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EP-4674470-B1 - DEVICE FOR AURICULAR NERVE STIMULATION

EP4674470B1EP 4674470 B1EP4674470 B1EP 4674470B1EP-4674470-B1

Inventors

  • ZEINER, Klaus
  • Kampusch, Stefan
  • MAYER, ANDREAS
  • FABIAN, BERNHARD
  • LE, Van Hoang

Dates

Publication Date
20260513
Application Date
20240701

Claims (17)

  1. A device for auricular nerve stimulation, comprising: a reusable module (1) comprising: - a stimulation circuit (4) configured to generate electrical stimulation signals, - a controller unit (2) configured to control a stimulation parameter of the electrical stimulation signals, such as the intensity, frequency, pulse width, and/or duration of the electrical stimulation signals, - a communication unit (5) configured to enable data exchange between the controller unit (2) and an external device (6), and - a power management unit (3) configured to regulate and distribute electrical power to the stimulation circuit (4), the controller unit (2) and the communication unit(5), a plurality of single-use modules comprising: - a fixation module (7) configured to be attached to a user's body, - a power source module (8), - an electrode module (9) comprising at least two electrodes, and - optionally a sensor module (10), wherein each of the single-use modules (7,8,9,10) and the reusable module (1) comprise mechanical connecting means for mechanically connecting each of the single-use modules (7,8,9,10) with the reusable module (1) in a releasable manner.
  2. Device according to claim 1, wherein the reusable module (1), the electrode module (9), the power source module (8) and the optional sensor (10) module comprise electrical connecting means for electrically connecting the electrode module (9), the power source module (8) and the optional sensor module (10), respectively, with the reusable module (1) in a releasable manner.
  3. Device according to claim 1 or 2, wherein the mechanical connecting means are configured to establish at least one of a magnetic connection, a friction-fit connection and a form-fit connection.
  4. Device according to claim 1, 2 or 3, wherein the stimulation circuit (4), the controller unit (2), the communication unit (5) and the power management unit (3) are arranged within a single housing of the reusable module (1).
  5. Device according to any one of claims 1 to 4, wherein the electrode module (9) comprises needle electrodes for delivering percutaneous stimulation or surface electrodes for delivering transcutaneous stimulation.
  6. Device according to any one of claims 1 to 5, wherein the fixation module (7) is configured to be adhesively attached to a user's body.
  7. Device according to any one of claims 1 to 6, wherein at least two of the single-use modules are combined in one housing, the combination being selected from the group consisting of: a) the power source module (8) and the electrode module (9), b) the electrode module (9) and the fixation module (7), c) the power source module (8) and the fixation module (7), d) the power source module (8), the electrode module (9), and the fixation module (7), e) the sensor module (10) and the power source module (8), and f) the power source module (8), the electrode module (9), and the sensor module (10) and optionally the fixation module (7).
  8. Device according to any one of claims 1 to 7, wherein the sensor module (10) comprises at least one sensor selected from the group consisting of an electrocardiogram sensor, an electroencephalogram sensor, a photoplethysmography sensor, and electromyography sensor, an electrical field plethysmography sensor, an electric skin conductance sensor, and an inertial measurement unit sensor.
  9. Device according to any one of claims 1 to 8, wherein the power source module (8), when electrically connected to the reusable module (1), provides electrical power to the power management unit (3).
  10. Device according to any one of claims 1 to 9, wherein the sensor module (10), when electrically connected to the reusable module (1), receives electrical power from the power management unit (3).
  11. Device according to any one of claims 2 to 10, wherein the electrical connecting means of the reusable module (1) for connecting the sensor module (10) to the reusable module (1) are configured to transmit sensor data from the sensor module (10) to the controller unit (2).
  12. Device according to any one of claims 1 to 11, wherein the controller unit (2) is configured to receive the sensor data from the sensor module (10), process the received sensor data, and adjust at least one stimulation parameter of the electrical stimulation signals based on the processed sensor data.
  13. Device according to any one of claims 1 to 12, wherein the reusable module (1) comprises a signal acquisition circuit electrically connected to the electrical connecting means for connecting the electrode module (9) to the reusable module (1), the signal acquisition circuit being configured to measure and record electrical impedance and potential signals from the tissue underlying the electrodes, and a signal processing unit electrically connected to the signal acquisition circuit, the signal processing unit being configured to analyze the measured electrical impedance and potential signals to extract physiological information, such as heart rate, heart rate variability, and respiration rate.
  14. Device according to claim 13, wherein the controller unit (2) is configured to receive the physiological information from the signal processing unit and use the physiological information to adapt the stimulation parameters of the electrical stimulation circuit (4) based on the user's current physiological state and/or response to the electrical stimulation.
  15. Device according to any one of claims 1 to 14 comprising at least two sensor modules (10) that have different types of sensors.
  16. Device according to claim 15, wherein a first sensor module (10) of the at least two sensor modules comprises one sensor selected from the group consisting of an electrocardiogram sensor, an electroencephalogram sensor, a photoplethysmography sensor, an electromyography sensor, an electric skin conductance sensor, an electrical field plethysmography sensor, and an inertial measurement unit sensor, and a second sensor module (10) of the at least two sensor modules comprises another sensor selected from the group consisting of an electrocardiogram sensor, an electroencephalogram sensor, a photoplethysmography sensor, an electromyography sensor, an electric skin conductance sensor, an electrical field plethysmography sensor, and an inertial measurement unit sensor.
  17. Device according to claim 16, wherein the first sensor module (10) and the second sensor module (10) each comprise a connecting means configured to mate with the connection means of the reusable module, and the connection means of the reusable module is configured to receive and establish an electrical and mechanical connection with either the first sensor module or the second sensor module, and wherein the controller unit is configured to detect which of the first sensor module or the second sensor module is connected to the connection means of the sensor module and to receive and process data from the connected sensor module, and optionally adjust at least one stimulation parameter of the electrical stimulation signals based on the processed data from the connected sensor module.

Description

The invention refers to a device for auricular nerve stimulation. Publications US 2024/042203 A1, US 2015/238094 A1 and EP 2 237 831 B1 disclose devices for auricular nerve stimulation relating to the subject matter of the present invention. Auricular nerve stimulation has gained increasing attention in recent years as a promising therapeutic approach for various medical conditions, including pain management, addiction, and mental health disorders. Several products are currently available or under development, utilizing both transcutaneous (surface electrodes) and percutaneous (needle electrodes) stimulation techniques. These devices differ in terms of electrode placement, stimulation parameters, stimulation duration, and device lifespan. Transcutaneous stimulation typically involves the use of reusable, handheld devices that feature specialized earpieces equipped with electrodes at fixed positions on the outer ear surface. These can be clips, in-ear electrodes for the ear canal, adhesive electrodes, or some other type of surface electrodes. Reusable transcutaneous devices are often bulky and less suitable for use during normal daily life activities due to issues such as electrode contact loss during movement, which limits the stimulation time per day (often a few minutes to hours per day). These devices rely on recharging or replaceable batteries to maintain functionality. On the other hand, percutaneous stimulators are compact units that are attached directly to the skin with adhesives. These devices utilize single-use needle electrodes for direct access to underlying nerves. The stimulator unit and fixation are usually combined in one device, which is designed for prolonged use (e.g. up to 7 days) during the patient's normal daily life. After one application, the entire device must be replaced as the power source is non-rechargeable and drained upon usage. In some embodiments the stimulator can be reused for a defined number of weeks, e.g., 2 weeks, while electrodes need to be changed weekly, and the stimulator needs to be replaced every 2 weeks, after the battery is empty. Several existing devices include internal sensors to measure biosignals like electrocardiogram (ECG) sensors, pulse plethysmography sensors (PPG), electroencephalogram sensors (EEG), electric skin conductance sensor (ESC), electromyography sensors (EMG) and electrical field plethysmography sensors (EFPG) or inertial measurement units (IMU) to keep track of activity or posture of the patient. The information gathered with these sensors can be used to tailor the stimulation. The current state of auricular nerve stimulation devices presents several challenges that need to be addressed to improve their usability, sustainability, and overall performance. Reusable devices tend to be bulky, limiting the users' ability to engage in normal daily activities while using them. Additionally, the design of these devices frequently allows for only short periods of stimulation, which restricts the potential therapeutic benefits. Earpieces, which are often used for stimulation in these devices, often disengage when the patient moves and do not guarantee good electrode contact. Compliance and therapy adherence is also a significant issue with these reusable devices, as many patients find them too cumbersome to use consistently over time. Single-use devices, while more compact, generate a significant amount of waste, raising environmental concerns and increasing costs for long-term use. In current devices, battery and electronics are often integrated into the same housing, meaning that even when the electronics could still be usable after the battery is drained, they will be disposed of together. Moreover, in some single-use devices, electrodes are fixed to the rest of the stimulator, so whenever any electrodes need to be changed, the whole device must be discarded. Furthermore, current single-use devices tend to be highly specialized in their application due to their fixed electrode setup, which limits their potential use cases and adaptability for different medical conditions or patient needs. This inflexibility could be addressed by developing more versatile designs that allow for customizable electrode configurations, which would enable a broader range of applications and make the devices more appealing to both patients and healthcare providers. Affordability is another challenge in the industry, as high upfront costs can make reusable devices less appealing to potential users. Meanwhile, single-use devices can be expensive for long-term use, especially considering their disposable nature. Therefore, the instant invention aims at overcoming the drawbacks mentioned above and providing an auricular nerve stimulation device that is convenient to use, fulfills highest hygiene standards and reduces waste and costs. In order to solve these objects, the invention provides a device for auricular nerve stimulation, comprising: a reusable module comprising: a