US20230355965A1

US20230355965A1 - Systems and methods for stimulating or blocking a nerve using an electrode device with a sutureless closure

Info

Publication number: US20230355965A1
Application number: US18/131,614
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: US20230355975A1; US20230355141A1; EP4518960A1; US20230355980A1; US20230355987A1; US20230355976A1; US20230355981A1; US20230355969A1; US20230355977A1; US20230355244A1; EP4518959A1; US20230355982A1; WO2023215671A1; US20250295924A1; WO2023215668A1

Abstract

System and methods for stimulating or blocking a nerve are provided. The system may include an implantable pulse generator configured to generate a current and an electrode device in communication with the implantable pulse generator and configured to surround the nerve. The electrode device may include a housing comprising an inner surface, a first edge, and a second edge opposite the first edge; at least one electrode disposed on the inner surface and configured to apply the current to the nerve; and at least one closure configured to couple the first edge to the second edge to form a seal.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of 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. 63/338,794, 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. 63/339,154, 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 with a sutureless closure 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 or blocking a nerve according to at least one embodiment of the present disclosure comprises an implantable pulse generator configured to generate a current; and an electrode device in communication with the implantable pulse generator and configured to surround the nerve, the electrode device comprising: a housing comprising an inner surface, a first edge, and a second edge opposite the first edge; at least one electrode disposed on the inner surface and configured to apply the current to the nerve; and at least one closure configured to couple the first edge to the second edge to form a seal.
Any of the aspects herein, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.
Any of the aspects herein, wherein the housing is cylindrical.
Any of the aspects herein, wherein the at least one electrode extends around an inner perimeter of the housing from the first edge to the second edge.
Any of the aspects herein, wherein the at least one electrode comprises a plurality of electrodes each spaced apart along a center axis of the housing.
Any of the aspects herein, wherein the at least one closure comprises a plurality of closures, each closure positioned adjacent to a corresponding electrode.
Any of the aspects herein, wherein each closure comprises a first closure component and a second closure component, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together.
Any of the aspects herein, wherein the electrode device is implanted during a laparoscopic procedure.
Any of the aspects herein, wherein the at least one closure is in communication with the implantable pulse generator and is configured to apply the current to the nerve.
An electrode device configured to surround a nerve according to at least one embodiment of the present disclosure comprises a housing comprising an inner surface, a first edge, and a second edge opposite the first edge; at least one electrode disposed on the inner surface and configured to apply a current to the anatomical element; and at least one closure configured to couple the first edge to the second edge to form a seal, the at least one closure comprising a first closure component and a second closure component configured to lock together, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first edge and the second edge are coupled together when the first closure component and the second closure component lock together.
Any of the aspects herein, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.
Any of the aspects herein, wherein the housing is cylindrical.
Any of the aspects herein, wherein the at least one electrode extends around an inner perimeter of the housing from the first edge to the second edge.
Any of the aspects herein, wherein the at least one electrode comprises a plurality of electrodes each spaced apart along a center axis of the housing.
Any of the aspects herein, wherein the at least one closure comprises a plurality of closures, each closure positioned adjacent to a corresponding electrode.
Any of the aspects herein, wherein the electrode device is implanted during a laparoscopic procedure.
Any of the aspects herein, wherein the at least one closure is configured to apply a current to the nerve.
A system for stimulating or blocking a nerve according to at least one embodiment of the present disclosure comprises an implantable pulse generator configured to generate a current; and an electrode device in communication with the implantable pulse generator and configured to surround the nerve, the electrode device comprising: a housing comprising an inner surface, a first edge, and a second edge opposite the first edge; at least one electrode disposed on the inner surface and configured to apply the current to the nerve; and at least one closure configured to couple the first edge to the second edge to form a seal; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: begin a treatment by causing the at least one electrode to apply the current to the nerve; and end the treatment.
Any of the aspects herein, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.
Any of the aspects herein, wherein each closure comprises a first closure component and a second closure component, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together.
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 additional system according to at least one embodiment of the present disclosure;

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

FIG. 3B is a side view of a closure device according to at least one embodiment of the present disclosure;

FIG. 3C is a top view of another closure device according to at least one embodiment of the present disclosure;

FIG. 3D is a top view of another closure device according to at least one embodiment of the present disclosure;

FIG. 4 is a diagram of a system according to at least one embodiment of the present disclosure; and

FIG. 5 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).
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, 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.
In instances where electrode devices or cuffs are used, the electrode cuffs are conventionally held in place with a suture hole. This technique has issues including uneven pressure on the nerve due to unequal suture lengths and tightness. Another issue is difficulty in creating the closure on a small nerve. Further, another difficulty may be the time required to suture a very small electrode cuffs in place.
At least one embodiment a kiss-lock design for the electrode cuff is used to close and lock the electrode cuff over a nerve. The kiss-lock design can be twisted quickly to enable an even-pressure seal around the nerve. In such embodiments, no suturing is necessary, thus removing a complicated and time-intensive step. It will be appreciated that other closures may be used such as, for example, a twist lock, a magnetic snap closure, or hook and loop fabric. The kiss-lock design may beneficially enable the electrode cuff to be implanted using a laparoscopic procedure or technique and the electrode cuff may simply be snapped closed using the kiss-lock design and does not require suturing to close the electrode cuff (though suturing may be used to couple the electrode cuff to a nerve, organ, fascial tissue, etc.). In some embodiments, the electrode cuff (and kiss-lock design) may be optimized to be delivered laparoscopically either manually (e.g., by a surgeon) or by a robotic system. In such embodiments, the electrode cuff may be configured to be grasped, carried, or otherwise moved by an instrument, and may have a deployment mechanism configured to enable the electrode cuff to be positioned and released at a target nerve. The electrode cuff may be sized so as to pass through, for example, a laparoscopic port and may be configured to be repositioned or moved intraoperatively by an instrument or tool.
Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) reducing the time to implant an electrode device or cuff on a nerve, (2) simplifying the process to implant an electrode device or cuff on a nerve, (3) providing an electrode device or cuff capable of providing an even-pressure seal around a nerve, (4) providing a closure for an electrode device or cuff that provides an even-pressure seal, and (5) increasing patient and medical personal safety during an implantation procedure.
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), described in detail in FIGS. 2 and 3A, 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).
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.
FIG. 2 depicts a system 200 according to at least one embodiment of the present disclosure is shown. In some examples, the system 200 may implement aspects of or may be implemented by aspects of the system 100 as described with reference to FIG. 1 . For example, the system 200 may be used to provide insulin production regulation for a patient and/or carry out one or more other aspects of one or more of the methods disclosed herein. Additionally, the system 200 may include at least a device 204 that is capable of providing a stimulation/blocking therapy that blocks excessive insulin production for patients with hyperinsulinism. In some examples, the device 204 may be referred to as an implantable pulse generator. Additionally, the system 200 may include one or more wires 208 (e.g., leads) that provide a connection between the device 204 and nerves of the patient for enabling the stimulation/blocking therapy. The device 204 and the one or more wires 208 may represent examples of the corresponding device 104 and the one or more wires 108, respectively, as described with reference to FIG. 1 .
The system 200 may block excess insulin production in the patient by delivering a current generated by the device 204 to an anatomical element via the one or more wires 208. For example, the current may be applied to one or more vagal trunks 216 of the patient using one or more electrode devices 212 that receive the current from the device 204 (e.g., via the wires 208 or wirelessly). In some examples, the electrode devices 212 may each include a body and a plurality of electrodes that are disposed on the respective bodies, where the plurality of electrodes are configured to apply the current generated by the device 204 to the one or more vagal trunks 216. As shown, a first electrode device 212A (e.g., a first electrode or first cuff electrode) may be configured for placement on a first vagal trunk 216A to apply a current to the first vagal trunk 216A (e.g., carried via a first wire 208A or wirelessly instructed to apply the current), and a second electrode device 212B (e.g., a second electrode or second cuff electrode) may be configured for placement on a second vagal trunk 216B to apply a current to the second vagal trunk (e.g., carried via a second wire 208B or wirelessly instructed to apply the current). In some examples, the electrode devices 212 may be referred to as cuff electrodes.
In some examples, the first vagal trunk 216A may represent a celiac vagal trunk of the patient, and the second vagal trunk 216B may represent a hepatic vagal trunk of the patient. Accordingly, applying the current to the first vagal trunk 216A via the first electrode device 212A may downregulate (e.g., block) neural activity of the celiac vagal trunk, and applying the current to the second vagal trunk 216B via the second electrode device 212B may upregulate (e.g., stimulate) neural activity of the hepatic vagal trunk. By downregulating the neural activity of the celiac vagal trunk, excess insulin production in the patient may be blocked or reduced based on signaling between the celiac vagal trunk and a patient’s pancreas being blocked, resulting in the pancreas decreasing insulin production and aiding in the treatment of hyperinsulinism.
In some examples, the current being applied to each vagal trunk 216 may be different per electrode device 212 or may include different parameters for application to each vagal trunk. For example, the first electrode device 212A may apply a high frequency stimulation (e.g., such as a given waveform at about 5 kHz) to provide an electrical blocking signal (e.g., a down-regulating signal) from the device 204 to the first vagal trunk 216A. Additionally or alternatively, the second electrode device 212B may apply a low frequency stimulation (e.g., such as a square wave or other waveform at 1 Hz) to provide an electrical stimulation signal (e.g., an up-regulating signal) from the device 204 to the second vagal trunk 216B. The combined effect of providing the same current with different parameters or respective currents with respective parameters to each of the vagal trunks 216 may result in providing a blocking of excessive insulin production in the patient when the stimulation/blocking therapy is applied. Subsequently, the patient may also experience an increase in blood sugar or glucose levels based on applying the stimulation/blocking therapy (e.g., to mitigate hypoglycemia).
Additionally, while not shown, the system 200 may also include a monitoring device (e.g., a glucose sensor) that is configured to continuously monitor glucose levels in the patient. In some examples, the electrode devices 212 may apply the current(s) to the vagal trunks 216 based on the monitoring device detecting decreased glucose levels in the patient. Accordingly, the monitoring device may communicate (e.g., wirelessly) with other components of the system 200 (e.g., the device 204, one or more processors, etc.) to achieve better glycemic control in addition to regulating insulin production. For example, the monitoring device may determine glucose levels are low in the patient and, as such, may communicate that glucose levels are getting low to the device 204 (e.g., via the one or more processors or directly) to signal for the device 204 to apply the stimulation/blocking therapy described herein to block insulin production in the patient as a possible technique to raise glucose levels in the patient and mitigate hyperinsulinism and/or hypoglycemia in the patient.
Turning to FIG. 3A, an electrode device 200 according to at least one embodiment of the present disclosure is shown. The electrode device 200 may be the same as or similar to the electrode device 212. The electrode device 200 may be configured to wrap around a nerve and to deliver a current generated by a device such as the device 104, 204 to the nerve via at least one electrode 310. The electrode device 200 may comprise a housing 302 having an inner surface 304, a first edge 306, and a second edge 308 opposite the first edge 306. The housing 302 may be cylindrical in some embodiments, though the housing 302 may be any shape in other embodiments. Though not shown, the housing 302 may comprise a hinge on which a first portion and a second portion of the housing 302 may rotate about to open or close the housing 302. The first portion and the second portion of the housing 302 may hinge open, placed over a nerve (wherein the nerve passes through an opening formed by the first edge 306 and the second edge 308), and hinged closed such that the housing 302 encompasses the nerve. In other instances, the housing may be formed from an elastic material or a shape-memory alloy material and may be simply forced open and closed.
The electrode device 200 may also comprise the at least one electrode 310 disposed on the inner surface 304 and at least one closure 312 configured to couple the first edge 306 to the second edge 308 to form a seal. In some embodiments, the at least one electrode 310 comprises a plurality of electrodes each spaced apart along a center axis 314 of the housing 302 and the at least one closure 312 comprises a plurality of closures each positioned adjacent to a corresponding electrode. For example, in the illustrated embodiment, three electrodes are spaced along the center axis 314 and three corresponding closures are positioned adjacent to each electrode. In other embodiments, the at least one electrode 310 may comprise one electrode and/or the at least one closure 312 may comprise one closure. Further, the electrode and the closure may be positioned separate from each other.
As illustrated, the at least one electrode 310 may extend around an inner perimeter of the housing 302 from the first edge 306 to the second edge 308. In other instances, the at least one electrode 310 may extend partially around the inner perimeter of the housing 302. In still other instances, some of the electrodes may extend around the entire inner perimeter and other electrodes may extend partially around the inner perimeter.
The at least one closure 312, in some instances, may be in communication with the device 104, 204. In such instances, the at least one closure 312 may be configured to apply the current generated by the device 104, 204 to the nerve. This may beneficially provide more surface area through which to apply the current to the nerve in addition to the at least one electrode 310. In such embodiments, the at least one closure 312 and the at least one electrode 310 may be formed as one piece or component. Alternatively, the at least one closure 312 may act as a contact or an electrode and the electrode device 200 may not include the at least one electrode 310.
The at least one closure 312 may comprise a first closure component 312A positioned on the first edge 306 and a second closure component 312B positioned on the second edge 308. The first closure component 312A and the second closure component 312B are configured to lock together. When the first closure component 312A and the second closure component 312B are locked together, the first edge 306 and the second edge 308 are coupled together and form a seal. In embodiments where the at least one closure 312 comprises a plurality of closures spaced apart along the first edge 306 and the second edge 308, closing or locking the plurality of closures may form an even pressure seal on the nerve along a length of the housing 302. Thus, the at least one closure 312 enables the electrode device 200 to be implanted on or otherwise coupled to the nerve with an even-pressure seal around the nerve, which may improve reliability and efficiency of the electrode device. The even-pressure seal may be confirmed by comparing an impedance of an open seal versus a closed seal. If there is a difference in the impedance by an order of magnitude, then this indicates that the electrode device 200 was properly sealed around the nerve. If there is no difference or little difference, then this indicates that the electrode device 200 was not properly sealed around the nerve. The at least one closure 312 is also sutureless and, as will be described in more detail below, is simply pushed together or otherwise snapped or coupled together. This enables the electrode device 200 to be implanted using a laparoscopic procedure or 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 electrode device 200 to the nerve.
Turning to FIGS. 3B-3C, various embodiments of the closure 312 are shown. It will be appreciated that each closure 312 of a plurality of closures may be the same type of closure or each closure may be a different type of closure. In FIG. 3B, a kiss lock design 316 is shown. The kiss lock 316 comprises a first kiss lock 316A (e.g., the first closure component 312A) and a second kiss lock 316B (e.g., the second closure component 312B). One of the first kiss lock 316A or the second kiss lock 316B may be attached to the first edge 306 and the other one of the first kiss lock 316A or the second kiss lock 316B may be attached to the second edge 308. Each of the first kiss lock 316A and the second kiss lock 316B comprise a first end 318A and a second end 318B, respectively, that engage each other when locked. In the illustrated embodiment, the first end 318A and the second end 318B are each a sphere. In other embodiments, the first end 318A and the second end 318B may be any shape such as a triangle, square, rectangle, oval, or may simply be the same shape as the stems from which the first end 318A and the second end 318B extend from. Further, in some embodiments the first end 318A may be a different shape from the second end 318B. To couple or lock the kiss lock design 316, the first end 318A and the second end 318B are pushed to each other until the first end 318A and the second end 318B push past each other and a surface or an edge of the first end 318A and the second end 318B engage each other in a snap fit. To open or uncouple the kiss lock design 316, the first end 318A and the second end 318B are simply pushed away from each other until the snap fit is disengaged.
In FIG. 3C, a snap closure 320 is shown. The snap closure 320 comprises a first snap component 320A (e.g., the first closure component 312A) and a second snap component 320B (e.g., the second closure component 312B). One of the first snap component 320A or the second snap component 320B may be attached to the first edge 306 and the other one of the first snap component 320A or the second snap component 320B may be attached to the second edge 308. The first snap component 320A may comprise a receiver 322A and the second snap component 320B may comprise a protrusion 322B receivable by the receiver 322A. During use, the receiver 322A and the protrusion 322B may lock together in a snap fit. Alternatively or additionally, the first snap component 320A may also have a first polarity and the second snap component 320B may also have a second polarity opposite the first polarity such that the first snap component 320A and the second snap component 320B are magnetically attracted to each other and can be magnetically coupled to each other. To couple or lock the snap closure together 320 (whether magnetic or not), the receiver 322A and the protrusion 322B are simply pushed together until the protrusion 322B engages the receiver 322A. To open or uncouple the snap closure 320, the protrusion 322B and the receiver 322A may be simply pulled apart until the snap fit is disengaged.
In FIG. 3D, a twist lock design 324 is shown. The twist lock design 324 comprises a first twist lock 324A (e.g., the first closure component 312A) and a second twist lock 324B (e.g., the second closure component 312B). One of the first twist lock 324A (or the second twist lock 324B may be attached to the first edge 306 and the other one of the first twist lock 324A or the second twist lock 324B may be attached to the second edge 308. Similarly to the kiss lock design 316 described above, each of the first twist lock 324A and the second twist lock 324B comprise a first end 326A and a second end 326B, respectively, that engage each other when locked. In the illustrated embodiment, the first end 326A and the second end 326B are each a sphere. In other embodiments, the first end 326A and the second end 326B may be any shape such as a triangle, square, rectangle, oval, or may simply be the same shape as the stems from which the first end 326A and the second end 326B extend from. Further, in some embodiments the first end 326A may be a different shape from the second end 326B. To couple or lock the twist lock design 324, the first end 326A and the second end 326B are pushed to each other until the first end 326A and the second end 326B push past each other and the first end 326A and the second end 326B are rotated around each other — as shown by the arrow 328 — until the stems from which the first end 326A and the second end 326B extend from are twisted around each other. To open or uncouple the twist lock design 324, the first end 326A and the second end 326B are simply rotated opposite from each other until the twist lock is disengaged.
It will be appreciated that the at least one closure 312 may be any of the embodiments (kiss lock, magnetic snap closure, twist lock design) described above or any form of closure that is simply locked together or otherwise engaged together without suturing. For example, the at least one closure 312 may be a releasable adhesive, hook and loop fabric, a clamp, or the like.
Turning to FIG. 4 , a block diagram of a system 400 according to at least one embodiment of the present disclosure is shown. The system 400 may be used with an implantable pulse generator 414 and/or the electrode device 212, 200, and/or carry out one or more other aspects of one or more of the methods disclosed herein. The system 400 comprises a computing device 402, a stimulating/blocking system 412, a database 430, and/or a cloud or other network 434. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 400. For example, the system 400 may not include one or more components of the computing device 402, the database 430, and/or the cloud 434.
The stimulating/blocking system 412 may comprise the implantable pulse generator 414 and the electrode device 212, 200. As previously described, the implantable pulse generator 414 may be configured to generate a current and the electrode device 212, 200 may comprise the plurality of electrodes 310 configured to apply the current to an anatomical element. The stimulating/blocking system 412 may communicate with the computing device 402 to receive instructions such as instructions 422 for applying a current to the anatomical element. The stimulating/blocking system 412 may also provide data (such as data received from an electrode device 212, 200 capable of recording data), which may be used to optimize the electrodes of the electrode device 212, 200 and/or to optimize parameters of the current generated by the implantable pulse generator 414.
The computing device 402 comprises a processor 404, a memory 406, a communication interface 408, and a user interface 410. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 402.
The processor 404 of the computing device 402 may be any processor described herein or any similar processor. The processor 404 may be configured to execute instructions stored in the memory 406, which instructions may cause the processor 404 to carry out one or more computing steps utilizing or based on data received from the stimulating/blocking system 412, the database 430, and/or the cloud 434.
The memory 406 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 406 may store information or data useful for completing, for example, any step of the method 500 described herein, or of any other methods. The memory 406 may store, for example, instructions and/or machine learning models that support one or more functions of the stimulating/blocking system 412. For instance, the memory 406 may store content (e.g., instructions and/or machine learning models) that, when executed by the processor 404, enable current optimization 420.
The current optimization 420 may correspond to a routine executed by the processor 404 to optimize current used in an electrical stimulation and/or nerve blocking. Optimization may be achieved by adjusting signal frequency, adjusting signal type (e.g., square wave, sinusoidal wave, triangle wave, etc.), adjusting duty cycle, adjusting treatment duration, etc. More specifically, the current optimization 420 may enable the processor 404 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 406, 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 406 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 404 to carry out the various method and features described herein. Thus, although various contents of memory 406 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 404 to manipulate data stored in the memory 406 and/or received from or via the stimulating/blocking system 412, the database 430, and/or the cloud 434.
The computing device 402 may also comprise a communication interface 408. The communication interface 408 may be used for receiving data (for example, data from an electrode device 212, 200 capable of recording data) or other information from an external source (such as the stimulating/blocking system 412, the database 430, the cloud 434, and/or any other system or component not part of the system 400), and/or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 402, the stimulating/blocking system 412, the database 430, the cloud 434, and/or any other system or component not part of the system 400). The communication interface 408 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 402.11a/b/g/n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 408 may be useful for enabling the device 402 to communicate with one or more other processors 404 or computing devices 402, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.
The computing device 402 may also comprise one or more user interfaces 410. The user interface 410 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 410 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 400 (e.g., by the processor 404 or another component of the system 400) or received by the system 400 from a source external to the system 400. In some embodiments, the user interface 410 may be useful to allow a surgeon or other user to modify instructions to be executed by the processor 404 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 410 or corresponding thereto.
Although the user interface 410 is shown as part of the computing device 402, in some embodiments, the computing device 402 may utilize a user interface 410 that is housed separately from one or more remaining components of the computing device 402. In some embodiments, the user interface 410 may be located proximate one or more other components of the computing device 402, while in other embodiments, the user interface 410 may be located remotely from one or more other components of the computer device 402.
Though not shown, the system 400 may include a controller, though in some embodiments the system 400 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 402 (e.g., via a communication interface 104) into commands for operating the stimulating/blocking system 412 (and more specifically, for actuating the implantable pulse generator 414 and/or the electrode device 212, 200). In other embodiments, the controller may be configured to process and/or convert signals received from the stimulating/blocking system 412. Further, the controller may receive signals from one or more sources (e.g., the stimulating/blocking system 412) and may output signals to one or more sources.
The database 430 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 430 may be configured to provide any such information to the computing device 402 or to any other device of the system 400 or external to the system 400, whether directly or via the cloud 434. In some embodiments, the database 430 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 434 may be or represent the Internet or any other wide area network. The computing device 402 may be connected to the cloud 434 via the communication interface 408, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 402 may communicate with the database 430 and/or an external device (e.g., a computing device) via the cloud 434.
The system 400 or similar systems may be used, for example, to carry out one or more aspects of any of the method 500 described herein. The system 400 or similar systems may also be used for other purposes.
FIG. 5 depicts a method 500 that may be used, for example, for stimulating an anatomical element such as, for example, a nerve.
The method 500 (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) 404 of the computing device 402 described above. A processor other than any processor described herein may also be used to execute the method 500. The at least one processor may perform the method 500 by executing elements stored in a memory such as the memory 406. 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 500. One or more portions of a method 500 may be performed by the processor executing any of the contents of memory, such as a current optimization 420.
The method 500 comprises coupling a plurality of electrodes to a nerve (step 504). The plurality of electrodes may be the same as or similar to the plurality of electrodes 310 of an electrode device such as the electrode device 212, 200. The electrode device may comprise a housing such as the housing 302 having an inner surface such as the inner surface 304, a first edge such as the first edge 306, and a second edge such as the second edge 308 opposite the first edge. The plurality of electrodes may be positioned on the inner surface of the housing. The electrode device may be configured to surround a nerve and the plurality of electrodes 310 (when implanted) may be configured to apply a current generated by a device such as the device 104, 204, or an implantable pulse generator such as the implantable pulse generator 414 to the nerve. The housing may also comprise a closure such as the closure 312 configured to couple the first edge and the second edge to form a seal. The closure comprises a first closure component such as the first closure component 312A and a second closure component such as the second closure component 312B. The first closure component and the second closure component are configured to simply snap or twist together or otherwise couple together to lock the closure (and thus, couple the first edge to the second edge). Thus, the closure is sutureless. This enables the electrode device to be implanted using a laparoscopic procedure or 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, 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 electrode device to the nerve.
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 500 also comprises beginning treatment by applying a current to the nerve (step 508). The current may be generated by the implantable pulse generator and applied by the electrode device to the anatomical element. In some embodiments, the processor may execute a current optimization such as the current optimization 420 to determine one or more parameters of the current.
The method 500 also comprises ending the treatment (step 512). The treatment may end when the current is no longer applied to the nerve — 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 504, 508 and/or 512, may be repeated. For example, treatment may be started (via the step 508) and ended (via the step 512) multiple times throughout the use and lifetime of the electrode device.
The present disclosure encompasses embodiments of the method 500 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. 5 (and the corresponding description of the method 500), as well as methods that include additional steps beyond those identified in FIG. 5 (and the corresponding description of the method 500). 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.
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 or blocking a nerve comprising:

an implantable pulse generator configured to generate a current; and

an electrode device in communication with the implantable pulse generator and configured to surround the nerve, the electrode device comprising:

a housing comprising an inner surface, a first edge, and a second edge opposite the first edge;

at least one electrode disposed on the inner surface and configured to apply the current to the nerve; and

at least one closure configured to couple the first edge to the second edge to form a seal.

2. The system of claim 1, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.

3. The system of claim 1, wherein the housing is cylindrical.

4. The system of claim 1, wherein the at least one electrode extends around an inner perimeter of the housing from the first edge to the second edge.

5. The system of claim 1, wherein the at least one electrode comprises a plurality of electrodes each spaced apart along a center axis of the housing.

6. The system of claim 5, wherein the at least one closure comprises a plurality of closures, each closure positioned adjacent to a corresponding electrode.

7. The system of claim 1, wherein each closure comprises a first closure component and a second closure component, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together.

8. The system of claim 1, wherein the electrode device is implanted during a laparoscopic procedure.

9. The system of claim 1, wherein the at least one closure is in communication with the implantable pulse generator and is configured to apply the current to the nerve.

10. An electrode device configured to surround a nerve comprising:

at least one electrode disposed on the inner surface and configured to apply a current to the anatomical element; and

at least one closure configured to couple the first edge to the second edge to form a seal, the at least one closure comprising a first closure component and a second closure component configured to lock together, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first edge and the second edge are coupled together when the first closure component and the second closure component lock together.

11. The device of claim 10, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.

12. The device of claim 10, wherein the housing is cylindrical.

13. The device of claim 10, wherein the at least one electrode extends around an inner perimeter of the housing from the first edge to the second edge.

14. The device of claim 10, wherein the at least one electrode comprises a plurality of electrodes each spaced apart along a center axis of the housing.

15. The device of claim 14, wherein the at least one closure comprises a plurality of closures, each closure positioned adjacent to a corresponding electrode.

16. The device of claim 10, wherein the electrode device is implanted during a laparoscopic procedure.

17. The device of claim 10, wherein the at least one closure is configured to apply a current to the nerve.

18. A system for stimulating or blocking a nerve comprising:

an implantable pulse generator configured to generate a current; and

at least one closure configured to couple the first edge to the second edge to form a seal;

a processor; and

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

begin a treatment by causing the at least one electrode to apply the current to the nerve; and

end the treatment.

19. The system of claim 18, wherein the closure comprises at least one of a kiss-lock, a twist lock, a magnetic snap closure, or hook and loop fabric.

20. The system of claim 18, wherein each closure comprises a first closure component and a second closure component, the first closure component positioned on the first edge and the second closure component positioned on the second edge, wherein the first closure component and the second closure component are configured to lock together.