CN112473005A

CN112473005A - Implanted nerve stimulator

Info

Publication number: CN112473005A
Application number: CN202011286870.1A
Authority: CN
Inventors: 张龙飞; 夏天; 李青峰; 陈浩
Original assignee: Beijing Pins Medical Co Ltd
Current assignee: Beijing Pins Medical Co Ltd
Priority date: 2020-11-17
Filing date: 2020-11-17
Publication date: 2021-03-12
Also published as: WO2022105037A1

Abstract

The present invention provides an implantable neurostimulator, comprising: a rechargeable battery for supplying electric energy; the stimulation output module is used for outputting stimulation signals; an auxiliary function module for providing auxiliary functions related to therapy; the acquisition module is used for acquiring the electric quantity data of the rechargeable battery; and the processor is used for controlling the working states of the stimulation output module and the auxiliary function module according to the electric quantity data so as to adjust the energy consumption of the stimulator.

Description

Implanted nerve stimulator

Technical Field

The invention relates to the field of implantable medical devices, in particular to an implantable nerve stimulator.

Background

An Implantable Medical Device (IMD) is a Medical Device installed inside the body of a user, and the Device has a rechargeable battery inside, and can implement corresponding therapy depending on the set program and operation parameters.

Current implantable medical devices, particularly stimulators, are being developed in the direction of miniaturization, multifunction, etc., the miniaturization results in smaller and smaller battery volume and capacity, while the multifunction results in no reduction in the functional and performance requirements of the product itself, which all affect the standby time and use experience of the stimulator and fail to meet the medical device regulations and production inventory time requirements.

Disclosure of Invention

In view of the above, the present invention provides an implantable neurostimulator, comprising:

a rechargeable battery for supplying electric energy;

the stimulation output module is used for outputting stimulation signals;

an auxiliary function module for providing auxiliary functions related to therapy;

the acquisition module is used for acquiring the electric quantity data of the rechargeable battery;

and the processor is used for controlling the working states of the stimulation output module and the auxiliary function module according to the electric quantity data so as to adjust the energy consumption of the stimulator.

Optionally, the auxiliary function module includes at least one module of a wireless communication module, an attitude detection module, and a physiological signal acquisition module; the processor determines the working gear of the stimulator according to the set interval where the electric quantity data is located, and the stimulation output module and the auxiliary function module are turned on or turned off in different gears.

Optionally, when the electric quantity data is in a first interval, the processor turns on the stimulation output module and all the auxiliary function modules.

Optionally, when the electric quantity data is in a second interval, the processor turns on the stimulation output module and turns off part of the auxiliary function module, and the second interval is lower than the first interval.

Optionally, the closed auxiliary function module is a physiological signal acquisition module.

Optionally, when the electric quantity data is in a third interval, the processor turns off the stimulation output module and a part of the auxiliary function modules, and only keeps turning on the wireless communication module, where the third interval is lower than the second interval.

Optionally, when the electric quantity data is in a fourth interval, the processor turns off the stimulation output module and all the auxiliary function modules, and the fourth interval is lower than the third interval.

Optionally, the processor is further configured to receive and execute a forced switching instruction for switching to a less energy consuming operating range.

Optionally, the processor is further configured to receive an external wake-up instruction, where the external wake-up instruction is used to switch to a working range with higher energy consumption; and the processor judges whether to execute the external awakening instruction according to the electric quantity data.

Optionally, the processor receives the external wake-up instruction by any one of: receiving the external awakening instruction by detecting the charging state of the rechargeable battery, receiving the external awakening instruction by a wireless communication module, and receiving the external awakening instruction by an electromagnetic switch;

the processor receives the forced switching instruction by any one of: and receiving the forced switching instruction through a wireless communication module and receiving the forced switching instruction through an electromagnetic switch.

According to the implantable neural stimulator, the acquisition module acquires the electric quantity information of the rechargeable battery, so that the processor determines the residual electric quantity, the working states of the stimulation output module and the auxiliary function module of the stimulator are automatically adjusted according to the electric quantity, the dynamic load adjustment is realized, the working time of the miniaturized and multifunctional stimulator is prolonged as far as possible, and the use experience of a user is improved.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is an implantable neurostimulator provided herein;

fig. 2 is a preferred implantable neural stimulator provided by the present invention.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

Embodiments of the present invention provide an implantable neural stimulator, which may specifically be a DBS (deep brain stimulation) stimulator, a VNS (vagus nerve stimulation) stimulator, an SCS (Spinal cord stimulation) stimulator, an SNM (Sacral nerve stimulation) stimulator, and the like. As shown in fig. 1, the stimulator includes a rechargeable battery 1, a stimulation output module 2, an auxiliary function module 3, an acquisition module 4, and a processor 5.

The rechargeable battery 1 is used for providing electric energy, a charging coil, a charging circuit and the like are further arranged in the stimulator, and a user can use the external control equipment to charge the rechargeable battery 1 in a wireless charging mode.

The stimulation output module 2 is used for outputting stimulation signals. The module specifically comprises a pulse control circuit and a plurality of output electrodes, and stimulation signals are output based on parameters such as preset frequency, amplitude and pulse width to realize corresponding therapy.

The auxiliary function module 3 is used to provide auxiliary functions related to therapy. The auxiliary function module 3 may be a hardware module and/or a software module. The optional auxiliary function modules are various, such as a wireless communication module, a posture detection module, a physiological signal acquisition module and the like. The wireless communication module may be a short-distance communication module based on a pulse signal, a medium-distance communication module based on bluetooth or WiFi, or a long-distance communication module based on a 4G or 5G mobile network, and is configured to send data such as stimulator parameters and human physiological parameters to the extracorporeal control apparatus, and also receive a setting instruction of the extracorporeal control apparatus to the stimulator. The posture detection module is used for detecting the posture of the stimulator relative to the ground or a human body, and is used for avoiding the implantation position error of the stimulator, detecting whether the posture of a patient changes or not and the like. The physiological signal acquisition module is used for acquiring information of the heart rate, the blood oxygen saturation, the body temperature, the respiration, the blood pressure and the like of a human body and knowing the physical state of a patient.

The information collected by the posture detection module and the physiological signal collection module can be stored in the stimulator, and the collected information can be sent to the in-vitro control equipment in real time or in response to an external instruction. The stimulator may have only one kind of auxiliary functional module 3, such as a wireless communication module. Some products may also include more auxiliary function modules, not limited to the above three modules.

The acquisition module 4 is used for acquiring the electric quantity data of the rechargeable battery 1.

The processor 5 is used for controlling the working states of the stimulation output module and the auxiliary function module according to the electric quantity data so as to adjust the energy consumption of the stimulator. Specifically, when the remaining capacity is high, the processor 5 may maintain the functions of the stimulus output module 2 and all the auxiliary function modules 3; along with the reduction of the residual electric quantity, the processor can automatically close part or all of the auxiliary function modules 3 and can also close the stimulation output module 2 in due time; when the user charges the stimulator, the processor 5 turns these modules on again as the remaining charge increases. The processor 5 automatically adjusts the whole load of the stimulator according to the residual capacity, and prolongs the working time under the condition of ensuring the stimulator to execute the treatment operation as far as possible.

According to the implantable neural stimulator provided by the embodiment of the invention, the acquisition module acquires the electric quantity information of the rechargeable battery, so that the processor determines the residual electric quantity, and further, the working states of the stimulation output module and the auxiliary function module of the stimulator are automatically adjusted according to the electric quantity, the dynamic load adjustment is realized, the working time of the miniaturized and multifunctional stimulator is prolonged as much as possible, and the use experience of a user is improved.

Referring to fig. 2, a preferred embodiment will be described, and the implantable neurostimulator shown in fig. 2 comprises a plurality of auxiliary functional modules 3, namely a wireless communication module 31, a posture detection module 32 and a physiological signal acquisition module 33. In this embodiment, four electric quantity intervals are preset, corresponding to four working gears, and the modules started at different working gears are different, as shown in the following table:

gear position	Interval of electric quantity	Stimulation output	Wireless communication	Attitude detection	Physiological signal acquisition
						4	100％～50％	√	√	√	√
3	50％～20％	√	√	√	×
						2	20％～2％	×	√	×	×
1	2％～0	×	×	×	×

When the electric quantity data is in the first interval, which is 100% -50% in this embodiment, the processor 5 starts the stimulation output module 2 and all the auxiliary function modules, and the stimulator is in the full load state of the gear 4, providing all the functions.

When the electric quantity data is in the second interval, which is 50% to 20% in the present embodiment, the processor 5 turns on the stimulation output module 2 and turns off part of the auxiliary function modules. In this embodiment, the physiological signal acquisition module is turned off, the stimulator is in the half-load state of the gear 3, and the acquisition of the physiological signal of the human body is stopped, so as to reduce the load. In an alternative embodiment, other or more auxiliary function modules, such as the gesture detection module, may also be turned off when the stimulator is in gear 3.

When the electric quantity data is in the third interval, which is 20% to 2% in the present embodiment, the processor 5 turns off the stimulation output module and part of the auxiliary function module. In this embodiment, only the wireless communication module is reserved, the stimulator is in the wireless communication state of the gear 2, the output of the stimulation signal is stopped, the provision of various auxiliary functions is stopped, and only the wireless communication module is reserved to receive the instruction sent by the external device, so that the load is further reduced.

When the electric quantity data is in the fourth interval, which is 2% -0 in this embodiment, the processor turns off the stimulation output module and all the auxiliary function modules, and the stimulator is in the deep sleep state of the gear 1, at this time, the stimulator can only be charged without providing any function, and only the processor 5 is in the working state.

In practical application, the processor 5 automatically switches the four gears to dynamically adjust the load of the stimulator as the working electric quantity of the stimulator decreases and the electric quantity increases as the user wirelessly charges the stimulator. According to the preferred scheme, the processor adjusts the working state of the stimulator according to the preset four working gears, and keeps outputting stimulation signals when the electric quantity is high, so that the treatment effect is maintained; when the electric quantity is reduced, the auxiliary function module which has small influence on the treatment of the patient is preferentially closed, and the stimulation output module is closed when the electric quantity is too low, so that the working time of the stimulator is further prolonged.

On this basis, in order to enable the user to actively adjust the loading condition of the stimulator, the processor 5 may further receive a forced switching instruction and an external wake-up instruction in this embodiment. The stimulator is provided with a wireless communication module, an electromagnetic switch and a charging coil, and all the components can be used for receiving instructions.

In particular, the forced switching command is used to switch to an operating range that is less energy consuming. Taking the above table as an example, assuming that the current stimulator is in the gear 4, the user may use the extracorporeal control device to issue a forced switching instruction and may set that it is expected to switch to the working

gear

3, 2, or 1, and the processor 5 directly performs the gear switching after receiving the instruction through the wireless communication module; the user can also use the external control equipment to control the action combination of the electromagnetic switch of the stimulator, and the processor 5 switches the working gear according to different action combinations of the electromagnetic switch. Specifically, one switching edge is generated when the electromagnetic switch is closed once, an interval between two switching edges is set to be less than a preset time length (for example, 5s) and recorded as an effective action, one or more continuous effective actions represent a forced switching instruction, for example, 3 continuous effective actions represent switching to the

operating range

3, 2 continuous effective inputs represent switching to the operating range 2, and so on. The operation that the user actively reduces the load of the stimulator can be realized through the two modes.

The external wake-up command is used for switching to a working gear which consumes more energy. For example, a user first switches the stimulator from the gear 3 to the gear 2 through a forced switching instruction, and then can send an external awakening instruction by using the external control equipment to request the stimulator to lift the working gear; the user can also use the external control equipment to control the action combination of the electromagnetic switch of the stimulator to express the requirement of gear lifting, and one or continuous multiple effective actions are expressed as an external awakening instruction similarly to the forced switching instruction; the user can also wirelessly charge the stimulator by using the in-vitro control device, receive an external awakening instruction according to the wireless charging state, and specifically determine whether the external awakening instruction is received by detecting the state indicating mark of the charging chip.

For the external wake-up command, the processor 5 needs to determine whether to perform the action of raising the gear according to the electric quantity data. For example, if the current operating range is 2 and the remaining power is 50% -20%, if an external wake-up instruction sent by the extracorporeal control device indicates to be lifted to range 4, the processor 5 determines that the current remaining power is not enough to provide the function of range 4, and does not execute the instruction, or only lifts to range 3; if the external wake-up instruction indicates a lift to gear 3, the processor 5 determines that the current remaining charge can provide the function of gear 3 and executes this instruction. I.e. the processor 5 determines the execution of the external wake-up command according to the highest operating range that the stimulator can currently reach.

According to the preferable scheme, a user can manually reduce the working gear by a forced switching instruction according to the actual use environment, such as inconvenient charging, and actively prolong the working time of the stimulator; and the working state of the stimulator can be restored by manually lifting the working gear through an external awakening instruction according to actual needs.

As will be appreciated by one skilled in the art, embodiments of the present invention may be provided as a method, system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, CD-ROM, optical storage, and the like) having computer-usable program code embodied therein.

The present invention is described with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each flow and/or block of the flow diagrams and/or block diagrams, and combinations of flows and/or blocks in the flow diagrams and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.

These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart flow or flows and/or block diagram block or blocks.

These computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.

Claims

1. An implantable neural stimulator, comprising:

a rechargeable battery for supplying electric energy;

the stimulation output module is used for outputting stimulation signals;

2. The stimulator of claim 1, wherein the auxiliary function module comprises at least one of a wireless communication module, a posture detection module, a physiological signal acquisition module; the processor determines the working gear of the stimulator according to the set interval where the electric quantity data is located, and the stimulation output module and the auxiliary function module are turned on or turned off in different gears.

3. The stimulator of claim 2, wherein the processor turns on the stimulation output module and all of the auxiliary function modules when the electrical data is in a first interval.

4. The stimulator of claim 3, wherein the processor turns on the stimulation output module and turns off a portion of the auxiliary function module when the electrical data is in a second interval, the second interval being lower than the first interval.

5. A stimulator according to claim 4, wherein the auxiliary function module that is turned off is a physiological signal collection module.

6. The stimulator of claim 4, wherein the processor turns off the stimulation output module and a portion of the auxiliary function module and only keeps turning on the wireless communication module when the power data is in a third interval, wherein the third interval is lower than the second interval.

7. The stimulator of claim 6, wherein the processor turns off the stimulation output module and all of the auxiliary function modules when the electrical data is in a fourth interval, the fourth interval being lower than the third interval.

8. The stimulator of any one of claims 2-7, wherein the processor is further configured to receive and execute a forced switching instruction for switching to a less energy consuming operating range.

9. The stimulator of claim 8, wherein the processor is further configured to receive an external wake-up command, the external wake-up command configured to switch to a more energy consuming operating range; and the processor judges whether to execute the external awakening instruction according to the electric quantity data.

10. The stimulator of claim 9, wherein the processor receives the external wake-up instruction by either: receiving the external awakening instruction by detecting the charging state of the rechargeable battery, receiving the external awakening instruction by a wireless communication module, and receiving the external awakening instruction by an electromagnetic switch;