Patent Description:
Therapeutic application of electrical signals to the human body, sometimes referred to as "electrostimulation" or "electrical stimulation therapy," has a long history'. Perhaps best known among contemporary, routine use of electrostimulation, Transcutaneous Electrical Nerve Stimulation (TENS) devices generate electrical impulses that are delivered through the skin, for relieving chronic or acute pain.

TENS signals characteristically range from below <NUM> to as high as <NUM>, with the intensity of the signal dependent on the involved frequency range and intended effect. For example, TENS signals below <NUM> may have a higher intensity, for inducing motor contractions, while TENS signals above <NUM> generally have lower intensities. However, other known electrostimulation devices operate at higher frequencies, or at least offer the capability to operate at higher frequencies. As one example, see <CIT>, <CIT>.

Wound healing represents another application of electrostimulation, with <CIT>, as <CIT>, offering one example. As one earlier example, see <CIT>, <CIT>. <CIT> offers another example of electrostimulation applied in the context of wound healing, in combination with the use of negative pressure treatment.

<CIT> discloses a wound dressing for covering a wound and an area of skin surrounding the wound comprising an electrically non-conductive base dressing and at least one electrode provided on a first surface of the base dressing for applying electrical signals to the skin when placed on the skin, wherein a cavity is provided in the base dressing to disperse pressure from the wound when pressure is applied to the wound dressing.

<CIT> discloses a patient treatment unit for delivering non-invasive pulsed energy to living tissue with a probe stimulus generator circuit configured to output, as a treatment signal, a sequence of DC electrical pulses at a controlled pulse frequency of about <NUM> and having a pulse voltage defined by a variable supply voltage of the probe stimulus generator circuit. The unit of <CIT> includes primary and secondary probes for contacting a body, an intensity adjustment circuit configured to control the variable supply voltage, and an electronic timer display configured to display an elapsed time in decimal numbers in minute and second format. An electrical current of the pulses is in a range of <NUM>-<NUM> mA while the probes are contacting the body. An operating output voltage across the probes while conducting the treatment signal does not exceed a maximum operating output voltage of <NUM> VDC while the probes are contacting the body.

The wide variation in electrostimulation device configurations and operational parameters seen in the field of electrostimulation reflects not only the wide range in intended uses, from pain relief to neuromuscular stimulation, but also continuing uncertainty about the parameters that are key for efficacy in any particular application. An acute need remains for electrostimulation devices and electrostimulation methods that yield high efficacy in the areas of pain relief and injury healing.

The invention relates to an apparatus as defined in claim <NUM> with advantageous embodiments as defined in the dependent claims referring to it and as disclosed herein.

An electrical stimulation apparatus provides an electrical stimulation signal as a DC pulse train at a frequency between <NUM> and <NUM>, with the electrical stimulation signal applied to the body of a patient at an injury site, based on sequentially activating respective subsets among a set of electrodes included in an electrode carrier that places the electrodes in contact with the body of the patient. An electrical stimulation method sequentially activates, via an electrical stimulation signal, respective subsets of electrodes among a set of electrodes contacting the body of a patient at an injury site on the body of the patient. Advantageously, in one or more embodiments, the sequential activation follows an activation sequence that "moves" the sources and sinks for the electrical stimulation signal in a scanning or circulating pattern around the injury site. An "injury site" as used herein includes a site where pain or dysfunction is indicated, regardless of whether the pain or dysfunction manifests as a discernible injury. However, visible injuries, such as a wounds, are encompassed by the term "injury site.

One embodiment of an apparatus configured for therapeutic electrical stimulation of a patient includes an electrode carrier and a stimulation module. The electrode carrier is configured to place a set of electrodes into contact with the body of the patient at an injury site on the body of the patient. Signal generation circuitry in the stimulation module is configured to generate an electrical stimulation signal as a Direct Current (DC) pulse train at a frequency of between <NUM> and <NUM>. Control circuitry in the stimulation module is configured to sequentially activate individual subsets of electrodes in the set of electrodes, each subset including one or more electrodes activated as a signal source for the electrical stimulation signal and one or more electrodes activated as a signal sink for the electrical stimulation signal.

Advantageously, in at least one embodiment of the apparatus, the sequential activation follows an activation sequence that "moves" the sources and sinks for the electrical stimulation signal around the injury site. Here, "moving" the signal sources and sinks does not mean physical movement; rather, it means changing which electrodes are active over time, according to a spatial pattern or sequence, such that the electrical stimulation signal is sourced/sunk from multiple positions around the injury at the injury site. Moving the signal sources and sinks create spatially distributed signal paths through or across the injury over time.

In a further advantageous arrangement used in at least one embodiment of the apparatus, the electrode carrier incorporates a ported chamber that is sealably closed with adherence of the electrode carrier on the body of the patient at the injury site. In such embodiments, 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 moving sources and sinks provided via the sequential electrode activation combine with negative pressure treatment, for synergistic application of injury-healing therapies.

In another embodiment, a method performed by an apparatus configured for therapeutic electrical stimulation of a patient includes the step or operation of providing an electrical stimulation signal as a DC pulse train at a frequency of between <NUM> and <NUM>. Further, the method includes sequentially activating respective subsets of electrodes among a set of electrodes contacting the body of the patient at an injury site on the body of the patient, via the electrical stimulation signal. For example, the sequential activation follows a defined activation sequence and activation cycle.

Of course, the present invention is not limited to the above features and advantages. Those of ordinary skill in the art will recognize additional features and advantages upon reading the following detailed description, and upon viewing the accompanying drawings.

<FIG> depicts example details for one embodiment of an electrostimulation apparatus <NUM> (hereafter "apparatus <NUM>") that is configured for therapeutic electrical stimulation of a patient at an area of the body involving pain, discomfort, or dysfunction, with such areas broadly referred to herein as "injury sites. " Although the diagram depicts a human patient, the term "patient" encompasses any living animal.

An electrode carrier <NUM> of the apparatus <NUM> includes a set <NUM> of electrodes <NUM>, while a stimulation module <NUM> of the apparatus <NUM> includes signal generation circuitry <NUM> that is configured to generate an electrical stimulation signal <NUM> that is provided to respective electrodes <NUM> in the electrode carrier <NUM> via a wired or wireless connection <NUM>. In at least some embodiments, one or more additional signals <NUM> go between the electrode carrier <NUM> and the stimulation module <NUM>, such as for use by the stimulation module <NUM> in sensing or reading the type, model, or configuration of the electrode carrier <NUM>, or in controlling which electrode(s) <NUM> are active at given times during electrostimulation therapy.

Control circuitry <NUM> in the stimulation module <NUM> controls electrode activation either directly via the signals <NUM>, such as in embodiments where stimulation-signal generation occurs on the electrode carrier <NUM>, or indirectly via control of the signal generation circuitry <NUM>. For example, the connection <NUM> in one embodiment carries an electrical connection for each electrode <NUM> and the signal generation circuitry <NUM> "activates" respective subsets <NUM> of the electrodes <NUM> responsive to control signaling by the control circuitry <NUM>.

Subsets <NUM>-<NUM>, <NUM>-<NUM>, and <NUM>-<NUM> appear in the diagram, but the example is non-limiting. There may be a smaller or a greater number of subsets <NUM>, any given subset <NUM> may include more than two electrodes <NUM>, and two or more subsets <NUM> may have one or more electrodes <NUM> in common. Further, the subsets <NUM> need not have the same number of members, e.g., one subset <NUM> may include two electrodes <NUM>, while another subset <NUM> includes three electrodes <NUM>, and so on.

Thus, while the subsets <NUM>-<NUM>, <NUM>-<NUM>, and <NUM>-<NUM> are shown as electrode pairs {A|B}, {C|D}, and {E|F}, other example subsets are {A|B, C], {C|D, B, F}, etc. Here, electrodes <NUM> in the subset that are listed to the left of the "|" character operate as a signal source of the electrical stimulation signal <NUM>, while electrodes <NUM> in the subset that are listed to the right of the " |" character operate as a signal sink of the electrical stimulation signal <NUM>. With that understanding, the subset <NUM> formed as {A|B} distinguishes from the subset <NUM> formed as {B|A).

One approach, noted above, for providing the control circuitry <NUM> with control of subset formation or activation relies on the connection <NUM> including an electrical connection for each electrode <NUM> carried by the electrode carrier <NUM>. In an example implementation, the signal generation circuitry <NUM> includes a multiplexer that selectively connects one or more electrodes <NUM> as signal sources and one or more electrodes <NUM> as signal sinks, with the selective connectivity controlled by the control circuitry <NUM>. In other embodiments, the signal generation circuitry <NUM> is programmed or arranged via fixed circuitry to activate predefined subsets <NUM>.

For example, the signal generation circuitry' <NUM> in one or more embodiments is configured to activate/deactivate individual ones of the electrodes <NUM> and to control whether a given electrode <NUM> is activated as a signal source or a signal sink. With this arrangement, arbitrary subsets <NUM> may be formed from among the overall set <NUM> of electrodes <NUM> of the electrode carrier <NUM>.

In yet other embodiments, circuitry on the electrode carrier <NUM> controls subset formation or activation, in dependence on signaling received from the stimulation module <NUM>, with such arrangements reducing or eliminating the number of wires needed in wired versions of the connection <NUM>. For example, the connection <NUM> in an example embodiment includes the positive and negative (or "ground") wires associated with sourcing and sinking the electrical stimulation signal <NUM>, with one or more additional wires associated with the signaling <NUM>, for controlling subset formation or activation on the electrode carrier <NUM>. In yet other embodiments, the signaling <NUM> may include high-frequency signaling impressed on the electrical stimulation signal <NUM>. In such embodiments, the electrode carrier <NUM> includes circuitry that is configured to detect or otherwise respond to the high-frequency signaling. Because of the high-frequency signals that can variously pass through different sets of wires going to the electrodes <NUM>, and the opportunity for interference as the energy rapidly moves about the electrode carrier <NUM>, additional dielectric isolation and/or electromagnetic-suppressing material can be provided between adjacent electrodes <NUM> to mitigate electromagnetic crosstalk.

Other example details in the embodiment of the apparatus <NUM> illustrated in <FIG> include elements of the control circuitry <NUM>, which include processing circuitry <NUM> and storage <NUM>, such as may be used for the storage of one or more computer programs <NUM> or configuration data <NUM>. Here, and elsewhere in the disclosure, the word "or" encompasses the conjunctive case, unless otherwise noted or otherwise clear from the context. That is, unless noted or excluded by the contextual usage, the phrase "A or B" means A singly, B singly, or both A and B.

The processing circuitry <NUM> comprises, for example, any one or more of one or more microprocessors, microcontrollers. Field Programmable Gate Arrays (FPGAs), Complex Programmable Logic Devices (CPLDs), Digital Signal Processors (DSPs), Application Specific Integrated Circuits (ASICs), or System-on-a-Chip (SoC) modules. Broadly, the processing circuitry <NUM> comprises fixed circuitry or programmatically-configured circuitry, or some mix of both.

In an example where the processing circuitry <NUM> comprises a microprocessor ("uP"), the microprocessor is, for example, a general-purpose microprocessor that is specially adapted to carry out the operations described herein for the apparatus <NUM>, based at least in part on its execution of computer program instructions from one or more computer programs ("CP") <NUM> held in storage <NUM>. That is, in one or more microprocessor-based embodiments of the apparatus <NUM>, the execution of computer program instructions by the microprocessor causes the apparatus <NUM> to function as described herein.

Correspondingly, the storage <NUM> comprises one or more types of computer-readable media, such as one or more types of memory circuits or storage devices and may be in whole or in part integrated with the processing circuitry <NUM>, or accessible to it. Non-limiting examples of memory circuits include volatile memory as working memory for "live" operation of the apparatus <NUM> and non-volatile memory for longer-term storage of program instructions and various parameter or settings values, referred to as configuration data ("CFG. DATA") <NUM>. Volatile memory examples include SRAM or DRAM, while non-volatile memory examples include EEPROM, FLASH, and Solid State Disk (SSD).

Other example elements of the apparatus <NUM> include a power supply <NUM>, which may include a battery', such as a lithium ion battery for portable operation of the apparatus <NUM>. In an example implementation, the power supply <NUM> is configured for a mains power connection, e.g., electrical power at <NUM>/<NUM> from <NUM> VAC to <NUM> VAC and includes one or more isolation transformers to foreclose the possibility of energizing the electrodes <NUM> with unsafe voltage or current levels. In general operation, the power supply <NUM> outputs one or more controlled supply signals, e.g., DC supply voltages at one or more voltage levels, for use by the various circuitry' within the apparatus <NUM>.

Examples of such other circuitry' include communication circuitry <NUM>, user interface circuitry <NUM>, and input/output (I/O) circuitry <NUM>. The communication, user interface, and I/O circuitry <NUM>, <NUM>, and <NUM> are shown in dashed boxes to indicate optional inclusion in one or more embodiments of the apparatus <NUM>. Similarly, the processing circuitry <NUM> and storage <NUM>, along with the CP <NUM> and CFG. DATA <NUM> are shown in dashed boxes to indicate that one or more embodiments of the apparatus <NUM> may not include them, such as where the control circuitry <NUM> exclusively relies on fixed circuitry' for its implementation.

In one or more embodiments, the communication circuitry <NUM> provides wireless communications, such as for wireless communication with the electrode carrier <NUM> in one or more embodiments, or for wirelessly coupling the apparatus <NUM> to a WI-FI access point or other type of Wireless Local Area Network (WLAN). Additionally, or alternatively, the communication circuitry <NUM> implements Near Field Communication (NFC) or Personal Area Network (PAN) connectivity, such as for registering or reading the particular type, model, or configuration of the electrode carrier <NUM>. to be used at any given time, with the electrode carrier <NUM> correspondingly incorporating complementary communications circuitry. PAN connectivity relies on, for example, BLUETOOTH communications.

In one or more embodiments, BLUETHOOTH, WI-FI, or other wireless connectivity provided by the communication circuitry <NUM> provides for implementation of user control or monitoring of the apparatus <NUM>, either via a local user having wireless connectivity to the apparatus <NUM> via a smartphone, tablet, laptop, or other computing device, or via a remote user connected via the Internet.

Further, in at least one embodiment of the apparatus <NUM> in which the communication circuitry <NUM> is included, the communication circuitry <NUM> includes one or more wired interfaces, such as an Ethernet connection supporting data networking of the apparatus <NUM>. Of course, data network via WLAN connectivity may also be used, or other data-connections, such as a Serial Peripheral Interface (SPI), or another serial interface. With such connectivity, the apparatus <NUM> may receive configuration data, for example, to tailor patient treatment to a particular patient or to a particular treatment session for a particular patient and may output treatment confirmation records. Such records may include time/date stamps, patient name, or ID, along proof-of-treatment, such as a unique nonce generated by the control circuitry <NUM>. All such data may be encrypted at rest or in communication.

In addition to user control being provided via a smartphone or other external computing device, or as addition or alternative to such arrangements, the apparatus <NUM> in one or more embodiments includes user interface circuitry <NUM> operative to provide user inputs - i.e., signals or data indicative of user actuations of user-interface elements or controls - to the control circuitry <NUM>. Example user inputs include on/off control, activation/deactivation of stimulation-signal generation, treatment timing control, or the adjustment of operating parameters, such as adjustment inputs of one or more electrical parameters of the electrical stimulation signal <NUM> or the configuration of (electrode) subsets <NUM> or the configuration of the activation sequence or cycle used for activating the respective subsets <NUM>. The reference number "'<NUM>" denotes any and all such user-input signaling into the control circuitry <NUM>.

The I/O circuitry <NUM>, as included in at least one embodiment of the apparatus <NUM>, provides, for example, a mass storage interface for reading and writing patient information regarding electrostimulation treatment via the apparatus <NUM>. Additionally, or alternatively, the I/O circuitry <NUM> provides one or more discrete input or output lines, such as for interfacing with annunciators to indicate the start or completion of treatment via the apparatus <NUM>.

With the above example details and implementation variations in mind, an apparatus <NUM> according to one or more embodiments includes an electrode carrier <NUM> that is configured to place a set <NUM> of electrodes <NUM> into contact with the body of the patient at an injury site on the body of the patient. Further included in the apparatus <NUM>, a stimulation module <NUM> includes signal generation circuitry <NUM> that is configured to generate an electrical stimulation signal <NUM> as a Direct, Current (DC) pulse train at a frequency of between <NUM> and <NUM>. The particular signal frequency may be fixed or adjustable.

Control circuitry <NUM> included in the stimulation module <NUM> is configured to sequentially activate individual subsets <NUM> of electrodes <NUM> in the set <NUM> of electrodes <NUM>. Each subset <NUM> includes one or more electrodes <NUM> activated as a signal source for the electrical stimulation signal <NUM> and one or more electrodes <NUM> activated as a signal sink for the electrical stimulation signal <NUM>.

<FIG> illustrates an example embodiment of the electrode carrier <NUM>, where the electrode carrier <NUM> comprises a flexible sheet or membrane <NUM> configured for conformable placement on the body of the patient, at the injury site. The flexible sheet or membrane <NUM> - hereafter "sheet <NUM>" - -has a top surface <NUM> facing away from the body of the patient and carries the set <NUM> of electrodes <NUM> on a patient-facing surface <NUM> of the flexible sheet <NUM>. In one or more embodiments, the sheet <NUM> may comprise two or more plies, with the electrodes <NUM> and the associated electrode wiring embedded therein for durability and protection. Of course, the patient-contacting portion of the electrodes <NUM> is exposed on the bottom ply - i.e., exposed on the patient- facing surface <NUM> of the sheet <NUM>. Another feature of the sheet <NUM> in one or more embodiments is oxygen permeability, meaning that the skin of the patient that is covered by the sheet <NUM> remains free to "breathe.

Because <FIG> provides a top-side perspective view of the electrode carrier <NUM>, the electrodes <NUM> are shown in hidden- view dotted lines, denoting the possibility that the electrodes <NUM> (and their associated wiring) may be embedded within the flexible sheet <NUM> as described above and exposed only on the patient-facing surface <NUM>, such as seen in <FIG>, where the individual electrodes <NUM> are hemispherical "buttons" or "nubs" that provide localized but, comfortable contact points on the skin of the patient.

In one or more embodiments, the flexible sheet <NUM> includes a central cutout or opening <NUM> for leaving exposed an injury at the injury site on the body of the patient. Correspondingly, the set <NUM> of electrodes <NUM> are arrayed at spaced- apart locations along the edge or perimeter <NUM> defining the cutout or opening <NUM>.

<FIG> illustrates another feature included in one or more embodiments of the electrode carrier <NUM>; namely, the electrode carrier <NUM> may include printed or flexible, embedded conductors <NUM> for electrically connecting to each electrode <NUM>, and may include an electrical connector <NUM>, for quick and convenient connection to cabling going to the stimulation module <NUM>. That is, in embodiments where the connection <NUM> between the electrode carrier <NUM> and the stimulation module <NUM> is a wired connection, a cable having a complementary connector may be used to electrically connect the electrode carrier <NUM> to the stimulation module <NUM>.

<FIG> illustrates same embodiment of the electrode carrier <NUM>, depicted in situ in a surrounding arrangement with respect to an injury on the body of the patient. Particularly, the example injury is an open wound. Correspondingly, <FIG> illustrate the same embodiment of the electrode carrier <NUM> before and after placement in the wound-surrounding arrangement. As seen in the side-view depictions provided in <FIG>, the electrodes <NUM> slightly depress the skin of the patient at the point of contact, without breaking the skin and without exerting undue pressure. In some embodiments, an example pressure that can be applied by the electrodes <NUM> is between <NUM> to <NUM> pounds or <NUM> lbs. /in<NUM> to <NUM> lbs. /in<NUM> pounds per square inch (PSI). In other embodiments, an example pressure that can be applied by the electrodes <NUM> corresponds to the surface tension applied by an adhesive material, such as described herein, or about <NUM> lbs. Also shown in <FIG> is an example cable <NUM>, for wired coupling back to the stimulation module <NUM> as the "connection <NUM>" introduced in <FIG>.

"Conformability" is one among the several advantages of using a flexible sheet <NUM> as the basis of the electrode carrier <NUM>. <FIG> highlights the conformability advantage, showing the electrode carrier <NUM> applied to the lower torso of a patient, near the buttocks region, for treatment of a pressure sore or other injury'.

Various embodiments of the electrode carrier <NUM> use some form of adhesive - either preapplied on the patient-facing surface <NUM> of the sheet <NUM> or applied to the skin of the patient before applying the sheet <NUM>. Other embodiments of the electrode carrier <NUM> use fasteners, straps, or elastic material, for fixing the electrode carrier <NUM> to the body of the patient.

The phrase "flexible sheet or membrane <NUM>" denotes not only the possible implementation of the electrode carrier <NUM> as latex or other rubber or polymer sheet, with molded- in or embedded electrodes <NUM> and associated wiring/connectors, but also the possible implementation of the electrode carrier <NUM> as a woven fabric sheet or web. Of course, the electrode carrier <NUM> also may comprise a mix of fabric and rubber or polymer elements. At least the portion of the electrode carrier <NUM> that contacts the skin of the patient may be porous or non- porous.

Further, although <FIG> offer the example of a rectangular shape for the flexible sheet <NUM> and the cutout <NUM>, that example is non-limiting. The sheet <NUM> may be ellipsoid, circular, arcuate, or irregularly shaped, for matching the electrode carrier <NUM> to various shapes or sizes of injuries, and to various bodily locations of injuries. In a contemplated arrangement, multiple shapes/types of electrode carriers <NUM> are provided, all being compatible with the stimulation module <NUM>. With this approach, treating an injury includes an initial step of selecting the shape, size, or type of electrode carrier <NUM> that is best suited to the nature and location of the injury, or to the nature of the treatment desired. For example, electrostimulation for relief of tendonitis pain favors a particular type or style of electrode carrier <NUM>, as opposed to what would he used for electrostimulation of an open wound for pain relief and tissue regeneration.

Treatment benefits may be particularly pronounced with respect to invasive injuries that involve openings or cuts in the skin of the patient, such as burns, ulcers, surgical excisions, or incisions, etc. Such benefits include but are not limited to pain relief, faster healing, and reduced scarring. However, use of the apparatus <NUM> is not limited to treatment of invasive injuries. For example, in one or more embodiments, the apparatus <NUM> is configured for the treatment of closed injuries, such as muscle tears or inflammatory conditions. Thus, the word "injury" has broad meaning herein. Correspondingly, not all embodiments of the electrode carrier <NUM> include a cutout <NUM>, and one or more embodiments carry the set of electrodes <NUM> as a rectangular grid or other arrayed pattern that provides a uniformly or non-uniformly spaced set of electrode contact points across a corresponding region of skin on the body of the patient.

in the example of <FIG>, the set <NUM> of electrodes <NUM> includes electrodes <NUM> labeled as electrodes A-L, with these electrodes <NUM> arrayed at spaced apart positions in a surrounding arrangement with respect to a central cutout <NUM> in a sheet <NUM> serving as the base element of the electrode carrier <NUM>. Particularly, the cutout <NUM> leaves the involved injury exposed, which may help with comfort and healing for certain types of injuries, while the electrodes <NUM> form an array along the perimeter or edge <NUM> of the cutout <NUM>. With proper sizing or selection of the electrode carrier <NUM> with respect to the injury size or shape, such an arrangement, positions the set <NUM> of electrodes <NUM> such that one or more subsets <NUM>, of electrodes <NUM> are bridging with respect to the injury.

Any number of subsets <NUM> may be formed, with <FIG> showing specific subsets <NUM>-<NUM>, <NUM>-<NUM>, through <NUM>-<NUM>. By way of example, the subset <NUM>-<NUM> comprises { K | L} (or {L | K }, the subset <NUM>-<NUM> comprises { I | J } (or {J | I}, and so on. A "treatment" of the patient with respect to the example electrode subsets depicted in <FIG> comprises, for example, sequentially activating two or more subsets <NUM> according to a defined activation sequence, over one or more activation cycles. While the activation sequence may exercise all possible permutations of source/sink electrodes available via the set <NUM> of electrodes <NUM> provided by the electrode carrier <NUM>, fewer subsets <NUM> may be used/defined by the activation sequence and different treatment regimens may use different subsets <NUM> and different activation timings or overall treatment time.

<FIG> illustrates another embodiment of the electrode carrier <NUM>, where the sheet <NUM> is divided into two pieces or parts, which may or may not be interconnected together. In the illustrated example, the sheet <NUM> comprises two strips <NUM> A and 76B, each carrying a number of electrodes <NUM> (e.g., one, two, three, four, five, six, seven, eight, nine, or ten). The strip 76A may be placed on one "side" of an injury, with the strip 76B placed on the opposing/other side of the injury, with the respective strips 76A and 76B coupled to the stimulation module <NUM> via cables 74A and 74B, which may nonetheless be consolidated into a single cable with a "Y" arrangement at the strips 76A and 76B. Although shown with three example electrodes <NUM> in <FIG>, one sheet <NUM> can include, e.g., one electrode <NUM> to act as a sink, while another sheet <NUM> can include, e.g., three or five electrodes <NUM> to act as a source.

Notably, the strips <NUM> A and 76B may he of any length and may be linear, arcuate, or irregularly shaped, for maximum flexibility with respect to matching the size of an injury. In some embodiments, the strips 76A and 76B may be cut to length and in other embodiments they are provided in predetermined lengths. Moreover, in at least one embodiment, the stimulation module <NUM> is configured to operate with up to N (N> <NUM>) individual electrode strips <NUM> collectively operating as the electrode carrier <NUM>, meaning that a multiplicity of electrode strips <NUM> may be placed at an injury site on the body of the patient in a generally surrounding arrangement with respect to the injury.

In some embodiments, or according to some treatment protocols, the electrodes <NUM> contact the skin just off from the injury itself- - periwound skin bordering an open wound, for example, in other embodiments or treatment protocols, one or more of the electrodes <NUM> contact the surface of the wound, which can be helpful particularly with deep, ulcerative wounds. In at least one embodiment, one or more of the electrodes <NUM> is configured as a "flying" electrode, e.g., it extends from the electrode carrier <NUM> via a lead extension, allowing it to be placed strategically on or within the wound, while other ones of the electrodes <NUM> contact the skin on one or more "sides" of the wound.

<FIG> illustrates an example use of a strip-based embodiment of the electrode carrier <NUM>, wherein two strips 76A and 76B are attached to the skin of a (human) patient along either side of a surgical incision at the knee of the patient. The strips 76A and 76B may be applied/fixed to the skin using adhesive, for example, or may be held in place via an elastic wrap or the like.

References here to an injury having "sides"' does not imply any particular injury geometry. Further, another advantage of the strip-based embodiments of the electrode carrier <NUM> is that the strips <NUM> A and 76B may be placed in a bridging arrangement with respect to the involved injury. <FIG> illustrates an example bridging embodiment, wherein the overall sheet <NUM> is divided into first and second strips 76A and 76B, where the strips 76A and 76B are placed in a bridging arrangement across the long axis of an elongate injury, here another closed surgical incision. In at least one such embodiment, the strips 76A and 76B are adhesive on the patient-facing surface <NUM> and are configured tor use as wound-closure strips, with the added advantage of providing electrostimulation therapy for the bridged wound.

Broadly, an injury being "bridged" by respective electrodes <NUM> in the set <NUM> of electrodes <NUM> means that at least a portion of the injury intervenes or lies between the skin contact point of one electrode <NUM> relative to the skin contact point(s) of one or more other ones of the electrodes <NUM>. Activating a given first electrode <NUM> as a signal source and, concurrently, activating a given second electrode <NUM> that is bridging with respect to the given first electrode <NUM> causes the electrical stimulation signal <NUM> to pass across or through the bridged portion of the injury. Of course, there may be multiple circuit paths between source and sink electrodes <NUM>, in dependence on skin conductivity and subcutaneous impedances. As a general proposition, however, activating electrodes <NUM> that are bridging with respect to the injury results in the passage of the electrical stimulation signal <NUM> through the injured tissue.

<FIG> illustrates another example use of a wearable strip-based embodiment of the electrode carrier <NUM>, wherein two strips 76A and 76B can be self-adhered to the skin of a patient. This example allows the patient to self-treat a situs of pain or injury, e.g., in conjunction with an app operated by the patient' s portable computing or mobile device, and even worn discretely by the patient depending on the situs while receiving treatment. The strip 76B can be referred to as a single nub strip because it has a single electrode <NUM>, and the strip 76A can be referred to as a five-nub strip because it has five electrodes <NUM> arranged in line along the strip 76A. In the upper part of <FIG>, the back sides of the strips 76A, 76B are shown, which would face away from the patient's skin. In the lower part of <FIG>, the front sides of the strips 76A, 76B are shown, which would be adhered to the patient's skin so that the nubs or electrodes <NUM> would be in contact therewith. An exploded view of the single nub strip 76B is shown in <FIG>, starting with an adhesive layer <NUM>, such as a <NUM> <NUM> MP transfer adhesive tape, against a flexible backing substrate <NUM>. A stainless steel nub (e.g., made from <NUM> stainless steel) forms the electrode <NUM>, which is electrically coupled to a flexible printed circuit <NUM> arranged on a clear film <NUM>, such as Autoflex EB <NUM> polyester clear film. The flexible printed circuit <NUM> terminates at a connector <NUM>. The clear- film <NUM> is adhered to an adhesive tape with release liner <NUM>, such as the Avery Dennison MED <NUM> acrylic adhesive tape with release liner. A QR code can be printed on a pad <NUM>, which can be linked to an app that can be used to control the electrode carrier <NUM>.

<FIG> shows an exploded view of the five-nub strip 76A shown in <FIG>. Similar to the one nub strip 76B, the five-nub strip 76A has an adhesive layer <NUM>, such as a <NUM> <NUM> MP transfer adhesive tape, against a flexible backing substrate <NUM>. Five stainless steel nubs (e.g., made from <NUM> stainless steel) form the electrodes <NUM>, each of which is electrically coupled to a flexible printed circuit <NUM> arranged on a clear film, such as Autoflex EB <NUM> polyester clear film. The flexible printed circuit <NUM> terminates at a connector <NUM> and is adhered to an adhesive tape with release liner <NUM>, such as the Avery Dennison MED <NUM> acrylic adhesive tape with release liner, which is adhered to a front substrate <NUM>, which contacts the skin. A QR code can be printed on a pad <NUM>, which can be linked to an app that can be used to control the electrode carrier <NUM>.

<FIG> illustrates an example cable set for use with the strips 76A, 76B, The connector <NUM> of the strip 76A is inserted into a dongle <NUM> having a corresponding female connector to receive the male connector <NUM>, such as a <NUM>-way Molex connector <NUM>. Correspondingly, the connector <NUM> of the strip 76B is inserted into a dongle <NUM> having a corresponding female connector to receive the male connector <NUM> of the strip 76B. Either or both dongles <NUM>, <NUM> can include a switch controller <NUM> configured to controlled by the app, such as via a Bluetooth or similar wireless connection, to set the intensity, duration, and/or frequency of the treatment plan from the app to the electrodes <NUM>. For example, the app can receive an input indicative of a type of treatment plan, e.g., tennis elbow, and automatically program the switch controller <NUM> to control the electrical parameters of the energy delivered to the electrodes <NUM>, as well as the energization pattern and timing to be delivered to the five nub strip 76A (in this example, the unused energy would be returned via the single nub strip 76B back to the power source).

To use the strips 76A, 76B shown in <FIG>, the patient or a clinician would adhere the strips 76A, 76B proximate the situs of injury or pain, as described herein. Die treatment type would be inputted into the app to indicate the nature and location of the injury or pain on the patient. The app would communicate the inputted treatment type to a switch controller or other controller (e.g., the stimulation module <NUM>) to control the electrical parameters of the energy delivered to the strips 76A, 76B as well as the timing and energization pattern of the electrodes <NUM> on the strip 76A. The strips 76A, 76B remain adhered to the patient's skin while the energy is delivered, and no further interaction is needed by the patient during the treatment session, nor does the patient need to hold the strips <NUM>, 76B or necessarily need to adjust any electrical parameters during the administration of the treatment through the electrodes <NUM>. Any energization strategy disclosed herein can be used in connection with the strips 76A, 76B shown in <FIG>. Advantageously, the strips 76A, 76B, cables, and control unit can be shipped as a kit to the patient directly, which can download an app (e.g., by scanning the QR code <NUM>) to begin self- treatment via the app. Alternately, a physician or clinician can utilize remote telemedicine technology to adjust the electrical parameters delivered to the strips 76A, 76B by communicating a treatment plan to the stimulation module <NUM> that controls the strips 76A, 76B, e.g., to the patient's mobile or portable computing device.

<FIG> illustrates another example of the electrode carrier <NUM>, where unique pairings <NUM> of electrodes <NUM> in the set <NUM> of electrodes <NUM> are used for electrical stimulation of an injury. The "pairings <NUM>" are merely a specific case or example of the earlier-mentioned subsets <NUM>. That is, a subset <NUM> may contain two electrodes <NUM> or more than two electrodes <NUM>, whereas <FIG> illustrates the specific case of electrode pairings <NUM>-<NUM> through <NUM>-<NUM>. At any given time, a first one of the electrodes <NUM> in a given pairing <NUM> is active as the signal source for the electrical stimulation signal <NUM> and a second one of the electrodes <NUM> in the pairing <NUM> is active as the signal sink for the electrical stimulation signal <NUM>.

In at least some embodiments, the pairings <NUM> are bridging pairs of electrodes <NUM>, at least nominally. That is, the stimulation module <NUM> may predefine which electrodes <NUM> of the electrode carrier <NUM> are operated as pairs <NUM>, based on the underlying assumption that those electrodes <NUM> are "bridging" with respect to the involved injury (assuming a certain type or shape of injury and proper orientation of the electrode carrier <NUM> with respect to the injury). In other embodiments, the patient or the person treating the patient can designate which electrodes <NUM> are operated as pairs <NUM> or otherwise operated as subsets <NUM>. Such designations may be input via the user interface <NUM> of the stimulation module <NUM>, in one or more embodiments.

<FIG> illustrates an example activation sequence <NUM> provided by the signal generation circuitry <NUM> or as otherwise controlled or selected by the control circuitry' <NUM>. The depicted activation sequence <NUM> refers to the unique electrode pairings <NUM> illustrated in <FIG>, but it should be understood that, in general, an activation sequence <NUM> specifies sequential activation of subsets <NUM> of electrodes <NUM>, where the subsets <NUM> may include more than two electrodes <NUM> and where the subsets <NUM> may or may not have an equal number of members. As will be explained, an activation sequence <NUM> may be predefined or may be user-defined, although the activation sequence <NUM> depicted in <FIG> exploits the advantageous injury-bridging arrangement of electrode pairings <NUM> seen in <FIG>.

Advantageously, in one or more embodiments, the activation sequence <NUM> "moves" the sources and sinks for the electrical stimulation signal <NUM> around the injury site, thereby creating spatially distributed signal paths through or across the injury over time. The activation sequence <NUM> may be predefined, e.g., selected from stored configuration data <NUM>, or may he user-defined, e.g., determined via user inputs, or may be randomized by the control circuitry <NUM>. A given activation sequence <NUM>, randomized or not, does not necessarily guarantee that every subset <NUM> included in the activation sequence <NUM> contains electrodes <NUM> that are in a bridging relationship with respect to the injury.

<FIG> illustrates an example activation cycle <NUM>, based on the example activation sequence <NUM> shown in <FIG>. Specifically, <FIG> illustrates an activation cycle <NUM>(n) that may be understood as one in series of one or more activation cycles <NUM>(n-<NUM>), <NUM>(n), <NUM>(n+<NUM>) and so on. In general, a "treatment program" comprises an overall time in which the apparatus <NUM> provides therapeutic treatment to a patient, such that a treatment program may be understood as constituting a "session" and with the understanding that a patient may receive one session per day, one session per week, or multiple sessions per day, etc., in dependence on the injury type and desired overall treatment protocol. An overall collection of sessions - e.g., how many treatment programs the patient undergoes and interval between treatment programs - may be regarded as a "treatment regimen" or "treatment protocol.

In at least one embodiment, the apparatus <NUM> may be programmed for a desired treatment regimen defining the number and length of sessions, how often the sessions occur, along with optional further details like the type/size of electrode carrier <NUM> to be used, or stimulation- signal intensity, frequency, activation sequence or activation cycle definitions, etc. As such, a doctor or other knowledgeable person may program the apparatus <NUM> for a particular treatment regimen and send the patient home with the desired treatment regimen programmed in. For example, a patient having undergone facial surgery or other surgery where minimization of scarring is an acute concern may be provided with the apparatus <NUM>, preprogrammed for a treatment regimen used expressly tailored for scarring reduction.

One area of programmability or adjustability involves the treatment program used by the apparatus <NUM>. A treatment program may comprise one activation cycle <NUM>, which steps through a defined activation sequence <NUM>, using a controlled dwell time and step time. The dwell time refers to how long a given subset <NUM> is active within the activation sequence <NUM>, and the step time refers to the delay between deactivating one subset <NUM> in the activation sequence <NUM> and activating the next subset <NUM> in the activation sequence <NUM>. The dwell and step times may or may not be uniform throughout the sequence. Non-limiting examples of dwell and step times are thirty seconds and one 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 sequences or within sequences. For example, the subset selections or subset order may be varied from activation cycle <NUM> to the next; that is, different activation sequences <NUM> may be used across multiple activation cycles <NUM>. One or more activation cycles <NUM> thus constitute a treatment program or session.

With the above sequence/cycle examples in mind, in one or more embodiments, the control circuitry <NUM> is configured to sequentially activate the individual subsets <NUM> according to a defined activation sequence <NUM> that activates the individual subsets <NUM> one at a time, over a defined activation cycle <NUM>. One or more other embodiments of the apparatus <NUM> provide for activating more than one subset <NUM> at a time.

In at least one embodiment, the defined activation sequence <NUM> is predefined and corresponds to a spatial arrangement of the set <NUM> of electrodes <NUM> on the body of the patient at the injury site that results from a specified placement of the electrode carrier <NUM> with respect to the injury site. That is, the spatial arrangement may or may not exist, in dependence on whether the electrode carrier <NUM> is positioned correctly on the body of the patient, or in dependence on whether the appropriate type, size, or model of electrode carrier <NUM> has been selected. However, as an example of a predefined activation sequence <NUM>, <FIG> illustrates subsets <NUM> - specifically, pairings <NUM> - that correspond to electrodes <NUM> on opposing sides of the cutout <NUM> in the flexible sheet <NUM> that serves as the electrode carrier <NUM> in <FIG>, with the assumption that the electrode carrier <NUM> will be placed on the body of the patient at the injury site, such that the injury lies within the skin area exposed by the cutout <NUM>.

In other embodiments, or when operating in another mode, the control circuitry <NUM> is configured to determine the defined activation sequence <NUM> according to signaling received by the control circuitry <NUM>. The signaling comprises, for example, any one of a signal <NUM> provided by or read from the electrode carrier <NUM>, an input signal <NUM> resulting from user control of a control input provided by the stimulation module <NUM> (e.g., via the user interface circuitry' <NUM>), or an input signal <NUM> received via the I/O circuitry <NUM>, or signaling <NUM> received via the communication circuitry <NUM>. For example, the control circuitry <NUM> receives a wireless communication signal via the communication circuitry <NUM>, from an external configuration device that is communicatively coupled to the stimulation module <NUM>.

The individual subsets <NUM> comprise, such as in the example of <FIG>, a plurality of electrode pairs <NUM>, with each electrode pair <NUM> being a unique pairing of two electrodes <NUM> from the set <NUM> of electrodes <NUM> provided by the electrode carrier <NUM>. One of the two electrodes <NUM> in each pairing <NUM> is operated as the signal source and the other one of the two electrodes <NUM> is operated as the signal sink. At least one among the plurality of electrode pairs <NUM>, is at least putatively an "opposing" electrode pair <NUM> in which the two electrodes <NUM> have an opposing relationship in which at least a portion of an injury at the injury site intervenes between respective contact points of the two electrodes <NUM> on the body of the patient. In other words, at least one of the electrode pairs <NUM> at least putatively is in a bridging relationship with respect to the injury to be treated. "At least putatively" refers to embodiments of the apparatus <NUM> where the subsets <NUM> / pairings <NUM> of electrodes <NUM> are fixed (predefined), such that whether they bridge the injury to be treated depends at least on proper placement of the electrode carrier <NUM> at the injury site.

<FIG> illustrates an example embodiment in which the configuration data <NUM> includes stored information, such as stored tables, that function as a carrier/injury type library <NUM> that maps different carrier/injury type entries <NUM> to different treatment programs <NUM> in a treatment program library <NUM>. For example, the different carrier/injury type entries <NUM> correspond to different sizes of the set <NUM> of electrodes <NUM>, or to different spatial arrangements of the electrodes <NUM> in the set <NUM>. Alternatively, the different carrier/injury type entries <NUM> correspond to different types of injuries, such as torn muscles versus inflammatory' conditions, or such as the size, shape, type, or depth of an invasive wound to be treated.

Correspondingly, then, the different treatment programs <NUM> in the treatment program library <NUM> distinguish from one another in any one or more of the following parameters: one or more parameters of the electrical stimulation signal <NUM>, different definitions of the subsets <NUM>, different definitions of the activation sequence <NUM>, different definitions of the activation cycle <NUM>, different numbers of activation-cycle repetitions to constitute the overall treatment program <NUM>, etc..

In at least one embodiment, a user provides a selection input via a user interface of the stimulation module <NUM> to indicate the carrier type or injury type <NUM>, with the control circuitry <NUM> correspondingly selecting the respective treatment program <NUM> that corresponds to the indicated carrier/injury type <NUM>. in another embodiment, the user selects a particular treatment program <NUM> directly. This embodiment is advantageous, for example, in cases where the treatment programs <NUM> are predefined and optimized for particular kinds of ailments, such as "tennis elbow," wherein the duration of treatment, and the most advantageous pattern and timing of "movements" of the source/sink electrodes <NUM> around or over the affected area may be preprogrammed into the apparatus <NUM>, based on empirical data,.

<FIG> illustrates an example selection arrangement, wherein the control circuitry <NUM> implements a selection-control function <NUM> that selects a particular treatment program <NUM> from the treatment program library <NUM> in response to one or more selection inputs. Such inputs may indicate (directly or indirectly) the injury type and/or the electrode-carrier type. Again, "injury" has broad meaning, such that "injury type" may be broadly understood as referring to the type of injury or ailment to be treated.

<FIG> shows that the same logic may additionally, or alternatively, be used for the selection of an overall treatment regimen <NUM>, e.g., for selecting between defined treatment regimens <NUM>-<NUM>, <NUM>-<NUM>, and so on. Here, a treatment regimen <NUM> represents an overall course of treatment and, as such, defines, for example, the particular treatment program(s) <NUM> to be used by the apparatus <NUM>, the length or timing of each treatment session, and the overall number or the frequency of treatment sessions. As an example, a given treatment regimen <NUM> is based on particular treatment program <NUM> being used, and it, specifies five-minute treatment sessions using that particular treatment program <NUM>, with three treatment sessions per day, over a total of five days. Again, in at least one embodiment, the apparatus <NUM> can be configured to use a particular treatment regimen <NUM>, such that the patient need do no more than "connect" the electrode carrier <NUM> to the stimulation module <NUM> and put it on (or leave it on, in a "wearable" implementation of the electrode carrier <NUM>),.

<FIG> illustrates another functional circuit realized in the processing circuitry <NUM>, namely, a treatment program tuning/creation function <NUM>. With this function, the processing circuitry <NUM> is operative to create a treatment program <NUM>, e.g., responsive to user input or responsive to received control signaling, or to modify ("tune") an existing treatment program <NUM>. Creation/tuning parameters include any one or more of the following items: (a) cycle time of the activation cycle <NUM> or overall treatment time, e.g., how many cycle repetitions to use, (b) sequence selection, (c) dwell/step control, (d) stimulation signal intensity or intensity profile, e.g., over the course of one activation cycle <NUM>, or over the course of the overall treatment session, (e) stimulation signal frequency or frequency profile, and (f) stimulation signal duty cycle, i.e., the duty cycle of the DC pulse train. Here, "intensity" refers to one or both of the stimulation signal current or voltage.

In at least one embodiment, the function <NUM> or other operational function of the control circuitry <NUM> provides a method by which a pair of electrodes <NUM> within the overall set <NUM> of electrodes <NUM> is chosen to be the source and sink electrodes for a specific amount of time before a new pair, which may include a previously used electrode <NUM>, is chosen in similar fashion to he the source and sink electrodes <NUM> for an additional specific amount of time. This continues in sequence and this process is repealed as pre-determined by the treatment protocol defined by the programming or configuration of the stimulation module <NUM>.

Further, in at least one such embodiment, the treatment provided by the apparatus <NUM> is tailored to the amount of time the user indicates is available for treating the patient - i.e., available for the currently contemplated treatment session. The user need only indicate the amount of time available for treatment and the control circuitry <NUM> optimizes the selection and pattern of activated source and sink electrodes <NUM> for the indicated amount of time made available. The control module <NUM> may impose boundaries, such as by enforcing a minimum treatment time required to initiate treatment activity at all.

For instance, referring back to the electrode carrier <NUM> illustrated in <FIG>, the minimum treatment time may be six minutes, in an example embodiment. In the minimum (<NUM> minutes) time setting, the control circuitry <NUM> activates electrodes L (Source) and D (sink) for one minute, then deactivates the L | D pairing and immediately activates electrodes K (source) and E (sink) for one minute; then deactivates the K | E pairing and immediately activates electrodes | (source) and K (sink) for one minute; then deactivates the I i K pairing and immediately activates electrodes A (source) and I (sink) for one minute; then deactivates the A | | pairing and immediately activates electrodes B (source) and H (sink) for one minute; then deactivates the B | H pairing, and, finally, activates electrodes C (source) and G (sink) for one minute.

Continuing the example, if the control circuitry <NUM> receives a user-input indication that <NUM> minutes is available for the treatment session, the control circuitry <NUM> uses a different pattern of activating the electrodes <NUM>. For example, the control circuitry <NUM> directly (or indirectly through the signal generation circuitry <NUM>) activates electrodes L (source) and D (sink) for two minutes, then deactivates the L, I D pairing and immediately activates electrodes K (source) and E (sink) for two minutes; then deactivates the K | E pairing and immediately activates electrodes | (source) and K (sink) for two minutes; then deactivates the I i K pairing and immediately activates electrodes A (source) and | (sink) for two minutes; then deactivates the A ! I pairing and immediately activates electrodes B (source) and H (sink) for two minutes; then deactivates the B I H pairing and immediately activates electrodes C (source) and G (sink) for two minutes; then deactivates the C i G pairing and immediately activates electrodes | (source) and F (sink) for one minute; then deactivates the I ! F pairing and immediately activates electrodes J (source) and D (sink) for one minute; then deactivates the <NUM><NUM> D pairing and immediately activates electrodes A (source) and G (sink) for one minute; then deactivates the A ! G pairing and, finally, activates electrodes C (source) and | (sink) for one minute.

As time available for treatment expands, the control circuitry <NUM> or signal generation circuitry <NUM> is/are configured to use longer periods of activation for each electrode pairing and to use a greater number of different pairings, to push current through the injury area in as many different ways as possible. Thus, referring again to <FIG>, as available time increases above <NUM> available minutes, activations may also include using activating electrodes L (source) and D (sink) for three minutes, but then leaving electrode L as the source and deactivating D (sink) and replacing it with E (sink) for an additional three minutes; and then leaving L as the source and deactivating E (sink) and replacing it with F (sink) for an additional three minutes. Other electrode groupings can likewise be alternated to create a "strobe" effect.

<FIG> illustrates another embodiment of the apparatus <NUM>, wherein the apparatus <NUM> is at least partially housed in a housing <NUM>, which includes a user interface <NUM>, such as one or more physical control knobs or switches <NUM>. Additionally, or alternatively, the user interface <NUM> provides one or more "soft" controls <NUM> displayed on a touch screen <NUM>. The touch screen <NUM> in one or more embodiments is a video-capable screen that provides an injury /carrier visualization <NUM> onscreen. In at least one such embodiment, the apparatus <NUM> includes or provides an interface for a camera <NUM> for imaging the injury site on the body of the patient and for determining the placement or orientation of the electrode carrier <NUM> at the injury site.

Further, in at least one such embodiment, the injury/carrier visualization <NUM> includes onscreen depictions of the electrodes <NUM> - e.g., video depictions of the electrodes or superimposed indications of their locations - and the control circuitry <NUM> is configured to define the subsets <NUM> of electrodes <NUM> based on receiving touch inputs from the user via the touchscreen <NUM>. That is, the signal(s) provided to the control circuitry <NUM> via the user interface circuitry <NUM> may include touchscreen data, allowing the processing circuitry <NUM> to determine which electrodes <NUM> the user wishes to designate as belonging to a subset <NUM>, based on the user directing touch inputs to the onscreen representations of the electrodes <NUM>. Additionally, or alternatively, in one or more embodiments of the apparatus <NUM>, the processing circuitry <NUM> is configured to receive touch inputs indicating which electrode(s) <NUM> in a subset <NUM> are source electrodes or sink electrodes.

The camera <NUM> may be dedicated to - specially adapted for - use with the apparatus <NUM> and in one or more embodiments is coupled to the apparatus <NUM> with a cable <NUM>. In other embodiments, the camera <NUM> wirelessly couples to the apparatus <NUM> via the communication circuitry <NUM> included in the stimulation module <NUM>. Similarly, although <FIG> suggests physical cabling between the electrode carrier <NUM> and the housing <NUM>, the connection <NUM> may be wireless in one or more embodiments.

<FIG> illustrates yet another embodiment wherein all or a least a portion of the user interface <NUM> is realized on the screen <NUM> of an external device or system <NUM>, such as a smartphone, tablet, laptop, or other computing device having a touch interface or other user-input capability. To the extent that the device <NUM> includes one or more cameras <NUM>, the aforementioned body /injury visualization may be implemented within the device <NUM>. Overall operation of the device <NUM> for supporting and interacting with the apparatus <NUM> is provided, for example, via the execution of a software app <NUM> that is installed from an app store or side loaded into the device <NUM>.

The communication circuitry <NUM> of the apparatus <NUM> provides a BLUETOOTH connection or other wireless link, for communicatively coupling to the device <NUM> via a wireless link <NUM>, for establishing the connection <NUM> between the electrode carrier <NUM> and the stimulation module <NUM>. Public Key Infrastructure (PKI) certificates, shared secrets, random nonces, or other security measures may be used between the apparatus <NUM> and the device <NUM>, e.g., via the app <NUM>, to ensure that connectivity and control is provided only to authorized devices <NUM>.

<FIG> illustrates yet another embodiment of the apparatus <NUM>, wherein the electrode carrier <NUM> further comprises a sealable/sealed covering <NUM>, covering the central cutout <NUM> of the flexible sheet <NUM>. The covering <NUM> is ported for application of negative pressure to the injury, e.g., via a port <NUM> that couples via pneumatic tubing <NUM> to the apparatus <NUM>, or to an associated vacuum apparatus. In at least one embodiment, the apparatus <NUM> incorporates the vacuum apparatus, shown in <FIG> as a negative pressure pump assembly <NUM>.

Significant therapeutic synergies arise with the concurrent or coordinated application of negative pressure therapy and electrostimulation therapy. In one embodiment, the apparatus <NUM> coordinates the application of negative pressure, including the duration or extent of negative pressure developed within a "chamber" formed over the injury via the sealed cover <NUM>. Note that the sealed cover <NUM> may be a separate membrane or sheet that adhesively couples to the underlying flexible sheet <NUM> comprising the electrode carrier <NUM>. Such an arrangement offers flexibility in the sense that the sheet <NUM> can be sealed to the skin at the injury site, with the negative-pressure arrangement then "built" or otherwise applied onto the sheet <NUM>.

In at least one embodiment of the apparatus <NUM> that includes negative pressure treatment, the treatment program(s) <NUM> implemented by the control circuitry <NUM> include negative pressure treatment protocols, e.g., defining any one or more of the duration of negative pressure application, the peak or average level of negative pressure applied, and the profile or variation in negative-pressure level used during the treatment session. Of course, in embodiments where the apparatus <NUM> has negative-pressure treatment capabilities, electrostimulation may be used with or without the concurrent use of negative-pressure treatment.

<FIG> offers another, more detailed view of the arrangement shown in Figure <NUM> and <FIG> illustrates the same arrangement as applied to an injury on the body of the patient. Additional details shown in <FIG> include the adhesive <NUM> that may be preapplied - e.g., a peel-off sticky cover - on the patient-facing surface <NUM> of the sheet <NUM>, or that may be applied before the sheet <NUM> is placed onto the skin at the injury site. Further details include the use of a sterile sponge <NUM> or other packing material to establish support for the flexible covering <NUM> to form a negative-pressure chamber <NUM> at the injury site.

<FIG> illustrates an embodiment where the electrode carrier <NUM> is formed as a flexible sleeve <NUM> that is configured to encircle at least a portion of an affected limb of the patient. The sleeve at least optionally includes a cutout <NUM> to avoid covering the injury being treated. The sleeve may include a lengthwise split or seam <NUM>, easing its installation on or removal from the affected limb. The sleeve <NUM> may be a fabric or plastic mesh or weave and may be elastic or use straps or hook-and-loop fasteners, for pressing the set <NUM> of electrodes <NUM> into a contacting arrangement with the skin of the patient at the injury site.

<FIG> illustrates another variation of the flexible sleeve <NUM>, where the sleeve <NUM> omits the cutout <NUM> and where the set <NUM> of electrodes <NUM> are arrayed throughout the sleeve <NUM>. Such an arrangement allows for creating/activating electrode subsets <NUM> all around the inner surface of the sleeve <NUM>, and, therefore, allows one sleeve <NUM> to be used for treating different kinds and locations of injuries on the affected limb.

<FIG> illustrates a similar embodiment of the sleeve <NUM>, but where the sleeve <NUM> is formed or contoured for use at a limb joint, with a (human) elbow sleeve shown as an example case. <FIG> illustrates another example case, where the sleeve <NUM> is configured for use on the ankle of a human leg, where this particular example uses a cutout <NUM>. Other sleeve configurations are contemplated. For example, sleeves <NUM> may be configured for non-human limbs and joints, such as in the veterinarian context for treating leg injuries of dogs or cats. In a particularly compelling example of veterinarian use, the sleeve <NUM> in one or more embodiments is configured for use on the legs of horses, such as for treating hygroma, joint effusion, or other ailments commonly associated with racehorses.

<FIG> illustrates another embodiment of the electrode carrier <NUM>, wherein the sleeve <NUM> is shown as an encircling wrap that includes, for example, hook and loop fasteners 173A and 173B, to allow cinching the sleeve <NUM> in wrap-like fashion around the affected limb or, in at least some configurations, around the torso of the patient. Of course, snaps, buckles, or other accoutrements besides the hook and loop fasteners 173A/B may be used to secure the sleeve <NUM> in place.

Broadly, the sleeve <NUM> may be formed as one integral piece or may be made up of different pieces, potentially of different materials. For example, it may include a latex or polymer portion for contacting around the injury' site and may include a fabric portion for cinching around the limb or torso.

In addition to using the hook and loop fasteners <NUM> A/B (or alternative fasteners) for cinching the sleeve <NUM> in place, the sleeve <NUM> may include an internal sleeve or compartment for an inflatable bladder <NUM>, similar to that used in blood-pressure cuffs. With the sleeve <NUM> cinched in place, inflating the bladder <NUM> causes the cinched sleeve <NUM> to tighten further against the body of the patient and thereby urge the electrodes <NUM> into better contact with (and correspondingly with greater pressure applied to) the skin of the patient. Of course, the bladder <NUM> may have an overpressure valve or other mechanism to prevent overinflation and thereby guard against blood circulation problems or discomfort that might otherwise arise.

<FIG> illustrates a further variation of the electrode carrier <NUM>, where the sleeve <NUM> includes straps 176A/B, which may have buckles or hook and loop fasteners, for strapping the sleeve <NUM> as a sleeve or encircling wrap around a limb or the torso of the patient.

Thus, in one or more embodiments, the electrode carrier <NUM> comprises some form of a compressive sleeve that exerts a biasing force urging the set <NUM> of electrodes <NUM> into contact with the body of the patient at the injury' site. The arrangements in <FIG>, <FIG> are examples formed or formable sleeves, offering biasing force obtained via at least one of: elastic material incorporated into the compressive sleeve, an inflatable bladder incorporated into the sleeve, or one or more cinching straps or fasteners incorporated into the sleeve.

<FIG> illustrate example connectivity options in cases where the connection <NUM> between the electrode carrier <NUM> and the stimulus module <NUM> is a physical (wired) connection. Beginning with <FIG>, the connection <NUM> in one or more embodiments includes a conductor <NUM> for each electrode <NUM> carried in the electrode carrier <NUM>. While this arrangement offers simplicity and direct control regarding activating individual electrodes <NUM> as signal sources or sinks, such advantages come at the expense of potentially bulkier connection cables and more wiring.

<FIG> illustrates another embodiment, where a multiplexer circuit <NUM> on the electrode carrier <NUM> reduces the wire count of the connection <NUM>. For example, depending on the implementation of the multiplexer circuit <NUM>, the connection <NUM> may include a signal source wire (+) and a signal sink wire (-) or "ground" connection, along with a clock/control signal ("CLK/CNTL"). A DC bias on the CLK/CNTL signal may be used to provide operating power for the multiplexer circuit <NUM>, thus removing the need for the electrode carrier <NUM> to have its own power source for operating the multiplexer circuit <NUM>.

<FIG> illustrates substantially the same arrangement as depicted in <FIG>, except that the electrode carrier <NUM> further includes a "load" circuit <NUM>. The load circuit <NUM> may be as simple as a pull-down resistor that connects in voltage-divider fashion to a pull-up resistor in the stimulation module <NUM>. Different values of pull-down resistors may be installed in different types or models of electrode carriers <NUM>, thereby providing the control circuitry <NUM> with a simple mechanism for "reading" the type or model of electrode carrier <NUM> that is attached to it. Such information is used, for example, in selecting/defining the activation sequence <NUM> or activation cycle <NUM>, or in selecting/defining the overall treatment program <NUM> / treatment regimen <NUM>, or in determining which treatment programs <NUM> or regimens <NUM> to offer for selection by the user.

In other variations, the load circuit <NUM> comprises a complex impedance, e.g., a notch or bandpass filter or resonant circuit. Correspondingly, the signal generation circuitry <NUM> of the stimulation module <NUM> is configured to generate an excitation signal at different frequencies corresponding to different types or models of the electrode carrier <NUM> and detect the response of the load circuit <NUM> at the different frequencies, for identifying the carrier type or model.

<FIG> illustrates yet another arrangement involving a more complex circuit implementation on the electrode carrier <NUM>. Here, the connection <NUM> may be wired or wireless and the electrode carrier <NUM> has its own power supply /battery <NUM>, for powering communication circuitry <NUM> that interfaces in wired or wireless fashion to the stimulation module <NUM>. The electrode carrier <NUM> further includes control circuitry' <NUM> that is responsive to signaling from the stimulation module <NUM>, as received via the communication circuitry' <NUM>, such as start/stop control, etc..

Still further, the illustrated embodiment of the electrode carrier <NUM> includes signal generation circuitry <NUM>. Thus, in at least one embodiment, generation of the electrical stimulation signal <NUM> occurs on the electrode carrier <NUM>. In that regard, the signal generation circuitry <NUM> may be regarded as a version of the earlier-depicted signal generation circuitry <NUM> but moved from the stimulation module <NUM> over to the electrode carrier <NUM>. Viewed another way, the circuitry depicted in <FIG> for the stimulation module <NUM> may be at least partially distributed between the electrode carrier <NUM> and a separate housing <NUM> that includes a user interface <NUM>, etc..

<FIG> builds on the idea of local generation of the electrical stimulation signal <NUM> onboard the electrode carrier <NUM> by attaching the entirety of the stimulation module <NUM> on the electrode carrier <NUM>. Here, the power supply/battery <NUM> of the stimulation module <NUM> comprises, for example, a lithium ion battery and associated charging and voltage-regulation circuitry, for battery-powered operation of the stimulation module <NUM>. Further, the communication circuitry' <NUM> may provide wireless connectivity to an external device <NUM>, for implementation of a user interface <NUM> on the external device <NUM>, for control of the apparatus <NUM>.

Whether the stimulation module <NUM> is on or separate from the electrode carrier <NUM>, the electrode carrier <NUM> in one or more embodiments comprises a flexible sheet <NUM> or sleeve <NUM>. In at least one such embodiment, at least a portion of the patient-facing surface <NUM> of the sheet <NUM> or sleeve <NUM> is an adhesive membrane for temporary adhesion to the skin of the patient at the injury site. The adhesion provides, for example, for retaining the electrode carrier <NUM> on the body of the patient at the injury site, at least during the treatment, or for longer periods, such as several days during which the apparatus <NUM> provides multiple treatments, e.g., every four hours, automatically. In at least one embodiment, a sleeve <NUM> may be understood as including a sheet <NUM> serving as the base electrode carrier <NUM>. That is, the sleeve <NUM> need not integrate the electrodes <NUM> directly, and instead can be understood as providing for the integration of a sheet <NUM> within its patient-facing interior surface, in a two-part assembly.

In any case, the use of an adhesive flexible membrane for carrying the electrodes <NUM> also provides for sealing engagement against the body of the patient, in turn, that sealing engagement provides for, for example, use of negative-pressure therapy in conjunction with electrostimulation, such as shown in <FIG>.

In further example details, such as shown in <FIG>, each electrode <NUM> in the set <NUM> of electrodes <NUM> may be considered as being a blunt contact-point electrode, such that bringing the set <NUM> of electrodes <NUM> into contact with the body of the patient defines a corresponding set of blunt contact points for point sourcing or sinking of the electrical stimulation signal <NUM>. Among their various advantages as compared to distributed-area or "patch" electrodes, blunt contact-point electrodes can reduce impedance at the point of contact between the electrode <NUM> and the skin of the patient, which reduces signal losses with respect to 'Injection" of the electrical stimulation signal <NUM> into the body of the patient at the injury site. Plus, the use of discrete contact points allows for the patterning or moving of the electrical stimulation signal around and through the injury site.

Other operational advantages of the apparatus <NUM> include, in one or more embodiments, the signal generation circuitry <NUM> being configured to control the frequency of the electrical stimulation signal <NUM> responsive to control by the control circuitry <NUM>. As an example, the control at issue is one of: selection of a particular frequency from among a set of predefined frequencies, continuous adjustment of the frequency, or stepped adjustment of the frequency. Additionally, or alternatively, the signal generation circuitry <NUM> may be configured to control an intensity of the electrical stimulation signal <NUM> responsive to control by the control circuitry <NUM>. Here, the control is at least one of: adjustment of the voltage of the electrical stimulation signal <NUM>, or adjustment of the current of the electrical stimulation signal <NUM>.

<FIG> illustrates one embodiment of a method <NUM> for therapeutic electrical stimulation of a patient and may be performed by the apparatus <NUM> introduced in <FIG> or by another appropriately configured apparatus. The depicted operations may be performed in an order other than the order suggested by the logic flow and may be performed repeatedly or in conjunction with other operations.

The method <NUM> includes providing (Block <NUM>) an electrical stimulation signal <NUM> as a Direct Current (DC) pulse train at a frequency of between <NUM> and <NUM>, and sequentially activating (Block <NUM>) respective subsets <NUM> of electrodes <NUM> among a set <NUM> of electrodes <NUM> contacting the body of the patient at an injury site on the body of the patient, via the electrical stimulation signal <NUM>.

Sequentially activating the respective subsets <NUM> of electrodes <NUM> comprises, for example, activating the individual subsets <NUM> according to a defined activation sequence <NUM> that activates the individual subsets <NUM> one at a time, over a defined activation cycle <NUM>. Thus, in one or more embodiments, the method <NUM> also includes determining (Block <NUM>) the activation sequence <NUM> and/or activation cycle <NUM> to use for applying the electrical stimulation signal <NUM>.

In at least one embodiment, the method <NUM> further includes varying the defined activation sequence <NUM> or the defined activation cycle <NUM> responsive to user input received via a user interface <NUM> of the apparatus <NUM> or via the communication circuitry <NUM> of the apparatus <NUM>.

The method <NUM> may also include varying one or more parameters responsive to user input received via a user interface <NUM> of the apparatus <NUM> or via the communication circuitry <NUM> of the apparatus <NUM>. The one or more parameters are, for example, any one or more of: a frequency of the electrical stimulation signal <NUM>, a voltage of the electrical stimulation signal <NUM>, a current of the electrical stimulation signal <NUM>, or a duty cycle of the electrical stimulation signal.

In at least one embodiment of the method <NUM>, sequentially activating the respective subsets <NUM> of electrodes <NUM> comprises activating the respective subsets <NUM> of electrodes <NUM> according to a treatment program <NUM>. The method <NUM> may include obtaining the treatment program <NUM> as a predefined treatment program stored as configuration data <NUM> in the apparatus <NUM> or creating or tuning the treatment program <NUM> responsive to user input. As noted, the treatment program <NUM> dictates which electrodes <NUM> are activated at which times and for how long, and according to which electrical and timing parameters, and may define an overall duration of treatment and the sequence/repetitions of electrode activation.

Advantageously, the sequential activation of electrode subsets <NUM> as contemplated herein increases the efficacy of electrostimulation for injury healing by scanning or distributing the electrical stimulation signal <NUM> across or through the injury site. The scanning effectively "circulates" or "moves" the active contact points around the injury by sequentially changing which electrodes <NUM> are active as sources and sinks for the electrical stimulation signal <NUM>, according to a defined activation sequence. <FIG> illustrate one such example of moving the signal sources and sinks around an injury.

In <FIG>, the black fill indicates which electrode <NUM> is active as a signal source and the black hatching indicates which electrode <NUM> is active as a signal sink. Although the figures show' only one signal source and one signal sink at a time, there may be more than one source or sink active at a time, in dependence on how the subsets <NUM> are defined by the involved activation sequence <NUM>.

Going from <FIG>, the signal source "moves" from left to right, relative to the depicted orientation of electrodes <NUM>, as does the signal sink. Effectively, this sequence moves the contact points for the electrical stimulation signal <NUM> across or over the extent of the injury, going from left to right. As such, more of the injury' is reached by the electrical stimulation signal <NUM>, or, put another way, the electrical stimulation signal <NUM> is better distributed in and through the injury site, over time.

As for generation of the electrical stimulation signal <NUM>, multiple arrangements are contemplated, and Figure <NUM> offers a non-limiting example of one arrangement of the signal generation circuitry <NUM> for generation of the electrical stimulation signal.

The signal generation circuitry <NUM> operates as a pulse forming circuit that isolates the high voltage for the electrodes <NUM> from the lower voltage control circuits to produce a cleaner stimulus-signal waveform with better pulse shape free of ringing. The resulting unipolar waveform output promotes unidirectional ionic flow, which the empirical evidence suggests provides for more efficacious electrostimulation.

The illustrated circuitry includes a high voltage generator <NUM>, a high voltage output circuit <NUM> and a low voltage output control circuit <NUM>, which provides for certain stimulation-signal tuning by the control circuitry <NUM>.

The high voltage generator <NUM> includes a step up transformer <NUM>, a set of MOSFETs <NUM> and <NUM> and a D flip flop <NUM>. A center tap input <NUM> is coupled to a control MOSFET <NUM> that is coupled to a DC voltage source such as the power supply battery <NUM> shown in <FIG>. The secondary coil of the transformer <NUM> is coupled to the inputs of a rectifier bridge <NUM>. The outputs of the rectifier bridge <NUM> are coupled to a capacitor <NUM>. The high voltage that will he applied to the body is created by the transformer <NUM> and then rectified by the bridge <NUM> and stored on the capacitor <NUM>. The transformer <NUM> in this example is relatively small and is driven by the push-pull circuit configuration composed of the primary coil of the transformer <NUM>, the MOSFETs <NUM> and <NUM> and the D flip flop <NUM> which is driven by a clock input, e.g., at <NUM>. A higher clock frequency allows a smaller transformer to be used.

The output voltage from the high voltage generator <NUM> is a function of the center tap voltage coupled to the control MOSFET <NUM> and the turns ratio of the transformer windings (primary to secondary turns), in the example arrangement illustrated, the output electrical stimulation signal <NUM> is obtained via the use of high voltage opto-isolators <NUM>, <NUM>, <NUM>, and <NUM>. Either the combination of opto-isolators <NUM> and <NUM> are used to output voltage to the electrodes <NUM> respectively, or to reverse the polarity, opto-isolators <NUM> and <NUM> are used to output voltage to the electrodes <NUM>. The output of the high voltage generator <NUM> is coupled to a positive high voltage rail <NUM> that is controlled by the high voltage ends of the opto-isolators <NUM>, <NUM>, <NUM>, and <NUM>.

The selection of the stimulation-signal polarity is made via the low voltage output control circuit <NUM>. The low voltage output control circuit <NUM> includes a polarity selection input <NUM> and a pulse width modulation control input <NUM>, which are driven/controlled by the control circuitry <NUM>.

The low voltage output control circuit includes an inverter <NUM>, AND gates <NUM> and <NUM>, and output MOSFETs <NUM> and <NUM>. The output MOSFET <NUM> controls activation of the low voltage end of the opto-isolators <NUM> and <NUM> while the output MOSFET <NUM> controls activation of the low voltage end of the opto-isolators <NUM> and <NUM>. The polarity selection signal is received via the selection input <NUM> and is directly coupled to one input of the. AND gate <NUM> and via the inverter <NUM> to one input of the AND gate <NUM>. The output of the AND gates <NUM> and <NUM> drive the MOSFETs <NUM> and <NUM>, respectively. The other input of the AND gates <NUM> and <NUM> are driven by a pulse width modulation control signal from the control input <NUM>. The pulse width control signal will time how long the output pulse is and at what frequency it is applied, and the control circuitry <NUM> is configured in one or more embodiments to set (or dynamically vary) the frequency of the electrical stimulation signal <NUM> to a frequency within the range of <NUM> to <NUM>.

Because the polarity selection signal is inverted to the AND gate <NUM>, only one set of opto-isolators <NUM> and <NUM> or <NUM> and <NUM> are activated to control high voltage output to the electrodes <NUM>. The opto- isolation of the low voltage control from the high voltage provides a cleaner pulse shape output. The transformer parameters do not limit stimulation frequency or pulse width for the electrical stimulation signal <NUM> in the illustrated circuit configuration.

Example operating electrical parameters for the electrical stimulation signal <NUM> include: a <NUM> Volt peak pulse amplitude (unloaded electrodes <NUM>), a <NUM>-<NUM> Volt pulse amplitude (loaded electrodes <NUM>), <NUM> to <NUM> pulse frequency, fixed or variable duty cycle of the pulses in the pulse train, an output current of about <NUM> milliamps, and a maximum charge per pulse of <NUM> micro Coulombs.

Of course, one or more of these example signal parameters may be different or may be variable, in dependence on the particular electrical circuitry used to generate the electrical stimulation signal <NUM>. Regardless of the circuitry used to generate the electrical stimulation signal <NUM>, and other arrangements besides the one illustrated will be appreciated by those of ordinary skill in the art in view of the operational descriptions herein, one mechanism available for selectively connecting the electrical stimulation signal <NUM> to respective electrodes <NUM> to form activated subsets <NUM> of electrodes <NUM> is a multiplexing or crossbar switch circuit <NUM>. Such a switch provides for selective connection of the positive connection <NUM>+ for the electrical stimulation signal <NUM> to any one or more of the conductors <NUM> that couple to the individual electrodes <NUM>, and selective connection of the negative connection <NUM>- for the electrical stimulation signal <NUM> to any one or more of the remaining ones of the conductors <NUM>.

Claim 1:
An apparatus (<NUM>) configured for therapeutic electrical stimulation of a patient, the apparatus (<NUM>) comprising:
an electrode carrier (<NUM>) configured to place a set (<NUM>) of electrodes (<NUM>) into contact with the body of the patient at an injury site on the body of the patient; and
a stimulation module (<NUM>) comprising:
control circuitry (<NUM>) that is configured to sequentially activate individual subsets (<NUM>) of electrodes (<NUM>) in the set (<NUM>) of electrodes (<NUM>), each subset (<NUM>) including one or more electrodes (<NUM>) activated as a signal source for the electrical stimulation signal (<NUM>) and one or more electrodes (<NUM>) activated as a signal sink for the electrical stimulation signal (<NUM>);
wherein the module (<NUM>) further comprises:
a signal generation circuitry (<NUM>), characterized in that said signal generation circuitry is configured to generate an electrical stimulation signal (<NUM>) as a Direct Current, DC, pulse train at a frequency of between <NUM> and <NUM>.