Systems and methods for electrophysiological stimulation treatment - Patents.com

Abstract

A system and method for therapeutic electrical stimulation of the wrist. A flexible band is secured around the wrist. The flexible band supports an electrode carrier 12 including a set of electrodes, one of which physically contacts the dorsal side of the wrist and a second of which physically contacts the ventral side of the wrist. A stimulation module is in electrical communication with the electrode carrier 12 and has a signal generation circuit 20 for generating electrical stimulation signals as direct current pulses at frequencies between 10 kHz and 50 kHz. A control circuit 30 sequentially activates different subsets of the electrodes 16 to act as signal sources or signal sinks of the electrical stimulation signal. The electrodes 16 are configured to deliver electrical stimulation to the arm or wrist to excite the median nerve, radial nerve, or ulnar nerve.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This patent application claims priority to International Patent Application No. PCT / US2022 / 018708, filed March 3, 2022, entitled "Method and Apparatus for Injury Treatment," and U.S. Provisional Patent Application No. 63 / 433,406, filed December 16, 2022, entitled "System and Method for Treatment by Electrophysiological Stimulation," each of which is incorporated herein by reference in its entirety. This patent application is related to U.S. Patent Application No. 17 / 193,725, filed March 5, 2021, entitled "Method and Apparatus for Injury Treatment."

[0002] An electrical stimulation device and method for applying an electrical stimulation signal to an injured area of ​​a patient's body. [Background technology]

[0003] The therapeutic application of electrical signals to the human body, sometimes referred to as "electrical stimulation" or "electrical stimulation therapy", has a long history. The modern, everyday use of electrical stimulation is best known through transcutaneous electrical nerve stimulation (TENS) devices, which deliver electrical impulses through the skin to relieve chronic or acute pain.

[0004] TENS signals range from below 10 Hz to 400 Hz, with the intensity of the signal depending on the frequency range involved and the intended effect. For example, TENS signals below 10 Hz are high intensity to induce motor contractions, while TENS signals above 50 Hz are generally low intensity. However, other known electrical stimulation devices operate at higher frequencies or at least offer the ability to operate at higher frequencies. See, for example, U.S. Patent No. 10,085,670B2, issued October 2, 2018.

[0005] Wound healing is another application of electrical stimulation, with U.S. Patent No. 7,520,849B1 issued April 21, 2009 being one example. For an earlier example, see U.S. Patent No. 4,846,186A issued July 11, 1989. U.S. Patent Publication No. 2010 / 020475A1 provides another example of applying electrical stimulation in combination with negative pressure therapy in the context of wound healing. Tremor nerve stimulation is yet another application of electrical stimulation, with U.S. Patent No. 10,960,207 providing one example.

[0006] The wide variability in electrical stimulation device configurations and operational parameters observed in the field of electrical stimulation reflects not only the wide range of intended applications, from pain relief to neuromuscular stimulation, but also the fact that the key parameters for efficacy in specific applications remain unclear. There remains a compelling need for electrical stimulation devices and methods that are highly effective in the fields of pain relief and wound healing. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 10085670B2 [Patent Document 2] U.S. Patent No. 7,520,849B1 [Patent Document 3] U.S. Patent No. 4,846,186A [Patent Document 4] US Patent Application Publication No. 2010 / 020475A1 [Patent Document 5] U.S. Pat. No. 1,096,0207 Summary of the Invention [Means for solving the problem]

[0008] The electrical stimulation device provides an electrical stimulation signal as a direct current pulse train at a frequency between 10 kHz and 50 kHz, based on sequential activation of respective subsets of a set of electrodes contained in an electrode carrier that contacts the electrodes with the patient's body, and applies the electrical stimulation signal to the patient's body at the site of injury. The electrical stimulation method sequentially activates, via an electrical stimulation signal, respective subsets of electrodes in a set of electrodes that contact the patient's body at the site of injury on the patient's body. Advantageously, in one or more embodiments, the sequential activation follows an activation order that "moves" the source and recipient of the electrical stimulation signal in a scanning or circular pattern around the site of injury.

[0009] One embodiment of a device configured for therapeutic electrical stimulation of a patient includes an electrode carrier and a stimulation module. The electrode carrier is configured to position a series of electrodes in contact with the patient's body at a site of injury thereon. Signal generation circuitry within the stimulation module is configured to generate electrical stimulation signals as a direct current (DC) pulse train at a frequency between 10 kHz and 50 kHz. Control circuitry within the stimulation module is configured to sequentially activate individual subsets of electrodes in the series of electrodes, each subset including one or more electrodes activated as signal sources of the electrical stimulation signal and one or more electrodes activated as signal sinks of the electrical stimulation signal.

[0010] Advantageously, in at least one embodiment of the device, the sequential activation follows an activation order that "moves" the source and sink of the electrical stimulation signal around the injury site, where "moving" the signal source and sink does not mean physical movement, but rather changing which electrodes are activated in a spatial pattern or sequence over time such that the electrical stimulation signal originates / receives from multiple locations around the injury site. Moving the signal source and sink creates spatially distributed signal paths through or across the injury site over time.

[0011] In a further advantageous arrangement for use in at least one embodiment of the device, the electrode carrier incorporates a ported chamber that is sealably closed by sealing the electrode carrier against the patient's body at the injury site. In such an embodiment, the control circuitry is configured to control application of negative pressure via the electrode carrier in conjunction with controlling application of the electrical stimulation signal. The source and sink movement provided via the sequential electrode activation is combined with negative pressure therapy to allow for synergistic application of injury healing therapy.

[0012] In another embodiment, a method performed by a device configured for therapeutic electrical stimulation of a patient includes providing an electrical stimulation signal as a DC pulse train at a frequency between 10 kHz and 50 kHz. The method further includes sequentially activating, via the electrical stimulation signal, a respective subset of electrodes in a series of electrodes contacting the patient's body at a site of injury thereon. For example, the sequential activation follows a defined activation order and activation cycle.

[0013] Of course, the present invention is not limited to the above features and advantages, and those skilled in the art will recognize additional features and advantages upon reading the following detailed description, and upon viewing the accompanying drawings. [Brief description of the drawings]

[0014] [Figure 1] FIG. 1 is a block diagram of one embodiment of a device configured for therapeutic electrical stimulation of a patient, also referred to as an electrical stimulation device. [Figure 2A] FIG. 2A is a diagram of an exemplary embodiment of an electrode carrier. [Figure 2B] FIG. 2B is a diagram of an exemplary embodiment of an electrode carrier. [Figure 2C] FIG. 2C is a diagram of an exemplary embodiment of an electrode carrier. [Figure 2D] FIG. 2D is a diagram of an exemplary embodiment of an electrode carrier. [Figure 2E] FIG. 2E is a diagram of an exemplary embodiment of an electrode carrier. [Figure 2F] FIG. 2F is a diagram of an exemplary embodiment of an electrode carrier. [Diagram 3] FIG. 3 is a diagram of an exemplary activation pattern and activation subsets of electrodes within an electrode carrier. [Figure 4A] FIG. 4A is a diagram of a further exemplary embodiment of an electrode carrier. [Figure 4B] FIG. 4B is an illustration of a further exemplary embodiment of an electrode carrier. [Figure 4C] FIG. 4C is a diagram of a further exemplary embodiment of an electrode carrier. [Diagram 5] FIG. 5 is a diagram of further examples of activation patterns and activation subsets of electrodes of an electrode carrier. [Figure 6] FIG. 6 is a diagram of an exemplary electrode activation sequence and activation cycle according to one or more embodiments. [Figure 7] FIG. 7 is a diagram of an exemplary electrode activation sequence and activation cycle according to one or more embodiments. [Figure 8] FIG. 8 is a diagram of example configuration data used by an electrical stimulation device according to one or more embodiments. [Figure 9A]FIG. 9A is a diagram of the functional logic used by an electrical stimulator for treatment program or treatment plan selection, according to one or more embodiments. [Figure 9B] FIG. 9B is a diagram of the functional logic used by the electrical stimulator for treatment program or treatment plan selection, according to one or more embodiments. [Figure 10] FIG. 10 is a diagram of the functional logic used by the electrical stimulator for therapy programming or adjustment, according to one or more embodiments. [Figure 11] FIG. 11 is a block diagram of an electrical stimulation device according to another embodiment. [Figure 12] FIG. 12 is a block diagram of an electrical stimulation device according to another embodiment. [Figure 13A] FIG. 13A is an illustration of an electrical stimulation device integrated with elements for providing negative pressure therapy, according to another embodiment. [Figure 13B] FIG. 13B is an illustration of an electrical stimulation device integrated with elements for providing negative pressure therapy, according to another embodiment. [Figure 13C] FIG. 13C is an illustration of an electrical stimulation device integrated with elements for providing negative pressure therapy, according to another embodiment. [Figure 14A] FIG. 14A is a diagram of an electrode carrier according to a further exemplary embodiment. [Figure 14B] FIG. 14B is an illustration of an electrode carrier according to a further exemplary embodiment. [Figure 14C] FIG. 14C is an illustration of an electrode carrier according to a further exemplary embodiment. [Figure 14D] FIG. 14D is an illustration of an electrode carrier according to a further exemplary embodiment. [Figure 15] FIG. 15 is a diagram of a further exemplary embodiment of an electrode carrier. [Figure 16] FIG. 16 is a diagram of a further exemplary embodiment of an electrode carrier. [Figure 17]FIG. 17 is a block diagram illustrating an exemplary interface between an electrode carrier and a stimulation module, according to various embodiments. [Figure 18] FIG. 18 is a block diagram illustrating an exemplary interface between an electrode carrier and a stimulation module, according to various embodiments. [Figure 19] FIG. 19 is a block diagram illustrating an exemplary interface between an electrode carrier and a stimulation module, according to various embodiments. [Figure 20] FIG. 20 is a block diagram illustrating an exemplary interface between an electrode carrier and a stimulation module, according to various embodiments. [Figure 21] FIG. 21 is a block diagram of another embodiment of an electrical stimulation device, in which the electrode carrier of the device integrates the stimulation module of the device. [Figure 22] FIG. 22 is a logic flow diagram of a method performed by an electrical stimulation device according to one embodiment. [Figure 23A] FIG. 23A illustrates an exemplary "moving" pattern for distributing or sweeping an electrical stimulation signal across or through an injury at an injury site on a patient's body. [Figure 23B] FIG. 23B illustrates an exemplary "moving" pattern for distributing or sweeping an electrical stimulation signal across or through an injury at an injury site on a patient's body. [Figure 23C] FIG. 23C illustrates an exemplary "moving" pattern for distributing or sweeping the electrical stimulation signal across or through the injury at the injury site on the patient's body. [Figure 23D] FIG. 23D illustrates an exemplary "moving" pattern for distributing or sweeping the electrical stimulation signal across or through the injury at the injury site on the patient's body. [Figure 24] FIG. 24 is a schematic diagram of an exemplary signal generation circuit according to one embodiment for generating an electrical stimulation signal. [Figure 25A]FIG. 25A is a diagram of an exemplary mat having a flexible cuff for delivering electrical stimulation signals through a wrist around which the cuff is secured, according to an exemplary embodiment. [Figure 25B] FIG. 25B shows the mat shown in FIG. 25A with one of the flexible cuffs partially wrapped around the wrist shown in the figure. [Figure 25C] FIG. 25C shows the mat shown in FIG. 25B with one of the flexible cuffs secured around the wrist and delivering electrical stimulation signals via the electrodes to excite the median nerve, radial nerve, and / or ulnar nerve. [Figure 26A] FIG. 26A is a diagram of an exemplary wrist-worn cuff having an inflatable bladder for tightening around the wrist to deliver an electrical stimulation signal for exciting the median nerve, radial nerve, and / or ulnar nerve, according to an exemplary embodiment. [Figure 26B] FIG. 26B shows the dorsal side of the cuff shown in FIG. 26A , illustrating an exemplary set of electrodes for exciting the median, radial, and / or ulnar nerves via delivery of an electrical stimulation signal while the cuff is tightly fastened around the wrist. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] 1 shows a detailed example of one embodiment of an electrical stimulation device 10 (hereinafter "device 10") configured to therapeutically electrically stimulate a patient at a body site associated with pain, discomfort, or dysfunction, such site being broadly referred to herein as an "injury site." Although the figure depicts a human patient, the term "patient" encompasses any living animal.

[0016] An electrode carrier 12 of the device 10 includes a set 14 of electrodes 16, and a stimulation module 18 of the device 10 includes signal generation circuitry 20 configured to generate electrical stimulation signals 22 that are delivered to each electrode 16 in the electrode carrier 12 via a wired or wireless connection 24. In at least some embodiments, one or more additional signals 26 are sent between the electrode carrier 12 and the stimulation module 18 for use by the stimulation module 18 in detecting or reading the make, model, or configuration of the electrode carrier 12, or to control which electrodes 16 are active at any given time during an electrical stimulation therapy.

[0017] Control circuitry 30 within the stimulation module 18 controls electrode activation either directly via the signals 26, such as in embodiments where stimulation signal generation occurs on the electrode carrier 12, or indirectly via control of the signal generation circuitry 20. For example, in one embodiment the connections 24 provide electrical connection for each electrode 16, and the signal generation circuitry 20 “activates” respective subsets 32 of the electrodes 16 in response to control signals by the control circuitry 30.

[0018] Although subsets 32-1, 32-2, and 32-3 are shown in the figures, this example is non-limiting. There may be fewer or more subsets 32, and any subset 32 ​​may include more than one electrode 16, and two or more subsets 32 may have one or more electrodes 16 in common. Furthermore, the subsets 32 need not have the same number of members, for example, one subset 32 ​​may include two electrodes 16, another subset 32 ​​may include three electrodes 16, etc.

[0019] Thus, the subsets 32-1, 32-2, 32-3 are designated as electrode pairs [AIB], [CID], [EIF], although other example subsets are [AIB, C], [CID, B, F], etc., where the electrodes 16 of the subset listed to the left of the letter "I" act as signal sources of the electrical stimulation signal 22, and the electrodes 16 of the subset listed to the right of the letter "I" act as signal sinks of the electrical stimulation signal 22. As such, the subset 32 ​​formed as [AIB] is distinct from the subset 32 ​​formed as [BIA].

[0020] One approach described above for providing the control circuitry 30 with control of subset formation or activation relies on the connections 24 including an electrical connection for each electrode 16 carried by the electrode carrier 12. In one embodiment, the signal generation circuitry 20 includes a multiplexer that selectively connects one or more electrodes 16 as signal sources and one or more electrodes 16 as signal sinks, the selective connections being controlled by the control circuitry 30. In other embodiments, the signal generation circuitry 20 is programmed or configured via fixed circuitry to activate predefined subsets 32.

[0021] For example, in one or more embodiments, the signal generation circuitry 20 is configured to activate / deactivate individual ones of the electrodes 16 to control whether a given electrode 16 is activated as a signal source or a signal sink. This arrangement allows any subset 32 ​​of the entire set 14 of electrodes 16 on the electrode carrier 12 to be formed.

[0022] In yet other embodiments, circuitry on the electrode carrier 12 controls subset formation or activation dependent on signaling received from the stimulation module 18, such an arrangement reducing or eliminating the number of wires required in a wired version of the connections 24. For example, the connections 24 in an exemplary embodiment include positive and negative (or "ground") wires associated with the source and sink of the electrical stimulation signal 22, along with one or more additional wires associated with the signaling 26 for controlling subset formation or activation on the electrode carrier 12. In yet other embodiments, the signaling 26 can include radio frequency signaling applied to the electrical stimulation signal 22. In such embodiments, the electrode carrier 12 includes circuitry configured to detect or otherwise respond to radio frequency signaling.

[0023] Other exemplary details of the embodiment of the device 10 shown in FIG. 1 include elements of the control circuitry 30, including processing circuitry 34 and memory device 36, which may be used for storing one or more computer programs 38 or configuration data 40. As used herein and elsewhere in this disclosure, the word "or" includes the conjunctive case unless otherwise indicated or clear from the context, i.e., the phrase "A or B" means A alone, B alone, or both A and B, unless otherwise indicated or excluded by contextual usage.

[0024] The processing circuitry 34 may, for example, be one or more microprocessors, microcontrollers, Field Programmable Gate Arrays (FPGAs), Complex Programmable Logie Devices (CPLDs), Digital Signal Processors (DSPs), Application Specific Integrated Circuits (ASICs), or System-on-Chip (SoC) modules. In general, the processing circuitry 34 may be comprised of fixed or programmably configured circuitry, or a mixture of both.

[0025] In examples in which the processing circuitry 34 comprises a microprocessor ("μP"), the microprocessor may be, for example, a general-purpose microprocessor specially adapted to perform the operations described herein for the device 10 based, at least in part, on the execution of computer program instructions from one or more computer programs ("CP") 38 stored in memory 36. That is, in one or more microprocessor-based embodiments of the device 10, execution of the computer program instructions by the microprocessor causes the device 10 to function as described herein.

[0026] Correspondingly, the storage device 36 may be comprised of one or more types of computer-readable media, such as one or more types of memory circuits or storage devices, and may be integral or partially integrated with or accessible to the processing circuitry 34. Non-limiting examples of memory circuits include volatile memory as working memory for the "live" operation of the device 10, and non-volatile memory for long-term storage of program instructions and various parameters or settings, referred to as configuration data ("CFG.DATA") 40. Examples of volatile memory include SRAM or DRAM, and examples of non-volatile memory include EEPROM, FLASH, and Solid State Disk (SSD).

[0027] Other exemplary elements of the device 10 include a power supply 42, which may include a battery, such as a lithium ion battery, for portable operation of the device 10. In an embodiment, the power supply 42 is configured for mains connection, e.g., 110V AC to 250V AC 50 / 60 Hz power, and includes one or more isolation transformers to eliminate the possibility of energizing the electrodes 16 at unsafe voltages or current levels. In general operation, the power supply 42 outputs one or more controlled supply signals, e.g., a DC supply voltage at one or more voltage levels, for use by various circuits within the device 10.

[0028] Examples of such other circuitry include communications circuitry 44, user interface circuitry 46, and input / output (I / O) circuitry 48. Communications circuitry, user interface circuitry, and I / O circuitry 44, 46, 48 are shown as dashed boxes to indicate that they are optionally included in one or more embodiments of the device 10. Similarly, the processing circuitry 34 and memory device 36, CP 38, and CFG.DATA 40 are shown as dashed boxes to indicate that one or more embodiments of the device 10 may not include them, such as when the control circuitry 30 relies solely on fixed circuitry for its implementation.

[0029] In one or more embodiments, the communications circuitry 44 provides wireless communications, such as for wireless communication with the electrode carrier 12 in one or more embodiments, or for wirelessly coupling the device 10 to a WI-FI access point or other type of wireless local area network (WLAN). Additionally or alternatively, the communications circuitry 44 implements near field communications (NFC) or personal area network (PAN) connectivity, e.g., for registering or reading the particular make, model, or configuration of the electrode carrier 12 in use at any one time, the electrode carrier 12 correspondingly incorporating complementary communications circuitry. PAN connectivity relies, for example, on BLUETOOTH® communications.

[0030] In one or more embodiments, the BLUETOOTH, WI-FI, or other wireless connection provided by the communications circuitry 44 provides for user control or monitoring of the device 10, either through a local user having a wireless connection to the device 10 via a smart phone, tablet, laptop, or other computing device, or through a remote user connected via the Internet.

[0031] Additionally, in at least one embodiment of the device 10 in which the communications circuitry 44 is included, the communications circuitry 44 includes one or more wired interfaces, such as an Ethernet connection, that support data networking of the device 10. Of course, data networking via a WLAN connection, or other data interfaces, such as a Serial Peripheral Interface (SPI) or other serial interface, can also be used. Such connectivity allows the device 10 to receive configuration data, for example, to tailor a patient's therapy to a particular patient or to a particular therapy session for a particular patient, and to output a therapy confirmation record. Such a record can include a time / date stamp, patient name, or ID, along with therapy credentials, such as a unique nonce generated by the control circuitry 30. All such data may be encrypted at rest or in transit.

[0032] In addition to user control provided via a smartphone or other external computing device, or in addition to or as an alternative to such combination, the apparatus 10 in one or more embodiments includes user interface circuitry 46 operable to provide user input, i.e., signals or data indicative of user actuation of user interface elements or controls, to the control circuitry 30. Exemplary user inputs include on / off control, activation / deactivation of stimulation signal generation, therapy timing control, or adjustment of operating parameters such as input of one or more electrical parameters of the electrical stimulation signal 22, configuration of the (electrode) subsets 32, or configuration of the activation sequence or cycles used to activate the respective subsets 32. Reference numeral "50" denotes any such user input signals to the control circuitry 30.

[0033] The I / O circuitry 48 as included in at least one embodiment of the device 10 provides a mass storage interface for, for example, reading and writing patient information related to electrical stimulation therapy via the device 10. Additionally or alternatively, the I / O circuitry 48 may provide one or more separate input or output lines for interfacing with a signal indicator, for example, to indicate the initiation or completion of therapy via the device 10.

[0034] With the above exemplary details and implementation variations in mind, the device 10 according to one or more embodiments includes an electrode carrier 12 configured to position a set 14 of electrodes 16 in contact with the patient's body at the site of injury thereon. The device 10 further includes a stimulation module 18 including a signal generation circuit 20 configured to generate an electrical stimulation signal 2.2. as a direct current (DC) pulse train at a frequency between 10 kHz and 50 kHz. The particular signal frequency may be fixed or adjustable.

[0035] A control circuit 30 included in the stimulation module 18 is configured to sequentially activate individual subsets 32 of electrodes 16 in the set 14 of electrodes 16. Each subset 32 ​​includes one or more electrodes 16 activated as signal sources of the electrical stimulation signal 22 and one or more electrodes 16 activated as signal sinks of the electrical stimulation signal 22.

[0036] 2A shows an exemplary embodiment of the electrode carrier 12, which comprises a flexible sheet or membrane 60 configured to be conformably placed on a patient's body at the site of the injury. The flexible sheet or membrane 60 (hereinafter "sheet 60") has a top surface 62 facing away from the patient's body and carries the set 14 of electrodes 16 on a patient-facing surface 64 of the flexible sheet 60. In one or more embodiments, the sheet 60 is comprised of two or more layers, and the electrodes 16 and associated electrode wiring are embedded therein for durability and protection. Of course, the patient-contacting portions of the electrodes 16 are exposed on the bottom layer, i.e., the patient-facing surface 64 of the sheet 60. Another feature of the sheet 60 in one or more embodiments is oxygen permeability, meaning that the patient's skin covered by the sheet 60 remains able to "breathe" freely.

[0037] Because FIG. 2A is a top perspective view of the electrode carrier 12, the electrodes 16 are shown with hidden dotted lines, indicating that the electrodes 16 (and their associated wiring) may be embedded within the flexible sheet 60 as described above, and only exposed at the patient-facing surface 64, as seen in FIG. 2B, where each electrode 16 is a hemispherical "button shape" or "bump" that provides a localized but comfortable contact point on the patient's skin.

[0038] In one or more embodiments, the flexible sheet 60 includes a central cutout or opening 66 for leaving an injury exposed at the site of the injury on the patient's body. Correspondingly, the set 14 of electrodes 16 are arranged at spaced apart locations along an edge or perimeter 68 that defines the cutout or opening 66.

[0039] 2B illustrates another feature included in one or more embodiments of the electrode carrier 12. That is, the electrode carrier 12 may include printed or flexible recessed connectors 70 for electrically connecting to each electrode 16, and may include an electrical connector 72 for quick and convenient connection to cabling leading to the stimulation module 18. That is, in embodiments in which the connection 24 between the electrode carrier 12 and the stimulation module 18 is a wired connection, a cable having a complementary connector may be used to electrically connect the electrode carrier 12 to the stimulation module 18.

[0040] FIG. 2C illustrates the same embodiment of the electrode carrier 12, depicted in a circumferential position relative to a wound on a patient's body. In particular, the exemplary wound is an open wound. Correspondingly, FIGS. 2D and 2E illustrate the same embodiment of the electrode carrier 12 before and after placement in a circumferential position relative to a wound. As seen in the side views provided in FIGS. 2D and 2E, the electrodes 16 slightly depress the patient's skin at the contact points, but do not break the skin or exert undue pressure. Also shown in FIGS. 2D and 2E is an exemplary cable 74 for wired connection back to the stimulation module 18 as "connection 24" introduced in FIG. 1.

[0041] "Conformability" is one of several advantages of using the flexible sheet 60 as the basis for the electrode carrier 12. Figure 2F shows the electrode carrier 12 applied to a patient's lower torso near the buttocks for the treatment of a bedsore or other injury, highlighting the benefit of conformability.

[0042] Various embodiments of the electrode carrier 12 use some form of adhesive that is either pre-applied to the patient-facing surface 64 of the sheet 60 or is applied to the patient's skin prior to application of the sheet 60. Other embodiments of the electrode carrier 12 use fasteners, straps, or elastic materials to secure the electrode carrier 12 to the patient's body.

[0043] The phrase "the flexible sheet or membrane 60" refers to the possible implementation of the electrode carrier 12 as a woven sheet or fabric, as well as a latex or other rubber or polymer sheet into which the electrodes 16 and associated wiring / connectors are molded or embedded. Of course, the electrode carrier 12 can also be constructed from a mixture of cloth and rubber or polymer elements. At least the portion of the electrode carrier 12 that contacts the patient's skin can be porous or non-porous.

[0044] Additionally, while FIGS. 2A-2F show examples of rectangular shapes for the flexible sheet 60 and the cutouts 66, such examples are non-limiting. The sheet 60 may be oval, circular, arc-shaped, or irregularly shaped to accommodate the electrode carrier 12 to various shapes or sizes of injuries and various physical locations of injuries. In a possible arrangement, multiple shapes / types of the electrode carrier 12 are provided, all adapted to fit the stimulation module 18. In this approach, treatment of an injury includes an initial step of selecting the shape, size, or style of the electrode carrier 12 that best suits the nature and location of the injury or the nature of the treatment desired. For example, electrical stimulation for pain relief from tendonitis would benefit from a particular model or style of electrode carrier 12 as opposed to one used for electrical stimulation of an open wound for pain relief and tissue regeneration.

[0045] The therapeutic benefits are particularly evident with respect to invasive injuries involving openings or cuts in the patient's skin, such as burns, ulcers, surgical excisions, incisions, etc. Such benefits include, but are not limited to, reduced pain, faster healing, and reduced scarring. However, the use of the device 10 is not limited to treating invasive injuries. For example, in one or more embodiments, the device 10 is configured for the treatment of closed injuries, such as muscle tears or inflammatory conditions. Thus, the term "injury" has a broad meaning herein. Correspondingly, not all embodiments of the electrode carrier 12 include cutouts 66, and one or more embodiments carry the set of electrodes 16 as a rectangular grid or other array pattern that provides a uniform or non-formatively spaced set of electrode contact points over a corresponding area of ​​skin on the patient's body.

[0046] In the example of FIG. 3, the set 14 of electrodes 16 includes electrodes 16 labeled as electrodes A-L, which are arranged in spaced apart positions in a circumferential configuration with respect to a central cutout 66 in a sheet 60 that serves as a base element of the electrode carrier 12. In particular, while the electrodes 16 form an array along the perimeter or edge 68 of the cutout 66, the cutout 66 leaves exposed an associated lesion that may aid in comfort and healing for certain injuries. By appropriate sizing or selection of the electrode carrier 12 with respect to the size or shape of the lesion, such an arrangement may position the set 14 of electrodes 16 such that one or more subsets 32 of the electrodes 16 span the lesion.

[0047] Any number of subsets 32 may be formed, with specific subsets 32-1, 32-2, 32-7 shown in FIG. 3. As an example, the subset 32-1 may consist of [KIL] or [LIK], the subset 32-2 may consist of [IIJ] or [JII], etc. A "treatment" of a patient with the exemplary electrode subsets depicted in FIG. 3 may consist of sequentially activating two or more subsets 32 according to a defined activation order, for example, over one or more activation cycles. The activation order may exercise all possible permutations of source / receiver electrodes available via the set 14 of electrodes 16 provided by the electrode carrier 12, although fewer subsets 32 may be used / defined by the activation order, and different treatment regimes may use different subsets 32 and different activation timings or overall treatment times.

[0048] 4A shows another embodiment of the electrode carrier 12, in which the sheet 60 is divided into two pieces or portions, which may or may not be interconnected. In the example shown, the sheet 60 consists of two strips 76A and 76B, each carrying a number of electrodes 16. The strip 76A may be placed on one "side" of the injury and the strip 76B may be placed on the opposite / other side of the injury, and the respective strips 76A and 76B may be coupled to the stimulation module 18 via cables 74A and 74B, or may nevertheless be integrated into a single cable having a "Y" configuration in the strips 76A and 76B.

[0049] Notably, the strips 76A and 76B may be of any length and may be straight, arcuate, or irregularly shaped for maximum flexibility in conforming to the size of the injury. In some embodiments, the strips 76A and 76B may be cut to length, while in other embodiments, they are provided at a predetermined length. Additionally, in at least one embodiment, the stimulation module 18 is configured to operate up to N (N>1) individual electrode strips 76 collectively as the electrode carrier 12, meaning that multiple electrode strips 76 may be placed at the site of the injury on the patient's body in a generally surrounding arrangement with respect to the injury.

[0050] In some embodiments, or according to some treatment protocols, the electrodes 16 contact the skin just off the injury itself, e.g., periwound skin adjacent to an open wound, while in other embodiments or treatment protocols, one or more of the electrodes 16 contact the surface of the wound, which can be particularly useful in deep ulcerated wounds. In at least one embodiment, one or more of the electrodes 16 are configured as "flying" electrodes, e.g., extending from the electrode carrier 12 via a lead extension, allowing for strategic placement on or within a wound, while others of the electrodes 16 contact the skin on one or more "sides" of the wound.

[0051] 4B shows an example of the use of a strip-based embodiment of the electrode carrier 12, where two strips 76A and 76B are attached to the skin of a (human) patient along either side of a surgical incision in the patient's knee. The strips 76A and 76B may be affixed / secured to the skin, for example with an adhesive, or may be held in place via an elastic wrap or the like.

[0052] Reference herein to a lesion having a "side" does not imply a particular lesion shape. Additionally, another advantage of strip-based embodiments of the electrode carrier 12 is that the strips 76A and 76B may be arranged in a bridging configuration with respect to the lesion of interest. FIG. 4C illustrates an exemplary bridging embodiment in which the overall sheet 60 is divided into first and second strips 76A and 76B, and the strips 76A and 76B are arranged in a bridging configuration across the long axis of an elongated lesion, here an otherwise closed surgical incision. In at least one such embodiment, the strips 76A and 76B are adhered onto the patient-facing surface 64 and configured for use as wound closure strips, with the added advantage of providing electrical stimulation therapy to the bridged wound.

[0053] Roughly speaking, a lesion is "bridged" by each electrode 16 of the set 14 of electrodes 16 means that at least a portion of the lesion is interposed or between the skin contact point of one electrode 16 to one or more skin contact points (s) of the electrodes 16. By activating a given first electrode 16 as a signal source and simultaneously activating a given second electrode 16 bridging the given first electrode 16, the electrical stimulation signal 22 crosses or passes through the bridging portion of the lesion. Of course, depending on the skin conductivity and subcutaneous impedance, there may be multiple circuit paths between the source and receiver electrodes 16. However, as a general proposition, activating an electrode 16 bridging the lesion will cause the electrical stimulation signal 22 to pass through the damaged tissue.

[0054] 5 illustrates another example of the electrode carrier 12 in which a unique pair 80 of electrodes 16 within the set 14 of electrodes 16 is used for electrical stimulation of injury. The pair 80 is merely a particular instance or example of the subset 32 ​​discussed above. That is, while subset 32 ​​may include two electrodes 16, or may include more than two electrodes 16, Figure 5 illustrates the particular case of electrode pairs 80-1 through 80-7. At any given time, a first one of the electrodes 16 in a given pair 80 is active as a signal source for the electrical stimulation signal 22, and a second one of the electrodes 16 in the pair 80 is active as a signal sink for the electrical stimulation signal 22.

[0055] In at least some embodiments, the pairs 80 are at least nominally bridging pairs of electrodes 16. That is, the stimulation module 18 may predefine which electrodes 16 of the electrode carrier 12 are to be operated as pairs 80 based on an underlying assumption that those electrodes 16 are to be "bridged" with respect to the associated lesion (assuming a particular type or shape of the lesion and an appropriate orientation of the electrode carrier 12 with respect to the lesion). In other embodiments, the patient or a person treating the patient may specify which electrodes 16 are to be operated as a pair 80 or as a subset 32. Such a specification may be input via the user interface 46 of the stimulation module 18 in one or more embodiments.

[0056] 6 illustrates an example of an activation sequence 82 that may be controlled or selected by the signal generation circuitry 20 or by the control circuitry 30. The illustrated activation sequence 82 refers to the specific electrode pair 80 illustrated in FIG. 5, but it should be understood that in general, the activation sequence 82 specifies an activation order for a subset 32 ​​of electrodes 16, the subset 32 ​​including two or more electrodes 16, and the subset 32 ​​may or may not have the same number of elements. As will be explained, the activation sequence 82 may be predefined or user defined, but the activation sequence 82 depicted in FIG. 6 takes advantage of the advantageous lesion spanning arrangement of electrode pairs 80 seen in FIG. 5.

[0057] Advantageously, in one or more embodiments, the activation sequence 82 "moves" the sources and recipients of the electrical stimulation signals 22 around the injury site, thereby creating spatially distributed signal paths through or across the injury over time. The activation sequence 82 may be predefined, e.g., selected from stored configuration data 40, user defined, e.g., determined by user input, or randomized by the control circuitry 30. A given activation sequence 82, whether randomized or not, does not necessarily guarantee that all subsets 32 included in the activation sequence 82 will include electrodes 16 that span the injury.

[0058] 7 illustrates an exemplary activation cycle 84 based on the exemplary activation sequence 82 shown in FIG. 6. Specifically, FIG. 7 illustrates an activation cycle 84(n), which may be understood as one in a series of one or more activation cycles 84(H-1), 84(H), 84(n+1), etc. In general, a "treatment program" refers to the overall time during which the device 10 provides therapeutic treatment to a patient, and a treatment program may be understood to constitute "sessions," and it may be understood that a patient may receive one session per day, one session per week, multiple sessions per day, etc., depending on the type of injury and the overall treatment protocol desired. The overall collection of sessions, e.g., the number of treatment programs a patient receives and the interval between treatment programs, may be considered a "treatment plan" or "treatment protocol."

[0059] In at least one embodiment, the device 10 can be programmed for a desired treatment regimen that defines the number and length of sessions, how often sessions occur, etc., along with optional further details such as the type / size of electrode carrier 12 to be used, stimulation signal strength, frequency, activation sequence or activation cycle definition, etc. In this manner, a physician or other knowledgeable person can program the device 10 for a particular treatment regimen and send the patient home with the desired treatment regimen programmed. For example, a patient who has undergone facial or other surgery where minimizing scarring is a compelling concern can be provided with the device 10 pre-programmed for a treatment regimen specifically tailored to be used for scar reduction.

[0060] One area of ​​programmability or adjustability relates to the treatment program used by the device 10. A treatment program may consist of one activation cycle 84 that steps through a defined activation sequence 82 using controlled dwell and step times. The dwell time refers to the time that a given subset 32 ​​is activated within the activation sequence 82, and the step time refers to the delay between deactivating one subset 32 ​​in the activation sequence 82 and activating the next subset 32 ​​in the activation sequence 82. The dwell and step times may or may not be uniform throughout the sequence. Non-limiting examples of dwell and step times are 30 seconds and 1 second, respectively, and as another point of flexibility, to the extent that a treatment program uses multiple activation sequences, essentially any operating parameter may be varied between or within sequences. For example, the selection of the subsets or the order of the subsets may be varied from activation cycle 84 to the next activation cycle 84, i.e., different activation sequences 82 may be used over multiple activation cycles 84. In this manner, one or more activation cycles 84 constitute a treatment program or session.

[0061] With the above example sequences / cycles in mind, in one or more embodiments, the control circuitry 30 is configured to sequentially activate the individual subsets 32 according to a defined activation order 82 that activates the individual subsets 32 one at a time over a defined activation cycle 84. One or more other embodiments of the device 10 provide for activating multiple subsets 32 at a time.

[0062] In at least one embodiment, the defined activation sequence 82 is predefined and corresponds to a spatial arrangement of the set 14 of the electrodes 16 on the patient's body at the site of an injury, which results from a specified arrangement of the electrode carrier 12 relative to the injury site. That is, the spatial arrangement may or may not be present depending on whether the electrode carrier 12 is correctly positioned on the patient's body or whether the appropriate make, size, or model of the electrode carrier 12 is selected. However, as an example of a predefined activation sequence 82, FIG. 6 illustrates a subset 32, specifically a pair 80, corresponding to electrodes 16 on opposite sides of the cutout 66 in the flexible sheet 60 that function as the electrode carrier 12 in FIG. 5, assuming that the electrode carrier 12 is positioned on the patient's body at the site of an injury such that the injury is within the skin area exposed by the cutout 66.

[0063] In other embodiments, or when operating in other modes, the control circuitry 30 is configured to determine the defined activation sequence 82 according to signaling received by the control circuitry 30, such as signals 26 provided by or read from the electrode carrier 12, input signals 50 resulting from user control of control inputs provided by the stimulation module 18 (e.g., via the user interface circuitry 46), or input signals 52 received via I / O circuitry 48, or signaling 54 received via the communications circuitry 44. For example, the control circuitry 30 receives wireless communication signals via the communications circuitry 44 from an external component communicatively coupled to the stimulation module 18.

[0064] The individual subsets 32, as in the example of FIG. 5, consist of a plurality of electrode pairs 80, each electrode pair 80 being a unique pair of two electrodes 16 from the set 14 of electrodes 16 provided by the electrode carrier 12. One of the two electrodes 16 of each pair 80 acts as the signal source, and the other of the two electrodes 16 acts as the signal sink. At least one of the plurality of electrode pairs 80 is at least tentatively an "opposing" electrode pair 80, in which the two electrodes 16 have an opposing relationship in which at least a part of the lesion at the lesion site is interposed between the respective contact points of the two electrodes 16 on the patient's body. In other words, at least one of the electrode pairs 80 is at least tentatively in a bridging relationship to the lesion to be treated. "At least tentatively" refers to an embodiment of the device 10 in which the subsets 32 / electrode pairs 80 of electrodes 16 are fixed (predefined), and bridging the lesion to be treated depends at least on a proper positioning of the electrode carrier 12 at the lesion site.

[0065] 8 illustrates an exemplary embodiment in which the configuration data 40 includes stored information, such as a stored table functioning as a carrier / injury type library 90 that maps different carrier / injury type entries 92 to different treatment programs 96 in a treatment program library 94. For example, the different carrier / injury type entries 92 may correspond to different sizes of the set 14 of the electrodes 16, or different spatial arrangements of the electrodes 16 within the set 14. Alternatively, the different carrier / injury type entries 92 may correspond to different types of injuries, such as a torn muscle versus an inflammatory condition, or the size, shape, type, or depth of an invasive injury being treated.

[0066] Correspondingly, the different treatment programs 96 in the treatment program library 94 are distinguished from one another in one or more parameters, such as one or more parameters of the electrical stimulation signal 22, different definitions of the subsets 32, different definitions of the activation order 82, different definitions of the activation cycle 84, different numbers of activation cycle repetitions that make up the overall treatment program 96, etc.

[0067] In at least one embodiment, a user makes a selection input via a user interface of the stimulation module 18 to indicate the carrier type or injury type 92, and the control circuitry 30 correspondingly selects the respective treatment program 96 corresponding to the indicated carrier / injury type 92. In another embodiment, a user directly selects a particular treatment program 96. This embodiment may be advantageous, for example, where the treatment program 96 is predefined and optimized for a particular type of ailment, such as "tennis elbow," in which case the duration of treatment and the most advantageous pattern and timing of "movement" of the source / receiver electrodes 16 around or over the affected area may be preprogrammed into the device 10 based on empirical data.

[0068] 9A illustrates an example of a selection arrangement in which the control circuitry 30 executes a selection control function 100 to select a particular treatment program 96 from the treatment program library 94 in response to one or more selection inputs. Such inputs may indicate (directly or indirectly) a type of injury and / or a type of electrode carrier. Again, "injury" is intended to be broad, such that "injury type" may be broadly understood to refer to the type of injury or condition to be treated.

[0069] FIG. 9B illustrates that the same logic may additionally or alternatively be used for selection of an overall treatment plan 98, e.g., selecting between defined treatment plans 98-1, 98-2, etc. Here, a treatment plan 98 represents an overall course of treatment and as such defines, for example, the particular treatment program 96 to be used by the device 10, the length or timing of each treatment session, and the overall number or frequency of treatment sessions. As an example, a given treatment plan 98 is based on the particular treatment program 96 to be used and specifies five minute treatment sessions using that particular treatment program 96, with three treatment sessions per day, for a total of five days. Again, in at least one embodiment, the device 10 may be configured to use a particular treatment plan 98 such that the patient need only "connect" the electrode carrier 12 to the stimulation module 18 and wear it (or, in a "wearable" embodiment of the electrode carrier 12, leave it on).

[0070] 10 illustrates another functional circuit implemented in the processing circuitry 30, namely, a treatment program adjustment / creation function 102. This function enables the processing circuitry 30 to operate to create a treatment program 96 or modify ("adjust") an existing treatment program 96, e.g., in response to user input or in response to received control signal transmissions. Creation / adjustment parameters include one or more of: (a) cycle time or overall treatment time of the activation cycle 84, e.g., how many cycle repetitions to use; (b) sequence selection; (c) dwell / step control; (d) stimulation signal intensity or intensity data, e.g., over the course of an activation cycle 84 or over the course of an overall treatment session; (e) stimulation signal frequency or frequency data; and (f) stimulation signal duty cycle, i.e., the duty cycle of the DC pulse train. Here, "intensity" refers to one or both of stimulation signal current or voltage.

[0071] In at least one embodiment, the function 102 or other operational function of the control circuitry 30 provides a method by which a pair of electrodes 16 within the overall set 14 of electrodes 16 are selected to be the source electrode 16 and receiver electrode 16 for a particular time before a new pair, which may include a previously used electrode 16, is similarly selected to be the source electrode 16 and receiver electrode 16 for an additional particular time. This continues in sequence, and the process is repeated as predetermined by the treatment protocol defined by the programming or configuration of the stimulation module 18.

[0072] Further, in at least one such embodiment, the device 10 provides Treatment is based on the amount of time the user indicates is available for patient treatment, i.e., currently scheduled The amount of time available for a therapy session is adjusted to the amount of time the user has available for therapy. It is only necessary to indicate the amount of time available and the control circuitry 30 will then The selection and pattern of activated source and receiver electrodes 16 for a given amount of time. The control module 30 optimizes the minimum treatment time required to initiate a treatment session. They can impose boundaries, such as enforcing

[0073] For example, referring back to the electrode carrier 12 illustrated in Figure 3, in an exemplary embodiment, the minimum treatment time may be six minutes. At the minimum (six minute) time setting, the control circuit 30 activates electrodes L (source) and D (receiver) for one minute, then deactivates the LID pair, immediately activates electrodes K (source) and E (receiver) for one minute, then deactivates the KIE pair, immediately activates electrodes I (source) and K (receiver) for one minute, then deactivates the IIK pair, immediately activates electrodes A (source) and I (receiver) for one minute, then deactivates the AII pair, immediately activates electrodes B (source) and H (receiver) for one minute, then deactivates the BIH pair, and finally activates electrodes C (source) and G (receiver) for one minute.

[0074] Continuing with the example, if the control circuitry 30 receives a user input indication that 20 minutes are available for the treatment session, the control circuitry 30 may use a different pattern of activating the electrodes 16. For example, the control circuitry 30 may directly (or indirectly via the signal generating circuitry 20) activate electrodes L (source) and D (receiver) for 2 minutes, then deactivate pair LID, immediately activate electrodes K (source) and E (receiver) for 2 minutes, then deactivate pair KIE, immediately activate electrodes I (source) and K (receiver) for 2 minutes, then deactivate pair IIK, immediately activate electrodes A (source) and I (receiver) for 2 minutes, then deactivate pair AII, and immediately activate electrodes B (source) and H (receiver). Activate pair BIH (source) and G (receiver) for 2 minutes, then deactivate pair BIH, immediately activate electrodes C (source) and G (receiver) for 2 minutes, then deactivate pair CIG, immediately activate electrodes I (source) and F (receiver) for 1 minute, then deactivate pair IIF, immediately activate electrodes J (source) and D (receiver) for 1 minute, then deactivate pair JID, immediately activate electrodes A (source) and G (receiver) for 1 minute, then deactivate pair AIG, and finally activate electrodes C (source) and I (receiver) for 1 minute.

[0075] As the time available for treatment expands, the control circuitry 30 or signal generating circuitry 20 is configured to use longer activation times for each pair of electrodes and to use more different pairs to drive current through the injury site in as many different ways as possible. Thus, referring again to FIG. 3, as the time available becomes longer than 20 minutes, activation may include activating electrodes L (source) and D (receiver) for 3 minutes, then leaving L as the source, deactivating D (receiver) and replacing it with E (receiver) for another 3 minutes, then leaving L as the source, deactivating E (receiver) and replacing it with F (receiver) for another 3 minutes. Other electrode groups may be similarly alternated to create a "strobe" effect.

[0076] 11 illustrates another embodiment of the device 10, at least partially housed in a housing 110 that includes a user interface 112, such as one or more physical control knobs or switches 114. Additionally or alternatively, the user interface 112 provides one or more "soft" controls 116 displayed on a touch screen 118. The touch screen 118 in one or more embodiments is a video-enabled screen that provides an injury / carrier visualization 120 on the screen. In at least one such embodiment, the device 10 includes, or provides an interface for, a camera 124 for imaging an injury site on a patient's body and determining the placement or orientation of the electrode carrier 12 at the injury site.

[0077] Further, in at least one such embodiment, the lesion / carrier visualization 120 includes an on-screen representation of the electrodes 16, e.g., a video representation of the electrodes or an overlaid display of their locations, and the control circuitry 30 is configured to define a subset 32 ​​of the electrodes 16 based on receiving touch input from a user via the touch screen 118. That is, signals provided to the control circuitry 30 via user interface circuitry 46 can include touch screen data, and the control circuitry 30 can determine which electrodes 16 a user wants to designate as belonging to subset 32 ​​based on the user indicating a touch input to the on-screen representation of the electrodes 16. Additionally or alternatively, in one or more embodiments of the device 10, the control circuitry 30 is configured to receive touch input indicating which electrodes 16 in subset 32 ​​are source electrodes or receiver electrodes.

[0078] The camera 124 may be dedicated for use with the device 10 and, in one or more embodiments, is coupled to the device 10 with a cable 126. In other embodiments, the camera 124 is wirelessly coupled to the device 10 via the communications circuitry 44 included in the stimulation module 18. Similarly, although FIG. 11 suggests a physical cable connection between the electrode carrier 12 and the housing 110, the connection 24 may be wireless in one or more embodiments.

[0079] 12 illustrates yet another embodiment in which all or at least a portion of the user interface 112 is realized on the screen 132 of an external device or system 130, such as a smartphone, tablet, laptop, or other computing device having a touch interface or other user input capabilities. The body / injury visualization described above may be performed within the device 130, so long as the device 130 includes one or more cameras 134. The overall operation of the device 130 for supporting and interacting with the device 10 is provided via execution of a software app 140, for example, installed from an app store or side-loaded onto the device 130.

[0080] The communications circuitry 44 of the device 10 provides a Bluetooth connection or other wireless link to communicatively couple with the device 130 via a wireless link 142 to establish the connection 24 between the electrode carrier 12 and the stimulation module 18. Public Key Infrastructure (PKI) certificates, shared secrets, random nonce, or other security measures may be used between the device 10 and the device 130, for example via the app 140, to ensure that connectivity and control is provided only to authorized devices 130.

[0081] 13A illustrates yet another embodiment of the device 10, where the electrode carrier 12 further includes a sealable / sealed covering 150 that covers the central cutout 66 of the flexible sheet 60. The covering 150 is ported for applying negative pressure to a lesion, for example, via a port 152 that couples to the device 10 via a pneumatic tube 144 or via a port 152 that couples to an associated vacuum device. In at least one embodiment, the device 10 incorporates the vacuum device, shown in FIG. 13 as a negative pressure pump assembly 156.

[0082] Simultaneous or coordinated application of negative pressure and electrical stimulation therapy results in important therapeutic synergies. In one embodiment, the device 10 regulates the application of negative pressure, including the duration or degree of negative pressure generated in a "chamber" formed over the injury via the sealing cover 150. Note that the sealing cover 150 may be a separate membrane or sheet that is adhesively bonded to an underlying flexible sheet 60 that comprises the electrode carrier 12. Such an arrangement provides flexibility in that the sheet 60 can be sealed to the skin at the injury site and the negative pressure arrangement can be "built" or otherwise applied on the sheet 60.

[0083] In at least one embodiment of the device 10 that includes negative pressure therapy, the therapy program 96 implemented by the control circuitry 30 includes a negative pressure therapy protocol that defines, for example, any one or more of the duration of negative pressure application, the peak or average level of negative pressure applied, and the cadence or variation of the negative pressure level used during a therapy session. Of course, in embodiments in which the device 10 has negative pressure therapy capabilities, electrical stimulation may be used with or without the simultaneous use of negative pressure therapy.

[0084] Figure 13B provides another, more detailed view of the arrangement shown in Figure 13A, and Figure 13C shows the same arrangement applied to an injury on a patient's body. Additional details shown in Figure 13C include the adhesive 160 (e.g., a peel-off adhesive cover) which may be pre-applied to the patient-facing surface 64 of the sheet 60 or applied before the sheet 60 is placed on the skin at the injury site. More details include the use of a sterile sponge 162 or other filler to establish support for the flexible covering 150 and form a negative pressure chamber 164 at the injury site.

[0085] 14A shows an embodiment in which the electrode carrier 12 is formed as a flexible sleeve 170 configured to surround at least a portion of a patient's affected limb. The sleeve at least optionally includes a cutout 66 to avoid covering the injury being treated. The sleeve may include a longitudinal split or seam 172 to facilitate easy application and removal from the affected limb. The sleeve 170 may be a cloth or plastic mesh or fabric and may be elastic or may use straps or hook-and-loop fasteners or magnets to press the set 14 of electrodes 16 into position against the patient's skin at the site of injury.

[0086] FIG. 14B shows another variation of the flexible sleeve 170, which omits the cutout 66, and has the set 14 of electrodes 16 arranged throughout the sleeve 170. Such an arrangement allows for electrode subsets 32 to be formed / activated over the entire inner surface of the sleeve 170, and thus allows one sleeve 170 to be used to treat different types and locations of injuries on an affected limb, for example, around the wrist region of a human forearm to treat pain, wounds, or tremors at sites such as essential tremor (ET), rest tremor, or action tremor. The wrist region includes the wrist joint and a portion of the forearm, and optionally a portion of the hypothenar of the palm, depending on the width of the sleeve that encircles the wrist region. As used herein, the term "wrist" encompasses the wrist region as defined above, since it can itself include the portions of the body immediately adjacent to the particular joint that constitutes the wrist. Further examples of wrist-related embodiments are discussed in connection with FIGS. 25-26 below. The tremor frequency can be between 3.5 kHz and 8 kHz, and the intensity of the electrical stimulation signal 12 applied to at least one electrode 16 of one of the distinct subsets 14 can be reduced when the tremor frequency drops below a threshold below 3.5 kHz.

[0087] FIG. 14C illustrates a similar embodiment of the sleeve 170, but where the sleeve 170 is shaped or contoured for use on a joint of a limb, with a (human) elbow sleeve being shown as an example. FIG. 14D illustrates another exemplary case where the sleeve 170 is configured for use at the ankle of a human leg, or around the wrist region of a human forearm, with this particular example using cutout 66. Other sleeve configurations are contemplated. For example, the sleeve 170 may be configured for non-human limbs and joints, such as for veterinarian use to treat leg injuries in dogs and cats. In a particularly compelling example of veterinarian use, the sleeve 170 in one or more embodiments is configured for use on a horse's leg, such as to treat edema, joint effusion, or other ailments commonly associated with race horses.

[0088] 15 shows another embodiment of the electrode carrier 12, in which the sleeve 170 is shown as an encircling wrap including, for example, hook-and-loop fasteners 173A and 173B or magnets so that the sleeve 170 can be fastened in a wrap around the affected limb, or in at least some configurations around the patient's torso. Of course, clasps, buckles, or other attachments other than the hook-and-loop fasteners 173A / B may be used to fasten the sleeve 170.

[0089] In general, the sleeve 170 may be integrally formed or may be composed of different sections, possibly of different materials, such as a latex or polymer section for contacting the periphery of the injury and a fabric section for tightening around the limb or torso.

[0090] In addition to using the hook-and-loop fasteners 173A / B (or alternative fasteners) to fasten the sleeve 170 in place, the sleeve 170 may include an internal sleeve or compartment for an inflatable bladder 174, similar to those used in blood pressure cuffs (see also Figs. 25A-26B). With the sleeve 170 fastened in place, inflating the bladder 174 further tightens the fastened sleeve 170 against the patient's body, thereby encouraging the electrodes 16 to be applied to the patient's skin for better skin contact. Of course, the bladder 174 may include an over-pressure valve or other mechanism to prevent over-inflation, so that circulation problems or discomfort do not result.

[0091] FIG. 16 shows a further variation of the electrode carrier 12 in which the sleeve 170 includes straps 176A / B, which may have buckles or hook-and-loop fasteners, for securing the sleeve 170 around a patient's limb or torso as a sleeve or encircling wrap.

[0092] Thus, in one or more embodiments, the electrode carrier 12 is comprised of some form of compression sleeve that exerts a biasing force urging the set 14 of electrodes 16 into contact with the patient's body at the site of injury. The arrangements of Figures 14A-D, 15, and 16 are examples of molded or formable sleeves that provide a biasing force achieved via at least one of a resilient material incorporated into the compression sleeve, an inflatable bladder incorporated into the sleeve, or one or more fastening straps or fasteners incorporated into the sleeve.

[0093] Figures 17-20 show examples of connection options where the connection 24 between the electrode carrier 12 and the stimulation module 18 is a physical (wired) connection. Starting with Figure 17, the connection 24 in one or more embodiments includes a conductor 70 for each electrode 16 carried on the electrode carrier 12. This arrangement offers simplicity and direct control over activating individual electrodes 16 as signal sources or sinks, but such advantages come at the expense of potentially bulky connecting cables and more wiring.

[0094] 18 illustrates another embodiment in which a multiplexer circuit 180 on the electrode carrier 12 reduces the wire count of the connections 24. For example, depending on the implementation of the multiplexer circuit 180, the connections 24 may include a signal source line (+) and a signal sink line (-) or "ground" connection along with a clock / control signal ("CLK / CNTL"). A DC bias of the CLK / CNTL signal may be used to provide operating power to the multiplexer circuit 180, thus eliminating the need for the electrode carrier 12 to have its own power supply to operate the multiplexer circuit 180.

[0095] FIG. 19 shows substantially the same arrangement as depicted in FIG. 18, except that the electrode carrier 12 further includes a "load" circuit 182. The load circuit 182 may be as simple as a pull-down resistor that connects in a voltage divider fashion to a pull-up resistor in the stimulation module 18. Different values ​​of pull-down resistors may be attached to different makes or models of the electrode carriers 12, thereby providing the control circuitry 30 with a simple mechanism to "read" the make or model of the electrode carrier 12 that is attached. Such information is used, for example, in selecting / defining the activation sequence 82 or activation cycle 84, or in selecting / defining the overall treatment program 96 / treatment plan 98, or in determining which treatment program 96 or treatment plan 98 to offer for selection by a user.

[0096] In other variations, the load circuit 182 comprises a complex impedance, such as a notch or bandpass filter or a resonant circuit. Correspondingly, the signal generation circuit 20 of the stimulation module 18 is configured to generate excitation signals at different frequencies corresponding to different makes or models of the electrode carrier 12 and detect the response of the load circuit 182 at the different frequencies in order to identify the make or model of the carrier.

[0097] 20 shows yet another arrangement including a more complex circuit implementation on the electrode carrier 12, where the connections 24 may be wired or wireless, and the electrode carrier 12 has its own power source / battery 184 to power communication circuitry 186 that interfaces wired or wirelessly to the stimulation module 18. The electrode carrier 12 further includes control circuitry 188 that is responsive to signaling from the stimulation module 18 received via the communication circuitry 186 (such as start / stop control).

[0098] Additionally, the illustrated embodiment of the electrode carrier 12 includes signal generation circuitry 190. Thus, in at least one embodiment, generation of the electrical stimulation signal 22 occurs on the electrode carrier 12. In that regard, the signal generation circuitry 190 can be considered a version of the previously illustrated signal generation circuitry 20, but moved from the stimulation module 18 to the electrode carrier 12. Viewed alternatively, the circuitry depicted in FIG. 1 for the stimulation module 18 may be at least partially distributed between the electrode carrier 12 and a separate housing 110 that includes a user interface 112, etc.

[0099] 21 builds on the idea of ​​generating the electrical stimulation signal 22 locally on the electrode carrier 12 by mounting the entire stimulation module 18 on the electrode carrier 12, where the power supply / battery 42 of the stimulation module 18 consists of, for example, a lithium-ion battery and associated charging and voltage regulation circuitry for battery-powered operation of the stimulation module 18. Additionally, the communication circuitry 44 can provide wireless connectivity to an external device 130 to realize a user interface 112 on the external device 130 for controlling the device 10.

[0100] Regardless of whether the stimulation module 18 is on the electrode carrier 12 or separate, in one or more embodiments, the electrode carrier 12 comprises a flexible sheet 60 or sleeve 1700. In at least one such embodiment, at least a portion of the patient-facing surface 64 of the sheet 60 or sleeve 170 is an adhesive membrane for temporary adhesion to the patient's skin at the site of the injury. This adhesion is provided to hold the electrode carrier 12 on the patient's body at the site of the injury, for example, at least during the treatment or for a longer period of time, such as several days, during which the device 10 automatically provides multiple treatments, e.g., treatments every four hours. In at least one embodiment, the sleeve 170 is understood to include the sheet 60 that functions as the base electrode carrier 12. That is, the sleeve 170 need not directly integrate the electrodes 16, but instead can be understood to provide a two-part assembly for integrating the sheet 60 within its patient-facing inner surface.

[0101] In any event, the use of an adhesive flexible membrane to carry the electrodes 16 also provides a sealing engagement against the patient's body that provides for the use of negative pressure therapy in combination with electrical stimulation as shown, for example, in Figures 13A-C.

[0102] In a more detailed example, as shown in FIG. 5, each electrode 16 of the set 14 of electrodes 16 can be considered a blunt contact point electrode such that contacting the set 14 of electrodes 16 with the patient's body defines a corresponding set of blunt contact points for point delivery or reception of the electrical stimulation signal 22. Among its various advantages over distributed area or "patch" electrodes, blunt contact point electrodes can reduce the impedance at the contact points between the electrodes 16 and the patient's skin, which reduces signal loss with respect to "injecting" the electrical stimulation signal 22 into the patient's body at the site of injury. Additionally, the use of discrete contact points allows for patterning or movement of the electrical stimulation signal around and through the site of injury.

[0103] Other operational advantages of the device 10 include that, in one or more embodiments, the signal generation circuitry 20 is configured to control the frequency of the electrical stimulation signal 22 in response to control by the control circuitry 30. By way of example, the control in question may be either selecting a particular frequency from a set of predefined frequencies, continuously adjusting the frequency, or adjusting the frequency in steps. Additionally or alternatively, the signal generation circuitry 20 is configured to control the intensity of the electrical stimulation signal 22 in response to control by the control circuitry 30, where the control is at least one of adjusting the voltage of the electrical stimulation signal 22 or adjusting the current of the electrical stimulation signal 22.

[0104] Figure 22 illustrates one embodiment of a method 2200 for therapeutic electrical stimulation of a patient, which may be performed by the device 10 introduced in Figure 1 or by any other suitably configured device. The depicted operations may be performed in orders other than those suggested by the logic flow, may be performed repeatedly, or may be performed in combination with other operations.

[0105] The method 2200 includes providing an electrical stimulation signal 22 as a direct current (DC) pulse train at a frequency between 10 kHz and 50 kHz (block 2202) and sequentially activating, via the electrical stimulation signal 22, respective subsets 32 of electrodes 16 of a set 14 of electrodes 16 that contact the patient's body at an injury site on the patient's body (block 2204).

[0106] Sequentially activating the respective subsets 32 of electrodes 16 may comprise, for example, activating the individual subsets 32 according to a defined activation order 82 that activates the individual subsets 32 one at a time over a defined activation cycle 84. Thus, in one or more embodiments, the method 2200 also includes determining the activation order 82 and / or activation cycle 84 to use to apply the electrical stimulation signal 22 (block 2206).

[0107] In at least one embodiment, the method 2200 further includes varying the defined activation order 82 or the defined activation cycle 84 in response to user input received via the user interface 112 of the device 10 or via the communication circuitry 44 of the device 10.

[0108] The method 2200 also includes varying one or more parameters in response to user input received via the user interface 112 of the device 10 or via communication circuitry 44 of the device 10. The one or more parameters may be, for example, one or more of the frequency of the electrical stimulation signal 22, the voltage of the electrical stimulation signal 22, the current of the electrical stimulation signal 22, or the duty cycle of the electrical stimulation signal.

[0109] In at least one embodiment of the method 2200, sequentially activating the respective subsets 32 of electrodes 15 comprises activating the respective subsets 32 of electrodes 16 according to a treatment program 96. The method 2200 may include obtaining the treatment program 96 as a predefined treatment program stored as configuration data 40 within the device 10, or creating or adjusting the treatment program 96 in response to user input. As previously discussed, the treatment program 96 may dictate which electrodes 16 are activated at what time, for how long, and according to what electrical and timing parameters, and may define the overall duration of treatment and the order / repetition of electrode activation.

[0110] Advantageously, the sequential activation of electrode subsets 32 as contemplated herein increases the effectiveness of electrical stimulation for wound healing by scanning or distributing the electrical stimulation signal 22 across or through the wound site. The scanning effectively "cycles" or "moves" active contact points around the wound by sequentially changing which electrodes 16 are activated as sources and recipients of the electrical stimulation signal 22 according to a defined activation sequence. Figures 23A-23D show one such example of moving the signal sources and recipients around the wound.

[0111] 23A electrical stimulation signal 23D, the solid black indicates which electrodes 16 are active as signal sources and the black shading indicates which electrodes 16 are active as signal sinks. Although the figure shows only one signal source and one signal sink at a time, multiple signal sources or sinks may be active at one time depending on how the subsets 32 are defined by their associated activation orders 82.

[0112] 23A through 23D, the signal source "moves" from left to right relative to the depicted orientation of the electrodes 16, and the signal receiver "moves" from left to right as well. In effect, this sequence moves the contact point of the electrical stimulation signal 22 from left to right across the extent of the injury or damage, so that the electrical stimulation signal 22 reaches more of the injury site, or stated differently, the electrical stimulation signal 22 is better distributed to the injury site.

[0113] There are several possible configurations for generating the electrical stimulation signal 22, and FIG. 24 illustrates a non-limiting example of one configuration of the signal generation circuitry 20 for generating the electrical stimulation signal.

[0114] The signal generating circuit 20 operates as a pulse forming circuit, isolating the high voltage of the electrodes 16 from the low voltage control circuitry to generate a stimulation signal waveform with better pulse shape and less resonance. As a result, experience suggests that a unipolar waveform output promotes unidirectional ion flow and provides more effective electrical stimulation.

[0115] The illustrated circuitry includes a high voltage generator 2402 , a high voltage output circuit 2404 and a low voltage output control circuit 2406 to provide a stimulation signal regulation by the control circuit 30 .

[0116] The high voltage generator 2402 includes a step-up transformer 2410, a set of MOSFETs 2412 and 2414, and a D flip-flop 2416. A center tap input 2418 is coupled to a control MOSFET 2420, which is coupled to a DC voltage source, such as the power battery 42 shown in FIG. 1. The secondary coil of the transformer 2410 is coupled to the input of a rectifier bridge 2422. The output of the rectifier bridge 2422 is coupled to a capacitor 2424. The high voltage applied to the body is generated by the transformer 2410, rectified by the bridge 2422, and stored in the capacitor 2424. The transformer 2410 in this embodiment is relatively small and is driven by a push-pull circuit configuration consisting of the primary coil of the transformer 2410, the MOSFETs 2412 and 2414, and a D flip-flop 2416 driven by a clock input, for example, 40 kHz. The higher the clock frequency, the smaller the transformer can be used.

[0117] The output voltage from the high voltage generator 2402 is a function of the center tap voltage and the turns ratio (primary turns to secondary turns) of the transformer winding coupled to the control MOSFET 2420, and in the illustrated arrangement, an output electrical stimulation signal 22 is obtained through the use of opto-isolators 2430, 2432, 2434, 2436. Either combination of the opto-isolators 2430 and 2436 may be used to output a voltage to the electrode 16, respectively, or, to reverse polarity, opto-isolators 2432 and 2434 may be used to output a voltage to the electrode 16. The output of the high voltage generator 2402 is coupled to a positive high voltage rail 2438 controlled by the high voltage ends of the opto-isolators 2430, 2432, 2434, 2436.

[0118] Selection of the polarity of the stimulation signal is performed via a low voltage output control circuit 2406. The low voltage output control circuit 2406 includes a polarity selection input 2440 and a pulse width modulation control input 2442, which are driven / electronically controlled by the control circuit 30.

[0119] The low voltage output control circuit includes an inverter 2444, AND gates 2446 and 2448, and output MOSFETs 2450 and 2452. The output MOSFET 2450 controls the activation of the low voltage ends of the opto-isolators 2430 and 2434, and the output MOSFET 2452 controls the activation of the low voltage ends of the opto-isolators 2430 and 2436. The polarity selection signal is received via the selection input 2440 and is coupled directly to one input of the AND gate 2446 and via the inverter 2444 to one input of the AND gate 2448. The outputs of the AND gates 2446 and 2448 drive the MOSFETs 2450 and 2452, respectively. The other inputs of the AND gates 2446 and 2448 are driven by a pulse width modulated control signal from the control input 2442. The pulse width control signal times how long and at what frequency the output pulse is applied, and in one or more embodiments the control circuit 30 is configured to set (or dynamically vary) the frequency of the electrical stimulation signal 22 to a frequency in the range of 10 kHz to 50 kHz.

[0120] Because the polarity selection signal is inverted in the AND gate 2446, only one set of opto-isolators 2430, 2436, 2432, 2434 operates to control the high voltage output to the electrodes 16. Low voltage control of opto-isolators from high voltage provides a cleaner pulse shaped output. Transformer parameters do not limit the stimulation frequency or pulse width of the electrical stimulation signal 22 in the circuit configuration shown.

[0121] Example operating electrical parameters of the electrical stimulation signal 22 include a peak pulse amplitude (unloaded electrode 16) of 190 volts, a pulse amplitude (loaded electrode 16) of 50-60 volts, a pulse frequency of 10 kHz to 50 kHz, a fixed or variable duty cycle of pulses within the pulse train, an output current of approximately 8.9 milliamps, and a maximum charge per pulse of 7 microcoulombs.

[0122] Of course, one or more of these exemplary signal parameters may be different or variable depending on the particular electrical circuitry used to generate the electrical stimulation signal 22. Regardless of the circuitry used to generate the electrical stimulation signal 22, and although other arrangements than those shown will be understood by those of skill in the art in light of the operational description herein, one mechanism that may be utilized to selectively connect the electrical stimulation signal 22 to respective electrodes 16 to form activated subsets 32 of electrodes 16 is a multiplexing or crossbar switch circuit 2460. Such a switch provides for selective connection of the positive connection 22+ of the electrical stimulation signal 22 to any one or more of the conductors 70 associated with the individual electrodes 16, and selective connection of the negative connection 22- of the electrical stimulation signal 22 to any one or more of the remaining conductors 70.

[0123] FIG. 25A is a diagram of a system 2500 for therapeutic electrical stimulation of the arm or wrist according to an exemplary embodiment, the system including an exemplary mat 2502 with flexible bands 2510, 2512 around which the cuffs 2510, 2512 are secured to deliver electrical stimulation signals 22 through the wrist. The bands 2510, 2512 can be arranged (bent, folded, wrapped) to form partial or complete loops, and optionally they can also be elastic so that they can be stretched along their length and provide tension to the wrist when they form a loop around the wrist. The flexible mat 2502 has a substrate 2504 on which the arm or wrist rests or is placed. If a patient suffers from tremors in the hand or arm, one or both hands / arms may be shaking too violently to allow the patient to wrap one of the flexible bands 2510, 2512 themselves using their free hand, and thus assistance from a helper may be required. Exemplary markings 2530 may be provided on the substrate 2504 to indicate to the patient where to place their hand on the substrate 2504 before securing their wrist with one of the flexible bands 2510, 2512.

[0124] Each of the flexible bands 2510, 2512 is configured to be secured around an arm or wrist to form a cuff while the arm or wrist is placed on the substrate 2504. Optionally, wrist straps 2553 can be provided between the flexible bands 2510, 2512 and the arm or wrist when placed on the substrate 2504, and these straps 2553 can be secured to the substrate 2504 by fasteners, magnets, hook and loop fasteners, or the like, which require a relatively small force to release the arm or wrist from the straps 2553, which is slightly more than the force exerted on the straps 2553 by a trembling or shaking hand or arm to ensure that a trembling or shaking movement does not release the straps 2553, but a slightly greater force is required to free the arm or hand from the straps 2553 and thereby the flexible bands 2510, 2512. When magnets are used to secure the flexible band 2510, 2512 and / or the strap 2553, a user can easily reposition their hand while the band 2510, 2512 is wrapped around their wrist without having to refasten the band / strap 2510, 2512, 2553. For example, the magnets allow the band 2510, 2512 or the strap 2553 to be slightly detached but not hovered over by magnetic force while the user repositions their hand to be over the indicia 2530. The flexible band 2510, 2512 supports an electrode carrier, which includes a set of electrodes 14 as described above. In the example shown in FIG. 25A, three electrodes 16 are shown, but any number of electrodes disclosed herein can be present on or integrated with the electrode carrier on the flexible band 2510, 2512. In the example shown, there are two electrodes 16 on each of the flexible bands 2510, 2512 that are positioned so as to be in physical contact with the ventral distal end of the arm or wrist when placed on the substrate 2504 over the markings 2530.One electrode 16 is shown positioned relative to the flexible band 2510, 2512 such that the electrode 16 is in physical contact with the dorsum of the arm or wrist when the band 2510, 2512 is wrapped around the wrist to form a cuff. When the flexible band 2510, 2512 is elastic (such as when made by a thermoforming process), the tension exerted on the wrist due to the elasticity of the band as the band 2510, 2512 encircles the wrist also exerts a positive pressure on the electrode 16 in contact with the wrist. This pressure is sufficient to deform the skin of the electrode 16 a distance substantially equal to the height of the electrode 16 or the distance that the outermost exposed tip of the electrode 16 protrudes away from the band 2510, 2512, which in some embodiments can be 1 / 16 to 3 / 8 inch. To ensure that the appropriate pressure is applied with or without tension from the bands 2510, 2512, the flexible bands 2510, 2512 can be thermoformed or fabricated from a thermoforming process and can have a deformable ridge or raised contour 2516 under the electrodes 16, as shown in the cut-out portions of FIGS. 25B-26C (areas of the flexible bands 2512 are cut-out to reveal and make visible the underlying deformable ridge or raised contour 2516). Although two electrodes 16 are shown contacting the dorsal side of the wrist, in other examples, only one electrode 16 or two or more electrodes 16 can be configured to contact the ventral side of the wrist. Similarly, two or more electrodes 16 can be configured to contact the dorsal side of the wrist. The present disclosure is not limited to the number of electrodes 16 contacting the ventral / dorsal side of the arm or wrist. The "moving" signal sources and receivers disclosed herein can be used to locate or pinpoint the appropriate nerve or nerves, such as the median, radial, and / or ulnar nerve, to suppress or stop tremor.

[0125] Thus, in FIG. 25A, a stimulation module 2520 is shown in electrical communication with the electrode carrier including the set of electrodes 16. The stimulation module 2520 includes a signal generation circuit (discussed above) configured to generate electrical stimulation signals as direct current (DC) pulses at frequencies centered between 10 kHz and 50 kHz as disclosed herein. The control circuitry disclosed herein is configured to sequentially activate different subsets of electrodes 16 in the set of electrodes 14. Each of the different subsets includes one or more electrodes 16 of the set of electrodes 14 activated as signal sources of the electrical stimulation signal and one or more electrodes 16 of the set of electrodes 14 activated as signal sinks of the electrical stimulation signal. The set of electrodes 14 is configured to deliver electrical stimulation from the stimulation module 2520 to the arm or wrist to excite nerves such as the median nerve, radial nerve, or ulnar nerve.

[0126] The mat 2502 may be flexible and may be rolled up for storage or transport. To that end, hook-and-loop fasteners or magnets 2560, 2552, 2556 may be provided to hold the mat 2502 in a rolled-up configuration while not in use. Instructions 2526, 2528 may be displayed on the mat 2502 above the areas where the left and right wrists should be placed to guide the user in proper positioning and use of the treatment system 2500. Indicators such as lights 2522, 2524 may be provided on the left and right sides of the mat 2502 to indicate whether the hand / wrist is in the proper position before applying the electrical stimulation signal 12 through the wrist to excite the median, radial, or ulnar nerves. Buttons or similar interfaces 2572, 2574 may be provided to adjust the intensity of the electrical stimulation signal 12, to start / stop the delivery of the electrical stimulation signal 12, or to cycle through menus provided by the stimulation module 2520. A display 2580 may show status information, the intensity level of the electrical stimulation signal 12, a menu, whether the electrical stimulation signal 12 is being applied (as some users feel nothing while the electrical stimulation signal 12 is being delivered through their wrist), which may additionally or alternatively be communicated via the indicators 2522, 2524 and an optional communication / charging port 2590, such as a USB-C port. A power button 2570 may be provided for turning the system 2500 on or off.

[0127] FIG. 25B shows the mat 2502 shown in FIG. 25A with one of the flexible bands 2512 partially wrapped around the wrist as shown. Here, the back 2584 of the band 2512 is grasped by the patient's free hand or by a helper's hand and wrapped around the wrist in the direction of arrow A until the fasteners 2556 are connected with the corresponding fasteners 2554. An optional inflatable balloon can be inflated to provide a secure and snug connection of the band 2512 around the wrist to form a tight-fitting cuff (see FIG. 25C). It has been found that a certain amount of pressure applied by the electrodes 16 directly to the skin of the wrist can be advantageous in reducing tremor activity. Once the band 2512 is properly secured, the indicator 2524 can indicate to the user or operator that the delivery of the electrical stimulation signal 12 can begin.

[0128] 25C shows the mat 2520 shown in FIG. 25B with one of the flexible bands 2512 secured around the wrist and delivering the electrical stimulation signal 12 via the electrodes 16 in that band 2512 to excite the median, radial, and / or ulnar nerves. Once treatment is completed or paused, the inflatable balloon, if present, can be deflated to release the positive pressure applied to the wrist by the electrodes 16 until the band 2512 is released from the wrist in a reverse motion, thereby freeing the wrist / hand from the band 2512. The fasteners 2560, 2550, 2552, 2554, 2556 can be any suitable fasteners, in one example they can be of the hook and loop type or can include magnets that allow for quick detachment without requiring significant effort to free the wrist or hand from the bands 2510 / 2512.

[0129] 26A is a diagram of an exemplary wrist-worn cuff system 2600 having an inflatable bladder 2642 for tightening around the wrist to deliver an electrical stimulation signal 12 for exciting the median, radial, or ulnar nerve, according to an exemplary embodiment. The system 2600 has a housing 2602 having a power button 2610, menu buttons 2612, 2614, plus / minus controls 2616, 2618, menu button 2620, and a charging / communication port 2622, such as a USB-C port. The housing 2602 is secured to a cuff 2604 having an inflatable bladder 2642 therein. Hook-and-loop fasteners 2630, 2632 (see FIG. 26B) are provided to form said cuff 2604 when joined together. A user or helper places the housing 2602 on the dorsal side of the arm or wrist, then wraps the band around and fastens the hook-and-loop fasteners 2630, 2632 together to form the cuff 2604. An inflatable bladder 2640 is then inflated until the cuff 2604 is snugly secured around the wrist. At the same time, electrodes 16 forming a set of electrodes 14 are placed on the dorsal / ventral side of the wrist / arm to deliver the electrical stimulation signal 12 therebetween. As disclosed herein, which electrodes 16 are selectively selected to be the source or receiver of the electrical stimulation signal 12 can be alternated or changed. Different source / receiver patterns can be tried until tremor relief is maximized, at which point a selection button 2614 can be selected to focus the electrical stimulation signal 12 on a particular source / receiver pair of electrodes 16 until tremor activity is suppressed or stopped. Additionally or alternatively, the amount of pressure applied by the inflatable bladder 2640 can be dynamically adjusted during delivery of the electrical stimulation signal 12 to "find" the optimal pressure to apply to the active electrodes 16 to optimize tremor suppression. FIG. 26B shows the rear side of the cuff 2604 shown in FIG. 26A , showing an exemplary set of electrodes 14 for exciting the median, radial, or ulnar nerves via delivery of the electrical stimulation signal 12 while the cuff 2604 is secured snugly around the wrist.

[0130] Another form factor contemplated by the present disclosure is a glove that partially or completely covers the hand. On some or all of the fingers of the glove, a set 14 of electrodes 16 is provided on an electrode carrier 12, one for each finger on which an electrode 16 is present, as disclosed herein, and while the glove is worn on the hand, different subsets of electrodes 16 are selectively activated and deactivated, for example to reduce hand tremors or tremors. Optionally, a wrist-worn cuff system 2600, such as the one shown in Figures 26A-26B, can also be worn on the user's wrist to hold the wiring between the system 2600 and the glove, carry optional data signals, and to provide localized energy delivery to the user's wrist simultaneously with the glove. In combination, the glove and wrist-worn cuff system 2600 can be very effective in suppressing or even eliminating arm / hand / wrist tremors or tremors. The glove can be ambidextrous so that it can be worn on either hand, or one glove can be worn on each hand to provide simultaneous treatment to both hands.

[0131] It should be noted that modifications and other embodiments of the disclosed invention will come to mind to one skilled in the art having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. It is understood, therefore, that the invention is not limited to the specific embodiments disclosed, but that modifications and other embodiments are intended to be included within the scope of the present disclosure. Although specific terms may be employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. 1. A system for therapeutic electrical stimulation of an arm or wrist, comprising: a flexible band configured to be secured around the arm or wrist of a patient, a flexible band supporting an electrode carrier configured to place a set of electrodes in physical contact with the arm or wrist; a stimulation module in electrical communication with the electrode carrier, the stimulation module having a signal generation circuit configured to generate electrical stimulation signals as direct current (DC) pulses at a frequency between 10 kHz and 50 kHz; a control circuit configured to sequentially activate different subsets of electrodes in the set of electrodes, each of the different subsets including one or more electrodes of the set of electrodes activated as signal sources of the electrical stimulation signal and one or more electrodes of the set of electrodes activated as signal sinks of the electrical stimulation signal; having the set of electrodes are spaced apart on the flexible band and configured to deliver electrical stimulation from the stimulation module to the arm or wrist to excite a first nerve selected from a median nerve, a radial nerve, or an ulnar nerve; At least one of the electrodes in the set of electrodes is positioned on a dorsal side of the arm or wrist and at least one other of the electrodes in the set of electrodes is positioned on a ventral side of the arm or wrist.

2. 2. The system of claim 1 , wherein the flexible band has a third electrode in electrical communication with the signal generation circuit, the first electrode and the third electrode are spaced apart on the flexible band to deliver the electrical stimulation signal from the signal generation circuit to the patient for exciting a second nerve other than the first nerve, the second nerve being selected from the patient's median nerve, radial nerve, or ulnar nerve, the first electrode and the third electrode are positioned and configured such that in a cross-sectional plane of the arm or wrist, there is an angle of 90 degrees to 180 degrees between a line connecting the second nerve and the first electrode and a line connecting the second nerve and the third electrode, the first nerve and the second nerve being different nerves, the system further comprising a switch matrix configured to switch the signal generation circuit between the first electrode and the second electrode, and the controller is further configured to deliver the electrical stimulation signal from the signal generation circuit to the first electrode, to the second electrode, and to the third electrode.

3. 2. The system of claim 1, wherein the control circuitry is configured to determine the defined activation sequence according to signaling received by the control circuitry, the signaling comprising any one of a signal provided by or read from the electrode carrier, an input signal resulting from user control of a control input provided to the system, or an input signal received wirelessly from a configuration device communicatively coupled to the stimulation module.

4. 10. The system of claim 1, wherein the electrode carrier comprises a flexible sheet or membrane configured to be conformably positioned on the arm or wrist, the flexible sheet or membrane carrying the set of electrodes on a surface of the flexible sheet or membrane facing the arm or wrist.

5. 5. The system of claim 4, wherein the flexible band comprises a flexible sheet or membrane and a compression sleeve that biases the set of electrodes into contact with the arm or wrist, the biasing force being obtained through at least one of an elastic material incorporated in or around the compression sleeve, an inflatable bladder incorporated in or around the sleeve, or one or more tightening straps incorporated in or around the sleeve.

6. 2. The system of claim 1, wherein the signal generating circuit is configured to control the frequency of the electrical stimulation signal in response to control by the control circuit, the control including any one of selecting a particular frequency from a set of predefined frequencies, continuously adjusting the frequency, or adjusting the frequency in steps, the frequency being between 10 kHz and 50 Hz.

7. 2. The system of claim 1, wherein the signal generating circuit is configured to control an intensity of the electrical stimulation signal in response to control by the control circuit, the control including one of adjusting a voltage of the electrical stimulation signal or adjusting a current of the electrical stimulation signal.

8. 8. The system of claim 7, further comprising a plus control coupled to the control circuit and configured to increase the intensity, and a minus control coupled to the control circuit and configured to decrease the intensity.

9. 10. The system of claim 1, further comprising a housing that houses the stimulation module and is coupled or integrated with the flexible band, at least a common electrode of the set of electrodes is disposed on the flexible band or on the housing against an underside of the housing, the underside facing the arm or wrist of the patient, and the housing has a plurality of connectors that operatively and electrically couple the housing to the set of electrodes on the flexible band when coupled to the flexible band.

10. 10. The system of claim 9, wherein the housing has a display configured to display status information and a timer that shows a real-time indication of the duration of time the electrical stimulus has been delivered to the arm or wrist, the display further configured to display an indication of the intensity of the electrical stimulus applied to the arm or wrist.

11. 10. The system of claim 1, wherein the flexible band extends circumferentially around and is secured to the arm or wrist, and is configured to have an adjustable diameter to accommodate the diameter of the arm or wrist to which the flexible band is secured.

12. 10. The system of claim 1, wherein at least one of the electrodes of the set of electrodes has a hemispherical contact point with the arm or wrist, the at least one electrode contacting the hemispherical contact point providing localized delivery of the electrical stimulation at the contact point.

13. 13. The system of claim 12, wherein at least two of the electrodes of the set of electrodes each have a hemispherical contact point with the arm or wrist that each of the at least two electrodes contacts.

14. 10. The system of claim 1, wherein at least one electrode of the set of electrodes has a flat surface having a maximum dimension not exceeding between 10 mm and 30 mm.

15. 10. The system of claim 1, further comprising a multi-axis motion sensor on the patient's arm or wrist, or on another arm or wrist, wherein the control circuitry or controller is configured to receive signals from the multi-axis motion sensor and determine therefrom a frequency of the patient's tremor while the electrical signal is applied to the arm or wrist.

16. 10. The system of claim 1, wherein the control circuitry or controller is further configured to monitor the frequency of the tremor in real time and alter which subset of electrodes are activated based on the monitored frequency, the set of electrodes including at least three electrodes, or at least four electrodes, or at least five electrodes, or at least six electrodes.

17. 17. The system of claim 16, wherein the control circuitry or controller is further configured to adjust the frequency of the electrical stimulation signal based on the monitored frequency of the tremor, wherein the adjusted frequency of the electrical stimulation signal is between 10 kHz and 50 kHz.

18. 17. The system of claim 16, wherein the frequency of the tremor is between 3.5 kHz and 8 kHz, and wherein in response to the frequency of the tremor dropping below a threshold below 3.5 kHz, the control circuitry or controller is further configured to reduce a strength of the electrical stimulation signal applied to at least one electrode of one of the distinct subsets.

19. 10. The system of claim 1, further comprising an impedance sensor in contact with the patient's arm or wrist, wherein the control circuit or controller is configured to receive signals from the impedance sensor in real time as the electrical stimulation signal is applied, and in response to a determination that the change in impedance exceeds a threshold, adjust at least one of the amplitude, phase or frequency of the electrical stimulation signal applied to different subsets of electrodes while continuing to monitor the impedance sensor.

20. 2. The system of claim 1, wherein in response to the flexible band being placed around the wrist, the first electrode is placed on a dorsal side of the wrist, the second electrode is placed on a ventral side of the wrist, and the third electrode is placed on the wrist between the first electrode and the second electrode.

21. 1. A system for therapeutic electrical stimulation of the arm or wrist, comprising: a substrate on which the arm or wrist rests or is placed; and a flexible band configured to be secured around the arm or wrist while resting on the substrate, the flexible band supporting an electrode carrier; a set of electrodes, at least a first electrode of which is part of the electrode carrier and at least a second electrode of which, the first electrode of the set of electrodes is in physical contact with a dorsal side of the arm or wrist and the second electrode of the set of electrodes is in physical contact with a ventral side of the arm or wrist in response to the arm or wrist resting on the substrate, the set of electrodes including a third electrode that is part of the electrode carrier or in or on a substrate; a stimulation module in electrical communication with the electrode carrier, the stimulation module having a signal generation circuit configured to generate electrical stimulation signals as direct current (DC) pulses at frequencies centered between 10 kHz and 50 kHz; a control circuit configured to sequentially activate different subsets of electrodes in the set of electrodes, each of the different subsets including one or more electrodes of the set of electrodes activated as signal sources of the electrical stimulation signal and one or more electrodes of the set of electrodes activated as signal sinks of the electrical stimulation signal; having The system, wherein the set of electrodes is configured to deliver electrical stimulation from the stimulation module to the arm or wrist to excite a first nerve selected from the median nerve, the radial nerve, or the ulnar nerve.

22. 22. The system of claim 21, wherein the flexible band has a fastener configured to secure the flexible band around the arm or wrist to the substrate, the substrate being generally flat while resting on a flat surface.

23. 22. The system of claim 21, wherein the substrate includes indicia indicating where to place the arm or wrist relative to the substrate prior to fastening the flexible band to the arm or wrist.

24. 24. The system of claim 23, further comprising an indicator to indicate proper placement of the arm or wrist relative to the placement location.

25. 22. The system of claim 21, further comprising an indicator having a first state indicating an absence of the electrical stimulation signal and a second state indicating the electrical stimulation signal is being delivered via at least one of the subset of electrodes in the set of electrodes.

26. 22. The system of claim 21, wherein the flexible band includes or is coupled to an inflatable bladder configured to expand to apply pressure to electrodes of the set of electrodes that are in physical contact with the arm or wrist while the electrical stimulation signal is applied to the electrodes.

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