spacer 430. The insulating housing 825 may be substantially the same as the insulating housing 405.

[0063] As shown in cross-sectional view 800, the first surfaces 830a and 830b of each needle electrode 815a and 815b are in contact with the treatment area 810. The needle electrode 815 may penetrate its surface so as to extend into the treatment area 810. The first surface 830 is the conductive treatment surface or portion of the electrode 815 that is in contact with the treatment area 810. The second surfaces 835a and 815b of each needle electrode 835 are in contact with the conductive spacer 820. The second surface 835 is the conductive non-treatment surface or portion of the electrode 815. The third surfaces 840a and 840b of each needle electrode 815 may be in contact with an insulating material such as an insulating housing 825, as shown in the embodiment of Figure 8A. The surface 845 of the conductive spacer 820 between the two electrodes 815 is in contact with the surface of the treatment area 810.

[0064] As shown, when a voltage is applied across the needle electrodes 815 (for example, electrode 815a may have a positive charge and electrode 815b may have a negative charge), an energy pulse is applied to the treatment area 810. The conductive spacer 820 may function to conduct a portion of the current from the energy pulse based on the second surface 835 of the needle electrodes 815 that is in contact with the conductive spacer 820. The conductivity of the material allows the energy pulse to be directed to the treatment area 810 between the needle electrodes 815 and to deeper within the treatment area 810. Such results are shown with respect to the models shown in Figures 12A–22B.

[0065] Figure 8B shows an alternative cross-sectional view 850 of a needle electrode assembly having a through electrode for applying electrotherapy to a patient's treatment area 810. In the cross-sectional view 850, the conductive spacer 860 includes a recess 880. The surface 845 of the conductive spacer 860, located between the two electrodes 815, is in contact with the surface of the treatment area 810. The conductive spacer 860 includes a first portion 865, as shown. The first portion 865a is positioned between the surface 835a of electrode 815a and the dashed line "A", and the first portion 865b is positioned between the surface 835b of electrode 815b and the dashed line "D". The first portion 865 has a first height such that the edge of the conductive spacer 860 having a first height is in contact with the conductive surface of electrode 815. The conductive spacer 860 includes a second portion 875 between the dashed lines "B" and "C". The second portion 875 has a second height that is lower than the first height. The second portion 875 may have a pointed edge as shown in Figures 8B and 21A, a flat edge as shown in Figures 21D and 21E, or a radial edge as shown in Figures 21B and 21C. The conductive spacer 860 includes a third portion 870, each of which includes an angled edge 885 extending from a first height in the first portion 865 to a second height in the second portion 875, defining a recess 880 (e.g., a "V" notch). As shown, the third portion 870a has an angled edge 885a extending from a first height in the first portion 865a to a second height in the second portion 875, and the third portion 870b has an angled edge 885b extending from a first height in the first portion 865b to a second height in the second portion 875. Since the illustrated recess 880 is illustrative, any shape or size of recess can be used to change the shape of the conductive spacer 860.

[0066] Figure 9A shows an exemplary cross-sectional view 900 of a composite electrode assembly 905 that applies treatment to a patient's treatment area 910. The treatment area 910 may be any suitable treatment area, including, for example, a skin or tissue surface with a tumor.

[0067] The combination electrode assembly 905 may include a plurality of needle electrodes 915 (shown as 915a and 915b, for example), a central surface electrode 950, conductive spacers 920 (shown as 920a and 920b, for example), and an insulating housing 925. In some embodiments, the central electrode 950 may be a needle electrode, and the outer electrode 915 may be a surface electrode. Other combinations of electrodes may be included in the combination electrode assembly, which may include through electrodes, catheter electrodes, surface electrodes, or any other type of electrode. For example, in some embodiments, the central electrode may be a needle electrode, and the outer electrode may be a ring-shaped surface electrode surrounding the central electrode. In another example, in some embodiments, the central electrode may be a disk-shaped surface electrode, and the outer electrode may be a ring-shaped surface electrode surrounding the central electrode. In yet another embodiment, the central electrode and the outer electrode may be the same type, which may include through electrodes, surface electrodes, catheter electrodes, or any other type of electrode. The needle electrodes 915a and 915b may be substantially the same as the needle electrode 425. The central surface electrode 950 may be substantially the same as the surface electrode 215. The conductive spacers 920a and 920b may be substantially the same as the conductive spacer 220.

[0068] As shown in cross-sectional view 900, the first surfaces 930a and 915b of each needle electrode 930 are in contact with the treatment area 910. The needle electrode 915 may penetrate the surface so as to extend into the treatment area 910. The first surface 930 is the conductive treatment surface or portion of the electrode 915. The second surfaces 935a and 915b of each needle electrode 935 are in contact with their respective conductive spacers 920. For example, the second surface 935a is in contact with the conductive spacer 920a. Similarly, the second surface 935b is in contact with the conductive spacer 920b. The second surface 935 is the conductive non-treatment surface or portion of the electrode 915. The third surfaces 940a and 940b of each needle electrode 915 may be in contact with an insulating material such as an insulating housing 925. The surfaces 945a and 945b of each conductive spacer 920 are in contact with the surface of the treatment area 910. In addition, the central surface electrode 950 includes a first surface 960 that contacts the surface of the treatment area 910, and second surfaces 955a and 955b, each of which contacts the respective conductive spacer 920.

[0069] As shown, when a voltage is applied across electrodes 915a, 915b, and 950 (for example, electrodes 915a and 915b may have a positive charge, and electrode 950 may have a negative charge, and vice versa), an energy pulse is applied to the treatment area 910. The conductive spacer 920 can conduct a portion of the current from the energy pulse based on the second surface 935 of the needle electrode 915 in contact with the conductive spacer 920 and the second surface 955 of the surface electrode 950 in contact with the conductive spacer 920. The conductivity of the material allows the treatment pulse to be directed to the treatment area 910 between the needle electrodes 915 and to deeper within the treatment area 910. Such results are shown with respect to the models shown in Figures 12A-22B.

[0070] Figure 9B shows an alternative exemplary cross-sectional view 970 of a composite electrode assembly 975 for applying treatment to a treatment area 910. In the cross-sectional view 970, conductive spacers 980a and 980b include recesses 985a and 985b, respectively. Each conductive spacer 980 may be similar to conductive spacer 860 in Figure 8B or conductive spacer 760 in Figure 7B. The recesses 985 depicted within the conductive spacer 980 are exemplified as "V" shaped notches. However, any shape may be used, and in some embodiments, the shape of each recess 985 may differ (for example, recess 985a may be a "rounded V" shape, and recess 985b may be a "U" shape). Since the illustrated recesses 985 are illustrative, any shape or size can be used to modify the shape of the conductive spacer 980.

[0071] Figure 9C shows a perspective view of an exemplary electrode assembly 990 having needle electrodes 992, a central surface electrode 994, and conductive spacers 996. In this example, the needle electrodes 992 include a row of electrodes 992a on one side of the electrode assembly 990 and a second row of electrodes 992b on the other side of the electrode assembly, and the surface electrode 994 (e.g., plate 994) may be arranged parallel to the two rows of electrodes 992a and 992b. The needle electrodes 992 may be substantially the same as the needle electrode 915 described with reference to Figures 9A and 9B. The surface electrode 994 may be substantially the same as the surface electrode 950 described with reference to Figures 9A and 9B. The conductive spacers 996a, 996b may be substantially the same as the conductive spacer 920 described with reference to Figure 9A or the conductive spacer 980 described with reference to Figure 9B.

[0072] A disclosed treatment system having any of the electrode assemblies having conductive spacers as described above may be used to provide effective electrotherapy to a patient. Figures 10A, 10B, and 11 provide some examples of process steps that can be selectively combined in various ways for the selection of electrode assemblies, the selection of electrotherapy parameters, the application of electrotherapy, and the display (or notification / communication) of treatment information. In general, the methods described herein, including the methods shown in Figures 10A-10B and 11, may be for the treatment of cosmetic indications, for example, to improve the appearance of the treatment area. Such cosmetic indications typically have no symptoms other than the visible effect being treated, and may be bothersome and have psychosocial adverse effects, but generally have no medical effect. For example, sebaceous gland hyperplasia (SH) is an example of a cosmetic indication. Figures 12A-22B provide models depicting electrotherapy distributions using various configurations of electrode assemblies.

[0073] Figure 10A shows a process 1000 for applying electrotherapy to a patient according to several embodiments. Process 1000 may be performed by a human user (e.g., a medical professional) operating the therapeutic device, or by a system such as system 100 in Figure 1. In some embodiments, in an optional step 1005, the user can select an electrode assembly based at least partially on the conductive spacer of the electrode assembly. For example, the user can select an electrode assembly having a conductive spacer having a conductivity suitable for the tissue to be treated. The conductivity of the conductive spacer may be greater than, less than, or substantially equal to the conductivity of the treatment area. In some embodiments, the conductivity of the conductive spacer may be in a range such as greater than or equal to the conductivity of the treatment area, and less than or equal to 100 times (100x) the conductivity of the treatment area, in some embodiments it may be slightly less than, approximately equal to, or about 10 times (10x) the conductivity of the treatment area, and in some embodiments it may be about 1 to 10 times (1x to 10x) the conductivity of the treatment area. The conductivity of the treatment area may be determined based on the type of tissue to be treated. For example, treatment may be for skin, liver tissue, heart tissue, or any other type of tissue or cell. The conductivity of the epidermis is about 1.1 S / m, and therefore the conductivity range of the conductive spacer may be slightly less than 1.1 S / m to 110 S / m, and in some embodiments, preferably about 11 S / m (about 10 times the conductivity of the treatment area). Treatment of other tissues may have different conductivity ranges, as the conductivity of the tissue may vary depending on the type of tissue being treated. As another example, the user may select an electrode assembly having a conductive spacer with a recess that is desirable for the tissue being treated. For example, recesses with a smaller or larger second height (e.g., a "V" or "U" shaped valley), a steeper or less steep angle of the edge connecting the first height to the second height, wider or narrower recesses, etc., may have various advantages for treating various types of tissue.In yet another embodiment, the controller of the pulse generator system (such as the embodiment shown in Figure 1) may receive information about the treatment area and / or the tissue being treated, make selections for use by the electrode assembly, and provide such selection information to the user (e.g., a technician or other healthcare professional) for acquisition and use for treatment. The electrode assembly may include at least two electrodes, each in conductive contact with a conductive spacer.

[0074] In some embodiments, in an optional step 1010, the user may apply a conductive gel to the surface of the treatment area to facilitate contact between the electrode assembly electrode and the treatment area, and / or between the conductive spacer of the electrode assembly and the treatment area. For example, conductive gels are often used to help facilitate uniform contact of the electrode to skin or other treatment areas that are not perfectly uniform and flat. Conductive gels differ from conductive spacers of electrode assemblies in several respects. For example, the viscosity of such conductive gels is typically much lower and firmer than that of conductive spacers. Furthermore, the conductive gel is placed between the surface of the conductive spacer and the surface of the treatment area, and in some embodiments of surface electrodes, between the surface of the surface electrode and the surface of the treatment area.

[0075] In step 1015, the user applies or positions the electrode assembly to the patient's treatment area. For example, any surface electrode and conductive spacer are positioned to make conductive contact (i.e., electrical contact) with the surface of the treatment area. Any needle electrode is inserted into the treatment area until the conductive spacer is pressed against the surface of the treatment area and makes conductive contact. In electrode assemblies with electrodes and conductive spacers embedded in a housing, tissue is drawn into the electrode assembly so that the tissue makes conductive contact with the electrodes and conductive spacers.

[0076] In step 1020, electrotherapy parameters are selected for electrotherapy to be applied to a treatment area. The electrotherapy parameters may include a voltage field applied to the treatment area, pulse width, pulse frequency, number of pulses, or any combination thereof. In some embodiments, the electrotherapy parameters may be selected at least in part on the conductive spacers in the electrode assembly. For example, an electrode assembly with conductive spacers according to this disclosure may require a lower voltage to provide effective treatment at a desired treatment depth throughout the treatment area than the voltage required to treat the treatment area using an electrode assembly with or without insulating spacers between electrodes. This lower voltage may be at least in part because the conductive spacers allow a relatively high electric field to be present over the treatment area and extend more effectively into the treatment area. In some embodiments, a controller of a pulse generator system (such as the example shown in Figure 1) may be configured to determine or recognize the conductivity of the selected electrode assembly and conductive spacers, and may also provide proposed electrotherapy parameter values ​​for treatment. For example, when the electrode assembly is attached to the handle of the pulse generator system, the controller may receive information identifying the electrode assembly (e.g., a model number). The controller can access memory containing a database or table containing information that can be used to determine electrotherapy parameter values ​​for treating a given treatment area using a selected electrode assembly. These electrotherapy parameter values ​​can be based on any combination of, for example, the conductivity of the conductive spacer, the geometric notch information of the conductive spacer, the conductivity of the treatment area, and the size or shape of the treatment area.

[0077] In some embodiments, in an optional step 1025, the user can apply electrotherapy to the treatment area via an electrode assembly. Such therapy may include high-voltage or low-voltage pulses. The pulses may be nanosecond pulses, picosecond pulses, microsecond pulses, millisecond pulses, etc. In some embodiments, the electrotherapy may be pulsed with direct current ("DC"). In some embodiments, the electrotherapy may be radio frequency ("RF") therapy.

[0078] Figure 10B shows an embodiment of another method 1050 for selecting an electrode assembly and / or parameters for electrotherapy. Method 1050 may be performed by a human user (e.g., a medical professional) operating a therapeutic device or system, such as system 100 in Figure 1. In some embodiments, method 1050 may be performed by a controller of the therapeutic system or device. Method 1050 may include, in step 1055, selecting an electrode assembly based at least partially on the conductive spacers of the electrode assembly. Step 1055 is described in detail above as optional step 1005 in process 1000 in Figure 10A.

[0079] In some embodiments, in an optional step 1060, a conductive gel may be applied to the surface of the treatment area to facilitate contact between the electrode assembly electrodes and the treatment area, and / or between the conductive spacers of the electrode assembly and the treatment area. Step 1060 is described in detail above as an optional step 1010 in process 1000 in Figure 10A.

[0080] In step 1065, electrotherapy parameters may be selected for the electrotherapy to be applied to the treatment area. Step 1065 is described in detail above as step 1020 in process 1000 in Figure 10A.

[0081] Figure 11 shows an embodiment of another method 1100 for configuring a pulse generator system for electrotherapy, or a method of operating an electrotherapy device. Method 1100 can be performed by a controller of the pulse generator system. The controller may perform Method 1100 by having one or more processors of the controller store instructions in the controller's memory that cause the controller to perform a step. In step 1105, the controller may determine or receive instructions for a replaceable electrode assembly of a treatment applicator. For example, a human user may select a replaceable electrode assembly and couple the replaceable electrode assembly to the handle of the treatment applicator. In some implementations, the system may determine and suggest, through a user interface, which electrode assembly to use for a particular treatment area or treatment, based, for example, on information stored in the memory of the system's controller / processor. The coupling may be mechanical, electrical, or both. The electrode assembly may include information transmitted when coupled to the controller to indicate the type of electrode assembly, including the size of the electrode assembly (e.g., 5mm x 5mm, 10mm x 5mm, 5mm x 10mm, etc.), the conductivity of the conductive spacer, the number of electrodes, and the type of electrode assembly (e.g., whether it is a surface electrode, needle electrode, or combination electrode assembly). In some embodiments, the model number of the electrode assembly may also be transmitted to the controller, which may use the model number to identify information about the electrode assembly, for example, in a table in memory.

[0082] In step 1110, the controller determines the characteristics of the conductive spacer based on the indication of the replaceable electrode assembly. For example, the indication may include conductivity information (e.g., conductivity, conductive zone, etc.), or the information provided may allow the controller to examine the conductivity information of the conductive spacer. As another example, the indication may include the shape of the recess of the conductive spacer or other characteristics.

[0083] In step 1115, the controller determines appropriate treatment configuration information, including, for example, electrotherapy parameters, based on the interchangeable electrode assembly. For example, the controller may retrieve configuration information in a table or database. The configuration information may include, for example, the preferred type of tissue to be treated with the electrode assembly, the peak voltage value for treatment, the treatment duration for performing electrotherapy, the treatment depth to which treatment is desired, the minimum effective treatment value for the tissue being treated at the treatment depth, and / or equivalents.

[0084] In some embodiments, the optional step 1120 is performed by the controller. The controller can use configuration information based on the selected interchangeable electrode assembly to set configurable electrotherapy parameters for electrotherapy. For example, the controller may set the peak voltage for treatment, the applied voltage field, pulse duration, pulse frequency, number of pulses, pulse width, etc. In some embodiments, the optional step 1120 may be performed by the user.

[0085] In step 1125, in some embodiments, the controller may optionally display preferred treatment configuration information and / or configurable electrotherapy parameters on a display device (e.g., interface 104). In some implementations, instead of displaying preferred treatment configuration information and / or treatment parameters, such information may be communicated or transmitted, for example, verbally (e.g., by sound) or by text. In some embodiments, the user may adjust the configurable parameters and / or modify the preferred or suitable treatment configuration information. For example, the user may modify the type of tissue to be treated or the peak voltage used. Such modifications may, in some embodiments, cause the controller to modify / update the determined preferred treatment configuration information, for example, based on a table or historical data. In some embodiments, the information in the controller's memory may include protection to prevent the configuration settings for a given interchangeable electrode assembly from providing unacceptable treatment, for example, by limiting the peak voltage, etc.

[0086] Figure 12A shows Model 1200 of a treatment area 1215 for a surface electrode assembly having an insulating spacer 1210 between electrodes 1205a and 1205b and surrounded by an insulator 1220. The described surface electrode 1205 having the insulating spacer 1210 may have been used in previously known treatments and does not implement the conductive spacer disclosed herein. This Model 1200 is provided for the purpose of depicting a treatment area 1215 using the insulating spacer 1210 to demonstrate the substantial advantages of using the conductive spacer of this disclosure as shown in Figure 12B.

[0087] Model 1200 is based on a treatment area 1215 treated with an insulating spacer 1210 between two surface electrodes 1205a and 1205b. The insulating spacer 1210 has a height that is 10% of its width. A voltage pulse is applied, for example, which may have a peak voltage of 2kV to 15kV. There are contour lines numbered from 1 to 10, as shown using the numerical values ​​in the model, which indicate the relative treatment value at each contour line. As shown in the figure, the treatment area 1215 directly below the center of the insulating spacer 1210 has a treatment value to a depth of approximately 2.5 at contour line 2.0. However, contour line 4.0 does not extend below the center of the insulating spacer 1210. For illustrative purposes, assume that the treatment area 1215 has an effective treatment value identified based on contour line 4.0. Directly below electrode 1205, the treatment value at contour line 4.0 is approximately 2.25. As shown using insulating spacers, the treatment is not uniformly distributed across the entire treatment area 1215. Isolines associated with the effective treatment value for the treatment area may be as horizontal as possible to indicate uniformly distributed treatment over a consistent depth within the treatment area. In the case of model 1200, none of the isolines indicate uniformly distributed treatment.

[0088] Figure 12B shows Model 1250 of a treatment area 1265 for a surface electrode assembly surrounded by an insulator 1270, with a conductive spacer 1260 between electrodes 1255a and 1255b. Model 1250 is based on a treatment area 1265 treated by a conductive spacer 1260 between two surface electrodes 1255. The conductive spacer 1260 has a height of approximately 10% of its width. The conductive spacer 1260 has substantially the same conductivity as the treatment area 1265. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. In Model 1250, directly below electrode 1255, the treatment value at contour line 4.0 is approximately 2.75 depth, and directly below the center of conductive spacer 1260, the treatment value at contour line 4.0 is approximately 1.25 depth. It should be noted that when the insulating spacer 1210 is used, the treatment is distributed more substantially more uniformly across the entire treatment area 1265 than through the treatment area 1215, as shown in Figure 12A. In this example, effective treatment to a depth of at least 1.25 is achieved across the entire treatment area 1265.

[0089] Figure 13A shows Model 1300 of a treatment area 1315 for a surface electrode assembly having insulating spacers 1310 between electrodes 1305 and surrounded by an insulator 1320. The surface electrode assembly shown in Figure 13A is smaller in size than the surface electrode assembly shown in Figure 12A. The distance between electrodes 1305 is half the distance between electrodes 1205 in Figure 12A. The described surface electrode 1305 with insulating spacers 1310 may have been used in a previous treatment and does not implement the conductive spacers disclosed herein. This Model 1300 is provided for the purpose of depicting a treatment area 1315 using insulating spacers 1310 to demonstrate the substantial advantages of using conductive spacers as shown in Figure 13B.

[0090] Model 1300 is based on a treatment area 1315 treated with an insulating spacer 1310 between two surface electrodes 1305a and 1305b. The insulating spacer 1310 has a height that is 20% of its width. A voltage pulse is applied, for example, which may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1315 directly below the insulating spacer 1310 has a treatment value up to a depth of approximately 1 at contour line 4.0. Directly below electrode 1305, the treatment value at contour line 4.0 is approximately 1.75 depth. However, the effective treatment value is not preferably distributed uniformly across the entire treatment area 1315.

[0091] Figure 13B shows Model 1350 of a treatment area 1365 for a surface electrode assembly having a conductive spacer 1360 between electrodes 1355a and 1355b and surrounded by an insulator 1370.

[0092] Model 1350 is based on a treatment area 1365 treated with a conductive spacer 1360 between two surface electrodes 1355. The conductive spacer 1360 has a height of approximately 20% of its width. The conductive spacer 1360 has substantially the same conductivity as the treatment area 1365. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. In Model 1350, directly below the center of the conductive spacer 1360, the treatment value at contour line 4.0 is approximately 1.6 depth, and directly below electrode 1355, the treatment value at contour line 4.0 is approximately 1.8 depth. Note that if an insulating spacer 1310 is used, the effective treatment value is distributed substantially more uniformly across the entire treatment area 1315 than through the treatment area 1365. In this example, effective treatment to a depth of approximately 1.6 is achieved across the entire treatment area 1365.

[0093] Figures 14A to 14E can be used to analyze the advantages of increasing the height of the conductive spacer.

[0094] Figure 14A shows Model 1400 of a treatment region 1406 of a surface electrode assembly having a conductive spacer 1404 between electrodes 1402a and 1402b. Region 1408 is insulating, like an insulating housing.

[0095] Model 1400 is based on a treatment area 1406 treated by a conductive spacer 1404 between two surface electrodes 1402. The conductive spacer 1404 has a height of approximately 10% of its width. The conductive spacer 1404 has substantially the same conductivity as the treatment area 1406. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1406 directly below the conductive spacer 1404 has a treatment value up to a depth of approximately 1.25 at contour line 4.0. Directly below electrode 1402, the treatment value at contour line 4.0 is approximately 2.75 at a depth.

[0096] Figure 14B shows model 1420 of a treatment area 1426 of a surface electrode assembly having a conductive spacer 1424 between electrodes 1422a and 1422b. Area 1428 is insulating, like an insulating housing.

[0097] Model 1420 is based on a treatment area 1426 treated by a conductive spacer 1424 between two surface electrodes 1422. The conductive spacer 1424 has a height of approximately 20% of its width. The conductive spacer 1424 has substantially the same conductivity as the treatment area 1426. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1426 directly below the conductive spacer 1424 has a treatment value up to a depth of approximately 1.75 at contour line 4.0. Directly below electrode 1422, the treatment value at contour line 4.0 is approximately 2.75 at a depth.

[0098] Figure 14C shows a model 1440 of a surface electrode assembly with a conductive spacer 1444 between electrodes 1442a and 1442b. The area 1448 is insulating, like an insulating housing.

[0099] Model 1440 is based on a treatment area 1446 treated by a conductive spacer 1444 between two surface electrodes 1442. The conductive spacer 1444 has a height of approximately 30% of its width. The conductive spacer 1444 has substantially the same conductivity as the treatment area 1446. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1446 directly below the conductive spacer 1444 has a treatment value up to a depth of approximately 1.75 at contour line 4.0. Directly below electrode 1442, the treatment value at contour line 4.0 is approximately 2.75 at a depth.

[0100] Figure 14D shows a model 1460 of a surface electrode assembly with a conductive spacer 1464 between electrodes 1462a and 1462b. The area 1468 is insulating, like an insulating housing.

[0101] Model 1460 is based on a treatment area 1466 treated by a conductive spacer 1464 between two surface electrodes 1462. The conductive spacer 1464 has a height of approximately 40% of its width. The conductive spacer 1464 has substantially the same conductivity as the treatment area 1466. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1466 directly below the conductive spacer 1464 has a treatment value up to a depth of approximately 2 at contour line 4.0. Directly below electrode 1462, the treatment value at contour line 4.0 is approximately 2.75 depth.

[0102] Figure 14E shows Model 1480 of a surface electrode assembly with a conductive spacer 1484 between electrodes 1482a and 1482b. Region 1488 is insulating, like an insulating housing.

[0103] Model 1480 is based on a treatment area 1486 treated by a conductive spacer 1484 between two surface electrodes 1482. The conductive spacer 1484 has a height that is approximately 50% of its width. The conductive spacer 1484 has substantially the same conductivity as the treatment area 1486. ​​For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1486 directly below the conductive spacer 1484 has a treatment value up to a depth of approximately 2 at contour line 4.0. Directly below electrode 1482, the treatment value at contour line 4.0 is approximately 2.75 depth.

[0104] As shown in Figures 14A-14E, increasing the height-to-width ratio of the conductive spacer increases the effective therapeutic depth in the treatment area beneath the conductive spacer, but only to a certain extent. Other models using various other tissues and conductivity of conductive spacers, as well as electrode assemblies of different sizes (e.g., 5mm x 5mm, 5mm x 10mm), show that effective therapeutic depth increases when the height of the conductive spacer is approximately 20-60 percent (20-60%) of the width of the conductive spacer, compared to using conductive spacers with smaller height-to-width ratios. The increase in effective therapeutic depth gradually decreases beyond 70%. Conductive spacers with a height of approximately 40 percent (40%) of the width of the conductive spacer provide good results. Therefore, in certain embodiments, conductive spacers with a height of 4mm and a width of 10mm (e.g., in a 5mm x 10mm electrode assembly) provide higher therapeutic depth and uniformity than conductive spacers with a height of less than 4mm and a width of 10mm. Similarly, a conductive spacer having a height of 2 mm and a width of 5 mm (for example, in a 5 mm x 5 mm electrode assembly) provides increased treatment depth compared to a conductive spacer having a height of less than 2 mm and a width of 5 mm.

[0105] Figure 15 shows an example of Graph 1500, illustrating the percentage change in the minimum effective therapeutic value when the height of the conductive spacer is increased as a percentage of its width, based on data collected in models 1400, 1420, 1440, 1460, and 1480. For example, the percentage change in the effective electric field due to a conductive spacer with a height-to-width ratio of 10% compared to a conductive spacer with a height-to-width ratio of 40% is approximately 30 percent (30%).

[0106] Figures 16A to 16D can be used to analyze the advantages of increasing the conductivity of conductive spacers.

[0107] Figure 16A shows Model 1600 of a treatment area 1606 of a surface electrode assembly having a conductive spacer 1604 between electrodes 1602a and 1602b. Area 1608 is insulating, like an insulating housing.

[0108] Model 1600 is based on a treatment area 1606 treated by a conductive spacer 1604 between two surface electrodes 1602. The conductive spacer 1604 has a height of approximately 20% of its width. The conductive spacer 1604 has substantially the same conductivity as the treatment area 1606. For example, a voltage pulse may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1606 directly below the conductive spacer 1604 has a treatment value up to a depth of approximately 1.75 at contour line 4.0. Directly below electrode 1602, the treatment value at contour line 4.0 is approximately 2.75 at a depth.

[0109] Figure 16B shows model 1620 of a treatment area 1626 of a surface electrode assembly having a conductive spacer 1624 between electrodes 1622a and 1622b. Area 1628 is insulating, like an insulating housing.

[0110] Model 1620 is based on a treatment area 1626 treated with a conductive spacer 1624 between two surface electrodes 1622. The conductive spacer 1624 has a height of approximately 20% of its width. The conductive spacer 1624 has a conductivity of approximately 10 times (10x) that of the treatment area 1626. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1626 directly below the conductive spacer 1624 has a treatment value up to a depth of approximately 2.75 at contour line 4.0. Directly below electrode 1622, the treatment value at contour line 4.0 reaches a depth of approximately 3mm. Note that this is a substantial improvement over conductive spacer 1604, which has a conductivity substantially equal to that of the treatment area 1606.

[0111] Figure 16C shows model 1640 of a treatment area 1646 of a surface electrode assembly having a conductive spacer 1644 between electrodes 1642a and 1642b. Area 1648 is insulating, like an insulating housing.

[0112] Model 1640 is based on a treatment area 1646 treated with a conductive spacer 1644 between two surface electrodes 1642. The conductive spacer 1644 has a height of approximately 20% of its width. The conductive spacer 1644 has a conductivity of approximately 100 times (100x) that of the treatment area 1646. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are shown by numbered contour lines as shown in Figure 12A. The treatment area 1646 directly below the conductive spacer 1644 has a treatment value up to a depth of approximately 3 at contour line 4.0. Directly below electrode 1642, the treatment value at contour line 4.0 is approximately 3.25 depth. Note that this is an improvement over conductive spacer 1624, which has a conductivity 10 times that of the treatment area 1646, as the effective treatment depth increases.

[0113] Figure 16D shows Model 1660 of a surface electrode assembly with a conductive spacer 1664 between electrodes 1662a and 1662b. Region 1668 is insulating, like an insulating housing.

[0114] Model 1660 is based on a treatment area 1666 treated with a conductive spacer 1664 between two surface electrodes 1662. The conductive spacer 1664 has a height of approximately 20% of its width. The conductive spacer 1644 has a conductivity approximately 1000 times (1000x) that of the treatment area 1646. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are shown by numbered contour lines as shown in Figure 12A. The treatment area 1666 directly below the conductive spacer 1664 has a treatment value up to a depth of approximately 3 at contour line 4.0. Directly below electrode 1662, the treatment value at contour line 4.0 is approximately 3.25 depth. Note that there is no significant improvement compared to the conductive spacer 1644, which has 100 times the conductivity of the treatment area 1646.

[0115] Figure 17 shows graph 1700 of the percentage change in minimum effective therapeutic value as the conductivity of the conductive spacer increases as a multiple of the conductivity of the treatment area, based on data collected in models 1600, 1620, 1640, and 1660. For example, the percentage change in minimum effective therapeutic value between a conductive spacer with substantially the same conductivity as the treatment area and a conductive spacer with 100 times the conductivity of the treatment area is approximately 72 percent (72%).

[0116] Figures 18A-18D show alternative configurations and results for three-row through-hole and combined electrode assemblies. Regions 1808, 1828, 1848, and 1868 are insulating, as is the case with the insulating housing.

[0117] Figure 18A shows Model 1800 for a three-row needle electrode assembly with insulating spacers 1804a and 1804b between the needle electrodes 1802a, 1802b, and 1802c.

[0118] Model 1800 in Figure 18A is based on a treatment area 1806 being treated with a three-row needle electrode configuration. For example, a voltage pulse with a peak voltage of 2kV to 15kV is applied. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1806 directly below needle electrodes 1802a and 1802c has a treatment value up to a depth of approximately 4 at the 4.0 contour line. Directly below needle electrode 1802b has a treatment value up to a depth of approximately 5.25 at the 4.0 contour line. Directly below the space between needle electrodes 1802, the treatment value at the 4.0 contour line is between approximately 4 and 5.25 depths. The intermediate row of needle electrode 1802b effectively ensures that the area between the edge electrodes 1802a and 1802c is treated, but this is considerably more expensive. Firstly, the treatment depth is even greater at the center of the electrode assembly. Secondly, the additional row of needles increases the "nail bed" phenomenon, making penetration more difficult. Thirdly, the manufacturing cost and complexity of a three-row needle electrode assembly are substantially greater than that of a two-row needle electrode assembly.

[0119] Figure 18B shows Model 1820 for a three-row needle electrode assembly with conductive spacers 1824a and 1824b between the needle electrodes 1822a, 1822b, and 1822c.

[0120] Model 1820 in Figure 18B is based on a treatment area 1826 treated with conductive spacers 1824a and 1824b between three needle electrodes 1822a, 1822b, and 1822c. Conductive spacers 1824 have substantially the same conductivity as the treatment area 1826. Conductive spacers 1824a and 1824b each have a height of approximately 80% of their width and 40% of the total width between electrodes 1822a and 1822c. A voltage pulse is applied, for example, which may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1826 directly below needle electrodes 1822a and 1822c has a treatment value up to a depth of approximately 4 at contour line 4.0. Directly below needle electrode 1822b, the therapeutic value extends to a depth of approximately 5.25 at the 4.0 contour. Directly below the space between needle electrodes 1822, the therapeutic value at the 4.0 contour is between approximately 4 and 5.25 depths. The central row needle electrode 1822b effectively ensures that the region between the edge electrodes 1822a and 1822c is treated, but the conductive spacer of this conductivity appears to have little effect on the three-row needle electrode without a conductive spacer.

[0121] Figure 18C shows Model 1840 for a combined electrode assembly, which includes needle electrodes 1842a and 1842c and surface electrode 1842b, with insulating spacers 1844a and 1844b between the needle electrodes 1842a and 1842c and the surface electrode 1842b.

[0122] Model 1840 in Figure 18C is based on a treatment area 1846 treated with two outer rows of needle electrodes 1842a and 1842c, and a central surface electrode 1842b positioned between the two rows of needle electrodes 1842a and 1842c, instead of a third row of needle electrodes. A voltage pulse may be applied, for example, with a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1846 directly below needle electrodes 1842a and 1842c has a treatment value up to a depth of approximately 2.75 at contour line 4.0. The treatment value up to a depth directly below surface electrode 1842b is approximately 3.75. Directly below the space between needle electrodes 1842a, 1842c and surface electrode 1842b, the treatment value reaches a depth of 2.75 to 3.75. The intermediate surface electrode 1842b helps distribute the treatment across the entire region between the edge electrodes 1842a and 1842c, but the distribution is not as uniform as in the case of three rows of needle electrodes.

[0123] Figure 18D shows Model 1860 for a combined electrode assembly, with a conductive spacer 1864a between the needle electrode 1862a and the surface electrode 1862b, and a conductive spacer 1864b between the needle electrode 1862c and the surface electrode 1862b.

[0124] Model 1860 in Figure 18D is based on a treatment area 1866 treated with two outer rows of needle electrodes 1862a and 1862c, and a central surface electrode 1862b positioned between the two rows of needle electrodes 1862a and 1862c, instead of a third row of needle electrodes. Conductive spacers 1864 have substantially the same conductivity as the treatment area 1866. Conductive spacers 1824a and 1824b each have a height of approximately 80% of their width and 40% of the total width between electrodes 1862a and 1862c. A voltage pulse is applied, for example, which may have a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1866 directly below needle electrodes 1862a and 1862c has a treatment value up to a depth of approximately 3.5 at contour line 4.0. The effective therapeutic value extends to a depth of approximately 4.25 directly below the surface electrode 1862b. The effective therapeutic value is at a depth of 3.5–4.25 directly below the space between the needle electrodes 1862a, 1862c and the surface electrode 1862b. This configuration provides a substantial improvement in the distribution of effective therapeutic value across the entire treatment area 1866, while also offering improvements known from eliminating the row of needle electrodes (e.g., avoiding the "nail bed" phenomenon) and reducing manufacturing costs and complexity by replacing the row of needle electrodes with a single surface electrode.

[0125] Figures 19A–19C show alternative configurations and results for an electrode assembly with surface electrodes and conductive spacers with multiple conductive zones. Regions 1908, 1928, and 1948 are insulating, as is the case with the insulating housing.

[0126] Figure 19A shows Model 1900 of an electrode assembly having surface electrodes 1902a, 1902b with conductive spacers having a first conductive zone 1904a, 1904b and a second conductive zone 1910 between the surface electrodes 1902.

[0127] Model 1900 in Figure 19A is based on a treatment area 1906 treated with a surface electrode assembly having a conductive spacer with conductive zones 1904 and 1910 between surface electrodes 1902. The conductivity of the first zone 1904 may be 10 times that of the treatment area 1906, and the conductivity of the second zone 1910 may be substantially the same as that of the treatment area 1906. The two conductive zones indicated by 1904 and 1910 are clearly depicted in this example, but in some embodiments, a stepwise change in conductivity in the conductive spacer may be used. The conductive spacer has a height of approximately 20% of its width. A voltage pulse may be applied, for example, having a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1906 directly beneath the surface electrodes 1902a and 1902b has a treatment value to a depth of approximately 3.25 at the 4.0 contour line. Directly beneath the conductive zones 1904 and 1910, the effective treatment value reaches a depth of approximately 4 mm and is substantially uniformly distributed. Referring again to Figure 16B, the conductive spacer 1624 has a height that is approximately 20% of its width and a conductivity that is approximately 10 times that of the treatment area 1626. Comparing the treatment distribution shown in Model 1620 with the distribution in Model 1900, the distribution is substantially more uniform in Model 1900, where conductive zones within the conductive spacer are used.

[0128] Figure 19B shows Model 1920 for an electrode assembly with surface electrodes 1922a, 1922b, and a conductive spacer having two conductive zones 1924a, 1924b, and 1930 between the surface electrodes 1922.

[0129] Model 1920 in Figure 19B is based on a treatment area 1926 treated with a surface electrode assembly having a conductive spacer with conductive zones 1924 and 1930 between surface electrodes 1922. The conductivity of the first zone 1924 may be 10 times that of the treatment area 1926, and the conductivity of the second zone 1930 may be substantially 0, i.e., insulating. The two conductive zones indicated by 1924 and 1930 are clearly depicted in this example, but in some embodiments, a stepwise change in conductivity in the conductive spacer may be used. The conductive spacer has a height of about 20% of its width. A voltage pulse may be applied, for example, having a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1926 directly below the surface electrodes 1922a and 1922b has a treatment value up to a depth of about 3 at contour line 4.0. Immediately below conductive zones 1924 and 1930, the therapeutic value reaches a depth of approximately 3.75. The region below conductive zones 1924 and 1930 is fairly uniformly distributed, but the region below conductive zones 1904 and 1910, shown in Figure 19A, appears to be slightly more uniformly distributed.

[0130] Figure 19C shows Model 1940 of an electrode assembly having surface electrodes 1942a, 1942b with conductive spacers having two conductive zones 1944a, 1944b, and 1950 between the surface electrodes 1942.

[0131] Model 1940 in Figure 19C is based on a treatment area 1946 treated with a surface electrode assembly having a conductive spacer with conductive zones 1944 and 1950 between surface electrodes 1942. The conductivity of the first zone 1924 may be 100 times that of the treatment area 1926, and the conductivity of the second zone 1930 may be 10 times that of the treatment area 1946. The two conductive zones 1944 and 1950 shown are clearly depicted in this example, but in some embodiments, a stepwise change in conductivity in the conductive spacer may be used. The conductive spacer has a height of approximately 20% of its width. A voltage pulse may be applied, for example, having a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 1946 directly beneath the surface electrodes 1942a and 1942b has a treatment value to a depth of approximately 3.25 at the 4.0 contour. Directly beneath the conductive zones 1944 and 1950, the treatment value at the 4.0 contour is approximately 3.75 at a depth. The areas below conductive zones 1944 and 1950 are fairly uniformly distributed, but the areas shown in Figure 19A below conductive zones 1904 and 1910 appear to be equally and uniformly distributed and may have lower costs due to the lower cost of the lower conductivity of the conductive spacers.

[0132] Figures 20A and 20B show alternative configurations and results for a three-row combination assembly. Regions 2008 and 2028 are insulating, as is the case with the insulating housing.

[0133] Figure 20A shows Model 2000 of an electrode assembly having three rows of surface electrodes 2002a, 2002b, 2002c with conductive spacers having first conductive zones 2004a, 2004b, 2004c, 2004d and second conductive zones 2010a, 2010b between the surface electrodes 2002.

[0134] Model 2000 in Figure 20A is based on a treatment area 2006 treated with a three-row surface electrode assembly having conductive spacers with conductive zones 2004, 2010 between surface electrodes 2002. The conductivity of the first zone 2004 may be 10 times that of the treatment area 2006, and the conductivity of the second zone 2010 may be substantially 0, i.e., insulating. The two conductive zones 2004, 2010 shown are clearly depicted in this example, but in some embodiments, a stepwise change in conductivity in the conductive spacers may be used. The conductive spacers have a height that is about 20% of the total width (i.e., the distance between electrodes 2002a and 2002c). The width of each conductive zone 2004 is 40% of the distance between electrodes in which the conductive spacers are placed. In other words, conductive spacer 2004a is 40% of the distance between electrodes 2002a and 2002b. For example, a voltage pulse with a peak voltage of 1kV to 15kV is applied. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2006 directly below surface electrodes 2002a and 2002c has a treatment value up to a depth of approximately 3 on the 4.0 contour line. Directly below surface electrode 2002b, there is a treatment value up to a depth of approximately 4.25 on the 4.0 contour line.

[0135] Figure 20B shows Model 2020 for a three-row electrode assembly having two outer rows of needle electrodes 2022a, 2022b and a central surface electrode 2032, and conductive spacers with first conductive zones 2024a, 2024b and second conductive zones 2030a, 2030b.

[0136] Model 2020 in Figure 20B is based on a treatment area 2026 being treated with a conductive spacer having two conductive zones 2030a, 2024a between a needle electrode 2022a and a surface electrode 2032, and a conductive spacer having two conductive zones 2030b, 2024b between a needle electrode 2022b and a surface electrode 2032. The conductivity of the first zone 2030 may be substantially 0 or insulating, and the conductivity of the second zone 2024 may be about 10 times that of the conductivity of the treatment area 2026. The two conductive zones 2024, 2030 shown are clearly depicted in this example, but in some embodiments, a stepwise change in conductivity in the conductive spacer may be used. The conductive spacer has a height that is about 20% of its total width (i.e., the distance between electrodes 2022a and 2022b). The width of each conductive zone 2024 is 40% of the distance between the electrodes in which the conductive spacer is placed. In other words, the conductive spacer 2024a is 40% of the distance between electrodes 2022a and 2032. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2026 directly below the needle electrodes 2022a and 2022b has a treatment value up to a depth of approximately 4 at the 4.0 contour line. Directly below the surface electrode 2032, the treatment value is up to a depth of approximately 4.75 at the 4.0 contour line. The treatment is uniformly distributed in this configuration, but through electrodes have the same problems as described above, and therefore surface electrode configurations such as those shown in Figures 19A, 19B, 19C, and / or 20A may be preferred.

[0137] Figures 21A–21E show alternative configurations and results for a surface assembly with a conductive spacer having recesses. Various recesses, such as geometric notches, may be similar to those of conductive spacers having conductive zones as shown and described in Figures 19A–20B. Regions 2108, 2128, 2148, 2168, and 2188 are insulating, as is the case with insulating housings.

[0138] Figure 21A shows a model 2100 of a treatment area 2106 for a surface electrode assembly, having a conductive spacer 2104 between electrodes 2102a and 2102b and surrounded by an insulator 2108.

[0139] Model 2100 is based on a treatment area 2106 treated using a geometrically molded conductive spacer 2104 between two surface electrodes 2102. The conductive spacer 2104 has a "V"-shaped recess 2116. The conductive spacer 2104 has a first height at 2110 which is 40% of the width of the conductive spacer 2104, and a second height at 2114 which is 12.5% ​​of the first height. The angle of the edge extending from the first height to the second height is 100 degrees. The conductive spacer 2104 has substantially the same conductivity as the treatment area 2106. Note that the recess 2116 acts effectively as an insulator. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. In this embodiment, the treatment area 2106 directly below the center of the conductive spacer 2104 has a treatment value up to a depth of approximately 4.25 at the 4.0 contour. Directly below the electrode 2102, the treatment value at the 4.0 contour is approximately 3.25 at a depth. The distribution of effective treatment is not as uniform as in Figure 19B, which has a conductive spacer with a conductive zone.

[0140] Figure 21B shows model 2120 of a treatment area 2126 of a surface electrode assembly having a conductive spacer 2124 between electrodes 2122a and 2122b. Area 2128 is insulating, like an insulating housing.

[0141] Model 2120 is based on a treatment area 2126 treated with a conductive spacer 2124 between two surface electrodes 2122. The conductive spacer 2124 has a “rounded V” shaped geometric notch 2136. The conductive spacer 2124 has a first height at 2130 which is 40% of the width of the conductive spacer 2124 spacer, and a second height at 2134 which is 12.5% ​​of the first height. In this example, the angle of the edge 2132 extending between the first and second heights is 90 degrees. In some embodiments, the radius of curvature of the notch in the “U” or “rounded V” shaped recess may help to smooth the electric field. Thus, the radius of curvature may be adjusted in some embodiments to produce a more uniform field throughout the treatment area. The conductive spacer 2124 is positioned between the two surface electrodes 2122. The conductive spacer 2104 has substantially the same conductivity as the treatment area 2106. Note that the recess 2116 acts effectively as an insulator. A voltage pulse may be applied, for example, with a peak voltage of up to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2126 directly beneath the conductive spacer 2124 has a treatment value up to a depth of approximately 4.25 at the 4.0 contour line. Directly beneath electrode 2122, the treatment value at the 4.0 contour line is approximately 3.25 at a depth.

[0142] Figure 21C shows Model 2140 of a surface electrode assembly with a conductive spacer 2144 between electrodes 2142a and 2142b, in a treatment area 2146. Area 2148 is insulating, like an insulating housing.

[0143] Model 2140 is based on a treatment area 2146 treated with a conductive spacer 2144 between two surface electrodes 2142. The conductive spacer 2144 has a "U"-shaped recess 2156. The conductive spacer 2144 has a first height of 40% of the width of the conductive spacer 2144 at 2150 and a second height of 12.5% ​​of the first height at 2154. The angle of the edge extending from the first height to the second height is 10 degrees. The conductive spacer 2144 has substantially the same conductivity as the treatment area 2146. Note that the recess 2156 acts effectively as an insulator. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2146 directly beneath the conductive spacer 2144 has a treatment depth of approximately 4.25 at the 4.0 contour line. Directly beneath the electrode 2142, the treatment depth at the 4.0 contour line is approximately 3.25.

[0144] Figure 21D shows model 2160 of a treatment area 2166 of a surface electrode assembly having a conductive spacer 2164 between electrodes 2162a and 2162b. Area 2168 is insulating, like an insulating housing.

[0145] Model 2160 is based on a treatment area 2166 treated with a conductive spacer 2164 between two surface electrodes 2162. The conductive spacer 2164 has a “flat V” shaped recess 2176. The conductive spacer 2164 has a first height of 40% of the width of the conductive spacer 2164 at 2170 and a second height of 12.5% ​​of the first height at 2174. The angle of the edge extending from the first height to the second height is 100 degrees. The conductive spacer 2164 has substantially the same conductivity as the treatment area 2166. Note that the recess 2176 acts effectively as an insulator. For example, a voltage pulse may have a peak voltage of 5kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2166 directly beneath the conductive spacer 2164 has a treatment depth of approximately 4.25 at the 4.0 contour line. Directly beneath the electrode 2162, the treatment depth at the 4.0 contour line is approximately 3.25.

[0146] Figure 21E shows Model 2180 of a surface electrode assembly with a conductive spacer 2184 between electrodes 2182a and 2182b, and a treatment area 2188. The area 2188 is insulating, like an insulating housing.

[0147] Model 2180 is based on a treatment area 2186 treated with a conductive spacer 2184 between two surface electrodes 2182. The conductive spacer 2184 has recesses 2196 of different "flat V" shapes. The conductive spacer 2184 has a first height of 40% of the width of the conductive spacer 2190 and a second height of 12.5% ​​of the first height in 2194. The angle of the edge extending from the first height to the second height is 10 degrees. The conductive spacer 2184 has substantially the same conductivity as the treatment area 2186. Note that the recesses 2196 act effectively as an insulator. For example, a voltage pulse may be applied that has a peak voltage of 5kV to 15kV. Approximate treatment values ​​at various depths in this example are shown by numbered contour lines as shown in Figure 12A. The treatment area 2186 directly beneath the conductive spacer 2184 has a treatment depth of approximately 4.5 at the 4.0 contour line. Directly beneath the electrode 2182, the treatment depth at the 4.0 contour line is approximately 3.25.

[0148] Figures 22A and 22B show strip electrodes on conductive spacers with different geometric shapes.

[0149] Figure 22A shows Model 2200 of the treatment region 2215 of an electrode assembly having strip electrodes 2205a, 2205b, 2205c, 2205d, 2205e, and 2205f with a conductive spacer 2210 placed on the strip electrode 2205. The conductive spacer 2210 can have substantially the same conductivity as the treatment region 2215. For example, a voltage pulse may be applied that has a peak voltage of 2kV to 20kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment region 2215 has treatment values ​​at contour line 4 for depths ranging from 5.0 to 7.0.

[0150] Figure 22B shows Model 2250 of the treatment area 2265 of an electrode assembly having strip electrodes 2255a, 2255b, 2255c, 2255d, 2255e, and 2255f with the conductive spacer 2260 positioned on the strip electrodes 2255. The conductive spacer 2260 may have geometric recesses or other recesses between the strip electrodes 2255. As shown, the recesses may be "V" shaped. The conductive spacer 2260 may have substantially the same conductivity as the treatment area 2265. A voltage pulse may be applied, for example, with a peak voltage of up to 20kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2215 has treatment values ​​at contour line 4 for depths ranging from 5.0 to 7.25. Although the range is slightly larger as shown in Figure 22B than in Figure 22A, the overall distribution of treatment appears more uniform across the treatment area 2265. Therefore, the distribution of treatment is improved when a recess, as shown in Figure 22B, is used on top of a conductive spacer without a recess, as shown in Figure 22A.

[0151] Figures 23A and 23B depict models of treatment areas using a unipolar electrode assembly.

[0152] Figure 23A shows Model 2300 of the treatment area 2306 for an electrode assembly having a unipolar electrode 2302 without a conductive spacer. For example, a voltage pulse may be applied that has a peak voltage of 1kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2306 has treatment values ​​at contour lines 4.0 up to a depth of 4.0, but because the shape is very rounded, the deepest region is only one point at the center of the treatment area.

[0153] Figure 23B shows Model 2350 of a treatment area 2356 for an electrode assembly having a monopolar electrode 2352 with a conductive spacer 2354 positioned around the monopolar electrode. In some embodiments, the conductive spacer 2354 can surround the monopolar electrode 2352 in a ring shape. A voltage pulse may be applied, for example, having a peak voltage of up to 20 kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2356 has a treatment value at contour line 4.0 up to a depth of 4.25. Note that with the conductive spacer, the treatment distribution in the treatment area 2356 is substantially less rounded and more uniformly distributed than the treatment shown in Figure 23A.

[0154] Figure 24 shows Model 2400 of a treatment area 2406 for an electrode assembly having two electrodes 2402a and 2402b and a conductive spacer 2404. The conductive spacer 2404 extends between the electrodes 2402 and is further positioned on the upper edge of the electrodes 2402 such that the conductive spacer is in direct contact with the treatment area 2406, while the electrodes 2402 are not in direct contact with the treatment area 2406. The electrodes 2402 provide treatment to the treatment area 2406 indirectly via the conductive spacer 2404. For example, a voltage pulse may be applied that has a peak voltage of 1kV to 15kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as shown in Figure 12A. The treatment area 2406 has a treatment value at contour line 4.0 up to a depth of 3.5, which is relatively consistent across the treatment area 2406.

[0155] Figure 25 illustrates another inventive concept of this disclosure by example. To optimize pulse shape, parallel resistors may be used in several electrode assemblies (e.g., treatment tips) to reduce treatment tip impedance and better match system impedance. In previous existing systems that use electrode assemblies connected to the handle of a treatment applicator to achieve this, one or more over-resistors are typically installed within the handle and, when connected to the handle, are positioned in parallel with the electrode assembly / treatment tip. The coupling of the electrode assembly to the handle portion of the treatment applicator activates the resistors within the handle portion. Such configurations add complexity to the handle portion of the treatment applicator, and in addition, in some implementations, the value of the parallel resistors within the handle portion may be limited. Using the novel configuration of this disclosure, as illustrated by the example in Figure 25, solves the above problems, can improve / simplify parts and manufacturing, and allows for custom tuning of various electrode assemblies.

[0156] Figure 25 shows a cross-sectional view of an example of a therapeutic applicator 2500 having an electrode assembly 2502 according to the present disclosure. The therapeutic applicator assembly 2500 may include a handle portion 2505 which can be releasably connected to different therapeutic tips (different electrode assemblies). A positive high voltage input HV+ of the handle portion 2505 can be coupled to the electrode 2502a of the therapeutic tip via a connector 2504a, and a negative high voltage input HV of the handle portion can be coupled to the electrode 2502b of the therapeutic tip via a connector 2504b. In this embodiment, electrodes 2502a and 2502b are shown as needle electrodes and may penetrate tissue 2506, but various configurations of the electrode assembly (penetrating and non-penetrating) may be used in different embodiments as described above. Instead of having one or more separate resistors in the handle portion, a conductive spacer 2512 located in the therapeutic tip / electrode assembly may serve a dual role and be configured to function as both a conductive spacer and a resistor 2512'. The conductive spacer / resistor 2512 / 2512' can be conductively coupled between electrode 2502a and electrode 2502b. Electrodes 2502a and 2502b may be similar to, for example, the needle electrode 425 as described with respect to Figure 4B. The conductive spacer / resistor may be a semiconductor material such as conductive plastic, allowing the conductive spacer 2512 to function as a parallel resistor.

[0157] For example, it may be desirable to have a resistance of 10-800 ohms (e.g., 10-500 ohms, 100-500 ohms, 100-400 ohms, 100-800 ohms, 150-350 ohms, 150-800 ohms, etc.). The resistance value (as parallel resistance) and the conductive spacer value (as a conductive spacer to improve treatment depth) can be adjusted by selecting the conductivity of the material and / or by changing the geometry of the conductive spacer / resistor. As mentioned above, the shape of the conductive spacer can change the shape of the treatment zone. The shape of the conductive spacer may also be used to change the value of the parallel resistance. For example, a smaller cross-sectional area results in higher resistance, and a larger cross-sectional area results in lower resistance. As an example, the tip in Figure 8A has a lower parallel resistance value than the tip in Figure 8B. Also, the smaller the distance between HV+ and HVgives, the lower the resistance. Therefore, for example, with exactly the same cross-sectional area, a smaller (e.g., 2.5 mm) treatment tip will have a lower parallel resistance than a larger (e.g., 5 mm) treatment tip. Taking the above into consideration, depending on the requirements and embodiment, the cross-sectional area can be adjusted, or the conductivity of the spacer material can be changed to optimize the dual function of the conductive spacer so that it also functions as an effective resistor. Spacer / resistors such as those described with reference to Figure 25 may be implemented in any of the other embodiments and examples of the electrode assemblies, treatment tips / treatment applicators, and electrotherapy devices of this disclosure.

[0158] In any of the methods of this disclosure, including those described with reference to Figures 10A-10B and Figure 11, the method may also include using a conductive spacer as a resistor by selecting an electrode assembly and / or conductive spacer to optimize both a desired resistance and treatment depth. Thus, the conductivity of the material and / or the geometric shape of the conductive spacer may be selected to improve treatment depth, or resistance, or both. Any such method may include adjusting the value of the conductive spacer as a resistor by changing the conductivity of the material and / or changing the geometry of the resistor. The method may also include adjusting the value of the conductive spacer to improve treatment depth by changing the conductivity of the material and / or changing the geometric shape of the conductive spacer. The method may include changing the value of parallel resistance using the shape of the conductive spacer. In various examples, the method may include using a conductive spacer as a resistor to match the impedance of an electrode assembly to the impedance of a pulse generator that generates and applies electrical energy through a replaceable electrode assembly. In some examples, the method may include using a conductive spacer to reduce the impedance of an electrode assembly. In various examples, the methods of the present disclosure may include selecting the shape of a conductive spacer to change the shape of a treatment zone or area.

[0159] Any of the methods described herein (including user interfaces) may be implemented as software, hardware, or firmware and may be described as a non-temporary computer-readable storage medium that stores a set of instructions that can be executed by a controller including one or more processors (e.g., a computer, tablet, smartphone, etc.), which, when executed by the controller / processor, controls or causes the controller / processor to perform any of the following steps, including but not limited to display, communicate with a user, analyze, modify, determine, warn, etc., parameters (including timing, frequency, intensity, etc.).

[0160] While various exemplary embodiments have been described above, several modifications can be made to these embodiments without departing from the scope of the Disclosure. For example, the order in which the steps of the various methods described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more steps of the method may be skipped entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0161] It is understood that the various embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention. For example, many of the materials and structures described herein can be replaced with other materials and structures without departing from the spirit of the invention, as will be apparent to those skilled in the art by examining this disclosure. Thus, although certain embodiments have been illustrated and described herein, any configuration calculated to achieve the same objective can be used in place of the specific embodiments shown. This disclosure is intended to cover all possible adaptations or variations of the various embodiments. Combinations of the above embodiments, or some features of the embodiments described, and other embodiments not specifically described herein will be apparent to those skilled in the art by examining the above description. Thus, the claimed invention may include variations from the specific examples and embodiments described herein. It is understood that various theories about why the invention works are not intended to limit it. Various embodiments of the subject matter of the invention, when multiple are disclosed, may be referred to herein individually or collectively by the term “invention” simply for convenience, without the intention to spontaneously limit the scope of this application to any single invention or concept of invention.

[0162] All measurements, dimensions, and materials provided herein or in the drawings are for illustrative purposes only. Where used in the specification and claims, and in the examples, all numbers, unless otherwise specified, can be read as if preceded by the words "about" or "approximately," even if the term is not explicitly indicated.

[0163] The phrases “a,” “an,” or “the” are intended to mean “one or more” unless otherwise indicated. A reference to a “first” component does not necessarily require that a second component be provided. Furthermore, a reference to a “first” or “second” component does not limit the referred component to a specific location unless expressly stated otherwise. Where a feature or element is referred to herein as “on top of” another feature or element, it may be directly on or interposed on the other feature or element. Where a feature or element is referred to as “connected,” “attached,” or “combined” to another feature or element, it should also be understood that it may be directly connected to, attached to, or combined with the other feature or element, or interposed therein. Features and elements described or shown in relation to one embodiment may be applicable to other embodiments. It will also be understood by those skilled in the art that references to structures or features positioned "adjacent" to other features may overlap with or have a portion beneath the adjacent features.

[0164] All publications referenced herein are incorporated herein by reference to disclose and describe the manner and / or materials by which the publications are cited. Publications considered herein are provided only for their disclosure prior to the filing date of this application. Nothing herein should be construed as an acknowledgment that the present invention is not given prior rights to such publications by prior art. Furthermore, the publication dates provided may differ from the actual publication dates, which may need to be independently verified.

Claims

1. An electrode assembly for delivering electrotherapy, wherein the electrode assembly comprises: A first electrode extending along a first side surface of the electrode assembly, including an electrically conductive treatment surface configured to apply electrotherapy to a treatment area and an electrically conductive non-treatment surface, A second electrode extending along a second side of the electrode assembly, the second electrode including an electrically conductive treatment surface configured to apply electrotherapy to a treatment area and an electrically conductive non-treatment surface, An electrically conductive spacer disposed between the first electrode and the second electrode, wherein the electrically conductive spacer is configured to electrically contact at least one electrically conductive non-treatment surface of the first electrode and the second electrode and the surface of the treatment area between the first electrode and the second electrode. An electrode assembly, including the electrode assembly.

2. The electrode assembly according to claim 1, wherein the electrically conductive spacer comprises one of a hydrogel, a conductive adhesive, a conductive gel, a conductive silicone, a urethane rubber, a thermoplastic resin, a thermosetting resin, or any combination thereof.

3. The electrode assembly according to claim 1 or 2, wherein the electrode assembly is mounted as a handheld device, as a catheter, as a clamp, or as a device delivered percutaneously.

4. The electrode assembly according to claim 1 or 2, wherein one side of the electrically conductive spacer is in contact with the non-treatment surface of the first electrode, and the opposite side of the electrically conductive spacer is in contact with the non-treatment surface of the second electrode.

5. The electrode assembly according to claim 1 or 2, wherein the electrically conductive spacer includes a plurality of electrically conductive zones.

6. The electrode assembly according to claim 5, wherein at least two of the plurality of electrically conductive zones have different electrical conductivity.

7. The electrode assembly according to claim 5, wherein at least one of the plurality of electrically conductive zones has substantially zero electrical conductivity.

8. The electrode assembly according to claim 1 or 2, further comprising an electrically insulating spacer between the first electrode and the second electrode.

9. The electrode assembly according to claim 8, wherein the electrically insulating spacer is positioned adjacent to the electrically conductive spacer.

10. The electrode assembly according to claim 9, wherein the electrically insulating spacer is surrounded by the electrically conductive spacer on both sides.

11. The electrode assembly according to claim 1 or 2, wherein the electrical conductivity of the electrically conductive spacer is greater than or substantially equal to the electrical conductivity of the tissue in the treatment area, and is 100 times (100x) or less the electrical conductivity of the tissue in the treatment area.

12. The electrode assembly according to claim 1 or 2, wherein the height of the electrically conductive spacer is based on the distance between the at least two electrodes.

13. The electrode assembly according to claim 1 or 2, wherein the first electrode and the second electrode include a bipolar electrode or a unipolar electrode.

14. The electrode assembly according to claim 1 or 2, wherein the first electrode and the second electrode include a surface electrode, a through electrode, or a combination of a surface electrode and a through electrode.

15. The electrode assembly according to claim 1 or 2, wherein the electrically conductive spacer has an electrical conductivity and / or geometric shape configured to allow the electrically conductive spacer to also function as a resistor.

16. The electrode assembly according to claim 1 or 2, wherein the electrically conductive spacer includes at least one recess.

17. An electrotherapy device, A therapeutic applicator configured to be coupled to one of several interchangeable electrode assemblies, An electrotherapy device comprising a plurality of interchangeable electrode assemblies, each according to claim 1.

18. The electrotherapy apparatus according to claim 17, further comprising a pulse generator, wherein the electrically conductive spacer is configured to match the impedance of one of the plurality of interchangeable electrode assemblies to the impedance of the pulse generator.

19. Further comprising a controller configured to execute an instruction, which, upon execution, has the following: The characteristics of the electrically conductive spacer are determined at least partially based on the instructions for the electrode assembly; and Based at least partially on the characteristics of the electrode assembly and the electrically conductive spacer, the treatment configuration information is selected. The electrotherapy device according to claim 17 or 18.

20. The electrotherapy device according to claim 19, wherein the treatment configuration includes treatment parameters, the treatment parameters include one or more of the following: the type of tissue to be treated using the electrode assembly, the duration of treatment, the depth of treatment, the voltage field, the duration of pulses, the pulse frequency, and the number of pulses.

21. The electrotherapy device according to claim 19, wherein the instruction for the electrode assembly includes at least one of the size of the electrode assembly, the type of the electrode assembly, the number of electrodes, or the model number of the electrode assembly.

Images