Systems and methods for targeted electrical stimulation

Abstract

This document provides a stimulation device and its method of use for generating a focused electric field for targeted electrical stimulation of muscles. The stimulation device described herein may include multiple current sources electrically coupled to multiple electrodes, which can deliver direct stimulation to muscles or organs containing muscles. The current sources can be connected in series through muscles or organs containing muscles. Using the stimulation device described herein, the currents delivered to the electrodes can be independent of each other and can be modulated to generate a focused electric field.

Description

[0001] Cross-references to related applications

[0002] This application claims priority and benefit to U.S. Provisional Application No. 63 / 588,500, filed October 6, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to targeted electrical stimulation of muscles or organs containing muscles, and more specifically to generating a focused electric field for targeted electrical stimulation of muscles or organs containing muscles. Background Technology

[0004] Implantable medical devices can be used to electrically stimulate patient tissues to treat a variety of medical conditions. For example, implantable devices can be used to stimulate muscles, organs, peripheral nerves, heart tissue, the brain, or other tissues for therapeutic purposes. Implantable devices can use a voltage or current source coupled to one or more electrodes to electrically stimulate tissues. The energy delivered to the electrodes via the current or voltage source may be uniform, thus generating a uniform electric field to stimulate the tissue. A uniform electric field is not ideal for stimulating organs, where the tissue properties undesirably modulate the distribution of the electric field, leading to inaccurate stimulation. For example, delivering a uniform energy source to a muscle or organ with varying tissue impedance (such as the bladder) may result in some areas of the intended tissue being understimulated or overstimulated, while other areas not intended for stimulation are stimulated.

[0005] To compensate for understimulation, practitioners of stimulation therapy may increase the total energy delivered to the electrodes using an electric or voltage source. However, uniformly increasing the energy delivered to the electrodes is not ideal, as it may lead to further overstimulation of other tissue areas, potentially causing damage. It may also increase the amount of tissue areas unintentionally stimulated. Furthermore, it may result in unnecessarily high power consumption from the implanted device's power source. For implanted devices, whose energy storage capacity is already limited due to their small size, increased power consumption can significantly shorten their lifespan, requiring more frequent charging or replacement. The increased charging frequency or subsequent replacement surgeries place a considerable psychological, physical, and financial burden on patients. Summary of the Invention

[0006] This document describes an implantable device for targeted electrical stimulation and a method for generating a focused electric field for muscle electrical stimulation. The stimulation device described herein may include multiple independent current sources configured to deliver independent currents to electrodes. Each current delivered by a current source can be independently adjusted to generate a focused electric field for targeted electrical stimulation. The energy delivered to a given electrode by a current source coupled to the electrode can 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 by various currents delivered to multiple electrodes for targeted electrical stimulation of the muscle. Using the implantable device and targeted stimulation system described herein, unintended energy distribution to the electrodes (or current sources coupled to the electrodes) can be avoided, thereby maintaining the state of the tissue at and around the electrode implantation site and also extending the lifespan of the implantable device. Furthermore, more customized, accurate, and effective muscle electrical stimulation protocols can be generated, thereby improving patient health outcomes.

[0007] In some examples, a stimulation device is provided, comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, the plurality of electrodes being configured to directly stimulate a muscle or an organ containing a muscle, wherein each of the plurality of electrodes is configured to operate using an independent current source among the plurality of current sources. Each of the plurality of current sources can be electrically coupled in series with at least one other current source among the plurality of current sources via the muscle or the organ containing the muscle. In some implementations, the independent current source among the plurality of current sources is configured to supply or absorb current, the current being independent of the current supplied or absorbed by the other current sources among the plurality of current sources. The current supplied by the plurality of current sources can be adjusted by control circuitry electrically coupled to each of the plurality of current sources. In some examples of the stimulation device, at least one of the plurality of current sources can be adjusted between supplying current or absorbing current by control circuitry electrically coupled to the at least one current source. A switch can be electrically coupled to the independent current source to control whether the independent current source supplies current to or absorbs current from the electrode.

[0008] The plurality of electrodes of the stimulation device can be configured to generate a focusable electrical stimulation field for targeted stimulation of the muscle or organ containing the muscle, based on independent currents from the plurality of current sources. The electrical stimulation field can be, for example, a two-dimensional or three-dimensional current field.

[0009] The stimulation device may include control circuitry electrically coupled to each of the plurality of current sources and configured to generate a current waveform to be delivered to the plurality of current sources. In some implementations of the device, the control circuitry is configured to receive a command from an external device, the command being configured to cause the control circuitry to deliver the current waveform to one or more of the plurality of current sources. The stimulation device may include, for example, one or more ultrasonic transducers, and the control circuitry receives the command from ultrasonic waves emitted by the external device. The control circuitry may, for example, be configured to communicate with the external device using ultrasonic backscattering. In another implementation of the device, the stimulation device includes a radio frequency antenna, and the control circuitry receives the command from radio waves emitted by the external device. Therefore, the control circuitry may be configured to communicate with the external device using radio wave backscattering.

[0010] In some implementations of the device, the stimulation device includes a radio frequency antenna, and the plurality of current sources are configured to receive energy from RF waves emitted by an external device. In other implementations of the device, the stimulation device includes one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

[0011] A first portion of the plurality of electrodes of the stimulation device may be disposed on a first electrode plate, the first electrode plate being configured to be implanted at a first location in the muscle or an organ containing the muscle, and a second portion of the plurality of electrodes may be disposed on a second electrode plate, the second electrode plate being configured to be implanted at a second location in the muscle or an organ containing the muscle. The first electrode plate and / or the second electrode plate may include, for example, a conductive shell configured as an electrode.

[0012] The stimulation device may include one or more stimulation leads that electrically couple each of the plurality of electrodes to an independent current source among the plurality of current sources.

[0013] In some implementations, the stimulation device further includes an energy storage device electrically coupled to the plurality of current sources.

[0014] In some implementations, the plurality of electrodes includes at least one anode and at least one cathode, the at least one anode and the at least one cathode being configured together to deliver bipolar stimulation to the muscle or an organ containing the muscle.

[0015] In some implementations, at least a portion of the plurality of current sources are configured to act as current sinks that absorb current.

[0016] In some implementations, the plurality of current sources includes one or more transistors.

[0017] In some implementations, the plurality of electrodes are configured to directly stimulate the bladder wall to trigger bladder emptying.

[0018] This document also provides a stimulation system including the 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.

[0019] In some examples, a method for generating a focused electric field to stimulate a muscle or an organ containing a muscle is provided, comprising: delivering an initial independent current to a plurality of electrodes implanted on the muscle or the organ containing a muscle; generating an initial electric field from the plurality of electrodes to stimulate the muscle or the organ containing a muscle; delivering a renewed independent current to one or more of the plurality of electrodes; and generating a focused electric field from the plurality of electrodes to directly stimulate the muscle or the organ containing a muscle.

[0020] The method may include delivering initial energy to the stimulation device; and stimulating the muscle or organ containing the muscle using an initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulation 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.

[0021] The method may further include transmitting one or more commands to the stimulation device indicative of operating parameters of the stimulation device. The commands may, for example, be encoded in ultrasound waves emitted by the external device. In another example, the commands are encoded in radio waves emitted by the external device.

[0022] This article also provides a method for treating bladder incontinence in subjects requiring treatment for bladder incontinence, including applying electrical stimulation using the stimulation device described herein.

[0023] A method for generating a focused electric field to stimulate a muscle or an organ containing a muscle is further described, comprising: delivering an initial independent current to a plurality of electrodes implanted on the muscle or organ containing a muscle; generating an initial electric field from the plurality of electrodes to stimulate the muscle or organ containing a muscle; delivering a renewed independent current to one or more of the plurality of electrodes; and generating a focused electric field from the plurality of electrodes to directly stimulate the muscle or organ containing a muscle. The initial electric field and / or the focused electric field is a two-dimensional or three-dimensional current field. In some implementations, the initial independent current delivered to the plurality of electrodes is supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes. Each of the plurality of electrodes can be operated using an independent current source among the plurality of current sources, and each of the plurality of current sources is configured to absorb or supply current independent of current supplied or absorbed by other current sources among the plurality of current sources. The current supplied by the plurality of current sources can be adjusted by control circuitry electrically coupled to each of the plurality of current sources. In some implementations, at least one of the plurality of current sources can be adjusted between supplying current and absorbing current via a control circuit electrically coupled to the at least one current source. Switches of the individual current sources electrically coupled to the plurality of current sources can be configured to control whether the individual current source supplies current to the electrode or absorbs current from the electrode.

[0024] According to some implementations of the method, delivering an updated independent current to one or more of the plurality of electrodes may include updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes, so that the one or more current sources deliver the updated independent current. In some examples, delivering an updated independent current to one or more of the plurality of electrodes includes updating the current waveform delivered to the one or more current sources.

[0025] In some embodiments, the updated independent current delivered to a given electrode among the one or more electrodes may be less than the initial independent current delivered to the given electrode among the one or more electrodes. In another example, the updated independent current delivered to a given electrode among the one or more electrodes is greater than the initial independent current delivered to the given electrode among the one or more electrodes. In other examples of the method, delivering an updated independent current to a given electrode among the one or more electrodes includes not delivering current to the given electrode among the one or more electrodes.

[0026] The plurality of electrodes of the device used in the method may include at least one anode and at least one cathode, wherein when the initial electric field and / or the focused electric field is generated, the at least one anode and the at least one cathode together deliver bipolar stimulation to the muscle or organ containing the muscle.

[0027] 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 waves emitted by the external device. In another example, the energy may be received from 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 instructing that the initial independent current should be delivered to the plurality of electrodes; and delivering the initial independent current to one or more of the plurality of electrodes. The command may, for example, be encoded in ultrasonic 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 may include: receiving from an external device a command indicating that the initial independent current delivered to one or more of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more 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.

[0030] In some implementations of the method, the method includes communicating with an external device using ultrasonic backscattering. In another example, the method includes communicating with an external device using radio wave backscattering.

[0031] This article further describes a method for treating bladder incontinence in subjects requiring bladder incontinence treatment, including the application of electrical stimulation according to the method described above. Attached Figure Description

[0032] Various aspects of the disclosed systems and methods are set forth in detail in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by referring to the detailed description of the illustrative embodiments and the accompanying drawings.

[0033] Figure 1A The illustration shows a schematic diagram of a first exemplary targeted electrical stimulation device on an organ containing muscle, according to some embodiments.

[0034] Figure 1B A schematic diagram of another exemplary targeted electrical stimulation device according to some embodiments is illustrated.

[0035] Figure 1C A schematic diagram of another exemplary targeted electrical stimulation device according to some embodiments is illustrated.

[0036] Figure 1D A schematic diagram of another exemplary targeted electrical stimulation device according to some embodiments is illustrated.

[0037] Figure 2 A block diagram of a first exemplary electrical stimulation system according to some embodiments is shown.

[0038] Figure 3 A block diagram of another exemplary electrical stimulation system according to some embodiments is illustrated.

[0039] Figure 4 The illustration shows a schematic diagram of a non-targeted electrical stimulation device on an organ containing muscle, according to some embodiments.

[0040] Figure 5 The illustration depicts a method for generating a focused electric field for targeted electrical stimulation, according to some embodiments. Detailed Implementation

[0041] This document describes implantable systems and devices for targeted electrical stimulation, as well as methods for generating focused electric fields for electrically stimulating tissue. The targeted electrical stimulation system may include multiple current sources electrically coupled to multiple electrodes, the current sources being connected in series through a muscle or an organ containing muscle. Each current source may be configured to deliver an independent current to a given electrode, and in combination, the energy at the multiple electrodes can generate a focused electric field. The current delivered to the electrodes can be modulated to accommodate varying tissue impedance throughout the muscle and to target the intended stimulation location, thereby reducing unintentional electrical stimulation of other areas of the muscle and extending the lifespan of the stimulation device by reducing the power consumed by the device.

[0042] The following disclosure describes targeted electrical stimulation devices and systems according to several embodiments. This disclosure also provides methods for generating focused electric fields for targeted stimulation, methods for electrically stimulating tissues using focused electric fields generated by the electrical stimulation systems described herein, and methods for performing treatments using the electrical stimulation systems described herein.

[0043] Stimulation devices and systems

[0044] An exemplary stimulation device may include one or more current sources coupled to one or more electrodes. Figures 1A-1D A schematic diagram of a targeted electrical stimulation device 100 according to some embodiments is illustrated. Figure 1AAs shown, device 100 may include a first plurality of current sources 102a, 102b, 102c, and 102d (hereinafter collectively referred to as current source 102 for simplicity). Device 100 may include a second plurality of current sources 104a, 104b, 104c, and 104d (hereinafter collectively referred to as current source 104 for simplicity). Device 100 may include any number of current sources 102 and 104. For example, device 100 may include 2, 3, 4, 5, 6, 7, 8, 9, 10, or more current sources 102 and 104.

[0045] Each first current source 102 can be electrically coupled in series with at least one second current source 104 via a muscle 108 or an organ containing muscle. For example, as Figure 1A As shown, current source 102a can be coupled in series with current sources 104a, 104b, 104c and / or 102d. Current source 102b can be coupled in series with current sources 104a, 104b, 104c and / or 104d via a muscle or an organ containing a muscle, and so on. In some embodiments, a first current source 102 (e.g., current source 102c) can be coupled in series with multiple current sources 104 (e.g., current sources 104c, 104d) via a muscle or an organ containing a muscle. Conversely, multiple first current sources 102 (e.g., current sources 102a, 102b, 102c and / or 102d) can be electrically coupled in series with a second current source 104 (e.g., current source 104a) via a muscle or an organ containing a muscle. Other configurations of current sources 102 and 104 are understood to be included within the scope of this disclosure.

[0046] In some embodiments, one of the first plurality of current sources 102 or the second plurality of current sources 104 may be a current trap. 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 trap. In this way, current source 102 may supply current, while current source 104 may receive (or absorb) the current transmitted by current source 102 through tissue. The reverse may also occur, where current source 102 may be a current trap, and current source 104 may be a current source, with current source 102 configured to absorb the current supplied by current source 104. In some embodiments, a first portion of current source 102 may be a current source, while a second portion of current source 102 may be a current trap. Similarly, a first portion of current source 104 may be a current source, while a second portion of current source 104 may be a current trap. In some embodiments, the current source may be configured to operate as a source or trap based on parameters programmed into the stimulation device.

[0047] Figure 1AThe arrangement of the medium current sources 102 and 104 on the muscle or organ 108 is not intended to be limited to opposite sides of the targeted stimulation area. Furthermore, current can be supplied by the current source to the electrodes and can be supplied in any direction, not limited to the bottom-up (or top-down) configuration shown. Figures 1B-1D An additional example current source and electrode configuration are illustrated. Figure 1B The illustration shows a stimulation system 100 in which the direction of the current delivered to electrode 106a and subsequently received by electrode 106b can be alternating. Figures 1C-1D The illustration shows a stimulation system 100, in which each of current sources 102 and 104 is electrically coupled to a single electrode 106, wherein one of the current sources 102 or 104 can be configured as a current trap (described in more detail below). Whether the current is delivered from current source 102 to electrode 106 or received from electrode 106 by current source 104 can be controlled by a control circuit coupled to current sources 102 and 104 (e.g., ...). Figure 2 As shown). Figure 1D As shown, 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.

[0048] In any case, each current source (e.g., current sources 102a, 102b, 104a, 104b, etc.) can be configured to supply and / or receive current, independent of the current supplied / received by the other current sources among the plurality of current sources 102, 104. For example, current source 102a can deliver a first current to electrode 106a, while current source 102b can deliver a second current to electrode 106b. The first current and the second current can be different. The first current can be greater than, less than, or equal to the second current. Current source 104a can be configured to receive a third current based on the first current and / or the second current delivered by current sources 102a, 102b, respectively. The third current received at current source 104 can be a combination of at least a portion of the first current and at least a portion of the second current. Current source 104b can be configured to receive a fourth current based on the first current and / or the second current delivered by current sources 102a, 102b, respectively. The fourth current received at current source 104 can 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 at current source 104a may be greater than, approximately equal to, or less than the current received at current source 104b. Each of the first, second, third, and fourth currents may be supplied and received independently of each other. One or more currents may be substantially the same, or one or more currents may be different. As will be described in more detail below, each current supplied by current source 102 and / or current source 104 may be independently adjustable.

[0049] Current sources 102, 104 may be electronic circuits or components thereof configured to deliver current. A current sink may be an electronic circuit or component thereof configured to sink current. As described herein, one or more current sources may additionally or alternatively serve as current sinks. In some embodiments, multiple current sources 102, 104 may include one or more operational amplifiers (op-amps). In some embodiments, multiple current sources 102, 104 may include one or more transistors. Exemplary transistors that can be used to implement current sources 102, 104 may include metal-oxide-semiconductor field-effect transistors, such as NMOS transistors, PMOS transistors, and CMOS transistors. In some embodiments, one or more current sources 102, 104 may be implemented using current sources (and / or sinks) capable of dynamically adjusting their resistance to adapt to changes in current. Such current sources may be circuits containing transistors such as MOSFETs.

[0050] As described above and in Figures 1A-1D As shown in the device 100, the stimulation device 100 may include a plurality of electrodes 106, such as electrodes 106a, 106b, 106c, and 106d (hereinafter collectively referred to as electrodes 106 for simplicity). Figure 1A As shown, each electrode 106 can be coupled to one or more current sources 102 and / or one or more current sources 104, for example, via one or more leads 116. Multiple electrodes 106 can be configured to directly stimulate muscle 108 or an organ containing muscle. For example, multiple electrodes 106 can be implemented in an implantable device for stimulating a muscle (e.g., muscle tissue) or an organ containing muscle to which the device is implanted.

[0051] In some embodiments, electrode 106 may include one or more supramuscular electrodes configured for direct implantation into a muscle or an organ containing a muscle. The supramuscular electrodes may be surgically attached to tissue surrounding the muscle (e.g., the epimysium). For example, electrode 106 may be disposed on one or more electrode plates configured for implantation into said muscle or an organ containing a muscle, as described herein with respect to device 300 and... Figure 3 As described above. In some embodiments, electrode 106 may include one or more button electrodes. In some embodiments, electrode 106 may be a platinum-iridium electrode, which may be fixed to an insulating substrate (and / or surrounded by an insulating substrate (e.g., silicone) to minimize the diffusion of current to other excitable areas of the muscle (or organ containing muscle). For example, one or more electrodes 106 may be molded into a medical-grade silicone-based electrode plate.

[0052] In some embodiments, one or more electrodes 106 may be electrically coupled to each other. For example, as described herein, one or more electrodes 106 may be electrically coupled in series via a muscle or an organ containing a muscle. In other words, the plurality of electrodes may include at least one anode and at least one cathode, the at least one anode and at least one cathode together being configured to deliver bipolar stimulation to a muscle 108 or an organ containing a muscle. The anode and cathode are respectively made of Figure 1A-Figure 1B The minus and plus signs are shown in the image. (See reference.) Figure 1A Electrode 106a can be electrically coupled to electrodes 106c and / or 106d via muscle or an organ containing muscle. Similarly, electrode 106b can be electrically coupled to electrodes 106c and / or 106d. As shown, a current source (e.g., current source 102a) can be electrically coupled to cathode electrode 106a, while a current trap (e.g., current source 104a) can be electrically coupled to anode electrode 106c. In some embodiments, a given anode and cathode can be positioned approximately 5 mm to 20 mm apart, for example, approximately 10 mm apart.

[0053] Each of the plurality of electrodes 106 can be configured to operate using an independent current source among current sources 102, 104. For example, electrode 106a can be electrically coupled to and operated by current source 102a. In this case, current source 102a can supply current to electrode 106a, which can be delivered to a muscle or organ containing a muscle, and then received at least at electrode 106c, which can then transmit the received current to current source 104a (operating as a current trap). The reverse may also occur, where current source 104a can be configured to supply current to electrode 106c, at least a portion of which can then be received by current source 102a (through electrode 106a). The current supplied to electrode 106a can be used to deliver electrical stimulation to muscle 108 or organ containing a muscle at / around electrode 106a. The same or similar configurations of electrodes 106b and 106d can be applied. 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 current through electrode 106.

[0054] 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-1DThe illustration shows a stimulation system 100 including an electrode 106 electrically coupled to a current source 102 configured to supply current and a current source 104 (e.g., a current trap) configured to absorb current. The electrode 106 can be operatively programmed as an anode or cathode. The current sources 102 and 104 can be interchangeably configured as a current source and / or trap. For example, the current sources 102 and 104 can be electrically coupled to a control circuit configured to control whether the current sources 102 and 104 are configured to absorb or supply current. Furthermore, the control circuit can control, in a given instance, whether the current source (e.g., current source 102) can deliver current to the electrode 106, or whether the current trap (e.g., current source 104) can absorb current from the electrode 106. Similarly, Figure 1D The diagram illustrates current sources 102 and 104 electrically coupled to switch 105, which is configured to control whether current is delivered to electrode 106 (e.g., from current source 102) or absorbed from electrode 106 (e.g., at current source 104). Switch 105 can be controlled by a control circuit.

[0055] In some embodiments, each current source 102, 104 may be independently electrically coupled to a control circuit for controlling the current delivered to each electrode 106. The current sources 102, 104 may (e.g., via the device's control circuitry) control the manner in which the current at the electrode 106 is controlled, as referred to below. Figure 2 To describe in more detail.

[0056] 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, the anode electrodes may not be electrically coupled to other anode electrodes, and / or the cathode electrodes may not be electrically coupled to other cathode electrodes. In any case, a given electrode (e.g., electrode 106a) may be positioned adjacent to another electrode (e.g., electrode 106b) to generate at least a portion of a focusable electric field.

[0057] The arrangement of electrode 106 is not intended to be limited to Figures 1A-1DThe horizontal linear arrangement is shown. For example, electrodes 106 can be arranged linearly, along a curve (in any direction), in different directions (e.g., vertical, diagonal, or other directions), in a certain shape (e.g., circular, elliptical, triangular, rectangular, or other polygons oriented in any way), in a zigzag pattern, or without a specific pattern (e.g., randomly). The arrangement of electrodes 106 can be designed to optimally achieve electrical stimulation when used on the intended muscle 108 or an organ containing muscle. Furthermore, as described above, the 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 can be implemented in the circuitry of the stimulation system 100, and are not limited to this. Figures 1A-1D The arrangement depicted is different. Conversely, the electrical configuration between current sources 102, 104 (via one or more electrodes 106) may be important. As described above, the plurality of current sources 102 may be electrically coupled in series with at least one other current source among the plurality of current sources 104 via muscle 108 or an organ containing muscle.

[0058] In some embodiments, a plurality of electrodes 106 may be configured to generate a focusable electrical stimulation field 110 for targeted electrical stimulation of muscle 108 or an organ containing muscle using independent currents delivered by current sources 102 (and / or 104). The electrical stimulation field 110 may be a two-dimensional or three-dimensional current field. As explained herein, muscle 108 or an organ containing muscle may have variable tissue impedance (or resistance) depending on the muscle region. For example, tissue impedance 108a in a first region of muscle 108 may differ from tissue impedance 108b in a second region of muscle 108 that is different from the first region. These variations in tissue impedance throughout the muscle may affect the electrical stimulation field 110 generated based on the current delivered to the electrodes 106. To account for these variations, device 100 may be configured to deliver independent currents to electrodes 106 by current sources 102 (and / or 104). In this way, a focusable electrical stimulation field 110 can be generated.

[0059] In some embodiments, muscle 108 may be a muscle of the bladder wall (e.g., a sphincter). Direct stimulation of these muscles of the bladder wall can be challenging. Therefore, using the targeted electrical stimulation device described herein, a plurality of electrodes 106 can be configured to directly stimulate the muscles of the bladder wall, for example, to trigger bladder emptying.

[0060] In some embodiments, the device 100 may be configured to generate an electric field (e.g., a current field) with a predetermined field strength. The field strength may be adjustable to effectively stimulate the bladder wall.

[0061] The aforementioned focusable electrical stimulation field 110 contrasts with an electrical stimulation field generated by a uniform voltage (or current) source. For example, Figure 4 An electrical stimulation device 400 is illustrated, wherein voltage sources 452, 454 are configured to deliver a uniform voltage to electrodes 456a, 456b (hereinafter collectively referred to as electrodes 456). Alternatively, voltage sources 452, 454 may be current sources delivering 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 variable tissue impedance in the muscle 458 or the organ containing the muscle. The varying tissue impedance throughout a given muscle or organ (e.g., the bladder) may cause certain areas of the muscle / organ to receive stimulation more readily than others, which may negatively impact the effectiveness of the stimulation protocol.

[0062] Furthermore, the electrical stimulation field 462 may not accurately capture the targeted stimulation area of ​​muscle 458 or the organ containing muscle. For example, the targeted stimulation area 460 may only be a small fraction of the size of the large electrical stimulation field 462. Figure 4 As shown. In this case, areas that may not require treatment may be affected by the electrical stimulation field 462, which is a poor use of the limited energy of the implantable device. In another example (not shown), the arrangement of electrodes 456 on the stimulation device may not accurately capture one or more intended stimulation areas of muscle 458 or an organ containing muscle. Generating the electrical stimulation field 462 by uniformly applying voltage (or current) at electrodes 456 may not adequately stimulate (e.g., may understimulate) the targeted stimulation area 460. In this case, the practitioner of the stimulation protocol may increase the energy delivered to electrodes 456 in an attempt to stimulate the targeted stimulation area 460, which may result in overstimulation of unintended areas of muscle 458 or an organ containing muscle. Such overstimulation of the tissue may have negative effects on the tissue and waste the power of the stimulation device.

[0063] Figure 2 The illustration shows a block diagram of a first exemplary electrical stimulation system according to some embodiments. The electrical stimulation system 230 may include a stimulation device 200, which includes the stimulation device described herein. Figures 1A-1D The described stimulation device 100 may include any one or more features. For example, current sources 202, 204 may include any one or more features of current sources 102, 104 (respectively) of device 100, and electrodes 206 (e.g., electrodes 206a, 206b, hereinafter collectively referred to as electrodes 206) may include any one or more features of electrodes 106 of device 100. Current source 202 may include one or more transistors in some embodiments. Multiple electrodes 206 may include one or more anodes and one or more cathodes configured to deliver bipolar stimulation.

[0064] Stimulation system 230 (e.g., stimulation device 200) may include control circuitry 212 for controlling the current delivered to current source 202. For example, control circuitry 212 may be configured to generate one or more current waveforms (otherwise more simply referred to as currents herein) that can be delivered to multiple current sources 202. Control circuitry 212 may more generally control the flow and storage of energy and information within stimulation device 200. Control circuitry 212 may be electrically coupled to each of the multiple current sources 202 via lead 216, as shown by the solid line in the box connecting current source 202 and control circuitry 212.

[0065] 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 stimulation device 200.

[0066] In some embodiments, the stimulation device 200 may include one or more leads 216 (e.g., stimulation leads) that can electrically couple each of the plurality of electrodes 206 to one or more independent current sources of the 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 method, contact geometry, etc. For example, the diameter of the leads 216 may be 1 mm to 2 mm, and may contain ethylene-tetrafluoroethylene copolymer (ETFE) conductive wire insulation material and / or 55D polyurethane lead body material.

[0067] An exemplary stimulation system may include a stimulation device 200 and an external device 220 configured to communicate with the stimulation device 200. For example, control circuitry 212 of the stimulation device 200 may be communicatively coupled to the external device 220. The control circuitry 212 may be configured to receive commands from the external device 220 to deliver a current waveform to one or more 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 placed near the implantation site of the stimulation device 200. In some embodiments, the external device 220 may be a separate device (at least partially) implanted in the patient's body. In this case, 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 stimulation device 200 when an appropriate command is received from the remote device.

[0068] In some embodiments, the external device 220 and the control circuitry 212 may be communicatively coupled via a transducer 214 configured to wirelessly receive and transmit energy and / or commands between the stimulation device 200 (e.g., the control circuitry 212 of the stimulation device 200) and the external device 220. These commands received at the transducer 214 may indicate operating parameters of the stimulation device 200. In some embodiments, the transducer 214 may be configured to convert energy received from the external device 220 into electrical current. In some embodiments, the stimulation device 200 may include communication circuitry electrically coupled to and configured to operate the transducer 214.

[0069] In some embodiments, transducer 214 may include one or more ultrasonic transducers. In this way, control circuitry 212 can receive commands from ultrasonic waves emitted by external device 220. In some embodiments, current source 202 may be configured to receive energy from ultrasonic waves emitted by external device 220. Exemplary ultrasonic transducers include, but are not limited to, bulk piezoelectric transducers, piezoelectric micromechanical transducers, or capacitive micromechanical transducers, each of which may be configured to convert the energy carried by ultrasonic waves emitted by external device 220 into a current signal.

[0070] In some embodiments, the transducer may include one or more radio frequency (RF) antennas or one or more radio frequency (RF) coils. In this way, control circuitry 212 can receive commands from radio waves emitted by external device 220. In some embodiments, current source 202 may be configured to receive energy from RF waves emitted by external device 220. The RF antenna and / or coil may be configured to convert the energy carried by the RF waves into a current signal.

[0071] In some embodiments, the transmission of information from the stimulation device 200 to the external device 220 may rely on a backscatter communication protocol. For example, the control circuitry 212 may communicate with the external device 220 using ultrasound backscatter or radio wave backscatter. As described above, the external device 220 may be configured to transmit wireless signals (e.g., ultrasound signals or radio frequency signals) to the stimulation device 200. When a patient wishes to retrieve information from the stimulation device 200, the control circuitry 212 may cause the modulation circuitry of the stimulation device 200 to encode information in a current flowing through the stimulation device 200. The encoded current may be transmitted from the modulation circuitry to a transducer 214, which may convert the encoded current into an encoded wireless signal (e.g., ultrasound signal or RF signal) of the same type transmitted by the external device 220. This encoded wireless signal (“backscatter” signal) may be transmitted by the transducer 214 and then received by the external device 220. The external device 220 may then decrypt the backscatter signal to retrieve the encoded information.

[0072] In addition to or instead of backscatter communication, the transmission of information from the stimulation device 200 to the external device 220 may rely on an active communication protocol (e.g., active radio wave or ultrasound transmission). Active radio wave or ultrasound 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 an embodiment, control circuitry 212 may cause transducer 214 to generate and transmit a signal encoding information. External device 220 may receive and decode the signal to retrieve the encoded information. In some embodiments, stimulation device 200 may include an energy storage device 218. The energy storage device 218 (e.g., a capacitor) may be independently electrically coupled to current source 202 and electrically coupled to transducer 214. To minimize size, stimulation device 200 may include only a small energy storage device 218 (e.g., a small capacitor). This energy storage device 218 may need to be periodically charged so that stimulation device 200 can provide treatment to the patient. For example, as described herein, energy for charging energy storage 218 can be delivered to stimulation device 200 by external device 220. In some embodiments, stimulation device 200 may include an AC / DC rectifier configured to convert current from transducer 214 from an AC (AV) signal to a DC signal that can be used to charge energy storage 218.

[0073] In some embodiments, the stimulation device 200 may include a power management unit (understood to include an energy storage 218) configured to store energy and distribute energy to components of the device, a modulation circuit configured to encode information in an electric 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).

[0074] In some embodiments, the exemplary stimulation system 230 may include the stimulation device 200 described herein and the external device 220, 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 to the vicinity of the stimulation device 200.

[0075] Figure 3 A block diagram of a second exemplary electrical stimulation device according to some embodiments is illustrated. Stimulation device 300 may include, as described herein with respect to FIG1 and Figure 2 Any one or more features of the stimulation device 100 and / or stimulation device 200 described respectively. For example, electrodes 306a, 306b may include features described herein. Figures 1A-1D and Figure 2The described electrodes 106, 206 may include any one or more features. Current sources 302a, 302b may include those described herein. Figures 1A-1D and Figure 2 The current sources 102 and 202 described herein may include any one or more features. Current sources 304a and 304b may include features described herein. Figures 1A-1D and Figure 2 The current sources 104, 204 described herein may include any one or more features. The control circuit 312 may include features described herein. Figure 2 Any one or more features of the described control circuit 212.

[0076] Figure 3 Device 300 can be demonstrated, wherein the components of the device can be distributed in different areas relative to the patient. For example, device 300 may include one or more electrode plates 300a, 300b, which can be implanted at a region of interest such as muscle 308, organ containing muscle, etc. Furthermore, as... Figure 3 As shown, device 300 may include a control unit 300c, which includes control circuitry 312 and can be electrically coupled to electrode plates 300a, 300b. The control unit 300c may be implanted remotely to or near one or more electrode plates 300a, 300b. In some embodiments, the control unit 300c may not be implanted in the patient's body, but may be an external device. The control unit 300c may include components described herein. Figure 2 The stimulation device 200 shown may include any one or more components described. For example, the control unit 300c may include one or more transducers, energy storage devices, etc., which are not shown for simplicity.

[0077] In some embodiments, one or more electrodes 306a may be disposed on a first electrode plate 300a, and one or more electrodes 306b may be disposed on a second electrode plate 300b. The electrodes may be anodes, cathodes, or may be configured to be interchangeable between anodes and cathodes. Figure 3 As shown, a first electrode plate 300a can be implanted at a first location in a muscle 308 or an organ containing a muscle, and a second electrode plate 300b can be implanted at a second location in a muscle 308 (or an organ containing a muscle). In some embodiments, the first electrode plate 300a and / or the second electrode plate 300b may include a conductive shell that can be used as an electrode. As described herein, the electrode plates 300a, 300b may include an insulating substrate, such as silicone, which may surround the electrodes 306a, 306b to prevent the stimulation current from diffusing into unintended areas of the muscle or the organ containing the muscle.

[0078] Each electrode 306a, 306b may be coupled to one or more current sources. For example, one or more leads (e.g., stimulation 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, electrode plate 300a may include one or more electrodes 306a, each of which may be coupled to an independent current source 302a, and electrode plate 300b may include one or more electrodes 306b, each of which may be coupled to a current source 304b (e.g., a current trap). In other words, electrode plate 300a may include one or more electrodes independently electrically coupled to one or more current sources, while electrode plate 300b may include one or more electrodes independently electrically coupled to one or more current traps (and vice versa).

[0079] In some embodiments, one or more components 300a, 300b, 300c may be reasonably combined, or one of electrode plates 300a or 300b may be omitted. For example, an exemplary device may include two components—electrode plate 300a and control unit 300c, the electrode plate 300a including one or more electrodes 306a coupled to independent current sources 302a, 304a, and the control unit 300c including control circuitry 312 at least (e.g., via one or more leads) coupled to the current sources 302a, 304a disposed on the electrode plate 300a. In another example, a single electrode plate (e.g., electrode plate 300a) may include the features of electrode plates 300a and 300b described herein. In another example, an implantable electrode plate (e.g., electrode plate 300b) may include the features of electrode plate 300b and control unit 300c. In this case, the system may also include an additional electrode plate 300a coupled to the combined electrode plate and control unit for stimulating muscle 308 or organs containing muscle in different regions of the implanted electrode plate 300a.

[0080] Methods for generating focused electric fields

[0081] Figure 5 The illustration depicts a method 500 for generating a focused electric field to stimulate a muscle or an organ containing a muscle, according to some embodiments. For example, method 500 can be used to stimulate the bladder wall (e.g., the sphincter muscle of the bladder). The method may include receiving energy (e.g., initial energy) from an external device (e.g., external device 220) at the stimulation device (e.g., stimulation device 100, 200, or 300) before stimulation begins, for example, to power the device. For example, the external device may be used to charge the stimulation device. In some embodiments, the energy may be received from ultrasound waves emitted by the external device. Alternatively, the energy may be received from radio waves emitted by the external device.

[0082] In step 502, method 500 may include delivering an initial independent current to a plurality of electrodes implanted on a muscle or an organ containing a muscle. For example, a first plurality of current sources may supply independent current to the electrodes, and a second plurality of current sources may receive the independent current supplied to the electrodes. Each current source may be configured to generate or receive an independent current that may have different amplitudes and / or waveforms. The first plurality of current sources and the second plurality of current sources may be coupled in series via the muscle or an organ containing the muscle (where at least one electrode is electrically coupled to a current source). In this way, each of the plurality of electrodes may be operated using an independent current source among the plurality of current sources. In some embodiments, a given electrode among the plurality of electrodes may be coupled to a plurality of current sources, such as a current source configured to deliver current to the electrode and a current trap configured to draw current from the electrode.

[0083] 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 instructing that an initial independent current should be delivered to multiple electrodes. Based on this command, an independent current may be delivered to one or more of the multiple electrodes of the stimulation device. This command may be encoded in ultrasound or radio waves emitted by the external device.

[0084] In step 504, method 500 may include generating an initial electric field from multiple electrodes to stimulate a muscle or an organ containing a muscle. The initial electric field may be a two-dimensional or three-dimensional current field. The initial electric field generated by the multiple electrodes may be based on independent currents delivered by a current source. The initial electric field may be generated by the multiple electrodes using initial energy delivered to the stimulation device by an external device. In some embodiments, the method may include receiving a command from the external device instructing that the initial independent currents delivered to one or more of the multiple electrodes should be updated. As described above, this command may be encoded in ultrasound or radio waves emitted by the external device.

[0085] In step 506, method 500 may include delivering an updated independent current to one or more of the plurality of electrodes. In some embodiments, delivering the updated independent current may include updating one or more operating parameters of one or more current sources electrically coupled to the one or more electrodes to cause the one or more current sources to deliver the updated independent current. Additionally or alternatively, delivering the updated current may include updating the current waveform delivered to the one or more current sources by control circuitry. In some embodiments, the updated independent current delivered to a given electrode among the one or more electrodes may be less than the initial independent current delivered to the given electrode among the one or more electrodes. In some embodiments, the updated independent current delivered to a given electrode among the one or more electrodes may be greater than the initial current delivered to the given electrode among the one or more electrodes. In some embodiments, delivering the updated independent current to a given electrode among the one or more electrodes may include not delivering current to the given electrode among the one or more electrodes (i.e., stopping current delivery to the given electrode).

[0086] In step 508, method 500 may include generating a focused electric field from multiple electrodes to directly stimulate a muscle or an organ containing a muscle. The focused electric field may be a two-dimensional or three-dimensional current field.

[0087] Methods for stimulating muscles or organs containing muscles

[0088] In some embodiments, a method for stimulating a muscle or organ containing muscle using the targeted electrical stimulation device described herein may be provided. For example, the method provided herein can be used to stimulate muscles of the bladder or bladder wall (e.g., sphincter muscles). The method may include delivering energy to the stimulation device. For example, the 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 prior to stimulation. The stimulation device may include 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 device capable of receiving and storing the current. Each current source of the stimulation device may be electrically coupled to the energy storage device to receive the stored current. As described herein, each 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, current can be delivered to each electrode in the desired amount for stimulation.

[0089] The method may include stimulating a muscle or organ containing a muscle using a focused electric field generated by energy delivered to a stimulation device from multiple electrodes. Generating the focused electric field may include methods described herein. Figure 5Any one or more steps described in method 500. 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 focused electric field using the updated (and, if applicable) initial current delivered by each independent current source to a given electrode among a plurality of electrodes. As described herein, the initial electric field may be a two-dimensional or three-dimensional current field.

[0090] Treatment

[0091] In some embodiments, a treatment method may be provided that includes using a targeted electrical stimulation device (e.g., device 100, 200, or 300) as described herein. For example, the 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 to urinate (or lack thereof).

[0092] In some embodiments, the method may optionally include implanting a stimulation device (e.g., stimulation device 100, 200, or 300) into the bladder wall. For example, at least the portion of the device including electrodes may be implanted into a muscle of the bladder wall (e.g., a sphincter). In some embodiments, as per [the relevant information]... Figure 3 As shown in the stimulation device 300, one or more electrode plates including electrodes (and current sources / sinks) can be implanted in the bladder wall, and the control unit of the device can be implanted at least partially in the patient, near or away from the one or more electrode plates.

[0093] In some embodiments, the treatment method may include powering a stimulation device to activate and / or charge the device, for example, via an external device (e.g., an interrogator). Once powered 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 associated with the initial current (e.g., intensity, pulse width, pulse duration, etc.) may be provided to the stimulation device, for example, automatically by the external device or manually by a user of the external device. For example, the external device may have stored operating parameters that can be transmitted to the stimulation device, or the user may program the operating parameters via the external device. In some embodiments, the stimulation device itself may have stored (e.g., initial) operating parameters, and the external device may transmit commands to initiate the delivery of stimulation using the stored operating parameters.

[0094] The independent currents supplied to each electrode can be combined to generate an initial electric field for stimulation. Data related to the initial electric field, the resulting stimulation, tissue resistance, etc. (collectively referred to below 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 can be transferred to an external device for recording and analysis. Based on the stimulation data, the system or the user of the system can determine whether the stimulation field needs to be adjusted. For example, one or more currents supplied to the electrodes can be adjusted to focus the electric field and generate a newer electric field. In some embodiments, one or more currents supplied to the electrodes can be automatically adjusted during a treatment cycle according to pre-programmed stimulation parameters. Alternatively, this can be done in accordance with the provisions of this document regarding method 500 and Figure 5 The electric field is adjusted in a similar manner as described.

[0095] As described herein, the operating parameters of the current source can be stored in some embodiments (e.g., in the memory of the stimulation device and / or external device). For example, the initial current delivered to the electrodes during a given treatment cycle and any subsequent current updates can be stored. In this case, an updated electric field can optionally be generated during the execution of a subsequent treatment regimen, at least because the initial electric field can be based on parameters stored from past treatment cycles.

[0096] Example parameters—pulse width, duration, current intensity, etc.

[0097] definition

[0098] As used in this article, the singular forms “a,” “one,” and “the” include plural references unless the context clearly indicates otherwise.

[0099] In this document, references to "about" a value or parameter include (and describe) changes to that value or parameter itself. For example, a reference to "about X" includes a description of "X".

[0100] It should be understood that aspects and variations of the invention described herein include aspects and variations that are “composed of” and / or “substantially composed of”.

[0101] When values ​​or ranges of values ​​are provided, it should be understood that every intermediate value between the upper and lower limits of the range, as well as any other value or intermediate value within the range, is covered by this disclosure. Where the range includes an upper or lower limit, the range excluding any of those included limits is also included in this disclosure.

[0102] The section headings used herein are for organizational purposes only and should not be construed as limiting the subject matter described. The description is provided to enable those skilled in the art to make and use the invention, and is provided in the context of the patent application and its claims. Various modifications to the described embodiments will be apparent to those skilled in the art, and the general principles herein can be applied to other embodiments. Therefore, the invention is not intended to be limited to the embodiments shown, but should be given the widest scope consistent with the principles and features set forth herein.

[0103] The accompanying drawings illustrate processes according to various embodiments. In the exemplary processes, some boxes may be optionally combined, the order of some boxes may be optionally changed, and some boxes may be optionally omitted. In some examples, additional steps may be performed in conjunction with the exemplary processes. Therefore, the operations illustrated (and described in more detail below) are exemplary in nature and should not be considered limiting.

[0104] Finally, it should be understood that the features and preferences described with respect to the "embodiments" are different preferences and are not limited to that particular embodiment; they can be freely combined with features from other embodiments where technically feasible, and can form preferred combinations. The description is provided to enable those skilled in the art to make and use the invention, and is provided in the context of the patent application and its claims. Various modifications to the described embodiments will be apparent to those skilled in the art, and the general principles herein can be applied to other embodiments. Therefore, the invention is not intended to be limited to the embodiments shown, but should be given the widest scope consistent with the principles and features set forth herein. Furthermore, section headings are provided for organizational purposes and should not be considered restrictive.

[0105] The entire disclosure of the patents and publications cited in this application is incorporated herein by reference for all purposes. In the event of any conflict between any cited reference and this disclosure, this disclosure shall prevail.

[0106] Example

[0107] The following examples are exemplary and are not intended to limit the scope of any invention described herein.

[0108] Example 1. A stimulation device comprising: a plurality of current sources; and a plurality of electrodes electrically coupled to the plurality of current sources, the plurality of electrodes being configured to directly stimulate a muscle or an organ containing a muscle, wherein each of the plurality of electrodes is configured to operate using an independent current source among the plurality of current sources.

[0109] Example 2. The stimulation device according to Example 1, wherein each of the plurality of current sources is electrically coupled in series with at least one other current source among the plurality of current sources through the muscle or an organ containing the muscle.

[0110] Example 3. The stimulation device according to Example 1 or 2, wherein the independent current source among the plurality of current sources is configured to supply or absorb current, the current being independent of the current supplied or absorbed by the other current sources among the plurality of current sources.

[0111] Example 4. The stimulation device according to any one of Examples 1 to 3, wherein the current supplied by the plurality of current sources can be adjusted by a control circuit electrically coupled to each of the plurality of current sources.

[0112] Example 5. The stimulation device according to any one of Examples 1 to 4, wherein at least one of the plurality of current sources is adjustable between a supply current and an absorption current via a control circuit electrically coupled to the at least one current source.

[0113] Example 6. The stimulation device according to any one of Examples 1 to 5 includes a switch 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.

[0114] Example 7. A stimulation device according to any one of Examples 1 to 6, wherein the plurality of electrodes are configured to generate a focusable electrical stimulation field for targeted stimulation of the muscle or an organ containing the muscle based on independent currents from the plurality of current sources.

[0115] Example 8. The stimulation device according to Example 7, wherein the electrical stimulation field is a two-dimensional current field or a three-dimensional current field.

[0116] Example 9. A stimulation device according to any one of Examples 1 to 8, comprising a control circuit electrically coupled to each of the plurality of current sources and configured to generate a current waveform to be delivered to the plurality of current sources.

[0117] Example 10. The stimulation device according to Example 9, wherein the control circuit is configured to receive a command from an external device, the command being configured to cause the control circuit to deliver the current waveform to one or more of the plurality of current sources.

[0118] Example 11. The stimulation device according to Example 9, wherein the stimulation device includes one or more ultrasonic transducers, and the control circuit receives the command from ultrasonic waves emitted by the external device.

[0119] Example 12. The stimulation device according to Example 10 or 11, wherein the control circuit is configured to communicate with the external device using ultrasound backscattering.

[0120] Example 13. The stimulation device according to Example 10, wherein the stimulation device includes a radio frequency antenna, and the control circuit receives the command from radio waves emitted by the external device.

[0121] Example 14. The stimulation device according to Example 10 or 13, wherein the control circuit is configured to communicate with the external device using radio wave backscattering.

[0122] Example 15. A stimulation device according to any one of Examples 1 to 10 or 13 to 14, wherein the stimulation device includes a radio frequency antenna and the plurality of current sources are configured to receive energy from RF waves emitted from an external device.

[0123] Example 16. A stimulation device according to any one of Examples 1 to 12, wherein the stimulation device includes one or more ultrasonic transducers, and the plurality of current sources are configured to receive energy from ultrasonic waves emitted by the external device.

[0124] Example 17. The stimulation device according to any one of Examples 1 to 16, wherein a first portion of the plurality of electrodes is disposed on a first electrode plate, the first electrode plate being configured to be implanted at a first location in the muscle or an organ containing the muscle, and a second portion of the plurality of electrodes is disposed on a second electrode plate, the second electrode plate being configured to be implanted at a second location in the muscle or an organ containing the muscle.

[0125] Example 18. The stimulation device according to Example 17, wherein the first electrode plate and / or the second electrode plate includes a conductive shell configured as an electrode.

[0126] Example 19. A stimulation device according to any one of Examples 1 to 18, comprising one or more stimulation leads, the one or more stimulation leads electrically coupling each of the plurality of electrodes to an independent current source among the plurality of current sources.

[0127] Example 20. The stimulation device according to any one of Examples 1 to 19 includes an energy storage device electrically coupled to the plurality of current sources.

[0128] Example 21. A stimulation device according to any one of Examples 1 to 20, wherein the plurality of electrodes comprises at least one anode and at least one cathode, the at least one anode and the at least one cathode being configured together to deliver bipolar stimulation to the muscle or an organ containing the muscle.

[0129] Example 22. The stimulation device according to any one of Examples 1 to 21, wherein at least a portion of the plurality of current sources is configured to act as a current trap for absorbing current.

[0130] Example 23. The stimulation device according to any one of Examples 1 to 22, wherein the plurality of current sources comprises one or more transistors.

[0131] Example 24. The stimulation device according to any one of Examples 1 to 23, wherein the plurality of electrodes are configured to directly stimulate the bladder wall to trigger bladder emptying.

[0132] Example 25. A stimulation system comprising: a stimulation device according to any one of Examples 1 to 24; and an external device configured to communicate with the stimulation device.

[0133] Example 26. The stimulation system according to Example 25 includes a magnet configured to turn the stimulation device on and / or off.

[0134] Example 27. A method for stimulating a muscle or an organ containing a muscle, comprising: delivering energy to a stimulation device according to any one of Examples 1 to 26; and stimulating the muscle or an organ containing a muscle using a focused electric field generated by the plurality of electrodes using the energy delivered to the stimulation device.

[0135] Example 28. The method according to Example 27 includes: delivering initial energy to the stimulation device; and stimulating the muscle or an organ containing the muscle using an initial electric field generated by the plurality of electrodes using the initial energy delivered to the stimulation device.

[0136] Example 29. The method according to Example 27 or 28, wherein the energy is delivered using an external device.

[0137] Example 30. The method according to Example 29, wherein the energy is delivered using ultrasound emitted by the external device.

[0138] Example 31. The method according to Example 29, wherein the energy is delivered using radio waves emitted by the external device.

[0139] Example 32. The method according to any one of Examples 27-31 includes transmitting one or more commands to the stimulation device indicating operating parameters of the stimulation device.

[0140] Example 33. The method according to Example 32, wherein the command is encoded in an ultrasonic wave emitted by the external device.

[0141] Example 34. The method according to Example 32, wherein the command is encoded in radio waves emitted by the external device.

[0142] Example 35. A method for treating bladder incontinence in a subject requiring treatment for bladder incontinence, comprising applying electrical stimulation using a stimulation device according to any one of Examples 1 to 26.

[0143] Example 36. A method for generating a focused electric field to stimulate a muscle or an organ containing a muscle, comprising: delivering an initial independent current to a plurality of electrodes implanted on the muscle or an organ containing a muscle; generating an initial electric field from the plurality of electrodes to stimulate the muscle or an organ containing a muscle; delivering a renewed independent current to one or more of the plurality of electrodes; and generating a focused electric field from the plurality of electrodes to directly stimulate the muscle or an organ containing a muscle.

[0144] Example 37. The method according to Example 36, wherein the initial independent current delivered to the plurality of electrodes is supplied or absorbed by a plurality of current sources electrically coupled to the plurality of electrodes.

[0145] Example 38. The method according to Example 37, wherein each of the plurality of electrodes is operated using an independent current source among the plurality of current sources, and each of the plurality of current sources is configured to absorb or supply current, the current being independent of the current supplied or absorbed by the other current sources among the plurality of current sources.

[0146] Example 39. The method according to Example 37 or 38, wherein the current supplied by the plurality of current sources can be regulated by a control circuit electrically coupled to each of the plurality of current sources.

[0147] Example 40. The method according to any one of Examples 37-39, wherein at least one of the plurality of current sources is adjustable between supply current and absorb current via a control circuit electrically coupled to the at least one current source.

[0148] Example 41. The method according to any one of Examples 38-40, wherein the switch of the independent current source electrically coupled to the plurality of current sources is configured to control whether the independent current source supplies current to the electrode or draws current from the electrode.

[0149] Example 42. The method according to any one of Examples 37-41, wherein delivering an updated independent current to one or more of the plurality of electrodes comprises updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes, so that the one or more current sources deliver the updated independent current.

[0150] Example 43. The method according to any one of Examples 37-42, wherein delivering an updated independent current to one or more of the plurality of electrodes includes updating the current waveform delivered to the one or more current sources.

[0151] Example 44. The method according to any one of Examples 36-43, wherein the updated independent current delivered to a given electrode among the one or more electrodes is less than the initial independent current delivered to the given electrode among the one or more electrodes.

[0152] Example 45. The method according to any one of Examples 36-43, wherein the updated independent current delivered to a given electrode among the one or more electrodes is greater than the initial independent current delivered to the given electrode among the one or more electrodes.

[0153] Example 46. The method according to any one of Examples 36-45, wherein delivering an updated independent current to a given electrode among the one or more electrodes includes not delivering current to the given electrode among the one or more electrodes.

[0154] Example 47. The method according to any one of Examples 36-46, wherein the plurality of electrodes includes at least one anode and at least one cathode, wherein when the initial electric field and / or the focused electric field is generated, the at least one anode and the at least one cathode together deliver bipolar stimulation to the muscle or an organ containing the muscle.

[0155] Example 48. The method according to any one of Examples 36-47 includes receiving energy from an external device.

[0156] Example 49. The method according to Example 48, wherein the energy is received from ultrasonic waves emitted by the external device.

[0157] Example 50. The method according to Example 48, wherein the energy is received from radio waves emitted by the external device.

[0158] Example 51. A method according to any one of Examples 36-50, comprising: receiving from an external device a command indicating that the initial independent current should be delivered to the plurality of electrodes; and delivering the initial independent current to one or more of the plurality of electrodes.

[0159] Example 52. The method according to Example 51, wherein the command is encoded in an ultrasonic wave emitted by the external device.

[0160] Example 53. The method according to Example 51, wherein the command is encoded in radio waves emitted by the external device.

[0161] Example 54. A method according to any one of Examples 36-53, comprising: receiving from an external device a command indicating that the initial independent current delivered to one or more of the plurality of electrodes should be updated; and delivering the updated independent current to the one or more of the plurality of electrodes.

[0162] Example 55. The method according to Example 54, wherein the command is encoded in an ultrasonic wave emitted by the external device.

[0163] Example 56. The method according to Example 55, wherein the command is encoded in radio waves emitted by the external device.

[0164] Example 57. The method according to any one of Examples 36-56 includes communicating with an external device using ultrasonic backscattering.

[0165] Example 58. The method according to any one of Examples 36-56 includes communicating with an external device using radio wave backscattering.

[0166] Example 59. The method according to any one of Examples 36-58, wherein each of the initial electric field and the focusing electric field is a two-dimensional current field or a three-dimensional current field.

[0167] Example 60. A method for treating bladder incontinence in a subject requiring treatment for bladder incontinence, comprising applying electrical stimulation according to any one of Examples 36-59.

[0168] Example 61. The stimulation device according to Example 10 or 11, wherein the control circuit is configured to communicate with the external device using active ultrasound transmission.

[0169] Example 62. The stimulation device according to Example 10 or 13, wherein the control circuit is configured to communicate with the external device using active radio wave transmission.

[0170] Example 63. The method according to any one of Examples 36-56 includes communicating with an external device using active ultrasonic transmission.

[0171] Example 64. The method according to any one of Examples 36-56 includes communicating with an external device using active radio wave transmission.

[0172] in conclusion

[0173] For purposes of explanation, the foregoing description has been given with reference to specific embodiments. However, the above illustrative discussion is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in light of the foregoing teachings. These embodiments were chosen and described in order to best explain the principles of these techniques and their practical application. Therefore, those skilled in the art will be able to best utilize these techniques and various embodiments with various modifications suitable for the intended particular use.

[0174] Although this disclosure and examples have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications should be understood to be included within the scope of this disclosure and the examples defined by the claims.

Claims

1. A stimulation device, comprising: Multiple current sources; as well as Multiple electrodes electrically coupled to the plurality of current sources, the plurality of electrodes being configured to directly stimulate muscles or organs containing muscles, wherein each of the plurality of electrodes is configured to operate using an independent current source among the plurality of current sources.

2. The stimulation device according to claim 1, wherein, Each of the plurality of current sources is electrically coupled in series with at least one other current source through the muscle or the organ containing the muscle.

3. The stimulation device according to claim 1 or 2, wherein, The independent current source among the plurality of current sources is configured to supply or absorb current, which is independent of the current supplied or absorbed by the other current sources among the plurality of current sources.

4. The stimulation device according to any one of claims 1 to 3, wherein, The current supplied by the plurality of current sources can be regulated by a control circuit electrically coupled to each of the plurality of current sources.

5. The stimulation device according to any one of claims 1 to 4, wherein at least one of the plurality of current sources is adjustable between a supply current and an absorption current via a control circuit electrically coupled to the at least one current source.

6. The stimulation device according to any one of claims 1 to 5, comprising a switch 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.

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

8. The stimulation device according to claim 7, wherein, The electrical stimulation field is a two-dimensional or three-dimensional current field.

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

10. The stimulation device according to claim 9, wherein, The control circuit is configured to receive commands from an external device, the commands being configured to cause the control circuit to deliver the current waveform to one or more of the plurality of current sources.

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

12. The stimulation device according to claim 10 or 11, wherein, The control circuit is configured to communicate with the external device using ultrasonic backscattering.

13. The stimulation device according to claim 10, wherein, The stimulation device includes a radio frequency (RF) antenna, and the control circuit receives the command from radio waves emitted by the external device.

14. The stimulation device according to claim 10 or 13, wherein, The control circuit is configured to communicate with the external device using radio wave backscattering.

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

16. The stimulation device according to any one of claims 1 to 12, wherein, The stimulation device includes 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. The stimulation device according to any one of claims 1 to 16, wherein, A first portion of the plurality of electrodes is disposed on a first electrode plate, the first electrode plate being configured to be implanted at a first location in the muscle or the organ containing the muscle, and a second portion of the plurality of electrodes is disposed on a second electrode plate, the second electrode plate being configured to be implanted at a second location in the muscle or the organ containing the muscle.

18. The stimulation device according to claim 17, wherein, The first electrode plate and / or the second electrode plate include a conductive shell, which is configured as an electrode.

19. The stimulation device according to any one of claims 1 to 18, comprising one or more stimulation leads, the one or more stimulation leads electrically coupling each of the plurality of electrodes to an independent current source among the plurality of current sources.

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

21. The stimulation device according to any one of claims 1 to 20, wherein, The plurality of electrodes includes at least one anode and at least one cathode, the at least one anode and the at least one cathode being configured together to deliver bipolar stimulation to the muscle or the organ containing the muscle.

22. The stimulation device according to any one of claims 1 to 21, wherein, At least a portion of the plurality of current sources are configured to act as current traps that absorb current.

23. The stimulation device according to any one of claims 1 to 22, wherein, The plurality of current sources includes one or more transistors.

24. The stimulation device according to any one of claims 1 to 23, wherein, The multiple electrodes are configured to directly stimulate the bladder wall to trigger bladder emptying.

25. A stimulation system comprising: The stimulation device according to any one of claims 1 to 24; as well as An external device configured to communicate with the stimulation device.

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

27. A method for stimulating a muscle or an organ containing a muscle, comprising: Delivering energy to the stimulation device according to any one of claims 1 to 26; as well as The muscle or organ containing the muscle is stimulated by a focused electric field generated by the energy delivered to the stimulation device using the plurality of electrodes.

28. The method of claim 27, comprising: Initial energy is delivered to the stimulation device; as well as The muscle or organ containing the muscle is stimulated by an initial electric field generated by the initial energy delivered to the stimulation device using the plurality of electrodes.

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

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

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

32. The method according to any one of claims 27-31, comprising transmitting one or more commands to the stimulation device indicative of operating parameters of the stimulation device.

33. The method according to claim 32, wherein, The command is encoded in an ultrasonic wave emitted by the external device.

34. The 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 subject requiring treatment for bladder incontinence, comprising applying electrical stimulation using a stimulation 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 a muscle, comprising: Initial independent currents are delivered to multiple electrodes implanted in the muscle or an organ containing muscle; An initial electric field is generated by the plurality of electrodes to stimulate the muscle or organ containing the muscle; Deliver updated independent currents to one or more of the plurality of electrodes; as well as A focused electric field is generated by the plurality of electrodes to directly stimulate the muscle or organ containing the muscle.

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

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

39. The method of claim 37 or 38, wherein the current supplied by the plurality of current sources can be regulated by a control circuit electrically coupled to each of the plurality of current sources.

40. The method according to any one of claims 37-39, wherein, At least one of the plurality of current sources can be adjusted between supply current and absorb current via a control circuit electrically coupled to the at least one current source.

41. The method according to any one of claims 38-40, wherein, The switches of the independent current sources electrically coupled to the plurality of current sources are configured to control whether the independent current source supplies current to the electrode or draws current from the electrode.

42. The method according to any one of claims 37-41, wherein, Delivering an updated independent current to one or more of the plurality of electrodes includes updating one or more operating parameters of one or more current sources of the plurality of electrodes electrically coupled to the one or more electrodes, so that the one or more current sources deliver the updated independent current.

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

44. The method according to any one of claims 36-43, wherein, The updated independent current delivered to a given electrode among the one or more electrodes is less than the initial independent current delivered to the given electrode among the one or more electrodes.

45. The method of any one of claims 36-43, wherein the updated independent current delivered to a given electrode among the one or more electrodes is greater than the initial independent current delivered to the given electrode among the one or more electrodes.

46. ​​The method according to any one of claims 36-45, wherein, Delivering an updated independent current to a given electrode among the one or more electrodes includes not delivering current to the given electrode among the one or more electrodes.

47. The method according to any one of claims 36-46, wherein, The plurality of electrodes includes at least one anode and at least one cathode, which together deliver bipolar stimulation to the muscle or organ containing the muscle when the initial electric field and / or the focused electric field is generated.

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

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

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

51. The method according to any one of claims 36-50, comprising: Receive a command from an external device instructing that the initial independent current should be delivered to the plurality of electrodes; as well as The initial independent current is delivered to one or more of the plurality of electrodes.

52. The method according to claim 51, wherein, The command is encoded in an ultrasonic wave emitted by the external device.

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

54. The method according to any one of claims 36-53, comprising: Receive a command from an external device indicating that the initial independent current delivered to one or more of the plurality of electrodes should be updated; as well as The updated independent current is delivered to one or more of the plurality of electrodes.

55. The method according to claim 54, wherein, The command is encoded in an ultrasonic wave emitted by the external device.

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

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

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

59. The method according to any one of claims 36-58, wherein, Each of the initial electric field and the focused electric field is a two-dimensional or three-dimensional current field.

60. A method for treating bladder incontinence in a subject requiring treatment for bladder incontinence, comprising applying electrical stimulation as described in any one of claims 36-59.

61. The stimulation device according to claim 10 or 11, wherein, The control circuit is configured to communicate with the external device using active ultrasonic transmission.

62. The stimulation device according to claim 10 or 13, wherein the control circuitry is configured to communicate with the external device using active radio wave transmission.

63. The method according to any one of claims 36-56, comprising communicating with an external device using active ultrasonic transmission.

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

Images