US20230355244A1

US20230355244A1 - Systems and methods for mechanically blocking a nerve

Info

Publication number: US20230355244A1
Application number: US18/131,513
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; US20230355976A1; US20230355969A1; US20230355981A1; US20230355980A1; US20230355987A1; US20230355141A1; EP4518959A1; US20230355977A1; US20230355982A1

Abstract

Systems and methods for mechanically blocking a nerve are provided. The system may comprise a blocking device configured to selectively compress the nerve. The system may also comprise a feedback mechanism configured to measure a response correlating to whether the nerve is blocked. When the blocking device compresses the nerve, a response from the feedback mechanism is received that correlates to the nerve being blocked or unblocked after a period of time.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of 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. 63/338,794, 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. 63/338,806, 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 to affect glycemic control of a patient. The blocking therapy may use a mechanical blocking device.
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 mechanically blocking a nerve according to at least one embodiment of the present disclosure comprises a blocking device configured to selectively compress the nerve; a feedback mechanism configured to measure a response correlating to whether the nerve is blocked; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: cause the blocking device to compress the nerve; and receive the response from the feedback mechanism that correlates to the nerve being blocked or unblocked after a period of time.
Any of the aspects herein, wherein the nerve is compressed between about 60 mmHg to about 100 mmHg.
Any of the aspects herein, wherein the period of time is about one minute.
Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: determine if the nerve is blocked based on the response; cause the blocking device to hold a compression on the nerve; and cause the blocking device to release the compression on the nerve.
Any of the aspects herein, wherein the blocking device comprises one or more pneumatic members forming a cuff configured to surround and compress the nerve.
Any of the aspects herein, wherein the blocking device comprises a screw jack configured to move a pressure plate that is configured to activate the pneumatic members.
Any of the aspects herein, wherein when the pressure plate moves in a first direction, the pneumatic members expand radially towards the nerve to induce a compressive force on the nerve and when the pressure plate moves in a second direction, the pneumatic members contract radially away from the nerve to release the compressive force on the nerve.
Any of the aspects herein, wherein the blocking device comprises a pressure sensor and the pressure plate comprises one or more safety mechanisms configured to actuate when a pressure on the nerve exceeds a pressure threshold.
Any of the aspects herein, wherein the one or more safety mechanisms comprises one or more holes on the pressure plate, wherein actuation of the one or more safety mechanisms causes the one or more holes to open, thereby releasing pressure in the one or more pneumatic members.
Any of the aspects herein, wherein the blocking device comprises a shape-memory cuff configured to surround the nerve and to move between a first state and a second state, wherein the shape-memory cuff compresses the nerve when in the first state and releases compression on the nerve when in the second state.
Any of the aspects herein, wherein the shape-memory cuff comprises nitinol.
A system for mechanically blocking a nerve according to at least one embodiment of the present disclosure comprises a blocking device configured to selectively compress the nerve until the nerve is blocked, the blocking device comprising a cuff configured to surround the nerve and one or more pneumatic members configured to cause the cuff to compress the nerve; a feedback mechanism configured to measure a response correlating to whether the nerve is blocked; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: cause the blocking device to compress the nerve; and receive the response from the feedback mechanism that correlates to the nerve being blocked or unblocked after a period of time.
Any of the aspects herein, wherein the feedback mechanism comprises one or more recording electrodes configured to measure a physiological response.
Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: determine if the nerve is blocked; cause the blocking device to hold a compression on the nerve; and cause the blocking device to release the compression on the nerve.
Any of the aspects herein, wherein determining if the nerve is blocked comprises comparing a peak of an action potential of a nerve without a block to a peak of an action potential when the nerve is compressed.
Any of the aspects herein, wherein the blocking device comprises a screw jack configured to move a pressure plate that is configured to activate the pneumatic members.
Any of the aspects herein, wherein when the pressure plate moves in a first direction, the pneumatic members expand radially towards the nerve to induce a compressive force on the nerve and when the pressure plate moves in a second direction, the pneumatic members to contract radially away from the nerve and releases the compressive force on the nerve.
Any of the aspects herein, wherein the blocking device comprises a pressure sensor and the pressure plate comprises one or more safety mechanisms configured to actuate when a pressure on the nerve exceeds a pressure threshold.
A system for mechanically blocking a nerve according to at least one embodiment of the present disclosure comprises a blocking device configured to selectively compress the nerve until the nerve is blocked, the blocking device comprising a shape-memory cuff configured to move between a first state and a second state, wherein the shape-memory cuff compresses the nerve when in the first state and releases compression on the nerve when in the second state; a feedback mechanism configured to measure a response correlating to whether the nerve is blocked; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: cause the blocking device to compress the nerve; and receive the response from the feedback mechanism that correlates to the nerve being blocked or unblocked after a period of time.
Any of the aspects herein, wherein the shape-memory cuff comprises nitinol.
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. 2A is a side cross-sectional view of a blocking device according to at least one embodiment of the present disclosure;

FIG. 2B is a side view of a portion of a blocking device according to at least one embodiment of the present disclosure;

FIG. 2C is a front cross-sectional view of a blocking device according to at least one embodiment of the present disclosure;

FIG. 2D is an isometric view of a pressure plate according to at least one embodiment of the present disclosure;

FIG. 3 is a side cross-sectional view of a blocking 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. In some embodiments where blocking is desired, a mechanical blocking device may be used in place of an electrical device.
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 or to mechanically block 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 or inducing a mechanical block of 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 or induce a mechanical block of 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) or mechanical blocks 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 or a mechanical blocking device) to provide electrical stimulation (e.g., electrical pulses/impulses) or a mechanical block 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 and/or the mechanical blocking 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). In other examples, the anterior sub diaphragmatic vagal trunk may be mechanically blocked by compressing the vagal trunk to between 60-100 mmHg. 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 or mechanical 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) or mechanical blocking devices 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.
The primary method for inducing a block of the nerve (or trunk of the nerve) is via low or high frequency stimulation. Alternative devices and methods to induce a nerve block include mechanically blocking the nerve. When using a mechanically block, the device providing a mechanical block may include a safety mechanism (e.g., valves, or any mechanism configured to relieve pressure) such that the device does not truncate the nerve during use. Although the primary focus is on blockage of the vagus nerve, it will be appreciated that the techniques described herein can be applied to other nerves to, for example, block pain (i.e., a peripheral nerve block).
In at least one embodiment of the present disclosure, a mechanical block between about 60 to about 100 mmHg is induced to cause a compressive force against a nerve that produces a nerve block. The mechanical block may be provided by a pneumatically active screw that compresses a cuff, which then blocks the nerve. More specifically, the screw may push a pressure plate against one or more pneumatic members. When the pneumatic members are compressed by the pressure plate, the pneumatic members may expand and compress the nerve. The pressure plate may have holes or valves that open if the pressure exceeds a predetermined threshold.
In another embodiment of the present disclosure, the mechanical block may be induced by a shape-memory cuff with mold compression that can be used to physically pinch a nerve.
Any embodiment of a blocking device may be used with a neurofeedback mechanism (i.e., a sensing electrode distal to the blocking device to confirm that a nerve block is occurring). The blocking device could be used to induce a block, followed by a wait period (e.g., one minute). At one minute intervals, the sensing electrode can confirm or reject that the nerve is being blocked by comparing a peak of the action potential without a block (e.g., the control) with a peak of the action potential during the compression. When the block is confirmed, any further compressive force on the cuff can be halted.
Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) providing a mechanical block to one or more nerves, (2) determining when a mechanical block of a nerve is induced, and (3) controlling a mechanical block of a nerve.
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 or mechanically compressing one or more nerves) 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. The blocking therapy may also alternatively be provided by a blocking device 200, 300 (shown in FIGS. 2A-2D, 3, and 4 ) that induces a mechanical block on a nerve.
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). Alternatively, in some embodiments, the blocking device 200, 300 may be used to provide a mechanical block of the first vagal trunk. 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 or mechanical 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 (or the blocking device 200, 300) 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, the device 104, and/or the blocking device 200, 300 may be delivered to the liver and/or pancreas of the patient to mute a glycemic response of the patient as described herein.
In some examples, the wires 108 may provide the electrical signals to the respective vagal trunks via electrodes of an electrode device (e.g., cuff electrodes) that are connected to the vagal trunks (e.g., sutured in place, wrapped around the nerves of the vagal trunks, etc.). In some examples, the wires 108 may be referenced as cuff electrodes or may otherwise include the cuff electrodes (e.g., at an end of the wires 108 not connected or plugged into the device 104). Additionally or alternatively, while shown as physical wires that provide the connection between the device 104 and the one or more vagal trunks, the cuff electrodes may provide the electrical blocking and/or stimulation signals to the one or more vagal trunks wirelessly (e.g., with or without the device 104).
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 blocking device 200, 300, 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 and/or the blocking device 200, 300 (e.g., via the one or more processors) to signal for the device 104 and/or the blocking device 200, 300 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. 2A-2C, the blocking device 200 according to at least one embodiment of the present disclosure is respectively shown in a cross-sectional view, a partial side view, and a front cross-sectional view. The blocking device 200 may be configured to selectively compress a nerve 206 until the nerve 206 is blocked. The blocking device 200 may comprise a housing 202 that houses one or more pneumatic members 204 that are configured to surround and compress the nerve 206. More specifically, the one or more pneumatic members 204 are configured to expand and contract. The one or more pneumatic members 204 may form a cuff surrounding the nerve 206. The housing 202 may also house a pressure plate 208—shown in FIGS. 2A and 2D— configured to activate the one or more pneumatic members 204 and a screw jack 210 configured to translationally move the pressure plate 208 to and from the one or more pneumatic members 204 along a center axis 216 of the housing 202. Alternatively or additionally, the pressure plate 208 may be translationally moved hydraulically, mechanically, and/or electro-mechanically. In some embodiments, the blocking device 200 may comprise two screw jacks 210. For example, a pair of screw jacks may be positioned on either side of the nerve 206. Though not shown, in some embodiments the blocking device 200 may comprise a motor configured to rotate the screw jack 210.
When the pressure plate 208 moves in a first direction, the one or more pneumatic members 204 may expand radially towards the nerve 206 to induce a compressive force on the nerve. More specifically, when the pressure plate 208 moves towards the one or more pneumatic members 204 in the direction of the arrow 212, the pressure plate causes the one or more pneumatic members 204 to expand in two directions shown by the arrow 214 in FIG. 2C. As the one or more pneumatic members 204 expand radially, the one or more pneumatic members 204 contact and press against the housing 202 and also contact and press against the nerve 206. The housing 202 may be rigid, and thus may cause the one or more pneumatic members 204 to expand more towards the nerve 206, thereby inducing a compressive force on the nerve 206. When the pressure plate 208 moves in a second direction, the one or more pneumatic members 204 may contract radially away from the nerve to release the compressive force on the nerve 206.
Though not shown, in some embodiments the one or more pneumatic members 204 may be expanded by adding a fluid (e.g., air, water, etc.) to the one or more pneumatic members 204 from a pneumatic source.
In the illustrated embodiment, the one or more pneumatic members 204 comprises a plurality of pneumatic members that surround the nerve 206. Alternatively, the one or more pneumatic members 204 may comprise one pneumatic member. For example, the pneumatic member may be a single piece cuff configured to expand and contract as a singular component. In embodiments where the one or more pneumatic members 204 comprise the plurality of pneumatic members, the pneumatic members 204 may comprise oval shaped flexible members surrounding the nerve 206, as shown in FIGS. 2B and 2C. In other embodiments, the one or more pneumatic members 204 may be any shape or size such as, for example, cylindrical, rectangular, or the like.
Turning to FIG. 2C, the housing 202 may comprise a lock 218 to secure the blocking device 200 on the nerve 206. More specifically, the housing 202, the one or more pneumatic members 204, and the pressure plate 208 may be opened (whether by a hinge and/or via the flexibility of each component) and placed over the nerve 206, then closed over the nerve 206 and locked with the lock 218. In some embodiments, the lock 218 may comprise sutures to suture the blocking device 200 closed. The sutures may also couple the blocking device 200 to surrounding tissue.
Turning to FIG. 2D, the pressure plate 208 may comprise one or more safety mechanisms 220 comprising one or more holes 222 on the pressure plate 208. Though not shown, the blocking device 200 may also comprise a pressure sensor (shown in FIG. 4 ) configured to sense a pressure. The one or more holes 222 may comprise, for example, valves configured to open when a pressure (sensed and measured by, for example, the pressure sensor) of the compression on the nerve 206 meets or exceeds a predetermined pressure threshold. In some embodiments, the one or more holes 222 may be in fluid communication with the one or more pneumatic members 204. When the safety mechanism 220 is actuated, the one or more holes may open to release pressure from the one or more pneumatic members 204 when the pressure of the compression on the nerve 206 meets or exceeds the predetermined pressure threshold. The safety mechanism 220 may be configured to self-release after a period of time. In other words, the safety mechanism 220 may be configured to have a timed release wherein the safety mechanism 220 is automatically actuated after a predetermined time period.
Turning to FIG. 3 , a blocking device 300 according to at least one embodiment of the present disclosure is provided. The blocking device 300 may comprise a shape-memory cuff 302 configured to surround a nerve 306 and to move between a first state and a second state. The shape-memory cuff 302 may compress the nerve 306 and induce a nerve block when in the first state and may release the compression on the nerve 306 when in the second state. In some embodiments, the shape-memory cuff 302 may be induced or triggered to move between the first state and the second state by a change in temperature. For example, a rise in a patient's body temperature may cause the shape-memory cuff 302 to move from the second state to the first state and a drop in the patient's body temperature may cause the shape-memory cuff 302 to move from the first state to the second state. The shape-memory cuff 302 may comprise nitinol, though the shape-memory cuff 302 may comprise any material capable of moving between a first state (e.g., an expanded state) and a second state (e.g., an original or resting state).
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 106, the blocking device(s) 200, 300, a feedback mechanism 418, 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 106, the feedback mechanism 418, and the blocking device 200, 300. As previously described, the implantable pulse generator 106 may be configured to generate a current and one or more wires (e.g., wires 108) may deliver the current to one or more nerves and the blocking device 200, 300 may provide a mechanical block the one or more nerves. The feedback mechanism 418 may be configured to measure a response correlating to whether the nerve is blocked. The feedback mechanism 418 may comprise, in some embodiments, one or more recording electrodes configured to measure a physiological response. It will be appreciated that in some embodiments, the stimulating/blocking system 412 may not comprise the implantable pulse generator 106, the feedback mechanism 418, and/or the blocking device 200, 300. For example, the stimulating/blocking system 412 may only comprise the implantable pulse generator 106 and the blocking device 200, 300. In other embodiments, the stimulating/blocking system 412 may comprise the blocking device 200, 300 and the feedback mechanism 418. The stimulating/blocking system 412 may communicate with the computing device 402 to receive instructions such as instructions 422 for applying a current or a mechanical compression to an anatomical element (e.g., a nerve). The stimulating/blocking system 412 may also provide data (such as data received from the feedback mechanism 418), which may be used to control a compression on the nerve provided by the blocking device 200, 300 and/or to optimize parameters of the blocking device 200, 300.
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 a nerve block determination 420.
The nerve block determination 420 enables the processor 404 to determine if a nerve is blocked (whether mechanically or electrically) based on a response from the feedback mechanism 418. More specifically, the nerve block determination 420 enables the processor 404 to compare a peak of an action potential of a nerve without a block to a peak of an action potential when the nerve is blocked. If the peaks are different, then this may indicate that the nerve is blocked. If the peaks are the same or similar, then this may indicate that the nerve is not blocked.
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 a feedback mechanism 418) 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.
The stimulating/blocking system 412 or the system 400 may comprise a sensor 424. The sensor 424 may be any kind of sensor 424 for measuring pressure induced by the blocking device 200, 300. The sensor 424 may include one or more or any combination of components that are electrical, mechanical, electro-mechanical, magnetic, electromagnetic, or the like. The sensor 424 may include, but is not limited to, one or more a torque sensor, a force sensor, and/or a pressure sensor. In some embodiments, the sensor 424 may include a memory for storing sensor data. In still other examples, the sensor 424 may output signals (e.g., sensor data) to one or more sources (e.g., the computing device 402, the blocking device 200, 300, etc.).
The sensor 424 may be positioned adjacent to or integrated with the blocking device 200, 300. In some embodiments, the sensor 424 is positioned as a standalone component. The sensor 424 may include a plurality of sensors and each sensor may be positioned at the same location or a different location as any other sensor. It will be appreciated that in some embodiments the sensor(s) 424 can be positioned at or on any component of the stimulating/blocking system 412 or environment (e.g., on any other component at the surgical site).
The sensor 424 may send the data to the computing device 402 or a processor of the stimulating/blocking system 412 when the sensor 424 detects that a pressure induced by the blocking device 200, 300 meets or exceeds a predetermined pressure threshold. Further, in some embodiments, the sensor 424 may send data to the computing device 402 to display on the user interface 410 or otherwise notify the surgeon or operator of the change in the characteristic. In other embodiments, the sensor 424 may alert a user or medical provider of the pressure meeting or exceeding the pressure threshold by an alert such as, but not limited to, a sound or a light display on a user device (e.g., a mobile device). The sensor 424 may advantageously provide a safety function by monitoring and alerting the user if the blocking device 200, 300 is not functioning properly.
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 404) into commands for operating the stimulating/blocking system 412 (and more specifically, for actuating the implantable pulse generator 106 and/or the blocking device 200, 300). 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, to provide a mechanical block of 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 404 or the processor(s) of the device 104 described above. The at least one processor may be part of the device 104 (such as an implantable pulse generator) or part of a control unit in communication with the device 104. 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 or a memory in the device 104 as described above or a control unit). 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 providing a stimulation/block therapy and/or any associated operations as described herein.
The method 500 comprises causing a blocking device to compress a nerve (step 504). The blocking device may be the same as or similar to the blocking device 200, 300. The blocking device may be configured to surround and selectively compress a nerve. The nerve may be compressed to, for example, between about 60 mmHg to about 100 mmHg. In some embodiments the blocking device may comprise one or more pneumatic members such as the one or more pneumatic members 204 configured to surround and compress the nerve. In such embodiments, the blocking device may also comprise a screw jack such as the screw jack 210 configured to move a pressure plate such as the pressure plate 208 that activates the pneumatic members. When the pressure plate moves in a first direction, the pneumatic members may expand radially towards the nerve to induce a compressive force on the nerve and when the pressure plate moves in a second direction, the pneumatic members may contract radially away from the nerve to release the compressive force on the nerve.
In other embodiments, the blocking device may comprise a shape-memory cuff such as the shape-memory cuff 302 configured to surround the nerve and move between a first state and a second state. The shape-memory cuff may compress the nerve when in the first state and release compression on the nerve when in the second state. The shape-memory cuff may be triggered to move between the first state and the second state by a change in temperature. In other instances, the shape-memory cuff may be electrically controlled to move between the first state and the second. For example, an electrical signal or a current may be applied to the shape-memory cuff to move the shape-memory cuff between from the first state to the second state or vice versa.
The method 500 also comprises receiving a first response from a feedback mechanism (step 508). The feedback mechanism may be the same as or similar to the feedback mechanism 418. The feedback mechanism is configured to measure the response correlating to whether the nerve is blocked. The first response may be measured after a period of time from when the blocking device begins compressing the nerve (for example, a period of time after the step 504). In some embodiments, the period of time is about one minute, though in other embodiments the period of time may be greater than or less than one minute. The feedback mechanism may comprise one or more recording electrodes configured to measure a physiological response from the patient correlating to whether the nerve is blocked. The response may be stored in a memory of the blocking device (or any memory such as the memory 406) and transmitted to a processor of the blocking device (or any processor such as the processor 404).
The method 500 also comprises determining if the nerve is blocked (step 512). Determining if the nerve is blocked may comprise the processor executing a nerve block determination such as the nerve block determination 420 and using the response received from the feedback mechanism in the step 508 as input. Execution of the nerve block determination may cause the processor to compare the response from the feedback mechanism when the nerve is blocked (whether mechanically or electrically) to a response from the feedback mechanism when the nerve is not blocked. The response may be, for example, a peak of an action potential of the nerve. In such examples, a peak of an action potential of the nerve without a block is compared to a peak of an action potential when the nerve is blocked. A difference in the peaks may indicate that the nerve is blocked and no difference or a small difference in the peaks may indicate that the nerve is not sufficiently blocked.
The steps 504, 508, and 512 may be repeated at a time interval (e.g., every one minute) until determination of a nerve block is confirmed in, for example, the step 512. In other words, the blocking mechanism may continuously apply more compressive force to the nerve until a desired nerve block is achieved and confirmed in the step 512.
The method 500 also comprises causing the blocking device to hold a compression on the nerve (step 516). When a desired block is determined in the step 512, the blocking device may stop any further compression of the nerve and may hold the current compression of the nerve for a blocking period of time. In other embodiments, the blocking device may hold the current compression of the nerve until a second response is received (described below in step 520). The blocking device may also hold the nerve in an unspecified state for a blocking period of time or until the second response is received. The blocking period of time may be predetermined, received as input (from, for example, a user or a medical personnel), or based on one or more factors such as a patient's temperature, a patient's activity, a patient's meal, time of day, etc. After the blocking period of time has elapsed, the step 524 below may automatically occur.
The method 500 also comprises receiving a second response from the feedback mechanism (step 520). It will be appreciated that in some embodiments, the method 500 may not include the step 520. The second response may signal or trigger an end to the blocking therapy. The second response may be measured by the feedback mechanism and may correlate to one or more parameters meeting a predetermined threshold. The one or more parameters may be, but not limited to, blood glucose level, heart rate, time of day, or duration of blocking. For example, the second response may be measured when the blood glucose level meets a desired predetermined blood glucose level.
The method 500 also comprises causing the blocking device to release the compression on the nerve (step 524). In embodiments where the blocking device comprises one or more pneumatic members and the pressure plate, the pressure plate may be moved in the second direction to cause the one or more pneumatic members to contract radially away from the nerve to release compression on the nerve. In embodiments where the blocking device comprises the shape-memory cuff, a change in the temperature may cause the shape-memory cuff to move from the first state to the second state to release compression on the nerve. In other instances, the shape-memory cuff may be electrically controlled to move between the first state and the second.
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.
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 mechanically blocking a nerve comprising:

a blocking device configured to selectively compress the nerve;

a feedback mechanism configured to measure a response correlating to whether the nerve is blocked;

a processor; and

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

cause the blocking device to compress the nerve; and

receive the response from the feedback mechanism that correlates to the nerve being blocked or unblocked after a period of time.

2. The system of claim 1, wherein the nerve is compressed between about 60 mmHg to about 100 mmHg.

3. The system of claim 1, wherein the period of time is about one minute.

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

determine if the nerve is blocked based on the response;

cause the blocking device to hold a compression on the nerve; and

cause the blocking device to release the compression on the nerve.

5. The system of claim 1, wherein the blocking device comprises one or more pneumatic members forming a cuff configured to surround and compress the nerve.

6. The system of claim 5, wherein the blocking device comprises a screw jack configured to move a pressure plate that is configured to activate the pneumatic members.

7. The system of claim 6, wherein when the pressure plate moves in a first direction, the pneumatic members expand radially towards the nerve to induce a compressive force on the nerve and when the pressure plate moves in a second direction, the pneumatic members contract radially away from the nerve to release the compressive force on the nerve.

8. The system of claim 7, wherein the blocking device comprises a pressure sensor and the pressure plate comprises one or more safety mechanisms configured to actuate when a pressure on the nerve exceeds a pressure threshold.

9. The system of claim 8, wherein the one or more safety mechanisms comprises one or more holes on the pressure plate, wherein actuation of the one or more safety mechanisms causes the one or more holes to open, thereby releasing pressure in the one or more pneumatic members.

10. The system of claim 1, wherein the blocking device comprises a shape-memory cuff configured to surround the nerve and to move between a first state and a second state, wherein the shape-memory cuff compresses the nerve when in the first state and releases compression on the nerve when in the second state.

11. The system of claim 10, wherein the shape-memory cuff comprises nitinol.

12. A system for mechanically blocking a nerve comprising:

a blocking device configured to selectively compress the nerve until the nerve is blocked, the blocking device comprising a cuff configured to surround the nerve and one or more pneumatic members configured to cause the cuff to compress the nerve;

a processor; and

cause the blocking device to compress the nerve; and

13. The system of claim 12, wherein the feedback mechanism comprises one or more recording electrodes configured to measure a physiological response.

14. The system of claim 12, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to:

determine if the nerve is blocked;

cause the blocking device to hold a compression on the nerve; and

cause the blocking device to release the compression on the nerve.

15. The system of claim 14, wherein determining if the nerve is blocked comprises comparing a peak of an action potential of a nerve without a block to a peak of an action potential when the nerve is compressed.

16. The system of claim 12, wherein the blocking device comprises a screw jack configured to move a pressure plate that is configured to activate the pneumatic members.

17. The system of claim 16, wherein when the pressure plate moves in a first direction, the pneumatic members expand radially towards the nerve to induce a compressive force on the nerve and when the pressure plate moves in a second direction, the pneumatic members to contract radially away from the nerve and releases the compressive force on the nerve.

18. The system of claim 17, wherein the blocking device comprises a pressure sensor and the pressure plate comprises one or more safety mechanisms configured to actuate when a pressure on the nerve exceeds a pressure threshold.

19. A system for mechanically blocking a nerve comprising:

a blocking device configured to selectively compress the nerve until the nerve is blocked, the blocking device comprising a shape-memory cuff configured to move between a first state and a second state, wherein the shape-memory cuff compresses the nerve when in the first state and releases compression on the nerve when in the second state;

a processor; and

cause the blocking device to compress the nerve; and

20. The system of claim 19, wherein the shape-memory cuff comprises nitinol.