Stack Design Embedded Devices

Abstract

Disclosed herein is a modular implant device (100) configured for stimulation of at least one nerve or muscle within a subject's body, the device comprising a housing (200) and at least one electrical lead (300) and / or at least one stimulation electrode (400), the at least one electrical lead (300) being partially disposed on the housing (200), the housing (200) comprising modular elements (210), the modular elements (210) being arranged in a stack (211). According to another aspect of the present disclosure, a system (900) for electrical nerve stimulation is presented, the system (900) comprising a network of at least two modular devices (100) configured for implantation inside a subject's body according to one of the preceding claims.

Description

[Technical field]

[0001] (Technical field) The disclosed subject matter described hereinafter refers to a device for electrical neurostimulation. Further, reference is made to the use of the device for electrical neurostimulation for correcting sleep disordered breathing. [Background technology]

[0002] Neuromodulation, e.g., electrical stimulation of nerves, is known in the art as a reliable and effective type of medical treatment. It presents an opportunity to address many physiological conditions and disorders by interacting with the body's own natural neural processes. Neuromodulation involves the inhibition (e.g., blocking), stimulation, modification, regulation, or therapeutic modification of electrical or chemical activity in the central, peripheral, or autonomic nervous system. By modulating the activity of the nervous system, several different goals can be achieved. For example, motor neurons can be stimulated at appropriate times to cause muscle contraction. Furthermore, sensory neurons can be blocked to relieve pain or stimulated to provide a signal to a subject or patient. In yet other examples, modulation of the autonomic nervous system can be used to regulate various involuntary physiological parameters, such as heart rate and blood pressure. Neuromodulation may provide an opportunity to treat several diseases or physiological conditions. Various devices and techniques have been used in an attempt to provide optimal stimulation of a tissue of interest.

[0003] One condition that can be amenable to neuromodulation is obstructive sleep apnea (OSA), a respiratory disorder characterized by repeated episodes of partial or complete obstruction of the upper airway during sleep. One of the causes of OSA is the inability of the tongue muscle to resist the negative inspiratory pressure in the pharynx due to the loss of muscle tone associated with sleep. When the tongue is pulled backward, this obstructs the upper airway, reducing ventilation and lowering oxygen levels in the lungs and blood. Stimulation of the hypoglossal nerve contracts the tongue muscle, e.g., the genioglossus muscle, as it is involved in the forward movement of the tongue as well as the stiffening of the anterior pharyngeal wall, thereby maintaining an open and unobstructed airway.

[0004] Another condition that neuromodulation can be applied to is the occurrence of migraine headaches.The pain sensations in the head are transmitted to the brain via the occipital nerves, particularly the greater occipital nerve and the trigeminal nerve.When a subject experiences headaches, such as during a migraine, the inhibition of these nerves can serve to reduce or eliminate the sensation of pain.

[0005] Neuromodulation can also be applied to hypertension. Blood pressure in the body is controlled through multiple feedback mechanisms. For example, baroreceptors in the carotid body in the carotid artery are sensitive to changes in blood pressure in the carotid artery. When blood pressure rises, the baroreceptors generate signals that are conducted to the brain via the glossopharyngeal nerve, signaling the brain to activate the body's regulatory systems to lower blood pressure, for example through changes in heart rate and vasodilation / vasoconstriction. Conversely, parasympathetic nerve fibers on and around the renal artery generate signals that are carried to the kidneys, initiating actions such as salt retention and release of angiotensin, which raises blood pressure. Modulating these nerves can provide the ability to impart a degree of external control over blood pressure.

[0006] The foregoing are just a few examples of conditions for which neuromodulation may be beneficial, however, the embodiments of the present disclosure described hereinafter are not limited to treating only those conditions described above.

[0007] (Prior Art) According to previous solutions, the application range of implanted devices used for functional electrical stimulation (FES) is often limited to a very small area due to lack of functional and structural flexibility. Furthermore, previous devices using lead wire electrodes for stimulation are often susceptible to lead wire damage due to the inevitable movement of device parts, thus leading to low durability of the device. Summary of the Invention [Means for solving the problem]

[0008] (Summary of the subject matter disclosed) One of the objectives of the present disclosure is to provide improved devices and systems for electrical nerve or muscle stimulation in a patient or recipient, responding to the demands of different areas of application of FES. In particular, the objective of the present disclosure is to present a device that can be used for a wide range of applications in FES. The device and system should be easy to manufacture and highly durable, while allowing for flexible arrangement.

[0009] According to one aspect of the present disclosure, a modular stimulation device configured for implantation inside a subject's body is provided, the device comprising a housing and at least one electrical lead and / or at least one stimulation electrode, the at least one electrical lead being partially attached to the housing, the housing comprising modular elements, the modular elements being arranged in a stack. Such a modular design is beneficial because it is applicable with respect to different product variants of the stimulation device. Furthermore, the stack design has the advantage of simplifying an otherwise complex manufacturing process. Also, the modular elements are preferably standardized, so that the manufacturing process can be significantly accelerated. Preferably, the stack comprises at least two modular elements attached to each other along a vertical axis, and the individual modular elements may be attached to each other via gluing, brazing, welding, or by any other hermetic fastening system.

[0010] The at least two modular elements may thereby consist of one electrically active module and one passive module (i.e. without ceramics), or they may consist of two electrically active modules. In the case of two electrically active modules, the two modules may be electrically connected to each other internally (e.g., within a sealed cavity created by the modules). It is also possible to stack the modular elements in a permutable order, allowing for even greater flexibility in application. The modular implant device described herein is applicable in any suitable FES situation. For example, the modular implant device may be used for stimulation therapy in cases of head or neck pain, spinal cord injury, stroke and upper limb recovery, foot drop, and sublingual stimulation.

[0011] According to one embodiment disclosed herein, each modular element comprises a frame, which may further have four sides, each side having a width. However, the frame may be of any shape, for example, round. As part of a preferred embodiment, the frame may be made at least partially from a titanium alloy. In addition, titanium is biocompatible and therefore can be used for implantation into a subject's body without the risk of being rejected or causing inflammation or allergies. Furthermore, titanium alloys are durable, durable, and lightweight without compromising strength. Providing a frame for the modular elements dramatically increases the stability of the modular elements, and thus the housing and modular implant device, respectively. In addition, the frame provides a working surface for assembling the modular elements into a stack, thus facilitating the manufacture of the modular implant device. Furthermore, it allows for the handling of the modular elements without the need to operate any complex components.

[0012] The modular device may be constructed in such a way that at least one modular element is a strain relief module, which comprises a cavity surrounded by a frame, and the frame is constructed as a strain relief ring. Such a strain relief module has the advantage of dramatically minimizing the risk of lead wire damage, thus increasing the durability of the modular device. To further increase durability and hermetically seal the housing, the cavity enclosed within the frame of the strain relief module may be backfilled with an insulating material, which may include silicone. Silicone is flexible and biocompatible, and therefore highly suitable for any application of FES.

[0013] In addition to the above, at least one electrical lead may include an electrical contact tip on at least one of its ends. The electrical contact tip may then be preferably disposed within the housing. Each electrical lead is configured to electrically communicate a signal from another circuit or from a power supply source. According to yet another beneficial enhancement, the electrical leads pass through a lead outlet disposed within at least one of the sides of the strain relief ring of the strain relief module. Preferably, the width of the side of the strain relief ring having the lead outlet is greater than the width of the side of the strain relief ring not having the lead outlet. In this way, the strain relief module provides more space for the electrical leads to pass through it and includes the functionality of strain relief. For example, the wider side allows the electrical lead to form a double bend when passing through the lead outlet of the strain relief ring. Such a double bend prevents the lead from losing contact with its respective circuit board electrical contact or feedthrough or from being inadvertently pulled out of the housing when subjected to a pulling force, for example, from the movement of the device or electrical lead inside the body. Furthermore, the above concept allows maximum freedom of electrical contact tips and lead exit position and orientation since the strain relief rings can be easily adapted for any lead exit location or orientation, providing the modular device with high flexibility for FES application.

[0014] It is also contemplated that at least one of the electrical leads is a stimulation lead configured for electrical stimulation of a target nerve, or a power lead configured to deliver power from a power source, or a connection lead configured to electrically connect the modular device to another electrical device. According to a preferred embodiment, each stimulation lead is disposed on an outer surface of the modular device housing and is electrically connected to a feedthrough, but includes a tip electrode at at least one of its ends positioned within a desired location relative to the tissue to be stimulated. Stimulation of tissue using a stimulation lead (e.g., at a location further away from the housing) may also be referred to as lead stimulation.

[0015] According to another embodiment of the modular device, at least one stimulating electrode is arranged on the outer surface of the housing face of the modular device. It may further be contemplated that the modular device comprises a plurality of stimulating electrodes, which are preferably arranged in an array. Theoretically, the number of electrodes arranged on the surface of the housing is only limited by the size of the modular implant device. An array that is very densely filled with stimulating electrodes is suitable for use in, for example, scanning applications. To provide stimulation to the desired tissue, the modular device may also be equipped with stimulating electrodes (e.g., electrode pads) of any shape and / or size, since the outer surface of the housing face of the modular implant device allows for freedom of configuration. Furthermore, the electrodes can be custom-sized electrodes applied to the ceramic outer surface instead of an array. Advantageously, the large shape of the outer stimulating electrodes does not impair the useful component space inside the modular device. Thus, in addition to conventional stimulation through electrical leads with tip electrodes at their ends (also referred to as lead stimulation), the implant device described herein also offers the option of performing local stimulation on the exposed surface of the implant itself. Stimulation of tissue using stimulation electrodes (eg, near the periphery of a housing) may also be referred to as localized surface stimulation.

[0016] Furthermore, at least one modular element may be a circuit module, which may comprise a circuit board surrounded by its frame. Preferably, the circuit board is soldered to the frame, but other means of connecting the board to the frame are also possible. According to yet another embodiment, the circuit board is a printed circuit board (PCB), which comprises a ceramic material, and which comprises at least one electrical contact and / or at least one feedthrough. The electrical contact is configured for connection with an electrical contact tip of one of the leads. The feedthrough is used to carry a signal through the circuit board, for example to another circuit board. Such a design leads to the non-essentiality of a separate PCB or feedthrough, since all components are easily integrated within the circuit module. The PCB may also include one or more processors configured for wired or wireless communication with a power source located outside the housing. The PCB may include any electrical circuit that may be configured to perform a logical operation on at least one input variable. Thus, a PCB may include one or more integrated circuits, microchips, microcontrollers, and microprocessors, which may be all or part of a central processing unit (CPU), digital signal processor (DSP), field programmable gate array (FPGA), or any other circuitry that may be suitable for executing instructions or performing logical operations.

[0017] This may also be beneficial when at least one electrical contact or at least one feedthrough of each circuit module is configured for electrical connection with the electrical contact tip of at least one electrical lead disposed on the outer surface of the housing of the modular device stacked directly above or below the circuit module. In this way, different modular elements can be electrically connected to each other in a simple manner, allowing a highly modular and flexible approach to stacking modular elements. Thus, any combination of lead stimulation and localized surface stimulation can be easily achieved with the modular implanted device described herein. Furthermore, only one housing surface (top or bottom) of any of the housing stacks can be functionally used for stimulation (single-sided), or both housing surfaces can be functionally used for stimulation (double-sided). In double-sided use, either the same type of stimulation (i.e., lead stimulation or localized surface stimulation) may be implemented on both housing sides (e.g., both housing sides are configured for lead stimulation), or different types of stimulation may be implemented on each housing side (e.g., lead stimulation on one housing side and localized surface stimulation on the other). Finally, both types of stimulation can be implemented in parallel on the same housing side.

[0018] According to another aspect of the present disclosure, a system for electrical nerve stimulation is provided, the system comprising a network of at least two modular devices, each device configured for implantation inside a subject's body, each modular device electrically connected to at least one other modular device through an electrical lead. Such a system may be applicable in any suitable FES situation. For example, the system described herein may be used for stimulation therapy in cases of head or neck pain, spinal cord injury, stroke and upper limb recovery, foot drop and sublingual stimulation. The present invention provides, for example, the following items. (Item 1) 1. A modular implant device (100) configured for stimulation of at least one nerve or muscle in a subject's body, the device comprising: A housing (200), At least one electrical lead (300) and / or at least one stimulation electrode (400); wherein at least one electrical lead (300) is partially attached to the housing (200), the housing (200) comprising modular elements (210), the modular elements (210) being arranged in a stack (211). (Item 2) 2. The modular implant device (100) according to item 1, characterized in that the stack (211) comprises at least two modular elements (210) attached to each other, which are hermetically sealed. (Item 3) 3. The modular implantation device (100) according to one of claims 1 or 2, characterized in that each modular element (210) comprises a frame (220). (Item 4) 4. The modular implantable device (100) according to item 3, characterized in that the frame (220) has four sides, each side (221a, b, c, d) having a width (222). (Item 5) 5. The modular implantation device (100) according to one of claims 3 or 4, characterized in that the frame (220) is made at least in part from a material comprising titanium. (Item 6) 6. The modular implant device (100) according to any one of items 3 to 5, characterized in that at least one modular element (210) is a strain relief module (500), said strain relief module (500) having a cavity (520) surrounded by said frame (220), said frame (220) being configured as a strain relief ring (510). (Item 7) 8. The modular implantation device (100) according to item 7, characterized in that the cavity (520) is backfilled with an insulating material. (Item 8) 9. The modular implant device (100) according to item 8, characterized in that the insulating material comprises silicone. (Item 9) 2. The modular implant device (100) according to any of the preceding items, characterized in that the at least one electrical lead (300) is provided with an electrical contact tip (310) on at least one of its ends. (Item 10) 10. The modular implantable device (100) of claim 9, characterized in that the electrical contact tips (310) are arranged on the housing (200), and in particular in the cavity (520) of one of the strain relief modules (500). (Item 11) 11. The modular implant device (100) according to any one of items 4 to 10, characterized in that the electrical lead (300) passes through a lead outlet (230) disposed within one of the sides (221 a, b, c, d) of the strain relief ring (510) of the strain relief module (500). (Item 12) 12. The modular implant device (100) of claim 11, wherein the width (222) of the side (221 a, b, c, d) of the strain relief ring (510) having the lead wire outlet (230) is greater than the width (222) of the side (221 a, b, c, d) of the frame (220) not having the lead wire outlet (230). (Item 13) 13. The modular implant device (100) of claim 11 or 12, wherein the electrical lead (300) forms a double bend (350) as it passes through the lead outlet (230) of the strain relief ring (510). (Item 14) The modular implant device (100) according to one of the preceding items, characterized in that at least one of the electrical leads (300) is a stimulation lead (320) configured for electrical stimulation of the target nerve, or a power lead (330) configured to deliver power from a power supply source (800) and / or deliver power and data from an antenna coil (810), or a connection lead (340) configured to electrically connect the modular device (100) to another electrical device. (Item 15) The modular implantable device (100) according to one of the preceding items, characterized in that the at least one stimulating electrode (400) is arranged on the outer surface of the housing face (240a, b) of the modular device (100). (Item 16) 4. The modular implant device (100) according to claim 1, characterized in that the modular device (100) comprises a plurality of stimulation electrodes (400). (Item 17) 17. The modular implantable device (100) according to item 16, characterized in that the plurality of stimulation electrodes (400) are arranged in an array (410). (Item 18) A modular embedded device (100) according to one of items 3 to 17, characterized in that at least one modular element (210) is a circuit module (600), said circuit module (600) comprising a circuit board (610) surrounded by said frame (220). (Item 19) 20. The modular implantable device (100) according to item 18, characterized in that the circuit board (610) is soldered to the frame (220). (Item 20) 20. The modular embedded device (100) of claim 18 or 19, wherein the circuit board (610) is a printed circuit board, the circuit board (610) comprising a ceramic material. (Item 21) A modular embedded device (100) according to one of items 18 to 20, characterized in that the circuit board (610) comprises at least one electrical contact (630) and / or feedthrough (620). (Item 22) 22. The modular implant device (100) of claim 21, wherein the at least one feedthrough (620) of each circuit module (600) is configured for electrical connection with the electrical contact tip (310) of at least one electrical lead (300) disposed within the cavity of the strain relief module (500) stacked directly above or below the circuit module (600). (Item 23) A system (900) for electrical nerve stimulation, the system (900) comprising a network of at least two modular devices (100) configured for implantation inside a subject's body according to one of the preceding items, each modular device (100) electrically connected to at least one other modular device (100) through an electrical lead (300). [Brief description of the drawings]

[0019] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosed subject matter.

[0020] [Figure 1] FIG. 1 depicts an exploded view of a modular implant device according to a preferred embodiment.

[0021] [Figure 2A] FIG. 2a depicts a schematic diagram of a single-sided modular embedded device according to another embodiment.

[0022] [Figure 2B] FIG. 2b depicts a cross-sectional view of a single-sided modular embedded device according to the embodiment of FIG. 2a.

[0023] [Figure 3A] FIG. 3a depicts a schematic diagram of a double-sided modular embedded device according to another embodiment.

[0024] [Figure 3B] FIG. 3b depicts a cross-sectional view of a double-sided modular embedded device according to the embodiment of FIG. 3a.

[0025] [Figure 4A] FIG. 4a depicts a schematic diagram of a double-sided modular embedded device according to another embodiment.

[0026] [Figure 4B] FIG. 4b depicts a cross-sectional view of a double-sided modular embedded device according to the embodiment of FIG. 4a.

[0027] [Figure 5A] FIG. 5a depicts a schematic diagram of a modular embedded system according to a preferred embodiment.

[0028] [Figure 5B] FIG. 5b depicts a schematic diagram of a modular embedded system according to another embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS FIG. 1 depicts an exploded view of a modular implant device 100 according to a preferred embodiment. The modular implant device 100, configured for implantation inside a subject's body, comprises a housing 200 consisting of two modules hermetically sealed together, and at least one electrical lead 300 and / or at least one stimulation electrode 400 (not shown in FIG. 1). The at least one electrical lead 300 is partially disposed within the housing 200, which comprises modular elements 210 arranged in a stack 211. Such a modular design is highly advantageous since it may be applicable for different product variants of the implantable stimulation device. Moreover, the stack 211 design has the advantage of simplifying an otherwise complex manufacturing process. According to FIG. 1, the stacked housing 200 comprises four modular elements 210 attached to each other along a vertical axis 700. The order of the modular elements 210 in the depicted stack 211 is not essential. Furthermore, the modular elements 210 can potentially be stacked 211 in any other (interchangeable) order, allowing for even greater flexibility in application. The individual modular elements 210 can be attached to one another via adhesive, brazing, welding, or by any other hermetic fastening system.

[0030] According to a preferred embodiment, each modular element 210 comprises a frame 220 having four sides 221a, b, c, d, each side 221a, b, c, d having a width 222. In the embodiment shown in FIG. 1, the frame 220 is essentially square. However, other shapes are equally conceivable (e.g. rectangular, circular, etc.). The frame 220 may be at least partially made of a titanium alloy. Providing a frame 220 for the modular elements 210 dramatically increases the stability of the housing 200 as a whole, and therefore of the modular device 100 as a whole. In addition, the frame 220 may serve as a working surface for mounting the modular elements 210 to the stack 211, thus facilitating the manufacture of the device 100 without the need to handle any complex components. Furthermore, titanium is biocompatible and therefore can be used for implantation in the subject's body without the risk of being rejected or causing inflammation or allergies. Additionally, titanium alloys are durable, durable, and lightweight without sacrificing strength.

[0031] According to the embodiment of FIG. 1, the housing comprises two strain relief modules 500 and two circuit modules 600, which are positioned ("sandwiched") between the two strain relief modules 500. Each strain relief module 500 comprises a cavity 520 surrounded by a frame 220, which is configured as a strain relief ring 510. Such a strain relief module 500 has the advantage of increasing the durability of the modular device 100, since it minimizes the risk of damage to the leads 300. To further increase the durability of the modular implant device 100, the cavity 520 enclosed within the frame 510 of the strain relief module 500 is backfilled with an insulating material, which may preferably be silicone.

[0032] The circuit module 600 comprises a circuit board 610 surrounded by a frame 220. The circuit board 610 is preferably soldered to the frame 220. According to a preferred embodiment, the circuit board 610 is a printed circuit board (PCB), which further comprises a ceramic material. Furthermore, the circuit board 610 comprises at least one feedthrough 620. Such a circuit, also referred to as hybrid ceramic, does not require any separate PCB or feedthrough, since all components are easily integrated in the circuit module. The PCB may include any electric circuit that may be configured to perform a logical operation on at least one input variable. Thus, the PCB may include one or more integrated circuits, microchips, microcontrollers, and microprocessors, which may be all or part of a central processing unit (CPU), a digital signal processor (DSP), a field programmable gate array (FPGA), or any other circuit that may be suitable for executing instructions or performing logical operations.

[0033] The electrical leads 300 shown in FIG. 1 include electrical contact tips 310 on one of their respective ends. The ends with the electrical contact tips 310 are disposed inside the housing 200, and more specifically, inside the cavity 520 of the strain relief module 500. Each electrical lead 300 is configured to electrically communicate a signal from a circuit or power source 800. As depicted in FIG. 1, the electrical leads 300 pass through lead outlets 230 disposed in at least one side 221 a, b, c, d of the strain relief ring 510 of the strain relief module 500. To allow for proper strain relief functionality, the width 222 of the side 221 a, b, c, d of the strain relief ring 510 having the lead outlets 230 is greater than the width of the side of the strain relief ring 510 without the lead outlets 230. Furthermore, the wider sides 221a,b,c,d of the strain relief ring 510 provide more space for the electrical leads 300 to pass through, leading to a higher strain relief factor. In addition, the electrical leads 300 can form a double bend 350 when passing through the lead outlet 230 of the strain relief ring 510. Such a double bend 350 prevents the leads 300 from losing contact with the respective circuit board 610 or being pulled out of the housing 200. Furthermore, the above concept allows maximum freedom of location and orientation of the electrical contacts 630 and the lead outlet 230. The strain relief ring 510 can be easily adapted for any lead outlet 230 location or orientation, giving the modular device 100 high flexibility for FES applications.

[0034] This may also be beneficial when at least one electrical contact 630 or at least one feedthrough 620 of each circuit module 600 is configured for electrical connection with an electrical contact tip 310 of at least one electrical lead 300 disposed in a cavity 520 of a strain relief module 500 stacked above or below the circuit module 600. In this manner, different modular elements 210 may be electrically connected to one another in a simplified manner, allowing for a highly modular and flexible approach to stacking modular elements 210. Thus, any combination of lead stimulation and / or localized surface stimulation is easily achieved with the modular implant device 100.

[0035] FIG. 2a depicts a schematic diagram of a single-sided modular implant device 100 according to another embodiment. FIG. 2b depicts a cross-sectional view of the same embodiment. For the modular device 100 described herein, it is possible to provide the device 100 with one stimulating housing side 240a, i.e., the stimulation signal can be generated only on one of the two housing sides 240a or 240b (single-sided). Furthermore, stimulation can be achieved through the use of at least one electrical lead 300, which is then configured as a stimulation lead 320. Each stimulation lead 320 is not disposed inside the housing 200 of the modular device 100, but instead comprises a tip electrode at one of its ends that is positioned in a desired location relative to the tissue to be stimulated. Stimulation of tissue using a stimulation lead (e.g., at a location further away from the housing) can also be referred to as lead stimulation. Stimulation via the stimulation lead 320 is also referred to as lead stimulation. Alternatively, or in addition, stimulation may be achieved through the use of at least one stimulation electrode 400. Stimulation via the stimulation electrode 400 is also referred to as localized surface stimulation.

[0036] The embodiment depicted in Figures 2a and 2b is single-sided, meaning that only one housing side 240a generates the stimulation signal. The embodiment shown in the figures uses lead stimulation, i.e., it comprises several stimulation leads 320 that stimulate at least one nerve or muscle of a subject within a location remote from the housing 200. The order of the stack 211 of modular elements 200 implemented in the embodiment shown in Figure 2b is as follows: circuit module 600 as the bottom side and strain relief module 500 as the top side.

[0037] The embodiment shown in Fig. 3a and Fig. 3b is configured to be a double-sided modular implant device 100, meaning that both its housing sides 240a and 240b are capable of generating stimulation signals. As depicted, the type of stimulation is lead stimulation, and the strain relief module 500 of each housing side 240a,b comprises two stimulation leads 320. In addition, the top housing side 240a comprises two additional electrical leads, which are power leads 340 configured to deliver power from an implanted coil 810 that receives power and potentially data (in a transcutaneous system) from a power supply 800. The order of the stack 211 of modular elements 200 implemented in the embodiment shown in Fig. 3b is as follows: a first strain relief module 500, a first circuit module 600 and a second circuit module 600' arranged in the middle of the stack 211, and then a second strain relief module 500'.

[0038] The embodiment shown in Fig. 4a and Fig. 4b is configured to be a double-sided modular device, meaning that both its housing sides 240a,b are capable of generating stimulation signals. However, in contrast to the embodiment depicted in Fig. 3a and Fig. 3b, the top housing side 240a comprises a stimulation electrode 400 attached to its outer surface. In this embodiment, the modular device 100 comprises a plurality of stimulation electrodes 400, which are arranged in an array 410. If the array 410 is densely filled with the stimulation electrodes 400 sufficiently, for example, it is suitable for use in scanning applications. The order of the stack 211 of modular elements 200 used in the embodiment shown in Fig. 4b is as follows: a strain relief module 500 as the bottom housing side, a first circuit module 600 in between, and a second circuit module 600' as the top housing side 240a, with the electrode array 410 being arranged on the outer surface of the second (top housing side 240a) circuit module 600'. The bottom housing side 240b of the modular device 100 of FIG. 4b is configured for lead stimulation.

[0039] FIG. 5a depicts a schematic diagram of a modular implant system 900 according to a first embodiment. Furthermore, FIG. 5b depicts a schematic diagram of a modular implant system 900 according to a second embodiment. The system 900 for electrical neurostimulation shown in FIG. 5a and FIG. 5b comprises a network of at least two modular implant devices 100, 100' configured for implantation inside a subject's body, each modular device being electrically connected to at least one other modular device through an electrical lead. Furthermore, according to the embodiment shown in FIG. 5b, the electrodes 400 can be of variable shapes and / or forms, for example, circular, semicircular, planar, in an array, etc.

[0040] The invention is not limited to one of the embodiments described herein, but can be modified in numerous other ways.

[0041] All features disclosed in the claims, the specification and the figures, and all advantages, including structural details, spatial arrangements and methodological steps, may be essential to the invention either by themselves or in various combinations with one another.

[0042] (List of reference numbers) [Table 1]

Claims

1. 1. A modular implant device (100) configured for stimulation of at least one nerve or muscle in a subject's body, the modular implant device (100) comprising: A housing (200); At least one electrical lead (300) and / or at least one stimulation electrode (400); Equipped with the at least one electrical lead (300) is partially attached to the housing (200), the housing (200) comprising a plurality of modular elements (210), the plurality of modular elements (210) being arranged in a stack (211); said stack (211) being characterised in that it comprises at least two modular elements (210) that are hermetically sealed and attached to one another; Each modular element (210) is characterized by comprising a frame (220), A modular implantation device (100), characterized in that at least one modular element (210) is a strain relief module (500), said strain relief module (500) having a cavity (520) surrounded by said frame (220), said frame (220) being configured as a strain relief ring (510).

2. 2. The modular implant device (100) of claim 1, wherein the frame (220) has four sides, each side (221a, b, c, d) having a width (222).

3. 3. The modular implantation device (100) according to claim 1 or 2, characterized in that the frame (220) is at least partially made from a material comprising titanium.

4. The modular implantation device (100) of claim 1, characterized in that the cavity (520) is backfilled with an insulating material.

5. The modular implant device (100) of claim 4, wherein the insulating material comprises silicone.

6. The modular implant device (100) according to any one of claims 1 to 5, characterized in that said at least one electrical lead (300) comprises an electrical contact tip (310) on at least one of its ends.

7. The modular embedded device (100) of claim 6, characterized in that the electrical contact tips (310) are arranged on the housing (200), and the electrical contact tips (310) are particularly arranged within the cavity (520) of the strain relief module (500).

8. The modular implant device (100) of any one of claims 1 to 7, characterized in that the at least one electrical lead (300) passes through a lead outlet (230) located within one of the sides (221 a, b, c, d) of the strain relief ring (510) of the strain relief module (500).

9. 9. The modular implantable device (100) of claim 8, wherein a width (222) of a side (221 a, b, c, d) of the strain relief ring (510) having a lead outlet (230) is greater than a width (222) of a side (221 a, b, c, d) of the frame (220) not having a lead outlet (230).

10. 10. The modular implant device (100) of claim 8 or claim 9, wherein the at least one electrical lead (300) forms a double bend (350) as it passes through the lead outlet (230) of the strain relief ring (510).

11. The modular implant device (100) of any one of claims 1 to 10, characterized in that at least one of the at least one electrical lead (300) is a stimulation lead (320) configured for electrical stimulation of the target nerve, or a power lead (330) configured to deliver power from a power supply source (800) and / or to deliver power and data from an antenna coil (810), or a connection lead (340) configured to electrically connect the modular implant device (100) to another electrical device.

12. The modular implantable device (100) according to any one of claims 1 to 11, characterized in that the at least one stimulation electrode (400) is arranged on an outer surface of a housing surface (240a, b) of the modular implantable device (100).

13. The modular implant device (100) according to any one of the preceding claims, characterized in that said modular implant device (100) comprises a plurality of stimulation electrodes (400).

14. 14. The modular implant device (100) of claim 13, wherein the plurality of stimulation electrodes (400) are arranged in an array (410).

15. The modular embedded device (100) of any one of claims 6 to 14, characterized in that at least one modular element (210) is a circuit module (600), said circuit module (600) comprising a circuit board (610) surrounded by said frame (220).

16. 16. The modular embedded device (100) of claim 15, wherein the circuit board (610) is brazed to the frame (220).

17. 17. The modular embedded device (100) of claim 15 or claim 16, wherein the circuit board (610) is a printed circuit board, the circuit board (610) comprising a ceramic material.

18. The modular embedded device (100) according to any one of claims 15 to 17, characterized in that the circuit board (610) comprises at least one electrical contact (630) and / or at least one feed-through (620).

19. The method of claim 1, wherein at least one modular element is a circuit module, the circuit module comprising a circuit board surrounded by the frame; The circuit board (610) is characterized by having at least one electrical contact (630) and / or at least one feedthrough (620); 7. The modular implant device (100) of claim 6, wherein the at least one feedthrough (620) of the circuit board (610) is configured for electrical connection with the electrical contact tip (310) of the at least one electrical lead (300) disposed within the cavity of the strain relief module (500) stacked directly above or below the circuit module (600).

20. A system (900) for electrical neurostimulation, the system (900) comprising a network of at least two modular implant devices (100) configured for implantation inside a subject's body according to any one of claims 1 to 19, each modular implant device (100) being electrically connected to at least one other modular implant device (100) through an electrical lead (300).

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