Conductive spacer in electrode assembly of electric treatment device

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, entitled “CONDUCTIVE SPACER IN AN ELECTRODE ASSEMBLY OF AN ELECTRICAL TREATMENT APPARATUS,” filed April 13, 2021, which is incorporated by reference in its entirety for all purposes.

[0002] FIELD OF THEINVENTION Described herein are electrode assemblies (e.g., electrical applicator tips) that may be preferentially used to apply high voltage ultrashort electrical pulses, such as nanosecond pulses, to treat a patient. More specifically, described herein are electrode assemblies having conductive spacers and methods of using them for electrical treatment to distribute the electrical treatment more uniformly to the treatment area. [Background technology]

[0003] Electrical therapy treatment, particularly ultrashort, high field strength electrical pulses, sometimes described as nanosecond pulsed electric field (nsPEF) treatment, 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 therapy treatments are often delivered using electrode assemblies (e.g., treatment tips) that incorporate either surface electrodes, which are placed over the treatment area without penetrating tissue, or needle electrodes, which penetrate tissue. A voltage is applied between the electrodes to induce an electric field in the treatment area, damaging cells in the treatment area. Current electrode assemblies that incorporate surface electrodes do not effectively distribute the electrical therapy to the treatment area between the electrodes. Needle electrodes distribute the electrical therapy more effectively. However, needle electrodes are more uncomfortable for the patient. Summary of the Invention

[0005] To distribute electrical therapy to a treatment area of ​​a patient, one general aspect includes an assembly for delivery of electrical therapy. The electrode assembly can include a conductive spacer and at least two electrodes. Each electrode can include a conductive treatment surface configured to apply electrical therapy to the treatment area and a conductive non-treatment surface. The conductive non-treatment surface can be configured to contact the conductive spacer. The conductive spacer is disposed between at least two of the electrodes and configured to electrically contact a surface of the treatment area between the electrodes.

[0006] The electrode assembly of the present disclosure may be implemented as a handheld device, as a catheter, or as other percutaneously delivered devices. Implementations 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 thermoset, a thermoplastic, 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 ten 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 is 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 greater than or equal to twenty percent (20%) of the distance between the electrodes and less than or equal to fifty percent (50%) 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, for example, between 20% and 60% of the distance, including between 30% and 50% of the distance between at least two electrodes.

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

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

[0013] In some embodiments, at least one or more of the electrodes are surface electrodes. In some embodiments, at least one or more of the electrodes are penetrating electrodes, such as needle, blade, or knife electrodes. In some examples, at least one or more of the electrodes comprise a combination of non-penetrating (e.g., surface) and penetrating electrodes.

[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, with the length of the conductive spacer being 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 which may have a different conductivity.

[0017] In some embodiments, the conductive spacer can include a recess, e.g., a geometric cutout. In further implementations and examples, the conductive spacer can include a semiconductor material and can be configured to act / function as both a conductive spacer and a resistor. In various examples, the conductive spacer can have a conductivity or a geometry, or both, configured to allow the conductive spacer to also function as a resistor. For example, in any of the embodiments and examples of the electrode assembly, treatment tip, electrotherapy device, and / or method of the present disclosure, the conductive spacer can be configured to act as a parallel resistor, e.g., 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 can be configured to reduce the impedance of the electrode assembly, for example.

[0018] According to one general aspect of the present disclosure, an electrical therapy device is provided. The device may include a plurality of replaceable electrode assemblies and a treatment applicator configured to be coupled to one of the plurality of replaceable electrode assemblies. Each of the plurality of electrode assemblies may include at least two electrodes, each electrode having a conductive treatment surface configured to apply electrical therapy to a treatment area of ​​a subject and a conductive non-treatment surface configured to contact a conductive spacer. The conductive spacer may be disposed between the at least two electrodes, where the conductive spacer is configured to electrically contact a surface of the treatment area of ​​the subject 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 having conductivity to achieve both of these two functions.

[0019] Another general aspect includes a method of administering, for example, electrical therapy to a patient. The method of administering electrical therapy can, in some implementations, include placing an electrode assembly including at least two electrodes and a conductive spacer disposed between two of the electrodes on the treatment area such that a conductive treatment surface of each of the electrodes is in electrical contact with the treatment area and the conductive spacer is in electrical contact with a surface of the treatment area between the electrodes. The treatment also includes applying a voltage to the treatment area via the electrodes. In some examples, administering electrical therapy can be for cosmetic indications, for example to improve the appearance of the treatment area.

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

[0021] In some embodiments, selecting an 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, hi 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, selecting the electrode assembly is further based at least in part on the size of the electrode assembly and / or the size of the treatment area.

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

[0024] In some embodiments, the method may include selecting a voltage to be applied to the treatment area based at least in part on the conductivity of the conductive spacer. In some embodiments, the method may include selecting an electrode assembly based at least in part on the conductivity of the conductive spacer. In various examples, the method may include using the 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 replaceable electrode assembly. In some examples, the method may include using the conductive spacer to reduce the impedance of the electrode assembly. In some examples, the method may include selecting the electrode assembly and / or the conductive spacer based on the conductivity of the material of the conductive spacer, or the shape, or both the conductivity of the material and the shape. Also, the conductivity of the material and / or the shape of the conductive spacer may be selected to improve the treatment depth, or the resistance value, or both. In various examples, the method may include selecting a shape of the conductive spacer to change the shape of the treatment zone or region. The method may also include using the shape of the conductive material to change the value of the parallel resistance.

[0025] Yet another general aspect of the present disclosure includes an electrical therapy device. According to some examples, the electrical therapy device includes a treatment applicator configured to be coupled to a replaceable electrode assembly (such a replaceable electrode assembly may be referred to as, for example, a treatment tip) and may further include a display device in some examples. Each of the replaceable electrode assemblies is configured to be coupled to and detached from the treatment applicator. Each replaceable electrode assembly includes at least two electrodes and a conductive spacer disposed between the electrodes to apply electrical therapy to a treatment area of ​​a subject (e.g., a patient). The electrical therapy 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, may optionally display configuration information on the display device based on the conductive spacer of the replaceable electrode assembly. Other modes of informing a 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 electrical treatment parameters for the treatment area based at least in part on the indication of one of the plurality of replaceable electrode assemblies.

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

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

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

[0029] In various examples, the method may include using the 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 may include using the conductive spacer to reduce the impedance of the electrode assembly. In some examples, the method may include selecting the electrode assembly and / or the conductive spacer based on the conductivity of the material of the conductive spacer, or the shape, or both the conductivity of the material and the shape. The conductivity of the material and / or the shape of the conductive spacer may also be selected to improve the treatment depth, 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 region. 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 treatment depth.

[0030] Other features and advantages of the disclosed apparatus and methods will become apparent from the following detailed description of various implementations. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 illustrates a nanosecond pulse generator according to some embodiments. [Diagram 2] FIG. 2 shows an electrode assembly having a surface electrode according to some embodiments. [Figure 3A] 3A shows an exposed view of a portion of some example configurations of the electrode assembly of FIG. [Figure 3B] 3B shows an exposed view of a portion of some example configurations of the electrode assembly of FIG. [Figure 4A] FIG. 4A illustrates a replaceable electrode assembly according to some embodiments. [Figure 4B]FIG. 4B shows an electrode assembly having needle electrodes, according to some embodiments. [Figure 4C] FIG. 4C shows a proximal end view of a replaceable electrode assembly according to some embodiments. [Figure 5A] FIG. 5A shows a replaceable electrode assembly prior to coupling with a handle portion of a treatment applicator, according to some embodiments. [Figure 5B] FIG. 5B shows the replaceable electrode assembly of FIG. 5A after it has been coupled with a handle portion. [Figure 6A] FIG. 6A illustrates an exemplary balloon catheter electrode assembly according to some embodiments. [Figure 6B] FIG. 6B illustrates an example of a percutaneous needle electrode assembly. [Figure 6C] FIG. 6C shows an embodiment of a percutaneous needle electrode assembly. [Figure 7A] FIG. 7A shows a cross-sectional view of an example electrode assembly having a surface electrode according to some embodiments. [Figure 7B] FIG. 7B shows a cross-sectional view of an example electrode assembly having a surface electrode according to some embodiments. [Figure 8A] FIG. 8A shows a cross-sectional view of an example of an electrode assembly having needle electrodes, according to some embodiments. [Figure 8B] FIG. 8B shows a cross-sectional view of an example of an electrode assembly having needle electrodes, according to some embodiments. [Figure 9A] FIG. 9A shows a cross-sectional view of an example of an electrode assembly having a needle electrode and a central surface electrode, according to some embodiments. [Figure 9B] FIG. 9B shows a cross-sectional view of an example of an electrode assembly having a needle electrode and a central surface electrode, according to some embodiments. [Figure 9C] FIG. 9C shows a perspective view of an exemplary electrode assembly having a needle electrode and a central surface electrode, according to some embodiments. [Figure 10A] FIG. 10A illustrates a method for delivering electrical therapy, according to some embodiments. [Figure 10B] FIG. 10B illustrates a method for selecting an electrode assembly and parameters for electrical therapy, according to some embodiments. [Figure 11] FIG. 11 illustrates a method for configuring a pulse generator to deliver electrical therapy, according to some embodiments. [Figure 12A] FIG. 12A shows an exemplary model of a treatment area of ​​a surface electrode assembly with an insulating spacer. [Figure 12B] FIG. 12B shows an exemplary model of a treatment area of ​​a surface electrode assembly with a conductive spacer, according to some embodiments. [Figure 13A] FIG. 13A shows an exemplary model of a treatment area of ​​another surface electrode assembly having an insulating spacer. [Figure 13B] FIG. 13B shows an exemplary model of a treatment area of ​​another surface electrode assembly having a conductive spacer, according to some embodiments. [Figure 14A] FIG. 14A shows an exemplary model of a treatment area for a surface electrode assembly having a conductive spacer with a height that is 10% of its width, according to some embodiments. [Figure 14B] FIG. 14B shows an exemplary model of a treatment area for a surface electrode assembly having a conductive spacer with a height that is 20% of its width, according to some embodiments. [Figure 14C] FIG. 14C shows an exemplary model of a treatment area for a surface electrode assembly having a conductive spacer with a height that is 30% of its width, according to some embodiments. [Figure 14D] FIG. 14D shows an exemplary model of a treatment area for a surface electrode assembly having a conductive spacer with a height that is 40% of its width, according to some embodiments. [Figure 14E] FIG. 14E shows an exemplary model of a treatment area for a surface electrode assembly having a conductive spacer with a height that is 50% of its width, according to some embodiments. [Figure 15]FIG. 15 shows a graph of the change in value as the height of the conductive spacer increases, according to some embodiments. [Figure 16A] FIG. 16A shows a model of a treatment area for a surface electrode assembly having a conductive spacer with a conductivity similar to that of the treatment area, in accordance with some embodiments. [Figure 16B] FIG. 16B shows a model of a treatment area for a surface electrode assembly having a conductive spacer with a conductivity about 10 times that of the treatment area, according to some embodiments. [Figure 16C] FIG. 16C shows a model of a treatment area for a surface electrode assembly having a conductive spacer with a conductivity about 100 times that of the treatment area, according to some embodiments. [Figure 16D] FIG. 16D shows a model of a treatment area for a surface electrode assembly having a conductive spacer with a conductivity about 1000 times that of the treatment area, according to some embodiments. [Figure 17] FIG. 17 shows a graph of the change in value as the conductivity of the conductive spacer increases, according to some embodiments. [Figure 18A] FIG. 18A shows a model of the treatment area for a triple-row needle electrode assembly with insulating spacers. [Figure 18B] FIG. 18B shows a model of a treatment area for a triple-row needle electrode assembly with conductive spacers, according to some embodiments. [Figure 18C] FIG. 18C shows a model of the treatment area for an electrode assembly with two rows of needle electrodes and a central surface electrode, with an insulating spacer. [Figure 18D] FIG. 18D shows a model of a treatment area for an electrode assembly with two rows of needle electrodes and a central surface electrode with a conductive spacer, according to some embodiments. [Figure 19A] FIG. 19A shows a model of a treatment area for an electrode assembly with surface electrodes having a conductive spacer with two conductive zones, one ten times larger than the other, according to some embodiments. [Figure 19B]FIG. 19B shows a model of a treatment area for an electrode assembly with a surface electrode having a conductive spacer with two conductive zones, one of which is insulating, according to some embodiments. [Figure 19C] FIG. 19C shows a model of a treatment area for an electrode assembly with surface electrodes having a conductive spacer with two distinct conductive zones, according to some embodiments. [Figure 20A] FIG. 20A shows a model of a treatment area for an electrode assembly with three surface electrodes having a conductive spacer with different conductive zones between the electrodes, according to some embodiments. [Figure 20B] FIG. 20B shows a model of a treatment area for an electrode assembly with needle and surface electrodes having a conductive spacer with different conductive zones, according to some embodiments. [Figure 21A] FIG. 21A shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21B] FIG. 21B shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21C] FIG. 21C shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21D] FIG. 21D shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 21E] FIG. 21E shows a model of the treatment area of ​​an electrode assembly having recesses of various shapes in the conductive spacer. [Figure 22A] FIG. 22A shows a model of a treatment area of ​​an electrode assembly having strip electrodes disposed on a conductive spacer, according to some embodiments. [Figure 22B] FIG. 22B shows a model of a treatment area of ​​an electrode assembly having a strip electrode disposed on a conductive spacer, according to some embodiments. [Figure 23A]FIG. 23A shows a model of the treatment area for an electrode assembly having a monopolar electrode. [Figure 23B] FIG. 23B illustrates a model of a treatment area for an electrode assembly having a monopolar electrode with a conductive spacer, according to some embodiments. [Figure 24] FIG. 24 shows a model of a treatment area for an electrode assembly having two electrodes with a conductive spacer, according to some embodiments. [Diagram 25] FIG. 25 shows an exemplary cross-sectional view of an electrode assembly portion of a treatment applicator, according to some embodiments, where a conductive spacer in the electrode assembly is configured to act both as a conductive spacer and as a parallel resistor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] It has been shown that electrical therapy, such as nsPEF therapy, can be used to cause unwanted cells, such as tumor cells and lesions, to undergo apoptosis, programmed cell death, among others. Tests have shown that such lesions and tumors can shrink to the point of being non-existent after treatment. Drugs may not be necessary. It has also been shown that the subject's immune system can be stimulated to attack all similar unwanted cells, such as tumor cells, including cells of tumors that are not in the nsPEF-treated tumor.

[0033] "Tumor" includes any neoplasm or abnormal, unwanted growth of tissue on or in a subject. A tumor may include a collection of one or more cells that exhibit abnormal proliferation. There are many types of tumors. Malignant tumors are cancerous, premalignant tumors are precancerous, and benign tumors are noncancerous. Examples of tumors include benign prostatic hyperplasia (BPH), uterine fibroids, psoriasis, seborrheic keratosis, warts, seborrheic hyperplasia, pancreatic carcinoma, liver carcinoma, kidney carcinoma, colon carcinoma, basal precellular carcinoma, melanoma, and Barrett's esophagus-associated tissue, to name just a few.

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

[0035] The disclosed instruments, systems, and methods involve the application of brief, high field strength electrical pulses for improved treatment of a variety of conditions, disorders, and diseases while minimizing or avoiding the risk of damaging non-target tissue.

[0036] Pulse lengths of less than 1000 nanoseconds have been specifically investigated as being effective in stimulating an immune response. Pulse lengths of about 10 to 1000 nanoseconds are of particular interest in that they are long enough to deliver enough energy to be effective at low pulse numbers, yet short enough to be effective in the desired manner.

[0037] In general, applying the therapy may include applying sub-microsecond electrical pulses. For example, applying the sub-microsecond electrical pulses may include applying a train of electrical pulses having a pulse width of 0.1 nanoseconds (ns) to 1000 nanoseconds (ns). In some variations, applying the sub-microsecond electrical pulses includes applying a train of nanosecond electrical pulses having a peak voltage of, for example, less than 1 kilovolt per 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 the sub-microsecond electrical pulses may include applying a train of sub-microsecond electrical pulses at a frequency of 0.1 (Hz) to 10,000 Hz. In other applications, other pulse frequencies and widths may be used. For example, microsecond or slower electrical pulses may be used. Additionally, the use of the conductive spacers described herein may be used in any electrical therapy treatment where an improvement in the electric field between the electrodes is desired. Thus, the present disclosure is not limited to only pulsed techniques, but may also be applied to, for example, radio frequency techniques.

[0038] Various therapeutic instruments including electrodes are known. In some of these instruments, multiple spaced apart electrodes are used. In other embodiments, an insulating spacer is placed between the electrodes. The insulating spacer may be used to avoid arcing and other problems that may result from current flowing through areas other than the tissue to be treated. Although surface electrodes offer improved safety, less risk of infection, and are preferred by both physicians and patients over penetrating electrodes (e.g., needle, blade, knife electrodes) that must puncture the skin or other tissue to be treated, surface electrodes with insulating spacers may not provide sufficient therapeutic value at the desired depth within the treatment area between the electrodes. Thus, needle electrodes are often more effective. However, for larger treatment areas, larger electrode assemblies are typically 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 with increasing the number of needle electrodes is that the insertion force required to drive all the needles into the skin increases. As a result, it may be difficult to push the needles in, and a "nail bed" phenomenon may occur where the needles do not penetrate the skin or otherwise result in insufficient needle penetration. Furthermore, even with needle electrodes it is difficult to effectively distribute electrical therapy to the treatment area.

[0039] To address these issues and provide a distributed, effective treatment in the treatment area that can reach sufficient depth and provide a safer alternative with fewer penetrating electrodes, new electrode assemblies are disclosed herein that include conductive spacers between the electrodes rather than insulating spacers. The use of such conductive spacers allows for a more consistent treatment depth in the treatment area while limiting the need for needle electrodes. Furthermore, even when needle electrodes are used, the conductive spacers can be used to reduce the need for additional rows of needles and / or some needles in a row. The conductive spacers in these treatments effectively prevent arcing between the electrodes and do not impede treatment, but rather improve it.

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

[0041] A human operator may input pulse number, amplitude, pulse duration and frequency information, for example, into a numeric keypad or touch screen of the interface 104. The interface 104 may provide the operator with information regarding the treatment, including configuration information for the user to view and adjust, as well as providing treatment values ​​and information during administration of the treatment. In some embodiments, the pulse width may be varied. A controller 107 in the housing 105 sends signals to the pulse control elements in the nsPEF system 100. The controller may be any suitable computing device that includes a memory for storing instructions and a processor for executing instructions. In some embodiments, a fiber optic cable allows for the transmission of control signals while simultaneously electrically isolating the contents of the metal cabinet with the high voltage circuitry of the nsPEF generation system 100 from the outside. To further isolate the system, the system 100 may be battery powered rather than wall outlet.

[0042] FIG. 2 shows a portion of an electrode assembly 200 according to some embodiments. In some embodiments, the electrode assembly 200 may be coupled to a handle of a treatment applicator, such as the treatment applicator 102. In some embodiments, the electrode assembly (such as the electrode assembly / treatment applicator 102) may be replaceable such that a different electrode assembly may be removably coupled to the handle. The replaceable electrode assembly may be disposable (e.g., the penetrating electrodes may be discarded after use) or may be reusable (e.g., the 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 electrical treatment device. The electrode assembly 200 may include an insulating housing 205 that may be coupled to a housing 210. In some embodiments, the insulating housing 205 and the housing 210 are a single piece, for example of molded plastic. The insulating housing 205 may be made of any suitable insulating material, such as, for example, plastic. The electrode assembly 200 also includes two surface electrodes 215 (shown as 215 a and 215 b ) 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 FIG. 18A, three rows of through electrodes are included, and in other examples, various numbers of electrodes may be provided. In some embodiments, the electrodes 215 are bipolar, such that one is negatively charged and the other is positively charged such that current flows between the two electrodes 215. The bipolar configuration may be used with additional electrodes. Additionally, while FIG. 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 monopolar electrodes such that current flows between the electrode and a return pad that is placed on the patient. The electrodes 215 may be, for example, about 1 millimeter wide (or thick) as measured on the side 225 (width of electrode 215a or 215b) and, for example, 5 millimeters long as measured on the side 230 (length of electrode 215a or 215b). The electrodes 215 may be made of any suitable conductive material, such as, for example, stainless steel, graphite, precious metals (e.g., gold, silver, platinum), copper, titanium, brass, or any other suitable material. The electrodes 215 may have a height that is not visible in this view as it extends into the insulating housing 205, but is shown in more detail in a later view. The electrodes 215 are positioned substantially parallel to one another at a fixed distance apart. For example, in a five millimeter by ten millimeter (5 mm x 10 mm) electrode assembly, the electrodes 215 are positioned 10 mm apart and have a length of 5 mm. In a 5 mm x 5 mm electrode assembly, the electrodes 215 are positioned 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 x 1.5 mm, 10 mm x 10 mm, 10 mm x 1.5 mm, 20 mm x 1 mm, etc. Furthermore, other configurations of electrodes 215 may include ring electrodes surrounding a central electrode, non-uniformly distributed electrodes, arrays of electrodes, etc. In addition, although surface electrodes are depicted in Figure 2, any type of electrode may be used including, for example, penetrating electrodes, catheter electrodes, clamp electrodes (e.g., parallel cardiac clamps or laparoscopic clamps), Barrett's esophagus devices, percutaneous needle electrodes, balloon electrodes, balloon catheter electrodes, etc.

[0044] The conductive spacer 220 is disposed between the electrodes 215a and 215b. The conductive spacer 220 can be made of any suitable conductive material having a desired conductivity for the conductive spacer 220. For example, the conductive spacer 220 may be made of a hydrogel, a conductive adhesive, a conductive gel, a conductive silicone, a urethane rubber, a carbon nanotube, a thermoplastic resin, a thermoset 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 conductivity as the treatment area of ​​the skin or tissue being treated, or may be up to about 100 times (100x) the conductivity of the treatment 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 conductivities and / or there may be a gradient of conductivity within the conductive spacer 220, as in the examples shown in Figures 19A, 19B, 19C, 20A, and 20B. The results of various conductivities are described with respect to Figures 12A-20B. The consistency of the conductive spacer 220 may be solid, compressible, or gelatinous, while being firm enough to maintain its shape and position within the electrode assembly 200. The conductive spacer 220 may contact the electrodes 215 to have a width of the distance between two electrodes 215, or in some embodiments, the distance between two rows of electrodes (e.g., rows of needle electrodes). 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 similar to the length of the electrodes 215. For example, if the electrode 215 has a length (measured on the side 230) of 5 mm, then the conductive spacer 220 may also have a length of 5 mm. The bottom of the conductive spacer 220 may be substantially flush with the bottom of the surface electrode 215 such that both the conductive spacer 220 and the surface electrode 215 contact the treatment area. In some embodiments, the conductive spacer 220 may extend into the insulating housing 205.In other words, the conductive spacer 220 and the electrode 215 may have conductive portions within the insulating housing 205 such that only a portion of the conductive spacer 220 and the electrode 215 are exposed.

[0045] The exposed surfaces of the conductive spacer 220 and the electrode 215, in some embodiments, are substantially flush with the opening in 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] 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 discovered that varying the shape or geometry of the conductive material, such as the conductive spacer between the electrodes, can help increase the field penetration and can also homogenize the treatment zone to make it more uniform. As shown in FIG. 3A, the conductive spacer 220a is substantially the same height as the electrode 215. In FIG. 3B, an alternative embodiment of the conductive spacer 220b includes a recess or notch such that the height of the conductive spacer 220b varies relative to the recess. In FIG. 3B, the recess is in the shape of a triangle with an angle, and the angle can vary in various embodiments. The recess in the conductive spacer may be varied in shape and size (and may be formed as a notch of various geometric shapes in some instances) to affect a more uniformly distributed treatment in some embodiments, as described in more detail herein. However, the shape of the recess is not limited to any geometric shape and can be formed in any suitable manner and does not require cutting out a portion of the spacer material. In some embodiments, the electrodes 215 may extend further into an insulating housing, such as the insulating housing 205, or may have insulating material wrapped around the electrodes 215, such that the conductive exposed portion of the electrodes 215 is flush with the conductive spacer 220 that is in contact with the electrodes 215. In some embodiments, the electrodes 215 may be coupled to a conductor in the insulating housing 205 or elsewhere in the electrode assembly 200. The height of the conductive spacer 220 may be selected, for example, based on the distance between the electrodes 215. For example, a conductive spacer 220 height that is about 10%-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 thus the height of the conductive spacer 220 may be about 10%-50% of the width of the conductive spacer 220. A conductive spacer 220 height of up to about forty percent (40%) of the distance between the electrodes 215 may 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 be 4 mm in height. The conductive spacer 220 and treatment surface of the electrode 215 may be placed on the surface of the treatment area 300, which may include the skin or other tissue containing the heart, liver, or any other cell or tissue type to which treatment is to be applied.

[0047] FIG. 4A shows a side view of one example of a replaceably / removably 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 view). Protruding from the proximal end of the electrode assembly 400 is a connector 415 that electrically connects the electrode (not shown in this view) to a pulse generator to apply electrical therapy to a 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 a handle of a treatment applicator.

[0048] FIG. 4B shows a diagram of 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 may have a cross-section of any shape, such as circular or elliptical. The needle electrode 425 extends from a distally facing (e.g., tissue facing) end. The needle electrode 425 may penetrate the patient's skin or tissue to apply electrical therapy to the treatment area. The needle electrode 425 may have a sharpened, beveled distal end, and in some embodiments may be a cylindrical needle. The conductive spacer 430 may be substantially the same as the conductive spacer 220. The conductive spacer 430 contacts 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 contacts the exposed conductive surface of the needle electrode 425. The needle electrode 425 may advance into the tissue until the conductive spacer 220 contacts the surface of the treatment area (e.g., skin or tissue). Although the replaceable electrode assembly 400 depicts a needle electrode 425, as described throughout this disclosure, plate or surface electrodes, such as the surface electrode 215, or a combination of surface and needle electrodes may be used in the replaceable electrode assembly 400.

[0049] 4C shows the proximal end of the replaceable electrode assembly 400. The mechanical connector 420 may snap or latch onto a handle (e.g., handle 114 of FIG. 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 electrically mate with electrical connectors in the handle. This proximal end may mate with the handle to provide both a mechanical and electrical connection between the replaceable electrode assembly 400 and the handle.

[0050] Within the replaceable electrode assembly housing 410, in some embodiments, the electrodes may form part of an electrode assembly that is coupled to the electrode assembly housing 410, such that the electrodes are locked in place relative to the insulative housing 405 and the electrode assembly housing 410.

[0051] The electrode assemblies described herein may be of a variety of different sizes and configurations that may be used in multiple indications. For example, the size (e.g., diameter) of the treatment area on the distal face of the device may vary (e.g., from about 1 mm to 150 mm or more) and may be any suitable shape (e.g., rectangular, circular, triangular, oval, etc.). The electrodes used may be penetrating electrodes, surface electrodes, or combinations thereof. The conductive surfaces of the electrodes that contact the treatment area may be of any suitable size and are described in more detail with respect to Figures 6-8. A portion of the electrode may be surrounded by an insulating material and a portion of the electrode may be in contact with a conductive spacer. Any portion of the electrode that contacts the conductive spacer extending from an insulating housing or the like may be adjusted as needed to apply the treatment as described herein.

[0052] A replaceable electrode assembly (e.g., a disposable or reusable electrode assembly) is generally configured to mate with a disposable or reusable handle. Figures 5A and 5B show a mechanical and electrical connection between a replaceable electrode assembly 500 and a portion of a handle 505. A connector 510 (shown as an example 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] FIG. 6A shows another example of an implementation of an electrode assembly with a conductive space for percutaneous applications. 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 that includes a first zone 615, a second zone 620, and another first zone 615. The first zone 615 can have a first conductivity and the second zone 620 can have a second conductivity. In some embodiments, the second zone 620 can be an insulating zone.

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

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

[0056] 7A shows a cross-sectional view 700 of a surface electrode assembly 705 applying treatment to a treatment area 710. Treatment area 710 may be any suitable treatment area including, for example, skin or a tissue surface bearing 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 out from the housing 725. In some embodiments, the surface electrode 715 and the conductive spacer 720 may be embedded within the housing 725 such that contact with the treatment area 710 is achieved by drawing tissue from the treatment area 710 into the housing 725. Such a configuration may be used throughout any of the electrode assemblies described herein.

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

[0059] As shown, when a voltage is applied across the surface electrodes 715 (e.g., 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 serve to conduct a portion of the current from the energy pulse based on the second surface 735 of the surface electrode 715 contacting the conductive spacer 720. The conductivity of the material allows the energy pulse to be directed to the treatment area 710 between the surface electrodes 715 and deeper into the treatment area 710. Such a result is illustrated with respect to the model shown by way of example in FIGS. 12A-18D.

[0060] FIG. 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, a conductive spacer 760 includes a recess 780. A surface 745 of the conductive spacer 760 between the two electrodes 715 contacts the surface of the treatment area 710. The conductive spacer 760 includes a first portion 765 as shown. The first portion 765a is disposed between the surface 735a of the electrode 715a and dashed line "A", and the first portion 765b is disposed between the surface 735b of the electrode 715b and dashed line "D". The first portion 765a has a first height such that an edge having a first height of the conductive spacer 760 contacts the conductive surface of the electrode 715. The conductive spacer 760 includes a second portion 775 between dashed lines "B" and "C". The second portion 775 has a second height that is less than the first height. The second portion 775 may have an edge that is radial as shown in FIG. 7B, an edge that is flat as depicted in FIG. 21D, or a tip as depicted in FIG. 21A. The conductive spacer 760 includes third portions 770, each of which includes an angled edge 785 that extends from a first height at the first portion 765 to a second height at the second portion 775 and defines a recess 780 (e.g., a "rounded V" notch). As shown, the third portion 770a has an angled edge 785a that extends from a first height at the first portion 765a to a second height at the second portion 775, and the third portion 770b has an angled edge 785b that extends from a first height at the first portion 765b to a second height at the second portion 775. The recesses 780 shown are exemplary, as any shape or size can be used to modify the shape of the conductive spacer 760.

[0061] 8A illustrates a cross-sectional view 800 of an example of a needle electrode assembly 705 having a piercing electrode that applies electrical treatment to a patient's treatment area 810. Treatment area 810 may be any suitable treatment area including, for example, skin or tissue surface having a tumor, lesion, or other undesirable condition.

[0062] Needle electrode assembly 805 may be similar to electrode assembly 400. Needle electrode assembly 805 may include a needle electrode 815, a conductive spacer 820, and an insulating housing 825. Needle electrode 815 may be substantially similar to needle electrode 425. Conductive spacer 820 may be substantially similar to conductive spacer 430. Insulating housing 825 may be substantially similar to insulating housing 405.

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

[0064] As shown, when a voltage is applied across the needle electrodes 815 (e.g., 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 contacting 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 deeper into the treatment area 810. Such results are illustrated with respect to the models shown in FIGS. 12A-22B.

[0065] FIG. 8B illustrates an alternative cross-sectional view 850 of a needle electrode assembly having a piercing electrode that applies electrical therapy to a treatment area 810 of a patient. In the cross-sectional view 850, a conductive spacer 860 includes a recess 880. A surface 845 of the conductive spacer 860 between the two electrodes 815 contacts the surface of the treatment area 810. The conductive spacer 860 includes a first portion 865 as shown. The first portion 865a is disposed between a surface 835a of the electrode 815a and dashed line "A", and the first portion 865b is disposed between a surface 835b of the electrode 815b and dashed line "D". The first portion 865 has a first height such that an edge having a first height of the conductive spacer 860 contacts the conductive surface of the electrode 815. The conductive spacer 860 includes a second portion 875 between dashed lines "B" and "C". The second portion 875 has a second height that is less than the first height. The second portion 875 can have a pointed edge as shown in Figures 8B and 21A, a flat edge as shown in Figures 21D and 21E, or a radiused edge as shown in Figures 21B and 21C. The conductive spacer 860 includes third portions 870, each of which extends from a first height at the first portion 865 to a second height at the second portion 875 and includes an angled edge 885 that defines a recess 880 (e.g., a "V" notch). As shown, the third portion 870a has an angled edge 885a that extends from the first height at the first portion 865a to the second height at the second portion 875, and the third portion 870b has an angled edge 885b that extends from the first height at the first portion 865b to the second height at the second portion 875. The illustrated recesses 880 are exemplary; recesses of any shape or size can be used to modify the shape of the conductive spacers 860 .

[0066] 9A illustrates an exemplary cross-sectional view 900 of a multiple electrode assembly 905 that applies treatment to a patient's treatment area 910. Treatment area 910 may be any suitable treatment area including, for example, skin or a tissue surface bearing 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, including through electrodes, catheter electrodes, surface electrodes, or any other type of electrodes. For example, in some embodiments, the central electrode may be a needle electrode and the outer electrode may be a surface electrode in the shape of a ring surrounding the central electrode. As 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 still other embodiments, the central electrode and the outer electrode may be the same type, including through electrodes, surface electrodes, catheter electrodes, or any other type of electrodes. The needle electrodes 915a, 915b may be substantially the same as the needle electrodes 425. The central surface electrode 950 may be substantially the same as the surface electrode 215. The conductive spacers 920a, 920b may be substantially the same as the conductive spacer 220.

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

[0069] As shown, when a voltage is applied across electrodes 915a, 915b, 950 (e.g., electrodes 915a and 915b may have a positive charge and electrode 950 may have a negative charge, or vice versa), an energy pulse is applied to the treatment area 910. The conductive spacer 920 can serve to conduct a portion of the current from the energy pulse based on the second surface 935 of the needle electrode 915 contacting the conductive spacer 920 and the second surface 955 of the surface electrode 950 contacting 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 deeper into the treatment area 910. Such a result is illustrated with respect to the models shown in FIGS. 12A-22B.

[0070] FIG. 9B illustrates an alternative exemplary cross-sectional view 970 of a composite electrode assembly 975 that applies treatment to a treatment area 910. In the cross-sectional view 970, conductive spacers 980a, 980b include recesses 985a, 985b, respectively. Each conductive spacer 980 may be similar to conductive spacer 860 of FIG. 8B or conductive spacer 760 of FIG. 7B. The recesses 985 depicted in the conductive spacer 980 are illustrated as "V" shaped notches. However, any shape may be used, and in some embodiments, the shape of each recess 985 may be different (e.g., recess 985a may be a "rounded V" shape and recess 985b may be a "U" shape). The illustrated recesses 985 are exemplary, and therefore any shape or size may be used to change the shape of the conductive spacer 980.

[0071] FIG. 9C shows a perspective view of an exemplary electrode assembly 990 having a needle electrode 992, a central surface electrode 994, and a conductive spacer 996. In this example, the needle electrode 992 includes 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 disposed parallel between the two rows of electrodes 992a and 992b. The needle electrode 992 may be substantially the same as the needle electrode 915 described with reference to FIGS. 9A and 9B. The surface electrode 994 may be substantially the same as the surface electrode 950 described with reference to FIGS. 9A and 9B. The conductive spacers 996a, 996b may be substantially the same as the conductive spacer 920 described with reference to FIG. 9A or the conductive spacer 980 described with reference to FIG. 9B.

[0072] The disclosed treatment system having any of the electrode assemblies with conductive spacers as described above may be used to provide effective electrical treatment to a patient. Figures 10A, 10B, and 11 provide some examples of process steps that can be selectively combined in various ways for electrode assembly selection, electrical treatment parameter selection, electrical treatment application, and displaying (or otherwise notifying / communicating) treatment information. In general, the methods described herein, including those shown in Figures 10A-10B and 11, may be for the treatment of cosmetic indications, e.g., to enhance the appearance of the treatment area. Such cosmetic indications typically have no symptoms other than the visible effects being treated, and generally have no medical consequences, although they may be bothersome and have adverse psychosocial effects. For example, sebaceous hyperplasia (SH) is one example of a cosmetic indication. Figures 12A-22B provide models depicting electrical treatment distribution using various configurations of electrode assemblies.

[0073] FIG. 10A illustrates a process 1000 for applying electrical therapy to a patient, according to some embodiments. Process 1000 may be performed by a human user (e.g., a medical professional) operating a treatment device, or by a system, such as, for example, system 100 of FIG. 1. In some embodiments, in optional step 1005, a user may select an electrode assembly based at least in part on a conductive spacer of the electrode assembly. For example, a user may select an electrode assembly having a conductive spacer with a conductivity appropriate 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 region. In some embodiments, the conductivity of the conductive spacer may be in a range equal to or greater than the conductivity of the treatment region, less than or equal to one hundred times (100x) the conductivity of the treatment region, in some embodiments, slightly less than, approximately equal to, or about ten times (10x) the conductivity of the treatment region, and in some embodiments, about one to ten times (1x to 10x) the conductivity of the treatment region. The conductivity of the treatment region may be determined based on the type of tissue to be treated. For example, the 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 range of conductivity of the conductive spacer may be from slightly less than 1.1 S / m to 110 S / m, and in some embodiments may be preferably about 11 S / m (about 10 times the conductivity of the treatment area). Treatment for other tissues may have different conductivity ranges, since the conductivity of the tissue may vary depending on the type of tissue being treated. As another example, a user may select an electrode assembly having a conductive spacer with a recess that is desirable for the tissue being treated. For example, a recess 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, a wider or narrower recess, etc. may have different advantages for the treatment of different types of tissue.In yet another embodiment, a controller of a pulse generator system (such as that shown by the embodiment of FIG. 1) may receive information regarding the treatment area and / or tissue being treated, make a selection for an electrode assembly to use, and provide such selection information to a user (e.g., a technician or other medical personnel) for acquisition and use for treatment. The electrode assembly can include at least two electrodes, each in conductive contact with a conductive spacer.

[0074] In some embodiments, in optional step 1010, the user may apply a conductive gel onto the surface of the treatment area to facilitate contact between the electrode assembly electrodes and the treatment area and / or between a conductive spacer of the electrode assembly and the treatment area. For example, conductive gels are often used to help facilitate uniform contact of the electrodes to skin or other treatment areas that are not precisely uniformly flat. Conductive gels differ in several ways from the conductive spacers of the electrode assemblies. For example, the consistency of such conductive gels is typically much less viscous and firmer than that of the conductive spacers. Additionally, the conductive gel is disposed between the surface of the conductive spacer and the surface of the treatment area, and in some surface electrode embodiments, between the surface of the surface electrode and the surface of the treatment area.

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

[0076] In step 1020, electrical treatment parameters are selected for electrical treatment to be applied to the treatment region. The electrical treatment parameters may include a voltage field applied to the treatment region, a pulse width, a pulse frequency, a number of pulses, or any combination thereof. In some embodiments, the electrical treatment parameters may be selected based at least in part on a conductive spacer in the electrode assembly. For example, an electrode assembly having a conductive spacer of the present disclosure may require a lower voltage to provide an effective treatment at a desired treatment depth throughout the treatment region than would be required to treat the treatment region with an electrode assembly having an insulating spacer or no spacer between the electrodes. This lower voltage may be possible at least in part because the conductive spacer allows a relatively high electric field to exist above the treatment region and extend more effectively into the treatment region. In some embodiments, a controller of a pulse generator system (such as that shown by way of example in FIG. 1) may be configured to determine or recognize the conductivity of the selected electrode assembly and conductive spacer, and may provide suggested electrical treatment parameter values ​​for the 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 a memory that includes a database or table containing information that can be used to determine electrical treatment parameter values ​​for treating a given treatment region using a selected electrode assembly. The electrical treatment parameter values ​​can be based on any combination of, for example, the conductivity of the conductive spacer, the geometric cutout information of the conductive spacer, the conductivity of the treatment region, the size or shape of the treatment region, etc.

[0077] In some embodiments, in optional step 1025, the user may apply electrical therapy to the treatment area via the 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. The electrical therapy may be direct current ("DC") pulsed in some embodiments. In some embodiments, the electrical therapy may be radio frequency ("RF") therapy.

[0078] 10B illustrates an example of another method 1050 for selecting an electrode assembly and / or selecting parameters for electrical therapy. The method 1050 may be performed by a human user (e.g., a medical professional) operating a treatment device or system, such as the system 100 of FIG. 1. In some embodiments, the method 1050 may be performed by a controller of the treatment system or device. The method 1050 may include, in step 1055, selecting an electrode assembly based at least in part on a conductive spacer of the electrode assembly. Step 1055 is described in detail above as optional step 1005 in the process 1000 of FIG. 10A.

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

[0080] Electrical treatment parameters may be selected for the electrical treatment to apply to the treatment area in step 1065. Step 1065 is described in detail above as step 1020 in process 1000 of FIG.

[0081] FIG. 11 illustrates another method 1100 for configuring a pulse generator system for electrical therapy, or an example of a method of operating an electrical therapy device. Method 1100 may be executed by a controller of the pulse generator system. The controller may execute method 1100 by storing instructions in a memory of the controller that, when executed by one or more processors of the controller, cause the controller to execute steps. In step 1105, the controller may determine or receive an indication of a replaceable electrode assembly of the treatment applicator. For example, a human user may select a replaceable electrode assembly and couple the replaceable electrode assembly to a 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 for a particular treatment, for example, based on information stored in a memory of the controller / processor of the system. The coupling may be mechanical, electrical, or both. The electrode assembly may include information that is transmitted upon coupling to the controller to indicate the type of electrode assembly, including the size of the electrode assembly (e.g., 5 mm x 5 mm, 10 mm x 5 mm, 5 mm x 10 mm, etc.), the conductivity of the conductive spacer, the number of electrodes, the type of electrode assembly (e.g., whether it is a surface electrode, needle electrode, or combination electrode assembly), etc. In some embodiments, a model number of the electrode assembly may be transmitted to the controller, and the controller 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 characteristics of the conductive spacer based on the instructions for the replaceable electrode assembly. For example, the instructions may include conductivity information (e.g., conductivity, conductive zones, etc.), or the information provided may enable the controller to look up the conductivity information of the conductive spacer. As another example, the indication may include the shape of the recesses or other characteristics of the conductive spacer.

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

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

[0085] At step 1125, in some embodiments, the controller may optionally cause the preferred treatment configuration information and / or configurable electrical treatment parameters to be displayed on a display device (e.g., interface 104). In some implementations, instead of displaying the 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 to be used. Such modifications may, in some embodiments, cause the controller to modify / update the preferred treatment configuration information determined, for example, based on a table or historical data. In some embodiments, the information in the memory of the controller may include protections that do not allow a configuration setting for a given replaceable electrode assembly to provide an unacceptable treatment, for example, by limiting peak voltages, etc.

[0086] 12A shows a model 1200 of a treatment area 1215 for a surface electrode assembly having an insulating spacer 1210 between electrodes 1205a, 1205b and surrounded by an insulator 1220. The illustrated surface electrode 1205 with insulating spacer 1210 may have been used in previous known treatments and does not implement the conductive spacer disclosed herein. This model 1200 is provided for the purpose of depicting the treatment area 1215 using the insulating spacer 1210 to show the substantial advantages of using the conductive spacer of the present disclosure as shown in FIG.

[0087] The model 1200 is based on a treatment area 1215 being 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 that may have a peak voltage of, for example, 2 kV to 15 kV. As shown using numerical values ​​in the model, there are isopleths numbered 1 to 10 that indicate the relative treatment value at each isopleth. As shown, the treatment area 1215 directly below the center of the insulating spacer 1210 has a treatment value at the 2.0 isopleth to a depth of about 2.5. However, the 4.0 isopleth does not extend below the center of the insulating spacer 1210. For purposes of illustration, it is assumed that the treatment area 1215 has an effective treatment value identified based on the 4.0 isopleth. Directly below the electrode 1205, the treatment value at the 4.0 isopleth is at a depth of about 2.25. As shown by the use of insulating spacers, the treatment is not evenly distributed throughout the treatment region 1215. The contour lines associated with the effective treatment value for the treatment region may be as horizontal as possible to show evenly distributed treatment for a consistent depth in the treatment region. In the case of model 1200, none of the contour lines show evenly distributed treatment.

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

[0089] FIG. 13A shows a 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 FIG. 13A is smaller in size than the surface electrode assembly shown in FIG. 12A. The distance between the electrodes 1305 is half the distance between the electrodes 1205 in FIG. 12A. The illustrated surface electrode 1305 with insulating spacers 1310 may have been used in previous treatments and does not implement the conductive spacer disclosed herein. This model 1300 is provided for the purpose of depicting a treatment area 1315 using insulating spacers 1310 to show the substantial benefits of using a conductive spacer as shown in FIG. 13B.

[0090] The model 1300 is based on a treatment area 1315 being 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 that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1315 directly below the insulating spacer 1310 has a treatment value to a depth of about 1 at the 4.0 contour line. Directly below the electrode 1305, the treatment value at the 4.0 contour line is at a depth of about 1.75. However, the effective treatment value is not uniformly distributed throughout the treatment area 1315 as would be preferred.

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

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

[0093] 14A-14E can be used to analyze the benefits of increasing the height of the conductive spacers.

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

[0095] The model 1400 is based on a treatment area 1406 being treated with 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 a conductivity substantially the same as that of the treatment area 1406. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1406 directly below the conductive spacer 1404 has a treatment value at the 4.0 contour line to a depth of approximately 1.25. Directly below the electrode 1402, the treatment value at the 4.0 contour line is at a depth of approximately 2.75.

[0096] 14B shows a model 1420 of a treatment region 1426 of a surface electrode assembly having a conductive spacer 1424 between electrodes 1422a, 1422b. Region 1428 is insulating, like the insulating housing.

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

[0098] 14C shows a model 1440 of a treatment region 1446 of a surface electrode assembly having a conductive spacer 1444 between electrodes 1442a, 1442b. Region 1448 is insulating, like the insulating housing.

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

[0100] 14D shows a model 1460 of a treatment region 1466 of a surface electrode assembly having a conductive spacer 1464 between electrodes 1462a, 1462b. Region 1468 is insulating, like the insulating housing.

[0101] The model 1460 is based on a treatment area 1466 being treated with a conductive spacer 1464 between two surface electrodes 1462. The conductive spacer 1464 has a height that is approximately 40% of its width. The conductive spacer 1464 has a conductivity that is substantially the same as the conductivity of the treatment area 1466. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1466 directly below the conductive spacer 1464 has a treatment value at the 4.0 contour line to a depth of approximately 2.0. Directly below the electrode 1462, the treatment value at the 4.0 contour line is at a depth of approximately 2.75.

[0102] 14E shows a model 1480 of a treatment region 1486 of a surface electrode assembly having a conductive spacer 1484 between electrodes 1482a, 1482b. Region 1488 is insulating, like the insulating housing.

[0103] The model 1480 is based on a treatment area 1486 being treated with 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 a conductivity that is substantially the same as the conductivity of the treatment area 1486. ​​A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1486 directly below the conductive spacer 1484 has a treatment value at the 4.0 contour line to a depth of approximately 2.0. Directly below the electrode 1482, the treatment value at the 4.0 contour line is at a depth of approximately 2.75.

[0104] As shown by Figures 14A-14E, increasing the height-to-width ratio of the conductive spacer increases the effective treatment depth in the treatment area under the conductive spacer, but only to a certain extent. Other models using various other tissues and conductivities of conductive spacers as well as different sizes of electrode assemblies (e.g., 5mm x 5mm, 5mm x 10mm) show that when the height of the conductive spacer is about twenty percent to sixty percent (20%-60%) of the width of the conductive spacer, the effective treatment depth is increased over using a conductive spacer with a smaller height-to-width ratio. The increase in effective treatment depth tapers off above 70%. A conductive spacer with a height of about forty percent (40%) of the width of the conductive spacer provides good results. Thus, in certain embodiments, a conductive spacer with a height of 4mm and a width of 10mm (e.g., in a 5mm x 10mm electrode assembly) provides greater treatment depth and uniformity than a conductive spacer 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 (eg, in a 5 mm x 5 mm electrode assembly) provides increased treatment depth over a conductive spacer having a height of less than 2 mm and a width of 5 mm.

[0105] 15 shows an example graph 1500 of the percentage change in the minimum effective therapeutic value as the height of a 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 effective electric field with a conductive spacer having a height-to-width ratio of 10% versus a conductive spacer having a height-to-width ratio of 40% is approximately thirty percent (30%).

[0106] 16A-16D can be used to analyze the benefits of increasing the conductivity of the conductive spacer.

[0107] 16A shows a model 1600 of a treatment region 1606 of a surface electrode assembly having a conductive spacer 1604 between electrodes 1602a, 1602b. Region 1608 is insulating, like the insulating housing.

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

[0109] 16B shows a model 1620 of a treatment region 1626 of a surface electrode assembly having a conductive spacer 1624 between electrodes 1622a, 1622b. Region 1628 is insulating, like the insulating housing.

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

[0111] 16C shows a model 1640 of a treatment region 1646 of a surface electrode assembly having a conductive spacer 1644 between electrodes 1642a, 1642b. Region 1648 is insulating, like the insulating housing.

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

[0113] 16D shows a model 1660 of a treatment region 1666 of a surface electrode assembly having a conductive spacer 1664 between electrodes 1662a, 1662b. Region 1668 is insulating, like the insulating housing.

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

[0115] 17 shows a graph 1700 of the percentage change in minimum effective therapeutic value as the conductivity of the conductive spacer is increased as a multiple of the conductivity of the treatment region 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 having substantially the same conductivity as the conductivity of the treatment region and a conductive spacer having a conductivity 100 times the conductivity of the treatment region is approximately seventy-two percent (72%).

[0116] 18A-18D show alternative configurations and results of a triple row pierce and combination electrode assembly. Regions 1808, 1828, 1848, 1868 are insulating, as is the insulating housing.

[0117] FIG. 18A shows a model 1800 for a triple row needle electrode assembly with insulating spacers 1804a, 1804b between needle electrodes 1802a, 1802b, and 1802c.

[0118] The model 1800 of FIG. 18A is based on a treatment area 1806 being treated with a three-row needle electrode configuration. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1806 directly under the needle electrodes 1802a and 1802c has a treatment value to a depth of about 4 at the 4.0 contour line. Directly under the needle electrode 1802b has a treatment value to a depth of about 5.25 at the 4.0 contour line. Directly under the space between the needle electrodes 1802, the treatment value at the 4.0 contour line is between about 4 and 5.25 deep. The middle row of needle electrodes 1802b effectively ensures that the area between the edge electrodes 1802a and 1802c receives treatment, but it comes at a significant cost. First, the treatment depth is greater in the center of the electrode assembly. Second, the additional row of needles increases the "nail bed" phenomenon, making penetration more difficult. Third, the manufacturing cost and complexity of a triple row needle electrode assembly is substantially greater than a dual row needle electrode assembly.

[0119] FIG. 18B shows a model 1820 for a triple row needle electrode assembly with conductive spacers 1824a, 1824b between the needle electrodes 1822a, 1822b, and 1822c.

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

[0121] FIG. 18C shows a model 1840 for a combination electrode assembly with needle electrodes 1842a and 1842c and a surface electrode 1842b with insulating spacers 1844a, 1844b between the needle electrodes 1842a, 1842c and the surface electrode 1842b.

[0122] The model 1840 of FIG. 18C is based on a treatment area 1846 that is treated with two outer rows of needle electrodes 1842a, 1842c and a central surface electrode 1842b located between the two rows of needle electrodes 1842a, 1842c, instead of the third row of needle electrodes. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1846 directly beneath the needle electrodes 1842a and 1842c has a treatment value to a depth of about 2.75 at the 4.0 contour line. The treatment value to a depth directly beneath the surface electrode 1842b is about 3.75. Directly beneath the space between the needle electrodes 1842a, 1842c and the surface electrode 1842b, the treatment value reaches a depth of 2.75 to 3.75. The intermediate surface electrode 1842b helps distribute the treatment over the area between the edge electrodes 1842a and 1842c, although the distribution is not as uniform as with the three rows of needle electrodes.

[0123] FIG. 18D shows a model 1860 for a combination 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] The model 1860 of FIG. 18D is based on a treatment area 1866 that is treated with two outer rows of needle electrodes 1862a, 1862c and a central surface electrode 1862b located between the two rows of needle electrodes 1862a, 1862c, instead of the third row of needle electrodes. The conductive spacer 1864 has a conductivity substantially the same as that of the treatment area 1866. The conductive spacers 1824a, 1824b each have a height that is approximately 80% of their width and 40% of the total width between the electrodes 1862a and 1862c. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1866 directly beneath the needle electrodes 1862a and 1862c has a treatment value at the 4.0 contour line to a depth of approximately 3.5. Directly beneath the surface electrode 1862b has an effective treatment value to a depth of about 4.25. Directly beneath the space between the needle electrodes 1862a, 1862c and the surface electrode 1862b, the effective treatment value is at a depth of 3.5-4.25. This configuration provides a substantial improvement in the distribution of effective treatment value across the treatment area 1866, while providing improvements known from eliminating the row of needle electrodes (e.g., avoiding the "nail bed" phenomenon) and reducing manufacturing cost and complexity by replacing the row of needle electrodes with a single surface electrode.

[0125] 19A-19C show alternative configurations and results for an electrode assembly with a surface electrode and a conductive spacer with multiple conductive zones. Regions 1908, 1928 and 1948 are insulating, like the insulating housing.

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

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

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

[0129] The model 1920 of FIG. 19B is based on a treatment area 1926 being treated with a surface electrode assembly having a conductive spacer with conductive zones 1924, 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 zero, i.e. insulating. The two conductive zones shown at 1924, 1930 are clearly depicted in this example, but in some embodiments a gradual 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 is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 1926 directly beneath the surface electrodes 1922a and 1922b has a treatment value at the 4.0 contour line to a depth of about 3. Directly beneath the conductive zones 1924, 1930, the treatment value reaches a depth of approximately 3.75. The areas beneath the conductive zones 1924, 1930 are fairly evenly distributed, while the areas beneath the conductive zones 1904, 1910 shown in FIG. 19A appear to be slightly more evenly distributed.

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

[0131] The model 1940 of FIG. 19C is based on a treatment area 1946 being treated with a surface electrode assembly having a conductive spacer with conductive zones 1944, 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 illustrated conductive zones 1944, 1950 are clearly depicted in this example, but in some embodiments a gradual 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 is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as described in FIG. 12A. The treatment area 1946 directly beneath the surface electrodes 1942a and 1942b has a treatment value at the 4.0 isoline to a depth of about 3.25. Directly beneath the conductive zones 1944, 1950 the treatment value at the 4.0 isoline is at a depth of about 3.75. The areas beneath the conductive zones 1944, 1950 are fairly evenly distributed, however the areas shown in FIG. 19A beneath the conductive zones 1904, 1910 appear to be equally evenly distributed and may have a lower cost due to the lower conductivity of the conductive spacers.

[0132] 20A and 20B show alternative configurations and results for a three row combination assembly. Regions 2008 and 2028 are insulating, like the insulating housing.

[0133] FIG. 20A shows a 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] The model 2000 of FIG. 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 the 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 zero, i.e. insulating. The two conductive zones 2004, 2010 shown are clearly depicted in this example, but in some embodiments a gradual change in conductivity in the conductive spacer may be used. The conductive spacer has a height that is approximately 20% of the overall width (i.e. the distance between electrodes 2002a and 2002c). The width of each conductive zone 2004 is 40% of the distance between the electrodes between which the conductive spacer is placed. In other words, the conductive spacer 2004a is 40% of the distance between electrodes 2002a and 2002b. For example, a voltage pulse is applied that may have a peak voltage of 1 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment region 2006 directly beneath surface electrodes 2002a and 2002c has a treatment value at the 4.0 contour line to a depth of about 3. Directly beneath surface electrode 2002b has a treatment value at the 4.0 contour line to a depth of about 4.25.

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

[0136] The model 2020 of FIG. 20B is based on a treatment area 2026 being treated with a conductive spacer having two conductive zones 2030a, 2024a between the needle electrode 2022a and the surface electrode 2032, and a conductive spacer having two conductive zones 2030b, 2024b between the needle electrode 2022b and the surface electrode 2032. The conductivity of the first zone 2030 may be substantially zero or insulating, and the conductivity of the second zone 2024 may be about 10 times 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 gradual change in conductivity in the conductive spacer may be used. The conductive spacer has a height that is about 20% of the overall width (i.e. the distance between the electrodes 2022a and 2022b). The width of each conductive zone 2024 is 40% of the distance between the electrodes between which the conductive spacer is placed. In other words, the conductive spacer 2024a is 40% of the distance between the electrodes 2022a and 2032. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 2026 directly beneath the needle electrodes 2022a and 2022b has a treatment value to a depth of about 4 at the 4.0 contour line. Directly beneath the surface electrode 2032 has a treatment value to a depth of about 4.75 at the 4.0 contour line. While the treatment is uniformly distributed with this configuration, the penetrating electrodes have the same problems discussed above, and therefore a surface electrode configuration such as that shown in FIG. 19A, 19B, 19C, and / or 20A may be preferred.

[0137] 21A-21E show alternative configurations and results of surface assemblies having conductive spacers with recesses. Various recesses, e.g., geometric cutouts, may be similar to the conductive spacers with conductive zones as shown and described in Figures 19A-20B. Regions 2108, 2128, 2148, 2168, and 2188 are insulating, like an insulating housing.

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

[0139] The model 2100 is based on a treatment area 2106 that is treated with a geometrically shaped 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 that is 40% of the width of the conductive spacer 2104 spacer and a second height at 2114 that 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. It is noted that the recess 2116 effectively behaves as an insulator. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as described in FIG. 12A. In this embodiment, the treatment area 2106 directly beneath the center of the conductive spacer 2104 has a treatment value at the 4.0 isoline to a depth of about 4.25. Directly beneath the electrode 2102, the treatment value at the 4.0 isoline is at a depth of about 3.25. The distribution of effective treatment is not as evenly distributed as that depicted in FIG. 19B with a conductive spacer having conductive zones.

[0140] 21B shows a model 2120 of a treatment region 2126 of a surface electrode assembly having a conductive spacer 2124 between electrodes 2122a, 2122b. Region 2128 is insulating, like the insulating housing.

[0141] The model 2120 is based on a treatment area 2126 that is treated with a conductive spacer 2124 between two surface electrodes 2122. The conductive spacer 2124 has a geometric cutout 2136 in the shape of a "rounded V". The conductive spacer 2124 has a first height at 2130 that is 40% of the width of the conductive spacer 2124 spacer and a second height at 2134 that is 12.5% ​​of the first height. In this example, the angle of the edge 2132 that extends between the first height and the second height is 90 degrees. In some embodiments, the radius of curvature of the cutout 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 generate a more uniform field throughout the treatment area. The conductive spacer 2124 is disposed 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 effectively acts as an insulator. A voltage pulse is applied that may have a peak voltage of, for example, up to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 2126 directly beneath the conductive spacer 2124 has a treatment value at the 4.0 contour line to a depth of about 4.25. Directly beneath the electrode 2122, the treatment value at the 4.0 contour line is at a depth of about 3.25.

[0142] 21C shows a model 2140 of a treatment region 2146 of a surface electrode assembly having a conductive spacer 2144 between electrodes 2142a, 2142b. Region 2148 is insulating, like the insulating housing.

[0143] The model 2140 is based on a treatment area 2146 being 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 at 2150 that is 40% of the width of the conductive spacer 2144 spacer and a second height at 2154 that is 12.5% ​​of the first height. 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 effectively behaves as an insulator. A voltage pulse is applied that may have a peak voltage of, for example, 2 kV to 15 kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as described in FIG. 12A. The treatment area 2146 directly beneath the conductive spacer 2144 has a treatment value at the 4.0 isoline to a depth of approximately 4.25. Directly beneath the electrode 2142, the treatment value at the 4.0 isoline is at a depth of approximately 3.25.

[0144] 21D shows a model 2160 of a treatment region 2166 of a surface electrode assembly having a conductive spacer 2164 between the electrodes 2162a, 2162b. Region 2168 is insulating, like the insulating housing.

[0145] The model 2160 is based on a treatment area 2166 being 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 conductive spacer 2164 spacer width 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 effectively behaves as an insulator. A voltage pulse is applied that may have a peak voltage of, for example, 5 kV to 15 kV. Approximate treatment values ​​at various depths are indicated by numbered contour lines as described in FIG. 12A. The treatment area 2166 directly beneath the conductive spacer 2164 has a treatment value at the 4.0 isoline to a depth of approximately 4.25. Directly beneath the electrode 2162, the treatment value at the 4.0 isoline is at a depth of approximately 3.25.

[0146] 21E shows a model 2180 of a treatment region 2186 of a surface electrode assembly having a conductive spacer 2184 between the electrodes 2182a, 2182b. Region 2188 is insulating, like the insulating housing.

[0147] The model 2180 is based on a treatment area 2186 that is treated with a conductive spacer 2184 between two surface electrodes 2182. The conductive spacer 2184 has a different "flat V" shaped recess 2196. The conductive spacer 2184 has a first height that is 40% of the width of the conductive spacer 2184 spacer at 2190 and a second height that is 12.5% ​​of the first height at 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 recess 2196 effectively behaves as an insulator. A voltage pulse is applied that may have a peak voltage of, for example, 5 kV to 15 kV. The approximate treatment values ​​at various depths in this example are indicated by the numbered contour lines as described in FIG. 12A. The treatment area 2186 directly beneath the conductive spacer 2184 has a treatment value at the 4.0 isoline to a depth of approximately 4.5. Directly beneath the electrode 2182, the treatment value at the 4.0 isoline is at a depth of approximately 3.25.

[0148] 22A and 22B show strip electrodes on conductive spacers having different geometries.

[0149] FIG. 22A shows a model 2200 of a treatment area 2215 of an electrode assembly having strip electrodes 2205a, 2205b, 2205c, 2205d, 2205e, and 2205f with a conductive spacer 2210 disposed on the strip electrode 2205. The conductive spacer 2210 can have substantially the same conductivity as the conductivity of the treatment area 2215. A voltage pulse is applied that can have a peak voltage of, for example, 2 kV to 20 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 2215 has a treatment value at the 4.0 contour line for a depth range of 5.0 to 7.0.

[0150] FIG. 22B shows a model 2250 of a treatment area 2265 of an electrode assembly having strip electrodes 2255a, 2255b, 2255c, 2255d, 2255e, and 2255f with a conductive spacer 2260 disposed on the strip electrodes 2255. The conductive spacer 2260 may have a geometric or other recess between the strip electrodes 2255. As shown, the recess may be "V" shaped. The conductive spacer 2260 may have a conductivity substantially the same as that of the treatment area 2265. A voltage pulse is applied that may have a peak voltage of, for example, up to 20 kV. Approximate treatment values ​​at various depths are shown by numbered contour lines as described in FIG. 12A. The treatment area 2215 has a treatment value at the 4.0 contour line for a depth range of 5.0 to 7.25. Although the coverage is a little larger in Figure 22B than in Figure 22A, the overall distribution of the treatment appears to be more uniform across the treatment area 2265. Thus, when a recess as shown in Figure 22B is used over a conductive spacer without a recess as shown in Figure 22A, the distribution of treatment is improved.

[0151] 23A and 23B depict a model of a treatment area using a monopolar electrode assembly.

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

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

[0154] FIG. 24 shows a 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 disposed at the upper edge of the electrodes 2402 such that the conductive spacer directly contacts the treatment area 2406 and the electrodes 2402 do not directly contact the treatment area 2406. The electrodes 2402 provide treatment to the treatment area 2406 indirectly through the conductive spacer 2404. A voltage pulse is applied which may have a peak voltage of, for example, 1 kV to 15 kV. Approximate treatment values ​​at various depths are shown by the numbered contour lines as described in FIG. 12A. The treatment area 2406 has a treatment value at the 4.0 contour line up to a depth of 3.5, which is relatively consistent across the treatment area 2406.

[0155] FIG. 25 demonstrates by example another inventive concept of the present disclosure. To optimize pulse shape, parallel resistors may be used in some electrode assemblies (e.g., treatment tips) to reduce treatment tip impedance and better match system impedance. To achieve this, in previously existing systems using electrode assemblies connected to the handle of a treatment applicator, one or more resistors are typically installed in the handle and arranged to be in parallel with the electrode assembly / treatment tip when connected to the handle. Coupling of the electrode assembly to the handle portion of the treatment applicator activates resistors in the handle portion. Such configurations add complexity to the handle portion of the treatment applicator, plus in some implementations may limit the value of the parallel resistors in the handle portion. Using the novel configuration of the present disclosure shown by the example of FIG. 25 solves the above problems and may improve / simplify parts and manufacturing, allowing various electrode assemblies to be custom tailored.

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

[0157] For example, it may be desirable to have a resistance between 10 and 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 a parallel resistor) 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 discussed above, the shape of the conductive spacer can change the shape of the treatment zone. The shape of the conductive spacer may be used to change the value of the parallel resistance. For example, a smaller cross-sectional area will result in a higher resistance and a larger cross-sectional area will result in a lower resistance. As an example, the tip of FIG. 8A has a lower parallel resistance value than the tip of FIG. 8B. Also, the smaller the distance between HV+ and HVgives, the lower the resistance. Thus, 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. In view of the above, depending on the requirements and implementation, the cross-sectional area can be adjusted or the conductivity of the spacer material can be modified to optimize the dual function of the conductive spacer to also act as an effective resistor. A spacer / resistor as described with reference to FIG. 25 may be implemented in any of the other examples and embodiments of the electrode assemblies, treatment tips / treatment applicators, and electrical treatment devices of the present disclosure.

[0158] In any of the methods of the present disclosure, including those described with reference to FIGS. 10A-10B and 11, the method may include using the conductive spacer as a resistor as well by selecting the electrode assembly and / or conductive spacer to optimize both the desired resistance and treatment depth. Thus, the conductivity of the material and / or the geometry of the conductive spacer may be selected to improve the treatment depth, or the 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 by changing the geometry of the resistor. The method may also include adjusting the value of the conductive spacer to improve the treatment depth by changing the conductivity of the material and / or by changing the geometry of the conductive spacer. The method may include using the shape of the conductive spacer to change the value of the parallel resistance. In various examples, the method may include using the 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 replaceable electrode assembly. In some examples, the method may include using the conductive spacer to reduce the impedance of the electrode assembly. In various examples, the methods of the present disclosure may include selecting a shape of a conductive spacer to alter the shape of a treatment zone or region.

[0159] Any of the methods (including user interfaces) described herein may be implemented as software, hardware, or firmware and may be described as a non-transitory computer-readable storage medium storing a set of instructions that may be executed by a controller including one or more processors (including, for example, a computer, tablet, smartphone, etc.) that, when executed by the controller / processor, cause the controller / processor to control or perform any of the steps including, but not limited to, displaying, communicating with a user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), making decisions, alerting, etc.

[0160] Although various exemplary embodiments have been described above, any of several modifications may be made to the various embodiments without departing from the scope of the present disclosure. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various apparatus and system embodiments may be included in some embodiments and not in other embodiments. Thus, the foregoing description has been provided primarily for illustrative purposes and should not be construed as limiting the scope of the invention, as set forth in the claims.

[0161] It is understood that the various embodiments described herein are by way of example only and are not intended to limit the scope of the invention. For example, many of the materials and structures described herein can be substituted with other materials and structures without departing from the spirit of the invention, as would be apparent to one of ordinary skill in the art upon review of this disclosure. Thus, while specific embodiments have been illustrated and described herein, any configuration calculated to achieve the same purpose may be substituted for the specific examples shown. The present disclosure is intended to cover any and all adaptations or modifications of the various examples. Combinations of the above examples, or some features of the examples described, and other examples not specifically described herein, will be apparent to one of ordinary skill in the art upon review of the above description. Thus, the invention as claimed can include variations from the specific examples and embodiments described herein. It is understood that various theories as to why the invention works are not intended to be limiting. Various embodiments of the subject matter of the invention, when in fact more than one is disclosed, may be referred to herein individually or collectively by the term "invention" merely for convenience, without intending to spontaneously limit the scope of this application to any single invention or inventive concept.

[0162] All measurements, dimensions, and materials provided herein or in the drawings are merely examples. As used in the specification and claims herein, including as used in the examples, unless otherwise indicated, all numbers can be read as if preceded by the word "about" or "approximately," even if that term is not expressly indicated.

[0163] References to "a," "an," or "the" are intended to mean "one or more," unless specifically indicated to the contrary. Reference to a "first" component does not necessarily require that a second component is provided. Furthermore, reference to a "first" or "second" component does not limit the referenced component to a particular location, unless expressly stated. When a feature or element is referred to herein as "on" another feature or element, it may be directly on the other feature or element, or intervening features and / or elements may also be present. It should also be understood that when a feature or element is referred to as "connected," "attached," or "coupled" to another feature or element, it may be directly connected, attached, or coupled to the other feature or element, or intervening features or elements may be present. Although described or illustrated with respect to one embodiment, the features and elements so described or illustrated may be applicable to other embodiments. Those skilled in the art will also understand that a reference to a structure or feature disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

[0164] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials for which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such publications by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

Claims

1. 1. An electrode assembly for delivery of electrical therapy, said electrode assembly comprising: At least two electrodes, each electrode comprising: a conductive treatment surface configured to apply electrical treatment to the treatment area; at least two electrodes including a conductive non-treatment surface configured to contact the conductive spacer; the conductive spacer disposed between two of the at least two electrodes, the conductive spacer configured to electrically contact a surface of the treatment area between the two of the at least two electrodes.

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

3. 3. The electrode assembly of claim 1, wherein the conductivity of the conductive spacer is substantially equal to ten times (10x) the conductivity of tissue in the treatment area.

4. 3. The electrode assembly of claim 1, wherein the conductivity of the conductive spacer is greater than or substantially equal to the conductivity of tissue in the treatment area and is up to 100 times the conductivity of the tissue in the treatment area.

5. The electrode assembly of any one of claims 1 to 4, wherein the height of the conductive spacer is based on the distance between the at least two electrodes.

6. 5. The electrode assembly of claim 1, wherein a height of the conductive spacer is greater than or equal to twenty percent (20%) of the distance between the at least two electrodes and less than or equal to fifty percent (50%) of the distance between the at least two electrodes.

7. 7. The electrode assembly according to any one of claims 1 to 6, wherein the conductive treatment surfaces of the at least two electrodes are in electrical and / or direct contact with the treatment area.

8. The electrode assembly of any one of claims 1 to 7, wherein the at least two electrodes comprise one of a bipolar electrode or a monopolar electrode.

9. The electrode assembly according to any one of claims 1 to 7, wherein the at least two electrodes comprise a combination of a surface electrode and a through electrode.

10. The electrode assembly of any one of claims 1 to 8, wherein at least one of the at least two electrodes comprises a surface electrode.

11. The electrode assembly according to any one of claims 1 to 8, wherein at least one of the at least two electrodes comprises a through electrode.

12. The electrode assembly according to any one of claims 1 to 11, wherein the length of the conductive spacer is substantially equal to the length of one or more of the at least two electrodes.

13. 12. An electrode assembly according to any one of claims 1 to 11, wherein the at least two electrodes comprise 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.

14. 14. The electrode assembly of claim 1, wherein the conductive spacer comprises at least two conductive zones, each of the conductive zones having a different conductivity.

15. The electrode assembly according to any one of claims 1 to 14, wherein the conductive spacer comprises at least one recess.

16. 16. An electrode assembly according to any preceding claim, wherein the conductive spacer comprises a semiconducting material and is configured to function as a parallel resistor.

17. 1. An electrotherapy device comprising: a treatment applicator configured to be coupled to one of a plurality of replaceable electrode assemblies; The plurality of replaceable electrode assemblies, each of the plurality of electrode assemblies comprising: At least two electrodes, each electrode comprising: a conductive treatment surface configured to apply electrical treatment to a treatment area of ​​a subject; at least two electrodes including a conductive non-treatment surface configured to contact the conductive spacer; and a plurality of replaceable electrode assemblies including the conductive spacer disposed between the at least two electrodes, the conductive spacer configured to electrically contact a surface of the treatment area of ​​the subject between the at least two electrodes.

18. 1. A method of administering electrical therapy, comprising: placing an electrode assembly on the treatment area, the electrode assembly comprising at least two electrodes and a conductive spacer disposed between two of the at least two electrodes; a conductive treatment surface of each of the at least two electrodes in electrical contact with the treatment area; positioning the conductive spacer so as to contact a surface of the treatment area between the two of the at least two electrodes; applying a voltage to the treatment area via the electrode assembly.

19. 20. The method of claim 18, comprising selecting the electrode assembly based on the conductive spacer having a conductivity substantially equal to ten times (10x) the conductivity of tissue in the treatment area.

20. 20. The method of claim 18, comprising selecting the electrode assembly based on the conductive spacer having a conductivity that is greater than or equal to a conductivity of tissue in the treatment area and less than or equal to one hundred times (100x) the conductivity of the tissue in the treatment area.

21. The method of any one of claims 18 to 20, comprising selecting the electrode assembly based at least in part on the size of the electrode assembly and / or the size of the treatment area.

22. 22. The method of any one of claims 18 to 21, further comprising disposing a conductive gel on the surface of the treatment area to promote contact between the conductive treatment surface of each of the one or more electrodes and the surface of the treatment area, between the conductive spacer and the surface of the treatment area, or both.

23. 23. The method of any one of claims 18 to 22, further comprising selecting the voltage applied to the treatment area via the electrode assembly based at least in part on the conductivity of the conductive spacer.

24. 24. The method of any one of claims 18 to 23, further comprising selecting the electrode assembly from a plurality of electrode assemblies based at least in part on the conductivity and / or geometry of the conductive spacer material.

25. 1. An electrotherapy device comprising: a treatment applicator configured to be coupled to one of a plurality of replaceable electrode assemblies; a plurality of replaceable electrode assemblies each configured to be coupled to and detached from the treatment applicator, each replaceable electrode assembly comprising two or more electrodes and a conductive spacer disposed between at least two of the two or more electrodes to apply electrical therapy to a treatment area of ​​a patient; and a controller configured to execute instructions that, when executed, cause the controller to An electrotherapy device that determines or receives an indication of the one of the plurality of replaceable electrode assemblies coupled to the treatment applicator.

26. 26. The electrotherapy device of claim 25, wherein the controller is further configured to cause configuration information to be displayed on a display device based on the conductive spacer of the one of the plurality of replaceable electrode assemblies.

27. 27. The electrotherapy device of claim 26, wherein the configuration information includes information regarding a type of tissue suitable for treatment by the one of the plurality of replaceable electrode assemblies.

28. 28. An electrotherapy device according to claims 25-27, wherein the conductive spacer has a conductivity and / or geometry configured to enable the conductive spacer to also function as a resistor to reduce impedance of the one of the plurality of replaceable electrode assemblies.

29. 29. An electrotherapy device according to claims 25-28, further comprising a pulse generator, the conductive spacer being configured to match the impedance of the one of the plurality of replaceable electrode assemblies to an impedance of the pulse generator.

30. 30. The electrotherapy device of claims 25-29, wherein the controller is further configured to provide electrical treatment parameters for the treatment area based at least in part on the indication of the one of the plurality of replaceable electrode assemblies.

31. 1. A method of operation of an electrotherapy device, the method comprising: determining or receiving an indication of an electrode assembly coupled to a treatment applicator, the electrode assembly comprising at least two electrodes in conductive contact with a conductive spacer; determining a characteristic of the conductive spacer based at least in part on the indication of the electrode assembly; and and selecting treatment configuration information based at least in part on the characteristics of the electrode assembly and the conductive spacer.

32. 32. The method of claim 31 , wherein selecting a treatment configuration comprises selecting treatment parameters, the method comprising selecting one or more of the type of tissue to be treated with the electrode assembly, treatment duration, treatment depth, voltage field, pulse duration, pulse frequency, and number of pulses.

33. The method of claims 31-32, wherein the indication of the electrode assembly includes at least one of a size of the electrode assembly, a type of the electrode assembly, a number of the electrodes, or a model number of the electrode assembly.

34. 34. The method of claim 31, further comprising using the conductive spacers as resistors based on either the conductivity of the conductive spacer material or the geometric shape of the conductive spacer, or both the conductivity and the geometric shape.

35. The method of any one of claims 31 to 34, further comprising displaying said treatment configuration information on a display device.

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