SYSTEMS AND METHODS FOR TREATING DIABETES WITH DORSAL ROOT GANGLION STIMULATION

BACKGROUND

Nerve stimulation is used to treat various conditions, such as pain, by stimulating the nerve with contacts or electrodes. When treating pain, for example, the contacts send an electrical signal generated by an implantable pulse generator to the nerve, which blocks the pain signal from the nerve to the brain.

BRIEF SUMMARY

Example aspects of the present disclosure include:

A system for treating metabolic syndrome, comprising a device comprising: a signal generator configured to generate an electrical signal; and at least one processor configured to: monitor a value of at least one parameter of the patient that is associated with diabetes; and control the signal generator based on a threshold value and the value of the at least one parameter. The system includes one or more electrodes coupled to the signal generator to stimulate at least one dorsal root ganglion nerve based on the electrical signal which causes a response by at least one anatomical element of the patient that changes the value of the at least one parameter of the patient.

Any of the aspects herein, wherein the signal generator is controlled to generate the electrical signal in a manner that keeps the value of the at least one parameter above a second threshold value that is less than the threshold value.

Any of the aspects herein, wherein the at least one parameter comprises a blood glucose level of the patient.

Any of the aspects herein, wherein the threshold value is 7 mmol/L.

Any of the aspects herein, wherein the at least one processor is configured to: control the signal generator to generate the electrical signal having a first current value for a first duration of time; and upon expiration of the first duration of time and when the value of the at least one parameter exceeds the threshold value, control the signal generator to generate the electrical signal having a second current value larger than the first current value for a second duration of time.

Any of the aspects herein, wherein when the value of the at least one parameter drops below the threshold value, control the signal generator to cease generating the electrical signal.

Any of the aspects herein, wherein the second current value is 0.05 mA larger than the first current value.

Any of the aspects herein, wherein the signal generator is controlled to adjust a pulse width of the electrical signal.

Any of the aspects herein, wherein the at least one anatomical element of the patient comprises the patient's pancreas.

Any of the aspects herein, wherein the response by the patient's pancreas comprises an increase in insulin production.

Any of the aspects herein, wherein the at least one dorsal root ganglion nerve comprises multiple dorsal root ganglion nerves.

Any of the aspects herein, wherein the one or more dorsal root ganglions are at one or more of thoracic levels T7, T8, T9, T10, T11, and/or T12, and/or lumbar levels L1 and/or L2 of the patient.

Any of the aspects herein, further comprising: a monitoring device configured to continuously provide data that enables the at least one processor to monitor the value of the at least one parameter.

Any of the aspects herein, wherein the data comprises the value of the at least one parameter.

Any of the aspects herein, wherein the at least one processor processes the data to determine the value of the at least one parameter.

An implantable device for treating metabolic syndrome, comprising: a signal generator configured to generate an electrical signal; and at least one processor configured to: monitor a value of at least one parameter of a patient that is associated with type 2 diabetes; and control, based on a threshold value and the value of the at least one parameter, the signal generator to output the electrical signal to one or more electrodes to stimulate at least one dorsal root ganglion nerve of the patient which causes a response by at least one anatomical element of the patient that changes the value of the at least one parameter.

Any of the aspects herein, wherein the at least one processor is configured to control the signal generator to generate the electrical signal when the value of the at least one parameter exceeds the threshold value, and wherein the at least one processor controls the signal generator to output the electrical signal with incremented current values until the at least one parameter drops below the threshold value.

Any of the aspects herein, wherein the at least one dorsal root ganglion nerve comprises one or more dorsal root ganglions at one or more of thoracic levels T7, T8, T9, T10, T11, and/or T12, and/or lumbar levels L1 and/or L2 of the patient, and wherein the at least one anatomical element comprises the patient's pancreas.

A method for treating metabolic syndrome, comprising monitoring a blood glucose level of a patient; determining the blood glucose level exceeds an upper limit threshold value; and generating an electrical signal for one or more electrodes to stimulate at least one dorsal root ganglion nerve of the patient to cause a response by a pancreas of the patient that reduces the blood glucose level of the patient to within a healthy range.

Any aspect in combination with any one or more other aspects.

Any one or more of the features disclosed herein.

Any one or more of the features as substantially disclosed herein.

Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

Any one of the aspects/features/embodiments in combination with any one or more other aspects/features/embodiments.

Use of any one or more of the aspects or features as disclosed herein.

It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

The phrases “at least one”, “one or more”, and “and/or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “one or more of A, B, or C” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as X1-Xn, Y1-Ym, and Z1-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

FIG. 1 is a diagram of a system according to at least one embodiment of the present disclosure;

FIG. 2 is a diagram of another system according to at least one embodiment of the present disclosure;

FIG. 3A depicts a schematic illustration of a lead according to at least one embodiment of the present disclosure;

FIG. 3B depicts a schematic illustration of a lead according to at least one embodiment of the present disclosure;

FIGS. 4A to 4C illustrate various views of spinal anatomy for explaining nerve stimulation according to at least one embodiment of the present disclosure;

FIG. 5 is a diagram that illustrates various physiological effects/relationships for certain anatomical elements according to at least one embodiment of the present disclosure;

FIG. 6 is a block diagram of a system according to at least one embodiment of the present disclosure; and

FIG. 7 is a flowchart according to at least one embodiment of the present disclosure.

DETAILED DESCRIPTION

It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and/or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a computing device and/or a medical device.

In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Alternatively or additionally, functions may be implemented using machine learning models, neural networks, artificial neural networks, or combinations thereof (alone or in combination with instructions). Computer-readable media may include non-transitory computer-readable media, which corresponds to a tangible medium such as data storage media (e.g., random-access memory (RAM), read-only memory (ROM), electrically erasable programmable ROM (EEPROM), flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

Instructions may be executed by one or more processing circuits or one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000-series processors, Nvidia GeForce RTX 3000-series processors, AMD Radeon RX 5000-series processors, AMD Radeon RX 6000-series processors, or any other graphics processing units), application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry. Accordingly, the term “processor” as used herein may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques. Also, the techniques could be fully implemented in one or more circuits or logic elements.

Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

Diabetes is a medical condition in which the pancreas does not produce enough insulin, which, in turn, leads to abnormally high blood glucose levels. Typical methods for treating diabetes (type 1 or type 2) involve regular insulin injections or activation of an insulin pump when a patient's blood glucose level approaches an upper limit threshold to restore the patient's insulin level which keeps the blood glucose level in a normal range. However, injections are painful and require patient awareness and cooperation. Meanwhile, insulin pumps (usually always attached to the patient) are bulky and require regular upkeep (e.g. insulin refill, battery replacement/recharge, programming, etc.). Inventive concepts propose to address these challenges with techniques that stimulate certain dorsal root ganglion nerves (also called dorsal root ganglion(s)) which in turn cases a response by one or more of the patient's organs (e.g., the brain and/or pancreas) that helps treat type 2 diabetes, in some cases, without using an exterior source of insulin by way of injection or pump.

As described herein, inventive concepts relate to stimulating one or more dorsal root ganglion nerves in a manner that causes a response by one or more anatomical elements of the patient, such as the patient's pancreas. The pancreas produces insulin and glucagon, compounds which lower blood glucose levels in patients, and the pancreas is innervated both vagally and sympathetically, where such vagal and sympathetic nerves pass afferent and efferent information. The afferent sympathetic nerves traffic sensory information via dorsal root ganglions. In addition, afferent nerves control metabolic homeostasis, inflammation, and/or pain. The dorsal root ganglions that may have an effect on the pancreas when stimulated travel via the celiac ganglion and can be found at spinal levels T6 thru L2. Inventive concepts, then, aim to restore insulin levels with increased pancreatic release of insulin and glucagon caused by stimulating the dorsal root ganglion (DRG) nerve endings at spinal levels T6 thru L2, which will lead to a decrease in blood glucose level. Stated another way, at least one example embodiment proposes to stimulate, with an electrical signal, one or more DRGs at one or more spinal levels within thoracic levels T6, T7, T8, T9, T10, T11, and/or T12, and/or lumbar levels L1 and L2 of the patient, which in turn, causes the pancreas to increase insulin and/or glucagon production to lower the patient's blood glucose level, thereby providing an effective treatment for type 2 diabetes.

In at least one embodiment, for example, a lateral epidural lead is implanted near the left and right sides of a patient's spine in areas where multiple dorsal root nerve endings at one or more of spinal levels T6 thru L2 of the patient can be stimulated with an electrical signal using multiple electrode pairs of the lead. Properties (e.g., current, frequency, pulse width, On-Off cycling, waveform, electrode combination) of the electrical signal are selected such that the stimulation of dorsal root ganglions (DRGs) causes the patient's pancreas to respond in a manner that decreases blood glucose while, in some cases, reducing or preventing side effects like motor stimulation. At least one embodiment relates to a closed loop technique that regulates properties of the electrical signal based on a patient's blood glucose level. The increased DRG activity achieved with stimulation promotes insulin and/or glucagon production by the pancreas leading to a decrease in blood glucose levels on a systemic level. Thus, DRG stimulation according to inventive concepts promotes glucogenesis and insulin release in the pancreas.

In accordance with example embodiments, DRG stimulation at one or more of spinal levels T6 thru L2 to treat diabetes may have other effects that help treat at least one condition of metabolic syndrome. Metabolic syndrome may be defined as a cluster of conditions that increase the risk of heart disease, stroke, and type 2 diabetes. These conditions include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. Patients with metabolic syndrome typically receive medication to reduce cholesterol, medication to treat blood glucose, and anti-hypertensive medication. Patients, however, often do not take all their medications. In addition, medications may cause side effects and may have limited efficacy. Inventive concepts propose to address the above challenges for metabolic syndrome with techniques that stimulate certain dorsal root ganglion nerves which in turn cases a response by one or more of the patient's organs (e.g., the brain, the liver, kidney(s), and/or pancreas) that helps treat at least one condition of metabolic syndrome (e.g., blood pressure, glucose level, cholesterol level, and/or triglyceride level).

For example, afferent stimulation of DRGs at one or more thoracic and lumbar levels T6 to L2 mimic signaling afferent information from the pancreas and in this way stimulate sympathetic activation of the pancreas. In one embodiment, afferent stimulation of DRGs at one or more spinal levels T6 thru TL2 (i.e., stimulation of DRG(s) at T7, T8, T9, T10, T11, T12, L1 and/or L2) may mimic signaling afferent information from the liver and in this way stimulates sympathetic activation to the pancreas to increase the secretion of insulin, which lowers blood glucose. Furthermore, DRG stimulation at one or more of spinal levels T6 thru L2 may also lower blood pressure via 1) the liver's response to the inhibited sympathetic nerves and/or an active vagal nerve and its subsequent action on sodium release, and/or 2) the kidney's response to inhibition of sympathetic activation leading to an increase in urinary excretion and decrease in sodium resorption. The glucagon is stored in the liver and muscles. In at least one example, properties (current, frequency, energy) of the electrical signal are selected such that the stimulation of dorsal root ganglions (DRGs) causes one or more organs of the patient to respond in a manner that decreases blood glucose level, cholesterol, and/or triglycerides while, in some cases, increasing natriuresis while reducing or preventing side effects like motor stimulation. At least one embodiment relates to a closed loop technique that provides an electrical signal with escalating current values based on blood glucose levels and/or blood pressure.

As may be appreciated, increased glucose levels in the portal vein activates afferent nerve traffic, which results in feedback. The increased DRG activity achieved with stimulation promotes vagal nerve activity to the pancreas and, in this way, promotes insulin production leading to a decrease in blood glucose levels on a systemic level. In addition, the increase in vagal activity and inhibition of sympathetic activity to the liver promotes glycogenesis—the process that converts glucose into glucagon, resulting in lower blood glucose levels. The glucagon is stored in the liver and muscles. DRG stimulation according to inventive concepts promotes glucogenesis in the liver and insulin release in the pancreas.

Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) treating type 2 diabetes and/or at least one condition of metabolic syndrome with painful injections and/or medication and/or surgery that has limited efficacy and/or aggravating side effects, (2) treating type 2 diabetes and/or at least one condition of metabolic syndrome by relying on patient cooperation, and (3) undesirable patient outcomes as a result of problems (1) and/or (2).

FIG. 1 illustrates a diagram of aspects of a system 100 according to at least one embodiment of the present disclosure. The system 100 may be used to provide electrical signals for a patient and/or carry out one or more other aspects of one or more of the methods disclosed herein. For example, the system 100 may include at least a device 104 that may be configured to generate a current or electrical signal, such as a signal capable of stimulating one or more nerves (e.g., dorsal root ganglion nerves). In some examples, the device 104 may be referred to as an implantable device. Additionally, the system 100 may include one or more wires or leads 108 that provide a connection between the device 104 and nerves of the patient for enabling nerve stimulation/blocking.

Neuromodulation techniques (e.g., technologies that act directly upon nerves of a patient, such as the alteration, or “modulation,” of nerve activity by delivering electrical pulses or pharmaceutical agents to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments of a patient. As described herein, neuromodulation techniques may be used to stimulate one or more nerves which causes a response in one or more anatomical elements of the patient that treats type 2 diabetes and/or one or more conditions of metabolic syndrome. For example, the device 104 may provide electrical stimulation to one or more nerves in the spinal cord of the patient (e.g., via the one or more leads 108) to cause the brain and subsequently the pancreas to respond in a manner that lowers the blood glucose level. The response by the anatomical element may be directly caused by the stimulation (e.g., stimulation of a nerve causes stimulation of the anatomical element that produces the response) and/or may be indirectly caused the stimulation (e.g., stimulation of a nerve causes the brain to send and/or block signals to an anatomical element that produces the response based on the signals). In one embodiment, stimulating DRGs at one or more spinal levels C8 thru L3 may cause responses in the patient's pancreas (and/or liver and/or kidney).

In some examples, as shown in FIG. 1, the one or more leads 108 include a single lead 108. In other embodiments, as will be described in FIG. 2, the one or more leads 108 may include multiple leads 208A, 208B. The lead 108 may be implanted on or near a target anatomical element, such as implanted in a location that enables stimulation of one or more DRGs at one or more spinal levels at cervical level C8, thoracic levels T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and/or T12, and/or lumbar levels L1, L2, and/or L3 of the patient. Stated another way, one or more DRGs at a single one of the above spinal levels may be stimulated or one or more DRGs at multiple ones of the above spinal levels may be stimulated. In some examples, the lead 108 is implanted near the spinal cord and more specifically, in the epidural space between the spinal cord and the vertebrae. Once implanted, the lead 108 may provide an electrical signal (whether stimulating or blocking) from the device 104 to the target anatomical element (e.g., one or more nerves in the spinal cord, the brain, etc.). The device 104 in some embodiments, may be implanted in the patient, though in other embodiments—such as during testing of the lead 108—the device 104 may be external to the patient's body.

In some examples, the lead 108 may provide the electrical signals to the respective nerves via electrodes that are connected to the nerves (e.g., sutured in place, wrapped around the nerves, etc.). In some examples, the lead 108 include cuff electrodes (e.g., at an end of the lead 108 not connected or plugged into the device 104). Additionally or alternatively, while shown as physical wires that provide the connection between the device 104 and the one or more nerves, the electrodes may provide the electrical signals to the one or more nerves wirelessly (e.g., with or without the device 104).

Electrodes of a lead 108 may comprise stimulating electrodes (e.g., electrodes configured to stimulate a target anatomical element). In some embodiments, electrodes of a lead 108 may further comprise recording electrodes (e.g., electrodes configured to record a physiological response to the stimulation). The stimulating electrodes may stimulate a target anatomical element such as a nerve and the recording electrodes may record a physiological response to the stimulation. More specifically in closed loop stimulation, the recording electrode may record or measure electrically evoked compound action potential (ECAP), which may be used to regulate or adjust the electrical signal generated by the device 104. For example, as a patient bends over, a distance between the lead 108 and the spinal cord (or other target anatomical element) may change, thus the resulting stimulation may be weaker or stronger based on the change in the distance. The recording electrode may measure and record the ECAPs and a processor may determine a difference in the ECAP. The difference may be used to adjust the electrical signal to cause an amplitude of the ECAP to remain within a range that is comfortable for the patient while still treating a condition of metabolic syndrome.

Additionally, while not shown, the system 100 may include one or more processors (e.g., one or more DSPs, general purpose microprocessors, graphics processing units, ASICs, FPGAs, or other equivalent integrated or discrete logic circuitry) that are programmed to carry out one or more aspects of the present disclosure. In some examples, the one or more processors may be used to drive a feedback loop in a closed-loop stimulation system, as will be discussed in detail with reference to the remaining figures and description. In other examples, the at least one processing circuit may include a memory or may be otherwise configured to perform aspects of the present disclosure. For example, the one or more processors may provide instructions to the device 104, the electrodes, or other components of the system 100 not explicitly shown or described with reference to FIG. 1 for treating diabetes (e.g., type 2) and/or metabolic syndrome as described herein. In some examples, the one or more processors may be part of the device 104 or part of a control unit for the system 100 (e.g., where the control unit is in communication with the device 104 and/or other components of the system 100—see, for example, processor 604 in FIG. 6).

The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the methods described herein. The system 100 or similar systems may also be used for other purposes. It will be appreciated that the human body has many nerves and the stimulation/blocking treatments described herein may be applied to any one or more nerves, which may reside at a suitable location of a patient (e.g., cervical, lumbar, thoracic, etc.).

FIG. 2 depicts a system 200 according to at least one embodiment of the present disclosure is shown. The system 200 is the same as or similar to the system 100 and comprises a device 204 which may be the same as or similar to the device 104. The system 200 also includes a lead that comprises a first lead 208A and a second lead 208B. The first lead 208A may comprise stimulating electrodes configured to stimulate a target anatomical element or elements (e.g., DRGs at one side of a spinal cord) and the second lead 208B may comprise additional stimulating electrodes configured to stimulate another target anatomical element or elements (e.g., DRGs at the other side of the spinal cord). The first lead 208A and the second lead 208B may be implanted near each other in in the same space (for example, the epidural space), or may be implanted in separate spaces. It will be appreciated that in some embodiments, the leads 108, 208A, 208B may comprise one lead, two leads, or more than two leads.

FIG. 3A and FIG. 3B depict a schematic illustration of a first lead 300 and a second lead 302, respectively. The first lead 300, as illustrated, comprises a paddle lead 304 and the second lead 302 comprises a cylindrical lead 306. It will be appreciated that while a paddle lead and a cylindrical lead are shown and described, any type of lead may be used to carry out inventive concepts.

The paddle lead 304 may enable directional stimulation such that stimulation can be directed in a target direction. For example, the paddle lead 304 may be implanted above the spinal cord such that electrodes 308 on the paddle lead 304 face the spinal cord. During stimulation, the electrodes 308 direct the stimulation in the direction of the spinal cord.

The cylindrical lead 306 may also provide directional stimulation when the cylindrical lead 306 is segmented, as described in detail below. Further, the cylindrical lead 306 may be beneficially implanted using a minimally invasive surgical procedure (as opposed to forming an incision to implant the lead). During such procedures, the cylindrical lead 306 can be inserted into the epidural space using an epidural needle.

In the illustrated embodiments, the paddle lead 304 comprises sixteen electrodes 308 and the cylindrical lead 306 comprises eight electrodes 310. It will be appreciated that in other embodiments, the paddle lead 304 may comprise less than or more than sixteen electrodes and the cylindrical lead 306 may comprise less than or more than eight electrodes. Though the electrodes 308 of the paddle lead 304 are shown as ovals, the electrodes 308 (and/or the electrodes 310 of the cylindrical lead 306) may be any shape or size and may be spaced from each other at any distance. Each electrode may also be a different shape or size than another electrode and each electrode may be spaced a different distance from adjacent electrodes. Further, though the electrodes 310 of the cylindrical lead are shown as ring electrodes, the cylindrical lead 306 may be segmented such that the electrodes 310 do not wrap around the entire cylindrical lead 306. More specifically, the cylindrical lead 306 can be segmented into any number of segments. For example, the cylindrical lead 306 can be bi-segmented or tri-segmented. In a segmented cylindrical lead 306, the electrode can be positioned in a segment such that the electrode will direct the stimulation in the direction that the electrode is facing. In other words, a segmented cylindrical lead 306 may enable directional stimulation in a target direction toward a target nerve.

FIG. 4A illustrates a cross-sectional view of a spine that shows possible stimulated regions of a nerve according to at least one example embodiment. The view in FIG. 4A may correspond to a cross-section taken at thoracic level T10 from below. Meanwhile, FIG. 4B illustrates a view showing a pair of epidural leads 108 implanted at the left and right sides of a patient's spine, where each lead 108 includes a pair of stimulating electrodes 400. FIGS. 4A and 4B illustrate various anatomical elements of the spine including a vertebral body, epidural space, transverse processes, spinal cord, superior facets, sympathetic ganglions, a spinal nerve, ventral roots, dorsal roots, and dorsal root ganglions (also called dorsal root ganglion nerves). FIG. 4A further illustrates stimulated regions on a right side R of the vertebral body. Although not explicitly shown, it should be appreciated that the stimulated regions exist in the same corresponding locations at a left side L of the vertebral body. A stimulation location in FIG. 4B may correspond to a location at which or near which one or more electrodes are implanted. As shown, the stimulation location corresponds to or is proximate to the dorsal root while the stimulated regions correspond to the dorsal root and/or the dorsal root ganglion.

FIG. 4B shows a set of electrodes that includes two pairs of stimulating electrodes 400 on two leads 108 that are positioned in a location that enables injection of an electrical signal at or near the stimulation location of the left and right sides of the vertebral body. Each pair of stimulating electrodes 400 may receive the electrical signal from a signal generator (e.g., signal generator 616 in FIG. 6) of the device 104 which in turn stimulates the dorsal root ganglion at the left and right sides of the vertebral body. In the example shown in FIG. 4B, each pair of stimulating electrodes 400 comprises one electrode at a top side of the dorsal root and one electrode at a bottom side of the dorsal root with each electrode receiving an electrical signal from a signal generator of the device 104. As shown, the stimulation location in FIG. 4B may be under or directly adjacent to a lead 108 between a pair of stimulating electrodes 400 in a lengthwise direction of the lead 108. In at least one embodiment, each stimulating electrode 400 may be about 1.5 mm in size and be within about 5 mm (+/−20%) of the dorsal root. Using an electrode configuration with pairs of stimulating electrodes 400 as shown in FIG. 4B may assist with focusing electrical energy to the stimulation location between a pair of stimulating electrodes 400. However, example embodiments are not limited to using pairs of electrodes to stimulate a dorsal root ganglion, and a single stimulating electrode on each lead 108 may be placed at or near the stimulation location on each side of the vertebral body to stimulate a respective dorsal root ganglion. Notably, the stimulating electrodes 400 may be passively held in place by surrounding tissue of the patient and should be located at a position that does not accidently stimulate the ventral root (which may cause negative side effects for the patient). As may be appreciated, remaining electrodes (i.e., non-stimulating electrodes) of each lead 108 do not receive the electrical signal for the purpose of treating one or more conditions of metabolic syndrome. However, depending on locations of the remaining electrodes, the remaining electrodes may receive electrical signals for other purposes (e.g., for treating another condition, like pain).

FIG. 4C illustrates another example configuration for leads 108 according to at least one example embodiment. As shown in FIG. 4C, each lead 108 may have curved structure designed to conform to or partially conform to a shape of a respective DRG so that one end of each lead 108 terminates at an outer part of the respective DRG while a section of the lead 108 curves around one edge of the respective DRG. Although not explicitly shown, each lead 108 in FIG. 4C may include a set of electrodes spaced apart from one another along the length of the lead 108 as in FIGS. 3A, 3B, and 4B. As in FIG. 4B, each lead 108 in FIG. 4C may include one or more stimulating electrodes to stimulate a respective DRG with an electrical signal from device 104 while other electrodes on each lead 108 may remain inactive.

In accordance with example embodiments, stimulating the dorsal root ganglions at one or more spinal levels C8 thru L3 may cause one or more responses by one or more anatomical elements of the patient that helps treat at least one condition associated with diabetes by lowering blood glucose levels. In at least one embodiment, the lowered blood glucose level is a result of increased insulin and/or glucagon by the pancreas. In some embodiments, dorsal root ganglion stimulation may additionally cause a response by the liver that promotes glucogenesis to reduce blood glucose level, and/or a response of the kidney or liver that results in lowering blood pressure. These responses may result from inhibiting sympathetic nerves and activating the vagal nerve when DRGs are stimulated. As noted above, the response by the liver, kidney, and/or pancreas may be the result of indirect stimulation (e.g., stimulation of DRGs causes the brain to send and/or block signals to the pancreas, liver, and/or kidney that produce the responses based on the signals).

Although FIGS. 4A and 4B have been described with reference to a single thoracic level (e.g., level T10), additional leads 108 with pairs of stimulating electrodes 400 may be implanted at the same or similar locations to achieve the same or similar stimulation effects at one or more other spinal levels, for example, at one more of thoracic levels T7, T8, T9, T11, and T12, and/or lumbar levels L1 and/or L2 of the patient.

FIG. 5 is a diagram that illustrates various physiological effects/relationships for certain anatomical elements. As shown, activation of the vagal (or vagus) nerve increases insulin production decreases glucose production in the pancreas. In some embodiments, activation of the vagal nerve increases glycogenesis and reduces glucose production in the liver. Meanwhile, activation of sympathetic nerves may increase sodium resorption and reduces urinary excretion by the kidneys while also decreasing glycogenesis and increasing glucose production by the liver. As may be appreciated, DRG stimulation according to example embodiments inhibits sympathetic nerves and activates the vagal nerve, which results in lower glucose production and increased glycogenesis while limiting food intake. In addition, DRG stimulation may cause release of a hepatic insulin sensitizing substance (HISS) from the liver to increase glucose storage in muscle. In one embodiment, DRG stimulation at one or more of spinal levels T12, L1, and L2 may affect feedback.

FIG. 6 depicts a block diagram of a system 600 according to at least one embodiment of the present disclosure. In some examples, the system 600 may implement aspects of or may be implemented by aspects of FIGS. 1-5 as described herein. For example, the system 600 may include a computing device 602, a monitoring device 614, and a stimulating/blocking system 612 with a signal generator 616 and/or one or more lead(s) 622 to carry out one or more aspects of one or more of the methods disclosed herein. A device 104, 204 as described with reference to FIGS. 1 and 2 may include aspects of the system 600, such as the signal generator 616, the computing device 602, and/or the monitoring device 614. In this case, the signal generator 616 and the computing device 602 may be integrated with one another in the same implantable device 104, 204. The lead(s) 622 may represent an example of the lead(s) 108, 208, 300, and/or 302 from FIGS. 1-3B. The system 600 may further comprise a database 630, and/or a cloud or other network 634. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 600. For example, the system 600 may not include one or more components of the computing device 602, the database 630, and/or the cloud 634.

The stimulating/blocking system 612 may comprise the signal generator 616 and the lead(s) 622. As previously described, the signal generator 616 may be configured to generate an electrical signal, and the lead 622 may comprise a plurality of electrodes 618 configured to apply the electrical signal to a target anatomical element (e.g., DRG(s)). The electrodes 618 may correspond to electrodes of leads 108 described herein and may include stimulating electrodes and, in some cases, non-stimulating electrodes. The stimulating/blocking system 612 may communicate with the computing device 602 to receive instructions such as instructions 624 for applying the electrical signal to the target anatomical element, where the electrical signal is intended to stimulate one or more DRGs at one or more spinal levels within thoracic levels T7, T8, T9, T10, T11, and T12, and/or lumbar levels L1 and/or L2 of the patient to thereby generate a response by at least one anatomical element such as the brain, pancreas, kidney(s), and/or liver.

The computing device 602 is illustrated to include a processor 604, a memory 606, a communication interface 608, and a user interface 610. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 602.

The processor 604 of the computing device 602 may comprise one or more suitable processing circuits such as one or more suitable processors described herein or any similar suitable processor. The processor 604 may be configured to execute instructions 624 stored in the memory 606, which instructions may cause the processor 604 to carry out one or more methods described herein. For example, as described in more detail below, the processor 604 may execute instructions 624 to monitor a parameter of a patient, such as a blood glucose level, and to control generation of the electrical signal by the signal generator 616 based on the monitored parameter and a threshold associated with the monitored parameter (e.g., a threshold blood glucose level).

The memory 606 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer-readable data and/or instructions. The memory 606 may store information or data useful for completing, for example, any steps of the method 700 described herein, or of any other methods. The memory 606 may store, for example, instructions and/or machine learning models that support one or more functions of the stimulating/blocking system 612. For instance, the memory 606 may store content (e.g., instructions 624 and/or machine learning models) that, when executed by the processor 604, cause the signal generator 616 to generate an electrical signal for lead(s) 622 which apply the electrical signal to a respective target anatomical element such as a DRG to cause a response in one or more anatomical elements that changes a value of the parameter being monitored to treat a condition, such as type 2 diabetes and/or a condition of metabolic syndrome.

The memory 606 may also store data for electrical signal optimization 620. Data for electrical signal optimization 220 may correspond to a routine executed by the processor 604 to optimize the electrical signal used in an electrical stimulation. Optimization may be achieved by adjusting signal current, adjusting signal amplitude, adjusting signal frequency, adjusting signal type (e.g., square wave, sinusoidal wave, triangle wave, etc.), adjusting duty cycle, adjusting treatment duration, electrode combination (e.g., which electrodes are stimulating), signal polarity (positive or negative), and/or the like. More specifically, the electrical signal optimization 620 may enable the processor 604 to determine one or more parameters of the electrical signal. Data for electrical signal optimization 620 may also enable the processor 604 to determine or adjust one or more parameters of the electrical signal based on a physiological response recorded during stimulation of the target anatomical element. The one or more parameters of the electrical signal may be adjusted to, for example, maintain one or more monitored parameters of the patient within an acceptable range. For example, as discussed in more detail below, current of the electrical signal may be gradually increased over time to bring a patient parameter (e.g., blood glucose) below a threshold value to treat type 2 diabetes and/or one or more conditions of metabolic syndrome. The data for electrical signal optimization 620 may be preprogrammed before or shortly after implantation of a device 104, 204, but may change as the computing device 602 learns more about which parameters of the electrical signal and/or other parameters of the treatment process result in better treatment of metabolic syndrome for a particular patient. For example, parameters related to treatment duration, current of the electrical signal, pulse width of the electrical signal, and/or frequency of the electrical signal may have initial values that are adjusted over time to better treat metabolic syndrome and saved as data for electrical signal optimization 620 (see, e.g., step 724 below). In addition, parameters may be optimized in a way that prevents glucose levels from becoming too low, causing hypoglycemia, which can be life threatening.

Content stored in the memory 606, if provided as instructions, may be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 606 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 604 to carry out the various method and features described herein. Thus, although various contents of memory 606 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and/or machine learning models (e.g., for electrical signal optimization). The data, algorithms, and/or instructions may cause the processor 604 to manipulate data stored in the memory 606 and/or received from or via the stimulating/blocking system 612, the database 630, and/or the cloud 634.

The computing device 602 may also comprise a communication interface 608. The communication interface 608 may be used for receiving data (for example, data from a recording electrodes capable of recording data) or other information from an external source (such as the stimulating/blocking system 612, the database 630, the cloud 634, and/or any other system or component not part of the system 600), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 602, the stimulating/blocking system 612, the database 630, the cloud 634, and/or any other system or component not part of the system 600). The communication interface 608 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and/or one or more wireless transceivers or interfaces (configured, for example, to transmit and/or receive information via one or more wireless communication protocols such as 802.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 608 may be useful for enabling the device 602 to communicate with one or more other processors 604 or computing devices 602, whether to reduce the time needed to accomplish a computing-intensive task or for any other suitable reason.

The computing device 602 may also comprise one or more (optional) user interfaces 610. The user interface 610 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and/or any other device for receiving information from a user and/or for providing information to a user. The user interface 610 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. In some embodiments, the user interface 610 may be used to select one or more parameters for the electrodes including, but not limited to, selecting whether an electrode is active or inactive. For example, the user interface 610 may receive input to select a first electrode as active and to select a second and a third electrode as inactive. Notwithstanding the foregoing, any required input for steps of methods described herein may be generated automatically by the system 600 (e.g., by the processor 604 or another component of the system 600) or received by the system 600 from a source external to the system 600. In some embodiments, the user interface 610 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 604 according to one or more embodiments of the present disclosure, and/or to modify or adjust a setting of other information displayed on the user interface 610 or corresponding thereto.

Although the user interface 610 is shown as part of the computing device 602, in some embodiments, the computing device 602 may utilize a user interface 610 that is housed separately from one or more remaining components of the computing device 602. In some embodiments, the user interface 610 may be located proximate one or more other components of the computing device 602, while in other embodiments, the user interface 610 may be located remotely from one or more other components of the computer device 602. In this case, the communication interface 608 may enable communication between the computing device 102 and the user interface 610.

The monitoring device 614 may include suitable hardware and/or software for monitoring at least one parameter of a patient that is useful for determining whether DRG stimulation is effectively treating one or more conditions of metabolic syndrome. The monitoring device 614 may continuously provide data that enables the processor 604 to monitor the value of the at least one parameter of the patient. The monitoring device 614 may be attachable to and/or or at least partially implanted in a patient. In one non-limiting example, the monitoring device 614 comprises a blood glucose monitor that monitors a blood glucose level of the patient. Another non-limiting example of a monitoring device 614 may include a blood pressure monitor, which may be incorporated into a wearable such as a fitness tracker or fitness watch. In other embodiments, the monitoring device 614 may include a device that monitors the patient's cholesterol levels, and/or triglyceride levels. Still further, the monitoring device 614 may comprise a device that monitors the status of (e.g., the amount of) body fluids, for example, with a suitable impedance sensor because stimulating DRGs may affect the splanchnic bed which, in turn, affects body fluid status and/or blood pressure. The monitoring device 614 may include additional or alternative devices that monitor any suitable parameter useful for determining whether DRG stimulation is successfully treating a condition of metabolic syndrome in the patient. The monitoring device 614 may be separate from the device 104, 204 in FIGS. 1 and 2 while being in wired or wireless communication with the computing device 602. In one embodiment, the monitoring device 614 is integrated with the device 104, 204 along with the stimulating/blocking system 612 and/or the computing device 602.

The database 630 may store information such as patient data, results of a stimulation and/or blocking procedure, stimulation and/or blocking parameters, electrical signal parameters, electrode parameters, electrode configurations and/or the like. The database 630 may be configured to provide any such information to the computing device 602 or to any other device of the system 600 or external to the system 600, whether directly or via the cloud 634. In some embodiments, the database 630 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and/or another system for collecting, storing, managing, and/or transmitting electronic medical records.

The cloud 634 may be or represent the Internet or any other wide area network. The computing device 602 may be connected to the cloud 634 via the communication interface 608, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 602 may communicate with the database 630 and/or an external device (e.g., a computing device) via the cloud 634.

The system 600 or similar systems may be used, for example, to carry out one or more aspects of any of the method 700 as described herein. The system 600 or similar systems may also be used for other purposes.

FIG. 7 depicts a method 700 that may be used, for example, to perform neuromodulation techniques (e.g., a stimulation/block therapy) to treat diabetes (e.g., type 2) and/or at least one condition of metabolic syndrome for a patient.

The method 700 (and/or one or more steps thereof) may be carried out or otherwise performed, for example, by at least one processor. The at least one processor may be the same as or similar to the processor 604 or the processor(s) of the device 104 or 204 described above. The at least one processor may be part of the device 104 or 204 (such as an implantable pulse generator) or part of a control unit in communication with the device 104 or 204. A processor other than any processor described herein may also be used to execute the method 700. The at least one processor may perform the method 700 by executing elements stored in a memory (such as a memory 606 in the device 104 as described above). The elements stored in the memory and executed by the processor may cause the processor to execute one or more steps of a function as shown in method 700. One or more portions of a method 700 may be performed by the processor executing any of the contents of memory, such as providing stimulation to a nerve with an electrical signal, executing an electrical signal optimization such as the electrical signal optimization 620, and/or any associated operations as described herein.

The method 700 includes monitoring a value of at least one parameter of the patient that is associated with diabetes (e.g., type 2) and/or at least one condition of metabolic syndrome (step 704). The at least one parameter of the patient may include any suitable parameter that is indicative of type 2 diabetes and/or a condition of metabolic syndrome. Such parameters may include one or more of blood pressure, blood glucose level, cholesterol level, and/or triglyceride level while conditions of metabolic syndrome include high blood pressure, type 1 diabetes, type 2 diabetes, excess fat around the waist, and/or other conditions of diabetes and/or metabolic syndrome that increase the risk of heart disease, stroke, and type 2 diabetes. Step 704 may monitor a single parameter of the patient or multiple parameters of the patient. Possible parameters for monitoring comprise a blood glucose level of the patient, blood pressure of the patient, a cholesterol level of the patient, and/or triglyceride levels of the patient. As discussed in more detail below, the method 700 includes controlling a signal generator 616 based on a threshold value and the value of the at least one parameter being monitored. In accordance with example embodiments, one or more electrodes are coupled to the signal generator 616 to stimulate at least one spinal nerve (e.g., one or more dorsal root ganglion nerves) based on the electrical signal which causes a response by at least one anatomical element (e.g., the brain, liver, and/or pancreas) of the patient that changes the value of the at least one parameter of the patient (e.g., in a manner that helps treat type 2 diabetes and/or a condition of metabolic syndrome).

As may be appreciated, a monitoring device 614 may provide data that enables monitoring the value of the at least one parameter. In one example, the data comprises the value or values of the parameter(s) being monitored (e.g., the monitoring device 614 itself is capable of determining the patient's blood glucose level). In another example, a device, such as processor 604, processes the data from the monitoring device 614 to determine the value or values of the parameter(s) being monitored (e.g., the monitoring device 614 passes raw data to the processor 604 that enables the processor 604 to determine the patient's blood glucose level). The data that enables parameter monitoring may be provided by the monitoring device 614 to the processor 604 continuously at regular or irregular intervals (e.g., every second, every 10 minutes, at particular times of the day or night, etc.). In one embodiment, the processor 604 may query the monitoring device 614 for the data. The query for data may be sent upon expiration of a timer that is tracking one or more aspects of a treatment, such as treatment duration (e.g., the processor 604 may query the monitoring device 614 upon expiration of the first and/or second durations of time discussed below).

The method 700 includes determining whether the value or values being monitored in step 704 are greater than respective threshold values (step 708). Each parameter being monitored may have an associated threshold value that is used to determine whether to activate or not activate the signal generator 616. For example, a threshold of 7 mmol/L may be implemented when the parameter being monitored includes blood glucose. Other thresholds may include a cholesterol level threshold value if monitoring cholesterol (e.g., a threshold of 5.0 mmol/L), a low-density lipoproteins (LDL) threshold value (e.g., a threshold of 3.5 mmol/L), triglyceride level threshold values if monitoring triglyceride levels (e.g., a threshold of 150 mg/dL), a blood pressure threshold value if monitoring blood pressure (e.g., a threshold of 140/100 mmHg), a threshold associated with an amount of body fluid (e.g., an impedance deviating more than 5% from normal within a week, assuming weight increase of 2.5 kg for someone of 50 kg), and/or the like.

If the value or values of the parameter or parameters being monitored do not exceed a respective threshold value, then the method 700 returns to step 704 to continue monitoring the parameter(s) of the patient. On the other hand, if the value or values of the parameter or parameters being monitored exceed a respective threshold value, then the method 700 includes controlling the signal generator 616 to generate the electrical signal (step 712). For example, when the patient's blood glucose level exceeds 7 mmol/L, then step 712 is carried out. In one example, the signal generator 616 is controlled to generate the electrical signal as a square wave with a frequency of 15 hz, a pulse width of 210 microseconds, and an initial current of 0.1 mA.

After step 712, the method 700 includes determining whether the value or values of parameters being monitored in step 704 are greater than their respective threshold values (step 716). The threshold value or values may be the same values used in step 708. If the respective threshold value or values are exceeded, the method 700 returns to step 712 and continues to generate the electrical signal. If the respective threshold value or values for the monitored parameter(s) is/are not exceeded, the method 700 includes controlling the signal generator 616 to cease generating the electrical signal (step 720). For example, when the patient's blood glucose level drops below 7 mmol/L, the signal generator 616 stops generating the electrical signal. Step 716 may be performed in conjunction with receiving the data from monitoring device 614. For example, step 716 may be performed each time data regarding the monitored parameter is received from the monitoring device 614.

In at least one embodiment, the method 700 includes iterating through steps 712 and 716 while adjusting at least one characteristic of the electrical signal in each iteration until the value(s) of the monitored parameter(s) drops below a respective threshold value. For example, the method 700 controls the signal generator 616 to output the electrical signal with incremented current values and/or adjusted pulse widths until the monitored parameter drops below the threshold value. By way of explanation, a first iteration of step 712 may include controlling the signal generator 616 to generate the electrical signal having a first current value for a first duration of time. Upon expiration of the first duration of time and when the value of the at least one parameter still exceeds the threshold value in step 716, the method 700 may iterate through step 712 again and control the signal generator 616 to generate the electrical signal having at least one adjusted characteristic compared to the previous iteration of step 712. For example, a second iteration of step 712 may include controlling the signal generator 616 to generate the electrical signal with a second current value larger than the first current value for a second duration of time. In at least one example embodiment, the current of the electrical signal is increased by 0.05 mA (starting with an initial current of 0.1 mA) for each iteration through step 712 until a maximum current is reached. In another embodiment, the current may be increased by different degrees for each iteration. For example, the amount of current increase may rise or fall for each subsequent iteration through step 712. For example, the current may be increased from an initial value by 0.25 mA, then increased by 0.5 mA, then increased by 0.75 mA, and so on for subsequent iterations until reaching the maximum current. The maximum current may be a current that is below a level that is known to stimulate the patient's ventral root (accidental stimulation of the ventral root may induce side effects for the patient). In another example, the current may be increased from an initial value by 0.75 mA, then increased by 0.5 mA, then increased by 0.25 mA, and so on for subsequent iterations until reaching the maximum current. As may be appreciated, the same approach as described above for current may be taken for adjusting pulse width of pulses of the electrical signal (e.g., a gradual increase or decrease in pulse width for each iteration of step 712).

Here, it should be understood that the determination in step 716 may depend on the type of parameter(s) being monitored. For example, although FIG. 7 is described with respect to keeping a value of a monitored parameter below an upper limit threshold value, the determination in step 716 may additionally or alternatively determine whether the value(s) of the monitored parameter(s) drops below a lower limit threshold value, and then generate the electrical signal in an iteration of step 712 in a manner that keeps the monitored parameter above the lower limit threshold value (and, in some cases, also below the parameter's upper limit threshold value). Keeping a monitored parameter above a lower limit threshold value may prevent potentially dangerous conditions from occurring, such as hypoglycemia (in the case of exceedingly low blood glucose levels), hypotension (in the case of exceedingly low blood pressure), and/or the like.

Other characteristics of the electrical signal that may be adjusted in each iteration of step 712 besides or in addition to current and/or pulse width include frequency, voltage, duty cycle, pulse type (e.g., square wave, sine wave, triangle wave), and/or the like.

As noted above, each iteration of step 712 may be carried out for a duration of time, where the duration of time is the same or different for some or all iterations. In at least one embodiment, each iteration of step 712 may be carried out for a shorter duration than the immediately preceding iteration, which may result in faster treatment of type 2 diabetes and/or the condition of metabolic syndrome such as a high blood glucose level because higher current levels are implemented more quickly. For a treatment session having a total duration of 2.5 hours, a first iteration of step 712 may be carried out for one hour, a second iteration for 45 minutes, a third iteration for 30 minutes, and a fourth iteration for 15 minutes, with the electrical signal in each iteration increasing in current by 0.5 mA per iteration. If a treatment session ends (or some other prescribed amount of time passes) and the monitored parameter(s) of the patient are still above respective threshold values, then the processor 604 may issue an audio and/or visual alarm to, for example, the patient's mobile phone or other device (e.g., user interface 610) that is capable of producing the alarm in a manner that alerts an interested party to a potential health issue of the patient that needs further attention from a medical professional or to a device malfunction (e.g., a malfunction of the monitoring device 614 and/or the stimulating/blocking system 612).

In accordance with example embodiments, the electrical signal generated in step 712 may be received by one or more stimulating electrodes 400 that stimulate one or more DRGs at one or more of at one more of thoracic levels T7, T8, T9, T11, and/or T12, and/or lumbar levels L1 and/or L2 of the patient, which causes feedback in the patient's brain that in turn causes the pancreas to respond by increasing insulating production. As may be appreciated and depending on which DRG(s) are stimulated, the feedback may further limit food intake, inhibits sympathetic drive (e.g., inhibits sympathetic nerves), and/or promotes vagal simulation, which in turn causes the liver to promote glycogenesis and/or to store more glucose in muscle tissue. In addition, the kidney's response to inhibition of sympathetic activation may lead to an increase in urinary excretion and decrease in sodium resorption.

Although not explicitly illustrated, it should be appreciated that the signal generator 616 may be controlled to stop generating the electrical signal in response to other triggers, such as in response to a maximum amount of time lapsing since beginning treatment and/or in response to instructions from patient or medical professional (e.g., provided to the system 600 through a mobile phone or other suitable device when, for example, the patient is experiencing negative side effects).

The method 700 may implement a feedback mechanism that enables the optimization of various parameters involved in the method 700 with the goal of obtaining desired patient outcomes as fast as possible. To this end, the method 700 may include storing and/or adjusting optimization data in memory 606 to improve future treatments (step 724). Such optimization data may include data for electrical signal optimization data 620. In at least one example, the processor 604 may correlate aspects of one or more iterations of step 712 during the treatment session with aspects of the patient outcome to train the system to improve subsequent treatment sessions. For example, data may be stored and/or adjusted to correlate the effect of each iteration of step 712 on the monitored parameter with the duration of each iteration of step 712, the characteristics of the electrical signal in each iteration of step 712, and/or the like. Other data may be stored and/or adjusted at step 724, such as how often the monitoring device 714 provides data to the processor 604. The stored data may include a listing of patient side effects and when they occurred, which may be used to take action aimed at reducing side effects in future treatments.

The present disclosure encompasses embodiments of the method 700 that comprise more or fewer steps than those described above, and/or one or more steps that are different than the steps described above.

As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in FIG. 7 (and the corresponding description of the method 700), as well as methods that include additional steps beyond those identified in FIG. 7 (and the corresponding description of the method 700). The present disclosure also encompasses methods that comprise one or more steps from one method described herein, and one or more steps from another method described herein.

It should be appreciated that example embodiments are shown and described with reference to specific values for various parameters (e.g., threshold values or levels, electrical signal characteristics, durations of iterations of step 712, etc.), but that these values may vary or be adjusted based on empirical evidence and/or design preference.

The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and/or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and/or configurations of the disclosure may be combined in alternate aspects, embodiments, and/or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and/or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

Moreover, though the foregoing has included description of one or more aspects, embodiments, and/or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and/or configurations to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges, or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

	Number	Date	Country
	63343217	May 2022	US
	63343196	May 2022	US

SYSTEMS AND METHODS FOR TREATING DIABETES WITH DORSAL ROOT GANGLION STIMULATION

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