CN-122028952-A - Wearable ear nerve stimulator and methods of use

Abstract

In an illustrative embodiment, a wearable ear stimulator includes a flexible body adapted to be worn at least partially around a pinna of a wearer, the flexible body including an exterior for positioning in contact with skin of the wearer, and an interior for supporting a three-dimensional (3D) circuitry layout, the 3D circuitry layout including traces deposited on a surface of the interior of the flexible body, electrodes for delivering electrical stimulation therapy to the wearer via a skin-facing side of the flexible body, and an electronics assembly electrically connected with the electrodes and the traces, the electronics assembly including processing circuitry elements for delivering electrical stimulation therapy via the electrodes.

Inventors

• COVALIN ALEJANDRO
• J. Weitenstein
• C. J. Chula
• N. Hoda palast

Assignees

• 火花生物医学股份有限公司

Dates

Publication Date

20260512

Application Date

20240528

Priority Date

20230614

Claims (20)

1. 1. A wearable ear stimulator, comprising: a first flexible body portion adapted to be worn at least partially around a pinna of a wearer, the first flexible body portion comprising Facing the outside of the skin, and An inner side opposite the skin-facing outer side, the inner side comprising at least one protrusion for supporting a three-dimensional circuitry layout, the at least one protrusion protruding away from the skin-facing outer side; Three-dimensional circuitry located on the inner side of the first flexible body portion, wherein the three-dimensional circuitry includes A plurality of conductive traces at least partially deposited on the first flexible body portion such that at least a portion of the plurality of conductive traces are configured to stretch and/or bend as the first flexible body portion moves, and A plurality of electrodes configured to deliver electrical stimulation therapy to the wearer via the skin-facing outer side of the first flexible body portion; a plurality of electronic components coupled to the three-dimensional circuitry, wherein Each of the plurality of electronic components is electrically coupled with one or more corresponding ones of the plurality of conductive traces and/or one or more corresponding ones of the plurality of electrodes of the three-dimensional circuitry, The plurality of electronic components includes two or more different types of elements selected from the group of element types consisting of lighting elements, processing circuitry elements, physical control elements, communication elements, memory elements, and combinations thereof, and Each of one or more of the plurality of electronic components being disposed on or over one or more corresponding ones of the at least one tab, and A second flexible body portion configured to mate with the first flexible body portion, thereby substantially encapsulating the three-dimensional circuitry and the plurality of electronic components.
2. 2. The wearable ear stimulator of claim 1, wherein a second one or more of the plurality of electronic components are integrated into at least one circuit component, wherein Coupling the one or more electronic components to the three-dimensional circuitry includes mounting the at least one circuit component to the inner side of the first flexible body portion.
3. 3. The wearable ear stimulator of claim 2, wherein the at least one circuit assembly includes one or more flex circuits, one or more rigidized flex circuits, and/or one or more rigid-flex circuits.
4. 4. A wearable ear stimulator according to claim 2 or claim 3, wherein the at least one circuit component comprises one or more three-dimensionally formed circuit components comprising one or more bends or curves.
5. 5. The wearable ear stimulator of claim 4, wherein the at least one protrusion comprises at least one set of flexible protrusions, each set of flexible protrusions of the at least one set of flexible protrusions at least partially supporting a respective electronic component of a third one or more electronic components of the plurality of electronic components, wherein Each set of flexible protrusions provides the respective electronic component with a limited range of motion relative to the first flexible body portion, an Each set of flexible protrusions is configured to apply a frictional force to resist movement of the respective electronic component.
6. 6. The wearable ear stimulator of claim 5, wherein a first set of flexible protrusions of the at least one set of flexible protrusions comprises a plurality of flexible posts.
7. 7. The wearable ear stimulator of claim 6, wherein a second set of flexible protrusions of the at least one set of flexible protrusions includes a second plurality of flexible posts disposed opposite the plurality of flexible posts.
8. 8. The wearable ear stimulator of any one of the preceding claims, wherein the inner side of the first flexible body portion includes at least one aperture, wherein Each of the second one or more of the plurality of electronic components is disposed on a respective one or more of the at least one aperture.
9. 9. The wearable ear stimulator of any of the preceding claims, wherein the first flexible body portion includes one or more openings therethrough such that at least one surface of each electrode of at least a portion of the plurality of electrodes is exposed for positioning in electrical communication with skin of the wearer proximate the pinna.
10. 10. The wearable ear stimulator of any of the preceding claims, wherein at least one of the first flexible body portion or the second flexible body portion includes one or more openings such that at least one of the plurality of electronic components is accessible via at least one respective opening of the one or more openings when the first flexible body portion and the second flexible body portion are mated.
11. 11. The wearable ear stimulator of claim 10, wherein the at least one electronic component includes a control button or a control switch.
12. 12. The wearable ear stimulator of any of the preceding claims, wherein the first flexible body portion is formed as a continuous molding of a single material.
13. 13. The wearable ear stimulator of any one of the preceding claims, wherein the first flexible body portion comprises: A first section configured to be aligned substantially in front of the auricle, and A second section configured to be substantially aligned against a rear portion of the pinna.
14. 14. The wearable ear stimulator of claim 13, wherein the plurality of conductive traces of the three-dimensional circuitry includes a first plurality of conductive traces electrically connecting a portion of the plurality of electronic components disposed in the second section with a portion of the three-dimensional circuitry disposed in the first section.
15. 15. The wearable ear stimulator of claim 14, wherein the first plurality of conductive traces of the three-dimensional circuitry electrically connects a portion of the plurality of electrodes disposed in the second section with at least one of a therapeutic stimulation source of the plurality of electronic components disposed in the first section or a return electrode of the plurality of electrodes disposed in the first section.
16. 16. The wearable ear stimulator of claim 14 or claim 15, wherein the first flexible body portion further comprises a third section configured to be retained on at least one of a concha or a cavity of the auricle.
17. 17. The wearable ear stimulator of claim 16, wherein at least one electrode of the plurality of electrodes is disposed in the third section.
18. 18. The wearable ear stimulator of any one of claims 13-17, wherein a first electrode of the plurality of electrodes configured to be positioned on, over, or near a branch of an ototemporal nerve (ATN) is disposed in the first section of the first flexible body portion.
19. 19. The wearable ear stimulator of claim 18, wherein the branch of the ATN is an external auditory canal nerve.
20. 20. The wearable ear stimulator of any of claims 13-19, wherein a first electrode of the plurality of electrodes is disposed in the second section of the first flexible body portion, the first electrode configured to be positioned on, over, or near an earbranch of a vagus nerve (ABVN), near a point where the ABVN emerges through a mastoid canal (MsC).

Description

Wearable ear nerve stimulator and methods of use Cross Reference to Related Applications The present application is a continuation of and claims priority to U.S. patent application Ser. No. 18/675,492, entitled "wearable ear nerve stimulator and method of use (Wearable Auricular Neurostimulator and Methods of Use)" and filed 5/28 of 2024, which is a continuation of and claims priority to U.S. patent application Ser. No. 18/209,852, entitled "wearable ear nerve stimulator and method of use" and filed 14 of 2023, 6. Background Non-invasive, easy to use and/or application of medical therapies is the goal of new non-drug therapies. A major example of such treatments are wearable medical devices. While the primary goal of medical devices is to be safe and effective, the goal of any wearable device is to be comfortable, easy to use, and aesthetically pleasing. These two sets of targets are often difficult to agree. The device for stimulating neural structures on and around the ear of a patient is designed to provide stimulation with or without puncturing the dermis layer on or around the ear. For example, the non-piercing electrode may be frictionally and/or adhesively held against the skin on and around the patient's ear to target various neural structures. The non-piercing electrode may have a substantial surface area compared to systems relying on dermal piercing electrodes, such that multiple nerve endings are stimulated by a single electrode during therapy. The plurality of nerve endings may be located directly under and/or under the skin where the non-piercing electrodes are located and in close proximity to the skin. By targeting multiple nerve endings, the positioning of each electrode need not necessarily be accurate. Thus, for example, a patient or caregiver may be able to apply and remove the device as desired/needed (e.g., for sleeping, showering, etc.). Furthermore, targeting multiple nerve endings is advantageous because stimulating multiple branches of a nerve causes a stronger response than stimulating a single branch, as is the case when using a needle tip electrode such as a needle electrode. Such devices are described, for example, in U.S. patent No. 10,695,568 entitled "device and Method for treating substance use disorders" (DEVICE AND Method for THE TREATMENT of Substance Use Disorders) and U.S. patent No. 11,623,088 entitled "device and Method for treating substance use disorders," each of which is incorporated herein by reference in its entirety. Transdermal stimulation of these nerve regions may achieve a variety of beneficial treatments. In some examples, these include treating acute or chronic pain, inflammation, and cognitive difficulties. For example, the solitary Nucleus (NTS) receives afferent connections from a number of regions, including the trigeminal-cervical complex (TCC), the cervical vagus nerve, and the auricular branches of the vagus nerve (ABVN). TCC is an area in the cervical and brain stem regions where trigeminal and occipital fibrous synapses, including the auriculotemporal nerve (ATN), occipital nerve and auricular nerve are located. TCC projects into multiple regions in the brain stem, including but not limited to the large central gap Nucleus (NRM) and other parts of the central gap nucleus (all specific central gap nuclei are referred to herein as central gap nuclei (RN)), blue spots (LC), periaqueductal gray (PAG), basal Nuclei (NBM), fuzzy Nuclei (NA), ventral capped regions (VTA), nucleus accumbens (NAc), NTS, and peribrachial nuclei (PbN). The NTS projects into the advanced centers of the RN (e.g., NRM), LC and PAG, and hypothalamus, among others, including into the arcuate nucleus (ARC), which receives most of the non-hypothalamic afferent signals from the NTS. In addition, there are many interconnections between different brain stem nuclei (e.g., PAG, LC, RN, NRM, NBM, pbN, PPN, NA, VTA, NAc), such as LC, PAG, and RN (e.g., NRM) projected into NA, and PPN projected into VTA. The VTA in turn projects into the prefrontal cortex, interconnecting the hypothalamus and the hippocampus. VTA is also projected directly onto the hippocampus. The hippocampus in turn projects to the NAc and interconnects with the hypothalamus. There is an indirect connection downstream from the heart, lung, intestine and spleen. Indirect connection includes connection with at least one synapse elsewhere before reaching the target. This means that modulating the activity of these neural circuits may affect the corresponding organs. For example, heart rate may be regulated (e.g., heart rate may be reduced and heart rate variability may be increased), oxygen absorption at the lungs may be increased by increasing compliance of the bronchial tissue and thereby increasing availability of oxygen transport, thus increasing the likelihood of more oxygen being absorbed into the blood, the down-channel from the dorsal motor nuclei (DMV) of the vagus nerve may enhance intestinal motility, intestina