Methods and devices for wound treatment

Abstract

The electrical stimulation device (10) provides an electrical stimulation signal (22) as a DC pulse train at a frequency between 10 kHz and 50 kHz based on sequential activation of respective subsets (32) of a set (14) of electrodes (16) included in an electrode carrier (12) that contacts the electrodes (16) with the patient's body, and applies the electrical stimulation signal (22) to the patient's body at the site of injury. A corresponding method (2200) sequentially activates respective subsets (32) of electrodes (16) of a set of electrodes (16) that contact the patient's body at the site of injury on the patient's body. In one or more embodiments, the sequential activation follows an activation sequence that "moves" the source and recipient of the electrical stimulation signal around the injury site, thereby forming a spatially distributed signal path through or across the injury site over time.

Description

[Technical field]

[0001] An electrical stimulation device and method for applying an electrical stimulation signal to an injured area of ​​a patient's body. [Background technology]

[0002] 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.

[0003] 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.

[0004] Wound healing is another application of electrical stimulation, such as U.S. Patent No. 7,520,849B1, issued April 21, 2009. 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 the application of electrical stimulation in combination with negative pressure therapy in the context of wound healing.

[0005] 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. Summary of the Invention

[0006] 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 series of electrodes included 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 series 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 sequence that "moves" the source and receiver of the electrical stimulation signal in a scanning or circular pattern around the site of injury. As used herein, "site of injury" includes the site where pain or dysfunction is exhibited, regardless of whether the pain or dysfunction is manifested as a discernible injury. However, visible damage, such as a wound, is encompassed by the term "site of injury".

[0007] 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.

[0008] 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.

[0009] 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.

[0010] 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.

[0011] 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]

[0012] [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. [Diagram 2] 2A-2F are diagrams 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 4] Figures 4A-4C are diagrams of a further exemplary embodiment of an electrode carrier, and Figures 4D-4G are diagrams of a further exemplary embodiment of a self-administered electrode carrier and cable system. [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 9] 9A and 9B are diagrams of functional logic used by an 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 13] 13A-13C are diagrams of an electrical stimulation device that integrates elements for providing negative pressure therapy, according to another embodiment. [Figure 14] 14A-14D are diagrams 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 23] 23A-23D show exemplary "moving" patterns for distributing or sweeping an electrical stimulation signal across or through an injury at an injury site on a patient's body. [Figure 24] FIG. 24 is a schematic diagram of an exemplary signal generation circuit for generating an electrical stimulation signal according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] 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.

[0014] 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 sensing 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.

[0015] 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.

[0016] 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.

[0017] Thus, the subsets 32-1, 32-2, 32-3 are shown as electrode pairs [A|B], [C|D], [E|F], although other example subsets are [A|B, C], [C|D, B, F], etc., where the electrodes 16 of the subsets listed to the left of the "|" character act as signal sources of the electrical stimulation signal 22, and the electrodes 16 of the subsets listed to the right of the "|" character act as signal sinks of the electrical stimulation signal 22. In this understanding, the subset 32 ​​formed as [A|B] is distinct from the subset 32 ​​formed as [B|A].

[0018] 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.

[0019] 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.

[0020] In yet other embodiments, circuitry on the electrode carrier 12 controls subset formation or activation depending 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 to control 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. Because of radio frequency signals that may traverse different sets of wires to the electrodes 16 and the opportunity for interference as energy travels rapidly through the electrode carrier 12, additional dielectric insulation and / or electromagnetic suppression material can be provided between adjacent electrodes 16 to mitigate electromagnetic crosstalk.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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).

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] FIG. 2C illustrates the same embodiment of the electrode carrier 12, depicted in a circumferential position relative to an injury on a patient's body. Notably, the exemplary injury 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 the wound. As seen in the side views provided in FIGS. 2D and 2E, the electrodes 16 slightly depress the patient's skin at the points of contact, but do not exert undue pressure without breaking the skin. In some embodiments, an exemplary pressure that may be applied by the electrodes 16 is between 0.05 and 10 pounds, or 0.5 pounds and 150 pounds per square inch. In other embodiments, an exemplary pressure that may be applied by the electrodes 16 corresponds to the surface tension applied by an adhesive material as described herein, or approximately 0.0055 pounds. Also shown in FIGS. 2D and 2E is an exemplary cable 74 for a wired connection back to the stimulation module 18 as "connection 24" introduced in FIG. 1.

[0039] "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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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.

[0044] 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.

[0045] 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 [K|L] or [L|K], the subset 32-2 may consist of [I|J] or [J|I], 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.

[0046] FIG. 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 illustrated example, the sheet 60 consists of two strips 76A and 76B, each carrying a number of electrodes 16 (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10). 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. Although shown with three exemplary electrodes 16 in FIG. 4A, one sheet 60 may include, for example, one electrode 16 acting as a receiver, while another sheet 60 may include, for example, three or five electrodes 16 acting as transmitters.

[0047] 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.

[0048] 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.

[0049] 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.

[0050] 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.

[0051] 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.

[0052] FIG. 4D shows another use of the wearable strip-based embodiment of the electrode carrier 12, where two strips 76A and 76B can be self-adhered to the patient's skin. In this example, the patient can self-treat the site of pain or injury, for example in conjunction with an app operated by the patient's portable computing device or mobile device, and can also be discreetly worn by the patient according to the site while receiving treatment. The strip 76B can be referred to as a single-prong strip since it has a single electrode 16, and the strip 76A can be referred to as a five-prong strip since it has five electrodes 16 arranged side by side along the strip 76A. In the upper part of FIG. 4D, the back side of the strips 76A, 76B is shown, which will be facing away from the patient's skin. In the lower part of FIG. 4D, the front side of the strips 76A, 76B is shown, which will be adhered to the patient's skin so that the prongs or electrodes 16 are in contact. An exploded view of the single protrusion strip 76B is shown in FIG. 4E, beginning with an adhesive layer 85, such as 3M 467 MP transfer adhesive tape, to a flexible backing substrate 86. Stainless steel protrusions (e.g., made from 316 stainless steel) form the electrodes 16, which are electrically coupled to a flexible printed circuit 87 disposed on a transparent film 88, such as Autoflex EB 130 polyester transparent film. The flexible printed circuit 87 terminates in a connector 83. The transparent film 88 is adhered to a release-lined adhesive tape 91, such as Avery Dennison MED 3044 acrylic adhesive tape with release liner. Pad 81 can be printed with a QR code, which can be linked to an app that can be used to control the electrode carrier 12.

[0053] FIG. 4F shows an exploded view of the five-bump strip 76A shown in FIG. 4D. Like the one-bump strip 76B, the five-bump strip 76A has an adhesive layer 93, such as 3M 467 MP transfer adhesive tape, attached to a flexible backing substrate 95. Five stainless steel bumps (e.g., made from 316 stainless steel) form the electrodes 16, each of which is electrically coupled to a flexible printed circuit 97 disposed on a transparent film, such as Autoflex EB 130 polyester transparent film. The flexible printed circuit 97 terminates in a connector 83, which is adhered to an adhesive tape with a release liner, such as Avery Dennison MED 3044 acrylic adhesive tape with release liner 99, which is adhered to a front substrate 101 that contacts the skin. Pads 81 can be printed with a QR code, which can be linked to an app that can be used to control the electrode carrier 12.

[0054] 4G shows an example of a cable set for use with the strips 76A, 76B, where the connector 83 of the strip 76A is inserted into a dongle 1044 having a corresponding female connector that receives the male connector 83, such as a 9-way Molex connector 039532094. Correspondingly, the connector 83 of the strip 76B is inserted into a dongle 103 having a corresponding female connector that receives the male connector 83 of the strip 76B. Either or both of the dongles 103, 104 can include a switch control 105 configured to be controlled by the app, such as via a Bluetooth or similar wireless connection, to set the intensity, duration, and / or frequency of the treatment regimen from the app to the electrodes 16. For example, the app can receive input indicating the type of treatment regimen, e.g., tennis elbow 7, and automatically program the switch control device 105 to control the electrical parameters of the power supplied to the electrodes 16, as well as the pattern and timing of current supplied to the five prong strips 76A (in this example, unused power is returned to the power source via the single prong strip 76B).

[0055] To use the strips 76A, 76B shown in FIGS. 4D-4G, a patient or clinician applies the strips 76A, 76B in proximity to a site of injury or pain, as described herein. A treatment type is entered into the app to indicate the nature and location of the patient's injury or pain. The app communicates the entered treatment type to a switch controller or other controller (e.g., the stimulation module 18) to control the electrical parameters of the power delivered to the strips 76A, 76B, as well as the timing and energization pattern of the electrodes 16 on the strip 76A. The strips 76A, 76B remain adhered to the patient's skin while power is delivered, and no further interaction by the patient is required during the treatment session, nor is the patient required to hold the strips 76A, 76B or necessarily adjust electrical parameters during application of the treatment via the electrodes 16. Any of the energization strategies disclosed herein may be used in conjunction with the strips 76A, 76B shown in FIGS. 4D-4G. Advantageously, the strips 76A, 76B, cable and control unit can be sent as a kit directly to the patient, who can download the app (e.g., by scanning the QR code 107) and begin self-treatment via the app. Alternatively, a doctor or clinician can utilize available telemedicine technology over a line of communication to adjust the electrical parameters delivered to the strips 76A, 76B by communicating a treatment plan to the stimulation module 18 controlling the strips 76A, 76B, for example to the patient's mobile or portable computing device.

[0056] FIG. 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 a lesion. The pair 80 is merely a particular instance or example of the subset 32 ​​described above. That is, while the subset 32 ​​may include two electrodes 16 or may include more than two electrodes 16, FIG. 5 illustrates the particular instance of pairs of electrodes 80-1 through 80-7. At any given time, a first one of the electrodes 16 within a given pair 80 is active as a signal source for the electrical stimulation signal 22, and a second one of the electrodes 16 within the pair 80 is active as a signal inductor for the electrical stimulation signal 22.

[0057] 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.

[0058] 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.

[0059] 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.

[0060] 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."

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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).

[0072] 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.

[0073] 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.

[0074] Moreover, in at least one such embodiment, the therapy provided by the device 10 is tailored to the amount of time the user indicates is available for treating the patient, i.e., the amount of time available for the currently scheduled therapy session. A user need only indicate the amount of time available for therapy, and the control circuitry 30 optimizes the selection and pattern of activated source and receiver electrodes 16 for the indicated amount of time made available. The control module 30 may impose boundaries, such as enforcing a minimum therapy time required to initiate therapy activity.

[0075] 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 circuitry 30 activates electrodes L (source) and D (receiver) for one minute, then deactivates the L|D pair, immediately activates electrodes K (source) and E (receiver) for one minute, then deactivates the K|E pair, immediately activates electrodes I (source) and K (receiver) for one minute, then deactivates the I|K pair, immediately activates electrodes A (source) and I (receiver) for one minute, then deactivates the A|I pair, immediately activates electrodes B (source) and H (receiver) for one minute, then deactivates the B|H pair, and finally activates electrodes C (source) and G (receiver) for one minute.

[0076] 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 the L|D pair, immediately activate electrodes K (source) and E (receiver) for 2 minutes, then deactivate the K|E pair, immediately activate electrodes I (source) and K (receiver) for 2 minutes, then deactivate the I|K pair, immediately activate electrodes A (source) and I (receiver) for 2 minutes, then deactivate the A|I pair, and immediately activate electrodes B (source) and H (receiver). immediately activate electrodes I (source) and F (receiver) for 1 minute, then deactivate pair I|F, immediately activate electrodes J (source) and D (receiver) for 1 minute, then deactivate pair J|D, immediately activate electrodes A (source) and G (receiver) for 1 minute, then deactivate pair A|G, and finally activate electrodes C (source) and I (receiver) for 1 minute.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] 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.

[0081] 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 the execution of a software app 140, for example, installed from an app store or side-loaded onto the device 130.

[0082] 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.

[0083] 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.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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 to press the set 14 of electrodes 16 into position against the patient's skin at the site of injury.

[0088] 14B illustrates another variation of the flexible sleeve 170, which omits the cutouts 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, thus allowing one sleeve 170 to be used to treat injuries of different types and locations on the affected limb.

[0089] 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 example where the sleeve 170 is configured for use on the ankle of a human leg, with cutout 66 being used in this particular example. 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 for 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.

[0090] 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 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.

[0091] 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.

[0092] In addition to using 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 monitors. With the sleeve 170 fastened in place, inflating the bladder 174 tightens the fastened sleeve 170 further against the patient's body, thereby encouraging the electrodes 16 to make better contact (and correspondingly apply more pressure) against the patient's skin. 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.

[0093] 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.

[0094] 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.

[0095] 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.

[0096] 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.

[0097] 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.

[0098] 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.

[0099] 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).

[0100] 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 distributed, at least in part, between the electrode carrier 12 and a separate housing 110 that includes a user interface 112, etc.

[0101] 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.

[0102] 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.

[0103] 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.

[0104] 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.

[0105] 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.

[0106] 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.

[0107] 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).

[0108] 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).

[0109] 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.

[0110] 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.

[0111] 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 in accordance with 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.

[0112] 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.

[0113] 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.

[0114] 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.

[0115] 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.

[0116] 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.

[0117] 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 .

[0118] 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.

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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. An apparatus (10) configured for therapeutic electrical stimulation of a patient, comprising: an electrode carrier (12) configured to place a set (14) of electrodes (16) in contact with the patient's body at a site of injury thereon; A stimulation module, comprising: a signal generating circuit (20) configured to generate an electrical stimulation signal (22) as a direct current (DC) pulse train at a frequency between 10 kHz and 50 kHz; a control circuit (30) configured to sequentially activate respective subsets (32) of electrodes (16) in said set (14) of electrodes (16), each subset (32) including one or more electrodes (16) activated as signal sources of said electrical stimulation signal (22) and one or more electrodes (16) activated as signal sinks of said electrical stimulation signal (22); A stimulation module having An apparatus (10).

2. 2. The apparatus (10) of claim 1, wherein the control circuit (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).

3. 3. The device (10) of claim 2, wherein the defined activation sequence (82) is predefined and corresponds to a spatial arrangement of the set (14) of electrodes (16) on the patient's body at the injury site and results from a designated arrangement of the electrode carrier (12) relative to the injury site.

4. The device (10) of any one of claims 2 or 3, wherein the control circuit (30) is configured to determine the defined activation sequence (82) in accordance with signaling received by the control circuit (30), the signaling comprising any one of a signal (26) provided by or read from the electrode carrier (12), an input signal (50) resulting from user control of a control input provided by a stimulation module (18), or an input signal (52) received wirelessly from a configuration device (110) communicatively coupled to the stimulation module (18).

5. The device (10) of any one of claims 2 to 4, wherein each of the subsets (32) has 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), one of the two electrodes (16) acting as the signal source and the other of the two electrodes (16) acting as the signal sink.

6. 5. The device (10) of claim 2, wherein at least one of the plurality of electrode pairs (80) is at least a putatively opposed electrode pair, in which the two electrodes (16) have an opposed relationship in which at least a portion of the injury at the injury site is interposed between the respective contact points of the two electrodes (16) on the patient's body.

7. 7. The device (10) of claim 1, wherein the electrode carrier (12) has a flexible sheet or membrane (60) configured to be conformably positioned on the patient's body at the site of injury, the flexible sheet or membrane (60) carrying the set (14) of electrodes (16) on a patient-facing surface (64) of the flexible sheet or membrane (60).

8. 8. The device (10) of claim 7, wherein the flexible sheet or membrane (60) includes a central cutout or opening (66) for leaving the injury site exposed, and the set (14) of electrodes (16) are arranged at spaced apart positions along an edge (68) defining the cutout or opening (66).

9. 9. The apparatus (10) of claim 8, wherein the electrode carrier (12) further comprises: The device (10) has a sealable covering (150) that covers the central cutout or opening and has a port for applying negative pressure to the wound.

10. The device (10) of any one of claims 7 to 9, wherein the electrode carrier (12) has a sleeve (170) configured to surround at least a portion of the patient's affected limb, the sleeve (170) including the flexible sheet or membrane (60).

11. 11. The device (10) of claim 10, wherein the sleeve (170) comprises a compression sleeve that biases the set (14) of electrodes (16) into contact with the patient's body at the injury site, the biasing force being obtained via at least one of an elastic material incorporated in the compression sleeve, an inflatable bladder incorporated in the sleeve, or one or more tightening straps incorporated in the sleeve.

12. 12. The device (10) of any one of claims 7 to 11, wherein the flexible sheet or membrane (60) has an adhesive membrane for temporary adhesion to the patient's body at the site of the injury.

13. 13. The device (10) of any one of claims 1 to 12, wherein the set (14) of electrodes (16) defines a corresponding set of contact points for point emission or reception of the electrical stimulation signal (22).

14. 14. The device (10) of any one of claims 1 to 13, wherein the signal generating circuit (20) is configured to control the frequency of the electrical stimulation signal (22) in response to control by the control circuit (30), the control being one of selecting a particular frequency from a set of predefined frequencies, continuously adjusting the frequency, or adjusting the frequency in steps.

15. 15. The device (10) of any one of claims 1 to 14, wherein the signal generating circuit (20) is configured to control the intensity of the electrical stimulation signal (22) in response to control by the control circuit (30), the control being one of adjusting a voltage of the electrical stimulation signal (22) or adjusting a current of the electrical stimulation signal (22).

16. 14. The device (10) of any one of claims 1 to 13, wherein the electrode carrier (12) incorporates a ported chamber (164) that is sealably closed when the electrode carrier (12) is in intimate contact with the patient's body at the site of injury.

17. 17. The device (10) of claim 16, wherein the control circuit (30) is configured to control application of negative pressure via the electrode carrier (12) in conjunction with controlling application of the electrical stimulation signal (22).

18. 18. The apparatus (10) of claim 16 or claim 17, wherein the apparatus (10) includes a negative pressure pump subassembly (156).

19. 1. A method (2200) performed by an apparatus (10) configured for therapeutic electrical stimulation of a patient, comprising: providing an electrical stimulation signal (22) as a direct current (DC) pulse train at a frequency between 10 kHz and 50 kHz; sequentially activating (2204) via the electrical stimulation signal (22) a respective subset (32) of electrodes (16) within a set (14) of electrodes (16) that contact the patient's body at the site of injury on the patient's body; The method (2200).

20. 20. The method (2200) of claim 19, wherein sequentially activating the respective subsets (32) of electrodes (16) comprises 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).

21. 21. The method (2200) of claim 19 or claim 20, further comprising: The method (2200), comprising the step of varying the defined activation sequence (82) or the defined activation cycle (84) in response to user input received via a user interface (112) of the device (10) or via a communication circuit (44) of the device (10).

22. The method (2200) of any one of claims 19 to 21, further comprising: A method (2200), comprising varying one or more parameters in response to user input received via a user interface (112) of the device (10) or via a communication circuit (44) of the device (10), the one or more parameters being any 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 (22).

23. A method (2200) according to any one of claims 19 to 22, wherein sequentially activating the respective subsets (32) of electrodes (16) comprises activating the respective subsets (32) of electrodes (16) according to a treatment program (96).

24. 24. The method (2200) of claim 23, further comprising: A method (2200), comprising obtaining the treatment program (96) as a predefined treatment program stored as configuration data (40) within the device (10).

25. 25. The method (2200) of claim 23 or claim 24, further comprising: A method (2200), comprising creating or adjusting the treatment program (96) in response to user input.

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