All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The inventions described herein relate to the field of implantable neuromodulators.
Implantable neuromodulators (e.g., implantable neurostimulators) are increasingly used to treat pain and other indications, in many cases by the direct application of electrical energy to one or more nerves, including nerve bundles. Such electrical modulation may be used to excite or inhibit nerves, or both. An implantable neuromodulator may be implanted on, around or adjacent to a patient's nerve or nerves for the delivery of electrical energy.
For example, electrical modulation may be applied to a nerve to treat the unwanted and/or uncoordinated generation of nerve impulses which may otherwise be a disabling factor in some medical conditions. Uncoordinated motor signals may produce spasticity in stroke, cerebral palsy, multiple sclerosis, and other conditions and may lead to pain, including pain resulting from amputation. The uncoordinated signals may result in the inability to make desired functional movements. Involuntary motor signals in conditions including tics, choreas, and so on, may produce unwanted movements. Unwanted sensory signals can cause pain.
Electrical modulation to treat a patient is generally sensitive to the amount, during and intensity of the applied energy. For example, one non-limiting type of electrical therapy is applying high-frequency alternating current (HFAC) to nerves that has been shown to block nerve activity, e.g., in the treatment of pain. An appropriate dose (e.g., the amount of electrical energy applied to the patient for effective treatment) may be set so that it causes the desired effect, such as inhibition of nerve activity to reduce pain. On the other hand, an inappropriate dosing may lead to no effect or possibly to irritation of the nerve.
Unfortunately, determining proper dosing for a patient may be time-intensive, and complicated. Further, the optimal dosing to treat a patient may be highly variable between patients, and indeed, even over time in the same patient. Thus, it would be beneficial to provide a method and/or apparatus for simplifying and reliably setting patient dosing. Described herein are methods and apparatuses that may address these needs.
Described herein are methods and apparatuses (devices, systems, etc., including neuromodulators and systems including them) for setting the therapeutic dosing of a neuromodulator that is implanted into a patient. A therapy dose typically includes a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage. The setting processes described herein may adjust (e.g., set) the peak voltage of ramp to a voltage that is beyond the patient's nerve activation level and within a nerve blocking level. The dose parameters may also include the waveform parameters applied, e.g., pulsatile or repeating (e.g., sinusoidal, square wave, saw-tooth, biphasic, etc.), and the frequency of the applied waveform (e.g., the high-frequency component). Other dose parameters may include the initial (e.g., starting) voltage, which may be, e.g., zero, or may be a minimum patient-detectable modulation voltage that is determined as described herein. In some variations, the therapeutic dose includes at last two parts; an initial ramp-up portion in which the voltage increases from the initial voltage up to a peak modulation voltage, and a plateau portion, referred to as a sustained peak modulation time, during which the voltage is sustained at the peak modulation voltage. The duration of the ramp-up portion may be referred to as the ramp-up time. The duration of the second portion may be referred to as the plateau time. In some variations, these two portions may repeat and/or alternate.
The methods and apparatuses described herein may use a testing ramp applied by the implanted neuromodulator to identify a peak modulation voltage that is patient-specific and provides that patient with a maximal therapeutic effect while remaining comfortably tolerable by the patient during the application of energy by the neuromodulator. The testing ramp may be applied as part of a therapy dose-setting procedure during which a ramped voltage, having the same or a similar frequency as the therapeutic dose will have, is applied by the implanted neuromodulator. Feedback, either direct (such as patient reporting) or indirect (e.g., from patient biometrics) or both may be used to select the target sensation intensity modulation voltage. The target sensation intensity modulation voltage identified during the testing ramp application may be used, along with the intended therapeutic ramp-up time to determine the therapeutic dose peak modulation voltage. Thus, the methods and apparatuses described herein may, using a single test including a ramp-up in voltage intensity, determine an optimal dosage.
In the absence of the teachings described herein, it is difficult to determine an optimal dosage at which the applied voltage is increase to a peak and sustained for sufficiently long to achieve a therapeutic benefit. The inventors have found that although it is generally beneficial to apply as high a voltage as possible to the patient, particularly (but not exclusively) in applications in which neural modulation comprises high-frequency (e.g., greater than 1 kHz) modulation from an implanted neuromodulator to inhibit activity of a nerve or nerve bundle, there is a difficulty to define voltage threshold, above which further voltage amplitude may result in pain and/or discomfort for the patient. This threshold is not only variable between different patients, but may vary with respect to the individual patient. For example, patient sensitivity appears to depend at least slightly on the rate of increase of the voltage. Slower ramp-up times may generally permit a higher final voltage. However, inventors have also found that it is beneficial to maintain the therapeutic modulation such that a longer time is spent at the maximum voltages (e.g., the sustained or plateau period). Surprisingly, the inventors have found that it is possible to use a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp and scale this target sensation intensity modulation voltage for other ramps, which may allow for the use of a single setting (e.g., therapy dose-setting) procedure to determine the target sensation intensity modulation voltage from a known ramp-up to be used to determine a therapeutic peak modulation voltage, as described in detail herein.
Note that the target sensation intensity modulation voltage may be the voltage that induces a target intensity of sensation in the patient during the test. More specifically, this target sensation intensity modulation voltage may be the maximum voltage that the patient can tolerate for the therapy period.
In any of the methods described herein, the testing may be performed on a patient after a period of inactivity (non-modulation) of the neuromodulator device. For example, there may be a recovery period during which the maximum voltage to induce the target intensity of sensation may change, and be unreliable. Thus, the method may have a delay period before applying the test ramp. This delay may be 1 minute or more, 5 minutes or more, 10 minutes or more, 15 minutes or more, 20 minutes or more, 25 minutes or more, 30 minutes or more, 35 minutes or more, 40 minutes or more, 1 hour or more, etc. The testing period may itself be brief (e.g., one or more trials of 30 min or less, which may be separated by this delay period).
In general these methods may be applied to, but are not limited to, the use with neuromodulation to provide a high-frequency block of a nerve or bundle of nerves. For example, these methods and apparatuses may be used to set and/or optimize therapy treatment dosing for a high-frequency block of a nerve such as the sciatic nerve, dorsal root ganglion (DRG), etc.
For example, described herein are methods of setting a therapeutic dose of a neuromodulator implanted into a patient, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage. The method may include: applying a test voltage ramp from the neuromodulator implanted into the patient; determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp; estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and the therapy ramp-up time to reach the peak modulation voltage; and setting the therapeutic dose using the estimated peak modulation voltage.
The target sensation intensity modulation voltage may be a maximum patient-tolerable modulation voltage.
In general, the therapy ramp-up time may be any appropriate portion of the therapeutic dose duration, such as between about 10% and about 90% (e.g., between about 30% and about 70%, between about 40% and about 60%, between about 45% and about 55%, about 50%, etc.). For example, the therapy ramp-up time to the peak modulation voltage may be set to be half of the therapeutic dose duration. The balance of the therapeutic dose duration may be the plateau period (e.g., the sustained peak modulation time). As mentioned, above, in some variations, the therapeutic dose may then repeat, either immediately or more preferably after a “lockout” period during which modulation is not applied by the neuromodulator. The lockout period may be 5 minutes or more (e.g., 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes, 35 minutes, 40 minutes, 45 minutes, 50 minutes, 55 minutes, 60 minutes, etc.).
The therapeutic dose duration may be any appropriate length of time, e.g., between about 5 minutes and about 2 hours, e.g., between about 10 minutes and 1 hours, between about 15 minutes and 50 minutes, between about 20 minutes and 45 minutes, between about 25 minutes and about 40 minutes, etc., such as about 30 minutes.
Determining the target sensation intensity modulation voltage may include determining the voltage of the test voltage ramp being applied when a patient-reported feedback indicating the strongest sensation that the patient can tolerate for a therapeutic dose is received during the application of the test voltage ramp. During the application of the voltage ramp, for example, the patient may self-report on the experienced sensation from the applied voltage ramp. In particular, the patient may report (verbally, by activating a control such as a button, touchscreen, etc.) that the sensation is first felt and/or barely noticeable, and/or when the sensation is strong (e.g., “strong but does not bother me”) and/or very strong (e.g., the “strongest sensation I can tolerate for the treatment period”).
In general, estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time may include estimating the peak modulation voltage as a product of a function of the therapy ramp-up time and a function of the target sensation intensity modulation voltage. For example, estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and therapy ramp-up time may comprise estimating the peak modulation voltage as a square root of a product of the therapy ramp-up time and the target sensation intensity modulation voltage.
Any of these methods may also include determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp and further wherein setting the therapeutic dose comprises using the minimum patient-detectable modulation voltage as a starting voltage for the therapeutic dose. For example, determining the minimum patient-detectable modulation voltage may include receiving patient reported feedback during the application of the test voltage ramp, as mentioned above.
In general, setting the therapeutic dose may include setting the therapeutic dose in the implanted neuromodulator or a controller in communication with the implanted neuromodulator. Setting the therapeutic dose may also include setting one or more of: the therapeutic dose duration, the therapy ramp-up time to reach the peak modulation voltage, and the sustained peak modulation time. These parameters may be set for the test voltage ramp.
In general, the applied therapeutic energy may include a high-frequency modulation signal (waveform) that is ramped up to a plateau value. As mentioned above, any of these methods may also include setting the frequency of the high-frequency component of the test voltage ramp applied and setting a frequency of the high-frequency component of the therapeutic dose to the frequency of the high-frequency component of the test voltage ramp applied. For example, the frequency of the high-frequency component of the test voltage ramp applied may be between 1 kHz and 100 kHz.
Any of these methods may also include setting an alternative therapeutic dose of the neuromodulator implanted into a patient. The alternative therapeutic dose may comprise an alternative peak modulation voltage that is between about 60% and 95% of the peak modulation voltage. The alternative therapy dose may be provided to allow the patient to apply one or the other therapy doses (the therapy dose or the alternative therapy dose) at their preference.
For example, a method of setting a therapeutic dose of a neuromodulator implanted into a patient, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage, may include: applying a test voltage ramp from the neuromodulator implanted into the patient; determining a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp; determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp; estimating the peak modulation voltage as a product of a function of the target sensation intensity modulation voltage and a function of the therapy ramp-up time to reach the peak modulation voltage; and setting the therapeutic dose using the estimated peak modulation voltage and using the minimum patient-detectable modulation voltage as a starting voltage for the therapeutic dose.
Also described herein are systems that are configured to implement any of the methods described herein either automatically or semi-automatically. For example, a system may include: an implantable neuromodulator; a controller for controlling the application of a therapeutic dose by the neuromodulator, wherein the therapeutic dose comprises a therapeutic dose duration including a therapy ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage, the controller comprising one or more processors; memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer-implemented method comprising: applying a test voltage ramp from the neuromodulator implanted into the patient; determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp; estimating the peak modulation voltage as a function of the target sensation intensity modulation voltage and the therapy ramp-up time to reach the peak modulation voltage; and setting the therapeutic dose using the estimated peak modulation voltage.
The computer-implemented method may include any of the steps described above, which may be implemented by the controller. For example, when determining a target sensation intensity modulation voltage that is specific to the patient from the test voltage ramp, the controller may prompt the patient or otherwise allow the patient to enter their reported sensation induced by the ongoing modulation.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
In general, the methods and apparatuses for performing them described herein allow optimized dose setting of a neuromodulation apparatus so that the therapy dose provided by the neuromodulator maximizes the energy which may enhance the effect of the neuromodulation on the target nerve(s) without irritating or harming the patient. These methods and apparatuses may be generally described for use with an implanted neuromodulator, but may be also or alternatively be used with external neuromodulators or neuromodulators prior to implantation. Further, the examples provided herein are provided in reference to neuromodulatory inhibition by the application of high-frequency neuromodulation, however these methods and apparatuses may also be used with other neurostimulatory regimes including general neuromodulation. Examples of neuromodulator apparatuses and methods that may benefit from these methods and apparatuses may include, for example, spinal cord stimulators (SCS) and any other neuromodulation application that may be improved by the optimization between therapeutic benefit and induced sensation.
The inventors have generally found that increasing the applied voltage of neuromodulation is beneficial, particularly when sustained at a high voltage (e.g., high peak voltage). However, high voltage neuromodulation applied to a patient's nerve may result in pain and discomfort when the modulation exceeds a threshold voltage during the ramp up to the sustained high voltage. The value of this threshold may vary between patients and also appears to vary based on the recent modulation already experienced by the nerve as well as the modulation parameters (e.g., frequency). In general, a slower ramp up to a peak modulation voltage in a therapeutic dose may result in lower intensities of induced sensation, and therefore correspondingly higher peak modulation voltages. However, it is also beneficial for a therapeutic dose to maintain the peak modulation voltage for as long as possible during the therapeutic dose.
Described herein are methods of determining a target sensation intensity modulation voltage using a generic test ramp and adapting this target intensity of modulation to determine an optimal peak modulation voltage for neuromodulation.
These methods and apparatuses may be used with any appropriate neuromodulator.
The nerve cuffs may encircle a particular segment of a targeted peripheral nerve, e.g., a sciatic nerve, a tibial nerve, etc. Using an implanted electrode connected to an electrical waveform generator, an electrical waveform may be applied for a time interval, e.g., 10 min (15 min, 20 min, 25 min, 30 min, 35 min, 40 min, etc.), sufficient to effect substantially immediate patient pain relief, e.g., within 10 min, and an extended period of pain relief up to several hours. The current may range, for example, from 4 mApp to 26 mApp.
The application of 10 kHz alternating current generated by a custom generator via a custom implanted nerve electrode may significantly reduce pain in the majority of patients treated. For example, an implantable electrode operatively connected to an external or implanted waveform generator may be used. The electrode may be a spiral cuff electrode similar to that described in U.S. Pat. No. 4,602,624. The electrode may be implanted in a human mammal on a desired peripheral nerve trunk proximal to the pain source (e.g., a neuroma), such that the cuff encircled the desired peripheral nerve in which the action potential was to be blocked. The cuff inner diameter may range from about 4 mm to about 13 mm. The sciatic nerve is known to have a relatively large nerve trunk; the diameter of the proximal part of the sciatic nerve in a human adult is about 12 mm. In one embodiment, the apparatus and method was used on the sciatic nerve to treat limb pain in above knee amputees. In one embodiment, the apparatus and method was used on the tibial nerve to treat limb pain in below knee amputees.
For example,
The system shown in
In general a therapeutic dose for a neuromodulator may have at least two portions.
During the ramp-up portion of the therapeutic dose, the neuromodulator may apply an increasing intensity of modulation from the start (time 0, T0) to the peak modulation voltage (V1) at time Tplateau. In
In general, the maximum peak voltage may be determined empirically for any patient by applying a test ramp. The test ramp is a test voltage ramp from the neuromodulator implanted into the patient. While applying the test ramp, the patient may be interrogated (either manually or automatically) to determine the intensity experienced by the patient from the modulation. In particular, the patient may be interrogated to determine the first point at which the modulation becomes either noticeable or consistently perceived (e.g., a minimum patient-detectable modulation voltage). In some variations, this value may be used as the starting voltage during the therapeutic dose. The patient may also be interrogated to determine the target sensation intensity modulation voltage to be applied during the therapy dose. In some variations, this may be the maximum patient-tolerable modulation voltage.
The patient may be interrogated by prompting and/or receiving patient self-reported sensations. These sensations may be ranked (e.g., 1, corresponding to “I just started to feel the therapy;” 2, corresponding to “I only notice it when I pay attention to it;” 3, corresponding to “strong sensation but it doesn't bother me;” 4, corresponding to “strongest sensation that I can tolerate for 15-20 min;” and 5, corresponding to “I cannot tolerate this sensation for longer than a few minutes”). The apparatus may include an input that receives the patient intensity reporting and correlates intensity input to the applied voltage and/or the time during which the intensity was reported (which is equivalent information).
Alternatively, in some variations the apparatus may interrogate the patient indirectly, by monitoring patient biometric information (heart rate, pulse, blood pressure, ensemble nerve activity, skin conductance, respiration, biomarker, including pain biomarker, levels, etc.) that may also be correlated with this applied ramp to determine a target sensation intensity modulation voltage, including a maximum patient-tolerable modulation voltage.
Based on the identified voltage of the target sensation intensity from the applied test ramp, the method and/or apparatus may determine a target sensation intensity modulation voltage that is specific to the patient. This target sensation intensity modulation voltage (e.g., Vs) may then be used to calculate, e.g., estimate, the peak modulation voltage (Vp) in conjunction with the intendent therapy ramp-up time to reach this peak modulation voltage (Tp). Although the intended ramp-up time may be set to different values (typically between 10% and 90% of the total duration of the therapeutic dose), it may be set to, for example, half of the duration of the therapeutic dose (e.g., T1/2). For example, the peak voltage may be set to be:
Vp=√(Tp×Vs)=√(Tp×Ts×Rs) (1)
As mentioned, Vs is the voltage of the target sensation intensity determined by from the test ramp, Tp is the ramp up time to get to the peak voltage, and Rs is the ramp rate used during the test (since Ts×Rs is equivalent to Vs).
In some cases, where it is assumed that the duration of a therapeutic dose will be approximately 30 minutes, a 15 minute ramp-up time will result in an approximation for the Vp from the identified Vs of:
Vp=4*√Vs (2)
An example of this method is provided below, and shown in corresponding
In one example, a maximum tolerable therapy voltage for each nerve was determined using the method described above. The implanted apparatus was similar to that shown in
General set (e.g., pre-set) parameters for test as shown in
The test is started by simultaneously starting a clock and starting dose 1. The time is recorded along with the patient-reported induced sensation strength on NRS (e.g., in this example, in table 1.2a shown in
Based on the time and therefore the voltage at which the sensation was first felt, a minimum patient-detectable modulation voltage that is specific to the patient from the test voltage ramp may be determined. Table 1.3 (
Similarly, the target sensation intensity modulation voltage that is specific to the patient may be determined from the test voltage ramp data.
When two dose variations are given, as shown, the subject may be instructed to use both dose 1 and dose 2 initially for several days and then pick the one they feel is more effective in pain reduction.
In some variations, the programming (the dose information) may be set, for example every week for 3-4 weeks following the initial setting and periodically thereafter. This may allow the method and/or apparatus to adjust the final amplitude to maximize therapy voltage within tolerable limits of induced sensation. The method described above may be adjusted based on patient-reported sensation. For example, the final voltage may be adjusted as indicated in
Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent is a continuation of U.S. patent application Ser. No. 17/455,392, filed Nov. 17, 2021, titled “APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE,” now U.S. Patent Application Publication No. 2022/0072310, which is a continuation of U.S. patent application Ser. No. 16/379,053, filed on Apr. 9, 2019, titled “APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE,” now U.S. Pat. No. 11,213,682, which claims priority to U.S. Provisional Patent Application No. 62/655,122, filed on Apr. 9, 2018, titled “APPARATUSES AND METHODS FOR SETTING AN ELECTRICAL DOSE,” each of which is herein incorporated by reference in its entirety. This patent may be related to one or more of: U.S. patent application Ser. No. 15/510,824, titled “NERVE CUFF ELECTRODE FOR NEUROMODULATION IN LARGE HUMAN NERVE TRUNKS” and filed on Sep. 12, 2014, which claims priority to U.S. patent application Ser. No. 14/276,200 (now U.S. Pat. No. 8,983,612) filed May 13, 2014; which is a continuation of U.S. patent application Ser. No. 13/474,926 filed May 18, 2012 now U.S. Pat. No. 8,731,676; which claims priority to U.S. patent application Ser. No. 61/487,877 filed May 19, 2011, each of which is expressly incorporated by reference herein in its entirety.
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