Vestibular stimulation for treating movement disorders

Abstract

Presented herein are techniques for a vestibular system for a particular electrical stimulation recipient in order to treat a movement disorder, such as ataxia or Parkinson's disease. More specifically, according to embodiments presented herein, one or more electrodes are implanted in a recipient to deliver an electrical stimulation (e.g., current) signal to a portion of the vestibule in a manner that repairs a symptom of dyskinesia experienced by the recipient.

Description

background Technical Field

[0002] The present invention generally relates to the treatment of movement disorders, such as Parkinson's disease or ataxia, by vestibular stimulation. Background Art

[0003] Medical devices have provided a wide range of therapeutic benefits to recipients over the last several decades. Medical devices may include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., devices having external components that communicate with implantable components). Medical devices, such as traditional hearing aids, partially or fully implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful over the years in performing life-saving and / or lifestyle-improving functions and / or recipient monitoring.

[0004] Over the years, the types of medical devices and the range of functions performed by them have increased. For example, many medical devices, sometimes referred to as "implantable medical devices," now typically include one or more instruments, devices, sensors, processors, controllers, or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient's body. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage disease / injury or its symptoms, or to study, replace, or modify anatomical structures or physiological processes. Many of these functional devices utilize power and / or data received from an external device that is part of or operates in conjunction with the implantable component. Summary of the invention

[0005] In one aspect, a method is provided. The method includes: assessing fine motor skills of a recipient of an implantable movement disorder stimulator device; and delivering an electrical stimulation signal to the vestibular system of the recipient with the implantable movement disorder stimulator device, wherein one or more parameters of the electrical stimulation signal are set based on the assessment of the fine motor skills of the recipient.

[0006] In another aspect, a method is provided. The method includes: sensing at least one of a hand tremor or a head tremor of a recipient; and delivering an electrical stimulation signal to the vestibular system of the recipient based on the sensing of the at least one of the hand tremor or the head tremor of the recipient.

[0007] In another aspect, one or more non-transitory computer-readable storage media are provided. The one or more non-transitory computer-readable storage media include instructions that, when executed by a processor, cause the processor to: deliver an electrical stimulation signal to the peripheral vestibular system of the inner ear of a recipient via at least one electrode configured to be implanted at the inner ear of the recipient; monitor one or more target movement disorder symptoms of the recipient after initiating delivery of the electrical stimulation signal; and adjust one or more parameters of the electrical stimulation signal based on the monitoring of the one or more target movement disorder symptoms of the recipient.

[0008] In another aspect, an implantable movement disorder stimulator system is provided. The implantable movement disorder stimulator comprises: one or more electrodes, the one or more electrodes being configured to be implanted in the inner ear of a recipient suffering from movement disorders; an implantable stimulator unit, the implantable stimulator unit being configured to deliver electrical stimulation signals to the vestibular system of the inner ear of the recipient via at least one of the one or more electrodes; and at least one processor, the at least one processor being configured to: analyze one or more movement disorder symptoms experienced by the recipient after delivering electrical stimulation to the vestibular system; and based on the analysis of the one or more movement disorder symptoms experienced by the recipient, adjust one or more parameters of the electrical stimulation signal to reduce the one or more movement disorder symptoms experienced by the recipient.

[0009] In another aspect, an implantable movement disorder stimulator is provided. The implantable movement disorder stimulator comprises: a stimulation assembly, the stimulation assembly comprising a plurality of stimulation elements, the plurality of stimulation elements being configured to be implanted in an inner ear of a recipient, adjacent to an otolith organ of the inner ear; and a stimulator unit, the stimulator unit being configured to generate an electrical stimulation signal and deliver the electrical stimulation signal to a vestibular nerve of the recipient via one or more of the otolith organs, wherein the electrical stimulation signal has stimulation parameters determined based on one or more assessments of the recipient's fine motor skills. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Embodiments of the present invention are described herein with reference to the accompanying drawings, in which:

[0011] Figure 1A is a schematic partial cross-sectional view showing the anatomical structure of the human inner ear;

[0012] Figure 1B To show Figure 1A A perspective view of additional detail of a portion of a human inner ear;

[0013] Figure 2A is a schematic diagram illustrating an otolith stimulation system according to certain embodiments presented herein;

[0014] Figure 2B According to certain embodiments presented herein Figure 2A A simplified block diagram of the vestibular stimulation system;

[0015] Figure 3A An image showing a stimulation component of an implantable movement disorder stimulator implanted in a recipient according to certain embodiments presented herein;

[0016] Figure 3B , 3C , 3D, 3E, 3F, and 3G are annotated computed tomography (CT) scans showing the stimulation component of an implantable movement disorder stimulator implanted in a recipient according to certain embodiments presented herein;

[0017] Figure 3H A medical image showing neural cells adjacent to an implantation site of a stimulation component of an implantable movement disorder stimulator according to certain embodiments presented herein;

[0018] Figure 4 is a schematic three-dimensional illustration of the inner ear of a recipient having a stimulation assembly implanted therein according to certain embodiments presented herein;

[0019] Figure 5 is a flow chart of a method according to certain embodiments presented herein;

[0020] Figure 6 is a flow chart of a method according to certain embodiments presented herein;

[0021] Figure 7 A schematic diagram illustrating an adaptation system with which aspects of the technology presented herein may be implemented;

[0022] Figure 8 is a flow chart of another method according to certain embodiments presented herein;

[0023] Fig. 9 is a flow chart of another method according to certain embodiments presented herein; and

[0024] Fig.10 is a flow diagram of another method according to certain embodiments presented herein. DETAILED DESCRIPTION

[0025] There are many different types of movement disorders that cause unwanted or uncontrollable movements of the body. For example, ataxia is one of a class of neurological diseases / disorders that can affect a patient's limb coordination, language function, eye movement, and muscle control at different levels. Ataxia occurs when a part of the brain called the cerebellum is damaged. There are several types of ataxia, including: ataxia telangiectasia (AT), paroxysmal ataxia, Friedreich's ataxia, multiple system atrophy (MSA), and spinocerebellar ataxia. This condition occurs when a part of the brain called the cerebellum is damaged.

[0026] Parkinson's disease (Parkinson's or PD) is another neurological disease that occurs when nerve cells (neurons) in an area of ​​the brain called the substantia nigra are damaged or die. These cells normally produce dopamine, a chemical (neurotransmitter) that helps brain cells communicate (transmit signals, "messages" between areas in the brain). When these nerve cells are damaged or die, they produce less dopamine. Dopamine is particularly important for the functioning of another area of ​​the brain called the basal ganglia. This area of ​​the brain is responsible for organizing the brain's commands for body movement. The loss of dopamine causes the movement symptoms seen in patients with Parkinson's disease.

[0027] Patients with Parkinson's disease also lose another neurotransmitter called norepinephrine. This chemical is needed for the sympathetic nervous system to function properly. This system controls some of the body's automatic functions, such as digestion, heart rate, blood pressure, and breathing. Loss of norepinephrine causes some of the non-motor-related symptoms of Parkinson's disease.

[0028] Essential tremor is another neurological disorder that causes rhythmic shaking or tremors. It can affect almost any part of the body, but the tremor most often occurs in the hands and is particularly troublesome during attempts to perform simple tasks such as drinking from a glass or writing with a pencil. Essential tremor may also affect a person's head, voice, arms, or legs. Although it is not the same as Parkinson's disease, the tremor of Parkinson's disease is similar to essential tremor.

[0029] The signs and symptoms of movement disorders may vary. For example, patients with ataxia lose muscle control of their arms and legs, which may lead to lack of balance, coordination and difficulty walking. Ataxia may affect fingers, hands, arms, legs, body, language and even eye movements. The symptoms of Parkinson's disease can usually be divided into motor and non-motor. Motor symptoms are symptoms that affect the movement of the body. These symptoms are the most obvious symptoms of the disease. The main motor symptoms of Parkinson's disease are tremors (e.g., head and / or hand tremors), slow movements (called "tardive movement"), stiffness ("rigidity") and poor balance ("postural instability" or "gait disorder"). These symptoms are usually milder in the early stages of the disease. The tremor symptoms caused by Parkinson's disease are most obvious when the individual is at rest. The tremors of early Parkinson's disease are intermittent and may not be obvious to others. Tremors are usually obvious in one hand at a time and extend to the second hand within a period of several years.

[0030] Most movement disorders gradually get worse over time, although the rate varies greatly from person to person. Many treatments are available to help control symptoms and improve a person's quality of life. However, there is currently no cure for these diseases.

[0031] Presented herein are techniques for electrically stimulating the vestibular system of a recipient in particular to treat movement disorders such as ataxia or Parkinson's disease. More specifically, according to the embodiments presented herein, one or more electrodes are implanted in a recipient so that electrical stimulation (e.g., electric current) signals are delivered to a portion of the vestibule in a manner that repairs the movement disorder symptoms experienced by the recipient. Typically, the vestibular stimulation presented herein can be delivered from / via one or more electrodes implanted in the inner ear (interior), or from / via one or more electrodes disposed at the outer surface of the inner ear (e.g., implanted adjacent to the inner ear).

[0032] Only for ease of description, the technology presented herein is mainly described with reference to a specific implantable medical device system, i.e., an independent vestibular stimulation system. However, it should be recognized that the technology presented herein can also be partially or completely implemented by other types of implantable medical devices, and the technology presented herein can be implemented by an auditory prosthesis system including one or more other types of auditory prostheses (e.g., cochlear implants, middle ear auditory prostheses, bone conduction devices, direct sound stimulators, electroacoustic prostheses, auditory brain stimulators, combinations or variations thereof, etc.). The technology presented herein can also be implemented by a dedicated tinnitus treatment device and a tinnitus treatment device system. In other embodiments, the technology presented herein can also be implemented by a visual device (i.e., a bionic eye), a sensor, a pacemaker, a drug delivery system, a defibrillator, a functional electrical stimulation device, a catheter, an epileptic seizure device (e.g., a device for monitoring and / or treating epileptic events), a sleep apnea device, an electroporation device, etc., or used in combination with them.

[0033] Before describing the details of the technology presented in this article, the following reference Figure 1A and 1B First, relevant aspects of an exemplary human inner ear are described. Specifically, Figure 1A 1 shows the bony labyrinth 101, which is the bony outer wall of the inner ear 100. The bony labyrinth 101 includes three sections / portions, called the vestibule 102 (which includes the otolith organs 111), the semicircular canals 104, and the cochlea 106. The vestibule 102, the semicircular canals 104, and the cochlea 106 are cavities that are lined with periosteum on the inside and contain a fluid called perilymph. For ease of illustration, a portion of the bony labyrinth 101 that forms the vestibule 102 has been removed from the Figure 1A omitted, and the entire bony labyrinth 101 has been removed from Figure 1B Omit.

[0034] Within the bony labyrinth 101 is the membranous labyrinth 103, which is composed of the semicircular canals 105, the otolith organs 111 (i.e., the utricle 112 and the saccule 114), and the cochlear duct 116. The membranous labyrinth 103 is filled with a fluid called endolymph, and is surrounded by the perilymph of the bony labyrinth 101. The membranous labyrinth 103 is also suspended from the bony labyrinth 101 by thin strands of connective tissue.

[0035] As shown, the bony labyrinth 101 includes three (3) semicircular canals 104, referred to as the superior or anterior semicircular canal 104 (A), the posterior semicircular canal 104 (B), and the horizontal or lateral semicircular canal 104 (C). The superior semicircular canal 105 (B) is within the superior semicircular canal 104 (A), the posterior semicircular canal 105 (B) is within the posterior semicircular canal 104 (B), and the horizontal semicircular canal 105 (C) is within the horizontal semicircular canal 104 (C). The semicircular canals 105 are located above and behind the vestibule 102, and each has a protuberance at one end, referred to as an ampulla 110 (i.e., Figure 1A and 1B 105 ). The semicircular canals 105 , utricle 112 , and saccule 114 are sometimes collectively referred to as the “peripheral vestibular apparatus” or “peripheral vestibular system” 125 .

[0036] The semicircular canals 105(A), 105(B), and 105(C) are semicircular interconnected canals that are aligned approximately orthogonally to one another (i.e., at right angles to one another) such that they measure motion in all three planes. Specifically, the lateral canal 105(C) is aligned approximately horizontally in the head, while the superior canal 105(A) and the posterior canal 105(B) are aligned approximately at a 45 degree angle to a vertical line passing through the center of the individual's head. The semicircular canals 105(A), 105(B), and 105(C) are each most sensitive to angular acceleration (head rotation) that lies in the plane of the canal. As a result of this arrangement, the three semicircular canals 105(A), 105(B), and 105(C) can uniquely specify the direction and magnitude of any arbitrary head rotation. That is, as the head moves, the flow of endolymph within the canals 105 changes speed and / or direction. Sensory receptors in the ampulla 110 detect these changes and send signals to the brain via the vestibular nerve 118 ( Figure 1B ), thereby allowing for processing balance.

[0037] As shown, the membranous labyrinth 103 also includes an utricle 112 and a saccule 114, which are collectively referred to as otolith organs 111. The utricle 112 and the saccule 114 are two membranous sacs located in the vestibule 102 that detect movement or acceleration (i.e., linear acceleration) of the head in the horizontal and vertical planes, respectively. The utricle 112 is the larger of the two and receives the three semicircular canals 105. The saccule 114 is spherical in shape and receives the cochlear duct 116.

[0038] The utricle 112 and saccule 114 each contain a macula, which is an organ composed of a sheet of hair cells covered by a colloid membrane containing calcium carbonate particles (called otoliths). Movement of the head causes the otolith organs 111 to pull on these hair cells, stimulating the vestibular nerve 118, which allows the individual to perceive linear acceleration (both horizontally and vertically) and gravity control (i.e., gravitational inertial information).

[0039] The vestibular nerve 118 is one of the two branches of the vestibulocochlear nerve (the other is the auditory nerve 119), which is used to relay / transmit sensory information transmitted by the vestibular hair cells located in the two otolith organs (i.e., the utricle 112 and the saccule 114) and the three semicircular canals 105 via the vestibular ganglion 121. Again, as described, the information from the otolith organs 111 reflects gravity and linear acceleration of the head, while the information from the semicircular canals 105 reflects rotational movement of the head.

[0040] The peripheral vestibular nerve fibers usually divide into three branches. First, the superior vestibular nerve branch 126 passes through a foramen in the superior region of the vestibule and terminates in the utricle 112 and in the ampulla 110 of the superior and horizontal semicircular canals 105 (A), 105 (C), respectively. Second, the inferior vestibular nerve branch 128 traverses a foramen in the inferior region of the vestibule and terminates in the saccule 114. Third, the posterior vestibular nerve branch 131 passes through a single foramen and supplies the ampulla 110 of the posterior semicircular canal 105 (B), being part of the inferior branch in more than 50% of cases.

[0041] Figure 1A Also shown in the figure are the round window 120 and the oval window 122. The round window 120 and the oval window 122 are two openings from the middle ear (not shown) into the inner ear 100. The round window 120 is located below (under) and behind (behind) the oval window 122, and the round window is separated from the oval window by a protuberance (rounded protuberance). The oval window 122 is sealed by a membrane (oval window membrane) and leads from the middle ear to the vestibule of the inner ear 100. Vibrations contacting the tympanic membrane (ear drum) in the external ear (not shown) travel through the three ossicles (i.e., the malleus, the incus, and the stapes) of the middle ear and enter the inner ear 100 via the oval window 122. That is, the oval window 122 is the intersection of the middle ear and the inner ear 100, which is directly contacted by the stapes. The round window 120 is also sealed by a membrane (round window membrane) that vibrates in a phase opposite to the vibrations entering the inner ear 100 through the oval window 122. The round window 120 allows for movement of fluid in the cochlea 106 .

[0042] Presented herein is a technique for treating movement disorders, such as ataxia or Parkinson's disease (Parkinson's disease or PD), by specifically electrically stimulating the vestibular system (e.g., stimulating the saccule, the inferior vestibular nerve, etc.) from an implantation location either in the inner ear or adjacent to the inner ear. According to the embodiments presented herein, the neurostimulation system includes a stimulation component configured to be implanted in a recipient (e.g., adjacent to the otolith organ), the stimulation component including one or more electrodes. The stimulation component can be implanted through an anterior opening such as a cochlear fenestration, for example, via the oval window of the recipient. Once the stimulation component is implanted, the system is configured to specifically electrically stimulate the vestibular system in a manner that repairs symptoms (e.g., motor or non-motor symptoms) associated with movement disorders.

[0043] Figure 2A and 2B 1 shows additional details of an exemplary neural stimulation system according to the embodiments presented herein. More specifically, Figure 2A 1 shows a perspective view of a movement disorder stimulation system 130, which includes an implantable movement disorder stimulator 132, and Figure 2B FIG. 1 is a block diagram of an implantable movement disorder stimulator 132. For ease of description, Figure 2A and 2B . Also for ease of illustration, refer to Figure 1A and 1B The inner ear 100 depicts certain components of an implantable movement disorder stimulator 132.

[0044] The implantable movement disorder stimulator 132 includes an implant body (main module) 134 and a stimulation device 136, both of which are implantable in a recipient (i.e., implanted beneath the skin / tissue 131 of the recipient). The implant body 134 generally includes a hermetically sealed housing 138 in which a radio frequency (RF) interface circuit system 140, at least one processor 142, a memory device (memory) 144 storing movement disorder repair logic 145, a stimulator unit 146, a rechargeable power source 148, and a wireless transmitter / receiver (transceiver) 150 are disposed. The implant body 134 also includes an internal / implantable coil 141, which is generally external to the housing 138 but is connected to the stimulation device 136 via a hermetic feedthrough ( Figure 2B ) is connected to the RF interface circuit system 140.

[0045] The processor 142 can be formed by one or more processors (e.g., one or more digital signal processors (DSPs), one or more uC cores, etc.), firmware, software, etc., arranged to perform the operations described herein. That is, the processor 142 can be implemented as a firmware element, partially or completely implemented with digital logic gates in one or more application-specific integrated circuits (ASICs), partially implemented in software, etc. Typically, the processor 142 can execute the movement disorder repair logic 145 and command the stimulator unit 146 to generate electrical stimulation signals and deliver them to the recipient. The processor 142 can also perform other operations, including data logging, battery monitoring, and low battery alarms, etc. The stimulator unit 146 may include, for example, one or more current sources, switches, etc., which operate together to generate electrical stimulation signals and deliver the electrical stimulation signals to the recipient via the stimulation device 136.

[0046] like Figure 2A As shown in , the vestibular stimulation device 124 includes leads 152 and a vestibular nerve stimulation (electrode) assembly 154. The stimulation assembly 154 includes a plurality of stimulation elements 156 disposed in a carrier member 158 (e.g., a flexible silicone body). In this particular example, the stimulation assembly 154 includes three (3) stimulation elements, and the stimulation elements include electrodes, referred to as electrodes 156(1), 156(2), and 156(3). As further described below, the electrodes 156(1), 156(2), and 156(3) act as an electrical interface to the vestibular system of the recipient. It should be recognized that this particular embodiment having three electrodes is merely illustrative, and the techniques presented herein can be used with stimulation assemblies having different numbers of electrodes, stimulation assemblies having different lengths, etc.

[0047] As described elsewhere herein, the stimulation assembly 154 is configured so that a surgeon can implant the stimulation assembly adjacent to the otolith organ 111 via, for example, the oval window 122 of the recipient. That is, the stimulation assembly 154 has sufficient stiffness and dynamic properties so that the stimulation assembly can be inserted through the oval window 122 and reliably placed adjacent to the otolith organ 111 within the bony labyrinth 101 (e.g., sufficient stiffness to insert the stimulation assembly to a desired depth between the bony labyrinth 101 and the membranous labyrinth 103). In some examples, the stimulation assembly 154 is configured to be placed adjacent to the balloon 114.

[0048] The stimulation assembly 154 can have a stiffness that allows for a single stroke atraumatic insertion to a desired depth in the bony labyrinth 101. However, the stimulation assembly 154 can also have sufficient flexibility to deflect and avoid damage to the delicate anatomy of the inner ear 100. In addition, the lead 152 can have a configuration (e.g., length, flexibility, etc.) that allows for easy surgical placement of the stimulation assembly 154 and improves lead reliability (impact, fatigue, stress, etc.). In some examples, the stimulation assembly 154 includes a removable or deformable reinforcement member that allows the stimulation assembly to be placed within the bony labyrinth 101.

[0049] As described above, the implantable movement disorder stimulator 132 includes an RF interface circuit system 140 and a rechargeable power source 148 (e.g., one or more rechargeable batteries). The power source 148 can be recharged, for example, using power received from an external charger device via the RF interface circuit system 140. That is, although Figure 2B Not shown, the external device 154 includes an external coil configured to be inductively coupled to the implantable coil 141. When inductively coupled, the external coil and the implantable coil 141 form a tightly coupled wireless link through which power is transmitted from a power source of the external device through the skin / tissue 131 of the recipient. In some examples, the tightly coupled wireless link is a radio frequency (RF) link. However, various other types of energy transfer (e.g., infrared (IR), electromagnetic, capacitive, and inductive transfer) can be used to transfer power and / or data from the external device to the implantable movement disorder stimulator 132.

[0050] As described elsewhere herein, implantable movement disorder stimulators according to certain embodiments presented herein do not necessarily need to rely on input from body movement sensors to deliver effective treatment to a recipient. However, Figure 2BAlso shown in the figure are optional one or more sensors 149 that can be used in some embodiments. One or more sensors 149 can include, for example, motion sensors (e.g., accelerometers, gyroscopes, magnetometers) or sensors configured to, for example, sense gravity inertial acceleration (e.g., measure linear acceleration). In some embodiments, one or more motion sensors 149 are used to detect head shaking / head tremors, etc.

[0051] According to some embodiments, implantable movement disorder stimulator 132 may operate in conjunction with one or more external devices. Figure 2A and 2B One such exemplary external device 155 is shown. In some examples, at least one of the one or more external devices may include, for example, an external charger configured to provide power to the implantable movement disorder stimulator 132. In other examples, at least one of the one or more external devices may be configured to provide data to the implantable movement disorder stimulator 132 for use in delivering effective treatment to the recipient. For example, at least one of the one or more external devices may be a mobile computing device (e.g., a mobile phone) or a wearable device having one or more motion sensors (e.g., accelerometers, gyroscopes, magnetometers, etc.) configured to sense kinematic data, for example. In some embodiments, the wearable device is configured to be worn on the recipient's wrist (e.g., a smart watch) and can be used to detect hand shaking / hand tremors, while in other embodiments, the wearable device is configured to be worn on the recipient's head (e.g., personal sound amplification products (PSAPS), earplugs, etc.) and can be used to detect head shaking / hand tremors. Multiple external devices can be used with the implantable movement disorder stimulator 132 simultaneously or at different times. Depending on its positioning and configuration, one or more external devices may communicate with the implantable movement disorder stimulator 132 via the RF interface circuitry 140 and / or the wireless transceiver 150 .

[0052] The use of sensors to detect kinematic data is merely illustrative, and other sensors may be used according to the embodiments presented herein. For example, sensor 149 or another sensor may be a sensor configured to detect / capture electromyography (EMG) signals (e.g., electrical activity of muscle reactions or responses to stimulation of muscles by nerves), electrocochlear electrogram (ECochG) signals (e.g., measurements of neural electrical events generated by cochlear structures and auditory nerves in response to acoustic stimulation), local field potential (LFP) signals (e.g., measurements of brain activity reflecting highly dynamic information flow between neural networks), neurochemical dynamic signals, etc.

[0053] In certain embodiments, the external device 155 and the implantable movement disorder stimulator 132 cooperate to perform vestibular response telemetry (VRT). As used herein, vestibular response telemetry refers to a process in which an implantable stimulation component is used to detect electrically induced compound action potentials from the vestibular nerve. More specifically, once the stimulation component is implanted, at least one electrode of the stimulation component is used to deliver electrical stimulation to the recipient. The ECAP induced by the electrical stimulation (if any) is recorded by one or more of the other implanted electrodes for subsequent analysis, display, etc. at, for example, the external device 155. The ECAP can be obtained from any number of electrode contacts 156 (1)-156 (3), or at least attempted to be obtained from any number of electrode contacts. In certain embodiments, the ECAP obtained from the electrode (e.g., magnitude) can be correlated with the effectiveness of the stimulation signal delivered by the electrode on the vestibular nerve. These effects can be considered during the adaptation process described below.

[0054] To realize that Figure 2A and 2B The specific arrangement shown in FIG. 1 for the implantable movement disorder stimulator 132, and more generally for the system 130, is merely illustrative. Thus, it is to be appreciated that the implantable movement disorder stimulator and associated system may have many different arrangements, including, for example, Figure 2B The various functional components shown in the drawings are implemented in one or more separate components, devices, etc.

[0055] The following provides additional details related to: (1) implanting a vestibular nerve stimulating component of an implantable movement disorder stimulator into a recipient; (2) "fitting" or "programming" an implantable movement disorder stimulator for a recipient to treat a movement disorder, and (3) operating an implantable movement disorder stimulator to electrically stimulate the vestibular system of a recipient to treat a movement disorder. For ease of description, this article will primarily refer to the treatment of Parkinson's disease and to Figure 2A and 2B 1 , the techniques are described more generally with reference to system 130. However, it is recognized that the techniques presented herein may be applied to treat other movement disorders using different system / device arrangements.

[0056] As described above, the stimulation assembly according to the embodiments presented herein is configured to be implanted in a recipient so as to specifically stimulate (i.e., deliver / apply stimulation to) the vestibular system of the recipient, which may include stimulating one or more of the oval window, the saccule, the inferior vestibular nerve, etc. In certain embodiments, the stimulation assembly is implanted via the oval window of the recipient adjacent to the otolith organ of the peripheral vestibular system of the recipient, particularly the balloon. From a surgical point of view, the balloon is the lowest (distal) entry point of the peripheral vestibular system of the recipient, and is positioned close to the lower branch of the vestibular nerve near the vestibular ganglion. Therefore, implanting the stimulation assembly adjacent to the balloon also places electrodes of the stimulation assembly adjacent to the lower branch of the vestibular nerve and the vestibular ganglion. Therefore, the positioning of the stimulation assembly adjacent to the balloon allows electrical stimulation of the lower branch of the vestibular nerve and the vestibular ganglion, and the electrical stimulation is direct stimulation or only indirect stimulation through the balloon. That is, the electrical stimulation (current) signal is transmitted directly from the electrode to the lower branch of the vestibular nerve and / or the vestibular ganglion, or from the electrode to the lower branch of the vestibular nerve and / or to the vestibular ganglion via the sacculus. Therefore, the positioning of the stimulation component adjacent to the sacculus can ensure that the lower branch of the vestibular nerve and the vestibular ganglion can be stimulated without passing the stimulation through the utricle (if stimulated by the sacculus, it may potentially cause problems for the patient). Typically, the vestibular stimulation presented herein can be delivered from / via a stimulation component implanted in the inner ear (interior), or from / via a stimulation component disposed at the outer surface of the inner ear (e.g., implanted adjacent to the inner ear).

[0057] Figure 3A is an image showing a stimulation component of a vestibular nerve stimulator implanted in a recipient according to an embodiment presented herein. More specifically, Figure 3A Insertion of the stimulation assembly through the recipient's oval window is shown. Figure 3B-3G A computed tomography (CT) scan showing a stimulation assembly according to an embodiment presented herein implanted in the inner ear of a recipient. Figure 3G and the accompanying Figure 3H As shown in the annotated medical image of , the stimulating component of a vestibular nerve stimulator according to embodiments presented herein is closely positioned to the vestibular ganglion of the inferior vestibular nerve.

[0058] Figure 4 is a schematic three-dimensional diagram of the inner ear 400 of a recipient. Figure 4 Also shown is the general positioning of a stimulation assembly 454 implanted in the inner ear 400 according to embodiments presented herein. Figure 4 In the embodiment of the present invention, stimulation assembly 454 is positioned adjacent to the balloon to enable electrical stimulation of the vestibular ganglion and the inferior branch of the vestibular nerve (eg, directly or only indirectly via the balloon).

[0059] As described, the signs and symptoms of movement disorders can vary and can include motor symptoms (e.g., head tremors and hand tremors, slow movements (e.g., tardive dyskinesia), stiffness (e.g., rigidity), poor balance (e.g., postural instability or gait disturbance), etc., as well as non-motor symptoms such as cognitive changes, constipation, excessive sweating, fatigue, hallucinations and delusions, dizziness, etc.

[0060] According to the embodiments presented herein, a recipient is diagnosed with a movement disorder (e.g., by a neurologist or other medical practitioner) and then assessed for suitability to have an implantable movement disorder stimulator (e.g., implantable movement disorder stimulator 132) implanted therein. If appropriate, implantable movement disorder stimulator 132 is then implanted in the recipient, and at some point thereafter, implantable movement disorder stimulator 132 is activated (turned on) and “fitted” to the recipient.

[0061] "Adaptation" (also sometimes referred to as "programming" or "mapping") of an implantable movement disorder stimulator to a recipient is the process of determining a set of configuration settings and other data that define specific operating characteristics of the implantable movement disorder stimulator. In the case of the implantable movement disorder stimulator presented herein, the adaptation determines how the implantable movement disorder stimulator operates to deliver electrical stimulation signals (sometimes referred to herein as electrical stimulation or stimulation) to the vestibular system in order to repair the symptoms of movement disorders. That is, the adaptation process is implemented to set the parameters of the electrical stimulation signals delivered to the bursa, inferior vestibular nerve, etc., to achieve therapeutic motor benefits for the recipient while limiting or minimizing cross-stimulation of non-target nerves (e.g., vagus nerve, facial nerve, auditory nerve, etc.).

[0062] According to the embodiment presented herein, the vestibular stimulation for treating the dyskinesia of the recipient can adopt many different forms.For example, as described in more detail below, vestibular stimulation can adopt the form of one or more continuous pulse trains generated by any sensor inputs related to the movement of the recipient's head, the angular acceleration of the head, the hand, etc., independently.That is, in certain embodiments, in order to ensure that the recipient continuously experiences the alleviation of the symptoms of dyskinesia, the electrical stimulation signal can deliver an extended time period, while considering the residual effects of the patient-specific characteristics and stimulation.In other embodiments presented herein, vestibular stimulation can ensure that the recipient continuously experiences the specific duty cycle delivery of the alleviation of the symptoms of dyskinesia.In other embodiments, vestibular stimulation can be delivered in response to one or more sensor inputs (for example, when one or more symptoms of dyskinesia are detected, vestibular stimulation is dynamically activated).The best vestibular stimulation scheme (for example, continuous stimulation, periodic stimulation, dynamic stimulation, etc.) and the parameters / attributes of the stimulation signal delivered to the recipient can be determined during the adaptation process. In general, vestibular stimulation presented herein can be delivered from / via a stimulation component implanted within (interior) the inner ear, or from / via a stimulation component disposed at an outer surface of the inner ear (eg, implanted adjacent to the inner ear).

[0063] Figure 5 and 6 Flowcharts showing two exemplary processes for fitting an implantable movement disorder stimulator to a recipient according to certain embodiments presented herein. Again, for ease of description only, reference will be made to Figure 2A and 2B The implantable movement disorder stimulator 132 shown in FIG. Figure 5 and 6 adaptation process.

[0064] First reference Figure 5, showing the adaptation process / method 560. Method 560 starts at 562, wherein one or more subjective or objective measurements / assessments are performed to record (e.g., identify and characterize) one or more target movement disorder symptoms of the recipient. In certain embodiments, recording one or more target movement disorder symptoms of the recipient may include assessing the fine motor skills of the recipient. The fine motor skills of the recipient may be assessed, for example, by one or more writing tests (e.g., assessing the recipient's writing), assessing the recipient's hand tremor or head tremor, assessing the recipient's gait, memory assessment (e.g., administering one or more memory tests), etc. The assessment of the recipient's fine motor skills may be based on, for example, visual observation, video graphics data, sensor data (e.g., smart watch data, earplug data, etc.) or other information. For example, this process may utilize one or more sensors to obtain / capture one or more sensor inputs associated with the kinematic data (e.g., linear acceleration, angular motion, or angular acceleration) of the recipient's head or hand. In other embodiments, one or more intraoperative tests (e.g., to capture ECAP measurements from the recipient's vestibular system) and the fine motor skills of the recipient based on the results of one or more intraoperative tests may be performed.

[0065] In some embodiments, recording one or more target movement disorder symptoms of the recipient may include subjectively or objectively determining an initial baseline level of one or more target movement symptoms of the recipient's movement, such as determining an initial baseline level of the recipient's head tremor, an initial baseline of the recipient's hand tremor, gait analysis to determine an initial baseline level of the recipient's gait, etc. In some embodiments, recording one or more objective measures of the recipient's movement disorder may include obtaining objective measures from the recipient, such as VRT or other neural response measures.

[0066] In certain embodiments, recording of one or more target movement disorder symptoms of a recipient's movement disorder can be based on data captured by sensors to perform the following operations: detecting / capturing electromyography (EMG) signals (e.g., electrical activity of muscle reactions or responses to stimulation of muscles by nerves), electrocochlear electrogram (ECochG) signals (e.g., measurement of neural electrical events generated by cochlear structures and auditory nerves in response to acoustic stimulation), local field potential (LFP) signals (e.g., measurement of brain activity reflecting highly dynamic information flow between neural networks), neurochemical dynamic signals, etc.

[0067] At 564, initial stimulation parameters are set for delivering a stimulation signal to the vestibular system via one or more electrode contacts 156(1)-156(3). The initial stimulation parameters may include, for example, a stimulation level (current level) of the stimulation signal, a dynamic range (e.g., threshold level and comfort level) of the stimulation signal, stimulation signal timing, etc. For example, in one illustrative embodiment, the dynamic range may be set to 1 current level (CL) and the comfort level may be set to 70% of a threshold vestibular response telemetry (VRT) (if known). If no VRT is available, the comfort level may be set to a predetermined value (e.g., 100 CL).

[0068] although Figure 5 Not shown, in some embodiments, one or more diagnostic operations may optionally precede the operations of 564 and / or 562. These diagnostic operations may include, for example, electrode contact impedance checks, one or more VRT measurements, etc.

[0069] return Figure 5 , at 566, vestibular stimulation is delivered to the recipient (e.g., using one or more electrode contacts 156(1)-156(3) of the implantable movement disorder stimulator 132 to deliver electrical stimulation signals directly to the recipient's vestibular system). Initially, the parameters of the electrical stimulation signals are those selected at 564. However, as further described below, the stimulation parameters may be adjusted / changed during the fitting process to optimize vestibular stimulation for treating the recipient's movement disorder. As described, vestibular stimulation may be delivered from / via a stimulation component implanted within (interior) the inner ear, or from / via a stimulation component disposed at an outer surface of the inner ear (e.g., implanted adjacent to the inner ear).

[0070] At 568, after initiating the delivery of vestibular stimulation, a further analysis / assessment of the recipient's movement disorder is performed. That is, one or more target movement disorder symptoms after stimulation are assessed relative to one or more target movement disorder symptoms before stimulation (e.g., rechecking head tremor or hand tremor, rechecking handwriting, rechecking memory, etc. to see if there is an improvement in response to stimulation). In certain embodiments, this further analysis / assessment may include the same or similar assessment as described at 562 to record (e.g., identify and characterize) the "current" or "immediate" level of one or more target movement disorder symptoms. Thereafter, the current level of one or more target movement disorder symptoms is assessed relative to (compared to) the baseline level of one or more target movement disorder symptoms. The operation at 568 may include an objective or subjective assessment of one or more target movement symptoms, such as an objective or subjective assessment of whether the recipient's head tremor or hand tremor has improved relative to an initial baseline level, an objective or subjective assessment of whether the recipient's gait has improved relative to an initial baseline level, analysis of further VRT or other neural response measurements, etc.

[0071] As described above, vestibular stimulation for treating a recipient's movement disorder can take many different forms, including continuous stimulation, periodic stimulation, dynamic stimulation, etc. Thus, the phrase "after initiating stimulation" can include determinations made in conjunction with any of these or other stimulation schemes, such as determinations made while the stimulation signal is being delivered to the recipient, determinations made after the stimulation signal is delivered to the recipient, etc.

[0072] return Figure 5 In the example of , if it is determined at 568 that one or more target movement disorder symptoms have not decreased, the method proceeds to 570, where stimulation parameters (e.g., current level, frequency, pulse rate, pulse interval, etc.) are adjusted to increase the effectiveness of vestibular stimulation. This adjustment may include, for example, increasing the current level of the stimulation signal, increasing the number of electrode contacts used to deliver the stimulation signal, changing which electrode contacts are used to deliver the stimulation, adjusting the timing of the stimulation signal, etc. After adjusting the stimulation parameters, the method 560 then returns to 566, where the vestibular stimulation is delivered to the recipient using the adjusted stimulation parameters.

[0073] Returning to 568, if it is determined that one or more target movement disorder symptoms have been reduced, the method proceeds to 572, where a determination is made as to whether one or more target movement disorder symptoms have disappeared or are below a threshold level associated with the symptom (e.g., whether hand tremors or head tremors have disappeared and / or have been reduced to an acceptable level). If it is determined at 572 that one or more target movement disorder symptoms have disappeared or are below a threshold level, method 560 ends at 574. Arrival of method 560 at 574 means that one or more target movement disorder symptoms have disappeared or are below a threshold level, and it has been identified that stimulation has no negative side effects, as described below. In alternative embodiments, 574 may be replaced with one or more operating cycles to further refine / optimize the stimulation signal for the recipient (e.g., fine-tune stimulation parameters).

[0074] Returning to 572, if it is determined that one or more target movement disorder symptoms have not disappeared and / or are not below a threshold level, method 560 further proceeds to 576, where another determination is made as to whether the recipient is experiencing a perceptible side effect (e.g., discomfort) due to vestibular stimulation. Determining whether the recipient is experiencing a side effect may include determining whether the recipient is experiencing any side effects, experiencing a specific side effect, experiencing a side effect that exceeds a threshold level, etc. Many different side effects may be evaluated at 576. In a specific example, the operations at 576 may include determining whether vestibular stimulation has affected a non-target area of ​​the recipient (e.g., vagus nerve, facial nerve, auditory nerve, etc.), whether vestibular stimulation has affected the balance of the recipient, etc.

[0075] If it is determined at 576 that the recipient is not experiencing perceptible side effects, the method proceeds to 570, where the stimulation parameters are adjusted to enhance the effect of the vestibular stimulation. As described above, this adjustment may include, for example, increasing the current level of the stimulation signal, increasing the number of electrode contacts used to deliver the stimulation signal, adjusting the timing of the stimulation signal, etc. Thereafter, the method 560 then returns to 566, where the vestibular stimulation is delivered to the recipient using the adjusted stimulation parameters.

[0076] Returning to 576, if it is determined that the recipient is experiencing perceptible side effects, the method proceeds to 578, where stimulation parameters (e.g., current level, frequency, pulse rate, pulse interval, etc.) are adjusted to reduce the perceptible effects of vestibular stimulation. These adjustments may include, for example, reducing the current level of the stimulation signal, changing which electrode contacts are used to deliver the stimulation, reducing the number of electrode contacts used to deliver the stimulation signal, adjusting the timing of the stimulation signal, etc.

[0077] Afterwards, method 560 proceeds to 580, wherein taking into account that the recipient has experienced perceptible side effects due to vestibular stimulation, a determination is made as to whether the adaptation process should continue. This determination can be based on, for example, whether the adjusted stimulation parameters (at 578) are expected to have eliminated and / or reduced perceptible side effects. If it is determined at 580 that the adaptation process can continue, method 560 returns to 566, wherein the vestibular stimulation is delivered to the recipient using the adjusted stimulation parameters. However, if it is determined at 580 that the adaptation process cannot continue, method 560 ends at 582. The arrival of method 560 at 582 means that one or more target movement disorder symptoms have not disappeared and / or are not below a threshold level, and one or more negative side effects of stimulation have been identified. This is an undesirable result, and will cause the adaptation process to be restarted using new parameters, a new stimulation scheme, etc.

[0078] In some embodiments, the operations of 566, 568, 570, 572, 576, 578, and 580 may be operated in a closed loop (e.g., an automated closed loop) that continues until the method reaches 574 or 580. This closed loop functionality is Figure 5 The dashed box 561 is roughly represented in the figure.

[0079] To realize that Figure 5 The order of operations of method 560 shown in is merely illustrative, and in certain embodiments, the various operations may be performed in a different order than shown and described. It is also recognized that certain operations may be added to or omitted from method 560 according to alternative embodiments.

[0080] As stated, Figure 6660 is a flow chart illustrating another exemplary fitting method 660 according to certain embodiments presented herein. It is to be appreciated that methods 560 and 660 are non-mutually exclusive and generally schematically complementary and / or overlapping techniques for fitting an implantable movement disorder stimulator (e.g., implantable movement disorder stimulator 132) to a recipient.

[0081] Method 660 begins at 662, where electrodes 156(1)-156(3) of a vestibular nerve stimulation assembly 154 are used for vestibular response telemetry (VRT) when implanted in a recipient, such that ECAPs are captured from the recipient's vestibular system. At 664, the captured ECAPs are used to determine a threshold (minimum) stimulation / current level (CL) that will produce an ECAP for one or more electrodes 156(1)-156(3). The minimum current level that produces an ECAP for an electrode is referred to as the recipient's "threshold level" for that electrode. The recipient's threshold level may be the same or different for each of electrodes 156(1)-156(3).

[0082] In some examples, a threshold level for a recipient is determined for "N" electrodes 156 (based on vestibular response telemetry) having the highest ECAP magnitude and / or lowest latency. In these examples, these N electrodes are the electrodes that will be used to deliver electrical stimulation to the recipient. In a specific example, N=3 (i.e., 3 electrodes with the highest ECAP magnitude and / or lowest latency are selected for stimulating the lower branch of the vestibular nerve). The use of three electrodes can provide superior performance (e.g., N=1 or N=2) compared to the use of one or two electrodes. For example, the use of three electrodes can stimulate more lower branches of the vestibular nerve than the use of one or two electrodes (e.g., due to increased excitation spread using three electrodes). If necessary, deactivate the inactive electrodes 156 by setting the current level to zero.

[0083] It is to be appreciated that the operations described above with respect to 662 and 664 are optional. That is, using vestibular response telemetry to obtain ECAP and determining the threshold level of the recipient based thereon can be beneficial in identifying the current level to use at the beginning of the fitting process, which can shorten the fitting process. However, the starting current level can also be estimated, although such an estimation may result in a longer fitting process.

[0084] Return to Figure 6 In the example of , at 666, initial stimulation parameters are set for delivering stimulation signals to the vestibular system via one or more electrode contacts 156(1)-156(3). The initial stimulation parameters may include, for example, a dynamic range of the stimulation signal (e.g., threshold level and comfort level), stimulation timing, etc. The initial stimulation parameters may be the same or different for each of the electrode contacts 156(1)-156(3).

[0085] After the initial stimulation parameters are set, the implantable movement disorder stimulator 132 is activated (i.e., turned on) and used to stimulate the vestibular system of the recipient at 668. At 668, vestibular stimulation is delivered according to the "current" (currently instantiated) stimulation parameters, which initially include the initial vestibular stimulation parameters.

[0086] At 670, one or more determinations are made as to whether the current stimulation parameters are optimal for treating the recipient's condition. In some embodiments, the one or more determinations at 670 may include an objective or subjective assessment of one or more specific or target movement symptoms of the recipient's movement disorder (target movement disorder symptoms), such as an objective or subjective assessment of whether the recipient's head tremor or hand tremor has improved relative to an initial baseline level, an objective or subjective assessment of whether the recipient's gait has improved relative to a baseline level, an analysis of further VRT or other neural response measurements, etc. The one or more determinations at 670 may also include an objective or subjective assessment of whether one or more target movement disorder symptoms have disappeared or are below a threshold level associated with the symptom (e.g., whether the head tremor or hand tremor has disappeared and / or has been reduced to an acceptable level). Moreover, the one or more determinations at 670 may also include or alternatively include a determination of whether the recipient is experiencing any perceptible side effects, which may include a determination of whether the recipient is experiencing a specific side effect, experiencing a side effect exceeding a threshold level, etc. Many different side effects may be assessed at 670, such as whether vestibular stimulation has affected the recipient's facial nerve.

[0087] As discussed above, the phrase "after initiating stimulation" may include determinations made in conjunction with any of these or other stimulation protocols, such as determinations made while a stimulation signal is being delivered to a recipient, determinations made after a stimulation signal is delivered to a recipient, and the like.

[0088] If it is determined at 670 that the current stimulation parameters are non-optimal (e.g., one or more of the recipient's target movement disorder symptoms have not disappeared and / or are not below a threshold level associated with the symptom, or the recipient is experiencing perceptible side effects), method 660 proceeds to 672. At 672, the stimulation parameters are adjusted. For example, the current level of the stimulation signal delivered via one or more electrodes can be increased (e.g., +2), the pulse rate can be changed, etc. Once selected, the adjusted stimulation parameters are instantiated in the implantable movement disorder stimulator 132 and become the "current" vestibular stimulation parameters.

[0089] After selecting and instantiating the adjusted stimulation parameters as the current vestibular stimulation parameters, method 660 returns to 668, where the adjusted stimulation parameters are used to stimulate the vestibular system of the recipient. Then, the operations at 670, 672, and 668 are iteratively repeated until a determination is made at 670 that the current stimulation parameters are optimal for treating the movement disorder of the recipient. Once it is determined at 670 that the current vestibular stimulation parameters are optimal, method 660 ends at 674.

[0090] As described above, using vestibular response telemetry to obtain ECAP and determining the recipient's threshold level based thereon can be beneficial to fitting to speed up the fitting process (i.e., the threshold level provides a good starting point for the fitting procedure, which means that the fitting process will take much less time). However, as also described, using vestibular response telemetry during fitting is optional, and fitting can instead be to some estimated current level.

[0091] In some examples, the ECAP (e.g., magnitude) obtained from an electrode can be correlated with the effectiveness of the stimulation signal delivered by that electrode on the vestibular nerve. These effects can be Figure 6 For example, if no ECAP is obtained from an implanted electrode (or the ECAP obtained is very low), then the electrode may be excluded from being used to deliver stimulation signals to the vestibular nerve, the level of stimulation signals delivered from the electrode may be reduced, etc.

[0092] To realize that Figure 6 The order of operations of method 660 shown in is merely illustrative, and in certain embodiments, the operations may be performed in a different order than shown and described. It is also recognized that certain operations may be added to or omitted from method 660 according to alternative embodiments.

[0093] exist Figure 7 A block diagram of an exemplary adaptation system 770 configured to perform various aspects of the techniques presented herein is shown in . The adaptation system 770 is typically a computing device that includes multiple interfaces / ports 778(1)-778(N), a memory 780, a processor 784, and a user interface 786. The interfaces 778(1)-778(N) may include, for example, any combination of network ports (e.g., Ethernet ports), wireless network interfaces, universal serial bus (USB) ports, Institute of Electrical and Electronics Engineers (IEEE) 1394 interfaces, PS / 2 ports, etc. In Figure 7In the example of , interface 778(1) is configured to communicate with a movement disorder stimulation system 130 having components implanted in recipient 771. For example, interface 778(1) may communicate directly with implantable movement disorder stimulator 132 (e.g., via wireless transceiver 150), or communicate with implantable movement disorder stimulator 132 via external device 155, which communicates with implantable movement disorder stimulator 132, as described above. Interface 778(1) may be configured to communicate via a wired or wireless connection (e.g., telemetry, Bluetooth, etc.).

[0094] The user interface 786 includes one or more output devices, such as a display screen (e.g., a liquid crystal display (LCD)) and a speaker, for presenting visual or auditory information to a clinician, audiologist, or other user. The user interface 786 may also include one or more input devices, such as a keypad, keyboard, mouse, touch screen, etc.

[0095] The memory 780 includes an implantable movement disorder stimulator adaptation logic 781, which can be executed to adapt the implantable movement disorder stimulator. For example, the implantable movement disorder stimulator adaptation logic 781 can be executed by the processor 784 to perform aspects of methods 560 and 660 as described above or other methods according to the adaptation techniques presented herein.

[0096] The memory 780 may include a read-only memory (ROM), a random access memory (RAM), a magnetic disk storage media device, an optical storage media device, a flash memory device, an electrical, optical or other physical / tangible memory storage device. The processor 784 is, for example, a microprocessor or microcontroller that executes instructions for the implantable movement disorder stimulator adaptation logic 781. Thus, in general, the memory 780 may include one or more tangible (non-transitory) computer-readable storage media (e.g., memory devices) encoded with software including computer-executable instructions, and when the software is executed (by the processor 784), it is operable to perform the techniques described herein.

[0097] As mentioned above, Figure 7 An exemplary adaptation system is shown, and Figure 5 and 6Two exemplary methods of adaptation methods are shown for use with an implantable movement disorder stimulator (e.g., implantable movement disorder stimulator 132). Adaptation of the implantable movement disorder stimulator 132 can occur shortly after initial implantation, but can also be performed regularly / periodically thereafter to ensure that stimulation remains optimal for the recipient's current stage of movement disorder. That is, as described, most movement disorders are progressive and the recipient's symptoms will become worse over time. Therefore, the above adaptation method or a modified form thereof can be performed regularly or periodically to adjust the stimulation settings to account for movement disorder progression.

[0098] After the implantable movement disorder stimulator 132 is implanted and fitted to the recipient, the implantable movement disorder stimulator will operate in real time to electrically stimulate the recipient's vestibular system (e.g., the saccule, the inferior vestibular nerve, the oval window, etc.) in order to repair the symptoms of the recipient's movement disorder. For example, in the context of Parkinson's disease, the implantable movement disorder stimulator 132 can be fitted to the recipient in order to reduce, minimize or possibly eliminate head tremors, hand tremors, improve gait, etc.

[0099] As described above, vestibular stimulation for treating a recipient's movement disorder can take many different forms, including continuous stimulation, periodic stimulation, dynamic stimulation, etc. The optimal vestibular stimulation regimen (e.g., continuous stimulation, periodic stimulation, dynamic stimulation, etc.) and the parameters / attributes of the stimulation signals delivered to the recipient can be determined during the fitting process as described above.

[0100] As described, in some embodiments, vestibular stimulation can take the form of one or more continuous pulse trains generated independently of any sensor inputs related to the movement of the recipient's head, angular acceleration of the head, hands, etc. That is, in some embodiments, to ensure that the recipient continues to experience relief from the symptoms of movement disorders, electrical stimulation signals can be delivered to the vestibular system over an extended period of time, taking into account patient-specific characteristics and residual effects of stimulation. In some such examples, electrical stimulation signals are delivered to the recipient continuously throughout the day (e.g., stimulation signals are delivered continuously for 8 hours, 12 hours, 14 hours, etc.).

[0101] As described, the implantable movement disorder stimulator according to the presented embodiment generally includes one or more electrode contacts (e.g., three electrode contacts, five electrode contacts, etc.) implanted in a recipient adjacent to the vestibular system. In the example of implanting multiple electrode contacts, one or all of the electrode contacts can be used to deliver vestibular stimulation to the recipient, and for different electrodes, the stimulation can be the same or different. For example, multiple electrodes can deliver a pulse train generated using the same fixed stimulation parameters. Alternatively, the implantable movement disorder stimulator can deliver at least a first continuous pulse train to a first stimulation element in a plurality of stimulation elements, and at least a second continuous pulse train to a second stimulation element in a plurality of stimulation elements, wherein the first pulse train and the second pulse train are generated according to different stimulation parameters (e.g., different current levels, different pulse rates, etc.). Again, different stimulation parameters for different pulse trains are determined during the adaptation process, wherein the difference can be based on electrode positioning, ECAP response, subjective recipient feedback, etc.

[0102] As described above, the implantable movement disorder stimulator is configured to repair the movement symptoms associated with movement disorders. In other words, the implantable movement disorder stimulator electrically stimulates the vestibular nerve (e.g., the lower branch of the vestibular nerve and / or the vestibular ganglion) of the recipient in a manner (e.g., timing, stimulation parameters, etc.) to improve (e.g., stabilize) the motor function of the recipient. In these embodiments, the stimulation parameters are generated and delivered independently of any sensor data.

[0103] As described, according to the embodiments presented herein, the electrical stimulation signal is delivered so that the recipient continuously experiences relief from one or more movement symptoms of movement disorders. In addition, as described above, in some embodiments, vestibular stimulation is delivered for an extended period of time, taking into account the specific characteristics of the recipient and the residual effects of the stimulation. In some examples, the electrical stimulation signal is continuously delivered to the recipient throughout the day (e.g., the stimulation signal is continuously delivered for 8 hours, 12 hours, 14 hours, etc.).

[0104] For some recipients, vestibular stimulation can produce residual effects in a certain period of time after the stimulation is stopped. These residual effects can be used in certain embodiments to implement a periodic stimulation mode (e.g., to ensure that the recipient continuously experiences a specific duty cycle of vestibular stimulation for relief from the symptoms of movement disorders). For example, an implantable movement disorder stimulator according to the embodiments presented herein can deliver stimulation signals to the vestibular system at a specific duty cycle during the day or when the device is used. In one example, the implantable movement disorder stimulator can operate with a fifty (50)% duty cycle (e.g., continuously delivering a stimulation signal for 30 minutes, and then not delivering stimulation for the next 30 minutes), a forty (40)% duty cycle (e.g., continuously delivering a stimulation signal for 24 minutes, and then not delivering stimulation for the next 36 minutes), a sixty (60)% duty cycle (e.g., continuously delivering a stimulation signal for 36 minutes, and then not delivering stimulation for the next 24 minutes), and the like. The use of these duty cycles may be feasible due to the residual effects of the stimulation signal in the vestibular system in a certain period of time after the stimulation is stopped.

[0105] The residual effect of vestibular stimulation can be different for different recipients, so the selected duty cycle can be different for different recipients (e.g., recipient-specific), and can be determined during the adaptation process. However, as described above, the implantable movement disorder stimulator according to the embodiment presented herein is configured to treat chronic movement disorders, and accordingly, the electrical stimulation signal causes the recipient to continuously experience relief from the movement disorder system. Therefore, the duty cycle is selected so that the stimulator will deliver the stimulation signal before the residual effect of the previous stimulation stops. For example, if the residual effect of the recipient lasts for 60 minutes, the vestibular stimulation can use a duty cycle in which the device only pauses the stimulation for 45 minutes. Therefore, the selected duty cycle (i.e., the pause in the stimulation) is based on recipient-specific information, such as its personal residual effect on vestibular nerve stimulation.

[0106] In yet other embodiments, vestibular stimulation can be delivered in response to one or more sensor inputs (e.g., vestibular stimulation is dynamically activated when one or more symptoms of a movement disorder are detected). For example, as described above, the implantable movement disorder stimulator 132 can include one or more sensors 149 and / or the implantable movement disorder stimulator 132 can communicate with an external device (e.g., a mobile phone, a smart watch, etc.) that includes one or more sensors. In these embodiments, the sensors can be used to detect symptoms of a movement disorder, such as head tremors or hand tremors, and generate sensor data representing attributes of the detected symptoms.

[0107] In an exemplary dynamic activation arrangement, one or more sensors may detect a head tremor or a hand tremor and provide sensor data representing the amount of tremor detected (e.g., a small amount of tremor, a large amount of tremor, a tremor that exceeds a threshold level, etc.). Information included in the sensor data may be used to activate / control the delivery of vestibular stimulation via the implantable dyskinesia stimulator 132. Such activation may include dynamically generating a stimulation signal based on the contents of the sensor data, activating one or more previously determined stimulation parameters (e.g., initiating the delivery of continuous stimulation over a period of time), etc. Thus, in certain embodiments, the dyskinesia stimulation system 130 operates in a closed loop to detect dyskinesia symptoms, and activates vestibular stimulation to remediate the detected dyskinesia symptoms, including real-time stimulation parameter adjustments based on the attributes of the dyskinesia symptoms experienced by the recipient.

[0108] Current treatments for movement disorders such as Parkinson's disease include drug treatment or therapy. Drug treatment or therapy can involve, for example, administration of a dopamine precursor (i.e., levodopa (L-dopa)) that is converted into dopamine in the central nervous system. Other types of drug therapy are also available. Unfortunately, over time, drug therapy often becomes less effective or ineffective for an undesirable large number of Parkinson's patients. For example, Parkinson's patients may require a combination of multiple drugs to extend the efficacy time period of drug therapy. Drug therapy also has the significant possibility of inducing undesirable physical side effects; motor function complications such as uncontrollable involuntary movements (dyskinesias) are particularly common side effects.

[0109] According to certain embodiments presented herein, vestibular stimulation can be used in conjunction with a drug therapy or therapy to treat a recipient's movement disorder. For example, as described, in the context of Parkinson's disease, certain drug therapies are intended to trigger the generation of dopamine. The vestibular stimulation techniques presented herein can also trigger the generation of dopamine. As a result, the combination of vestibular stimulation with drug therapy can, for example, reduce the required drug dosage and may extend the time period over which the drug therapy remains effective / provide a longer time period over which the drug dosage can be increased. Conversely, the combination of vestibular stimulation with drug therapy can result in vestibular stimulation using lower current levels to achieve a therapeutic effect.

[0110] Figure 8 890 is a flow chart of a method 890 according to an embodiment presented herein. The method 890 begins at 892, where the fine motor skills of a recipient of an implantable movement disorder stimulator device are assessed. At 894, the implantable movement disorder stimulator device delivers an electrical stimulation signal to the vestibular system of the recipient. One or more parameters of the electrical stimulation signal are set based on the assessment of the fine motor skills of the recipient.

[0111] Fig. 9990 is a flow chart of a method 990 according to an embodiment presented herein. The method 990 begins at 992, where at least one of a hand tremor or a head tremor of a recipient is sensed. At 994, an electrical stimulation signal is delivered to the vestibular system of the recipient based on the sensing of at least one of the hand tremor or the head tremor of the recipient.

[0112] Fig.10 1090 is a flow chart of a method 1090 according to an embodiment presented herein. The method 1090 begins at 1092, where an electrical stimulation signal is delivered to the peripheral vestibular system of the inner ear via at least one electrode configured to be implanted at the inner ear of the recipient. At 1094, one or more target movement disorder symptoms of the recipient are monitored after initiating the delivery of the electrical stimulation signal. At 1096, one or more parameters of the electrical stimulation signal are adjusted based on the monitoring of the one or more target movement disorder symptoms of the recipient.

[0113] It should be understood that the embodiments described above are not mutually exclusive and that the various embodiments may be combined in various ways and arrangements.

[0114] The invention described and claimed herein is not limited in scope by the specific preferred embodiments disclosed herein, because these embodiments are intended to be illustrative, rather than limiting several aspects of the present invention. Any equivalent embodiments are intended to be within the scope of the present invention. In fact, in addition to those modifications shown and described herein, various modifications of the present invention will become apparent to those skilled in the art based on the foregoing description. Such modifications are also intended to fall within the scope of the appended claims.

Claims

1. A method comprising: Assess fine motor skills in recipients of implantable movement disorder stimulator devices; as well as delivering electrical stimulation signals to the vestibular system of the recipient with the implantable movement disorder stimulator device, Wherein one or more parameters of the electrical stimulation signal are set based on the assessment of the fine motor skills of the recipient. 2 . The method of claim 1 , wherein assessing the fine motor skills of the recipient comprises assessing the recipient's handwriting. 3 . The method of claim 1 , wherein assessing the fine motor skills of the recipient comprises assessing at least one of a hand tremor or a head tremor of the recipient.

4. The method according to claim 3, further comprising: One or more sensor inputs related to linear acceleration, angular motion, or angular acceleration of the recipient's head are captured.

5. The method according to claim 3, further comprising: One or more sensor inputs related to linear acceleration, angular motion, or angular acceleration of the recipient's hand are captured. The method of claim 1 , wherein assessing the fine motor skills of the recipient comprises assessing the recipient's gait.

7. The method of claim 1, wherein assessing the fine motor skills of the recipient comprises: performing one or more intraoperative tests; as well as The fine motor skills of the recipient are assessed based on the one or more intraoperative tests.

8. The method of claim 7, wherein performing one or more intraoperative tests comprises: One or more electrically evoked compound action potential (ECAP) measurements are obtained from the vestibular system of the recipient.

9. The method of claim 1, 2, 3, 4, 5, 6, 7, or 8, wherein assessing the fine motor skills of the recipient comprises: The recipient is confirmed to suffer from movement disorder.

10. The method of claim 9, wherein confirming that the recipient suffers from a movement disorder comprises: The recipient is confirmed to have Parkinson's disease.

11. The method of claim 9, wherein the recipient is confirmed to suffer from a movement disorder: The recipient is confirmed to suffer from ataxia.

12. A method according to claim 1, 2, 3, 4, 5, 6, 7 or 8, wherein one or more stimulation parameters of the electrical stimulation signal set based on the assessment of the fine motor skills of the recipient include one or more of the current level, frequency, pulse rate or pulse interval of the electrical stimulation signal.

13. The method of claim 1, 2, 3, 4, 5, 6, 7 or 8, further comprising: The electrical stimulation signals are delivered independent of any sensor input related to linear acceleration, angular motion, or angular acceleration of the head or the hand of the recipient.

14. The method of claim 13, wherein delivering the electrical stimulation signal further comprises: At least a first continuous train of pulses is delivered via at least a first stimulation element of a plurality of stimulation elements configured to be implanted at an inner ear of the recipient.

15. The method of claim 14, wherein delivering the electrical stimulation signal further comprises: At least a first continuous train of pulses is delivered via at least a first stimulation element of a plurality of stimulation elements configured to be implanted in the inner ear of the recipient.

16. The method of claim 1, 2, 3, 4, 5, 6, 7, or 8, wherein delivering the electrical stimulation signal to the vestibular system of the recipient comprises: The electrical stimulation signal is delivered to at least the inferior branch of the vestibular nerve via one or more of the otolith organs.

17. The method of claim 1, 2, 3, 4, 5, 6, 7, or 8, wherein delivering the electrical stimulation signal to the vestibular system of the recipient comprises: The electrical stimulation signal is delivered to at least a vesicle of the recipient.

18. The method of claim 1, 2, 3, 4, 5, 6, 7, or 8, wherein delivering the electrical stimulation signal to the vestibular system of the recipient comprises: The electrical stimulation signal is delivered to at least the oval window of the recipient.

19. A method comprising: sensing at least one of a hand tremor or a head tremor of the recipient; as well as An electrical stimulation signal is delivered to a vestibular system of the recipient based on the sensing of the at least one of the hand tremor or the head tremor of the recipient.

20. The method of claim 19, wherein the electrical stimulation signal is configured to reduce the at least one of the hand tremor or the head tremor of the recipient.

21. The method of claim 19 or 20, wherein sensing at least one of a hand tremor or a head tremor of the recipient comprises: Head tremors are sensed with an implantable motion sensor configured to be implanted in the recipient.

22. The method of claim 19, wherein sensing at least one of a hand tremor or a head tremor of the recipient comprises: Head tremors are sensed with a motion sensor worn on the recipient's head.

23. The method of claim 19 or 20, wherein sensing at least one of a hand tremor or a head tremor of the recipient comprises: Hand tremors are sensed using a motion sensor worn on the recipient's arm.

24. The method of claim 19 or 20, wherein delivering the electrical stimulation signal to the vestibular system of the recipient based on the sensing of the at least one of the hand tremor or the head tremor comprises: determining one or more attributes of the at least one of the hand tremor or the head tremor of the recipient; as well as One or more stimulation parameters of the electrical stimulation signal are set based on the one or more properties of the at least one of the hand tremor or the head tremor.

25. The method of claim 24, wherein setting one or more stimulation parameters of the electrical stimulation signal based on the one or more attributes of the at least one of the hand or the head comprises: At least one of the one or more attributes of the at least one of the hand tremor or the head tremor of the recipient is compared to a baseline value of at least one of the one or more attributes.

26. The method of claim 19 or 20, wherein delivering the electrical stimulation signal to the vestibular system of the recipient based on the sensing of the at least one of the hand tremor or the head tremor of the recipient comprises: A predetermined stimulation sequence is activated in response to sensing the at least one of the hand tremor or the head tremor.

27. The method of claim 26, wherein activating a predetermined stimulation sequence comprises: Activate a stimulation sequence comprising one or more consecutive trains of electrical pulses.

28. The method according to claim 27, further comprising: The one or more consecutive trains of electrical pulses are delivered over a period of time.

29. The method according to claim 19 or 20, further comprising: monitoring the recipient for the at least one of the hand tremor or the head tremor; determining that the at least one of the hand tremor or the head tremor of the recipient is below a threshold level; as well as One or more stimulation parameters of the electrical stimulation signal are adjusted after determining that the at least one of the hand tremor or the head tremor of the recipient is below the threshold level.

30. The method of claim 29, wherein adjusting one or more stimulation parameters of the electrical stimulation signal after determining that the at least one of the hand tremor or the head tremor of the recipient is below the threshold level comprises: Delivery of the electrical stimulation signal to the vestibular system of the recipient is ceased.

31. One or more non-transitory computer-readable storage media comprising instructions that, when executed by a processor, cause the processor to: delivering an electrical stimulation signal to a peripheral vestibular system of an inner ear via at least one electrode configured to be implanted at an inner ear of a recipient; monitoring the recipient for one or more target movement disorder symptoms after initiating delivery of the electrical stimulation signal; and One or more parameters of the electrical stimulation signal are adjusted based on the monitoring of the one or more target movement disorder symptoms of the recipient.

32. The one or more non-transitory computer-readable storage media of claim 31 , further comprising instructions operable to: Prior to delivering the stimulation signal, the one or more target movement disorder symptoms of the recipient are recorded.

33. The one or more non-transitory computer-readable storage media of claim 32, wherein the instructions operable to record the one or more target movement disorder symptoms of the recipient comprise instructions operable to: A baseline level of the one or more target movement disorder symptoms is determined for the recipient.

34. The one or more non-transitory computer-readable storage media of claim 33, wherein the instructions operable to monitor the recipient for one or more target movement disorder symptoms after initiating delivery of the electrical stimulation signals comprise instructions operable to: determining a current level of the one or more target movement disorder symptoms of the recipient; and The current level of the one or more target movement disorder symptoms is compared to the baseline level of the one or more target movement disorder symptoms.

35. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, further comprising instructions operable to: The recipient is monitored to determine whether the stimulation signal has cross-stimulated one or more non-target neural regions.

36. The one or more non-transitory computer-readable storage media of claim 35, further comprising instructions operable to: determining that the electrical stimulation signal has affected one or more non-target areas; and The electrical stimulation signal is adjusted to reduce cross stimulation of the one or more non-target neural areas.

37. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to monitor the recipient for one or more target movement disorder symptoms after initiating delivery of the electrical stimulation signals comprise instructions operable to: The recipient is monitored for at least one of a hand tremor or a head tremor.

38. The one or more non-transitory computer-readable storage media of claim 37, further comprising instructions operable to: One or more sensor inputs related to linear acceleration, angular motion, or angular acceleration of at least one of a head or a hand of the recipient are captured.

39. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to monitor the recipient for one or more target movement disorder symptoms after initiating delivery of the electrical stimulation signals comprise instructions operable to: The recipient's gait is monitored.

40. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to adjust one or more parameters of the electrical stimulation signal based on the monitoring of the one or more target movement disorder symptoms of the recipient comprise instructions operable to: Adjust the level of the electrical stimulation signal.

41. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the at least one electrode comprises a plurality of stimulation elements, and wherein the instructions operable to adjust one or more parameters of the electrical stimulation signal based on the monitoring of the one or more target movement disorder symptoms of the recipient comprise instructions operable to: Changing which stimulation elements of the plurality of stimulation elements are used to deliver the electrical stimulation signals.

42. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to deliver the electrical stimulation signal to the peripheral vestibular system of the inner ear comprise instructions operable to: At least a first continuous pulse train is delivered via the at least one electrode.

43. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to deliver the electrical stimulation signal to the peripheral vestibular system of the inner ear comprise instructions operable to: The electrical stimulation signal is delivered to at least the inferior branch of the vestibular nerve via one or more of the otolith organs.

44. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to deliver the electrical stimulation signal to the peripheral vestibular system of the inner ear comprise instructions operable to: The electrical stimulation signal is delivered to at least a vesicle of the recipient.

45. The one or more non-transitory computer-readable storage media of claim 31, 32, 33, or 34, wherein the instructions operable to deliver the electrical stimulation signal to the peripheral vestibular system of the inner ear comprise instructions operable to: The electrical stimulation signal is delivered to at least the oval window of the recipient.

46. ​​An implantable movement disorder stimulator system comprising: one or more electrodes configured to be implanted at an inner ear of a recipient suffering from a movement disorder; an implantable stimulator unit configured to deliver electrical stimulation signals to a vestibular system of the inner ear of the recipient via at least one of the one or more electrodes; as well as at least one processor configured to: analyzing one or more movement disorder symptoms experienced by the recipient after delivering electrical stimulation to the vestibular system; and One or more parameters of the electrical stimulation signal are adjusted based on the analysis of the one or more movement disorder symptoms experienced by the recipient to reduce the one or more movement disorder symptoms experienced by the recipient.

47. The implantable movement disorder stimulator system of claim 46, wherein to analyze the one or more movement disorder symptoms experienced by the recipient, the at least one processor is configured to: receiving output from one or more sensors related to at least one of a hand tremor or a head tremor of the recipient; and The at least one of the hand tremor or the head tremor of the recipient is analyzed.

48. The implantable movement disorder stimulator system of claim 47, wherein to adjust the one or more parameters of the electrical stimulation signal to reduce the one or more movement disorder symptoms experienced by the recipient, the at least one processor is configured to: The electrical stimulation signal is adjusted to reduce the at least one of the hand tremor or the head tremor of the recipient.

49. The implantable movement disorder stimulator system of claim 46, 47 or 48, wherein to adjust the one or more parameters of the electrical stimulation signal to reduce the one or more movement disorder symptoms experienced by the recipient, the at least one processor is configured to: A predetermined stimulation sequence is activated in response to sensing at least one of a hand tremor or a head tremor of the recipient.

50. The implantable movement disorder stimulator system of claim 49, wherein to activate a predetermined stimulation sequence, the at least one processor is configured to: Activate a stimulation sequence comprising one or more consecutive trains of electrical pulses.

51. The implantable movement disorder stimulator system of claim 50, wherein the at least one processor is configured to: The one or more consecutive trains of electrical pulses are delivered over a period of time.

52. The implantable movement disorder stimulator system of claim 46, 47 or 48, wherein the at least one processor is configured to: monitoring the recipient for at least one of a hand tremor or a head tremor; determining that the at least one of the hand tremor or the head tremor of the recipient is below a threshold level; and The one or more stimulation parameters of the electrical stimulation signal are adjusted after determining that the at least one of the hand tremor or the head tremor of the recipient is below the threshold level.

53. An implantable movement disorder stimulator, comprising: a stimulation assembly comprising a plurality of stimulation elements configured to be implanted in an inner ear of a recipient adjacent to an otolith organ of the inner ear; as well as a stimulator unit configured to generate electrical stimulation signals and to deliver the electrical stimulation signals to the vestibular nerve of the recipient via one or more of the otolith organs, Wherein the electrical stimulation signal has stimulation parameters determined based on one or more assessments of the recipient's fine motor skills.

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