US20230355987A1

US20230355987A1 - Systems and methods for stimulating an anatomical element using an electrode device

Info

Publication number: US20230355987A1
Application number: US18/131,500
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; US20230355980A1; US20230355141A1; EP4518959A1; US20230355977A1; US20230355982A1

Abstract

Systems and methods for stimulating an anatomical element are provided. The system may comprise an implantable pulse generator configured to generate a current and an electrode device comprising a plurality of electrodes configured to apply the current to the anatomical element. Each of the plurality of electrodes may comprise at least one of an anode or a cathode. The electrode device may be customized by assigning each of the plurality of electrodes as at least one of an anode or a cathode and at least one of active or inactive. The current may be applied to the anatomical element in a predetermined pattern using the plurality of electrodes.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of 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. 63/338,806, 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. 63/339,101, 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 using an electrode device 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 stimulating an anatomical element according to at least one embodiment of the present disclosure comprises an implantable pulse generator configured to generate a current; an electrode device comprising a plurality of electrodes configured to apply the current to the anatomical element, wherein each of the plurality of electrodes comprises at least one of an anode or a cathode; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: customize the electrode device by assigning each of the plurality of electrodes as at least one of an anode or a cathode and each of the plurality of electrodes as at least one of active or inactive; and apply the current to the anatomical element in a predetermined pattern using the plurality of electrodes.
Any of the aspects herein, wherein the anatomical element comprises a celiac vagal trunk and a hepatic vagal trunk.
Any of the aspects herein, wherein the electrode device is implantable using a laparoscopic technique.
Any of the aspects herein, wherein the electrode device is configured to target dual nerve branches.
Any of the aspects herein, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.
Any of the aspects herein, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.
Any of the aspects herein, wherein the electrode device comprises a body and the plurality of electrodes are coupled to the body, the body configured to couple to the anatomical element such that the plurality of electrodes is in contact with the anatomical element.
Any of the aspects herein, wherein the body comprises a T-shaped body, the T-shaped body configured to wrap around the anatomical element.
Any of the aspects herein, wherein the body comprises a spiral-shaped body, the spiral-shaped body configured to wrap around and conform to a shape of the anatomical element.
Any of the aspects herein, wherein the body comprises a carbon nanotube thin film and the plurality of electrodes comprise one or more yarn electrodes disposed on the carbon nanotube thin film.
Any of the aspects herein, wherein the body is three-dimensionally printed.
Any of the aspects herein, wherein the body is formed from injecting epoxy on the anatomical element.
A system for stimulating an anatomical element according to at least one embodiment of the present disclosure comprises an implantable pulse generator configured to generate a current; an electrode device comprising: a body; a plurality of electrodes disposed on the body and configured to apply the current to the anatomical element, wherein each of the plurality of electrodes comprises at least one of an anode or a cathode; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: apply the current from the implantable pulse generator to the anatomical element in a predetermined pattern using the plurality of electrodes.
Any of the aspects herein, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.
Any of the aspects herein, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.
Any of the aspects herein, further comprising: a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: apply the current to the anatomical element in a predetermined pattern using the plurality of electrodes.
A system for stimulating an anatomical element according to at least one embodiment of the present disclosure comprises an implantable pulse generator configured to generate a current; an electrode device comprising a plurality of electrodes configured to apply the current to the anatomical element, wherein each of the plurality of electrodes comprises at least one of an anode or a cathode; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: assign each of the plurality of electrodes to be at least one of the anode or the cathode, and apply the current to the anatomical element in a predetermined pattern using the plurality of electrodes.
Any of the aspects herein, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.
Any of the aspects herein, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.
Any of the aspects herein, wherein the electrode device comprises a body and the plurality of electrodes are coupled to the body, the body configured to couple to the anatomical element such that the plurality of electrodes is in contact with the anatomical element.
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 an electrode device according to at least one embodiment of the present disclosure;

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

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

FIG. 5 is a diagram of an electrode device according to at least one embodiment of the present disclosure;

FIG. 6 is a diagram of an electrode device according to at least one embodiment of the present disclosure;

FIG. 7 is a diagram of an electrode device according to at least one embodiment of the present disclosure;

FIG. 8 is a block diagram of a system according to at least one embodiment of the present disclosure; and

FIG. 9 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, different lead configurations are described and may be designed so as to optimize current density and provide the current (e.g., stimulation and/or blocking) at different angles to a target anatomical element. The lead may comprise electrode(s) that may be selected to comprise an anode or a cathode. In some embodiments, the electrode(s) may comprise a combination of anodes or cathodes and in other embodiments the electrode(s) may comprise all anodes or cathodes. The electrode(s) may also be selected to be active or inactive.
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 visceral organs of the patient (for example, liver, pancreas, etc.)), 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, this 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).
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. The nervous system can be divided into two areas, called the autonomic nervous system: 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. Electrical pulses or impulses of this nature 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 at 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, this 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 blocking hepatic glucose production and also by stimulating pancreatic insulin production needed for glycemic control, where the lack of insulin sensitivity can potentially lead 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 may be provided using electrodes. However, conventional electrode designs may not conform to or otherwise fit to an anatomical element, and may need multiple implantation procedures for insertion. Further, typical electrode designs are restrained to an initial design of the electrode(s) and may not enable customization of the electrode(s).
Thus, embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) providing a customizable electrode device, (2) providing an electrode device capable of insertion without suturing, and (3) enabling optimization of stimulation and/or blocking parameters.
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 102 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. More specifically, the implantable pulse generator 106 may be configured to generate a current or electrical signal. Additionally, the system 100 may include one or more wires 104 (e.g., leads) that provide a connection between the device 102 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, these 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 102 may provide electrical stimulation to one or more trunks of the vagus nerve of the patient (e.g., via the one or more wires 104) to provide the stimulation/blocking therapy for supporting glycemic control in the patient.
In some examples, the one or more wires 104 may include at least a first wire 104A and a second wire 104B 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 104A 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 102 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 104B 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 102 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 this 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 104 may provide the electrical signals to the respective vagal trunks via electrodes of an electrode device 200 (discussed in detail in FIGS. 2-7 ) 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 104 may be referenced as cuff electrodes or may otherwise include the cuff electrodes (e.g., at an end of the wires 104 not connected or plugged into the device 102). Additionally or alternatively, while shown as physical wires that provide the connection between the device 102 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 102).
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) shown and described in FIG. 8 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 102, 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 102 or part of a control unit for the system 100 (e.g., where the control unit is in communication with the device 102 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 FIGS. 2-7 , various embodiments of an electrode device 200 are shown and described. The electrode device 200 may also be referred to as a lead. The electrode device 200 comprises a plurality of electrodes 206 configured to apply current (generated by, for example, the implantable pulse generator 106) to an anatomical element. It will be appreciated that in some embodiments, the electrode device 200 may only comprise one electrode 206. The anatomical element may be, for example, one or more nerves and more specifically, a celiac vagal trunk and a hepatic vagal trunk. The electrode device 200 also comprises a body 204 and the plurality of electrodes 206 may be coupled to, disposed on, or otherwise positioned on the body 204 such that the plurality of electrodes is in contact with the anatomical element. The body 204 may be designed so as to optimize current density and provide the current (e.g., stimulation and/or blocking) at different angles. Each of the plurality of electrodes 206 may be selected to comprise an anode or a cathode. In some embodiments, the plurality of electrodes 206 may comprise a combination of anodes or cathodes and in other embodiments the plurality of electrodes 206 may comprise anodes or cathodes. Additionally, in some embodiments, each of the plurality of electrodes may be selected to activate or not activate. It will be appreciated that each of the plurality of electrodes 206 can be selected to activate or not activate and to comprise an anode or a cathode to enable a specific pattern of the current applied to the anatomical element. A response of the specific pattern may be measured and used the optimize the plurality of electrodes 206 to obtain a desired response. For example, each of the plurality of electrodes 206 may then be selected again to activate or not activate and to comprise an anode or a cathode based on the response of the initial settings. As such, the electrode device 200 is highly customizable for a given application.
Turning to FIGS. 2-3 , the body 204 may comprise a T-shaped body 304. The T-shaped body 304 may be configured to wrap about the anatomical element. In some embodiments, the T-shaped body 304 may only comprise one electrode 206 and the electrode 206 may wrap around the nerve. In other embodiments, the T-shaped body 304 may comprise the plurality of electrodes 206. The T-shaped body 304 advantageously enables the electrode device 200 to be simply wrapped around the anatomical element (e.g., a nerve). For example, the T-shaped body 304 may advantageously enable a cuff electrode to be wrapped at a junction of a main vagal and sub-branches of interest. Security of the lead to the nerve can be adjusted during implantation by applying a proper pressure on the suture holes while implanting and checking for impedance values. The plurality of electrodes 206 may be highly configurable in that, as previously described, each electrode may be selected to be active or inactive and an anode or a cathode. Further, this T-shaped body 304 allows the stimulation to be steered towards the branch of interest by controlling which electrode is an anode or cathode, which electrode is being activated, and how much percentage current to apply to each electrode. For example, a 50% current on each anode and a 100% current on each cathode may steer the current towards branch(es) of interest other than the main branch. In the illustrated embodiment, the plurality of electrodes 206 comprises six electrodes (206A, 206B, 206C, 206D, 206E, 206F), though it will be appreciated that in other embodiments the plurality of electrodes 206 may comprise less than or greater than six electrodes. Each of the plurality of electrodes 206 may be different sizes and/or shapes and may be symmetrical or asymmetrical. For example, an electrode further away from a target anatomical element may be larger to encourage stimulation propagation in the direction of the target anatomical element. The plurality of electrodes 206 are shown as rings for illustrative purposes and may, in other embodiments, be partial segments or split into multiple sub-segments for additional control of the stimulation applied to the target anatomical element.
For example, electrodes 206B, 206C, and 206F may be initially activated, then electrodes 206A, 206D, 206E may be additionally activated, thereby increasing a surface area of the anatomical element that is being stimulated.
Turning to FIG. 4 , the body 204 may comprise a spiral body 404 on which one electrode or a plurality of electrodes 206 may be disposed upon. The spiral body 404 also advantageously enables the electrode device 200 to be simply wrapped around the anatomical element. In the illustrated embodiment, eight electrodes are shown spaced along the spiral body 404. It will be appreciated that one, two, or more than two electrodes may be disposed on the spiral body 404 and the electrode(s) may be spaced in any configuration, pattern, or distance from each other on the spiral body 404. The spiral body 404 may advantageously conform to the shape of the anatomical element (e.g., a nerve) and thus enabling a tight, solid contact between the electrodes and the anatomical element. In some embodiments, the spiral body 404 may be inserted with the aid of one or more instruments or tools such as, for example, a sheath.
Turning to FIG. 5 , the body 204 may comprise a carbon nanotube thin film 504 and the plurality of electrodes 206 may comprise one or more yarn electrodes disposed on the carbon nanotube thin film 504. In such embodiments, the carbon nanotube thin film 504 is flexible and configured to adapt to a curvature of the anatomical element (e.g., a nerve). Further, the carbon nanotube thin film 504 is easily implantable as the carbon nanotube thin film 504 can be pierced into the anatomical element without altering or necrosing the anatomical element. Thus, the carbon nanotube thin film 504 may be implanted using, for example, a laparoscopic technique. More specifically, the laparoscopic technique may be used during a minimally invasive surgery in which a small incision is formed and one or more narrow tubes may be inserted through the incision to a target area. Instruments, such as the electrode device 200, may be inserted through the tubes. Further, a laparoscope may be used to relay images to a medical provider such as, for example, a surgeon during implantation of the carbon nanotube thin film 504 to a nerve.
Turning to FIG. 6 , the body 204 may be an elongate body 604 capable of supporting the plurality of electrodes 206 on the elongate body 604. The plurality of electrodes 206 may be configured to provide stimulation via a current and to record a result of the stimulation. More specifically, one or more electrodes may be used to provide stimulation and another one or more electrodes may be configured to record the result of the stimulation. The electrode device 200 advantageously provides for a device 200 that can be implanted with a single implant procedure that can both provide stimulation and recording, whereas conventional devices require at least two implant procedures. In the illustrated embodiment, the elongate body 604 may comprise a non-conductive silicone, though in other embodiments the elongate body 604 may comprise any material. The elongate body 604, as shown, may have a diameter about 1.5 to 2.0 mm, though the diameter may be greater than or less than 1.5 and 2.0 mm. Also shown in the illustrated embodiment, the plurality of electrodes 206 may comprise 10 electrodes and a width of a first electrode may be about 500 um and a width of a second electrode may be about 10 mm, though it will be appreciated that the width of the first electrode may be greater than or less than 500 um and the width of the second electrode may be greater than or less than 10 mm. Further, each electrode of the plurality of electrodes 206 may have a different width, size, and/or shape depending on whether the electrode is recording or stimulating. For example, an electrode configured to stimulate may have a larger surface area than an electrode configured to record. A spacing of the plurality of electrodes 206 may be similarly customized based on the electrode purpose.
Turning to FIG. 7 , a schematic diagram of an electrode device 200 is shown. Similarly, to the electrode device described in FIG. 6 above, the electrode device 200 may comprise the plurality of electrodes 206 configured to both provide stimulation and record data (e.g., a result of the stimulation). As shown, the plurality of electrodes 206 may comprise three electrodes 206 configured to provide stimulation and four electrodes 206 configured to record data. The four electrodes 206 may be split into pairs of electrodes positioned on either side of the three electrodes 206. It will be appreciated that more or fewer than three electrodes 206 may be configured to provide stimulation and more or fewer than four electrodes 206 may be configured to record data. In such embodiments, a width of each contact may be about 1.5 mm, though the width may be less than or greater than 1.5 mm, and a spacing between each contact may be about 2 mm, though the spacing may be less than or greater than 2 mm.
Though not shown, the body 204 may be formed using any material in may be formed in any way. In other words, the body 204 may be customizable for a patient. For example, the body 204 may have patient specific conductive surfaces that may serve as therapy delivery mechanisms. In at least one embodiment, the body 204 may be formed by using an injector to inject conductive epoxy into an anatomical element such as, for example, a nerve. The conductive epoxy may flow inside and/or around the anatomical element and may provide an anatomically specific electrode device 200. Such injection may be used with, for example, a laparoscopic technique, as it may obviate a need to position and/or suture a traditional electrode device such as a cuff electrode. As previously described, the laparoscopic technique may be used during a minimally invasive surgery in which a small incision is formed and one or more narrow tubes may be inserted through the incision to a target area. Instruments, such as the electrode device, may be inserted through the tubes. Further, a laparoscope may be used to relay images to a medical provider such as, for example, a surgeon during injection of the epoxy to a nerve. In another embodiment, the body 204 may be three-dimensionally printed or otherwise formed using a three-dimensional model (whether physical and/or virtual) of the anatomical element. The body 204 may be custom designed based on the model of the anatomical element and three-dimensionally printed, machined, injection molded, or formed in any way. In still other embodiments, an injectable liquid metal may be injected over a surface of the anatomical element and may act as an electrode. In such embodiments, the electrode may act as its own body or housing.
Turning to FIG. 8 , a block diagram of a system 800 according to at least one embodiment of the present disclosure is shown. The system 800 may be used with the implantable pulse generator 106 and/or the electrode device 200, and/or carry out one or more other aspects of one or more of the methods disclosed herein. The system 800 comprises a computing device 802, a system 812, a database 830, and/or a cloud or other network 834. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 800. For example, the system 800 may not include one or more components of the computing device 802, the database 830, and/or the cloud 834.
The system 812 may comprise the implantable pulse generator 106 and the electrode device 200. As previously described, the implantable pulse generator 106 may be configured to generate a current and the electrode device 200 may comprise the plurality of electrodes 206 configured to apply the current to an anatomical element. The system 812 may communicate with the computing device 802 to receive instructions such as instructions 822 for applying a current to the anatomical element. The system 812 may also provide data (such as data received from an electrode device 200 capable of recording data), which may be used to optimize the electrodes of the electrode device 200 and/or to optimize parameters of the current generated by the implantable pulse generator 106.
The computing device 802 comprises a processor 804, a memory 806, a communication interface 808, and a user interface 810. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 802.
The processor 804 of the computing device 802 may be any processor described herein or any similar processor. The processor 804 may be configured to execute instructions stored in the memory 806, which instructions may cause the processor 804 to carry out one or more computing steps utilizing or based on data received from the system 812, the database 830, and/or the cloud 834.
The memory 806 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 806 may store information or data useful for completing, for example, any step of the method 900 described herein, or of any other methods. The memory 806 may store, for example, instructions and/or machine learning models that support one or more functions of the system 812. For instance, the memory 806 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 804, enable electrode(s) optimization 820.
The electrode optimization 820 enables the processor 804 to assign one or more electrodes of the electrode device 200 as active or inactive. The electrode optimization 820 also enables the processor 804 to assign the activated electrodes as a cathode or an anode. The electrode optimization 820 also further enables the processor 804 to generate instructions 822 which may comprise, for example, current parameters for the implantable pulse generator 106 to generate a current.
Content stored in the memory 806, 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 806 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 804 to carry out the various method and features described herein. Thus, although various contents of memory 806 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 804 to manipulate data stored in the memory 806 and/or received from or via the system 812, the database 830, and/or the cloud 834.
The computing device 802 may also comprise a communication interface 808. The communication interface 808 may be used for receiving data (for example, data from an electrode device 200 capable of recording data) or other information from an external source (such as the system 812, the database 830, the cloud 834, and/or any other system or component not part of the system 800), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 802, the system 812, the database 830, the cloud 834, and/or any other system or component not part of the system 800). The communication interface 808 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 808 may be useful for enabling the device 802 to communicate with one or more other processors 804 or computing devices 802, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
The computing device 802 may also comprise one or more user interfaces 810. The user interface 810 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 810 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 800 (e.g., by the processor 804 or another component of the system 800) or received by the system 800 from a source external to the system 800. In some embodiments, the user interface 810 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 804 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 810 or corresponding thereto.
Although the user interface 810 is shown as part of the computing device 802, in some embodiments, the computing device 802 may utilize a user interface 810 that is housed separately from one or more remaining components of the computing device 802. In some embodiments, the user interface 810 may be located proximate one or more other components of the computing device 802, while in other embodiments, the user interface 810 may be located remotely from one or more other components of the computer device 802.
Though not shown, the system 800 may include a controller, though in some embodiments the system 800 may not include the controller. The controller may be an electronic, a mechanical, or an electro-mechanical controller. The controller may comprise or may be any processor described herein. The controller may comprise a memory storing instructions for executing any of the functions or methods described herein as being carried out by the controller. In some embodiments, the controller may be configured to simply convert signals received from the computing device 802 (e.g., via a communication interface 108) into commands for operating the system 812 (and more specifically, for actuating the implantable pulse generator 106 and/or the electrode device 200). In other embodiments, the controller may be configured to process and/or convert signals received from the system 812. Further, the controller may receive signals from one or more sources (e.g., the system 812) and may output signals to one or more sources.
The database 830 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 830 may be configured to provide any such information to the computing device 802 or to any other device of the system 800 or external to the system 800, whether directly or via the cloud 834. In some embodiments, the database 830 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 834 may be or represent the Internet or any other wide area network. The computing device 802 may be connected to the cloud 834 via the communication interface 808, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 802 may communicate with the database 830 and/or an external device (e.g., a computing device) via the cloud 834.
The system 800 or similar systems may be used, for example, to carry out one or more aspects of any of the method 900 described herein. The system 800 or similar systems may also be used for other purposes.
FIG. 9 depicts a method 900 that may be used, for example, for stimulating an anatomical element.
The method 900 (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) 804 of the computing device 802 described above. A processor other than any processor described herein may also be used to execute the method 900. The at least one processor may perform the method 900 by executing elements stored in a memory such as the memory 806. 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 900. One or more portions of a method 900 may be performed by the processor executing any of the contents of memory, such as an electrode(s) optimization 820.
The method 900 comprises assigning each of a plurality of electrodes as active or inactive (step 904). The plurality of electrodes may be the same as or similar to the plurality of electrodes 206 of an electrode device such as the electrode device 200. The plurality of electrodes may be configured to apply a current generated by an implantable pulse generator such as the implantable pulse generator 106 to an anatomical element. The electrode device may comprise a body such as the body 204 to which the plurality of electrodes is integrated with or disposed thereon. Each of the plurality of electrodes may be configured, assigned, or cause to be an active electrode or an inactive electrode, thereby enabling customization of the electrode device for multiple applications. For example, all electrodes may be activated when the electrode device is used with a first anatomical element and half of the electrodes may be activated when the electrode device is used with a second anatomical element. Thus, the electrode device may be customized for multiple applications.
In some embodiments, a processor such as the processor 804 may execute an electrode optimization such as the electrode optimization 820 to determine which electrodes to activate or inactivate. Such optimization may receive, for example, user input to determine which electrodes to activate or inactivate. In other instances, the optimization may receive results from a prior stimulation and/or blocking procedure as input and may use such results to determine which electrodes to activate.
The method 900 also comprises assigning each of the plurality of electrodes as an anode or a cathode (step 908). Of the plurality of electrodes that are assigned as activated in step 904 above, the activated electrodes may also be assigned as an anode or a cathode. As similarly described above, assigning, configuring, or causing each of the activated electrodes to be an anode or a cathode enables further customization of the electrode device for multiple applications. More specifically, the current may be steered based on which electrodes are cathodes or anodes. For example, the stimulation to may be steered towards the branch of interest by controlling which electrode is an anode or cathode being activated and how much current percentage to apply to each electrode. For example, a 50% current on each anode and a 100% current on each cathode may steer current towards branch(es) of interest other than the main branch.
In some embodiments, a processor such as the processor 804 may execute an electrode optimization such as the electrode optimization 820 to determine which electrodes are cathodes or anodes. Such optimization may receive, for example, user input to determine which electrodes are cathodes or anodes. In other instances, the optimization may receive results from a prior stimulation and/or blocking procedure as input and may use such results to determine with electrodes are cathodes or anodes.
The method 900 also comprises coupling the plurality of electrodes to an anatomical element (step 912). The step 912 may be carried out prior to or after the steps 904 and/or 908. The plurality of electrodes may be coupled to an anatomical element such as, for example, a nerve during an implantation process. The plurality of electrodes may be coupled to the anatomical element via suturing, wrapping the plurality of electrodes around the anatomical element, implanting the plurality of electrodes into the anatomical element, and/or injecting the plurality of electrodes into the anatomical element (using, for example, conductive epoxy). During the implantation process, impedances may be checked for connectivity to ensure that the electrodes are properly attached to the anatomical element. If the impedances are high, this may indicate that the electrodes are not properly attached to the anatomical element.
The method 900 also comprises beginning treatment by applying a current to an anatomical element in a predetermined pattern (step 916). The current may be generated by the implantable pulse generator and applied by the electrode device to the anatomical element. In some embodiments, the anatomical element may comprise a nerve. The predetermined pattern may be received as input from, for example, a user interface such as the user interface 810. In other embodiments, the processor may execute the electrode optimization to determine the predetermined pattern.
The method 900 also comprises ending the treatment (step 920). The treatment may end when the current is no longer applied to the anatomical element—whether by causing the implantable pulse generator to stop current generation or otherwise. The treatment may automatically end after a predetermined period of time or after a blood sugar level of a user is at or below a predetermined threshold. The user may also manually end the treatment.
It will be appreciated that the steps 904, 908, 912, 916, and/or 920, may be repeated. For example, step 908 may be repeated to change one or more electrodes from a cathode to an anode, or vice versa. In another example, step 904 may be repeated to activate an inactivate electrode, or vice versa. Thus, the electrode device may be customized throughout use of the device. Further, treatment may be started (via the step 916) and ended (via the step 920) multiple times throughout the use and lifetime of the electrode device.
The present disclosure encompasses embodiments of the method 900 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. 9 (and the corresponding description of the method 900), as well as methods that include additional steps beyond those identified in FIG. 9 (and the corresponding description of the method 900). 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 stimulating an anatomical element comprising:

an implantable pulse generator configured to generate a current;

an electrode device comprising a plurality of electrodes configured to apply the current to the anatomical element, wherein each of the plurality of electrodes comprises at least one of an anode or a cathode;

a processor; and

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

customize the electrode device by assigning each of the plurality of electrodes as at least one of an anode or a cathode and each of the plurality of electrodes as at least one of active or inactive; and

apply the current to the anatomical element in a predetermined pattern using the plurality of electrodes.

2. The system of claim 1, wherein the anatomical element comprises a celiac vagal trunk and a hepatic vagal trunk.

3. The system of claim 1, wherein the electrode device is implantable using a laparoscopic technique.

4. The system of claim 3, wherein the electrode device is configured to target dual nerve branches.

5. The system of claim 1, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.

6. The system of claim 5, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.

7. The system of claim 1, wherein the electrode device comprises a body and the plurality of electrodes are coupled to the body, the body configured to couple to the anatomical element such that the plurality of electrodes is in contact with the anatomical element.

8. The system of claim 7, wherein the body comprises a T-shaped body, the T-shaped body configured to wrap around the anatomical element.

9. The system of claim 7, wherein the body comprises a spiral-shaped body, the spiral-shaped body configured to wrap around and conform to a shape of the anatomical element.

10. The system of claim 7, wherein the body comprises a carbon nanotube thin film and the plurality of electrodes comprise one or more yarn electrodes disposed on the carbon nanotube thin film.

11. The system of claim 7, wherein the body is three-dimensionally printed.

12. The system of claim 1, wherein the body is formed from injecting epoxy on the anatomical element.

13. A system for stimulating an anatomical element comprising:

an implantable pulse generator configured to generate a current;

an electrode device comprising:

a body;

a plurality of electrodes disposed on the body and configured to apply the current to the anatomical element, wherein each of the plurality of electrodes comprises at least one of an anode or a cathode;

a processor; and

apply the current from the implantable pulse generator to the anatomical element in a predetermined pattern using the plurality of electrodes.

14. The system of claim 13, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.

15. The system of claim 14, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.

16. The system of claim 14, further comprising:

a processor; and

17. A system for stimulating an anatomical element comprising:

an implantable pulse generator configured to generate a current;

a processor; and

assign each of the plurality of electrodes to be at least one of the anode or the cathode, and

18. The system of claim 17, wherein the electrode device is configured to apply the current to the anatomical element and record data resulting from the applied current.

19. The system of claim 18, wherein at least two electrodes of the plurality of electrodes applies a current to the anatomical element and one of the electrodes of the plurality of electrodes measures and stores data resulting from the applied current.

20. The system of claim 17, wherein the electrode device comprises a body and the plurality of electrodes are coupled to the body, the body configured to couple to the anatomical element such that the plurality of electrodes is in contact with the anatomical element.