Omnidirectional attachment system for controller and GEL pad of neuromodulation device

Abstract

Introduced here are neuromodulation devices with components that can be placed in multiple orientations due to having radially symmetrical geometry. As an example, a neuromodulation device may include a controller that generates an electrical current and is connectable to a gel pad, via which the electrical current can be administered to a living body. The controller may include a transmitting element at which the electrical current is output, while the gel pad may include a receiving element at which the electrical current is received. Specific electrical pin placement on the transmitting and receiving elements may allow for greater flexibility in how the gel pad is connected to the controller.

Description

PATENTAttorney Docket No. 125847.8050.W001OMNIDIRECTIONAL ATTACHMENT SYSTEM FOR CONTROLLER AND GEL PAD OF NEUROMODULATION DEVICETECHNICAL FIELD

[0001] Various embodiments relate to electrical neuromodulation. More particularly, methods and devices herein provide electrical neuromodulation for treating symptoms of chronic and acute pain as well as other conditions.BACKGROUND

[0002] Pain is the mental manifestation of a neurological response to various physiological and psychological ailments. Pain serves as a warning of physical injury or biological dysfunction. Sometimes pain persists much longer than it takes for the healing of the initial injury to occur and, therefore, may be very difficult to alleviate. The most common pain relief methods employ drugs (e.g., opioids) that act to block neurotransmission pathways within the body. Often, such drugs are not effective for pain relief over the long term or produce unacceptable side effects. Consequently, various forms of electrical stimulation, such as spinal cord stimulation (SCS) and transcutaneous electrical nerve stimulation (TENS), have also been employed to alleviate pain.

[0003] SCS is effective, but it is an invasive procedure and has all the typical risks associated with implantable devices, as well as the risk of serious damage to the spinal cord. Conventional neuromodulation devices are not effective in all patients due to the difficulty in picking effective settings, and they may produce effects that only last during stimulation and do not produce long-term pain relief. Moreover, many patients find conventional TENS at therapeutically effective levels to be uncomfortable.1183186298.1PATENTAttorney Docket No. 125847.8050.W001BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Figure 1 illustrates a conventional example of a neuromodulation device for applying TENS.

[0005] Figure 2 is a block diagram illustrating modules of a neuromodulation device, according to some embodiments.

[0006] Figure 3 is a block diagram illustrating phases of an electrical pulse output from a neuromodulation device, according to some embodiments.

[0007] Figure 4A is an isometric view of an embodiment of a neuromodulation device being placed on a pad.

[0008] Figure 4B is a perspective view of an embodiment of the neuromodulation device of Figure 4A connected to the pad of Figure 4A.

[0009] Figure 5 is a top view of an embodiment of the pad and the pad tray of Figure 4A.

[0010] Figure 6A is a bottom view of an embodiment of the neuromodulation device of Figure 4A.

[0011] Figure 6B is a perspective view of an embodiment of the neuromodulation device of Figure 4A.

[0012] Figure 7A illustrates a pin geometry.

[0013] Figure 7B illustrates an alternate embodiment of a pin geometry.

[0014] Figure 7C illustrates an alternate embodiment of a pin geometry.

[0015] Figure 7D illustrates an alternate embodiment of a pin geometry.

[0016] Various features of the technology described herein will become more apparent to those skilled in the art from a study of the Detailed Description in conjunction with the drawings. Various embodiments are depicted in the drawings for the purpose of illustration. However, those skilled in the art will recognize that alternative embodiments may be employed without departing from2183186298.1PATENTAttorney Docket No. 125847.8050.W001 the principles of the technology. Accordingly, although specific embodiments are shown in the drawings, the technology is amenable to various modifications.3183186298.1PATENTAttorney Docket No. 125847.8050.W001DETAILED DESCRIPTION

[0017] Many conventional neuromodulation devices offer limited effectiveness in patients for a variety of reasons. One reason is that the physical construction of many neuromodulation devices means that the devices are not effective in offering a user of the device pain relief while also enabling a user to easily secure and remove the neuromodulation device from the pad secured to the user’s skin. For example, many conventional neuromodulation devices are bulky or difficult to wear and require the user to place the neuromodulation device in a specific orientation on the pad. The pad is placed on the user’s skin and distributes the electrical signal to the user’s body. To properly apply the electric signal, conventional neuromodulation devices must be placed in a specific orientation on the pad, oftentimes leading to a user misplacing the neuromodulation device.This can cause frustration for a user and can prevent the neuromodulation device from properly supplying the electric signal to the pad. For example, conventional neuromodulation devices may appear to be able to be placed in any orientation, but the placement of the electrical pins on the pad and the corresponding electrical pins on the neuromodulation device do not allow a conventional neuromodulation device to function in every orientation because the two sets of pins will not properly align.

[0018] Introduced here are neuromodulation devices and methods that overcome the deficiencies of conventional neuromodulation devices to enable the placement of a neuromodulation device in multiple orientations relative to the pad. The neuromodulation device can be placed in multiple orientations due to the radially symmetrical geometry of the neuromodulation device, the corresponding radially symmetrical geometry of the pad tray, and the placement of the electrical pins on the neuromodulation device and pad.

[0019] As further discussed below, the neuromodulation devices introduced here overcome the issues of conventional neuromodulation devices by using specific electrical pin placement on a transmitting element of the4183186298.1PATENTAttorney Docket No. 125847.8050.W001 neuromodulation device and a receiving element of the pad. The neuromodulation device has at least two pairs of electrical transmitting pins that connect to at least one pair of electrical receiving pins on the pad. A single transmitting pin from each pair of transmitting pins connects to a receiving pin. The orientation of the receiving pins on the pad is configured so that only a single transmitting pin from each pair of transmitting pins connects to a receiving pin. Therefore, a current is always supplied from the neuromodulation device to the pad, no matter which orientation the neuromodulation device is positioned relative to the pad.

[0020] Given that the neuromodulation device can be placed in multiple orientations, a neuromodulation device according to embodiments herein can:• Enable a user to mate the neuromodulation device without needing to verify the orientation of the neuromodulation device;• Provide redundancy if a transmitting pin is struck or breaks; and• Enable the electrical pins to always mate properly, meaning the neuromodulation device can supply the proper electrical signal from every orientation.

[0021] Embodiments herein may be described in the context of a “user”. A “user” may be a living body receiving electrical signals from an electrode or transmitting signals to an electrode. In some embodiments, a user may be human. In other embodiments, a user may be an animal. Accordingly, electrodes and neuromodulation devices according to embodiments herein may be used in connection with any living body.

[0022] In some embodiments herein, a neuromodulation device may be a self- contained device. For example, in some embodiments, a neuromodulation device may include a housing that houses a first electrode and a second electrode. In some embodiments, a first electrode and second electrode may have a fixed relationship to one another. In other embodiments, a first electrode and a second electrode may be independent from one another, such that the first electrode and5183186298.1PATENTAttorney Docket No. 125847.8050.W001 the second electrode are able to be independently positioned on a user’s skin. In some embodiment embodiments, a first electrode and a second electrode may be connected to a controller via respective flexible wires.

[0023] Some embodiments herein are discussed with reference to a flow of current from a first electrode to a second electrode. In other embodiments, current may flow from a second electrode to a first electrode. As a part of TENS treatment, a direction of current flow may be reversed during a treatment session. Accordingly, electrodes described herein may be employed interchangeably as a source electrode or a sink electrode.

[0024] Embodiments may be described in the context of computer-executable instructions for the purpose of illustration. However, aspects of the approach could be implemented via hardware or firmware instead of, or in addition to, software.Terminology

[0025] References in the present disclosure to “an embodiment” or “some embodiments” mean that the feature, function, structure, or characteristic being described is included in at least one embodiment. Occurrences of such phrases do not necessarily refer to the same embodiment, nor are they necessarily referring to alternative embodiments that are mutually exclusive of one another.

[0026] Unless the context clearly requires otherwise, the terms “comprise,” “comprising,” and “comprised of” are to be construed in an inclusive sense rather than an exclusive or exhaustive sense. That is, in the sense of “including but not limited to.” The term “based on” is also to be construed in an inclusive sense. Thus, the term “based on” is intended to mean “based at least in part on.”

[0027] The terms “connected,” “coupled,” and variants thereof are intended to include any connection or coupling between two or more elements, either direct or indirect. The connection or coupling can be physical, logical, or a combination thereof. For example, elements may be electrically or communicatively coupled to one another despite not sharing a physical connection.6183186298.1PATENTAttorney Docket No. 125847.8050.W001

[0028] The term “module” may refer broadly to software, firmware, hardware, or combinations thereof. Modules are typically functional components that generate one or more outputs based on one or more inputs. A computer program may include or utilize one or more modules. For example, a computer program may utilize multiple modules that are responsible for completing different tasks, or a computer program may utilize a single module that is responsible for completing all tasks.

[0029] When used in reference to a list of multiple items, the word “or” is intended to cover all of the following interpretations: any of the items in the list, all of the items in the list, and any combination of items in the list.Overview of Conventional Neuromodulation Device

[0030] Figure 1 illustrates a conventional example of a neuromodulation device 100. The neuromodulation device 100 is configured to apply an electrical signal to a user of the neuromodulation device to inhibit transmission of pain signals through the nervous system to the brain. The neuromodulation device 100 is configured as a patch 102 configured to be worn on the skin of a user. The patch 102 may include an adhesive material allowing the neuromodulation device 100 to adhere to the skin. The neuromodulation device 100 includes a controller 104 configured to control generation of the electrical signal. The controller 104 may be powered by an onboard power source, such as a battery.

[0031] As shown in Figure 1 , the neuromodulation device 100 includes a source electrode 106 disposed in a first gel pad 108. Electrical current is configured to flow through the source electrode 106, through the gel pad 108, and into the skin of the user of the neuromodulation device 100. The neuromodulation device 100 also includes a sink electrode 1 10 disposed in a second gel pad 112. Current is configured to flow from the source electrode 106, into a user’s skin, and to the sink electrode 110. The passage of this electrical current is configured to disrupt pain signals in the neurological system of the user, thereby alleviating pain. The first gel pad 108 and the second gel pad 1127183186298.1PATENTAttorney Docket No. 125847.8050.W001 are configured to distribute the current over a wider area than the point source provided by the source electrode 106 and the point sink provided by the sink electrode 110.

[0032] As discussed further below, physical arrangements and / or methods described with reference to embodiments herein may improve user comfort, ease of use, and therapeutic effectiveness of a neuromodulation device without substantially increasing the physical dimension of the neuromodulation device, improving wearability and further increasing user comfort.Overview of Neuromodulation Device and Method of Operation

[0033] Figure 2 is a block diagram illustrating modules of a neuromodulation device 200, according to some embodiments. The control electronics module 202 generally comprises a microcontroller which may be programmable to provide the desired pulse signals to the patient. The control electronics module 202 may also include the various electronics which are used to effect the treatment, e.g., timers, clocks, DACs, etc. which control the output on / off state, pulse amplitude, timing, modulation, and other pulse parameters. In order to actuate and / or interface with the control electronics module 202, a controls module 204 may be in communication with the control electronics module 202 through any number of interface mechanisms, e.g., buttons, knobs, sliders, capacitive touch sensors, etc. through which a user can turn the device on / off, adjust amplitude or other settings, etc. Additionally, the controls module 204 or other controller may communicate locally or remotely with the control electronics module 202 through a communication interface module 208 which may include any number of various wired and / or wireless communication mechanisms, e.g., Bluetooth®, Bluetooth® Low Energy or Bluetooth® Smart (Bluetooth SIG, Inc., Kirkland, Wash.), ANT, ZigBee, WiFi, infrared (e.g., Infrared Data Association (IrDA) associated wireless communications, etc.).

[0034] The control electronics module 202 may provide any number of details, feedback, or information about its operation through an indicator module 206,8183186298.1PATENTAttorney Docket No. 125847.8050.W001 which may include any variety of indicators (e.g., light-emitting diodes or other types of illuminants), displays such as LCD displays, segment displays, etc., which may be positioned directly upon the neuromodulation device or separately in communication with the control electronics module 202.

[0035] In order for the neuromodulation device to provide the electrical stimulation to the patient’s body, the control electronics module 202 may be in communication with a pulse generating electronics module 210 which is in communication with a electrodes 214 through a connecting elements 212. The control electronics module 202 and pulse generating electronics module 210 may be in communication with a power supply module 216 which supplies the power for the electrical stimulation. The power supply module 216 may include a battery such as a lithium-ion battery with associated circuits such as voltage regulators, LDOs, boost or buck converters, etc. The device output may utilize a voltage which is much higher than that available from the battery, and therefore the power supply may optionally include a generating mechanism for providing the high voltage as well as regulated low voltages for the other internal circuits.

[0036] The pulse generating electronics module 210 may include various components, including, but not limited to, amplifiers, op-amps, output filtering or pulse shaping circuits, output limiting or sensing and feedback circuits, elements which provide galvanic isolation, DC blocking, etc., which are configured to produce the electric pulses with controlled shape and amplitude as described herein.

[0037] Each of the various components may be in electrical communication through the connecting elements 212. The connecting elements used may comprise any number of electrically conductive elements, e.g., connectors, printed conductive traces, flex circuit boards, etc., which provide electrical connection from the electronics to the electrodes or between any number of electrical components.

[0038] The electrodes 214 electrically coupled to the pulse generating9183186298.1PATENTAttorney Docket No. 125847.8050.W001 electronics module 210 may be shaped in various configurations for facilitating placement upon the patient depending upon the region of the body to be treated. Accordingly, the electrodes may be external for providing an electrical connection from the device output to the body through the skin, particularly to the target tissues or nerves.

[0039] External electrodes, in one variation, may be constructed of a conductive current-distributing element, an electrochemical electrode interface (such as a silver chloride coated silver, stainless steel, graphite, etc.) at which an electrochemical reaction may occur and a hydrogel (such as polyacrylamide or other stable and biocompatible gel with good adhesion) which contains a conductive solution (typically sodium chloride). The electrodes may be a driven as a pair of electrodes where the current flows from a first electrode to a second electrode, or as a more complex multi-polar setup, e.g., in a quadrupolar setup, with four electrodes driven as any one of six alternating pairs.

[0040] In other variations, the neuromodulation device may additionally and / or optionally include additional features or elements. For example, in one variation, the device may be controlled entirely via a communication interface using, e.g., wireless communication from a controller located remotely from the neuromodulation device. Such remotely located controllers may include, e.g., smartphones or other programmable devices, which may communicate via any number of wireless communication protocols, e.g., Bluetooth® Low Energy interface. Such a variation may remove the need for any controls or indicators on the device itself as the controls module 204 may be located remotely. In yet another alternative, the device may directly incorporate the controls module 204 upon the neuromodulation device itself so that it may be controlled entirely through an interface located upon the device.

[0041] Additionally, and / or alternatively, the control electronics module 202 and power supply module 216 may be packaged as a compact device which may be removably attached as a unit upon electrodes 214 which are disposable, e.g.,10183186298.1PATENTAttorney Docket No. 125847.8050.W001 polyacrylamide hydrogel with silver ink conductive traces printed on a polymer film base. The electrodes 214 may be placed upon the region of interest upon the patient body and the device may be temporarily coupled to an engagement mechanism which also allows for the electrical communication between the pulse generating electronics module 210 and the electrodes 214 to effect treatment upon the patient. This variation as well as others described may be combined in any number of combinations as practicable.

[0042] Figure 3 is a block diagram illustrating phases of an electrical pulse output from a neuromodulation device, according to some embodiments. Specifically, Figure 3 shows a block diagram of a representative pulse waveform 300 illustrating the major phases of an electrical pulse output. Using the neuromodulation device 200 of Figure 2, the control electronics module 202 may be programmed to affect a specified pulse waveform generated by the pulse generating electronics module 210 and transmitted through the electrodes 214 and to the area of the patient’s body upon which the electrodes 214 are positioned for treatment. Generally, the pulse waveform 300 may have a primary phase 306 followed by an optional dead time 308 period and then a secondary phase 310. Initiating the primary phase 306 is a leading edge 302 having a relatively fast rise time which leads to a spike 304 having an intensity greater than an average intensity of the primary phase 306. The remainder of the primary phase 306 may have an intensity which is lower than the intensity of the spike 304. In some embodiments, the remainder of the primary phase 306 may have an intensity approximately half intensity of the spike 304.

[0043] The dead time 308 period, if included, may have an output amplitude of zero. If the dead time 308 period is omitted, the secondary phase 310 may follow immediately after the primary phase 306 where the secondary phase 310 may have a polarity opposite to that of the primary phase 306. Like the dead time 308 period, the secondary phase 310 may be optionally omitted entirely from the pulse waveform 300. The treatment pulses having the pulse waveform 300 may be repeated during a treatment where a specified time interval period 312 may1 1183186298.1PATENTAttorney Docket No. 125847.8050.W001 be present between each individual pulse waveform 300.

[0044] While the output is described here in terms of amplitude, this may include a measure of either current or voltage. In one embodiment, the pulse waveforms 300 may be produced by a circuit which is a voltage-limited current source, and the amplitudes may comprise current amplitudes. Using a current control allows for the effective movement of charges to be less dependent on the electrode impedance (which may change with skin condition or over time) and less dependent on the tissue impedance (which may change with placement or individually).

[0045] In another embodiment, the output may also comprise a voltage source or current-limited voltage source, since in the short term the tissue and electrode impedances are relatively constant and so the current is approximately equal to the voltage times a constant factor. In this case, the output may require more frequent adjustments. However, controlled or produced, the amplitude pattern shown describes the variation in electrical field strength independent of the effects of variation in electrode impedance or the specifics of the control circuit.

[0046] If any parameters (such as timings or amplitude) of the output electrical pulses depend on the load impedance, they may be measured using a resistive- capacitive test load simulating the electrodes and human body.System for Connecting Neuromodulation Device to Pad

[0047] Figure 4A is a perspective view of an embodiment of a neuromodulation device 402 being placed on a pad 404. Figure 4B is a perspective view of the neuromodulation device 402 connected to the pad 404. The neuromodulation device 402 provides an electrical signal to the pad 404. The electrical signal is transferred through the pad 404 into the user’s skin so treatment can occur. The neuromodulation device 402 attaches to the pad 404 using the pad tray 406. The neuromodulation device 402 can have a concave and / or convex geometry that couples to a complementary geometry of the pad12183186298.1PATENTAttorney Docket No. 125847.8050.W001 tray 406. The pad tray 406 can include a receiving element 506 that receiving a corresponding recess of the neuromodulation device 402. The pad tray 406 enables the neuromodulation device 402 to be connected to the pad 404 in multiple orientations. The pad tray can be located in the center of the pad 404, on either side of the pad 404, or somewhere between. The pad tray 406 has inverse geometry to the neuromodulation device 402. The inverse geometry enables the neuromodulation device 402 to fit into the pad tray 408 securely.

[0048] Figure 5 is a top view of an embodiment of the pad 404 and the pad tray 406. The pad tray 406 can be located in the center and / or at any position on the pad 404. The pad tray 406 can include multiple securing features that clip or mate with complementary features on the neuromodulation device. The securing features enable the neuromodulation device to be fully seated into the pad tray 406 in different orientations. The geometry of the securing features enables four possible orientations of the neuromodulation device 402, where each orientation is rotated 90 degrees from the other. The pad tray 406 includes at least one cutout surface 502 and preferably four cutout surfaces 502. The cutout surfaces 502 create a gap between each securing element. The gap created by each cutout surface 502 creates a void, for example, for a power button on the neuromodulation device or for removal of the neuromodulation device. The cutout surface 502 enables the user to access the underside of the device to allow them to easily remove the device from the gel pad tray, regardless of which orientation the device is mounted in. For example, the cutout surface 502 forms a “U” that tapers at the edges. The cutout surface 502 includes a first portion at the bottom crest of the “II” that has rounded edges, a second portion on a first side of the first portion, and a third portion on the opposite side of the first portion. The second portion and third portion each taper towards a point.

[0049] The pad tray 406 can include a series of ribs 504 disposed between each cutout surface 502. For example, the pad tray 406 can include four sets of ribs 504 disposed at each corner of the pad tray 406. Each rib 504 can be on a shared curve about the receiving element 506. Each rib 504 can extend from the13183186298.1PATENTAttorney Docket No. 125847.8050.W001 pad tray in a direction parallel to the pad 404. The ribs 504 can decrease in size the further each rib 504 is from the pad 404. Each rib 504 can be on a shared curve about the receiving element 506. Each set of ribs 504 can be flexible to enable flexibility in the pad tray 406. The flexibility enables the pad tray 406 to better form the body of the user to create a transition point between the pad tray 406 and pad 404 that prevents a user from experiencing uncomfortable pressure points caused by the hard material of the pad tray 406.

[0050] The pad tray 406 includes a securement surface 516 disposed at each corner of the pad tray 406. The securement surface 516 has an opposite geometry to the corners of the neuromodulation device 402. For example, the securement surface 516 can be a rounded spherical void having three sides and a bottom. The securement surface 516 can include a surface or lip at the center side that snaps to and / or over a surface of the neuromodulation device 402 to attach the neuromodulation device 402 securely to the pad tray 406.

[0051] The pad tray 406 includes a receiving element 506. The receiving element 506 is a connector and can protrude from the pad tray 406 and / or be recessed into the pad tray 406. The receiving element 506 can include a magnet 508 or a ferromagnetic material used to secure the neuromodulation device 402 to the pad 404. The magnet 508 can be located in the center of the receiving element 506. The receiving element 506 can also include an alignment feature 514. The alignment feature 514 can be used to align the neuromodulation device onto the receiving element and to ensure the electrical signal pins are aligned and connected.

[0052] The receiving element 506 includes a first electrical signal receiving pin 510a (receiving pin) and a second receiving pin 510b (the pair of receiving pins 510). The first receiving pin 510a is offset diagonally from the second receiving pin 510b. The receiving element 506 can also include a first dummy pin 512a and a second dummy pin 512b (the pair of dummy pins 512). The pair of dummy pins 512 cannot receive an electrical signal and prevents any pin on the14183186298.1PATENTAttorney Docket No. 125847.8050.W001 neuromodulation device 402 connected to the dummy pin from transmitting an electrical signal to the pad 404. By having a pair of receiving pins 510 and a pair of dummy pins 512, the neuromodulation device 402 can have four pins, where only two pins on the neuromodulation device 402 are transmitting to the pad 404 at a time. Therefore, a signal can be transmitted from the neuromodulation device 402 through the pad 404 and to the user’s body, no matter what position the neuromodulation device 402 is in on the pad tray 406.

[0053] Note that while the pad tray 406 of Figures 4A-B and 5 allows the neuromodulation device 402 to be detachably secured thereto in four different orientations, the pad tray 406 could be designed to allow for a greater or lesser number of orientations. For example, the pad tray 406 — and more specifically, its cutout surfaces 502 — could instead be designed to accommodate two or three different orientations. As another example, the pad tray 406 — and more specifically, its cutout surfaces 502 — could instead be designed to accommodate five, six, or eight different orientations. In these embodiments, the receiving element 506 would also be designed to accept the neuromodulation device 402 in an equal number of orientations. Accordingly, while nearly any number of potential orientations may be possible through design of the pad tray 406, an actual number of potential orientations may be limited by design constraints on the receiving element 506.

[0054] Figure 6A is a bottom view of an embodiment of a neuromodulation device 402. Figure 6B is a perspective view of an embodiment of the neuromodulation device 402. The neuromodulation device 402 includes a rounded corner 602 that causes the neuromodulation device to have a “squircle” shape. The term “squircle” is commonly used to refer to a square with rounded corners. The squircle shape of the neuromodulation device 402 enables the neuromodulation device 402 to fit securely in the securement surface 516 of the pad tray 406. Additionally, the squircle shape causes the neuromodulation device 402 to have four distinct but visually identical orientations (with minor exceptions for some features such as the power button 604 and light-emitting diode (LED)).15183186298.1PATENTAttorney Docket No. 125847.8050.W001Because the neuromodulation device 402 can be placed in multiple orientations (e.g., four possible orientations), the power button 604 can be oriented differently relative to the pad 404.

[0055] The neuromodulation device 402 includes a transmitting element 606. The transmitting element 606 is a connector that mates or couples to the receiving element 506 on the pad tray 406. The transmitting element 606 can be a recess (as shown) and / or a protrusion.

[0056] The transmitting element 606 can include a magnet or ferromagnetic material 614 that can couple or attach to the corresponding magnet or ferromagnetic material in the receiving element 506. For example, if the receiving element 506 has a ferromagnetic material, the transmitting element 606 would have a magnet and vice versa. In some embodiments, the transmitting element 606 and the receiving element 506 both include magnets of opposite polarity. The transmitting element 606 can include alignment elements 612. The alignment elements 612 are rounded protrusions used to align the neuromodulation device 402 onto the receiving element. The alignment elements 612 aid in the alignment of the electrical signal pins on the neuromodulation device 402 and the pad tray 406. The transmitting element 606 includes a first electrical signal transmitting pin 608a (transmitting pin) and a second transmitting pin 608b (the first pair of transmitting pins 608). The first transmitting pin 608a and the second transmitting pin 608b have the same electrical potential. The first transmitting pin 608a and the second transmitting pin 608b can be located on adjacent corners of the transmitting element 606. The transmitting element 606 includes a third transmitting pin 610a and a fourth transmitting pin 610b (the second pair of transmitting pins 610). The third transmitting pin 610a and the fourth transmitting pin 610b have the same electrical potential. The third transmitting pin 610a and the fourth transmitting pin 610b can be located on adjacent corners of the transmitting element 606. The first pair of transmitting pins 608 and the second pair of transmitting pins 610 form a square with each pin in a corner. The first pair of transmitting pins 608 and the second pair of transmitting pins 610 have different16183186298.1PATENTAttorney Docket No. 125847.8050.W001 electrical potentials. The orientation of the first pair of transmitting pins 608 and the second pair of transmitting pins 610 causes one pin from the first pair of transmitting pins 608 and one pin from the second pair of transmitting pins 610 to connect to a receiving pin 510 on the receiving element 506. The non-used electrical signal pins from the first pair of transmitting pins 608 and the second pair of transmitting pins 610 mate with the pair of dummy pins 512 and are not in use. The orientation of the neuromodulation device 402 in the pad tray 406 determines which pins from the first pair of transmitting pins 608 and the second pair of transmitting pins 610 are applying the electrical signal to the pad 404.

[0057] Figures 7A, 7B, 7C, and 7D illustrate different embodiments of the electrical signal pin placement on the receiving element 506 and the transmitting element 606. Connector side 1 can refer to the receiving element 506, and the connector side 2 can refer to the transmitting element 606 and vice versa. The multiple orientations provided by the different electrical signal pin placements can provide redundancy when a transmitting pin breaks or is struck. For example, if there are four possible orientations and a transmitting pin breaks, a user can rotate the neuromodulation device 402 90 degrees. This means that two of the four orientations are still operable and enable the neuromodulation device to function properly when conventional neuromodulation devices would not.

[0058] Figure 7A illustrates an electrical pin geometry similar to that described above in Figures 5 and 6. Connector side 1 includes the pair of receiving pins 702a, 702b. Receiving pins 702a, 702b are disposed in opposite corners from one another. Each receiving pin 702a, 702b can be positioned in any corner, provided that the other pin is located in the opposing corner. Connector side 2 includes a first pair of transmitting pins 704a, 704b and a second pair of transmitting pins 706a, 706b. Each transmitting pin 704a, 704b can be located in adjacent corners and across from transmitting pins 706a, 706b. Transmitting pin 706a, 706b can be located in adjacent corners to each other. Each transmitting pin in the first pair of transmitting pins 704a, 704b and the second pair of transmitting pins 706a, 706b can be located in a corner of connector side 2. Each transmitting pin in a pair of17183186298.1PATENTAttorney Docket No. 125847.8050.W001 transmitting pins has the same electrical potential, while the two different pairs of transmitting pins have differing electrical potentials. The geometry of the pins on each connector means that the receiving pins 702a, 702b of connector side 1 will always interface with one pin from each pair of transmitting pins. This causes the receiving pins 702a, 702b of connector side 1 to always interface with transmitting pins of different electrical potentials.

[0059] Figure 7B illustrates an alternate embodiment of an electrical signal pin geometry including two pairs of receiving pins on connector side 1 and four pairs of transmitting pins on connector side 2. A first pair of receiving pins 708a, 708b can be located in opposite corners of connector side 1 along a first axis X — X that crosses the center of connector side 1 . In some embodiments, a second pair of receiving pins 710a, 710b is located between the first pair of receiving pins 708a, 708b along a first axis X — X. In some other embodiments, the second pair of receiving pins 710a, 710b is disposed along the second axis Y— Y between the first pair of receiving pins 708a, 708b. The first axis X — X can be perpendicular to the second axis Y — Y and both the first axis X — X and the second axis Y — Y can be perpendicular to a central axis in a “z” direction.

[0060] Connector side 2 has a first pair of transmitting pins 716a, 716b and a second pair of transmitting pins 720a, 720b configured to connect to the first pair of receiving pins 708a, 708b. The transmitting pin 716a and the transmitting pin 720b are disposed in opposite corners of connector side 2 on the second axis Y — Y. The transmitting pin 716b and the transmitting pin 720a are disposed in opposite corners of connector side 2 on the first axis X — X. The transmitting pin 716a and the transmitting pin 716b are disposed in adjacent corners.

[0061] Connector side 2 further includes a third pair of transmitting pins 718a, 718b, and a fourth pair of transmitting pins 722a, 722b can be configured to mate with the second pair of receiving pins 710a, 710b. The transmitting pins 718a and the transmitting pin 722b are disposed on the second axis Y — Y between transmitting pin 716a and transmitting pin 720b. The transmitting pin 718b and the18183186298.1PATENTAttorney Docket No. 125847.8050.W001 transmitting pin 722a are disposed on the first axis X — X between transmitting pin 716b and transmitting pin 720a.

[0062] Due to the location of each electrical signal pin on connector side 1 and connector side 2, only one transmitting pin from each pair of transmitting pins on connector side 2 interfaces with a receiving pin from connector side 1. Each transmitting pin in a pair of transmitting pins on connector side 2 has the same electrical potential, while each pair of transmitting pins has a different electrical potential compared to another.

[0063] Figure 7C illustrates an alternate embodiment of an electrical signal pin geometry. The electrical signal pin geometry can have fewer pins if internal switching in the neuromodulation device enables the electrical signal pins to dynamically adjust the electrical potentials. Connector side 1 can have a first pair of receiving pins 724a, 724b disposed on the second axis Y — Y and a second pair of receiving pins 726a, 726b disposed on the first axis X — X. Connector side 2 can have transmitting pins 728, 730, 732, 734. Each of the transmitting pins 728, 730, 732, 734 can have different electrical potentials. The transmitting pins 728, 730, 732, 734 are configured to align with and interface with the first pair of receiving pins 724a, 724b and the second pair of receiving pins 726a, 726b. Each of the transmitting pins 728, 730, 732, 734 can be disposed in any corner and on either the first axis X — X and / or the second axis Y — Y so long as they interface with a receiving pin 724a, 724b, 726a, 726b.

[0064] Figure 7D illustrates an alternate embodiment of an electrical signal pin geometry of a non-square-shaped connector. Connector side 1 can have a pair of receiving pins 736a, 736b. Connector side 2 can have a first set of transmitting pins 738a, 738b, 738c and a second set of transmitting pins 740a, 740b, 740c. Each set of transmitting pins on connector side 2 has a different electrical potential. The electrical signal pin geometry of connector side 1 and connector side 2 enables the neuromodulation device to be placed in multiple orientations while allowing the receiving pins from connector side 1 to properly align and interface19183186298.1PATENTAttorney Docket No. 125847.8050.W001 with the transmitting pins from connector side 2.Remarks

[0065] The foregoing description of various embodiments of the claimed subject matter has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit the claimed subject matter to the precise forms disclosed. Many modifications and variations will be apparent to one skilled in the art. Embodiments were chosen and described in order to best describe the principles of the invention and its practical applications, thereby enabling those skilled in the relevant art to understand the claimed subject matter, the various embodiments, and the various modifications that are suited to the particular uses contemplated.

[0066] Although the Detailed Description describes certain embodiments and the best mode contemplated, the technology can be practiced in many ways no matter how detailed the Detailed Description appears. Embodiments can vary considerably in their implementation details, while still being encompassed by the specification. Particular terminology used when describing certain features or aspects of various embodiments should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the technology with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the technology to the specific embodiments disclosed in the specification, unless those terms are explicitly defined herein. Accordingly, the actual scope of the technology encompasses not only the disclosed embodiments, but also all equivalent ways of practicing or implementing the embodiments.

[0067] The language used in the specification has been principally selected for readability and instructional purposes. It may not have been selected to delineate or circumscribe the subject matter. It is therefore intended that the scope of the technology be limited not by this Detailed Description, but rather by20183186298.1PATENTAttorney Docket No. 125847.8050.W001 any claims that issue on an application based hereon. Accordingly, the disclosure of various embodiments is intended to be illustrative, but not limiting, of the scope of the technology as set forth in the following claims.21183186298.1

Claims

1. PATENTAttorney Docket No. 125847.8050.W001CLAIMSWhat is claimed is:1 . A neuromodulation system comprising: a gel pad that is electrically connected with a first and second electrodes and is configured to be placed in contact with the skin of the living body, the gel pad including: the first electrode via which an electrical signal is to be applied to the skin of the living body at a first location; and the second electrode at which the electrical signal is received after traveling through an anatomical region of the living body; a pad tray connected to the gel pad and having a receiving surface with a receiving element extending from a securement surface opposite the gel pad, wherein the receiving element has at least one pair of receiving pins disposed about a central axis extending through a center of the receiving element, wherein each receiving pin in the pair of receiving pins is configured to receive an electrical signal and direct the electrical signal to the first electrode; and a neuromodulation device including: an outer surface that couples to the securement surface of the pad tray in multiple orientations; a transmitting element extending into the neuromodulation device along the central axis and having a first pair of transmitting pins and a second pair of transmitting pins, wherein one transmitting pin from each pair of transmitting pins contacts a receiving pin on the receiving element for each orientation of the neuromodulation device relative to the pad tray, and22183186298.1PATENTAttorney Docket No. 125847.8050.W001 wherein each transmitting pin aligns with each receiving pin to transmit an electrical signal to the receiving pin.

2. The neuromodulation system of claim 1 , wherein neuromodulation device controls an electrical potential of the first pair of transmitting pins independently from an electrical potential of the second pair of transmitting pins.

3. The neuromodulation system of claim 1 , wherein each receiving pin is disposed along a first axis perpendicular to the central axis; and wherein each receiving pin is disposed on opposing sides of a second axis that is perpendicular to the central axis and the first axis.

4. The neuromodulation system of claim 3, wherein a first transmitting pin from the first pair of transmitting pins and a third transmitting pin of the second pair of transmitting pins are disposed along the first axis on opposing sides of the second axis; and wherein a second transmitting pin of the first pair of transmitting pins and a fourth transmitting pin of the second pair of transmitting pins are disposed along the second axis on opposing sides of the first axis.

5. The neuromodulation system of claim 1 , wherein the receiving element of the pad tray includes two pairs of receiving pins and the transmitting element of the neuromodulation device includes four pairs of transmitting pins.

6. The neuromodulation system of claim 5, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central axis, and wherein each receiving pin of a second pair of receiving pins is disposed between the first pair of receiving pins on the first axis perpendicular.

7. The neuromodulation system of claim 5, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central23183186298.1PATENTAttorney Docket No. 125847.8050.W001 axis on opposing sides of a second axis that is perpendicular to the central axis and intersects with the first axis, and wherein each receiving pin of a second pair of receiving pins is disposed along the second axis on opposing sides of the first axis.

8. The neuromodulation system of claim 5, wherein the receiving element includes a third pair of receiving pins disposed on a third axis perpendicular to the central axis; and wherein the third axis intersects the first axis and the second axis.

9. A neuromodulation device including: an outer surface that couples to a securement surface of a pad tray in multiple orientations; and a transmitting element extending into the neuromodulation device along a central axis and having a first pair of transmitting pins and a second pair of transmitting pins, wherein one transmitting pin from each pair of transmitting pins contacts a receiving pin on a receiving element of a gel pad for each orientation of the neuromodulation device relative to a pad tray coupled to the gel pad, and wherein each transmitting pin aligned with each receiving pin transmits an electrical signal to the receiving pin.

10. The neuromodulation device of claim 9, wherein the first pair of transmitting pins and the second pair of transmitting pins have different electrical potentials.1 1 . The neuromodulation device of claim 9, wherein a first transmitting pin of the first pair of transmitting pins and a third transmitting pin of the second pair of transmitting pins are disposed along a first axis on opposing sides of a24183186298.1PATENTAttorney Docket No. 125847.8050.W001 second axis; and wherein a second transmitting pin of the first pair of transmitting pins and a fourth transmitting pin of the second pair of transmitting pins are disposed along the second axis on opposing sides of the first axis.

12. The neuromodulation device of claim 1 1 , wherein the transmitting element includes a third pair of transmitting pins disposed on a third axis perpendicular to the central axis; and wherein the third axis intersects the first axis and the second axis.

13. The neuromodulation device of claim 9, wherein a receiving element of a pad tray includes two pairs of receiving pins, wherein the receiving elements mates with the transmitting element of the neuromodulation device, and wherein the transmitting element includes four pairs of transmitting pins.

14. The neuromodulation device of claim 13, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central axis, and where each receiving pin of a second pair of receiving pins is disposed between the first pair of receiving pins on the first axis perpendicular.

15. The neuromodulation device of claim 13, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central axis on opposing sides of a second axis that is perpendicular to the central axis and the first axis, and wherein each receiving pin of a second pair of receiving pins is disposed along the second axis on opposing sides of the first axis.

16. A system comprising: a gel pad that is electrically connected with a first and second electrodes and is configured to be placed in contact with the skin of the living body, the gel pad including:25183186298.1PATENTAttorney Docket No. 125847.8050.W001 the first electrode via which an electrical signal is to be applied to the skin of the living body at a first location; and the second electrode at which the electrical signal is received after traveling through an anatomical region of the living body; a pad tray connected to the gel pad and having a receiving surface with a receiving element extending from a securement surface opposite the gel pad, wherein the receiving element has at least one pair of receiving pins disposed about a central axis extending through a center of the receiving element, wherein each receiving pin in the pair of receiving pins is configured to receive an electrical signal and direct the electrical signal to the first electrode.

17. The system of claim 16, wherein each receiving pin is disposed along a first axis perpendicular to the central axis; and wherein each receiving pin is disposed on opposing sides of a second axis that is perpendicular to the central axis and the first axis.

18. The system of claim 16, wherein the receiving element of the pad tray includes two pairs of receiving pins, wherein the receiving element mates with a transmitting element of a neuromodulation device, and where the transmitting element of the neuromodulation device includes four pairs of transmitting pins.

19. The system of claim 18, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central axis, and26183186298.1PATENTAttorney Docket No. 125847.8050.W001 where each receiving pin of a second pair of receiving pins is disposed between the first pair of receiving pins on the first axis perpendicular.

20. The system of claim 18, wherein each receiving pin of a first pair of receiving pins is disposed on a first axis perpendicular to the central axis on opposing sides of a second axis that is perpendicular to the central axis and the first axis, and wherein each receiving pin of a second pair of receiving pins is disposed along the second axis on opposing sides of the first axis.27183186298.1

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