Systems and methods for nerve regeneration therapy

Abstract

An electrical stimulation system includes a stimulation device and a container. The stimulation device may be sealed within the container. A port in the container allows the stimulation device to couple with the lead. The stimulation device may be used before, during, and after a subcutaneous surgical procedure to apply electrical stimulation for nerve regeneration.

Description

[0001] This application is a divisional application based on the Chinese patent application with application number 201980088686.5 (international application number PCT / US2019 / 060532), application date November 8, 2019, and invention name “System and method for neural regeneration therapy”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 757,444, filed on November 8, 2018, entitled “Nerve Regeneration Therapy Stemand Method,” the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present invention relates generally to neural stimulation and, more particularly, to systems and methods for accelerating or enhancing the regrowth or recovery of injured or potentially injured nerves before, during, after, or independent of a surgical procedure. Background Art

[0005] Nerve injuries present clinicians with significant challenges in determining the appropriate course of treatment to restore impaired motor and / or sensory function. Ultimately, the severity of the nerve injury and the time since injury have the greatest impact on the treatment plan and the likelihood of success. In many cases, surgical intervention may be required to increase the likelihood of being able to restore control of muscle function or sensation. Surgical treatment of nerve injuries does not typically provide immediate functional restoration because nerve fibers must grow from the point of intervention or repair to the target muscle. Nerve fibers grow at a rate of approximately 1-3 mm / day, so recovery requires a significant amount of time.

[0006] Despite advances in surgical techniques and medical device technology, fiber growth direction and tissue rate remain significant factors limiting functional outcomes.

[0007] It may be desirable to provide a method for delivering electrical stimulation for a certain duration prior to a surgical procedure and in an operating room prior to a surgical procedure in place of a surgical procedure to improve functional outcomes. It may also be desirable to provide stimulation to an injured nerve in a medical office or outside of an office without the need for a subsequent surgical procedure or other surgical procedure. In addition, it may be desirable to be able to start stimulation for a certain duration prior to a surgical procedure, then in the operating room and continue into a post-operative setting. Alternatively or additionally, it may be desirable to start stimulation during and / or after a surgical procedure. In addition, stimulation may be started in an office or operating room and may be continued as the patient moves between rooms. It may also be desirable to deliver repeated stimulation of various durations during recovery or as part of a neurorestorative therapy without the need to replace electrodes before each application. Summary of the invention

[0008] The following is a summary of the invention disclosed herein to provide a basic understanding of some aspects. This summary is neither intended to identify key or important elements nor to limit any limitation of the embodiments or claims. In addition, the summary may provide a simplified overview of some aspects that may be described in more detail in other parts of the disclosure.

[0009] An electrical stimulation system comprises: a stimulation device comprising a housing; a control circuit operable to generate a stimulation signal, wherein the control circuit is disposed within the housing; and a container housing the stimulation device, the container comprising at least one port, and wherein the container may (or may not) be hermetically sealed.

[0010] A method for stimulating tissue comprises providing a stimulation device; placing a lead within the range of a target tissue area, wherein the lead is operably attached to the stimulation device; applying a stimulation signal to the target tissue area via the lead and the stimulation device; terminating the application of the stimulation signal; and performing a subcutaneous surgical procedure after terminating the application of the stimulation signal.

[0011] Also disclosed is a method for stimulating tissue, comprising providing a stimulation device, placing the stimulation device within a container comprising at least one port, and wherein the container may or may not be hermetically sealed; placing a lead within the range of a target tissue area, wherein the lead is operably attached to the stimulation device via the at least one port; and applying a stimulation signal to the target tissue area via the lead and the stimulation device to treat the target tissue area.

[0012] The following description and the accompanying drawings disclose various illustrative aspects. Some improvements and novel aspects can be clearly identified, while other aspects can be apparent from the description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The drawings illustrate various systems, devices, apparatus, and methods, wherein like reference numerals refer to like parts throughout.

[0014] Figure 1 shows a partial cross-sectional view of a stimulation device according to various disclosed aspects;

[0015] Figure 2 It shows the Figure 1 Side view of the stimulation device;

[0016] Figure 3 A transcutaneous electrode according to various disclosed aspects is shown;

[0017] Figure 4A Another transcutaneous electrode according to various disclosed aspects is shown;

[0018] Figure 4B Another transcutaneous electrode according to various disclosed aspects is shown;

[0019] Figure 5 An adapter including a transcutaneous electrode according to various disclosed aspects is shown;

[0020] Figure 6 An adapter including two connectors according to various disclosed aspects is shown;

[0021] Figure 7 The invention shows a device coupled to an adapter according to various disclosed aspects. Figure 1 Stimulation device;

[0022] Figure 8 shows a top view of a container for receiving a stimulation device according to various disclosed aspects;

[0023] Fig. 9 shows a top view of another container for receiving a stimulation device according to various disclosed aspects;

[0024] Fig.10 It shows the Fig. 9 A rear view of the container;

[0025] Fig.11 According to various disclosed aspects, the Figure 8 Container, Figure 1 The system of connecting the stimulation device and electrodes;

[0026] Fig.12 shows a perspective view of a splitter device according to various disclosed aspects;

[0027] Fig.13 shows a partial cross-sectional perspective view of a splitter device according to various disclosed aspects;

[0028] Fig.14 A device coupled to a percutaneous lead according to various disclosed aspects is shown. Fig.12 A perspective view of a splitter device;

[0029] Fig.15 shows a perspective view of another stimulation device according to various disclosed aspects;

[0030] Fig.16 Shown is a diagram without a band according to various disclosed aspects. Fig.15 Embodiments of the stimulation device in;

[0031] Fig.17 It shows the Fig.16 A rear view of the stimulation device; and

[0032] Fig.18 A method of manufacturing a transcutaneous lead having one or more percutaneous leads and a return electrode according to various disclosed aspects is shown. Fig.15 An embodiment of a stimulation device in.

[0033] The present invention can be implemented in several forms without departing from its spirit or essential characteristics. The scope of the present invention is defined in the appended claims rather than in the detailed description preceding them. Therefore, all embodiments falling within the meaning and scope of the equivalents of the claims are intended to be included in the claims. DETAILED DESCRIPTION

[0034] Reference will now be made in detail to exemplary embodiments of the present invention, examples of which are shown in the accompanying drawings. It should be understood that other embodiments may be utilized without departing from the corresponding scope of the present invention, and structural and functional changes may be made. In addition, the features of the various embodiments may be combined or changed without departing from the scope of the present invention. Therefore, the following description is given only as an illustration, and should not limit in any way the various substitutions and modifications that may be performed on the illustrated embodiments and that are still within the spirit and scope of the present invention.

[0035] As used herein, the words "example" and "exemplary" mean an instance or illustration. The words "example" or "exemplary" do not indicate a critical or preferred aspect or embodiment. Unless the context indicates otherwise, the word "or" is intended to be inclusive and not exclusive. For example, the phrase "A employs B or C" includes any inclusive arrangement (e.g., A employs B; A employs C; or A employs B and C). On the other hand, the articles "a" and "an" generally mean "one or more" unless the context indicates otherwise.

[0036] It should be noted that the various embodiments described herein may include other components and / or functions. It should also be noted that although the various embodiments relate to stimulators or stimulation devices, in view of the embodiments described herein, various other systems may also be utilized. For example, the embodiments may be used for various surgical procedures, other medical procedures, or as independent surgical procedures. Therefore, for the purpose of explanation, the embodiments may refer to specific surgical procedures. However, it should be noted that aspects of the embodiments may be used for various other surgical procedures or as independent surgical procedures.

[0037] The present disclosure generally relates to systems and methods for improving nerve healing, including nerve regeneration, Wallerian degeneration, axon regeneration, or tissue nerve regeneration that increases the rate or amount of nerve growth via electrical stimulation. Unless the context otherwise indicates, the term "nerve" or "nerve tissue" generally refers to any part of a nerve, including but not limited to axons, axon terminals, soma, dendrites, etc. In addition, the aspects disclosed herein can be applicable to nerve tissue throughout the body, whether peripheral nerve tissue or other tissue. In addition, although the embodiments may refer to a surgeon performing a specific (multiple) action, it should be noted that other clinicians or users, automated machines, etc. can perform such actions.

[0038] In an embodiment, an electrical stimulation system may include a stimulation device comprising a housing; a control circuit operable to generate a stimulation signal, wherein the control circuit is disposed within the housing; and a container for housing the stimulation device, the container comprising at least one port, and wherein the container is sealed, wherein the container prevents the stimulation device from being contaminated, such that the stimulation device can be used during at least two occasions selected from before, during, or after subcutaneous surgery.

[0039] Electrical stimulation may also include any combination of the following:

[0040] wherein the port is operable to couple a lead to a stimulation device;

[0041] wherein the stimulation device is operable to generate a first stimulation signal for application to a target tissue region prior to a subcutaneous surgical procedure, and a second stimulation signal post-surgically for stimulating the target tissue region after the subcutaneous surgical procedure;

[0042] wherein the stimulation device is operable to generate a third stimulation signal for stimulating the target tissue area during a subcutaneous surgical procedure;

[0043] wherein the stimulation device terminates generation of a first stimulation signal before the subcutaneous surgical procedure begins and does not generate another stimulation signal until after the subcutaneous surgical procedure ends;

[0044] wherein the stimulation device generates the first stimulation signal for between approximately ten minutes and approximately fifteen minutes;

[0045] wherein the stimulation device generates a second stimulation signal for between approximately ten minutes and approximately fifteen minutes;

[0046] wherein the stimulation device generates a third stimulation signal for between approximately ten minutes and approximately fifteen minutes; and / or

[0047] • wherein the first stimulation signal comprises a different attribute than the second stimulation signal.

[0048] • Wherein the stimulation device further comprises a pulse counter operable to count the number of pulses generated by the control circuit.

[0049] • Wherein the stimulation device further comprises a timer operable to measure the passage of time during which the control circuit generates the stimulation signal.

[0050] • Wherein the stimulation device further comprises an action potential sensor operable to sense invoked action potentials through the target tissue region.

[0051] In one embodiment, a method for stimulating tissue may include providing a stimulation device and a container for containing the stimulation device; placing a lead within the range of a target tissue area, wherein the lead is operably attached to the stimulation device; applying a first stimulation signal to the target tissue area through the lead and the stimulation device; terminating the application of the first stimulation signal; performing a subcutaneous surgical procedure after terminating the application of the first stimulation signal; and applying a second stimulation signal to the target tissue area after terminating the application of the first stimulation signal.

[0052] The aforementioned method may also include any of the aforementioned contents in any combination:

[0053] Applying a second stimulation signal after subcutaneous surgery;

[0054] Applying a third stimulation signal during subcutaneous surgery;

[0055] Applying a second stimulation signal during subcutaneous surgery;

[0056] Applying the first stimulation signal comprises applying the first stimulation signal for at least approximately ten minutes; and /

[0057] or

[0058] • Applying the second stimulation signal comprises applying the second stimulation signal for at least approximately ten minutes.

[0059] One embodiment of an electrical stimulation system may include a stimulation device comprising a housing; a control circuit operable to generate a stimulation signal, wherein the control circuit is disposed within the housing; wherein the stimulation device operable to generate a first stimulation signal for application to a target tissue area to promote a healing process of a first mechanism, and wherein the stimulation device operable to generate a second stimulation signal for stimulating the target tissue area to promote a healing process of a second mechanism.

[0060] The electrical stimulation system may include any of the foregoing in any combination:

[0061] • wherein the first stimulation signal is applied for a first dosing duration, the first dosing duration being between approximately ten minutes and approximately fifteen minutes.

[0062] wherein the first stimulation signal is applied for a plurality of dosing durations, wherein each of the dosing durations is an equal amount of time;

[0063] wherein the first stimulation signal is applied for a plurality of dosing durations, wherein each of the dosing durations is a different amount of time; and / or

[0064] • An electrical stimulation system according to claim 16, wherein the second stimulation signal is applied for between approximately ten minutes and approximately fifteen minutes.

[0065] It should be noted that the described system and method can be used in combination with various systems and methods to prevent nerve, muscle and tendon damage during surgical procedures, other surgical procedures or as an independent surgical procedure, or to confirm the identification and / or location of nerves, muscles and tendons, and evaluate their function or the function of muscles weakened by these nerves. The system and method are particularly suitable for helping nerve regeneration via a device, which can also be used by surgeons or clinicians in identifying nerves and muscles, so as to ensure the integrity of nerves and muscles during medical surgical procedures using medical devices such as stimulation monitors, cutting, drilling and screwing devices, guide spiral drills and fixation devices, including but not limited to the system disclosed in U.S. Patent No. 10470678, which is incorporated herein by reference. However, it should be noted that the described system and method can utilize other devices that are not utilized during surgical procedures. In addition, various disclosed aspects can be utilized independently of such systems and methods.

[0066] The embodiments described herein provide stimulation of one or more target nerves as an alternative to a surgical procedure or during a surgical procedure or before a surgical procedure or other medical surgical procedure (including but not limited to perioperative). Such stimulation before, during or independently of a surgical procedure can lead to more effective recovery than a surgical procedure without pre-procedural stimulation or any stimulation. Effective recovery can include reducing the time of nerve regeneration, reducing the need for nerve regeneration, improving postoperative neural function, reducing the need (or not) for surgical intervention, etc. Additionally or alternatively, embodiments can utilize continuous stimulation delivered as treatment without surgery during surgery, before repairing or treating nerve damage and / or after repairing or treating nerve damage and / or after surgery.

[0067] In one example, a surgeon, clinician or other medical professional can apply one or more leads to the user. The leads can be percutaneous, percutaneous, surface electrodes or leads directly attached to the nerves. The leads can be placed in areas of suspected nerve damage or hypofunction, areas of possible nerve damage or hypofunction and / or areas where surgery is to be performed or is being performed. For example, a certain surgical procedure may be planned to require surgery at or near a nerve. This may expose the nerve to the risk of damage, temporary or permanent hypofunction or post-operative repair. The described embodiments stimulate the nerve before the surgical procedure. The stimulation before the surgical procedure can reduce the recovery or repair time after the surgical procedure, can reduce or prevent hypofunction, etc. In addition, the surgeon can apply additional stimulation during or after the surgical procedure, which is combined with or substituted for the stimulation before the surgical procedure. Additional stimulation can be combined with stimulation before the surgical procedure to provide benefits for nerve repair. Additionally or alternatively, the clinician can apply stimulation without performing a surgical procedure to help the nerve heal or regenerate.

[0068] In various embodiments described herein, systems and methods provide stimulation of one or more target nerves as a treatment for one or more target nerves for the purpose of nerve regeneration and / or healing the nerve or more nerves. Therefore, although some examples may refer to postoperative and preoperative stimulation, various embodiments may include stimulation without surgical operation or in place of surgical intervention. Further, such stimulation may be provided during applicable surgical procedures. It should be noted that similar or different stimulation parameters (e.g., stimulation mode, intensity, duration, frequency, single dosing, repeated dosing, etc.) may be applied to stimulation without surgical operation, or to stimulation during postoperative and preoperative surgical operations. In addition, the stimulation parameters may or may not be related to the type of stimulation applied, i.e., whether it is part of a surgical operation, preoperatively, during a surgical operation, postoperatively, or in the absence of a surgical operation. In other embodiments, the stimulation parameters may all be the same, regardless of the type of stimulation applied.

[0069] The described surgical procedures can result in more effective restoration or regeneration of damaged or potentially damaged nerves. Stimulation itself can be provided as a treatment, independent of any surgical procedure, or can be the entire surgical procedure. It should be noted that stimulation can be performed via percutaneous stimulation delivery, transcutaneous stimulation delivery, transdermal delivery (e.g., implanted electrodes and surface coils for power delivery and communication), or a combination thereof.

[0070] As a non-limiting example of transdermal delivery, the electrodes may be implanted and may be wirelessly and operably coupled to a surface coil, or may be directly and operably attached to a surface coil for power delivery and communication so that the electrodes may apply appropriate stimulation. The electrodes may be positioned in any suitable manner, such as by a needle, by surgical intervention, or any other suitable method.

[0071] In an example, the stimulation of the target nerve tissue for nerve regeneration can be applied as a treatment replacing surgery or as an alternative to surgery. For example, target electrical stimulation can be applied to suitable nerves for carpal tunnel treatment (however, this is merely exemplary, and electrical stimulation can be applied to any type of nerve damage, damage or other preventive measures). Treatment can include fixation and stimulation therapy to avoid surgery (if possible). In another example, stimulation can be applied after injury as primary treatment. A surgeon or other professional can place electrodes, and can stimulate nerve tissue (or nerve fibers) or surrounding tissues (Schwan cells, macrophages) that support nerve healing, to accelerate regeneration and healing when no surgical intervention is needed, such as treating muscle weakness, loss of sensation after trauma or long-term injury or other problems related to nerves or surrounding tissues. In some cases, this treatment may be successful enough for the patient to avoid surgical intervention. Stimulation therapy can accelerate nerve regeneration, which is enough to accelerate healing without the need for surgery.

[0072] In at least some embodiments, a surgeon or clinician can utilize a handheld stimulation device to generate stimulation signals at sufficiently high levels for the purpose of locating, stimulating, and evaluating the integrity of nerves or muscles or both nerves and muscles in a number of medical surgical procedures. This can also include, but is not limited to, assessing proximity to a target tissue area, assessing proximity to a nerve or identifying nerve tissue, assessing nerve integrity (i.e., following a traumatic or repetitive motion injury) to determine if repair is needed, assessing muscle contraction to determine if a muscle is innervated and / or if a muscle is intact and / or if a muscle is severed, identifying specific nerve branches or bundles for repair or transfer, and assessing muscle and tendon length and function following a repair or tendon transfer prior to completing a surgical procedure.

[0073] When treatment is performed before a surgical procedure or without a separate surgical procedure, the surgeon may place electrodes or leads on or near the nerve to be stimulated and / or near the site of injury, potential injury or repair. The electrodes may be percutaneous or non-percutaneous (e.g., surface electrodes or implanted electrodes). In some embodiments, the electrodes may be percutaneously positioned, while the components transmit energy to the percutaneously positioned electrodes through the tissue. It should be noted that the transmission component may be positioned in an appropriate position on the skin, i.e., it may be an external electrical stimulator (or pulse generator). On the one hand, the percutaneous leads may be kept in an appropriate position on the patient's skin with tape or other means. This may allow for easy removal after long-term stimulation. Such an exemplary embodiment includes a patch that may be adhered to the patient's skin. The patch may generally define an insertion point for the percutaneous lead, and may allow a portion of the lead to extend therethrough. In this embodiment, a connector may be used to operably couple the percutaneous lead to a stimulation device. Alternatively, the lead may be operably coupled to the patch, and the patch may include an adapter operably coupled to the stimulation device. The patch may include an electrical path between the percutaneous lead and the adapter so that electrical stimulation can pass from the stimulation device through the patch and to the percutaneous lead. The lead may be connected to the stimulation device used during the surgical procedure or another stimulation device via a wire or other connector (permanently or removably). The stimulation device may be placed in a sealed housing to prevent cross contamination.

[0074] The sealed housing may include one or more connectors that maintain the stimulation device and stabilize the device during transport. The housing may include a port that allows a lead to be connected to the stimulation device (or in some embodiments, the lead may be permanently attached to the stimulation device), and another port for connecting a percutaneous electrode or a surface electrode (such as a patch) as a return current path (or in some embodiments, the percutaneous electrode or surface electrode may be permanently fixed). The stimulation device may generate a signal to stimulate neural tissue, as described in more detail herein.

[0075] On the one hand, the stimulation device can generate a signal to stimulate nerve tissue before the surgical procedure. In some embodiments, the stimulation device can additionally generate a signal to stimulate nerve tissue during a surgical procedure (e.g., a surgical procedure), before the completion of the surgical procedure, or in place of the surgical procedure. The placement of a percutaneous lead can allow a surgeon to place a lead and stimulate a nerve with a stimulation device during or after a surgical procedure without the need for the surgeon or any other person to keep the stimulation device in place; the stimulation device can be kept in an operating position without the need for manual intervention. When delivering stimulation percutaneously, a clinician can place electrodes during a surgical procedure. This can be achieved in any way. For example, a clinician or surgeon can position a percutaneous lead relative to a nerve in an operating position with or without the help of a guide needle, and the percutaneous lead has an electrode at its distal end. The clinician or surgeon can apply electrical stimulation to a suitable nerve to regenerate and / or heal the nerve. Additionally or alternatively, a clinician can position a percutaneous lead with an electrode at the distal end by ultrasound guidance placement, such as when a guide needle is used. This can be done during a surgical procedure or without surgery at all. Ultrasound guided placement can be accomplished in any manner; the present teachings are not limited to a particular method. As a non-limiting example, a clinician can insert a guide needle into the patient's body. The clinician can use an ultrasound machine to determine the position of the guide needle and electrode. Once in the proper position, the clinician can eject the electrode and remove the guide needle. The electrode can then be in its operating position relative to the appropriate nerve. The clinician can then apply electrical stimulation to the appropriate nerve through the electrode for the purpose of nerve regeneration and / or healing. In some embodiments, a marking or identification device can be used in conjunction with the guide needle to help identify the position of the guide needle through ultrasound.

[0076] Embodiments provide stimulation that begins at various times before, after, during, or as a treatment independent of a surgical procedure, as well as stimulation of various lengths of time. On the one hand, stimulation can typically be performed for a predetermined length of time (e.g., i minutes, where i is a number) before a surgical procedure. In at least one embodiment, stimulation can be performed about an hour or less before a surgical procedure, but can occur more than an hour before a surgical procedure, for example, stimulation can include a short stimulation of about one to five minutes or a long stimulation of about one hour. However, it should be understood that when the time of a therapy is disclosed, deviations from the disclosed time are also considered. For example, a deviation of 20-30% may also be included as part of the disclosed time. Stimulation before a surgical procedure (e.g., nerve transfer or nerve release) can increase the speed, quality, or amount of nerve regeneration.

[0077] In some embodiments, stimulation can occur before a surgical procedure, during a surgical procedure, in multiple situations after a surgical procedure, and / or as a stimulation for a treatment independent of a surgical procedure. For example, a doctor can determine a schedule of hours, months, weeks, or days of stimulation before a surgical procedure or in the absence of a surgical procedure (such as as an alternative to a surgical procedure). The schedule can define a time duration (e.g., 1 minute, 5 minutes, 10 minutes, 30 minutes, 60 minutes, etc.), parameters of the stimulation signal (e.g., intensity, frequency, etc.), date / time of stimulation, etc. for each stimulation session. In at least one embodiment, nerves can be stimulated during multiple sessions of a day, such as the day of the surgical procedure or according to a treatment plan. In at least one case, before surgery, nerves can be stimulated for a first time length, stimulation can be removed for a second time length, and stimulation can be applied again for a third time length. This process of applying and resting nerves can continue until the surgical procedure is performed, and can continue for a defined time length during and / or after the surgical procedure. In addition, the parameters of the stimulation signal may be different during different stimulation sessions. In at least one example, the intensity of the stimulation is adjusted (e.g., increased or decreased) between stimulation sessions. In some cases, the intensity of stimulation may be gradually increased between sessions prior to a surgical procedure, or may be gradually decreased prior to a surgical procedure.

[0078] One aspect enables additional stimulation to be started in the operating room before the surgical procedure is completed and continued additionally or alternatively to the postoperative setting. In some embodiments, stimulation can be started during the surgical procedure and continued after the surgical procedure without interrupting the stimulation. Reducing the delay from the completion of the surgical intervention to the start of the stimulation can provide further clinical benefits. This additional post-procedural stimulation can be utilized in conjunction with pre-procedural stimulation.

[0079] It should be noted that stimulation can be applied in an office, in a preoperative setting, or in another location (e.g., outside a surgical facility or room). In addition, placement of electrodes can be accomplished in any suitable location, such as outside or inside a medical facility. Application of stimulation can also occur at any suitable location. In some examples, the patient can apply stimulation at home via a suitable stimulation device. The stimulation device can be preprogrammed with stimulation parameters, can communicate with a server to receive updated parameters, can communicate with a user device (e.g., a mobile phone, laptop, desktop computer, tablet computer, etc.), etc. The stimulation device can report to a physician or provider regarding the use of the stimulation device.

[0080] In one example, electrical stimulation can be applied before or at the beginning of surgery, or before or at the beginning of treatment without surgery to determine the baseline level of nerve excitability, i.e., a threshold test. During or near the completion of surgery or treatment plan, a second nerve excitability test can be performed. The second test can be compared with the first test. If the second test results in lower nerve excitability, extended stimulation can be applied after surgery to help nerve regeneration. This series of tests can be completed with a single electrode and stimulation device, or with two or more electrodes or stimulation devices. In addition, the initial threshold test can be completed with different stimulations and the same lead or different stimulation devices and leads (such as a stimulation device with a permanently fixed lead) or with the same stimulation device and the same lead. The application of the second test can determine whether nerve regeneration stimulation is necessary or desired for the patient, for example, for treating any potential nerve damage or trauma suggested by the reduction in nerve excitability between the first test and the second test, or for determining whether the patient needs surgery. The threshold test can include electrical stimulation of one or more nerves in the target tissue area to determine or measure the excitability of one or more nerves. In this case, it may only be necessary to test nerve excitability to determine whether post-procedural nerve regeneration therapy is needed before applying such nerve regeneration therapy. Threshold testing can be performed at any time during the surgical procedure, such as when retractors are removed, when forces are applied to the patient's limb, etc. Threshold testing can also be used to determine stimulation parameters to apply, what type or level of stimulation administration should be authorized, or any other stimulation factor.

[0081] In another example, neural stimulation can be applied before surgical procedures and during surgical operations before treating or repairing nerve damage, suspected nerve damage, future nerve damage risks, etc. Percutaneous leads can be placed at or near the nerve (e.g., within the range of the signal) to allow the stimulation device to generate signals and apply signals to the nerve tissue. The stimulation can be performed for a predetermined duration and can be performed at any time during the surgical operation. For example, the stimulation can occur immediately at the beginning of the surgical operation and can be performed for an hour or less. It should be noted that stimulation can be applied with different intensities, frequencies, modes, etc. Stimulation during surgical operations can increase the speed, quality, or amount of nerve regeneration or nerve function recovery. The percutaneous lead can be anchored, maintained, or otherwise retained in place after stimulation, before, during, and / or after the surgical operation, such as without manual intervention.

[0082] As described herein, the parameters of the stimulation signal for stimulation before the surgical procedure, stimulation during the surgical procedure, stimulation after the surgical procedure, or stimulation as a treatment independent of the surgical procedure can be preprogrammed or can be set by a surgical clinician. In at least one embodiment, during stimulation, the pulse width can remain constant (e.g., not adjusted). On the one hand, the stimulation signal can be applied between approximately 2-100 Hz, 15-30 Hz, or approximately 16-20 Hz. In some embodiments, the applied stimulation signal can be as low as 0.1 Hz or as high as 1 kHz. Further, the applied stimulation signal includes a random frequency (within the range of 0.1 Hz to 1 kHz), within a predetermined frequency range, optimized to prevent the occurrence of pain in the patient, pseudo-random, non-constant, or any combination of the foregoing. The amplitude of the stimulation can remain constant or be adjusted by the surgeon. In general, the stimulation amplitude will typically be between 0.1-20 mA, typically between 1.0-2.0 mA. In addition, the stimulation signal can be applied for a certain extended period of time (e.g., one hour).

[0083] It should be noted that the extended stimulation signal can be applied in a single dose or multiple doses, or last up to or more than 8 hours. For example, multiple doses can be applied by the same percutaneous lead, which can be kept in place between doses, or can be removed between doses. Multiple doses can utilize similar or different parameters. For example, the dose can gradually become shorter, longer, follow a curve, or be in any appropriate pattern. In some embodiments, between doses, the intensity of the stimulation can be similar or adjustable. In addition, whether it is a single dose or repeated dose, the duration of the dose can include a relatively short stimulation duration (e.g., 0-5 minutes) to a relatively long stimulation duration (e.g., up to one hour or longer). In such an example, according to the position of the patient during stimulation, i.e., the position before the surgical operation, the position of the surgical operation, or the position after the surgical operation, a lead can be utilized and different stimulation devices can be utilized. In these embodiments, the lead can be selectively attached to the stimulation device and can be removed from the stimulation device. In an alternative, a lead can be utilized and a single stimulation device can be utilized, regardless of the patient's position during stimulation. In these embodiments, the leads may be permanently affixed to the stimulation device, or may be selectively attached to and removable from the stimulation device, or the leads may be permanently affixed. In yet another alternative, different leads and different stimulation devices may be utilized depending on the patient's position during stimulation. In these embodiments, the leads may be selectively attached to and removable from the stimulation device, or the leads may be permanently affixed. In such a dosing example, electrical stimulation may be applied for a certain length of time, such as k minutes, where k is a number (e.g., 1, 2, 5, 10, 15, 60, etc.). In an example, the duration may be between about 10 minutes and an hour or more.

[0084] The stimulation system described herein can deliver electrical stimulation to peripheral nerves before, after, or otherwise (e.g., as a treatment independent of the surgical procedure) before a surgical procedure, for a certain period of time, and the peripheral nerves will be repaired in the future. Accessories (e.g., percutaneous electrode lead accessories, such as those described in U.S. Patent Application US2014 / 0073985A, which is incorporated herein by reference) can be connected to the stimulation device after the surgical procedure. It should be noted that the stimulation device can be a stimulation device that will be used or has been used during the surgical procedure. For example, the surgeon can use a handheld stimulation device to apply stimulation. The handheld stimulation device can be positioned in an airtight sealed container or in a container without an airtight seal. The surgeon can place one or more implantable leads in a position where the lead can stimulate the nerve, which may have damage, potential damage, or may need to be restored after the surgical operation is completed. The surgeon can remove the stimulation device from the container for use in the surgical operation, and can place the stimulation device in a container or a different container after the surgical operation.

[0085] It is important to note that the present disclosure contemplates providing electrical stimulation as a preventative or as an alternative to surgery, i.e., to mitigate the effects of, the risk of, or suspected nerve damage, other than during a surgical procedure. For example, a surgeon may place a handheld stimulation device into a sterile container, and one or more leads may be electrically attached to the handheld stimulation device via a port of the container, or the leads may be permanently affixed to the stimulation device. Thus, a patient's nerves may be stimulated before, during, or independent of a surgical procedure. In some cases, a surgeon may stimulate a nerve after or during a surgical procedure via the same stimulation device used for a surgical procedure. Once stimulation is complete, the stimulation device may be discarded or otherwise removed.

[0086] However, it should be noted that different stimulation devices can be utilized to stimulate before, during, or after a surgical procedure. For example, a first stimulation device can be utilized before a surgical procedure. The devices can be reusable or disposable. During the surgical procedure, a second stimulation device can be utilized. After the surgical procedure, the surgeon can utilize the first stimulation device, the second stimulation device, or a third stimulation device to provide postoperative stimulation. Additionally, the stimulation devices can include wire connections to the electrodes, or power can be applied via a surface coil that delivers power through the patient's skin.

[0087] As described herein, the stimulation device may be disposable or reusable. The described system may allow stimulation electrodes to be placed near the nerve to be stimulated during a surgical procedure; allowing leads to be passed through tissue and permanently or selectively attached to the stimulation device.

[0088] The stimulation device can provide long-term stimulation before a surgical procedure, or as a non-surgical treatment. In some cases, it can provide additional long-term stimulation after the incision is closed or after a certain initial treatment period. In surgical applications, at the desired stop time, if post-surgical stimulation is not applied, the lead can be removed after or during the surgical procedure. On the one hand, this can eliminate the need for extended surgical time and can free the surgeon or staff from keeping the stimulator on the nerve for long-term stimulation. The lead can also be retained for a certain period of time to enable repeated stimulation delivery over multiple days or weeks without the need to place another lead.

[0089] According to some embodiments, the surgeon may place the stimulation device in a container. The container may include a bag, box, or other container. The container may seal the stimulation device within the container to prevent or reduce the chance of contamination, provide stability, etc. In at least one embodiment, the container may include one or more ports that may allow the stimulation device to be connected to a wire or lead, or may allow a lead permanently attached to the stimulation device to leave the container. The return current electrode may be attached to the side of the container that contacts the patient, or may be an external electrode connected to a second port on the container. As described herein, the container may include a suitable material, such as plastic, vinyl, metal, or other material.

[0090] It should be noted that the disclosed systems and methods are suitable for use in a variety of medical procedures involving peripheral nerves, whether surgical or non-surgical. As non-limiting examples, various aspects of the present invention are used to treat nerve transection injuries, nerve compression injuries, suspected nerve injuries, risk of nerve injury or reduced function, or nerve transfer procedures, including but not limited to nerve decompression procedures (such as carpal tunnel or cubital tunnel syndrome), neurolysis, nerve transfer, nerve repair (e.g., direct repair, autograft, allograft or catheter), and iatrogenic injuries (thermal injury, stretch injury, compression injury or transection injury).

[0091] In at least one embodiment, the electrical stimulation system may include a stimulation device and an adapter. The stimulation device may include a housing; a control circuit that is operable to generate a stimulation signal, wherein the control circuit is disposed within the housing; and an operating element that is coupled to the housing and includes at least one electrode. The housing may be configured as a handheld housing suitable for use by a surgeon / clinician with one hand. The adapter may be selectively attached to the operating element and may include a percutaneous lead electrically coupled to the stimulation device via at least one electrode, the percutaneous lead being insertable into a patient during and after subcutaneous surgery, and wherein the stimulation device is capable of applying electrical stimulation during and after subcutaneous surgery. The percutaneous lead may include a multi-strand stainless steel wire insulated with a biocompatible material.

[0092] The control circuit can apply electrical stimulation before subcutaneous surgery for preventive nerve regeneration therapy, post-surgical treatment or treatment without surgical operation. Nerve regeneration therapy can include stimulation of nerves to change the recovery of stimulated nerves (e.g., improve, enhance, accelerate, etc.) in the following ways: as a substitute for surgery, or to prevent or reduce the need for surgery. On the other hand, the control circuit can apply electrical stimulation for a duration of 5 minutes to one hour. The electrical stimulation system can further include a container that can operably receive the stimulation device, wherein the container includes at least one connection port, and the connection port connects the stimulation device operably and electrically to the percutaneous lead. In at least one embodiment, the electrical stimulation system can further include a branching device that can operably connect to the stimulation device, the electrical stimulation system and at least one other lead, wherein the branching device receives the stimulation signal and generates a substantially uniform output signal to the lead and at least one other lead. The branching device can be arranged in a container, in a different container or not in a container. The container can include an attachment device that can operably attach the container to an object. The container may additionally or alternatively include one or more fasteners to selectively secure the control circuit within the container. It should be noted that at least one connection port may include a return port that is operable to receive a return electrode of the stimulation device from within the container. The return port can operably and electrically connect the return electrode to the return lead.

[0093] On the other hand, embodiments include methods for stimulating tissue prior to subcutaneous surgery and may include performing subcutaneous surgery. The method may include stimulating tissue using a stimulation device and placing a lead within the range of a target tissue area, wherein the lead is operably (selectively or permanently) attached to the stimulation device, and applying a stimulation signal to the target tissue area via the lead and the stimulation device prior to the subcutaneous surgery. Placing the lead may include percutaneous placement of the lead or non-percutaneous placement of the lead. The stimulation device may be a handheld stimulation device or a non-handheld device. The method may include placing the stimulation device within a container prior to performing subcutaneous surgery.

[0094] Now go to Figure 1 and 2 , there is a stimulation system 100, which may include a stimulation device 102 configured to locate, monitor, and stimulate tissue and other structures throughout the body. The stimulation system 100 can be used to locate and identify tissue and prevent tissue and / or bone damage during surgical procedures. On the other hand, the stimulation device 102 can be used to stimulate nerves percutaneously before surgery, and in some examples, percutaneously during or after surgery for a desired amount of time. In other embodiments, stimulation can be applied as a therapeutic procedure (such as an alternative to surgery) to prevent or reduce the need for surgery, or independently of surgery.

[0095] The stimulation device 102 may include or be coupled to one or more accessories or operating elements, including, for example, a probe 110 (e.g., which may be blunt, needle-like, etc.), a cutting device, a drilling or screwing device, a guide screw drill, and a fixation device. It should be noted that the accessories may be removable, attachable, or permanently attached to the stimulation device 102. It should be noted that although embodiments may describe the use of a particular accessory (e.g., a probe 110) for simplicity of description, various embodiments may utilize other types of accessories.

[0096] In an exemplary embodiment, the stimulation device 102 includes a control circuit 104 disposed in a housing 120 that can apply a stimulation signal to a desired tissue area. The control circuit 104 can be connected to a power source, such as a battery, a power mains, etc. As described herein, the control circuit 104 can generate a stimulation signal with desired parameters. In one aspect, a user can adjust the parameters and / or control the control circuit 104 to generate the stimulation signal via one or more user interfaces 108, which can include at least one of a switch, a button, a slider, a touch screen, etc.

[0097] For example, a user can grasp the stimulation device 102 via the housing 120. The housing 120 may include a gripping portion 122. The gripping portion 122 may include indentations, protrusions, resilient materials, rough materials, or other features that may help a user grasp the stimulation device. The gripping portion 122 of the housing 120 may include an overmolded portion that may include all or part of the length of the housing 120. In one aspect, the overmolded portion may include a thermoplastic elastomer material. It should be noted that the gripping portion 122 may be removable, attached to the housing 120, or integrally formed with the housing 120.

[0098] In an example, a user can position the probe 110 so that the uninsulated or stimulating portion or electrode 114 is located at a desired location. This can include positioning the electrode 114 relative to a nerve or positioning the electrode 114 within a container or attachment. The user can interact with one or more of the user interfaces 108 to control the delivery of the stimulation signal generated by the control circuit 104 to the desired tissue area. The gripping portion 122 can help the user hold the stimulation device 102. In one aspect, the control circuit 104 communicates the stimulation signal to the stimulation probe 110 via the lead 112 that can pass through the insulated portion 112 of the probe to the uninsulated portion 114.

[0099] It should be noted that the probe 110 may include one or more flexible materials (e.g., metal, plastic, etc.) so that the user can bend or otherwise manipulate the probe 110. On the other hand, the stimulation device 102 may include a nose cone 124, which may be flexible or rigid. An operating element (e.g., the probe 110) may extend from the proximal end of the nose cone 124. The user may apply pressure to the nose cone 124 so that it moves or otherwise manipulates the probe 110. This may allow a surgeon or other user to position the uninsulated portion 114 at a desired location in a target tissue region. For example, the uninsulated portion 114 of the probe 110 is positioned to be in conductive contact with at least one of a muscle, a nerve, or other tissue.

[0100] The flexible nose cone 124 can allow the surgeon to fine-tune the position of the probe 110 in the target tissue area using a finger or thumb positioned on the nose cone 124. The surgeon can grasp the housing 120 with the fingers and palm, position the thumb on the nose cone 124, and apply pressure with the thumb to move the probe 110 while maintaining a stable position of the housing 120. The flexible nose cone 110 can allow for increased control of the position of the probe 110 as the surgeon's thumb (or finger, depending on how the stimulation probe is held) moves. In another aspect, the nose cone 124 can include gripping features, such as ribs, indentations, rough surfaces, etc.

[0101] It should be noted that the nose cone 124 can include a single piece, or it can include one or more pieces attached together. For example, the nose cone 124 can include an inner portion and an outer portion, the inner portion can include a thermoplastic material having flexibility (e.g., LUSTRAN.RTM.ABS 348 or similar material), and the outer portion can include a softer overmolded portion and can be made of a thermoplastic elastomer material having flexibility (e.g., VERSAFLEX.TM.OM3060-1 from GLS Corporation). However, it should be noted that in at least some embodiments, the nose cone 124 can be generally rigid.

[0102] Although described as a “cone,” the nose cone 124 may include a generally conical shape or a different shape (e.g., round, square, prismatic, conical, etc.) Furthermore, in embodiments, the stimulation device 102 may not include a nose cone 124 such that the probe 110 extends directly from the housing 120 .

[0103] As described herein, stimulation signals can flow from the stimulation device 102 through the lead 112 to the probe 110, which can act as an electrode. The stimulation system 100 may include one or more other electrodes, such as a return electrode, as described herein. For example, in monopolar operation, the return electrode (or indifferent electrode) provides a return path for electrical signals that pass through tissue and return to the stimulation device 102. It should be noted that the stimulation system 100 can be operated in a monopolar, bipolar, or other configuration, as described herein and elsewhere in the present disclosure.

[0104] In various embodiments, the control circuit 104 can generate a stimulation signal to operatively generate a physical movement response of a tissue (e.g., a muscle, an innervated muscle, a nerve, etc.). The physical movement response can indicate whether the stimulation signal was delivered and / or whether sufficient stimulation signal was delivered. For example, the movement response can include a physical movement response (e.g., a twitch or contraction).

[0105] In another aspect, the stimulation device 102 can generate one or more visual or audio signals (e.g., via a speaker (not shown)) that indicate status or diagnostic information to the surgeon. For example, the stimulation device 102 can include an indicator light 126. The indicator light can include one or more light sources, such as light emitting diodes (LEDs). In one aspect, the indicator light 126 can include a transparent (e.g., translucent, fully transparent, etc.) surface that can operably illuminate or scatter light from an internal light source (not shown). In one aspect, the light source can generate one or more colors of light (e.g., green, yellow, blue, red, etc.), patterns (e.g., flashing rates, color patterns, etc.), etc. According to an embodiment, the status or diagnostic information can indicate whether a stimulation signal is delivered and / or whether a sufficient stimulation signal is delivered, i.e., a requested amount of stimulation signal or a specified stimulation signal is delivered. For example, the status or diagnostic information can indicate that an electrical signal is returned from the tissue, which can indicate sufficient proximity, contact, or delivery of a stimulation signal requested via an operating element (e.g., probe 110). In another aspect, the indicator light 126 can indicate that the stimulation device 102 is on / off, generates or does not generate a stimulation signal, etc. In addition, the indicator light 126 can indicate that the stimulation signal requested by the user from the stimulation device 102 has completed the current path through the operating element (e.g., probe 110) and the target tissue area and returned through the return electrode at a specified stimulation level equivalent to the control setting selected by the user on the stimulation device 102. In response to determining whether the electrical stimulation signal has completed the current path through the operating element (e.g., probe 110) and the target tissue area and returned through the return electrode according to the specified stimulation level, the indicator light can provide a first indication signal for confirming that the electrical stimulation signal has completed the current path of the electrical stimulation signal delivered to the target tissue area through the operating element and returned through the return electrode at the specified stimulation level. In response to determining whether the electrical stimulation signal does not go to the operating element and the target tissue area at the specified stimulation level and return through the return electrode, the indicator light 126 can also provide a second indication signal to at least one indicator for indicating that the delivery of the electrical stimulation signal to the target tissue area at the specified stimulation level through the operating element to the target tissue area and back through the return electrode has failed. The indicator light 126 combined with the housing can provide reliable feedback to the surgeon / user regarding the request and delivery of the stimulation current.

[0106] In the example, the indicator light 126 allows the surgeon to confirm the delivery of the stimulation current to the tissue, or more specifically to confirm the delivery of the preselected or desired stimulation current to the tissue. By using different tones, colors, different flash rates, etc., the indicator 126 allows the surgeon to confirm that the uninsulated tip 114 is in place, the stimulation device 102 / instrument is turned on, and the stimulation current is flowing to the tissue with sufficient (i.e., desired) delivery. Therefore, the surgeon has greater confidence that the desired stimulation amplitude is actually delivered to the nerve, because in the case of a nerve transfer of a nerve transplant, muscle contraction will not be observed because the nerve is no longer continuous. These indicators can be checked regularly to ensure that the stimulation (e.g., the desired stimulation) is delivered for the desired duration (e.g., between about 1 minute and one hour). In these embodiments, the indicator 126 not only determines whether the operating element is providing stimulation, it also indicates whether the electrical stimulation signal completes the current path through the operating element (e.g., probe 110) and the target tissue area and returns through the return electrode at a specified stimulation level based on the control settings selected by the user on the stimulation device 102.

[0107] As another example, in use, the indicator 126 can be configured to illuminate continuously in one color when the stimulation device 102 is turned on but not in contact with tissue. After contact with tissue, the indicator 126 can flash (i.e., blink) to indicate that stimulation is being delivered (as described above). If stimulation has been requested, i.e., the stimulation probe has been turned on, but no stimulation is delivered due to lack of continuity between the probe 110 and the return electrode 130, or insufficient connection of the probe 110 or the return electrode 130 to the patient's tissue, or the stimulation device is not delivering the desired / preselected stimulation signal to the tissue, the indicator 126 can illuminate in a different color and can illuminate continuously or can flash.

[0108] As described herein, the indicator 126 can include a ring that provides a visual indication around at least a portion of the periphery of the stimulation device 102 approximately proximate the nose cone 124, and ideally around the entire periphery of the stimulation device 102 approximately proximate the nose cone 124. The ring indicator can be an element of the grip portion 122, or it can be an element of the flexible nose cone 124, or the ring indicator can be positioned between the grip portion 122 and the nose cone 124. The ring can also include a reflective element to improve and focus the light effect of the light source, such as one or more LEDs. The ring and reflective element can be a single component, or more than one component. Audio feedback can also enable features that help surgeons monitor nerve integrity during surgery.

[0109] Although the stimulation device 102 is described as generating an indication, it should be noted that various other components of the stimulation system 100 may generate all or part of the indication. For example, the stimulation device 102 (or a separate device) may monitor the delivery of the stimulation signal. The stimulation device 102 may transmit status and diagnostic information (e.g., delivered current, stimulation duration, contraction presence, etc.) to a separate device (e.g., a laptop, a wearable electronic device, a mobile phone, a tablet computer, a computer, a speaker, a light source, etc.). In one aspect, the stimulation device 102 may include a wired or wireless communication component. For example, the stimulation device 102 may include a wireless transmitter / receiver configured to communicate via one or more communication protocols (e.g., Wi-Fi, Bluetooth, NFC, etc.).

[0110] In an embodiment, the stimulation device 102 may include a handheld stimulation device. The housing 120 may be generally tubular, hexagonal, or other elongated shapes. According to one aspect, the housing 120 may be ergonomic and sterile for use in an operating surgical procedure. For example, the stimulation device 120 may be packaged in a sealed container that may allow a surgeon to open and use the stimulation device 120 without the need for sterilization. However, it should be noted that portions of the stimulation system 100 may be sterilized, such as the probe 110. On the other hand, the stimulation device 120 may include a disposable instrument used during a surgical procedure to identify nerves and muscles, muscle attachments, contract muscles to assess the quality of surgical intervention or the need for surgical intervention, assess the function of nerves that have been identified by visual means, or provide continuous stimulation of nerves.

[0111] The stimulation device 120 can be sized small enough to be held and used with one hand during a surgical procedure, and can be ergonomically designed for use in either the left or right hand. In an embodiment, the stimulation device 120 can have a width of about 20 mm to about 30 mm, and ideally about 25 mm. The length of the stimulation device 120 (excluding the operating element) can be about 18 cm to about 22 cm, and ideally about 20 cm. The operating element (e.g., probe 110) can also include an angle or bend 116 to facilitate access to deep and superficial structures without the need for a large incision. As shown, relative to Figure 1 and 2 In the orientation shown, the curved portion 116 can be generally downward. In one aspect, this can allow the surgeon to maintain line of sight with the target tissue and / or the uninsulated portion 114.

[0112] In one or more embodiments, as described herein and elsewhere in the present disclosure, the operative element can be monopolar or bipolar. For example, the probe 110 can be monopolar. The return electrode 130 can be coupled to the control circuit 104 via an insulated conductor 132. The return electrode 130 can include any of a variety of electrode types (e.g., a paddle, needle, wire, or surface electrode). On the other hand, the stimulation device 102 can be bipolar and can include a return electrode or other operative element in the probe 110.

[0113] The user interface 108 can allow the user to turn the stimulation device 102 on / off (or set it to standby), and can allow the user to control the stimulation signal amplitude selection within a predetermined range (e.g., 0.1, 0.5, 2.0 and / or 20 mA). In a configuration, the user interface 108 can be a four or five position switch. It should be noted that the user interface 108 can allow the frequency to be selected and changed within a range. Before the first use of the stimulation device 102, the user interface 108 is in the off position and keeps the stimulation probe closed. After the user interface 108 has been turned on (e.g., by moving the switch 155 to the amplitude selection), the off position now corresponds to the standby state, and no stimulation will be delivered in the standby state. In an embodiment, once the stimulation device has been turned on, it cannot be turned off, it can only return to the standby state, and will remain operational for a predetermined time, such as at least about seven hours. This can allow the stimulation device 102 to be a one-time use device only, so it cannot be turned off and then used again later. However, it should be noted that some embodiments can allow the user to turn off the stimulation device 102 after the stimulation device is turned on. In an example, the user interface 108 can allow the selection of "continuous stimulation". Once continuous stimulation is selected, the stimulation device 102 may disable the user from controlling certain stimulation parameters, may allow the stimulation device 102 to shut down, or may shut down after a certain time (eg, 1 hour) in the continuous stimulation mode.

[0114] In addition, the stimulation device 102 can automatically shut down after a predetermined period, such as two hours or longer, one hour, thirty minutes, fifteen minutes, ten minutes, five minutes, one minute or thirty seconds, as non-limiting examples. Any predefined time can be used. In these embodiments, the stimulation device 102 may include a timer 109. The timer 109 may be operably connected to or integrated into the control circuit 104. As previously described, the timer (time) 109 can be triggered when the stimulation device 102 is turned on by the user. For example, the user can start, touch or otherwise engage the user interface 108 to turn the stimulation device 102 on to an active state. The timer 109 can then count down a predetermined amount of time, and at the end of the predetermined amount of time, the stimulation device 102 can be turned off, such as without manual intervention.

[0115] In some embodiments, the timer 109 may continue to run for a second predetermined amount of time, which may be greater than, less than, or equal to the predetermined amount of time. At the end of the second predetermined amount of time, the stimulation device 102 may automatically turn back on to apply electrical stimulation, or it may use an indicator 126 to identify to the user / surgeon that the second predetermined time has expired and the stimulation device 102 may turn on to provide stimulation; during the second predetermined amount of time, the stimulation device 102 may not turn on. In this case, the user / surgeon or even the patient may use the user interface 108 to manually turn on the stimulation device 102 to apply electrical stimulation. This may allow the stimulation device 102 to provide an automatic dosing scheme. In fact, this process may be repeated for any number of stimulation cycles, whereby the stimulation device 102 automatically turns on (without human intervention) within the stimulation predetermined amount of time and automatically turns off within the static time amount. Each cycle may have a different stimulation predetermined amount of time, such as a cascading time amount, or the time may be the same as other stimulation predetermined amounts of time. Similarly, the static time amount may be constant, or may vary according to a dosing schedule, for example, it may increase in each consecutive cycle. In addition, the stimulation predetermined amount of time can be the same or different from the resting amount of time. The stimulation device 102 can apply the dosing scheme using a cycle of stimulation predetermined amounts of time with different stimulation modes (or in some embodiments, the same stimulation mode). The stimulation predetermined amount of time and the resting predetermined amount of time can include any suitable cycle, such as one or more hours, thirty minutes, twenty minutes, fifteen minutes, ten minutes, one minute, or thirty seconds. The present teaching is not limited to a specific time.

[0116] In some embodiments, once the predetermined amount of time has elapsed, the stimulation device 102 may not be turned back on to apply stimulation. This essentially renders the stimulation device a one-time use device.

[0117] Further, the stimulation device 102 may include a pulse counter 105 of any suitable configuration. The pulse counter 105 may count the number of pulses applied by the stimulation device 102 and turn off after applying a predetermined number of pulses. The pulse counter 105 may be operably coupled to or integrated into the control circuit 104. Once a predetermined number of pulses occurs, the stimulation device 102 may automatically turn off. The stimulation device may then turn on to apply electrical stimulation after a predetermined amount of time using a timer 109 as described above, or it may use an indicator 126 to identify to the user / surgeon that the predetermined time has expired and the stimulation device 102 may turn on to provide stimulation. In this case, the user / surgeon or even the patient may use the user interface 108 to manually turn on the stimulation device 102 to apply electrical stimulation. This may allow the stimulation device 102 to provide an automatic dosing regimen. In fact, the process may be repeated for any number of stimulation cycles, whereby the stimulation device 102 automatically turns on (without human intervention) within a predetermined number of pulses and automatically turns off within a static amount of time. Each cycle may have a different predetermined number of pulses, such as a cascade number of pulses, or may have the same predetermined number of pulses. The amount of rest time can be constant or can vary according to a dosing schedule, for example, it can increase or decrease in each consecutive cycle. The stimulation device 102 can apply the dosing scheme using cycles of a predetermined number of pulses with different stimulation patterns (or in some embodiments, the same stimulation pattern). The predetermined number of pulses and the predetermined amount of rest time can include any suitable period, such as one or more hours, thirty minutes, twenty minutes, fifteen minutes, ten minutes, one minute, or thirty seconds. The present teachings are not limited to specific times and / or numbers of pulses.

[0118] In some embodiments, once a predetermined number of pulses have occurred, the stimulation device 102 cannot be turned back on to apply stimulation. This essentially results in the stimulation device being a single-use device.

[0119] In some embodiments, the pulse counter 105 may include one or more sensors that can determine the number of pulses generated from the stimulation device 102 (or more specifically from the probe 110). Further, the pulse counter 105 may include a stimulation sensor or multiple stimulation sensors that sense or determine the number of pulses actually delivered to the patient's target tissue (or nerve) from the stimulation device 102 through the probe 110. The stimulation sensor is capable of determining whether the electrical pulses emitted from the probe 110 are actually delivered to the patient. Therefore, in this embodiment, the pulse counter 105 will count the total number of pulses actually delivered to the patient. If for any reason, the pulse is not delivered to the patient, the pulse counter 105 will not count it, and such a pulse will not count toward the predetermined number of pulses that the pulse counter 105 is counting. In addition, the system is able to compare the number of electrical pulses sent from the device with the number of pulses actually delivered to the patient. This can be used to determine the function of the device and / or the stimulation parameters sent. Such a sensor may include an electrode attached to a nerve to determine whether a pulse is delivered to the nerve. The electrode can be configured to pick up a generally weak signal in the "background noise" in the patient's body.

[0120] Further, the pulse counter 105 may include an action potential sensor 107 or multiple action potential sensors, which can determine the number of action potentials generated from the stimulation device 102 (or more specifically from the probe 110) through one or more nerves of the patient. The action potential sensor 107 or multiple action potential sensors may include an accelerometer, an electrode (in any suitable configuration), etc. In an example, the system may include one or more leads for stimulation and (multiple) action potential sensors 107 including one or more leads for recording activity, such as recording electrical activity. The action potential sensor 107 can determine the action potential generated by one or more nerves stimulated by the stimulation device 102 through the probe 110. The action potential sensor 107 is capable of determining whether the electrical pulse emitted from the probe 110 is actually delivered to the patient and that it generates an action potential. For example, the action potential sensor 107 can be placed, connected to, or otherwise attached to a position on the patient, whereby the action potential can be detected when the stimulation is applied. In this case, the electrode can be located in the patient's body in the proximal and / or distal regions of the stimulation position innervated by the stimulated nerve. In an example, action potentials to the spinal cord, to muscle tissue, or to other directions may be recorded. The electrodes may determine, alone or in combination with other components (e.g., a processor and memory) whether an action potential is generated, and send a signal to the pulse counter 105 to indicate that an action potential has been generated, so that the pulse counter 105 can count the generation of action potentials. Further, the action potential sensor 107 may include an accelerometer that may be placed on, coupled to, or otherwise attached to the patient to determine whether an action potential is generated by stimulation from the stimulation device 102. The accelerometer may be useful if the applied stimulation is strong enough to cause a muscle contraction that the accelerometer can sense and send a signal to the pulse counter 105 to indicate that an action potential has been generated. Regardless of the configuration of the action potential sensor 107, the pulse counter 105 will count the total number of action potentials generated in the patient. If, for any reason, no action potential is generated in the patient, the pulse counter 105 will not count it, and such pulses will not count toward the predetermined number of action potentials that the pulse counter 105 is counting. In this case, the indicator can notify the user that not enough stimulation is being delivered and that treatment is paused until stimulation parameters are adjusted, or stimulation adjustment can be done automatically by software until an action potential is observed. In some embodiments, the indicator can be triggered after a given number of ungenerated action potentials are not identified within a given time frame or are otherwise missed (e.g., missed x in a row, missed i out of the last j, missed x within the past y milliseconds, etc.).

[0121] It should be noted that in some embodiments, one or more of the pulse counter 105, action potential sensor 107, or timer 109 may be contained in a single device, in multiple devices, in dedicated hardware and software, or as software stored in a memory and executed by a processor.

[0122] The user interface 108 may allow the stimulation signal pulse width to be adjusted from a predetermined range (e.g., about zero to about 200 microseconds). In an embodiment, the user interface 108 may be a potentiometer to allow a slide control to increase or decrease the stimulation signal pulse width within a predetermined range. The stimulation pulses may have a non-adjustable frequency in the range of about 10 Hz to about 30 Hz, and ideally about 16 Hz. In some embodiments, the stimulation pulses may include an adjustable frequency.

[0123] As a representative example, the stimulation pulse can have a biphasic waveform with controlled current during the cathodic (lead) phase and a net DC current of less than 10 microamperes, the switch adjustable from about 0.1 mA to about 20 mA, and the pulse duration adjustable from about 0 microseconds to about 1 millisecond.

[0124] An operative element (e.g., probe 110) exits or is attached to housing 120 at nose cone 124 to deliver stimulation current to excitable tissue. Probe 110 includes a length and diameter of conductive material and is ideally fully insulated, except for an uninsulated portion 114, e.g., about 1.0 mm to about 10 mm, and ideally about 4 mm to about 6 mm, which is non-insulated and serves as a stimulus to allow the surgeon to deliver stimulation.

[0125] The dimensions of the uninsulated portion 114 (active electrode) of the probe 110 ensure a high current density that will stimulate nearby excitable tissue. The insulating portion 112 may include a medical grade heat shrink material.

[0126] The conductive material of the probe 110 includes a diameter having a range between about 0.5 mm and about 1.5 mm, and may be ideally about 1.0 mm. The length of the operating element 110 may be about 50 mm to about 60 mm, but it should be understood that the length may vary depending on the specific application. As shown, the probe 110 may include one or more bends to facilitate accurate placement of the uninsulated portion 114. In an embodiment, the conductive material of the probe 110 is made of a stainless steel solid wire, although other conductive materials may also be used. In addition, the probe 110 may include an anchor 116. The anchor 116 may be any suitable configuration. As a non-limiting example, the anchor 116 may include a bend in the probe 110 so that when the probe 110 is inserted into the patient's tissue, or more specifically, when the anchor 116 is inserted into the patient's tissue, the anchor 116 prevents the undesired withdrawal of the anchor 116 and / or the probe 110.

[0127] As previously described, in monopolar operation, the return electrode 131 (or indifferent electrode), for example, provides an electrical path from the body to the stimulation device 102. The return electrode 130 may be placed on the surface of intact skin (e.g., a surface electrode used for electrocardiogram or electromyogram monitoring during a surgical procedure), or it may be needle-shaped and placed in the surgical area or through intact skin or an incision.

[0128] The configuration of the stimulation medical device that forms part of the system may vary in form and function.Various representative embodiments of illustrative medical devices will be described.

[0129] Reference now Figure 3-4A According to various disclosed aspects, there are percutaneous electrodes 300 and 400. Percutaneous electrodes 300 and 400 may generally include an insulating body 302 / 402, an anchor 304 / 404, and one or more uninsulated portions 306 / 406. It should be noted that percutaneous electrode 300 may include similar aspects to percutaneous electrode 400 unless the context indicates otherwise or specifically mentions differences between the two. Therefore, although an example may refer to one of percutaneous electrodes 300 and 400, for simplicity of explanation, the other may be utilized. In addition, the embodiments disclosed herein may utilize various other percutaneous electrodes.

[0130] In an example, the percutaneous electrode 300 can be placed at or near the target tissue area and can be coupled with a percutaneous lead or wire, as described herein. It should be noted that the percutaneous electrode 300 can be positioned when the incision is open and can remain in place when the incision is closed. In at least one other embodiment, the percutaneous electrode 300 can be positioned when the incision is closed or by deploying the percutaneous electrode 300.

[0131] In an embodiment, the percutaneous electrode 300 may include a multi-strand stainless steel wire insulated with a biocompatible polymer. Each wire strand may have a diameter of about 34 μm, and the insulated multi-strand lead may have a diameter of about 250 μm. However, it should be understood that these dimensions and materials are merely exemplary, and the present teaching is not limited thereto. Electrodes and percutaneous leads of any appropriate size, shape, and configuration may be used. The insulated wire may be formed into a spiral or helical shape, as has been found, to accommodate the high dynamic stresses during muscle flexion and extension while maintaining low sensitivity to fatigue. The outer diameter of the percutaneous electrode 300 may be about 580 μm, and it may be wrapped or filled with silicone or the like. In at least some embodiments, the percutaneous electrode 300 may be made of a different material (e.g., another metal, a conductive polymer), may be insulated with another material, or may not be insulated. In addition, the lead may be cylindrical or paddle-shaped.

[0132] Unlike surface electrodes that are applied to the surface of a patient's skin using an adhesive, the percutaneous electrode 300 can be surgically implanted or otherwise inserted into a selected tissue. The terminal or anchor 304 may include one or more tines 308 (e.g., tines 408 of the percutaneous electrode 400). The anchor 304 may be insulated or non-insulated. In at least some embodiments, the anchor 304 can be inserted directly into the tissue and can deliver stimulation signals to the tissue. On the other hand, the anchor 304 can generally hold the percutaneous electrode 300 in place. For example, one or more tines 308 may include a bend, a bend, a barb, etc. that substantially prevents the percutaneous electrode 300 from moving or inadvertently becoming loose. As shown in FIG. Figure 3 As shown in Figures 4 and 5, the disclosed embodiments may include different types of anchors 304 / 404. For example, the anchor may include j tines, where j is a number. In an exemplary embodiment, the patch assembly may be used in conjunction with the transcutaneous electrode 300. The patch assembly may include several layers, including an adhesive layer, an electrode layer, a reinforcement layer, and a cover layer. In an embodiment, the patch assembly may include a power supply for the stimulation device. In addition, the patch assembly may act as a surface electrode. In an embodiment, the patch assembly may include one or more engagement members that electrically couple the stimulation device to the transcutaneous electrode 300 to provide nerve regeneration stimulation. The engagement member may include a snap, a magnetic male and female member capable of operating the engagement, a bayonet engagement device, or any known engagement mechanism capable of electrically coupling the stimulation device to the transcutaneous electrode 300. The present disclosure contemplates any such configuration of the patch assembly.

[0133] In another aspect, the anchor may include a threaded member (e.g., a screw) or the like. In addition, the percutaneous electrode 300 may not include any tines or anchors. In these embodiments, the percutaneous electrode 300 may be placed near or around the applicable nerve, i.e., generally around all or part of the applicable nerve. In addition, the percutaneous electrode 300 may be placed above the applicable nerve in any manner, i.e., at the top or bottom of the applicable nerve, or near the applicable nerve, i.e., at an operating distance from the applicable nerve. The present teachings may not be limited to a particular configuration. Embodiments may include a nerve cuff, a coiled lead, a straight lead, a lead with a hook, a lead with one or more tines, and the like.

[0134] According to an embodiment, the transcutaneous electrode 300 may include a flexible material that allows some or all of the transcutaneous electrode 300 to bend or deform. In an example, the insulating portion 302 may be a generally flexible lead to allow the transcutaneous electrode 300 to be removed, positioned, or otherwise manipulated.

[0135] In an embodiment, the uninsulated portion 306 section may be separated from the insulating portion 310 (eg, Figure 4AThe uninsulated portion 306 is separated from the percutaneous electrode 300 by an insulating portion 410 in the non-insulated portion 306. It should be noted that different sections of the uninsulated portion 306 can be electrically insulated from each other to allow for bipolar stimulation. On the other hand, the insulating portion 310 can allow the percutaneous electrode 300 to increase strength, positioning, etc. The uninsulated portion 306 can be operable to deliver stimulation current. It should be noted that the uninsulated portion 306 can be disposed anywhere along the percutaneous electrode 300. For example, the uninsulated portion 306 can be disposed at one or more tines 308, at the anchor 304, etc.

[0136] Figure 4B Another percutaneous electrode 450 is shown that includes an insulating body 452 and an anchor 454. The anchor 454 may include a twisted or braided wire. The anchor 454 may be conductive and not insulated so that it can apply a stimulation signal to the tissue. In one aspect, the anchor 454 may include a spiral portion 458. In another aspect, the body 452 may include a twisted, braided or spiral portion 460. The spiral portion 458 and the spiral portion 460 may anchor the percutaneous electrode 450 in place. In one aspect, the percutaneous electrode 450 may allow for extended use or implantation. For example, tissue around the spiral portion 458 or the spiral portion 460 may heal. The shape of these portions allows tissue to grab and grow between the turns or bends of the spiral portion 458 and the spiral portion 460. Tissue growth will anchor the percutaneous electrode 450 and may prevent or reduce the chance of infection as the tissue heals around the percutaneous electrode 450. This may allow the electrode 450 to remain in place for an extended period of time or a short period of time. Additionally, the helical portion 460 may include a finely coiled wire with an insulating material surrounding it.

[0137] Now go to Figure 5-7 ,refer to Figure 1 -4, there is an adapter 500 (which includes the percutaneous electrode 400 (and may also include electrodes 300 and 450) and a lead 502), an adapter 600 (which may be coupled to a stimulation device and / or percutaneous electrodes), and a stimulation system 700 (which may include the stimulation device 102). It should be noted that similarly named components of various embodiments may include similar aspects unless the context indicates otherwise or a specific distinction is made.

[0138] In an embodiment, the adapter 500 may mainly include a percutaneous electrode 400, a lead 502, and a connector 512. The lead 502 may connect the terminal 412 of the percutaneous electrode 400 to the connector 512. In one aspect, the lead 502 may include an insulated wire that is removably or non-removably attached to the percutaneous electrode 400 and / or the attachment 512. As described herein, the adapter 500 may be configured to allow the stimulation probe 110 to deliver stimulation signals under the skin of a subject.

[0139] In one aspect, the connector 512 may include an opening 514 that may receive an operating element. Figure 7 As shown, the opening 514 can receive the probe 110 of the stimulation device 102. The opening 514 can be tapered to maintain a friction fit of the probe 110 within the connector 512. The connector can also include other retention features, such as fasteners (e.g., threads, buckles, threaded portions, VELCRO, magnets, etc.) to maintain the connection between the connector 512 and the probe 110. It should be noted that the connector 512 can include an electrical connection disposed within the connector 512 that can operably couple the uninsulated or stimulation portion of the probe 110 with the lead 502.

[0140] Wire 502 may extend from connector 512. Wire 502 may be an electrical conductor that is electrically connected to probe 110 when probe 110 is operably inserted into connector 512. It should be noted that wire 502 may be any suitable length, such as 24 inches or a length between 12 inches and 48 inches. The lead wire may also be of any suitable gauge, such as 24 AWG (American Wire Gauge) wire.

[0141] The transcutaneous electrode 400 can be coupled to the lead 502 at the terminal 412. Depending on the embodiment, the lead 502 can be removably or non-removably coupled to the terminal. It should be noted that the lead 502 can be directly coupled to the terminal 412 and / or can be indirectly coupled to the terminal 412, for example, through one or more other connectors (not shown). In addition, the lead 502 can be coupled to other parts of the transcutaneous electrode 400. In one aspect, the connection between the lead 502 and the transcutaneous electrode 400 can be insulated or non-insulated.

[0142] like Figure 6As shown, the adapter 600 may include a wire 602 and one or more connectors 612 / 622. Each connector 612 / 622 may include an opening 614 / 624. In one aspect, the openings 614 / 624 may include similar or different sizes. For example, the size and shape of the openings 614 / 624 may be operably configured to receive an operating element and / or a transcutaneous electrode (e.g., a transcutaneous electrode 300 / 400). In at least one embodiment, the size of the opening 614 is operably configured to receive an operating element, and the size of the opening 624 is operably configured to receive a transcutaneous electrode. On the other hand, the connector 612 / 622 may include an elastic material that may be stretched, compressed, or otherwise adapted to fit components of different sizes. In addition, although the embodiments disclose the connector 612 / 622 as a female connector, it should be noted that one or more connectors 612 / 622 may be a male connector. In another aspect, the conductor 602 (or 502 ) may include one or more branches or paths such that the connector 614 may be electrically coupled to one or more other connectors via the conductor 602 , for example.

[0143] Steering Figure 7 As described herein, the system 700 can include a stimulation device 102 that can be coupled to an adapter 500 (or other described adapters). In one aspect, the surgeon can utilize the stimulation device 102 prior to or during a surgical procedure (e.g., nerve localization, nerve assessment, etc.). In some embodiments, the surgeon can place percutaneous electrodes or non-percutaneous electrodes at desired locations prior to a surgical procedure. The surgeon can couple the electrodes to the stimulation device 102 via the connector 500.

[0144] As shown, connector 512 can be attached to probe 110. The surgeon can select a stimulation process using user interface 108. For example, the surgeon can operably set stimulation device 102 to deliver continuous stimulation to the target tissue. In one aspect, continuous stimulation can be applied before surgical intervention (e.g., nerve repair, nerve release, or nerve transfer). In one aspect, continuous stimulation can be delivered to nerves or muscles distal to the surgical intervention site to increase muscle viability while nerve regrowth occurs.

[0145] It should be noted that the stimulation device 102 may include a pre-programmed stimulation procedure that may be operable to generate stimulation signals for continuous stimulation. In another aspect, the user interface 108 may allow a user to manually program or adjust stimulation parameters, such as intensity, pattern, time, and the like.

[0146] Figure 8-10 A container 800 is shown that may operably receive a stimulation device (eg, stimulation device 102). Fig.11The stimulation device 102 is shown disposed within the container 800 and connected to the adapter 500 .

[0147] In at least one embodiment, the stimulation device 102 can be placed in the container 800 prior to the surgical procedure. When the stimulation device 102 is in the container, the container 800 can be sealed to prevent contamination of the stimulation device 102. In some embodiments, the stimulation device 102 can be placed directly in the container 800 by the manufacturer and can be hermetically sealed therein. Therefore, the stimulation device 102 is not exposed to the external environment.

[0148] The stimulation device 102 can be used to stimulate the target tissue within the container 800 prior to surgery. The same stimulation device 102 can be removed from the container 800 and utilized during surgery. For example, the container 800 can be sterilized prior to entering a surgical operating room. Once in the room, the stimulation device 102 can be removed from the sterilized container 800 for use during surgery.

[0149] In some other examples, the stimulation device 102 can be provided in a liner (not shown) or other sealed packaging and then placed in the container 800. Thus, the container 800 can be discarded after the continued stimulation and before the surgical procedure. The stimulation device 102 can then be removed from the liner for use in the surgical procedure. The container 800 can include various materials, such as one or more of plastics, metals, etc. In at least one embodiment, the container 800 can include a sterilizing material. In addition, the liner can include various materials, such as one or more of plastics, metals, etc.

[0150] The body 802 of the container 800 may include a terminal end 804 and a proximal end 806. The terminal end 804 may include a sealed opening 808 that can be opened when the surgeon desires to remove the stimulation device 102 from the container 800. It should be noted that the sealed opening 808 may include adhesive, perforations, etc. For example, a user may tear or tear off the perforations to expose the stimulation device 110. In some cases, the container 800 may include a pull tab that allows a user to grasp and pull the tab to open the sealed opening 808.

[0151] It should be noted that various other sides or portions of the body 802 may include openable flaps or seals to allow the surgeon to remove the stimulation device 102 from the container 800. In addition, the surgeon may use a cutting device, such as sterile scissors, etc. to open the container 800. It should be noted that the container 800 may include markings indicating where the user should cut to avoid damaging the stimulation device 110.

[0152] According to an embodiment, the container 800 may include one or more fasteners 810 that can secure or hold the stimulation device 110 within the container 800. The fastener 810 may include a hook, a buckle, a threaded member, an adhesive, or other fastener. For example, the fastener 810 may include a buckle that is sized and shaped to allow the body 120 of the stimulation device 102 to snap into the buckle. In one aspect, the buckle can be frictionally engaged with the body 120 to hold the stimulation device 102 in a general position relative to the container 800.

[0153] The body 802 may include one or more ports, such as port 812 and port 814. Port 812 and port 814 may be disposed in different locations, and in an example, port 812 is disposed in a location that allows an operative element of the stimulation device 102 to be inserted or otherwise attached to the port 812 when the stimulation device 102 is attached to the fastener 810. Port 814 may operably receive the return electrode 130. It should be noted that port 812 and port 814 may be positioned substantially proximate to each other, or may be positioned in other locations.

[0154] In at least some embodiments, ports 812 and 814 can allow components disposed within the container to be electrically coupled to components disposed outside the container while maintaining a hermetic seal of the container 800, while maintaining a non-hermetic seal of the container 800, or while not maintaining a seal of the container 800. In an example, port 812 can receive a connector (e.g., connector 512 as shown in expanded view 1100). For example, port 812 can receive a portion of connector 512 and can operably hold connector 512 in place (e.g., via a friction fit, a fastener, etc.).

[0155] In at least one embodiment, port 812 (and / or 814) can include connector 512 built into container 800. For example, stimulation device 110 can be disposed within container 800, and connector 512 can be attached to port 812 by a user or otherwise. In another aspect, a return electrode can be coupled to another connector of port 814.

[0156] The user can connect the adapter 500 to the port 812 from the outside of the container 800 so that the container 800 remains hermetically sealed or non-hermetically sealed. In another aspect, the user can connect the return electrode 1102 to the port 814 via the wire 1104 and / or another connection. According to one aspect, this can reduce or prevent matter (e.g., bodily fluids, debris, etc.) from diffusing into the container 800 and contaminating the stimulation device 110.

[0157] The body 802 may include other or additional components. For example, the body 802 may include an electrode 816 attached to the outer surface of the container. The electrode 816 may be electrically connected to a return electrode of the stimulation device through the port 814. In this embodiment, the integrated system will reduce the need for connection of an additional return current electrode such as 1102.

[0158] exist Fig.11 In another aspect shown, the body 802 can include an attachment device, such as a strap 124, which can help attach the container 800 to an object, such as a patient's limb, a belt, a hospital device, etc. For example, the container 800 can be attached to a patient's limb prior to a surgical procedure for continuous stimulation. This can allow the user to move while the stimulation is applied. Various other attachment devices can be utilized, such as hook and loop materials, magnets, elastic materials, etc.

[0159] Figure 12-14 A splitter device 1200 is shown that can operably split a stimulation signal and / or a return signal. According to an embodiment, the stimulation device 1200 generally includes a housing 1202 that houses a circuit 1220. The housing can include an input port 1206 and one or more output ports 1212, 1214, 1216, and 1218. It should be noted that the splitter device 1200 can include any number of input or output ports. The internal circuitry therein can be used to deliver an input signal to multiple output channels, maintaining the current level at a set output, such as at 1.0 or 2.0 mA.

[0160] The branching device 1200 can receive a first lead 1230 via an input port 1206. In one aspect, the first lead 1230 can be connected to a stimulation device (not shown) that can operably apply a stimulation signal to the input port 1206. The circuit 1220 can separate the stimulation signal to one or more output ports 1212, 1214, 1216, 1218 that can be connected to one or more operating elements, percutaneous leads (e.g., percutaneous leads 300, 400, etc.), non-percutaneous leads, or connectors as described herein. In an example, a surgeon can place a percutaneous lead 400 in different target tissues of one or more patients. The surgeon can attach the percutaneous lead 400 to the branching device 1200, and can attach the stimulation device to the branching device. The stimulation device 1200 can apply a continuous stimulation signal to multiple tissue regions via the branching device 1200 and / or the percutaneous lead 400.

[0161] As described herein, circuit 1220 can be an interface between a stimulation signal (received at input port 1206) and split the input signal into one or more output signals through attached electrodes, selectively output at one or more of output port(s) 1212, 1214, 1216, and 1218. This can allow the stimulation device to utilize additional channels or contacts in addition to other available channels or contacts.

[0162] It should be noted that the circuit 1220 may include a power source (e.g., a battery), or may receive power from a stimulation device or other external source. In an example, the circuit may include an inductive circuit that is operable to store power in one or more capacitors. According to another embodiment, the input signal received at the input port 1206 may provide power. The circuit may include a component that ensures that the output is maintained within a specified range (e.g., 2.0 mA) whenever a stimulation pulse is delivered to the input port. In addition, the circuit 1220 may include a demodulator (e.g., receiving and decoding information) and one or more switches or registers that control the output to the percutaneous lead 400 or other electrical contacts, etc. In one aspect, the switch can be used to detect whether the electrical contacts are connected to the output ports 1212, 1214, 1216, and 1218 so that power can be selectively applied to the ports.

[0163] In embodiments, the splitter device 1200 or aspects thereof can be disposed on or within a container (e.g., the container 800), or placed on a body external to the container. For example, the housing 1202 can be disposed within a layer of material in the container 800. In another aspect, the circuit 1220 can be disposed within the material of the container 800 (e.g., the housing can include the material of the container). The splitter device 1200 can be sterilized prior to and / or after a surgical procedure.

[0164] According to various embodiments, the splitter device 1200 may include a clip, fastener, magnet, or the like to operably attach the splitter device to a patient, clothing, hospital equipment, or the like.

[0165] Figure 15-17A stimulation system 1500 is shown that mainly includes a stimulation (simulation) device 1501. The stimulation system 1500 can operably control the stimulation of tissue via one or more stimulation medical devices, which include, for example, a stimulation (simulation) device 1501, a probe 1510, a percutaneous electrode 300 / 400, a cutting device, a drilling device, an auger, a fixing device, etc. The stimulation system 1500 may include an external stimulator that can be selectively attached to the patient's body. The stimulation system 1500 may include a box that can be attached to the patient, such as by adhering to a patch assembly or other adhesive device to the patient, selectively attaching the stimulation device 1501 to the patient's clothing, including a belt or necklace that the patient can wear to hold the stimulation device 1501, attaching the stimulation device 1501 to the patient or the patient's clothing using hook and loop fasteners, etc.

[0166] In one aspect, stimulation device 1501 may include a circuit operable to generate an electrical stimulation signal to be applied to tissue. In one aspect, stimulation device 1501 may include similar functionality described with reference to other stimulation devices (e.g., stimulation device 102). In addition, stimulation device 1501 may include a user interface 1508 that includes a display 1502. As described herein, user interface 1508 may include an input / output device operable to receive user input. The user may interact with user interface 1508 to adjust the parameters of the stimulation signal and / or receive information from display 1502. For example, display 1502 may indicate to the user the remaining length of time for the current treatment, the time the treatment has been applied, the number of doses of the applied treatment, and / or the number of treatments to be applied. As a non-limiting example, if the treatment has an expected duration of one hour and twenty minutes of treatment have been applied, display 1502 may display that there are forty minutes left for the treatment. Display 1502 may include an LED screen that may provide any information indicated in the present disclosure to the user, patient, and / or clinician. In addition, the stimulation device 1501 may include a user interface 1508, which includes a display 1502 and audio feedback. In at least some embodiments, the user interface 1508 can generate an alarm that is auditory, visual, tactile (e.g., vibration), or a combination of the above. For example, the user interface 1508 can generate an alarm to indicate that the treatment is complete, the lead has moved, the lead has been detached, the stimulation has been interrupted, an error has occurred, a warning (e.g., low battery), etc. As described herein, the user interface 1508 may include an input / output device that is operable to receive user input. The display 1502 with or without additional audio tones can display to the user a signal recorded on one or more input ports 1506, which can be connected to other sensors or systems to record physiological signals, such as pressure, electromyography, stretching, force, etc. In one aspect, the stimulation device 1501 may include a wired or wireless communication component. For example, the stimulation device 1501 may include a wireless transmitter / receiver configured to communicate via one or more communication protocols (e.g., Wi-Fi, Bluetooth, NFC, etc.).

[0167] Stimulation device 1501 may include one or more output ports 1512 that are operably coupled to an operative element (eg, probe 100), one or more percutaneous leads 400, and / or a connector 500 (eg, Fig.181500) or other components. According to one or more embodiments, the stimulation device 1501 may include one or more output ports 1506, which may be connected to the return electrode 1802 via a wire 1804. It should be noted that the return electrode 1802 may include a pad type, a needle type, or other types of electrodes described herein. In embodiment 1700, the return electrode 1516 may be fixed to the back of the stimulation device 1512.

[0168] In embodiments, a first side 1510 of the stimulation device 1501 may include a user interface 1508 as described herein. A second side 1512, generally opposite the first side 1510, may include a return current electrode 1516. The second side 1512 or sides of the device may operably receive a strap 1530. The strap 1530 may be connected to an object, such as a patient, hospital equipment, etc. It should be noted that the stimulation device 1501 may be attached to an object via other components, such as clips, magnets, Velcro, adhesives, etc. It should also be noted that, as described with reference to Figure 8-11 As described, stimulation device 1501 can be disposed in a container (e.g., container 800). In addition, stimulation (simulation) device 1501 can apply stimulation to the target tissue area before surgery. In some embodiments, different stimulation devices (e.g., stimulation device 110) can be used during and / or after surgery.

[0169] As described herein, a stimulation device (e.g., stimulation device 102, 1501, etc.) can be operable to apply continuous stimulation to a target tissue. In an example, continuous stimulation can be applied before a surgical procedure is performed, during a surgical procedure, after a surgical procedure is performed, or as a treatment independent of a surgical procedure. The stimulation can be applied in a surgical operating room or in a different room. If in a surgical operating room, tissue and other objects may be sterilized before the stimulation is started. Therefore, it may not be necessary to sterilize the stimulation device or container before starting a surgical procedure. In addition, in treatments without a surgical procedure, the stimulation can be applied in an office or any other location.

[0170] In other examples, stimulation can occur in a different room so that the surgical room can be used for other purposes. Some examples provide for disposal of the stimulation device after pre-surgical stimulation. Other examples can be arranged to use different stimulation devices before and during surgery. In addition, stimulation can be applied before surgery, but not during or after surgery. Thus, the electrodes can be positioned for pre-surgical stimulation. The electrodes can then be removed before or during surgery.

[0171] On the one hand, the surgeon can selectively apply stimulation before, during or after surgery in response to an assessment of neural function in which pre-surgical stimulation is used as a baseline for comparison. For example, pre-surgical stimulation can be applied to the target tissue. The stimulation can be terminated and the surgery can be performed. During and / or after the surgery, the surgeon can apply stimulation to assess neural function. If the neural function is below a threshold (or a previously established threshold hold value), the surgeon can apply stimulation before, after or before the end of the surgery. In this case, electrical stimulation can be applied before or at the beginning of the surgery, or before or at the beginning of a treatment without surgery to determine a baseline level of neural excitability. During or near completion of the surgery or treatment plan, a second neural excitability threshold test can be performed. The second threshold test can be compared with the first threshold test. If the second threshold test results in lower neural excitability, continuous stimulation can be applied after surgery or treatment to help neural regeneration. The application of the second threshold can determine whether neural regeneration stimulation is necessary or desired for the patient, for example, to treat any potential neural damage or trauma implied by a decrease in neural excitability between the first and second thresholds, or to determine whether the patient needs surgery. In addition, the application of a second threshold test can help determine the amount of time, parameters of the electrical stimulation (e.g., amplitude, speed, time period, stimulation pattern, etc.) applied as part of the nerve regeneration stimulation. For example, based on the severity of the injury from the threshold test, the stimulation can be performed for a longer duration or at a higher amplitude. For example, if the nerve is less responsive to the stimulation, a larger amplitude can be applied, such as 10 mA instead of 2 mA.

[0172] Threshold testing may include electrical stimulation of one or more nerves within the target tissue area to determine or measure the excitability and / or conduction of the one or more nerves. In such cases, it may only be necessary to test nerve excitability to determine whether post-procedural nerve regeneration therapy is needed before applying such nerve regeneration therapy, or to determine how to apply nerve regeneration therapy. Threshold testing may be performed at any time during the surgical procedure, such as when a retractor is removed, when force is applied to a patient's limb, etc.

[0173] For example, during a surgical procedure, a surgeon may make an incision in a patient. The surgeon may apply a stimulation signal in the incision using a stimulation device. Although in some embodiments, the stimulation signal may not be used during the surgical procedure. Instead, the stimulation may be applied only after the surgical procedure, such as, as a non-limiting example, during sensory nerve repair, motor or mixed nerves, where the clinician does not need or otherwise use a stimulator for nerve identification. It should be noted that the stimulation may be applied to motor or mixed nerves, where the surgical procedure does not use stimulation during the surgical procedure. Whether the stimulation is applied during the surgical procedure or after the incision is closed, the surgeon may place a percutaneous lead in or near the target tissue. The percutaneous lead may be attached to the stimulation device. The stimulation device may apply continuous stimulation. In an example, the stimulation device may be the same stimulation device used during the surgical procedure, or may be a different stimulation device. On the other hand, the stimulation device may be disposed in a container that generally prevents contamination or movement of the stimulation device.

[0174] As described herein, after stimulation is complete, the surgeon or clinician can remove the percutaneous lead.In one aspect, the percutaneous lead can be pulled out of the target tissue.

[0175] In some embodiments, the above-mentioned stimulation can be completed as a part of an overall multi-stage treatment plan. In such an example, as a part of neural regeneration treatment, different treatments or the same treatment pattern can be applied within a limited cycle. The entire multi-stage treatment plan can last for any appropriate time. According to the overall goal of treatment, the state of the nerves to be treated, the healing ability of the people to be treated, or any other relevant factors (e.g., excitability, conduction velocity, axon count, Schwann cell count, axon growth distance from the injury site based on the measured electrical activity point, etc.), it can include about 5 minutes to up to several months. In addition, the timing of distribution can include any suitable cycle, such as 1,5,10,15,30,45 minutes, one hour, two hours or even longer. The cycle between distribution can include any suitable cycle, such as 1,5,10,15,30,45 minutes, one hour, two hours or even days, weeks or months. The timing of dosing and the time period between dosing durations will depend on many different factors, including, but not limited to, the nerve injury, the amount of nerve damage, the location of the injury, the patient's regenerative capacity, the stimulation therapy applied to the patient (the mode and settings of electrical stimulation (e.g., frequency, amplitude, waveform shape, etc.)), the leads utilized in the stimulation, and the stimulation device utilized. However, it should be understood that this is not an exhaustive list; any suitable factors may be utilized in determining appropriate timing. In at least one embodiment, recovery can be tracked and the stimulation pattern can be adjusted or changed based on patient response, such as nerve healing or regrowth identified by physical assessment, electrodiagnostic testing, functional testing, etc.

[0176] An example of a multi-stage treatment may include providing a stimulation treatment as described above to one or more nerves at a first treatment time. The treatment applied may include any electrical stimulation treatment for the above-mentioned nerve regeneration. The treatment may be directly related to the healing process that promotes one or more specific mechanisms, such as axonal growth. The stimulation may be applied in any manner, for example, the stimulation may be applied for a first time period and then repeated a limited number of times within the first treatment time. During the first treatment, the stimulation may be dispensed so that the stimulation is turned off during a non-stimulation time period and then reopened in a second time period to regenerate the nerve. The dispensing may be done in any manner, such as, as a non-limiting example, as part of a random dispensing (each stimulation cycle is a different time or frequency), pseudo-random (the stimulation cycle is pseudo-random and / or the frequency within a cycle is pseudo-random), constant, patterned (e.g., cascaded or simulated physiological responses), or any combination of the foregoing. The stimulation system 100 may be configured to apply all different stimulation modes required as part of a multi-dispensing program.

[0177] The multi-stage treatment plan may include optimizing the stimulation pattern applied to the patient to promote the healing process of one or more mechanisms of the patient. For example, the stimulation pattern applied can be optimized for angiogenesis, axon growth, cell migration (e.g., Schwann cells or macrophages), muscle and / or neuromuscular junction maintenance or any other suitable treatment. The stimulation pattern can be optimized based on many different factors, including but not limited to the treatment provided, nerve injury, the amount of nerve damage, the patient's tolerance, the patient's composition (body mass index, age, etc.), the location of the nerve to which the stimulation is applied, the time point in the regeneration process, etc. The stimulation pattern can be optimized by using computer modeling to determine the optimized stimulation pattern for a specific treatment and / or patient. In addition, the optimized stimulation pattern can depend on the stage of the multi-stage stimulation treatment. The optimized stimulation pattern can be changed according to whether the treatment is in the early or late stages. For example, a stronger stimulation can be applied earlier in a continuous treatment than during the late stage when the nerve has already begun its healing process. Of course, the opposite may also be true, that is, the optimized stimulation pattern can be a weaker stimulation earlier in a continuous treatment and becomes stronger during the stimulation treatment cycle. This may be particularly true if there is significant damage to the nerves and the patient can only tolerate weaker stimulation early in the treatment. In addition, treatment can be optimized based on the healing or regeneration stage. For example, early stimulation can be targeted to increase the early regenerative response (including but not limited to cell recruitment and differentiation, angiogenesis, etc.), then changed to help axon guidance or growth to the target, and these two stages can be combined with stimulation of the innervated target to improve the viability of the target and overall reinnervation. Any combination of the foregoing can be applied.

[0178] Throughout the healing process, the stimulation pattern can be changed to achieve different optimizations of the neural healing mechanism. The pattern of the neural healing mechanism can be selected by the clinician, which is determined based on previous experience, computer modeling, known treatment results, etc. The stimulation system 100 can be configured to apply all different stimulation patterns required as part of the different optimization mechanisms contemplated herein. For example, a pattern can be applied based on macrophage recruitment or Schwann cell recruitment, first angiogenesis, and then axon guidance.

[0179] The process may further include the delivery of biological agents, drugs, other electrical stimulation treatments or other non-electrical stimulation treatments. The delivery of these additional therapies can fill the gaps of the above-mentioned electrical stimulation treatments to further enhance nerve regeneration and growth. For example, in addition to the above-mentioned electrical stimulation treatments for nerve regeneration, a drug treatment regimen can be used. In these embodiments, drug treatment can be applied before, at the same time, or after the electrical stimulation treatment. In addition, drug treatment (or alternative treatment) can be applied as part of the distribution treatment, for example, the electrical stimulation cycle is followed by a drug treatment cycle, and then electrical stimulation again, which can be followed by drug treatment (or any alternative treatment) again. Any suitable combination of electrical stimulation treatment and alternative treatment for nerve regeneration can be applied in any suitable combination. Examples may include, but are not limited to, electrical stimulation applied for a period of time by the stimulation system 100, followed by a drug treatment regimen. Further distribution of electrical stimulation by the stimulation system 100 can be further applied. It is also possible to perform additional drug treatment subsequently. These steps can be repeated in any order, any number of distributions, and any suitable duration. In addition, the dispensing of electrical stimulation and drug therapy does not have to be continuous, that is, there can be one or more electrical stimulations, followed by a single or multiple applicable drug therapy. In addition, although drug therapy is described as following electrical stimulation, the present teaching is not limited to this configuration. Drug therapy dispensing can be applied before, at the same time, or after electrical stimulation. In some embodiments, electrical stimulation can enhance the efficacy of drug therapy, or drug therapy can enhance the efficacy of electrical stimulation. In addition, although drug therapy has been described, any other nerve regeneration treatment can be utilized, including but not limited to biological preparations, stem cell therapy, gene therapy, vitamin therapy, laser therapy, laminin-coated chitosan catheters, or any combination of the foregoing. The applied electrical stimulation for nerve regeneration can be the primary treatment, or can be an auxiliary or secondary treatment of any other aforementioned treatment. Each of these treatments can be used as part of a dispensing regimen, for example, together with immunosuppressive drugs (e.g., tacrolimus, also referred to as FK506). The present teaching is not limited to those described herein, which are not described in full for the sake of brevity, but are considered by the present teaching.

[0180] The foregoing is considered to be merely an illustration of the principles of the present invention. In addition, since many modifications and variations will readily occur to those skilled in the art, it is not desirable to limit the present invention to the exact structure and operation shown and described. Although preferred embodiments have been described, details may be changed without departing from the present invention as defined by the claims.

Claims

1. An electrical stimulation system, comprising: A stimulation device, comprising case; a control circuit operable to generate a stimulation signal, wherein the control circuit is disposed within the housing; wherein the stimulation device is operable to generate a first stimulation signal for application to a target damaged nerve, thereby directly activating the excitable tissue of the target damaged nerve to change the recovery of the target damaged nerve, and the stimulation device is operable to generate a second stimulation signal for stimulating the target damaged nerve, thereby directly activating the excitable tissue of the target damaged nerve, wherein the second stimulation signal is applied for a total treatment time of between ten minutes and fifteen minutes to change the recovery of the target damaged nerve.

2. The electrical stimulation system according to claim 1, wherein: The first stimulation signal occurs before a subcutaneous surgical procedure and the second stimulation signal occurs after a subcutaneous surgical procedure.

3. The electrical stimulation system according to claim 1, wherein: The stimulation device is operable to generate a third stimulation signal for stimulating the target damaged nerve during subcutaneous surgery.

4. The electrical stimulation system according to claim 1, wherein: The stimulation device terminates generation of the first stimulation signal before the subcutaneous surgery begins, and does not generate another stimulation signal until after the subcutaneous surgery ends.

5. The electrical stimulation system according to claim 1, wherein: The stimulation device also includes a pulse counter operable to count the number of pulses generated by the control circuit.

6. The electrical stimulation system according to claim 1, wherein: The stimulation device further comprises a timer operable to measure the passage of time during which the control circuit generates the stimulation signal.

7. The electrical stimulation system according to claim 1, wherein: The stimulation device also includes an action potential sensor operable to sense invoked action potentials through the target tissue region.

8. The electrical stimulation system according to claim 1, wherein: The first stimulation signal is applied for a first dosing duration, the first dosing duration being between ten and fifteen minutes.

9. The electrical stimulation system according to claim 1, wherein: The first stimulation signal is applied for a plurality of dosing durations, wherein each of the dosing durations is an equal amount of time.

10. The electrical stimulation system according to claim 1, wherein: The first stimulation signal is applied for a plurality of dosing durations, wherein each of the dosing durations is a different amount of time.

11. An electrical stimulation system comprising: A stimulation device, comprising: a handheld housing configured to be held in a single hand by a user; a control circuit operable to generate a stimulation signal, wherein the control circuit is disposed within the handheld housing; Wherein, the stimulation device is operable to generate a first stimulation signal for application to a target damaged nerve, thereby directly activating the excitable tissue of the target damaged nerve for a total treatment time of between ten minutes and fifteen minutes to change the recovery of the target damaged nerve.

12. The electrical stimulation device according to claim 11, wherein: The stimulation device is operable to generate a second stimulation signal for stimulating the target damaged nerve to promote a second mechanism of healing.

13. The electrical stimulation system according to claim 11, wherein: The stimulation device also includes a pulse counter operable to count the number of pulses generated by the control circuit.

14. The electrical stimulation system according to claim 11, wherein: The stimulation device further comprises a timer operable to measure the passage of time during which the control circuit generates the stimulation signal.

15. The electrical stimulation system according to claim 11, wherein: The stimulation device also includes an action potential sensor operable to sense invoked action potentials through the target tissue region.

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