Systems and methods for targeted electrical stimulation

Abstract

Provided herein are stimulation devices for generating a focused electric field for targeted electrical stimulation of muscle, and methods for using the same. The stimulation devices described herein may comprise multiple current sources electrically coupled to multiple electrodes that can directly deliver stimulation to muscle or a muscle-containing organ. The current sources may be connected in series via muscle or a muscle-containing organ. By using the stimulation devices described herein, the currents delivered to the electrodes may be independent of each other and may be regulated to generate a focused electric field.

Description

Technical Field

[0001] Cross-Reference to Related Applications This application claims priority and the benefit of U.S. Provisional Patent Application No. 63 / 588,500, filed on October 6, 2023, the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates generally to targeted electrical stimulation of muscles or organs comprising muscles, and more specifically to generating a focused electric field for targeted electrical stimulation of muscles or organs comprising muscles.

Background Art

[0003] Implantable medical devices may be used to electrically stimulate patient tissue to treat various medical conditions. For example, implantable devices may be used to stimulate muscles, organs, peripheral nerves, cardiac tissue, the brain, or other tissues for therapeutic treatment. Implantable devices may use a voltage source or a current source coupled to one or more electrodes to electrically stimulate tissue. The energy delivered to the electrodes via the current source or voltage source may be uniform, thus generating a uniform electric field for stimulating tissue. Uniform electric fields are not ideal for stimulating organs where tissue properties undesirably modulate the distribution of the electric field, thus causing inaccurate stimulation of the tissue. For example, delivering a uniform energy source to a muscle or organ with variable tissue impedance, such as the bladder, may result in some regions of the tissue intended to be stimulated being understimulated or overstimulated, and other regions of tissue not intended to be stimulated being stimulated.

[0004] To compensate for understimulation, the administrator of the stimulation therapy may increase the total amount of energy delivered to the electrodes via the current or voltage source. However, uniformly increasing the energy delivered to the electrodes is also not ideal, as it may lead to further overstimulation of other areas of tissue, which could cause damage to these areas. It may also increase the amount of tissue being stimulated, which is not intended to be stimulated. Furthermore, it may result in unnecessarily high power draws from the power source of the implanted device. For implanted devices whose energy storage capacity is already limited due to their small size, increased power draws can significantly shorten the lifespan of the implanted device, requiring more frequent charging or replacement. Increasing the number of charging regimens or follow-up surgeries to replace the implanted device places a considerable mental, physical, and financial burden on the patient. [Overview of the project]

[0005] This specification describes an implantable device for targeted electrical stimulation and a method for generating a focused electric field for electrical stimulation of muscle. The stimulation device described herein may comprise a plurality of independent current sources configured to deliver independent currents to electrodes. Each of the currents delivered by the current sources may be independently adjustable to generate a focused electric field for targeted electrical stimulation. The amount of energy delivered to a given electrode via the current sources coupled to the electrodes may be modified, for example, based on the impedance of the tissue at the site of the implanted electrode. In this way, a focused electric field can be generated for targeted electrical stimulation of muscle, produced by various currents delivered to a plurality of electrodes. By using the implantable device and targeted stimulation system described herein, unintended distribution of energy to the electrodes (or current sources coupled to the electrodes) can be avoided, thus maintaining the state of the tissue at and around the implanted electrode site, and extending the lifespan of the implantable device. Furthermore, it is possible to generate more customized, precise, and effective electrical stimulation regimens for muscle, thus improving patient health outcomes.

[0006] In some examples, a stimulation device is provided comprising multiple current sources and multiple electrodes electrically coupled to the multiple current sources, wherein the electrodes are configured to directly stimulate a muscle or a muscle-containing organ, and each electrode of the multiple electrodes is configured to be actuated using an independent current source of the multiple current sources. Each current source of the multiple current sources may be electrically coupled in series to at least one other current source of the multiple current sources via a muscle or a muscle-containing organ. In some implementations, the independent current sources of the multiple current sources are configured to supply or absorb current independently of the current supplied or absorbed by the other current sources of the multiple current sources. The current supplied by the multiple current sources may be adjustable by a control circuit electrically coupled to each current source of the multiple current sources. In some examples of the stimulation device, at least one current source of the multiple current sources is adjustable between supplying or absorbing current by a control circuit electrically coupled to at least one current source. A switch may be electrically coupled to the independent current source to control whether the independent current source supplies current to the electrode or absorbs current from the electrode.

[0007] Multiple electrodes in a stimulating device may be configured to generate a focused electrical stimulation field for targeted stimulation of a muscle or a muscle-containing organ, based on independent currents from multiple current sources. The electrical stimulation field may be, for example, a two-dimensional or three-dimensional current field.

[0008] A stimulating device may include a control circuit configured to generate a current waveform that is electrically coupled to each of a plurality of current sources and delivered to the plurality of current sources. In some implementations of the device, the control circuit is configured to receive commands from an external device, which are configured to cause the control circuit to deliver a current waveform to one or more of the plurality of current sources. The stimulating device may include, for example, one or more ultrasonic transducers, and the control circuit receives commands from ultrasonic waves emitted by an external device. The control circuit may be configured to communicate with the external device using, for example, ultrasonic backscatter. In another implementation of the device, the stimulating device includes a radio frequency (RF) antenna, and the control circuit receives commands from radio waves emitted by an external device. Thus, the control circuit may be configured to communicate with the external device using radio wave backscatter.

[0009] In some implementations of the device, the stimulating device comprises a radio frequency (RF) antenna, and multiple current sources are configured to receive energy from RF waves emitted by an external device. In other implementations of the device, the stimulating device comprises one or more ultrasonic transducers, and multiple current sources are configured to receive energy from ultrasonic waves emitted by an external device.

[0010] A first portion of the multiple electrodes of the stimulating device may be arranged on a first paddle configured to be embedded in a first location in a muscle or organ containing muscle, and a second portion of the multiple electrodes may be arranged on a second paddle configured to be embedded in a second location in a muscle or organ containing muscle. The first paddle and / or the second paddle may include, for example, a conductive shell configured as an electrode.

[0011] The stimulation device may include one or more stimulation leads, each electrically coupled to an independent current source of a plurality of current sources.

[0012] In some implementations, the stimulating device further includes energy storage electrically coupled to multiple current sources.

[0013] In some implementations, the multiple electrodes each comprise at least one anode and at least one cathode configured to deliver bipolar stimulation to a muscle or organ containing muscle.

[0014] In some implementations, at least some of the multiple current sources are configured to function as current sinks that absorb current.

[0015] In some implementations, multiple current sources comprise one or more transistors.

[0016] In some implementations, multiple electrodes are configured to directly stimulate the bladder wall to induce bladder emptying.

[0017] Also provided herein is a stimulation system comprising a stimulation device and an external device configured to communicate with the stimulation device. Optionally, the system includes a magnet configured to turn the stimulation device on and / or off.

[0018] In some examples, a method is provided for generating a focused electric field to stimulate a muscle or a muscle-containing organ, the method comprising: delivering initial independent currents to a plurality of electrodes embedded in the muscle or a muscle-containing organ; generating an initial electric field for stimulating the muscle or a muscle-containing organ by the plurality of electrodes; delivering updated independent currents to one or more electrodes of the plurality of electrodes; and generating a focused electric field for directly stimulating the muscle or a muscle-containing organ by the plurality of electrodes.

[0019] The method may include delivering initial energy to a stimulating device and stimulating a muscle or a muscle-containing organ using an initial electric field generated by multiple electrodes using the initial energy delivered to the stimulating device. The energy may be delivered, for example, using an external device. In some implementations, the energy is delivered using ultrasound emitted by the external device. In another example, the energy is delivered using radio waves emitted by the external device.

[0020] The method may further include sending one or more commands to the stimulating device that indicate the operating parameters of the stimulating device. The commands may be encoded, for example, into ultrasound emitted by an external device. In another example, the commands may be encoded into radio waves emitted by an external device.

[0021] Furthermore, provided herein are methods for treating bladder incontinence in subjects requiring treatment for bladder incontinence, which include applying electrical stimulation using the stimulation devices described herein.

[0022] Further described is a method for generating a focused electric field to stimulate a muscle or a muscle-containing organ, comprising: delivering initial independent currents to a plurality of electrodes embedded in the muscle or a muscle-containing organ; generating an initial electric field for stimulating the muscle or a muscle-containing organ by the plurality of electrodes; delivering updated independent currents to one or more electrodes of the plurality of electrodes; and generating a focused electric field for directly stimulating the muscle or a muscle-containing organ by the plurality of electrodes. The initial electric field and / or focused electric field are two-dimensional or three-dimensional current fields. In some implementations, the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes. Each electrode of the plurality of electrodes may be actuated using an independent current source of the plurality of current sources, each of which is configured to absorb or supply a current independent of the current supplied or absorbed by the other current sources of the plurality of current sources. The currents supplied by the plurality of current sources may be tunable by a control circuit electrically coupled to each current source of the plurality of current sources. In some implementations, at least one current source of a group of current sources may be adjustable between supplying or absorbing current by a control circuit electrically coupled to at least one current source. Switches electrically coupled to independent current sources of the group of current sources may be configured to control whether an independent current source supplies current to an electrode or absorbs current from the electrode.

[0023] According to some implementations of the method, delivering updated independent currents to one or more electrodes of a plurality of electrodes may include updating one or more operating parameters of one or more current sources of a plurality of electrodes electrically coupled to one or more electrodes in order to deliver updated independent currents to one or more current sources. In some examples, delivering updated independent currents to one or more electrodes of a plurality of electrodes includes updating the current waveform delivered to one or more current sources.

[0024] In some embodiments, the updated independent current delivered to a given electrode of the one or more electrodes may be smaller than the initial independent current delivered to the given electrode of the one or more electrodes. In another example, the updated independent current delivered to a given electrode of the one or more electrodes is greater than the initial independent current delivered to the given electrode of the one or more electrodes. In other examples of the method, delivering the updated independent current to a given electrode of the one or more electrodes includes not delivering current to the given electrode of the one or more electrodes.

[0025] The plurality of electrodes of the device used in the method may include at least one anode and at least one cathode that together deliver bipolar stimulation to a muscle or an organ comprising a muscle when an initial electric field and / or a focused electric field is generated.

[0026] In some examples of the method, the method may include receiving energy from an external device. For example, the energy may be received from ultrasound emitted by the external device. In another example, the energy may be received from radio waves emitted by the external device.

[0027] In some implementations of the method, the method may include receiving a command from an external device indicating that an initial independent current is to be delivered to the plurality of electrodes, and delivering the initial independent current to one or more electrodes of the plurality of electrodes. The command may be encoded, for example, in ultrasound emitted by the external device. In another example, the command is encoded in radio waves emitted by the external device.

[0028] In some implementations of the method, the method may include receiving a command from an external device indicating that initial independent currents delivered to one or more electrodes of the plurality of electrodes are to be updated, and delivering updated independent currents to the one or more electrodes of the plurality of electrodes. The command may, for example, be encoded in ultrasound waves emitted by the external device. In another example, the command is encoded in radio waves emitted by the external device.

[0029] In some implementations of the method, the method includes communicating with an external device using ultrasound backscatter. In another example, the method includes communicating with an external device using radio wave backscatter.

[0030] Further described herein is a method for treating bladder incontinence in a subject in need of treatment for bladder incontinence, comprising applying electrical stimulation according to the method described above. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of exemplary embodiments and the accompanying drawings.

[0032] [Figure 1A] FIG. 1A shows a schematic diagram of a first exemplary targeted electrical stimulation device on an organ comprising muscle, according to some embodiments.

[0033] [Figure 1B] FIG. 1B shows a schematic diagram of another exemplary targeted electrical stimulation device, according to some embodiments.

[0034] [Figure 1C] FIG. 1C shows a schematic diagram of another exemplary targeted electrical stimulation device, according to some embodiments.

[0035] [Figure 1D] Figure 1D shows a schematic diagram of another exemplary targeted electrical stimulation device according to several embodiments.

[0036] [Figure 2] Figure 2 shows a block diagram of a first exemplary electrical stimulation system according to several embodiments.

[0037] [Figure 3] Figure 3 shows a block diagram of another exemplary electrical stimulation system according to several embodiments.

[0038] [Figure 4] Figure 4 shows schematic diagrams of non-target electrical stimulation devices on muscle-containing organs according to several embodiments.

[0039] [Figure 5] Figure 5 shows several embodiments of methods for generating a focused electric field for target electrical stimulation. [Modes for carrying out the invention]

[0040] Described herein are implantable systems and devices for targeted electrical stimulation, and methods for generating a focused electric field to electrically stimulate tissue. A targeted electrical stimulation system may comprise multiple current sources electrically coupled to multiple electrodes, the current sources connected in series via muscle or a muscle-containing organ. Each current source may be configured to deliver an independent current to a given electrode, and together they may generate a focused electric field across the multiple electrodes. The current delivered to the electrodes can be adjusted to target an intended stimulation site, as well as to accommodate varying tissue impedances throughout the muscle, thereby reducing unintended electrical stimulation of other areas of the muscle and extending the lifespan of the stimulation device by reducing power consumption.

[0041] The following disclosure describes targeted electrical stimulation devices and systems in several embodiments. The disclosure also provides methods for generating a focused electric field for targeted stimulation, methods for electrically stimulating tissue using a focused electric field generated using an electrical stimulation system described herein, and methods for therapeutic use of an electrical stimulation system described herein.

[0042] Stimulation devices and systems An exemplary stimulation device may comprise one or more current sources coupled to one or more electrodes. Figures 1A to 1D show schematic diagrams of a target electrical stimulation device 100 according to several embodiments. As shown in Figure 1A, the device 100 may comprise a first plurality of current sources 102a, 102b, 102c, 102d (hereinafter collectively referred to as current source 102 for simplicity). The device 100 may comprise a second plurality of current sources 104a, 104b, 104c, 104d (hereinafter collectively referred to as current source 104 for simplicity). The device 100 may comprise any number of current sources 102, 104. For example, the device 100 may comprise 2, 3, 4, 5, 6, 7, 8, 9, 10 or more current sources 102, 104.

[0043] Each of the first current sources 102 may be electrically coupled in series to at least one of the second current sources 104 via a muscle 108 or a muscle-containing organ. For example, as shown in Figure 1A, current source 102a may be coupled in series to current sources 104a, 104b, 104c, and / or 102d. Current source 102b may be coupled in series to current sources 104a, 104b, 104c, and / or 104d, etc., via a muscle or a muscle-containing organ. In some embodiments, a first current source 102 (e.g., current source 102c) may be coupled in series to a plurality of current sources 104 (e.g., current sources 104c, 104d) via a muscle or a muscle-containing organ. An opposite scenario may also occur in which multiple first current sources 102 (e.g., current sources 102a, 102b, 102c, and / or 102d) may be electrically coupled in series to a second current source 104 (e.g., current source 104a) via muscle or a muscle-containing organ. It is understood that other configurations of current sources 102, 104 are included within the scope of this disclosure.

[0044] In some embodiments, either the first plurality of current sources 102 or the second plurality of current sources 104 can be a current sink. For example, the first plurality of current sources 102 may be a current source, while the second plurality of current sources 104 may be a current sink. Thus, the current source 102 may supply current, and the current source 104 may receive (or absorb) current transmitted through the tissue by the current source 102. The opposite scenario can also occur, where the current source 102 is a current sink and the current source 104 is a current source, with the current source 102 configured to absorb current supplied by the current source 104. In some embodiments, the first portion of the current source 102 may be a current source, and the second portion of the current source 102 may be a current sink. Similarly, the first portion of the current source 104 may be a current source, and the second portion of the current source 104 may be a current sink. In some embodiments, the current sources may be configured to operate as either a source or a sink based on parameters programmed into the stimulation device.

[0045] The arrangement of current sources 102 and 104 on the muscle or organ 108 in Figure 1A is not intended to be limited to the opposite side of the target stimulation area. Furthermore, the current can be supplied to the electrodes by the current sources in any direction and is not limited to the bottom-to-top (or top-to-bottom) configuration shown. Figures 1B–1D show additional exemplary current source and electrode configurations. Figure 1B shows a stimulation system 100 in which the direction of current delivered to electrode 106a and then received by electrode 106b may alternate. Figures 1C–1D show a stimulation system 100 in which current sources 102 and 104 are each electrically coupled to a single electrode 106, and either current source 102 or 104 may be configured as a current sink (described in more detail below). Whether the current is delivered from current source 102 to electrode 106 or received from current source 104 to electrode 106 may be controlled by a control circuit (as shown in Figure 2) coupled to current sources 102 and 104. As shown in Figure 1D, the control circuit can control one or more switches 105 electrically coupled to current sources 102, 104 to control whether current is delivered to or received from electrode 106.

[0046] In any scenario, each of the current sources (e.g., current sources 102a, 102b, 104a, 104b, etc.) may be configured to supply and / or receive a current independent of the currents supplied / received by the other current sources 102, 104. For example, current source 102a may deliver a first current to electrode 106a, while current source 102b may deliver a second current to electrode 106b. The first and second currents may be different. The first current may be greater than, less than, or equal to the second current. Current source 104a may be configured to receive a third current based on the first and / or second currents delivered by current sources 102a, 102b, respectively. The third current received by current source 104 may be a combination of at least a portion of the first current and at least a portion of the second current. Current source 104b may be configured to receive a fourth current based on the first and / or second currents delivered by current sources 102a and 102b, respectively. The fourth current received by current source 104 may be a combination of at least a portion of the first current and at least a portion of the second current. The third current received by current source 104a may be greater than, approximately equal to, or less than the current received by current source 104b. Each of the first, second, third, and fourth currents may be supplied and received independently of each other. One or more of the currents may be substantially the same, or one or more of the currents may be different. Each of the currents supplied by current source 102 and / or current source 104 may be independently adjustable, as will be described in more detail below.

[0047] Current sources 102, 104 may be electronic circuits or components thereof configured to deliver current. Current sinks may be electronic circuits or components thereof configured to absorb current. As described herein, one or more current sources may further, or instead, function as current sinks. In some embodiments, a plurality of current sources 102, 104 may comprise one or more operational amplifiers (op-amps). In some embodiments, a plurality of current sources 102, 104 may comprise one or more transistors. Exemplary transistors that may be used to implement current sources 102, 104 may include metal-oxide-semiconductor field-effect transistors (MOSFETs), such as NMOS transistors, PMOS transistors, and CMOS transistors. In some embodiments, one or more of the current sources 102, 104 may be implemented using current sources (and / or sinks) whose resistances can be dynamically adjusted to accommodate changes in current. Such current sources may be circuits comprising transistors such as MOSFETs.

[0048] As described above and shown in the device 100 in Figures 1A to 1D, the stimulating device 100 may be equipped with multiple electrodes 106 such as electrodes 106a, 106b, 106c, and 106d (hereinafter collectively referred to as electrodes 106 for simplicity). As shown in Figure 1A, each electrode 106 may be coupled to one or more current sources 102 and / or one or more current sources 104 via one or more leads 116, etc. Multiple electrodes 106 may be configured to directly stimulate a muscle 108 or an organ containing muscle. For example, multiple electrodes 106 may be implemented in an implantable device for stimulating a muscle (e.g., muscle tissue) or an organ containing muscle into which the device is implanted.

[0049] In some embodiments, electrode 106 may comprise one or more epimysial electrodes configured to be directly implanted on a muscle or organ containing muscle. The epimysial electrodes may be surgically attached to the tissue surrounding the muscle (e.g., the epimysium). For example, electrode 106 may be arranged on one or more paddles configured to be implanted on a muscle or organ containing muscle, as described herein with respect to device 300 and Figure 3. In some embodiments, electrode 106 may comprise one or more button electrodes. In some embodiments, electrode 106 may be platinum-iridium electrodes that can be fixed to (and / or surrounded by) an insulating substrate (e.g., silicone) to minimize the spread of current to other excitable areas of the muscle (or organ containing muscle). For example, one or more electrodes 106 may be molded within a medical-grade silicone substrate paddle.

[0050] In some embodiments, one or more electrodes 106 may be electrically coupled to one another. For example, as described herein, one or more electrodes 106 may be electrically coupled in series via a muscle or a muscle-containing organ. In other words, a plurality of electrodes may include at least one anode and at least one cathode configured to together deliver bipolar stimulation to a muscle 108 or a muscle-containing organ. The anode and cathode are indicated by minus and plus signs in Figures 1A-1B, respectively. Referring to Figure 1A, electrode 106a may be electrically coupled to electrodes 106c and / or 106d via a muscle or a muscle-containing organ. Similarly, electrode 106b may be electrically coupled to electrodes 106c and / or 106d. As shown, a current source (e.g., current source 102a) may be electrically coupled to cathode electrode 106a, and a current sink (e.g., current source 104a) may be electrically coupled to anode electrode 106c. In some embodiments, a predetermined anode and cathode may be arranged within approximately 5 to 20 mm of each other, such as being about 10 mm apart from each other.

[0051] Each electrode of the multiple electrodes 106 may be configured to be actuated using an independent current source, current sources 102, 104. For example, electrode 106a may be electrically coupled to current source 102a and actuated by current source 102a. In this case, current source 102a may supply current to electrode 106a, which may be delivered to a muscle or organ containing muscle at least before being received by electrode 106c, and electrode 106c may transmit the received current to current source 104a (acting as a current sink). The opposite scenario may also occur in which current source 104a is configured to supply current to electrode 106c, and at least a portion of it may then be received by current source 102a (via electrode 106a). The current supplied to electrode 106a may be used to deliver electrical stimulation to a muscle 108 or organ containing muscle at / around electrode 106a. The same or similar configurations may be applied to electrodes 106b and 106d. For example, electrode 106b may be electrically coupled to current source 102b, and electrode 106d may be electrically coupled to current source 104b. Either current source 102 or 104 (or a combination thereof) may supply and / or receive the current passed through electrode 106.

[0052] In some embodiments, a given electrode 106 (e.g., electrode 106a) may be electrically coupled to a plurality of current sources 102, 104. For example, Figures 1C-1D show a stimulation system 100 comprising an electrode 106 which may be electrically coupled to a current source 102 configured to supply current and a current source 104 (e.g., a current sink) configured to absorb current. Electrode 106 may be programmed to operate as an anode or cathode. The current sources 102, 104 may be configured interchangeably as current sources and / or sinks. For example, the current sources 102, 104 may be electrically coupled to a control circuit configured to control whether the current sources 102, 104 are configured to absorb or supply current. Furthermore, in a given example, the control circuit may control whether a current source (e.g., current source 102) can deliver current to electrode 106 or whether a current sink (e.g., current source 104) can absorb current from electrode 106. Similarly, Figure 1D shows current sources 102 and 104 electrically coupled to a switch 105 configured to control whether current is delivered to electrode 106 (e.g., from current source 102) or absorbed from electrode 106 (e.g., by current source 104). Switch 105 may be controlled by a control circuit.

[0053] In some embodiments, each of the current sources 102 and 104 may be independently electrically coupled to a control circuit for controlling the current delivered to each of the electrodes 106. The methods by which the current sources 102 and 104 can control the current at the electrodes 106 (e.g., via the device's control circuit) are described in more detail below with reference to Figure 2.

[0054] In some embodiments, one or more cathode electrodes may be electrically coupled (e.g., via one or more leads) to one or more other cathode electrodes of the stimulation system 100. For example, electrode 106a may be electrically coupled to electrode 106b. Similarly, in some embodiments, one or more anode electrodes may be electrically coupled (e.g., via one or more leads) to one or more other anode electrodes. For example, electrode 106c may be electrically coupled to electrode 106d. In some embodiments, an anode electrode may not be electrically coupled to another anode electrode, and / or a cathode electrode may not be electrically coupled to another cathode electrode. In any example, in order to generate at least a portion of a focusable electric field, a given electrode (e.g., electrode 106a) may be positioned in close proximity to another electrode (e.g., electrode 106b).

[0055] The arrangement of electrodes 106 is not intended to be limited to the horizontal and linear configuration shown in Figures 1A-1D. For example, electrodes 106 may be arranged in a linear configuration oriented in different directions (e.g., vertical, oblique, or other), along curves (in any orientation), in shapes (e.g., circular, oval, triangular, rectangular, or other polygons oriented in any orientation), in a zigzag pattern or without a specific pattern (e.g., randomly). The arrangement of electrodes 106 may be designed to best achieve electrical stimulation using electrodes 106 on the intended muscle 108 or organ containing muscle. Furthermore, as stated above, the illustrated arrangement of current sources 102, 104 relative to the electrodes is for illustrative purposes only. Those skilled in the art will understand that current sources 102, 104 may be implemented in the circuit of the stimulation system 100 in a manner not limited to the arrangement depicted in Figures 1A-1D. Rather, the electrical configuration between current sources 102, 104 (via one or more electrodes 106) may be important. As described above, the multiple current sources 102 may be electrically coupled in series to at least one other current source of the multiple current sources 104 via a muscle 108 or an organ containing muscle.

[0056] In some embodiments, multiple electrodes 106 may be configured to generate a focusable electrical stimulation field 110 for targeted electrical stimulation of a muscle 108 or an organ comprising muscle, using independent currents delivered by a current source 102 (and / or current source 104). The electrical stimulation field 110 may be a two-dimensional (2D) or three-dimensional (3D) current field. As described herein, a muscle 108 or an organ comprising muscle may have tissue impedance (or resistance) that varies depending on the region of the muscle. For example, the tissue impedance 108a in a first region of muscle 108 may differ from the tissue impedance 108b in a second region of muscle 108 that is different from the first region. These variations in tissue impedance across the muscle may affect the electrical stimulation field 110 generated based on the currents delivered to the electrodes 106. To account for these variations, the device 100 may be configured to deliver independent currents to the electrodes 106 by a current source 102 (and / or current source 104). In this way, a focusable electrical stimulation field 110 can be generated.

[0057] In some embodiments, the muscle 108 may be a muscle of the bladder wall (e.g., a sphincter). Directly stimulating these muscles of the bladder wall can be difficult. Therefore, using the targeted electrical stimulation device described herein, a plurality of electrodes 106 may be configured to directly stimulate the muscles of the bladder wall, for example, to induce bladder emptying.

[0058] In some embodiments, the device 100 may be configured to generate an electric field (e.g., an electric field) having a predetermined electric field strength. The electric field strength may be adjustable to effectively stimulate the bladder wall.

[0059] The focusable electrical stimulation field 110 described above is in contrast to an electrical stimulation field generated by a uniform voltage (or current) source. For example, Figure 4 shows an electrical stimulation device 400 in which voltage sources 452, 454 are configured to deliver a uniform voltage to electrodes 456a, 456b (hereinafter collectively referred to as electrodes 456). Voltage sources 452, 454 could instead be current sources that deliver a uniform current to electrodes 456. Based on this voltage (or current), electrodes 456 can generate a uniform electrical stimulation field 462 regardless of the fluctuating tissue impedance of the muscle 458 or organ containing muscle. The varying tissue impedances throughout a given muscle or organ (e.g., bladder) can cause certain areas of the muscle / organ to receive stimulation more easily than other areas, which can negatively affect the effectiveness of the stimulation regimen.

[0060] Furthermore, the electrical stimulation field 462 may not accurately capture the target stimulation area of ​​the muscle 458 or organ containing muscle. For example, as shown in Figure 4, the target stimulation area 460 may be only a small part of the size of the large electrical stimulation field 462. In this case, areas that may not require treatment may be affected by the electrical stimulation field 462, which is an inefficient use of the limited energy resources of the implantable device. In another (not shown) example, the placement of electrodes 456 on the stimulation device may not accurately capture the intended stimulation area of ​​the muscle 458 or organ containing muscle. Generating the electrical stimulation field 462 by uniformly applying voltage (or current) to electrodes 456 may not adequately stimulate the target stimulation area 460 (e.g., it may be understimulated). In this case, the administrator of the stimulation regime may increase the energy delivered to electrodes 456 in an attempt to stimulate the target stimulation area 460, which may result in overstimulation of unintended areas of the muscle 458 or organ containing muscle. This excessive stimulation of the tissue can have adverse effects and waste the power of the stimulation device.

[0061] Figure 2 shows a block diagram of a first exemplary electrical stimulation system according to several embodiments. The electrical stimulation system 230 may include a stimulation device 200 having any one or more features of the stimulation device 100 described herein with respect to Figures 1A to 1D. For example, current sources 202, 204 may have any one or more features of the current sources 102, 104 (each) of device 100, and electrodes 206 (e.g., electrodes 206a, 206b, hereinafter collectively referred to as electrodes 206) may have any one or more features of electrodes 106 of device 100. In some embodiments, the current source 202 may include one or more transistors. The plurality of electrodes 206 may include one or more anodes and one or more cathodes configured to deliver bipolar stimulation.

[0062] The stimulation system 230 (e.g., the stimulation device 200) may include a control circuit 212 for controlling the current delivered to the current sources 202. For example, the control circuit 212 may be configured to generate one or more current waveforms (also referred to more simply as currents herein) that can be delivered to a plurality of current sources 202. More generally, the control circuit 212 may control the flow and storage of energy and information within the stimulation device 200. The control circuit 212 may be electrically coupled to each of the plurality of current sources 202 via leads 216, as shown by solid lines connecting the current sources 202 and the block of the control circuit 212.

[0063] In some embodiments, the control circuit 212 may include an application-specific integrated circuit (ASIC) and / or a low-power microcontroller configured to control the ASIC and other electronic components of the stimulator device 200.

[0064] In some embodiments, the stimulating device 200 may comprise one or more leads 216 (e.g., stimulating leads) capable of electrically coupling each electrode of a plurality of electrodes 206 to one or more independent current sources of a plurality of current sources 202, 204. The leads 216 may be similar to leads commonly used in the art in terms of size, material, construction, contact shape, etc. For example, the leads 216 may have a diameter of 1 to 2 mm and may include ethylene-tetrafluoroethylene (ETFE) copolymer conductive wire insulating material and / or 55D urethane lead body material.

[0065] An exemplary stimulation system may comprise a stimulation device 200 and an external device 220 configured to communicate with the stimulation device 200. For example, the control circuit 212 of the stimulation device 200 may be communicatively coupled to the external device 220. The control circuit 212 may be configured to receive commands from the external device 220 to cause the control circuit 212 to deliver current waveforms to one or more current sources of a plurality of current sources 202. The stimulation device 200 may be configured to receive energy transmitted by the external device 220. The stimulation device 200 may be configured to receive energy from the external device 220 whenever the external device 220 is positioned in proximity to the implanted location of the stimulation device 200. In some embodiments, the external device 220 may be a separate device implanted (at least partially) in the patient. In such cases, the external device 220 may be programmed to periodically deliver energy to the stimulation device 200. In some embodiments, the external device 220 may be configured to be remotely controlled by a device such as a smartphone or computer (e.g., the patient's smartphone), and may transmit energy to the stimulating device 200 whenever it receives an appropriate command from the remote device.

[0066] In some embodiments, the external device 220 and the control circuit 212 may be communicatively coupled by a transducer 214 configured to wirelessly receive and transmit energy and / or commands between the stimulating device 200 (e.g., the control circuit 212 of the stimulating device 200) and the external device 220. These commands received by the transducer 214 may indicate operating parameters of the stimulating device 200. In some embodiments, the transducer 214 may be configured to convert the energy received from the external device 220 into an electric current. In some embodiments, the stimulating device 200 may include a communication circuit electrically coupled to the transducer 214 and configured to actuate the transducer 214.

[0067] In some embodiments, the transducer 214 may comprise one or more ultrasonic transducers. Thus, the control circuit 212 may receive commands from ultrasonic waves emitted by the external device 220. In some embodiments, the current source 202 may be configured to receive energy from ultrasonic waves emitted by the external device 220. Exemplary ultrasonic transducers include, but are not limited to, bulk piezoelectric transducers, piezoelectric micromachining transducers, or capacitive micromachining transducers, each of which may be configured to convert the energy carried by ultrasonic waves emitted by the external device 220 into an electric current signal.

[0068] In some embodiments, the transducer may include one or more radio frequency (RF) antennas or one or more RF coils. Thus, the control circuit 212 may receive commands from radio waves radiated by the external device 220. In some embodiments, the current source 202 may be configured to receive energy from RF waves radiated by the external device 220. The RF antennas and / or coils may be configured to convert the energy carried by the RF waves into current signals.

[0069] In some embodiments, the transfer of information from the stimulating device 200 to the external device 220 may depend on a backscatter communication protocol. For example, the control circuit 212 may communicate with the external device 220 using ultrasonic backscatter or radio wave backscatter. The external device 220 may be configured to transmit radio signals (e.g., ultrasonic signals or RF signals) to the stimulating device 200, as discussed. If the patient wishes to obtain information from the stimulating device 200, the control circuit 212 may cause the modulation circuit of the stimulating device 200 to encode information into a current flowing through the stimulating device 200. The encoded current may be transmitted from the modulation circuit to a transducer 214, which may convert the encoded current into an encoded radio signal (e.g., ultrasonic signal or RF signal) of the same type as that radiated by the external device 220. This encoded radio signal ("backscatter" signal) may be radiated by the transducer 214 and subsequently received by the external device 220. Next, the external device 220 can decode the backscatter signal to obtain the encoded information.

[0070] In addition to, or instead of, backscatter communication, the transfer of information from the stimulating device 200 to the external device 220 may rely on an active communication protocol (e.g., active radio wave or ultrasonic transmission). The active radio wave or ultrasonic transmission may be modulated using amplitude modulation (AM), frequency modulation (FM), phase modulation (PM), pulse code modulation (PCM), polarization modulation, quadrature amplitude modulation (QAM), or any other suitable modulation scheme. In such embodiments, the control circuit 212 may cause the transducer 214 to generate and transmit a signal encoding information. The external device 220 may receive and decode the signal to obtain the encoded information. In some embodiments, the stimulating device 200 may include energy storage 218. The energy storage 218 (e.g., a capacitor) may be electrically coupled independently to the current source 202 and electrically coupled to the transducer 214. To minimize size, the stimulating device 200 may include only small energy storage 218 (e.g., a small capacitor). For the stimulating device 200 to provide therapy to a patient, the energy storage 218 may need to be charged periodically. For example, as described herein, energy for charging the energy storage 218 may be delivered to the stimulating device 200 by an external device 220. In some embodiments, the stimulating device 200 may include an AC / DC rectifier configured to convert the current from the transducer 214 from an alternating current (AC) signal to a direct current (DC) signal, which may be used to charge the energy storage 218.

[0071] In some embodiments, the stimulating device 200 may include a power management unit configured to store energy and distribute it to the device's components (understood to include an energy storage 218), a modulation circuit configured to encode information into current, a transmitter configured to wirelessly receive, convert, and transmit energy from an external device 220, and / or a memory configured to store data received from one or more sensors (e.g., electrodes 206).

[0072] In some embodiments, the exemplary stimulation system 230 may comprise the stimulation device 200 and external device 220 described herein, as well as an external magnet. The magnet may be configured to turn the stimulation device 200 on and off, for example, by moving the magnet in close proximity to the stimulation device 200.

[0073] Figure 3 shows a block diagram of a second exemplary electrical stimulation device according to several embodiments. The stimulation device 300 may each comprise any one or more features of the stimulation device 100 and / or stimulation device 200 described herein with respect to Figures 1 and 2. For example, electrodes 306a and 306b may comprise any one or more features of electrodes 106 and 206 described herein with respect to Figures 1A to 1D and 2. Current sources 302a and 302b may comprise any one or more features of current sources 102 and 202 described herein with respect to Figures 1A to 1D and 2. Current sources 304a and 304b may comprise any one or more features of current sources 104 and 204 described herein with respect to Figures 1A to 1D and 2. The control circuit 312 may comprise any one or more features of the control circuit 212 described herein with respect to Figure 2.

[0074] Figure 3 can illustrate a device 300 in which the device components may be distributed to different regions relative to the patient. For example, the device 300 may comprise one or more paddles 300a, 300b that can be implanted on a region of interest such as a muscle 308 or an organ containing muscle. Furthermore, as shown in Figure 3, the device 300 may comprise a control unit 300c comprising a control circuit 312 that can be electrically coupled to the paddles 300a, 300b. This control unit 300c may be implanted away from or in close proximity to the one or more paddles 300a, 300b. In some embodiments, the control unit 300c may not be implanted in the patient and may instead be an external device. The control unit 300c may comprise any one or more components described herein with respect to the stimulating device 200 shown in Figure 2. For example, the control unit 300c may comprise one or more transducers, energy storage, etc., which are not shown for simplification.

[0075] In some embodiments, one or more electrodes 306a may be arranged on a first paddle 300a, and one or more electrodes 306b may be arranged on a second paddle 300b. The electrodes may be anode, cathode, or configured to be interchangeable between anode and cathode. As shown in Figure 3, the first paddle 300a may be embedded in a first location of muscle 308 or organ comprising muscle, and the second paddle 300b may be embedded in a second location of muscle 308 (or organ comprising muscle). In some embodiments, the first paddle 300a and / or the second paddle 300b may comprise a conductive shell that can function as an electrode. As described herein, the paddles 300a, 300b may include an insulating substrate, such as silicone, that can surround the electrodes 306a, 306b to prevent the spread of stimulating current to unintended areas of muscle or organ comprising muscle.

[0076] Each electrode 306a, 306b may be coupled to one or more current sources. For example, one or more leads (e.g., stimulating leads) may electrically couple electrode 306a to one or more current sources 302a, 304a. Similarly, one or more leads may electrically couple electrode 306b to one or more current sources 302b, 304b. In some embodiments, a paddle 300a may comprise one or more electrodes 306a, each capable of being coupled to an independent current source 302a, and a paddle 300b may comprise one or more electrodes 306b, each capable of being coupled to a current source 304b (e.g., a current sink). In other words, a paddle 300a may comprise electrodes electrically coupled independently to current sources, and a paddle 300b may comprise electrodes electrically coupled independently to a current sink (or vice versa).

[0077] In some embodiments, one or more of components 300a, 300b, and 300c may be reasonably combined, or one of the paddles 300a or 300b may be omitted. For example, an exemplary device may comprise two components: a paddle 300a having one or more electrodes 306a coupled to independent current sources 302a, 304a; and a control unit 300c having at least a control circuit 312 and coupled (e.g., via one or more leads) to the current sources 302a, 304a located on the paddle 300a. In another example, a single paddle (e.g., paddle 300a) may have the features of paddles 300a and 300b described herein. In yet another example, an embedded paddle (e.g., paddle 300b) may have the features of paddle 300b and control unit 300c. In this scenario, the system may further include additional paddles 300a coupled to the combined paddles and control unit to stimulate muscles 308 or organs containing muscles in different regions in which the paddles 300a are embedded.

[0078] Method for generating a focused electric field Figure 5 shows a method 500 for generating a focused electric field to stimulate a muscle or an organ comprising muscle, according to several embodiments. For example, method 500 may be used to stimulate the bladder wall (e.g., the bladder sphincter). The method may include receiving energy (e.g., initial energy) from an external device (e.g., external device 220) to a stimulating device (e.g., stimulating devices 100, 200, or 300) before initiating stimulation, for example, to power the device. For example, the external device may be used to charge the stimulating device. In some embodiments, the energy may be received from ultrasound emitted by the external device. Alternatively, the energy may be received from radio waves emitted by the external device.

[0079] In step 502, method 500 may include delivering initial independent currents to a plurality of electrodes embedded in a muscle or a muscle-containing organ. For example, the current sources of a first plurality of current sources may supply independent currents to the electrodes, and the current sources of a second plurality of current sources may receive the independent currents supplied to the electrodes. Each of the current sources may be configured to generate or receive independent currents which may be of varying magnitudes and / or waveforms. The current sources of the first plurality of current sources and the current sources of the second plurality of current sources may be connected in series via the muscle or a muscle-containing organ (with at least one electrode electrically coupled to the current source). Thus, each electrode of the plurality of electrodes may be actuated using the independent current sources of the plurality of current sources. In some embodiments, a given electrode of the plurality of electrodes may be coupled to the plurality of current sources, such as a current source configured to deliver current to the electrode and a current sink configured to absorb current from the electrode.

[0080] In some embodiments, an initial independent current may be delivered to multiple electrodes based on a command from an external device. For example, the method may include receiving a command from an external device indicating that an initial independent current should be delivered to multiple electrodes. Based on the command, the independent current may be delivered to one or more electrodes of the multiple electrodes of the stimulating device. The command may be encoded in ultrasound or radio waves emitted by the external device.

[0081] In step 504, method 500 may include generating an initial electric field for stimulating a muscle or an organ comprising muscle using a plurality of electrodes. The initial electric field may be a 2D or 3D current field. The initial electric field generated by the plurality of electrodes may be based on independent currents delivered by a current source. The initial electric field may be generated by the plurality of electrodes using initial energy delivered to the stimulating device by an external device. In some embodiments, the method may include receiving a command from an external device indicating that the initial independent currents delivered to one or more electrodes of the plurality of electrodes should be updated. As described above, the command may be encoded in ultrasound or radio waves emitted by the external device.

[0082] In step 506, method 500 may include delivering updated independent currents to one or more electrodes of a plurality of electrodes. In some embodiments, delivering updated independent currents may include updating one or more operating parameters of one or more current sources electrically coupled to one or more electrodes in order to deliver updated independent currents to one or more current sources. Furthermore, or instead, delivering updated currents may include updating the current waveforms delivered to one or more current sources by a control circuit. In some embodiments, the updated independent current delivered to a given electrode of one or more electrodes may be less than the initial independent current delivered to the given electrode of one or more electrodes. In some embodiments, the updated independent current delivered to a given electrode of one or more electrodes may be greater than the initial current delivered to the given electrode of one or more electrodes. In some embodiments, delivering updated independent currents to a given electrode of one or more electrodes may include not delivering current to that given electrode of one or more electrodes (i.e., stopping the delivery of current to the given electrode).

[0083] In step 508, method 500 may include generating a focused electric field by multiple electrodes for directly stimulating a muscle or an organ comprising muscle. The focused electric field may be a 2D or 3D current field.

[0084] Methods for stimulating muscles or organs containing muscles In some embodiments, methods for stimulating muscles or organs comprising muscles may be provided using the targeted electrical stimulation devices described herein. For example, the methods provided herein may be used to stimulate the bladder or the muscles of the bladder wall (e.g., sphincter muscles). The method may include delivering energy to the stimulation device. For example, energy may be delivered to the stimulation device via an external device. In some embodiments, the external device may be used to charge the stimulation device before stimulation. The stimulation device may comprise a transducer configured to receive energy from the external device and convert the energy into an electric current. The transducer may be electrically coupled to an energy storage that can receive and store electric current. Each of the current sources of the stimulation device may be electrically coupled to the energy storage to receive the stored electric current. As described herein, each electrode of a plurality of electrodes configured for stimulation may be independently coupled to one or more current sources. Thus, by providing energy to the stimulation device, electric current can be delivered to each electrode in a desired amount for stimulation.

[0085] The method may include stimulating a muscle or an organ comprising muscle using a focused electric field generated by a plurality of electrodes using energy delivered to a stimulating device. Generating a focused electric field may include any one or more steps described herein with respect to Method 500 shown in Figure 5. For example, the method may include generating an initial electric field using an initial current delivered by independent current sources, updating one or more currents delivered by independent current sources, and generating an updated and focused electric field using the updated currents, (and the initial current, where applicable) delivered by each of the independent current sources to a given electrode of the plurality of electrodes. As described herein, the initial electric field may be a 2D or 3D current field.

[0086] Methods for treatment In some embodiments, methods of treatment may be provided that involve the use of a targeted electrical stimulation device described herein (e.g., device 100, 200, or 300). For example, a targeted electrical stimulation device may be used to treat (e.g., alleviate) incontinence or overactive bladder. Electrical stimulation may be used to control a patient's urge (or lack thereof) to urinate.

[0087] In some embodiments, the method may optionally include implanting a stimulating device (e.g., stimulating device 100, 200, or 300) onto the bladder wall. For example, at least a portion of the device having electrodes may be implanted in the muscles of the bladder wall (e.g., the sphincter). In some embodiments, as described with respect to stimulating device 300 illustrated with respect to Figure 3, one or more paddles having electrodes (and current sources / sinks) may be implanted onto the bladder wall, and the control unit of the device may be at least partially implanted in the patient's body at a distance adjacent to or away from one or more paddles.

[0088] In some embodiments, the treatment method may include, for example, an external device (e.g., an interrogator) powering on the device and / or providing power to the stimulating device for charging. Once powered on and charged, the method may include initiating a treatment cycle for stimulating the bladder wall. The treatment cycle may include delivering an initial current to one or more electrodes, each electrically coupled to an independent current source. Parameters related to the initial current (e.g., intensity, pulse width, pulse duration, etc.) may be provided to the stimulating device automatically by, for example, an external device, or manually by a user of the external device. For example, the external device may have stored operating parameters that can be sent to the stimulating device, or a user may program operating parameters via the external device. In some embodiments, the stimulating device itself may have stored (e.g., initial) operating parameters, and the external device may send a command to initiate the delivery of stimulation using the stored operating parameters.

[0089] Independent currents supplied to each electrode can combine to generate an initial electric field for stimulation. Data related to the initial electric field, the resulting stimulation, tissue resistance, etc. (hereinafter collectively referred to as stimulation data) can be measured and recorded. For example, stimulation data can be stored at least temporarily in the memory of the stimulation device and / or transmitted to an external device for recording and analysis. Based on the stimulation data, the system or the user of the system can determine whether it is necessary to adjust the field for stimulation. For example, one or more currents supplied to the electrodes can be adjusted to focus the electric field and generate an updated electric field. In some embodiments, one or more currents supplied to the electrodes can be automatically adjusted during the course of the treatment cycle according to pre-programmed stimulation parameters. Alternatively, the adjustment of the electric field can be performed in a manner similar to that described herein with respect to Figure 5 and Method 500.

[0090] As described herein, the operating parameters of the current source may be stored in some embodiments (e.g., in the memory of the stimulating device and / or an external device). For example, the initial current and any updated current delivered to the electrodes during a given treatment cycle may be stored. In this case, in subsequent implementations of the treatment regimen, it may be optional to generate the updated electric field, since at least the initial electric field can be based on the stored parameters from previous treatment cycles.

[0091] Exemplary parameters - pulse width, duration, current intensity, etc.

[0092] definition As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly indicates otherwise.

[0093] References to values ​​or parameters in this specification that use the term "about" include (and should be described) variations directed to the value or parameter itself. For example, a statement referring to "about X" includes a statement of "X".

[0094] It is understood that the embodiments and variations of the present invention described herein include embodiments and variations that "consist of" and / or "essentially consist of".

[0095] Where a range of values ​​or values ​​are provided, it should be understood that each intermediate value between the upper and lower limits of that range, and any other stated or intermediate values ​​within that stated range, are included within the scope of this disclosure. Where the stated range includes an upper or lower limit, the range excluding either of those limits is also included within this disclosure.

[0096] Section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described herein. Descriptions are provided to enable those skilled in the art to create and use the invention, and are provided in the context of a patent application and its requirements. Various modifications to the embodiments described herein will be readily apparent to those skilled in the art, and the general principles herein may be applicable to other embodiments. Therefore, the invention is not intended to be limited to the embodiments shown, but rather should be given the broadest scope consistent with the principles and features described herein.

[0097] The drawings illustrate the process according to various embodiments. In the exemplary process, some blocks are combined at will, the order of some blocks is changed at will, and some blocks are omitted at will. In some examples, additional steps may be performed in combination with the exemplary process. Therefore, the operations shown (and described in more detail below) are illustrative in nature and should not be considered limiting.

[0098] Finally, it should be understood that the features and preferences described in relation to “Embodiments” are distinct preferences and are not limited to those particular embodiments, and they may be freely combined with features from other embodiments where technically feasible, to form a preferred combination of features. The descriptions are provided to enable those skilled in the art to create and use the invention and are provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be readily apparent to those skilled in the art, and the general principles described herein may be applied to other embodiments. Accordingly, the invention is not intended to be limited to the embodiments shown, but rather should be given the broadest scope consistent with the principles and features described herein. Furthermore, section headings are provided for structural purposes and should not be considered restrictive.

[0099] The entirety of the patent and publication disclosures referenced in this application is incorporated herein by reference for all purposes. To the extent that any reference incorporated by reference conflicts with this disclosure, this disclosure shall prevail.

[0100] Embodiment The following embodiments are illustrative and are not intended to limit the scope of any invention described herein.

[0101] Embodiment 1 A stimulation device comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, wherein the plurality of electrodes are configured to directly stimulate muscles or organs comprising muscles, and each electrode of the plurality of electrodes is configured to be operated using an independent current source of the plurality of current sources.

[0102] Embodiment 2 A stimulator according to Embodiment 1, wherein each of the plurality of current sources is electrically coupled in series to at least one other current source of the plurality of current sources via the muscle or the organ comprising the muscle.

[0103] Embodiment 3 A stimulator according to Embodiment 1 or 2, wherein the independent current source of the plurality of current sources is configured to supply or absorb a current independent of the current supplied or absorbed by the other current sources of the plurality of current sources.

[0104] Embodiment 4 A stimulation device according to any one of Embodiments 1 to 3, wherein the current supplied by the plurality of current sources is adjustable by a control circuit electrically coupled to each of the plurality of current sources.

[0105] Embodiment 5 A stimulator according to any one of Embodiments 1 to 4, wherein at least one of the plurality of current sources is adjustable between supplying or absorbing current by a control circuit electrically coupled to the at least one current source.

[0106] Embodiment 6 A stimulating device according to any one of Embodiments 1 to 5, comprising a switch electrically coupled to the independent current source for controlling whether the independent current source supplies current to the electrode or absorbs current from the electrode.

[0107] Embodiment 7 A stimulator according to any one of Embodiments 1 to 6, wherein the plurality of electrodes are configured to generate a focused electrical stimulation field for targeted stimulation of the muscle or the organ comprising the muscle, based on independent currents from the plurality of current sources.

[0108] Embodiment 8 A stimulator according to Embodiment 7, wherein the electrical stimulation field is a two-dimensional current field or a three-dimensional current field.

[0109] Embodiment 9 A stimulation device according to any one of Embodiments 1 to 8, comprising a control circuit configured to be electrically coupled to each of the plurality of current sources and to generate a current waveform delivered to the plurality of current sources.

[0110] Embodiment 10 A stimulator according to Embodiment 9, wherein the control circuit is configured to receive a command from an external device, and the command is configured to cause the control circuit to deliver the current waveform to one or more of the plurality of current sources.

[0111] Embodiment 11 A stimulator according to Embodiment 9, wherein the stimulator comprises one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device.

[0112] Embodiment 12 A stimulator according to Embodiment 10 or 11, wherein the control circuit is configured to communicate with the external device using ultrasonic backscatter.

[0113] Embodiment 13 A stimulator according to Embodiment 10, wherein the stimulator comprises a high-frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device.

[0114] Embodiment 14 A stimulator according to Embodiment 10 or 13, wherein the control circuit is configured to communicate with the external device using radio wave backscatter.

[0115] Embodiment 15 A stimulator according to any one of embodiments 1 to 10 or 13 to 14, wherein the stimulator comprises a radio frequency (RF) antenna, and the plurality of current sources are configured to receive energy from RF waves radiated by an external device.

[0116] Embodiment 16 A stimulating device according to any one of Embodiments 1 to 12, wherein the stimulating device comprises one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

[0117] Embodiment 17 A stimulating device according to any one of Embodiments 1 to 16, wherein a first portion of the plurality of electrodes is arranged on a first paddle configured to be embedded in a first position of the muscle or the organ comprising the muscle, and a second portion of the plurality of electrodes is arranged on a second paddle configured to be embedded in a second position of the muscle or the organ comprising the muscle.

[0118] Embodiment 18 A stimulating device according to Embodiment 17, wherein the first paddle and / or the second paddle each comprises a conductive shell configured as an electrode.

[0119] Embodiment 19 A stimulation device according to any one of Embodiments 1 to 18, comprising one or more stimulation leads that electrically couple each of the plurality of electrodes to an independent current source of the plurality of current sources.

[0120] Embodiment 20 A stimulator according to any one of Embodiments 1 to 19, comprising an energy storage device electrically coupled to the plurality of current sources.

[0121] Embodiment 21 A stimulator according to any one of Embodiments 1 to 20, wherein the plurality of electrodes each comprises at least one anode and at least one cathode configured to together deliver bipolar stimulation to the muscle or the organ comprising the muscle.

[0122] Embodiment 22 A stimulator according to any one of Embodiments 1 to 21, wherein at least a portion of the plurality of current sources are configured to function as current sinks that absorb current.

[0123] Embodiment 23 A stimulation device according to any one of Embodiments 1 to 22, wherein the plurality of current sources comprises one or more transistors.

[0124] Embodiment 24 A stimulating device according to any one of Embodiments 1 to 23, wherein the plurality of electrodes are configured to directly stimulate the bladder wall to induce bladder urination.

[0125] Embodiment 25 A stimulation system comprising one stimulation device according to any one of embodiments 1 to 24, and an external device configured to communicate with the stimulation device.

[0126] Embodiment 26 A stimulation system according to Embodiment 25, comprising a magnet configured to turn the power of the stimulation device on and / or off.

[0127] Embodiment 27 A method for stimulating a muscle or an organ comprising muscle, comprising: delivering energy to a stimulating device described in any one of Embodiments 1 to 26; and stimulating the muscle or the organ comprising muscle using a focused electric field generated by a plurality of electrodes using the energy delivered to the stimulating device.

[0128] Embodiment 28 A method according to Embodiment 27, comprising: delivering initial energy to the stimulating device; and stimulating the muscle or the organ comprising the muscle using the initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulating device.

[0129] Embodiment 29 A method according to Embodiment 27 or 28, wherein the energy is delivered using an external device.

[0130] Embodiment 30 A method according to Embodiment 29, wherein the energy is delivered using ultrasound emitted by the external device.

[0131] Embodiment 31 A method according to Embodiment 29, wherein the energy is delivered using radio waves emitted by the external device.

[0132] Embodiment 32 A method according to any one of embodiments 27 to 31, comprising transmitting one or more commands indicating the operating parameters of the stimulating device to the stimulating device.

[0133] Embodiment 33 A method according to Embodiment 32, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0134] Embodiment 34 A method according to Embodiment 32, wherein the command is encoded in radio waves emitted by the external device.

[0135] Embodiment 35 A method for treating bladder incontinence in a subject requiring treatment for bladder incontinence, comprising providing electrical stimulation using any one of the stimulating devices of Embodiments 1 to 26.

[0136] Embodiment 36 A method for generating a focused electric field to stimulate a muscle or an organ comprising muscle, comprising: delivering initial independent currents to a plurality of electrodes embedded on the muscle or the organ comprising muscle; generating an initial electric field for stimulating the muscle or the organ comprising muscle by the plurality of electrodes; delivering updated independent currents to one or more electrodes of the plurality of electrodes; and generating a focused electric field for directly stimulating the muscle or the organ comprising muscle by the plurality of electrodes.

[0137] Embodiment 37 A method according to Embodiment 36, wherein the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes.

[0138] Embodiment 38 A method according to Embodiment 37, wherein each electrode of the plurality of electrodes is operated using an independent current source of the plurality of current sources, and each of the plurality of current sources is configured to absorb or supply a current independent of the current supplied or absorbed by the other current sources of the plurality of current sources.

[0139] Embodiment 39 A method according to embodiment 37 or 38, wherein the current supplied by the plurality of current sources is adjustable by a control circuit electrically coupled to each of the plurality of current sources.

[0140] Embodiment 40 A method according to any one of embodiments 37 to 39, wherein at least one of the plurality of current sources is adjustable between supplying or absorbing current by a control circuit electrically coupled to the at least one current source.

[0141] Embodiment 41 A method according to any one of embodiments 38 to 40, wherein a switch electrically coupled to the independent current source of the plurality of current sources is configured to control whether the independent current source supplies current to the electrode or absorbs current from the electrode.

[0142] Embodiment 42 A method of any one of embodiments 37 to 41, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes includes updating one or more operating parameters of one or more current sources of the plurality of electrodes that are electrically coupled to the one or more electrodes, in order to deliver the updated independent current to the one or more current sources.

[0143] Embodiment 43 A method according to any one of embodiments 37 to 42, wherein delivering updated independent currents to one or more electrodes of the plurality of electrodes includes updating the current waveforms delivered to the one or more current sources.

[0144] Embodiment 44 A method according to any one of embodiments 36 to 43, wherein the updated independent current delivered to a predetermined electrode of the one or more electrodes is smaller than the initial independent current delivered to the predetermined electrode of the one or more electrodes.

[0145] Embodiment 45 A method according to any one of embodiments 36 to 43, wherein the updated independent current delivered to a predetermined electrode of the one or more electrodes is greater than the initial independent current delivered to the predetermined electrode of the one or more electrodes.

[0146] Embodiment 46 A method according to any one of embodiments 36 to 45, wherein delivering an updated independent current to a predetermined electrode of the one or more electrodes includes not delivering a current to the predetermined electrode of the one or more electrodes.

[0147] Embodiment 47 A method according to any one of embodiments 36 to 46, wherein the plurality of electrodes include at least one anode and at least one cathode that together deliver bipolar stimulation to the muscle or the organ comprising the muscle when the initial electric field and / or the focused electric field are generated.

[0148] Embodiment 48 A method comprising receiving energy from an external device, which is one of the embodiments 36 to 47.

[0149] Embodiment 49 A method according to Embodiment 48, wherein the energy is received from ultrasonic waves emitted by the external device.

[0150] Embodiment 50 A method according to Embodiment 48, wherein the energy is received from radio waves emitted by the external device.

[0151] Embodiment 51 A method according to any one of embodiments 36 to 50, comprising: receiving a command from an external device indicating that the initial independent current should be delivered to the plurality of electrodes; and delivering the initial independent current to one or more electrodes of the plurality of electrodes.

[0152] Embodiment 52 A method according to Embodiment 51, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0153] Embodiment 53 A method according to Embodiment 51, wherein the command is encoded in radio waves emitted by the external device.

[0154] Embodiment 54 A method of any one of embodiments 36 to 53, comprising: receiving a command from an external device indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more electrodes of the plurality of electrodes.

[0155] Embodiment 55 A method according to Embodiment 54, wherein the command is encoded in ultrasonic waves emitted by the external device.

[0156] Embodiment 56 A method according to Embodiment 55, wherein the command is encoded in radio waves emitted by the external device.

[0157] Embodiment 57 A method according to any one of embodiments 36 to 56, comprising communicating with an external device using an ultrasonic backscatter.

[0158] Embodiment 58 A method according to any one of embodiments 36 to 56, comprising communicating with an external device using radio wave backscatter.

[0159] Embodiment 59 A method according to any one of embodiments 36 to 58, wherein the initial electric field and the focused electric field are each two-dimensional current fields or three-dimensional current fields.

[0160] Embodiment 60 A method for treating bladder incontinence in a subject requiring treatment for bladder incontinence, comprising administering electrical stimulation according to any one of embodiments 36 to 59.

[0161] Embodiment 61 A stimulator according to Embodiment 10 or 11, wherein the control circuit is configured to communicate with the external device using the transmission of active ultrasound.

[0162] Embodiment 62 A stimulator according to Embodiment 10 or 13, wherein the control circuit is configured to communicate with the external device using active radio wave transmission.

[0163] Embodiment 63 A method according to any one of embodiments 36 to 56, comprising communicating with an external device using active ultrasonic transmission.

[0164] Embodiment 64 A method according to any one of embodiments 36 to 56, comprising communicating with an external device using active radio wave transmission.

[0165] conclusion The above description is written with reference to specific embodiments for illustrative purposes. However, the above exemplary discussion is not intended to be exhaustive or to limit the invention to the exact form disclosed. Many modifications and variations are possible in light of the above teachings. The embodiments have been selected and described to best illustrate the principles of the art and its practical applications. This will enable other persons skilled in the art to best utilize the art and various embodiments with various modifications suitable for specific intended uses.

[0166] While the present disclosure and examples are fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will be apparent to those skilled in the art. Such changes and modifications should be understood to be within the scope of the present disclosure and examples as defined by the claims.

Claims

1. Multiple current sources, A plurality of electrodes electrically coupled to the plurality of current sources, wherein the plurality of electrodes are configured to directly stimulate a muscle or an organ containing muscle, and each electrode of the plurality of electrodes is configured to be operated using an independent current source of the plurality of current sources, A stimulating device equipped with the following features.

2. A stimulating device according to claim 1, wherein each of the plurality of current sources is electrically coupled in series to at least one other current source of the plurality of current sources via the muscle or the organ comprising the muscle.

3. A stimulator according to claim 1 or 2, wherein the independent current source of the plurality of current sources is configured to supply or absorb a current independent of the current supplied or absorbed by the other current sources of the plurality of current sources.

4. A stimulator according to any one of claims 1 to 3, wherein the current supplied by the plurality of current sources is adjustable by a control circuit electrically coupled to each of the plurality of current sources.

5. A stimulator according to any one of claims 1 to 4, wherein at least one of the plurality of current sources is adjustable between supplying or absorbing current by a control circuit electrically coupled to the at least one current source.

6. A stimulator according to any one of claims 1 to 5, comprising a switch electrically coupled to the independent current source for controlling whether the independent current source supplies current to the electrode or absorbs current from the electrode.

7. A stimulator according to any one of claims 1 to 6, wherein the plurality of electrodes are configured to generate a focused electrical stimulation field for targeted stimulation of the muscle or the organ comprising the muscle, based on independent currents from the plurality of current sources.

8. A stimulator according to claim 7, wherein the electrical stimulation field is a two-dimensional current field or a three-dimensional current field.

9. A stimulator according to any one of claims 1 to 8, comprising a control circuit configured to be electrically coupled to each of the plurality of current sources and to generate a current waveform delivered to the plurality of current sources.

10. A stimulator according to claim 9, wherein the control circuit is configured to receive a command from an external device, and the command is configured to cause the control circuit to deliver the current waveform to one or more of the plurality of current sources.

11. A stimulator according to claim 9, wherein the stimulator comprises one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device.

12. A stimulator according to claim 10 or 11, wherein the control circuit is configured to communicate with the external device using an ultrasonic backscatter.

13. A stimulator according to claim 10, wherein the stimulator comprises a high-frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device.

14. A stimulator according to claim 10 or 13, wherein the control circuit is configured to communicate with the external device using radio wave backscatter.

15. A stimulator according to any one of claims 1 to 10 or 13 to 14, wherein the stimulator comprises a radio frequency (RF) antenna, and the plurality of current sources are configured to receive energy from RF waves radiated by an external device.

16. A stimulator according to any one of claims 1 to 12, wherein the stimulator comprises one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

17. A stimulating device according to any one of claims 1 to 16, wherein a first portion of the plurality of electrodes is arranged on a first paddle configured to be embedded in a first position of the muscle or the organ comprising the muscle, and a second portion of the plurality of electrodes is arranged on a second paddle configured to be embedded in a second position of the muscle or the organ comprising the muscle.

18. A stimulating device according to claim 17, wherein the first paddle and / or the second paddle each comprises a conductive shell configured as an electrode.

19. A stimulating device according to any one of claims 1 to 18, comprising one or more stimulating leads that electrically couple each of the plurality of electrodes to an independent current source of the plurality of current sources.

20. A stimulator according to any one of claims 1 to 19, comprising an energy storage electrically coupled to the plurality of current sources.

21. A stimulator according to any one of claims 1 to 20, wherein the plurality of electrodes each comprises at least one anode and at least one cathode configured to deliver bipolar stimulation to the muscle or the organ comprising the muscle.

22. A stimulator according to any one of claims 1 to 21, wherein at least a portion of the plurality of current sources are configured to function as current sinks that absorb current.

23. A stimulator according to any one of claims 1 to 22, wherein the plurality of current sources each comprises one or more transistors.

24. A stimulator according to any one of claims 1 to 23, wherein the plurality of electrodes are configured to directly stimulate the bladder wall to induce bladder urination.

25. A stimulator according to any one of claims 1 to 24, An external device configured to communicate with the aforementioned stimulating device, A stimulation system equipped with the following features.

26. A stimulation system according to claim 25, comprising a magnet configured to turn the power of the stimulation device on and / or off.

27. A method for stimulating a muscle or an organ containing muscle, To deliver energy to the stimulating device according to any one of claims 1 to 26, Using the energy delivered to the stimulating device, the focused electric field generated by the plurality of electrodes is used to stimulate the muscle or the organ comprising the muscle, Methods that include...

28. The method according to claim 27, To deliver initial energy to the aforementioned stimulating device, Using the initial electric field generated by the plurality of electrodes with the initial energy delivered to the stimulating device, the muscle or the organ comprising the muscle is stimulated. Methods that include...

29. A method according to claim 27 or 28, wherein the energy is delivered using an external device.

30. A method according to claim 29, wherein the energy is delivered using ultrasound emitted by the external device.

31. A method according to claim 29, wherein the energy is delivered using radio waves emitted by the external device.

32. A method according to any one of claims 27 to 31, comprising transmitting one or more commands indicating operating parameters of the stimulating device to the stimulating device.

33. A method according to claim 32, wherein the command is encoded in ultrasonic waves emitted by the external device.

34. A method according to claim 32, wherein the command is encoded in radio waves emitted by the external device.

35. A method for treating bladder incontinence in a person requiring treatment for bladder incontinence, comprising providing electrical stimulation using a stimulating device according to any one of claims 1 to 26.

36. A method for generating a focused electric field to stimulate a muscle or an organ containing muscle, To deliver an initial independent current to a plurality of electrodes embedded on the muscle or the organ comprising muscle, The plurality of electrodes generate an initial electric field for stimulating the muscle or the organ containing the muscle, Delivering an updated, independent current to one or more electrodes of the plurality of electrodes, The plurality of electrodes generate a focused electric field for directly stimulating the muscle or the organ containing the muscle, Methods that include...

37. A method according to claim 36, wherein the initial independent currents delivered to the plurality of electrodes are supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes.

38. A method according to claim 37, wherein each electrode of the plurality of electrodes is operated using an independent current source of the plurality of current sources, and each of the plurality of current sources is configured to absorb or supply a current independent of the current supplied or absorbed by the other current sources of the plurality of current sources.

39. A method according to claim 37 or 38, wherein the current supplied by the plurality of current sources is adjustable by a control circuit electrically coupled to each of the plurality of current sources.

40. A method according to any one of claims 37 to 39, wherein at least one of the plurality of current sources is adjustable between supplying or absorbing current by a control circuit electrically coupled to the at least one current source.

41. A method according to any one of claims 38 to 40, wherein a switch electrically coupled to the independent current sources of the plurality of current sources is configured to control whether the independent current sources supply current to the electrodes or absorb current from the electrodes.

42. A method according to any one of claims 37 to 41, wherein delivering an updated independent current to one or more electrodes of the plurality of electrodes includes updating one or more operating parameters of one or more current sources of the plurality of electrodes that are electrically coupled to the one or more electrodes in order to deliver the updated independent current to the one or more current sources.

43. A method according to any one of claims 37 to 42, wherein delivering updated independent currents to one or more electrodes of the plurality of electrodes includes updating the current waveform delivered to the one or more current sources.

44. A method according to any one of claims 36 to 43, wherein the updated independent current delivered to a predetermined electrode of the one or more electrodes is smaller than the initial independent current delivered to the predetermined electrode of the one or more electrodes.

45. A method according to any one of claims 36 to 43, wherein the updated independent current delivered to a predetermined electrode of the one or more electrodes is greater than the initial independent current delivered to the predetermined electrode of the one or more electrodes.

46. A method according to any one of claims 36 to 45, wherein delivering an updated independent current to a predetermined electrode of one or more electrodes includes not delivering a current to the predetermined electrode of one or more electrodes.

47. A method according to any one of claims 36 to 46, wherein the plurality of electrodes include at least one anode and at least one cathode that together deliver bipolar stimulation to the muscle or the organ comprising the muscle when the initial electric field and / or the focused electric field are generated.

48. A method according to any one of claims 36 to 47, comprising receiving energy from an external device.

49. A method according to claim 48, wherein the energy is received from ultrasonic waves emitted by the external device.

50. A method according to claim 48, wherein the energy is received from radio waves emitted by the external device.

51. A method according to any one of claims 36 to 50, Receiving a command from an external device indicating that the initial independent current should be delivered to the plurality of electrodes, To deliver the initial independent current to one or more electrodes of the plurality of electrodes, Methods that include...

52. A method according to claim 51, wherein the command is encoded in ultrasonic waves emitted by the external device.

53. A method according to claim 51, wherein the command is encoded in radio waves emitted by the external device.

54. A method according to any one of claims 36 to 53, Receiving a command from an external device indicating that the initial independent current delivered to one or more electrodes of the plurality of electrodes should be updated, To deliver the updated independent current to one or more electrodes of the plurality of electrodes, Methods that include...

55. A method according to claim 54, wherein the command is encoded in ultrasonic waves emitted by the external device.

56. A method according to claim 55, wherein the command is encoded in radio waves emitted by the external device.

57. A method according to any one of claims 36 to 56, comprising communicating with an external device using an ultrasonic backscatter.

58. A method according to any one of claims 36 to 56, comprising communicating with an external device using radio wave backscatter.

59. A method according to any one of claims 36 to 58, wherein the initial electric field and the focused electric field are each two-dimensional current fields or three-dimensional current fields.

60. A method for treating bladder incontinence in a person requiring treatment for bladder incontinence, comprising providing electrical stimulation according to any one of claims 36 to 59.

61. A stimulator according to claim 10 or 11, wherein the control circuit is configured to communicate with the external device using the transmission of active ultrasound.

62. A stimulator according to claim 10 or 13, wherein the control circuit is configured to communicate with the external device using active radio wave transmission.

63. A method according to any one of claims 36 to 56, comprising communicating with an external device using the transmission of active ultrasound.

64. A method according to any one of claims 36 to 56, comprising communicating with an external device using active radio wave transmission.

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