US20230355980A1

US20230355980A1 - Systems and methods for wirelessly stimulating or blocking at least one nerve

Info

Publication number: US20230355980A1
Application number: US18/131,542
Authority: US
Inventors: Maneesh Shrivastav; ShaileshKumar V. Musley; Kanthaiah Koka; Steven M. Goetz; Suryakiran Vadrevu; Rebecca K. Gottlieb; David John Miller; Leonid M. Litvak
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2022-05-05
Filing date: 2023-04-06
Publication date: 2023-11-09
Also published as: WO2023215671A1; WO2023215668A1; US20230355975A1; EP4518960A1; US20230355965A1; US20250295924A1; US20230355244A1; US20230355976A1; US20230355969A1; US20230355981A1; US20230355987A1; US20230355141A1; EP4518959A1; US20230355977A1; US20230355982A1

Abstract

Systems and methods for wirelessly providing therapy to one or more anatomical elements may comprise a first capsule and a second capsule. The first capsule may be configured to wirelessly transmit instructions to a second capsule and the second capsule may be configured to receive the wirelessly transmitted instructions. The first capsule may receive an activation signal and apply a first current to a first anatomical element. The first capsule may also wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No. 63/338,806, filed on May 5, 2022, entitled “Systems and Methods for Wirelessly Stimulating or Blocking at Least One Nerve”, and further identified as Attorney Docket No. A0008251US01 (10259-211-3P); U.S. Provisional Application No. 63/338,794, filed on May 5, 2022, entitled “Systems and Methods for Stimulating an Anatomical Element Using an Electrode Device”, and further identified as Attorney Docket No. A0008247US01 (10259-211-1P); U.S. Provisional Application No. 63/339,049, filed on May 6, 2022, entitled “Systems and Methods for Mechanically Blocking a Nerve”, and further identified as Attorney Docket No. A0008250US01 (10259-211-2P); U.S. Provisional Application No. 63/339,101, filed on May 6, 2022, entitled “Neuromodulation Techniques to Create a Nerve Blockage with a Combination Stimulation/Block Therapy for Glycemic Control”, and further identified as Attorney Docket No. A0008252US01 (10259-211-4P); U.S. Provisional Application No. 63/339,136, filed on May 6, 2022, entitled “Neuromodulation for Treatment of Neonatal Chronic Hyperinsulinism”, and further identified as Attorney Docket No. A0008253US01 (10259-211-5P); U.S. Provisional Application No. 63/342,945, filed on May 17, 2022, entitled “Neuromodulation Techniques for Treatment of Hypoglycemia”, and further identified as Attorney Docket No. A0008255US01 (10259-211-6P); U.S. Provisional Application No. 63/342,998, filed on May 17, 2022, entitled “Closed-Loop Feedback and Treatment”, and further identified as Attorney Docket No. A0008258US01 (10259-211-7P); U.S. Provisional Application No. 63/338,817, filed on May 5, 2022, entitled “Systems and Methods for Monitoring and Controlling an Implantable Pulse Generator”, and further identified as Attorney Docket No. A0008259US01 (10259-211-8P); U.S. Provisional Application No. 63/339,024, filed on May 6, 2022, entitled “Programming and Calibration of Closed-Loop Vagal Nerve Stimulation Device”, and further identified as Attorney Docket No. A0008260US01 (10259-211-9P); U.S. Provisional Application No. 63/339,304, filed on May 6, 2022, entitled “Systems and Methods for Stimulating or Blocking a Nerve Using an Electrode Device with a Sutureless Closure”, and further identified as Attorney Docket No. A0008262US01 (10259-211-11P); U.S. Provisional Application No. 63/339,154, filed on May 6, 2022, entitled “Personalized Machine Learning Algorithm for Stimulation/Block Therapy for Treatment of Type 2 Diabetes”, and further identified as Attorney Docket No. A0008263US01 (10259-211-12P); U.S. Provisional Application No. 63/342,967, filed on May 17, 2022, entitled “Patient User Interface for a Stimulation/Block Therapy for Treatment of Type 2 Diabetes”, and further identified as Attorney Docket No. A0008264US01 (10259-211-13P); and U.S. Provisional Application No. 63/339,160, filed on May 6, 2022, entitled “Utilization of Growth Curves for Optimization of Type 2 Diabetes Treatment”, and further identified as Attorney Docket No. A0008265US02 (10259-211-14P), all of which applications are incorporated herein by reference in their entireties.

BACKGROUND

The present disclosure is generally directed to therapeutic neuromodulation and relates more particularly to a stimulation/block therapy to affect glycemic control of a patient.
Diabetes represents a large and growing global health issue with estimates of over 537 million patients worldwide having been diagnosed with type 2 diabetes and estimates of 6.7 million annual deaths related to complications of diabetes. Despite different types of treatments being developed and utilized (e.g., medication, surgery, diet, etc.), type 2 diabetes remains challenging to effectively treat. Type 2 patients must frequently contend with keeping their blood sugar levels in a desirable glycemic range. Prolonged deviations can lead to long term complications such as retinopathy, nephropathy (e.g., kidney damage), cardiovascular disease, etc. Because treatment for diabetes is self-managed by the patient on a day-to-day basis (e.g., the patients self-inject the insulin), compliance or adherence with treatments can be problematic.

BRIEF SUMMARY

Example aspects of the present disclosure include:
A system for wirelessly providing therapy to one or more anatomical elements according to at least one embodiment of the present disclosure comprises a first capsule configured to wirelessly transmit instructions to a second capsule; a second capsule configured to receive the wirelessly transmitted instructions; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive an activation signal; apply a first current to a first anatomical element using the first capsule based on the activation signal; and wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element.
Any of the aspects herein, wherein the first current comprises a low frequency stimulation, the first anatomical element comprises a celiac branch of a nerve, the second current comprises a high frequency blockade, and the second anatomical element comprises a hepatic branch of the nerve.
Any of the aspects herein, wherein the first capsule comprises a first body and the second capsule comprises a second body, each of the first body and the second body being configured to wrap around the anatomical element and at least one electrode configured to apply a current to the anatomical element, each of the first body and the second body comprising a hinge that moves between an open position and a closed position.
Any of the aspects herein, wherein each of the first body and the second body comprises a first bore and a second bore, respectively, wherein at least one first electrode is positioned in the first bore and at least one second electrode is positioned in the second bore. Any of the aspects herein, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel.
Any of the aspects herein, wherein the third device is a user device.
Any of the aspects herein, wherein each of the first capsule and the second capsule are configured to record data resulting from the applied first current and the applied second current, respectively.
Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate
Any of the aspects herein, wherein the activation signal is triggered when a predetermined parameter is met.
Any of the aspects herein, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation.
Any of the aspects herein, wherein the second capsule is configured to only receive instructions and execute the instructions from the first capsule.
Any of the aspects herein, wherein the second set of instructions is sent at an end of the period of time.
A system for wirelessly providing therapy to one or more anatomical elements according to at least one embodiment of the present disclosure comprises a first capsule configured to wirelessly transmit instructions to a second capsule, the first body configured to wrap around a first anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: apply a first current to the first anatomical element using the first capsule; wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element; and wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate.
Any of the aspects herein, wherein the second set of instructions is sent based on user input received by the first capsule.
Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: receive an activation signal.
Any of the aspects herein, wherein the activation signal is triggered when a predetermined parameter is met.
Any of the aspects herein, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation.
Any of the aspects herein, wherein each of the first capsule and the second capsule are configured to record data.
Any of the aspects herein, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel.
A system for wirelessly providing therapy to one or more anatomical elements according to at least one embodiment of the present disclosure comprises a first capsule configured to wirelessly transmit instructions to a second capsule, the first capsule comprising a first body and one or more first electrodes configured to apply a current to an anatomical element; a second capsule configured to receive the wirelessly transmitted instructions, the second capsule comprising a second body and one or more second electrodes configured to apply a current to an anatomical element; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: receive an activation signal; apply a first current to a first anatomical element using the first capsule based on the activation signal, the first current applied using the one or more first electrodes; wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element using the one or more second electrodes; and wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate.
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 a first electrode capsule and a second electrode capsule according to at least one embodiment of the present disclosure;

FIG. 3 is a diagram of an electrode capsule according to at least one embodiment of the present disclosure;

FIG. 4 is a diagram of an electrode capsule according to at least one embodiment of the present disclosure;

FIG. 5 is a diagram of an electrode capsule 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 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. The processors listed herein are not intended to be an exhaustive list of all possible processors that can be used for implementation of the described techniques, and any future iterations of such chips, technologies, or processors may be used to implement the techniques and embodiments of the present disclosure as described herein.
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.
Vagus nerve stimulation (VNS) is a technology that has been developed to treat different disorders or ailments of a patient, such as epilepsy and depression. In some examples, VNS involves placing a device in or on a patient's body that uses electrical impulses to stimulate the vagus nerve. For example, the device may be usually placed under the skin of the patient, where a wire (e.g., lead) and/or electrode connects the device to the vagus nerve. Once the device is activated, the device sends signals through the vagus nerve to the patient's brainstem (e.g., or different target area in the patient, such as other organs of the patient), transmitting information to their brain. For example, with VNS, the device may be configured to send regular, mild pulses of electrical energy to the brain via the vagus nerve. In some examples, the device may be referred to as an implantable pulse generator. An implantable vagus nerve stimulator has been approved to treat epilepsy and depression in qualifying patients.
The vagus nerve (e.g., also called the pneumogastric nerve, vagal nerve, the cranial nerve X, etc.) is responsible for various internal organ functions of a patient, including digestion, heart rate, breathing, cardiovascular activity, and reflex actions (e.g., coughing, sneezing, swallowing, and vomiting). Most patients may have one vagus nerve on each side of their body, with numerous branches running from their brainstem through their neck, chest, and abdomen down to part of their colon. The vagus nerve plays a role in many bodily functions and may form a link between different areas of the patient, such as the brain and the gut. The vagus nerve is a critical nerve for supplying parasympathetic information to the visceral organs of the respiratory, digestive, and urinary systems. Additionally, the vagus nerve is important in the control of heart rate, bronchoconstriction, and digestive processes. In some cases, the vagus nerve may be considered a mixed nerve based on including both afferent (sensory) fibers and efferent (motor) fibers. As such, based on including the two types of fibers, the vagus nerve may be responsible for carrying motor signals to organs for innervating the organs (e.g., via the efferent fibers), as well as carrying sensory information from the organs back to the brain (e.g., via the afferent fibers). In some cases, the vagus nerve may be considered a mixed nerve based on including both afferent (sensory) fibers and efferent (motor) fibers. As such, based on including the two types of fibers, the vagus nerve may be responsible for carrying motor signals to organs for innervating the organs (e.g., via the efferent fibers), as well as carrying sensory information from the organs back to the brain (e.g., via the afferent fibers).
The vagus nerve has a number of different functions. Four key functions of the vagus nerve are carrying sensory signals, carrying special sensory signals, providing motor functions, and assisting in parasympathetic functions. For example, the sensory signals carried by the vagus nerve may include signaling between the brain and the throat, heart, lungs, and abdomen. The special sensory signals carried by the vagus nerve may provide signaling of special senses in the patient, such as the taste sensation behind the tongue. Additionally, the vagus nerve may enable certain motor functions of the patient, such as providing movement functions for muscles in the neck responsible for swallowing and speech. The parasympathetic functions provided by the vagus nerve may include digestive tract, respiration, and heart rate functioning. In some cases, the nervous system can be divided into two areas: sympathetic and parasympathetic. The sympathetic side increases alertness, energy, blood pressure, heart rate, and breathing rate. The parasympathetic side, which the vagus nerve is heavily involved in, decreases alertness, blood pressure, and heart rate, and helps with calmness, relaxation, and digestion.
VNS is considered a type of neuromodulation (e.g., a technology that acts directly upon nerves of a patient, such as the alteration, or “modulation,” of nerve activity by delivering electrical impulses or pharmaceutical agents directly to a target area). For example, as described above, VNS may include using a device (e.g., implanted in a patient or attached to the patient) that is configured to send regular, mild pulses of electrical energy to a target area of the patient (e.g., brainstem, organ, etc.) via the vagus nerve. The electrical pulses or impulses may affect how that target area of the patient functions to potentially treat different disorders or ailments of a patient.
In some examples, for epileptic patients that suffer from seizures, VNS may change how brain cells work by applying electrical stimulation to certain areas involved in seizures. For example, research has shown that VNS may help control seizures by increasing blood flow in key areas, raising levels of some brain substances (e.g., neurotransmitters) important to control seizures, changing electroencephalogram (EEG) patterns during a seizure, etc. As an example, an epileptic patient's heart rate may increase during a seizure or epileptic episode, so the VNS device may be programmed to send stimulation to the vagus nerve regular intervals and when periods of increased heart rate are seen, where applying stimulation at those times of increased heart rate may help stop seizures. Additionally or alternatively, depression has been tied to an imbalance in certain brain chemicals (e.g., neurotransmitters), so VNS is believed to assist in treating patients diagnosed with depression by using electricity (e.g., electrical pulses/impulses) to influence the production of those brain chemicals.
Diabetes represents a large and growing global health issue with estimates of over 537 million patients worldwide having been diagnosed with type 2 diabetes and estimates of 6.7 million annual deaths related to complications of diabetes. Despite different types of treatments being developed and utilized (e.g., medication, surgery, diet, etc.), type 2 diabetes remains challenging to effectively treat. Type 2 patients must frequently contend with keeping their blood sugar levels in a desirable glycemic range. Prolonged deviations can lead to long term complications such as retinopathy, nephropathy (e.g., kidney damage), cardiovascular disease, etc. Because treatment for diabetes is self-managed by the patient on a day-to-day basis (e.g., the patients self-inject the insulin), compliance or adherence with treatments can be problematic. Additionally, in a financial sense, global expenditures for type 2 diabetes treatments, preventive measures, and resulting consequences are estimated at about $966 billion per year. Compounding this issue of high global expenditures is the increasing price of insulin.
As described herein, a neuromodulation technique is provided for glycemic control (e.g., as a treatment for diabetes) using a stimulation/block therapy (e.g., type of VNS). For example, the neuromodulation technique may generally include using a device (e.g., including at least an implantable pulse generator) to provide electrical stimulation (e.g., electrical pulses/impulses) on one or more trunks of the vagus nerve (e.g., vagal trunks) to mute a glycemic response for patients with diabetes. The “patient” as used herein may refer to Homo sapiens or any other living being that has a vagus nerve.
In some examples, the device may provide stimulation/blocking of the celiac and hepatic vagal trunks (e.g., using the device) for the purposes of glycemic control. For example, the anterior sub diaphragmatic vagal trunk at the hepatic branching point of the vagus nerve may be electrically blocked (e.g., down-regulated) by delivering a high frequency stimulation (e.g., of about 5 kilohertz (kHz) or in a range between 1 kHz to 50 kHz). Additionally or alternatively, the posterior sub diaphragmatic vagal trunk at the celiac branching point of the vagus nerve may be electrically stimulated (e.g., up-regulated) by delivering a low frequency stimulation (e.g., a square wave at 1 Hz or within a range from 0.1 to 20 Hz). In some examples, the electrical blocking and/or electrical stimulating of the respective vagal trunks may be performed by using one or more cuff electrodes (e.g., of the device) placed on the corresponding vagal trunks (e.g., sutured or otherwise held in place). The desired response by providing the stimulation/block therapy is a muting of the glycemic response of a patient. In some examples, muting of the glycemic response may refer to a lower post prandial peak of the glycemic response as compared to a peak without the stimulation/block therapy being applied.
Using the stimulation/block therapy to achieve a muting of the glycemic response is advantageous for those with type 2 diabetes where the postprandial glycemic response (e.g., occurring after a meal) can be very high. For example, some patients with type 2 diabetes may have high blood sugar levels (e.g., glucose levels) after eating a meal based on their reduced or lack of insulin production (e.g., normal insulin production in the body lowers blood sugar levels postprandially by promoting absorption of glucose from the blood into different cells). Additionally or alternatively, patients diagnosed with type 2 diabetes may generally have high glycemic levels at different points of the day (e.g., not necessarily postprandially or immediately after a meal). Over time, the effect of high glycemic values can have a detrimental effect on one's health, leading to neuropathy, retinopathy, and other ailments. Accordingly, by using the stimulation/block therapy provided herein, a high glycemic response experienced by type 2 diabetes patients may be muted (e.g., the glycemic response is reduced, particularly post prandially). Additionally, the therapy aims to improve insulin sensitivity by not only blocking hepatic glucose production but also by stimulating pancreatic insulin production needed for glycemic control, the lack of which leads to an imbalance in glycemic control and consequent systemic complications in patients with type 2 diabetes. In some examples, the therapy may also improve fasting hyperglycemia, which can be commonly seen in patients with type 2 diabetes.
As previously described, the electrical blocking and/or stimulation n may be provided using electrodes coupled to an implantable pulse generator. However, conventional electrode designs may use wires, which may be cumbersome and difficult to maintain. Thus, embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) providing stimulation and/or blocking therapy wirelessly, (2) providing a self-contained capsule configured to provide stimulation and/or blocking therapy (2) automatically controlling one or more capsules, and (3) increase patient comfort and safety.
Turning to FIG. 1 , a diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to provide glycemic control 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 is capable of providing a stimulation/blocking therapy that mutes a glycemic response for patients with diabetes. In some examples, the device 104 may be referred to as an implantable pulse generator, an implantable neurostimulator, or another type of device not explicitly listed or described herein. Additionally, the system 100 may include one or more wires 108 (e.g., leads) that provide a connection between the device 104 and nerves of the patient for enabling the stimulation/blocking therapy.
As described previously, 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 impulses or localized pharmaceutical agents directly to a target area) may be used for assisting in treatments for different diseases, disorders, or ailments of a patient, such as epilepsy and depression. Accordingly, as described herein, the neuromodulation techniques may be used for muting a glycemic response in the patient to assist in the treatment of diabetes for the patient. For example, the device 104 may provide electrical stimulation to one or more trunks of the vagus nerve of the patient (e.g., via the one or more wires 108) to provide the stimulation/blocking therapy for supporting glycemic control in the patient.
In some examples, the one or more wires 108 may include at least a first wire 108A and a second wire 108B connected to respective vagal trunks (e.g., different trunks of the vagus nerve). As described previously, most patients have one vagus nerve on each side of their body, running from their brainstem through their neck, chest, and abdomen down to part of their colon. The vagus nerve plays a role in many bodily functions and may form a link between different areas of the patient, such as the brain and the gut. For example, the vagus nerve is responsible for various internal organ functions of a patient, including digestion, heart rate, breathing, cardiovascular activity, and reflex actions (e.g., coughing, sneezing, swallowing, and vomiting).
Accordingly, the first wire 108A may be connected to a first vagal trunk of the patient (e.g., the anterior sub diaphragmatic vagal trunk at the hepatic branching point of the vagus nerve) to provide an electrical blocking signal (e.g., a down-regulating signal) from the device 104 to that first vagal trunk (e.g., by delivering a high frequency stimulation, such as a given waveform at about 5 kHz). Additionally or alternatively, the second wire 108B may be connected to a second vagal trunk of the patient (e.g., the posterior sub diaphragmatic vagal trunk at the celiac branching point of the vagus nerve) to provide an electrical stimulation signal (e.g., an up-regulating signal) from the device 104 to that second vagal trunk (e.g., by delivering a low frequency stimulation, such as a square wave or other waveform at 1 Hz). By providing the electrical blocking signal and the electrical stimulation signal to the respective vagal trunks, the system 100 may provide a muting of the glycemic response of the patient when the stimulation/blocking therapy is applied. For example, muting of the glycemic response may refer to a lower post prandial peak of the glycemic response as compared to a peak without the stimulation/block therapy being applied.
In some examples, the vagal trunks to which the wires 108 are connected may be connected to or otherwise in the vicinity of one or more organs of the patient, such that the blocking/stimulation signals provided to the respective vagal trunks by the wires 108 and the device 104 are delivered to the one or more organs. For example, the first vagal trunk (e.g., to which the first wire 108A is connected) may be connected to a first organ 112 of the patient, and the second vagal trunk (e.g., to which the second wire 108B is connected) may be connected to a second organ 116. Additionally or alternatively, while the respective vagal trunks are shown as being connected to the corresponding organs of the patient as described, the vagal trunks to which the wires 108 are connected may be connected to the other organ (e.g., the first vagal trunk is connected to the second organ 116 and the second vagal trunk is connected to the first organ 112) or may be connected to different organs of the patient. In some examples, the first organ 112 may represent a liver of the patient, and the second organ 116 may represent a pancreas of the patient. In such examples, the blocking/stimulation signals provided by the wires 108 and the device 104 may be delivered to the liver and/or pancreas of the patient to mute a glycemic response of the patient as described herein.
In some examples, the wires 108 may provide the electrical signals to the respective vagal trunks via electrodes of an electrode device (e.g., cuff electrodes) that are connected to the vagal trunks (e.g., sutured in place, wrapped around the nerves of the vagal trunks, etc.). In some examples, the wires 108 may be referenced as cuff electrodes or may otherwise include the cuff electrodes (e.g., at an end of the wires 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 vagal trunks, the cuff electrodes may provide the electrical blocking and/or stimulation signals to the one or more vagal trunks wirelessly (e.g., with or without the device 104), as will be described in FIG. 2-7 .
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 include a memory or may be otherwise configured to perform the aspects of the present disclosure. For example, the one or more processors may provide instructions to the device 104, the cuff electrodes, or other components of the system 100 not explicitly shown or described with reference to FIG. 1 for providing the stimulation/blocking therapy to promote glycemic control in a patient 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).
In some examples, the system 100 may also optionally include a glucose sensor 120 that communicates (e.g., wirelessly) with other components of the system 100 (e.g., the device 104, the one or more processors, etc.) to achieve better glycemic control in the patient. For example, the glucose sensor 120 may continuously monitor glucose levels of the patient, such that if the glucose sensor 120 determines glucose levels are outside a normal or desired range for the patient (e.g., glucose levels are too high or too low in the patient), the glucose sensor 120 may communicate that glucose levels are outside the normal or desired range to the device 104 (e.g., via the one or more processors) to signal for the device 104 to apply the stimulation/blocking therapy described herein to adjust glucose levels in the patient (e.g., mute the glycemic response to lower glucose levels in the patient, block insulin production in the patient as a possible technique to raise glucose levels in the patient, etc.).
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 vagal nerves and the stimulation and/or blocking therapies described herein may be applied to one or more vagal nerves, which may reside at any location of a patient (e.g., lumbar, thoracic, etc.). Further, a sequence of stimulations and/or blocking therapies may be applied to different nerves or portions of nerves. For example, a low frequency stimulation may be applied to a first nerve and a high frequency blockade may be applied to a second nerve.
Turning to FIG. 2 , a capsule 200 comprising a first capsule 200A and a second capsule 200B are shown. The first capsule 200A and the second capsule 200B may be used to wirelessly stimulate and block vagal nerves and may receive instructions for turning on and off from, for example, a command module. The first capsule 200A and the second capsule 200B may include a power source such as a battery element or a rechargeable battery element and as such, does not need a separate implantable pulse generator to operate. In other words, each of the first capsule 200A and the second capsule 200B may generate and deliver a current as a single unit. In other instances, the first capsule 200A and/or the second capsule 200B may have an external battery source. In such instances, the first capsule 200A and/or the second capsule 200B may have an antenna configured to receive power sent from the external unit. Such external battery source may be also positioned external to the user. For example, the external battery source may be positioned on a user's abdomen.
As shown in the illustrated embodiment, the first capsule 200A may be coupled to a first anatomical element 204—which may be, for example, a celiac branch of a vagal nerve—and the second capsule 200B may be coupled to a second anatomical element 206—which may be, for example, a hepatic branch of the vagal nerve. Each of the first capsule 200A and the second capsule 200B may be configured to generate a current. The first capsule 200A and the second capsule 200B may also comprise at least one electrode (such as an electrode 208) configured to apply the current to an anatomical element. The anatomical element may comprise, for example, one or more nerves. More specifically, the one or more nerves may be the vagal or hepatic branches of the vagal nerve. In some embodiments, the first capsule 200A may be configured to apply a first current to the first anatomical element 204—such as one of the vagal or hepatic branches of the vagal nerve—and the second capsule 200B may be configured to apply a second current to the second anatomical element 206—such as another one of the vagal or hepatic branches of the vagal nerve. The first current and the second current may have different parameters in some instances and may have the same parameters in other instances. For example, in some embodiments, the first current may comprise a low frequency stimulation and the second current may comprise a high frequency blockade.
The first capsule 200A may also be configured to wirelessly transmit instructions to the second capsule 200B and the second capsule 200B may be configured to receive and process the wirelessly transmitted instructions. It will be appreciated that in other instances, the first capsule 200A may be configured to wirelessly receive and/or transmit instructions and the second capsule 200B may be configured to wirelessly transmit and/or receive instructions. During use, the first capsule 200A may be configured to activate and apply the first current to the first anatomical element 204 and send a first set of instructions to the second capsule 200B to cause the second capsule 200B to apply the second current to the second anatomical element 206. In this manner, the first capsule 200A may act as a primary capsule and the second capsule 200B may act as a secondary capsule where the primary capsule is configured to control the secondary capsule. Such a configuration may enable automatic stimulation/block therapy to affect glycemic control of a patient without the use of cumbersome wires.
The first capsule 200A and the second capsule 200B may also be configured to simultaneously record data and apply a current to an anatomical element. In such embodiments, the first capsule 200A and the second capsule 200B may also be configured to store the recorded data. For example, each of the first capsule 200A and the second capsule 200B may each comprise a memory device configured to store the recorded data. The first capsule 200A and the second capsule 200B may each be configured to establish and utilize a communication channel configured to wirelessly transmit data to another device such as, for example, a smart phone, a computing device (which may be the same as the computing device 602), or any other device. More specifically, the first capsule may comprise a first interface (e.g., an antenna, a transmitter, a driver, etc.) and the second capsule may comprise a second interface. Each of the first interface and the second interface may be configured to utilize the communication channel to wirelessly transmit data to another device.
Turning to FIGS. 3-5 , a schematic side view of a capsule 200 in an open position, a schematic top view of the capsule 200 in a closed position, and a cross-sectional top view of the capsule 200 in an open position are respectively shown. It will be appreciated that reference to a “capsule” can refer to the first capsule 200A and/or the second capsule 200B. The capsule 200 comprises a body 210 configured to wrap around or encompass an anatomical element. More specifically, the first capsule 200A may comprise a first body and the second capsule 200B may comprise a second body. In the illustrated embodiment the capsule 200 is configured to move between a first position and a second position. In the first position, the body 210 is open and can be wrapped around or otherwise coupled to an anatomical element. In the second position, the body 210 is closed around or otherwise coupled to the anatomical element. In the illustrated embodiment, the capsule 200 comprises one or more hinges 212 which enables the body 210 to move between the first position and the second position. It will be appreciated that in other embodiments, the capsule 200 may comprise a flexible body configured to move between the first position and the second position. The capsule 200 also comprises a lock 214 configured to lock the body 210 in the second position and secure the body 210 to the anatomical element. In the illustrated embodiment, the lock 214 comprises a kiss clasp. In other embodiments, the lock 214 may comprise, for example, a snap lock, hook and loop fabric, or any other fastener or lock configured to lock the body 210 in the second position.
The capsule may be adapted to be inserted and implanted during an implantation procedure, and in some instances, may be implanted laparoscopically. The capsule 200 may be sized and/or shaped to fit through a typical trocar or any other surgical instrument or tool. The capsule 200 may also have elements facilitating suturing or stapling so as to fixate it in place relative to the nerve target. The capsule 200 may further may have elements to adapt the capsule 200 to a robotic procedure.
The body 210 may be elongated and extend from a first end to a second end. The first end and the second end may be rounded, though in other embodiments, the first end and the second end may be any shape. In the illustrated embodiment, the body 210 comprises a bore 216 and at least one electrode 208 may be positioned in the bore 216. More specifically, the first body may comprise a first bore and the second body may comprise a second body. Further, at least one first electrode may be positioned in the first bore and at least one second electrode may be positioned in the second bore. It will be appreciated that in other embodiments, the body 210 may comprise, for example, a cavity and the at least one electrode may be positioned in the cavity. The bore 216 may form a seat for an anatomical element such as, for example, a nerve and may be configured to at least partially encompass an anatomical element. When the bore 216 surrounds the anatomical element and the capsule 200 is in the second position, the at least one electrode 208 in contact with the anatomical element when the capsule 200. The body 210 may also form a housing 218 in which to store one or more components such as, for example, memory, a processor, a pulse generator, a power source, a controller, and/or a transmitter.
Turning to FIG. 6 , a block diagram of a system 600 according to at least one embodiment of the present disclosure is shown. The system 600 may be used with the first capsule 200A, and/or the second capsule 200B, and/or carry out one or more other aspects of one or more of the methods disclosed herein. The system 600 comprises a computing device 602, a capsule system 612, 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 capsule system 612 may comprise the first capsule 200A and/or the second capsule 200B. As previously described, each of the first capsule 200A and the second capsule 200B may be configured to generate a current and may comprise the plurality of electrodes 208 configured to apply the current to an anatomical element. The capsule system 612 may communicate with the computing device 602 to receive instructions such as instructions 622 for applying a current to the anatomical element. The capsule system 612 may also provide data (such as data received from the first capsule 200A and/or the second capsule 200B), which may be used to optimize the electrodes of the first capsule 200A and/or the second capsule 200B and/or to optimize parameters of the generated current.
The computing device 602 comprises 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 be any processor described herein or any similar processor. The processor 604 may be configured to execute instructions stored in the memory 606, which instructions may cause the processor 604 to carry out one or more computing steps utilizing or based on data received from the capsule system 612, the database 630, and/or the cloud 634.
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 step 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 capsule system 612. For instance, the memory 606 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 604, enable current optimization 620.
The current optimization 620 enables the processor 604 to optimize a current generated and applied by electrodes of the first capsule 200A and/or the second capsule 200B. More specifically, the current optimization 620 may enable the processor 604 to determine one or more parameters of the current and/or a period of time to generate and apply the current.
Content stored in the memory 606, if provided as in instruction, may, in some embodiments, 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. 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 capsule 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 the first capsule 200A and/or the second capsule 200B transmitted via the first communication channel and/or the second communication channel, respectively) or other information from an external source (such as the capsule 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 capsule 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 602.11a/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 reason.
The computing device 602 may also comprise one or more 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. Notwithstanding the foregoing, any required input for any step of any method 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.
The database 630 may store information such as patient data, results of a stimulation and/or blocking procedure, stimulation and/or blocking parameters, current parameters, electrode parameters, etc. 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 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, for wirelessly providing therapy to one or more anatomical elements.
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(s) 604 of the computing device 602 described above. 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 the memory 606. 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 a current optimization 620.
The method 700 comprises receiving an activation signal (step 704). The activation signal may be received by a first capsule such as the first capsule 200A. The activation signal may be triggered when a predetermined parameter is met. For example, the predetermined parameter may comprise a high glycemic value, a post prandial response, or a patient activation. Such activation signal may be received wireless from, for example, a sensor such as a continuous glucose monitor, a computing device such as the computing device 602, or a user device. In some embodiments, the first capsule may monitor the predetermined parameter and generate the activation signal. For example, the first capsule may comprise a sensor for monitoring glucose level(s) and may also comprise a processor to determine when the glucose level(s) has met or exceeded a predetermined parameter.
The first capsule may comprise a body such as the body 210, or more specifically, may comprise a first body. The first body may be configured to encompass or wrap around an anatomical element which may comprise, for example, one or more nerves. The first body may also comprise a bore such as the bore 216 and more specifically may comprise a first bore. At least one first electrode may be positioned in the first bore. The first bore may be configured to wrap around the anatomical element, thereby placing the at least one first electrode in contact with the anatomical element.
The method 700 also comprises applying a first current to a first anatomical element (step 708). The first current may be applied by the first capsule. The first anatomical element may comprise, for example, a celiac branch of a nerve and the first current may comprise a low frequency stimulation. The first current may be applied for a period of time.
In some embodiments, a processor such as the processor 604 may execute a current optimization such as the current optimization 620. Such optimization may determine one or more parameters of the first current (and the second current, described below) and the period of time to generate and apply the current(s).
The method 700 also comprises transmitting a first set of instructions (step 712). The first set of instructions may be generated and transmitted from the first capsule to a second capsule such as the second capsule 200B. It will be appreciated that in some embodiments, the first set of instructions may be generated and transmitted from the second capsule to the first capsule or from a third device (e.g., a user device, a computing device, a mobile device, etc.) to the first capsule and/or the second capsule. In still other embodiments, the second capsule may be configured to only receive instructions and execute instructions from the first capsule.
The second capsule may comprise a body such as the body 210, or more specifically, may comprise a second body. The second body may be configured to encompass or wrap around an anatomical element which may comprise, for example, one or more nerves. The second body may also comprise a bore such as the bore 216 and more specifically may comprise a second bore. At least one second electrode may be positioned in the second bore. The at least one second electrode may comprise one electrode, two electrodes, or more than two electrodes. The second bore may be configured to wrap around the anatomical element, thereby placing the at least one second electrode in contact with the anatomical element.
The first set of instructions may be transmitted prior to the first capsule applying the first current to the first anatomical element in some instances, though in other instances the first set of instructions may be transmitted simultaneously or at the same time as when the first capsule begins applying the first current to the first anatomical element. The first set of instructions, when executed, cause the second capsule to apply a second current to a second anatomical element. In some embodiments, the second current comprises a high frequency blockage and the second anatomical element comprises a hepatic branch of the nerve.
The method 700 also comprises transmitting a second set of instructions (step 716). The second set of instructions may be generated and transmitted from the first capsule to the second capsule. It will be appreciated that in some embodiments, the second set of instructions may be generated and transmitted from the second capsule to the first capsule or from a third device (e.g., a user device, a computing device, a mobile device, etc.) to the first capsule and/or the second capsule.
The second set of instructions may be transmitted based on user input received by the first capsule. The user input may be transmitted from, for example, a user device or a computing device such as the computing device 602. In other embodiments, the second set of instructions may be transmitted automatically at an end of the period of time. In other embodiments, the second set of instructions may be transmitted in response to a monitored parameter meeting a predetermined threshold. For example, a blood glucose monitor such as the glucose sensor 120 may monitor a parameter such as user's blood glucose level. When the blood glucose level has reached or met a desired threshold, the second set of instructions may be transmitted to the second capsule. The second set of instructions, when executed, may cause the second capsule to deactivate. Such deactivation may cause the second capsule to cease application of the second current to the second anatomical element and may also power off the second capsule or cause the second capsule to transition to a standby mode.
In some embodiments, the method 700 may not include the step 716. In such embodiments, the second capsule may automatically deactivate after a quiescent period or after the period of time.
The method 700 also comprises deactivating the first capsule (step 720). The first capsule may be deactivated after the second set of instructions are transmitted in step 716. In some instances, the first capsule may be deactivated simultaneously with transmission of the second set of instructions. Such deactivation may cause the first capsule to cease application of the first current to the first anatomical element and may also power off the first capsule or cause the first capsule to transition to a standby mode.
It will be appreciated that the steps 704, 708, 712, 716, and/or 720 may be repeated. For example, step 704 may be repeated multiple times as the therapy may be needed by a patient multiple times a day. Similarly, steps 708 and 712 may be repeated to activate the first capsule and the second capsule to provide the therapy, and step 716 may be repeated to deactivate the first capsule and the second capsule. In some embodiments, the first set of instructions 712 as sent during the step 712 and the second set of instructions as sent during the step 716 may be sent multiples times and may be used to control the timing of a stimulation and a block. In such embodiments, the timing of instructions sets may be simultaneous, completely or partially overlapping, sequenced, interleaved, or the like.
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. Any correlation described herein may be or comprise a registration or any other correlation.
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.

Claims

What is claimed is:

1. A system for wirelessly providing therapy to one or more anatomical elements comprising:

a first capsule configured to wirelessly transmit instructions to a second capsule;

a second capsule configured to receive the wirelessly transmitted instructions;

a processor; and

a memory storing data for processing by the processor, the data, when processed, causes the processor to:

receive an activation signal;

apply a first current to a first anatomical element using the first capsule based on the activation signal; and

wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element.

2. The system of claim 1, wherein the first current comprises a low frequency stimulation, the first anatomical element comprises a celiac branch of a nerve, the second current comprises a high frequency blockade, and the second anatomical element comprises a hepatic branch of the nerve.

3. The system of claim 1, wherein the first capsule comprises a first body and the second capsule comprises a second body, each of the first body and the second body being configured to wrap around the anatomical element and at least one electrode configured to apply a current to the anatomical element, each of the first body and the second body comprising a hinge that moves between an open position and a closed position.

4. The system of claim 3, wherein each of the first body and the second body comprises a first bore and a second bore, respectively, wherein at least one first electrode is positioned in the first bore and at least one second electrode is positioned in the second bore.

5. The system of claim 1, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel.

6. The system of claim 5, wherein the third device is a user device.

7. The system of claim 1, wherein each of the first capsule and the second capsule are configured to record data resulting from the applied first current and the applied second current, respectively.

8. The system of claim 1, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:

wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate

9. The system of claim 1, wherein the activation signal is triggered when a predetermined parameter is met.

10. The system of claim 9, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation.

11. The system of claim 1, wherein the second capsule is configured to only receive instructions and execute the instructions from the first capsule.

12. The system of claim 1, wherein the second set of instructions is sent at an end of the period of time.

13. A system for wirelessly providing therapy to one or more anatomical elements comprising:

a first capsule configured to wirelessly transmit instructions to a second capsule, the first body configured to wrap around a first anatomical element;

a processor; and

apply a first current to the first anatomical element using the first capsule;

wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element; and

wirelessly transmit a second set of instructions to the second capsule to cause the second capsule to deactivate.

14. The system of claim 13, wherein the second set of instructions is sent based on user input received by the first capsule.

15. The system of claim 13, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:

receive an activation signal.

16. The system of claim 15, wherein the activation signal is triggered when a predetermined parameter is met.

17. The system of claim 16, wherein the predetermined parameter comprises at least one of a high glycemic value, a post prandial response, or a patient activation.

18. The system of claim 13, wherein each of the first capsule and the second capsule are configured to record data.

19. The system of claim 13, wherein each of the first capsule and the second capsule comprises a first interface and a second interface, respectively, each of the first interface and the second interface configured to utilize a communication channel between each of the first capsule and the second capsule, respectively, and a third device, and wherein each of the first capsule and the second capsule is configured to wirelessly transmit data to the third device via the communication channel.

20. A system for wirelessly providing therapy to one or more anatomical elements comprising:

a first capsule configured to wirelessly transmit instructions to a second capsule, the first capsule comprising a first body and one or more first electrodes configured to apply a current to an anatomical element;

a second capsule configured to receive the wirelessly transmitted instructions, the second capsule comprising a second body and one or more second electrodes configured to apply a current to an anatomical element;

a processor; and

receive an activation signal;

apply a first current to a first anatomical element using the first capsule based on the activation signal, the first current applied using the one or more first electrodes;

wirelessly transmit a first set of instructions to the second capsule to cause the second capsule to apply a second current to a second anatomical element using the one or more second electrodes; and