CN117959598A - Nerve stimulation implantation device, nerve stimulation apparatus, and nerve stimulation method - Google Patents

Abstract

The present application relates to a nerve stimulation implantation device, a nerve stimulation apparatus, and a nerve stimulation method. The nerve stimulation implantation device comprises an implantation type pulse generator, wherein the implantation type pulse generator is used for receiving an external control signal and acquiring sleeping posture information and breathing information of a human body from the inside of the body so as to respond to the external control signal and the sleeping posture information and the breathing information to generate an internal stimulation control signal. The nerve stimulation implantation device can realize stimulation closed loop, and improves the treatment effect.

Description

Nerve stimulation implantation device, nerve stimulation apparatus, and nerve stimulation method

Technical Field

The application relates to the technical field of medical equipment, in particular to a nerve stimulation implantation device, nerve stimulation equipment and a nerve stimulation method.

Background

With the development of technology, the technology of stimulating peripheral nerves is increasingly applied to the treatment of neuropathic pain, for example, peripheral nerve stimulation (PNS for short) is applied to the treatment of migraine and bladder overactive.

In the related art, the nerve stimulating device includes an Implantable Pulse Generator (IPG), an electrode assembly, and an electrode lead between the implantable pulse generator and the electrode assembly, and the IPG, the electrode assembly, and the electrode lead are implanted into a patient during use. The IPG utilizes the electrode lead to realize the transmission of control signals to the electrode assembly so that the electrode assembly stimulates the nerve contacted with the electrode assembly, thereby achieving the aim of treatment

However, the IPG of the related art does not have a function of stimulating a closed loop, and thus the stimulation effect is poor. If the stimulation closed loop is needed, an additional sensor is needed to acquire the data needed by the stimulation closed loop, but the additional sensor needs to further increase the operation wound to cause adverse reaction.

Disclosure of Invention

In view of the above, it is desirable to provide a nerve stimulation implant device, a nerve stimulation apparatus, and a nerve stimulation method that can reduce a wound and enhance a stimulation effect.

A neural stimulation implant device, comprising: an implantable pulse generator; the implantable pulse generator is used for receiving the external control signal and acquiring sleeping posture information and breathing information of a human body from the human body so as to generate an internal stimulation control signal in response to the external control signal and the sleeping posture information and the breathing information.

According to the nerve stimulation implantation device, the implanted pulse generator can acquire sleeping posture information and breathing information of a human body from the body, and the implanted pulse generator can acquire the sleeping posture information and the breathing information of the human body from the body, so that the problem of increased wounds caused by the fact that a sensor is additionally added for realizing stimulation closed loop is solved. And the implantable pulse generator receives the external control signal, can realize the operation of the implantable pulse generator according to the external control signal so as to realize the generation of the stimulation signal of the nerve stimulation, and can also realize the adjustment of the internal stimulation signal according to the sleeping posture information and the breathing information acquired from the body so as to obtain the internal stimulation control signal, so that the stimulation signal for the nerve stimulation is attached to the sleeping posture information and the breathing information of the human body, the accuracy of stimulation is improved, the stimulation meets the actual requirement, and the stimulation effect is improved.

In one embodiment, the method further comprises: the implantable pulse generator comprises a shell, and an accelerometer and a gyroscope which are integrated in the shell; the accelerometer is used for acquiring breathing information; the gyroscope is used for acquiring sleeping posture information. In the above embodiment, the accelerometer and the gyroscope are integrated in the casing of the implantable pulse generator, so that the implantable pulse generator has the functions of acquiring the respiratory information and the sleeping posture information, and a sensor for detecting the respiratory information and the sleeping posture information is not required to be additionally arranged, so that the wound can be effectively reduced.

In one embodiment, an implantable pulse generator comprises: a housing; an electrode lead of the cardioverter defibrillator is positioned outside the shell and connected with the shell to form a measuring loop; wherein the implantable pulse generator obtains sleep posture information and respiratory information based on the measurement loop.

In one embodiment, a cardioverter-defibrillator electrode lead is interposed and left in the odd vein. In the above embodiment, one end of the electrode lead of the cardioverter defibrillator is connected to the implantable pulse generator shell, and the other end is inserted into and kept in the vein, so that the small wound can be punctured on the blood vessel, the wound is effectively reduced, and the sleeping posture information and the respiratory information are acquired by the electrode lead of the cardioverter defibrillator, so that the stimulation closed loop is realized, and the treatment effect is improved.

In one embodiment, the implantable pulse generator is further configured to: generating an on signal, an off signal and a stimulation intensity signal of the implantable pulse generator in response to the in vitro control signal; in response to the respiratory information, determining a respiratory cycle of the human body to generate an in-vivo stimulation start signal at an end of expiration of the respiratory cycle and an in-vivo stimulation end signal at an end of inspiration of the respiratory cycle; generating an in vivo stimulation parameter adjustment signal in response to the sleep posture information; wherein the in vivo stimulation control signal comprises: an on signal, an off signal, a stimulation intensity signal, an in vivo stimulation start signal, an in vivo stimulation end signal, and an in vivo stimulation parameter adjustment signal.

In one embodiment, the stimulation electrode is connected to an implantable pulse generator for implantation into a nerve to be stimulated of a human body to apply an in vivo stimulation signal to the nerve to be stimulated in response to an in vivo stimulation control signal.

A nerve stimulation device, comprising: the neural stimulation implant device of any of the above embodiments, and a neural stimulation in vitro control device, wherein the neural stimulation in vitro control device is configured to send an in vitro control signal to an implanted pulse generator of the neural stimulation implant device.

In one embodiment, a method of neural stimulation is provided, comprising:

the implantable pulse generator receives the external control signal and acquires sleeping posture information and breathing information of a human body;

The implantable pulse generator generates an in-vivo stimulation control signal in response to the in-vitro control signal and the sleep posture information and the breathing information, so as to control the stimulation electrode to apply the in-vivo stimulation signal to the nerve to be stimulated according to the in-vivo stimulation control signal.

In one embodiment, the implantable pulse generator generates an in vivo stimulation control signal in response to the in vitro control signal and the sleep posture information, the respiration information, comprising: generating an on signal, an off signal and a stimulation intensity signal of the implantable pulse generator in response to the in vitro control signal; in response to the respiratory information, determining a respiratory cycle of the human body to generate an in-vivo stimulation start signal at an end of expiration of the respiratory cycle and an in-vivo stimulation end signal at an end of inspiration of the respiratory cycle; generating an in vivo stimulation parameter adjustment signal in response to the sleep posture information; wherein the in vivo stimulation control signal comprises: an on signal, an off signal, a stimulation intensity signal, an in vivo stimulation start signal, an in vivo stimulation end signal, and an in vivo stimulation parameter adjustment signal.

In one embodiment, an implantable pulse generator acquires sleep posture information and respiration information of a human body, comprising: the implantable pulse generator acquires sleeping posture information and breathing information through an acceleration sensor integrated in the shell; or the implantable pulse generator acquires sleeping posture information and breathing information through a bioimpedance sensor which is positioned outside the shell and connected with the shell.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments or the conventional techniques of the present application, the drawings required for the descriptions of the embodiments or the conventional techniques will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to the drawings without inventive effort for those skilled in the art.

FIG. 1 is a schematic diagram of a neural stimulation device in one embodiment;

FIG. 2 is a schematic diagram of a neural stimulation device in another embodiment;

FIG. 3 is a schematic diagram of a neural stimulation device in yet another embodiment;

FIG. 4 is a schematic diagram of an implantable pulse generator according to one embodiment;

FIG. 5 is a schematic view of an embodiment of an implantable electrode assembly;

FIG. 6 is a schematic view showing the structure of an implantable electrode assembly according to another embodiment;

Fig. 7 is a flow chart of a neural stimulation method in one embodiment.

Detailed Description

In order that the application may be readily understood, a more complete description of the application will be rendered by reference to the appended drawings. Embodiments of the application are illustrated in the accompanying drawings. This application may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

It will be understood that the terms first, second, etc. as used herein may be used to describe various elements, but these elements are not limited by these terms. These terms are only used to distinguish one element from another element.

Spatially relative terms, such as "under", "below", "beneath", "under", "above", "over" and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use and operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements or features described as "under" or "beneath" other elements would then be oriented "on" the other elements or features. Thus, the exemplary terms "below" and "under" may include both an upper and a lower orientation. Furthermore, the device may also include an additional orientation (e.g., rotated 90 degrees or other orientations) and the spatial descriptors used herein interpreted accordingly.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or be connected to the other element through intervening elements. Further, "connection" in the following embodiments should be understood as "electrical connection", "communication connection", and the like if there is transmission of electrical signals or data between objects to be connected.

As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," and/or the like, specify the presence of stated features, integers, steps, operations, elements, components, or groups thereof, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, or groups thereof. Also, the term "and/or" as used in this specification includes any and all combinations of the associated listed items.

In one embodiment, as shown in fig. 1, a nerve stimulation apparatus 100 is provided that includes a nerve stimulation implant device and a nerve stimulation in vitro control device 102.

Optionally, the neural stimulation implant device comprises: an implantable pulse generator 104.

The implantable pulse generator 104 is configured to receive the external control signal and obtain sleep posture information and respiration information of the human body from the human body, so as to generate an internal stimulation control signal in response to the external control signal and the sleep posture information and respiration information.

Alternatively, the neurostimulation implant device may include an implantable electrode assembly 106. In one embodiment, the implantable pulse generator 104 may be electrically connected to the implantable electrode assembly 106, and the implantable electrode assembly 106 is in contact with the nerve to be stimulated. The implantable pulse generator 104 transmits an in-vivo stimulation control signal to the implantable electrode assembly 106 through the connection path, and the implantable electrode assembly 106 stimulates a nerve to be stimulated, such as a hypoglossal nerve, in contact with the implantable electrode assembly 106 according to the received in-vivo stimulation control signal.

In one embodiment, the implantable pulse generator 104 may be electrically connected to the neural stimulation external control device 102, and the external control signal is initiated by the neural stimulation external control device 102 and transmitted to the implantable pulse generator 104.

Alternatively, the extracorporeal control signal may include, but is not limited to, an on command, an off command, a stimulation intensity command, and the like.

The on command is used for indicating the implantable pulse generator to start working, and the implantable pulse generator is converted into an on signal after receiving the on command, so that the implantable pulse generator can start working according to the on signal, for example, the implantable pulse generator can be awakened from a dormant state, and a sensing device included in the implantable pulse generator works to detect biological parameters of a human body, for example, sleeping posture information and/or breathing information of the human body. The turn-off instruction is used for indicating the implantable pulse generator to turn off, and the implantable pulse generator converts the turn-off instruction into a turn-off signal after receiving the turn-off instruction, so that the implantable pulse generator can realize the turn-off according to the turn-off signal, for example, the implantable pulse generator is in a dormant state. Alternatively, the on command and/or the off command may be manually controlled, for example, the user may initiate an on signal with the neurostimulation external control device 102 when sleep is desired, and may initiate an off signal with the neurostimulation external control device 102 when sleep is completed. In an alternative embodiment, the on command and/or the off command may also be generated according to detected data, for example, the on command is initiated when the neurostimulation external control device 102 receives a signal that the user is in a sleep state, the off command is initiated when the neurostimulation external control device 102 receives a signal that the user is awake from the sleep state, and detection that the specific user is in a sleep state and that the user is awake from a sleep state may be implemented by the neurostimulation external control device 102, or may be detected by the implantable pulse generator 104, or may be detected by a third party device, such as a smart watch, for example.

The stimulation intensity instruction is used for indicating initial stimulation parameters, and the stimulation parameters are used for representing parameters for realizing nerve stimulation. In one embodiment, the stimulation parameters include a stimulation parameter name and a stimulation parameter value corresponding to the stimulation parameter name, e.g., the stimulation parameter name is a stimulation pulse frequency and the corresponding pulse frequency value is 10Hz.

In one embodiment, implantable pulse generator 104, upon receiving the stimulation intensity command, reads the initial parameters carried in the stimulation intensity command to determine initial stimulation parameters, optionally including, but not limited to, pulse frequency values, pulse width values, and corresponding pulse width fingers, voltages, and corresponding voltage values, etc. for which the pulse frequency is expected. Optionally, the stimulation intensity instructions may include a plurality of levels, e.g., low, medium, and high, the different levels of stimulation intensity instructions indicating different initial signal parameter values, e.g., the low level stimulation intensity instructions including a first pulse frequency value, a first pulse width value, a first voltage value, the medium level stimulation intensity instructions including a second pulse frequency value, a second pulse width value, a second voltage value, the high level stimulation intensity instructions including a third pulse frequency value, a third pulse width value, a third voltage value, wherein the first pulse frequency value < the second pulse frequency value < the third pulse frequency value, the first pulse width value < the second pulse width value < the third pulse width value, the first voltage value < the second voltage value < the third voltage value.

In an alternative embodiment, controls may be provided on the neurostimulation extracorporeal control apparatus 102 such that the user effects initiation of the on command, the off command, and the intensity stimulation command via the controls. Optionally, three different controls may be set on the neurostimulation extracorporeal control apparatus 102 for the on command, the off command, and the intensity stimulation command, respectively, so that the user may operate the different controls to implement different functions as required. In one embodiment, only one control may be set, and different functions may be distinguished by controlling different actions of the control, for example, the control is a button, the first time of pressing is to initiate an opening instruction, the second time of pressing is to initiate a closing instruction, the first time of pressing is to initiate a low-level stimulation intensity instruction, the second time of pressing is to initiate a medium-level stimulation intensity instruction, and the third time of pressing is to initiate a high-level stimulation intensity instruction.

It will be appreciated that, after receiving the external control signal sent by the external nerve stimulation control device 102, the implantable pulse generator 104 may convert the external control signal to obtain an internal control signal, for example, when the external control signal is an on command, the implantable pulse generator 104 converts the on command to an on signal, when the external control signal is an off command, the implantable pulse generator 104 converts the off command to an off signal, and when the external control signal is a stimulation intensity command, the implantable pulse generator 104 converts the stimulation intensity command to a stimulation intensity signal.

In an alternative embodiment, a medical stimulator and medical regulator may also be included, which may be operated by a physician to configure or control the operation of the implantable pulse generator, and in particular, during a physician's surgery on a patient to place the implantable pulse generator 104 within the patient, the medical stimulator may temporarily replace the neural stimulation extracorporeal control apparatus 102 to electromagnetically couple with the implantable pulse generator 104 and provide stimulation energy to the device. In this way, the physician can know whether the placement position of the implantable pulse generator 104 and the contact between the implantable electrode assembly and the peripheral nerve are effective during the surgical procedure, and can adjust the position of the implantable pulse generator 104 in the body in time, thereby achieving the optimal implantation effect. The medical regulator and the medical stimulator may communicate in a wireless or wired manner to enable control of the medical stimulator, such as configuring the maximum voltage amplitude, pulse width, pulse frequency, etc. of the stimulation signal applied during surgery or at periodic follow-up of the patient. In some embodiments, the application of the regulator and medical stimulator may be used for periodic follow-up of the patient, typically 1 week, 2 weeks, 4 weeks, etc. after the implantation procedure, a process also referred to as "titration". During the follow-up procedure, the physician may again perform one or more titrations. In each titration process, the medical regulator can automatically analyze historical data related to a patient, establish a lookup table of linear relations among nerve interface impedance, stimulation threshold voltage and stimulation parameters, and obtain parameters of stimulation signals to be regulated by querying the lookup table after calculating new nerve interface impedance, wherein the parameters can be configured in a stimulation energy generator for daily treatment of the patient. It will be appreciated that the medical regulator may be used with a medical stimulator (which is typically a desktop device rather than a wearable device), but it may also be used with a stimulation energy generator, for example in a similar manner as the neurostimulation extracorporeal control apparatus 102.

The sleeping gesture information is used for representing the current sleeping gesture of the user. Optionally, the sleeping posture information includes, but is not limited to, supine, side-to-side, prone, recumbent, turn-over, etc.

The respiration information is used to characterize the current respiration of the user, including but not limited to expiration, inspiration, respiratory rhythm, and the like.

In one embodiment, the sensing device is configured to enable acquisition of user sleep posture information and respiration information.

Alternatively, as shown in FIG. 2, the sensing device may include an accelerometer 108 and a gyroscope 110.

Wherein accelerometer 108 is used to obtain respiration information. It can be understood that respiratory motion of a person is caused by contraction and relaxation of respiratory muscles, comprising two processes of inspiration and expiration, when in inspiration, diaphragm and intercostal muscles contract, causing the anterior-posterior, left-right and up-down diameters of a chest to be increased, and lungs are enlarged, so that the air pressure in the lungs is lower than the external atmospheric pressure, and external air enters the lungs to form active inspiration motion; during exhalation, when diaphragm and intercostal external muscles are relaxed, ribs and sternum return due to gravity and elasticity, so that the chest is reduced, and the lung is retracted, so that the air pressure in the lung is greater than the external air pressure, and the air in the lung is discharged out of the lung to form passive exhalation movement. Therefore, the expansion of the thorax leads to inspiration and the reduction of the thorax leads to expiration, while the acceleration sensor obtains data of the breathing rhythm by detecting the fluctuation of the thorax. Optionally, a three-axis accelerometer can be selected to realize respiration information of the human body in a sleep state, the three-axis accelerometer detects the change, direction and variation of acceleration on three spatial coordinate axes of X, Y and Z, and the respiration information can be determined according to the change, direction and variation of acceleration on the three spatial coordinate axes of X, Y and Z. In an alternative embodiment, an accelerometer can be fixed on the upper chest, the accelerometer can sense and record the fluctuation of the chest before and after, left and right and up and down during respiration, then the stage of respiration is judged to be an expiration stage or an inspiration stage through a preset algorithm, and then the implantable pulse generator generates an in-vivo stimulation control signal according to the respiration information so as to stimulate peripheral nerves to form a stimulation closed loop.

In one embodiment, the implantable pulse generator 104 receives the data information communicated by the accelerometer 108, determines respiratory information, and in response to the respiratory information, determines a respiratory cycle of the human body, and may adjust the in-vivo stimulation signal based on the respiratory cycle. For example, an in-vivo stimulation initiation signal is generated at the end of expiration of the respiratory cycle, an in-vivo stimulation end signal is generated at the end of inspiration of the respiratory cycle, and control of the implantable electrode assembly is achieved in accordance with the in-vivo stimulation initiation signal and the in-vivo stimulation end signal.

Optionally, the gyroscope 110 may be used to obtain sleep position information, and whether the human body turns over or not may be determined according to the data detected by the gyroscope 110, or the sleep position information of the human body may be determined according to the data detected by the gyroscope 110, so that the implantable pulse generator 104 may adjust the in-vivo stimulation parameter according to the sleep position information of the human body, for example, based on the initial parameter, according to the sleep position information. For example, if a person is lying on his side with the tongue not collapsing to the airway as severely as on his back, the stimulation amplitude may be reduced adaptively while the person is lying on his side.

In one embodiment, as shown in FIG. 2, the implantable pulse generator 104 includes a housing, and the sensing device is integrated into the housing of the implantable pulse generator 104 such that the sensing device forms a unitary structure with the implantable pulse generator 104. The sensing device and the implantable pulse generator 104 form an integral structure, so that the implantable pulse generator 104 has the function of detecting sleeping posture information and breathing information, the treatment effect is effectively improved, and the defect that the existing implantable pulse generator 104 cannot form closed loop stimulation due to the fact that the existing implantable pulse generator 104 does not have sleeping posture and breathing sensing is overcome. In addition, the existing related implantable pulse generator does not have the function of detecting sleeping posture information and breathing information, so that if the sleeping posture information and the breathing information are to be detected, a sensor for detecting the sleeping posture information and the breathing information is required to be additionally arranged, a wound provided with the sensor for detecting the sleeping posture information and the breathing information is required to be additionally arranged on a human body, and a buried wire wound in communication connection between the sensor and the implantable pulse generator is required, namely if the existing implantable pulse generator without integrating the sensor is required to realize stimulation closed loop according to the sleeping posture information and the breathing information, the wound of the human body is required to be increased, and the pain of the human body is increased; after the sensing device and the implantable pulse generator 104 form an integral structure, when the nerve stimulation implantation device is implanted into a human body, the wound is an implantation wound of the implantable pulse generator 104, an implantation wound of the implantable electrode assembly 106, and a buried wire wound of a wire electrically connected with the implantable pulse generator 104 and the implantable electrode assembly 106, and if wireless communication is adopted between the implantable pulse generator 104 and the implantable electrode assembly 106, the buried wire wound can be omitted, so that after the sensing device and the implantable pulse generator 104 are integrated into a whole, the implantation wound is less than or equal to three, and the sensing device and the implantable pulse generator are integrated to enable the implantable pulse generator to have the function of detecting sleeping posture information and breathing information, thereby well overcoming the problem that the implantable pulse generator wound which does not have the function of detecting sleeping posture information and breathing information in the prior art.

It will be appreciated that transthoracic impedance fluctuates regularly with respiratory motion, with high transthoracic impedance during inspiration and low transthoracic impedance during expiration, so that respiratory cycles can be identified by the detected transthoracic impedance, and differences in transthoracic impedance during one cycle reflect tidal volume, so that differences in transthoracic impedance during one cycle can be used to estimate changes in tidal volume, from which it is determined whether a respiratory disturbance event exists. For example, a respiratory disorder is defined when the tidal volume decreases by greater than or equal to 26% from baseline, and may also be identified when the apnea is determined to be greater than or equal to 10 seconds based on the tidal volume.

Alternatively, identification of transthoracic impedance may be achieved using a bioimpedance sensor. As shown in fig. 3, in one embodiment, the bioimpedance sensor may include a cardioverter-defibrillator electrode lead 112, with the cardioverter-defibrillator electrode lead 112 being located outside of and connected to the housing of the implantable pulse generator 104 to form a measurement loop. In an alternative embodiment, cardioverter-defibrillator electrode lead 112 is interposed and left in the extra-venous, a 320 μa,19.5 μs,20Hz subthreshold pulse is delivered from implantable pulse generator 104 to the coil of cardioverter-defibrillator electrode lead 112, the voltage of the housing of implantable pulse generator 104 to the tip of cardioverter-defibrillator electrode lead 112 is measured, and the current flowing through the cardioverter-defibrillator electrode lead is obtained, and the transthoracic impedance is calculated from the current and voltage. In one embodiment, the acquired voltages and currents are filtered and recalculated in order to avoid the effects of systole, body posture and respiratory motion. In the above embodiment, the electrode lead of the cardioverter defibrillator is connected to the existing implantable pulse generator to realize the detection of the biological impedance of the implantable pulse generator, so that the implantable pulse generator can regulate the stimulation signal according to the biological impedance, and the problem that the implantable pulse generator in the prior art cannot detect the biological impedance to realize the closed loop stimulation, thereby causing poor stimulation effect is solved. In addition, if the implantable pulse generator in the related prior art needs to realize the detection of the biological impedance, a sensor needs to be additionally arranged, at the moment, a wound is needed to be additionally arranged for the implantation of the sensor, the communication connection between the sensor and the implantable pulse generator also needs to be established for subcutaneous tunneling, a plurality of operation wounds are additionally arranged, the implantable pulse generator shell is led out of the electrode wire of the cardioverter-defibrillator, and the electrode wire of the cardioverter-defibrillator is led in and is reserved in an odd vein, so that when the implantable medical device is implanted in a human body, only a small wound is needed to be punctured in a blood vessel, the operation wounds are effectively reduced, and the problem of excessive operation wounds in the prior art is overcome.

In one embodiment, cardioverter-defibrillator electrode lead 112 includes a proximal lead that is connected to the housing of implantable pulse generator 104 and a distal coil that is interposed and indwelling in the vena cava.

In one embodiment, as shown in fig. 2 and 3, the implantable pulse generator 104 is connected to the implantable electrode assembly 106 by an electrode lead 114. Optionally, wireless communication may also be provided between the implantable pulse generator 104 and the implantable electrode assembly 106.

Optionally, the implantable pulse generator 104 includes an implanted circuit, as shown in fig. 4, including a feedthrough 1041, a housing assembly 1042, a circuit assembly 1043, and a battery 1044.

The feedthrough 1041 is used to transmit an in-vivo stimulation control signal to the implantable electrode assembly 106 via the electrode cable 114, so that the implantable electrode assembly 106 can stimulate nerves.

The housing assembly 1042 is configured to house a feedthrough 1041, a circuit assembly 1043, and a battery 1044. Alternatively, the housing assembly 1042 may be a housing of the implantable pulse generator 104.

The circuit component 1043 may receive the in-vivo stimulation control signal, and convert the in-vivo stimulation control signal and transmit the in-vivo stimulation control signal to the implantable electrode component 106 through the feedthrough 1041, for example, the implantable pulse generator includes a control module, and the control module is communicatively connected to the neural stimulation in-vitro control device, and receives the in-vitro stimulation control signal sent by the neural stimulation in-vitro control device and converts the in-vivo stimulation control signal into the in-vivo stimulation control signal, and converts the in-vivo stimulation control signal into an electrical signal by the circuit component 1043 and transmits the electrical signal to the implantable electrode component through the feedthrough 1041. Alternatively, the circuit assembly 1043 may also be communicatively coupled directly to the neural stimulation external control device 102 for receiving external control signals sent by the neural stimulation external control device 102.

A battery 1044 for powering the implantable pulse generator. Alternatively, the battery may be a disposable battery. In an alternative embodiment, the battery may be a rechargeable battery, and the battery may be charged by using an external charging device, so that when the battery is in a low power state, the battery is charged by using the external charging device, so as to overcome the problem of increased wound caused by the fact that the implantable pulse generator needs to be removed from the body before the battery is replaced when the battery is in a low power state.

In one embodiment, as shown in fig. 5, the implantable electrode assembly 106 may include a stimulation electrode 1061 and an electrode sheath 1062.

Optionally, the stimulating electrode 1061 is electrically connected to the implantable pulse generator 104 through the electrode lead 114, so that the implantable pulse generator 104 transmits an in-vivo control stimulating signal to the stimulating electrode 106 through the electrode lead 114, so as to control the operation of the stimulating electrode 106.

In one embodiment, as shown in fig. 6 (a), the electrode sleeve 1062 is a hollow surrounding structure with an axial opening, as shown in fig. 6 (b), the electrode sleeve 1062 includes a first bending structure 10621 and a second bending structure 10622, where the first bending structure 10621 and the second bending structure 10622 have an overlapping angle θ, and optionally, the overlapping angle θ takes a value in a range of 0 to 360 °.

In an alternative embodiment, as shown in fig. 6 (a), the stimulation electrode 1061 includes a plurality, for example, may be 3. Optionally, a plurality of stimulating electrodes 1061 are attached to the hollow inner wall of the electrode casing 1042 and are axially arranged along the electrode casing 1062.

In one embodiment, the electrode sheath 1062 is made of a flexible material, such as silicone, or other flexible polymer material, so that the electrode sheath 1062 is elastic, and the electrode sheath is slightly expanded outwards during the implantation of the implantable electrode assembly into a human body, so that the nerve can be substantially completely wrapped therein, the contact between the electrode sheath and the peripheral nerve is increased, and the stability of the contact is improved.

In an alternative embodiment, a nerve stimulation device is provided, comprising the nerve stimulation implant device of any one of the embodiments above and a nerve stimulation in vitro control device. The nerve stimulation external control device is used for sending an external control signal to the implanted pulse generator of the nerve stimulation implantation device.

In one embodiment, as shown in fig. 7, a method of neural stimulation is provided, the method comprising:

In step S702, the implantable pulse generator receives the external control signal and obtains sleeping posture information and breathing information of the human body from the inside.

In step S704, the implantable pulse generator generates an in-vivo stimulation control signal in response to the in-vitro control signal, the sleep posture information and the respiration information, so as to control the stimulation electrode to apply the in-vivo stimulation signal to the nerve to be stimulated according to the in-vivo stimulation control signal.

Wherein the external control signal is a signal which is initiated by the external nerve stimulation control device and is used for controlling the operation of the nerve stimulation equipment.

In one embodiment, a nerve stimulation device includes an implantable pulse generator and an implantable electrode assembly, the implantable pulse generator being electrically connected to the implantable electrode assembly. Optionally, the implantable pulse generator generates an in-vivo control signal according to the in-vitro control signal, and then controls the implantable electrode assembly to work according to the in-vivo control signal.

In one embodiment, the implantable electrode assembly includes a plurality of stimulation electrodes that may be operated simultaneously or one or more stimulation electrodes may be selected to be operated based on an in vivo control signal.

In an alternative embodiment, the extracorporeal control signals include, but are not limited to, on commands, off commands, stimulation intensity commands, and the like. Optionally, after receiving the external control signal, the implantable pulse generator converts the corresponding on command, off command and stimulation intensity command into an on signal, an off signal and a stimulation intensity signal, so as to determine whether the implantable pulse generator operates or not and parameters during operation according to the on signal, the off signal and the stimulation intensity signal.

In one exemplary embodiment, the implantable pulse generator may obtain respiration information and sleep information from the body after receiving the external control signal to effect operation, and may effect adjustment of the internal control signal based on the respiration information and the sleep information.

Optionally, determining a respiratory cycle of the human body in response to the respiratory information, to generate an in vivo stimulation initiation signal at an end of expiration of the respiratory cycle, and to generate an in vivo stimulation end signal at an end of inspiration of the respiratory cycle; in response to the sleep posture information, an in-vivo stimulation parameter adjustment signal, such as adjusting a pulse width for stimulation, is generated.

Optionally, the implantable pulse generator obtains sleep and respiration information via a gyroscope and accelerometer integrated within the housing. In one embodiment, the implantable pulse generator obtains sleep and respiration information via cardioverter defibrillator electrode leads located outside and coupled to the housing.

It should be understood that, although the steps in the flowcharts related to the above embodiments are sequentially shown as indicated by arrows, these steps are not necessarily sequentially performed in the order indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least some of the steps in the flowcharts described in the above embodiments may include a plurality of steps or a plurality of stages, which are not necessarily performed at the same time, but may be performed at different times, and the order of the steps or stages is not necessarily performed sequentially, but may be performed alternately or alternately with at least some of the other steps or stages.

Based on the same inventive concept, the embodiment of the application also provides a nerve stimulation device for realizing the above-mentioned nerve stimulation method. The implementation of the solution provided by the device is similar to that described in the above method, so specific limitations in one or more embodiments of the neural stimulation device provided below may be found in the limitations of the neural stimulation method described above, and will not be repeated here.

In one embodiment, a neural stimulation module is provided for use in a neural stimulation device, the neural stimulation module comprising: the device comprises an information acquisition module and a stimulation signal generation module, wherein:

The information acquisition module is used for receiving the external control signal and acquiring sleeping posture information and breathing information of a human body from the inside of the human body.

And the stimulation signal generation module is used for responding to the external control signal, the sleeping posture information and the breathing information to generate an internal stimulation control signal.

In one embodiment, the stimulation signal generation module is further configured to generate an on signal, an off signal, and a stimulation intensity signal of the implantable pulse generator in response to the in vitro control signal; in response to the respiratory information, determining a respiratory cycle of the human body to generate an in-vivo stimulation start signal at an end of expiration of the respiratory cycle and an in-vivo stimulation end signal at an end of inspiration of the respiratory cycle; generating an in vivo stimulation parameter adjustment signal in response to the sleep posture information; wherein the in vivo stimulation control signal comprises: an on signal, an off signal, a stimulation intensity signal, an in vivo stimulation start signal, an in vivo stimulation end signal, and an in vivo stimulation parameter adjustment signal.

In an alternative embodiment, the stimulation signal generation module is further used for the implantable pulse generator to acquire sleeping posture information and breathing information through a gyroscope and an accelerometer integrated in a shell of the implantable pulse generator; or the implantable pulse generator acquires sleeping posture information and breathing information through an electrode lead of the cardioverter defibrillator which is positioned outside the shell and connected with the shell.

The various modules in the above-described neural stimulation device may be implemented in whole or in part by software, hardware, and combinations thereof. The above modules may be embedded in hardware or may be independent of a processor in the computer device, or may be stored in software in a memory in the computer device, so that the processor may call and execute operations corresponding to the above modules.

In one embodiment, an implantable pulse generator is provided, comprising a memory and a processor, the memory having stored therein a computer program, the processor performing the steps of the method embodiments described above when the computer program is executed.

In one embodiment, a computer device is provided, comprising a memory and a processor, the memory having stored therein a computer program, the processor implementing the steps of the method embodiments described above when the computer program is executed.

In one embodiment, a computer-readable storage medium is provided, on which a computer program is stored which, when executed by a processor, carries out the steps in the method embodiments.

In one embodiment, a computer program product is provided comprising a computer program which, when executed by a processor, implements the steps of the method embodiments.

It should be noted that, the user information (including but not limited to user equipment information, user personal information, etc.) and the data (including but not limited to data for analysis, stored data, presented data, etc.) related to the present application are information and data authorized by the user or sufficiently authorized by each party, and the collection, use and processing of the related data need to comply with the related laws and regulations and standards of the related country and region.

Those skilled in the art will appreciate that implementing all or part of the above-described methods in accordance with the embodiments may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed may comprise the steps of the embodiments of the methods described above. Any reference to memory, database, or other medium used in embodiments provided herein may include at least one of non-volatile and volatile memory. The nonvolatile Memory may include Read-Only Memory (ROM), magnetic tape, floppy disk, flash Memory, optical Memory, high density embedded nonvolatile Memory, resistive random access Memory (ReRAM), magneto-resistive random access Memory (Magnetoresistive Random Access Memory, MRAM), ferroelectric Memory (Ferroelectric Random Access Memory, FRAM), phase change Memory (PHASE CHANGE Memory, PCM), graphene Memory, and the like. Volatile memory can include random access memory (Random Access Memory, RAM) or external cache memory, and the like. By way of illustration, and not limitation, RAM can be in various forms such as static random access memory (Static Random Access Memory, SRAM) or dynamic random access memory (Dynamic Random Access Memory, DRAM), etc. The databases referred to in the embodiments provided herein may include at least one of a relational database and a non-relational database. The non-relational database may include, but is not limited to, a blockchain-based distributed database, and the like. The processor referred to in the embodiments provided in the present application may be a general-purpose processor, a central processing unit, a graphics processor, a digital signal processor, a programmable logic unit, a data processing logic unit based on quantum computing, or the like, but is not limited thereto.

In the description of the present specification, reference to the terms "some embodiments," "other embodiments," "desired embodiments," and the like, means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic descriptions of the above terms do not necessarily refer to the same embodiment or example.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The foregoing examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims (10)

1. A neural stimulation implant device, comprising: an implantable pulse generator;

The implantable pulse generator is used for receiving an external control signal and acquiring sleeping posture information and breathing information of a human body from the inside of the body so as to respond to the external control signal, the sleeping posture information and the breathing information to generate an internal stimulation control signal.

2. The neurostimulation implant device of claim 1, wherein the implantable pulse generator comprises a housing and a speedometer and gyroscope integrated within the housing;

The accelerometer is used for acquiring the breathing information;

The gyroscope is used for acquiring the sleeping posture information.

3. The neurostimulation implant device of claim 1, wherein the implantable pulse generator comprises:

a housing;

An electrode lead of the cardioverter defibrillator is positioned outside the shell and connected with the shell to form a measuring loop;

wherein the implantable pulse generator obtains the sleep posture information and the respiration information based on the measurement loop.

4. A neurostimulation implant device according to claim 3, wherein said cardioverter-defibrillator electrode lead is interposed and left in an odd vein.

5. The neurostimulation implant device of claim 1, wherein,

The implantable pulse generator is further configured to: generating an on signal, an off signal and a stimulation intensity signal of the implantable pulse generator in response to the in vitro control signal; determining a respiratory cycle of the human body in response to the respiratory information, to generate an in-vivo stimulation start signal at an end of expiration of the respiratory cycle, and to generate an in-vivo stimulation end signal at an end of inspiration of the respiratory cycle; generating an in vivo stimulation parameter adjustment signal in response to the sleep posture information;

wherein the in vivo stimulation control signal comprises: the on signal, the off signal, the stimulation intensity signal, the in vivo stimulation start signal, the in vivo stimulation end signal, and the in vivo stimulation parameter adjustment signal.

6. The neurostimulation implant device of any of claims 1-5, further comprising:

and the implantation electrode assembly is connected with the implantation pulse generator and is used for implanting the nerve to be stimulated of the human body so as to respond to the in-vivo stimulation control signal and apply an in-vivo stimulation signal to the nerve to be stimulated.

7. A nerve stimulation device, comprising:

the neurostimulation implant device of any one of claims 1-6;

And a neural stimulation in vitro control device for sending the in vitro control signal to the implantable pulse generator of the neural stimulation implant device.

8. A method of neural stimulation, comprising:

the implantable pulse generator receives the external control signal and acquires sleeping posture information and breathing information of a human body from the inside of the body;

the implantable pulse generator is used for responding to the external control signal, the sleeping posture information and the breathing information to generate an internal stimulation control signal so as to control the stimulation electrode to apply an internal stimulation signal to the nerve to be stimulated according to the internal stimulation control signal.

9. The neural stimulation method of claim 8, wherein the implantable pulse generator generates an in vivo stimulation control signal in response to the in vitro control signal and the sleep posture information, the respiration information, comprising:

Generating an on signal, an off signal and a stimulation intensity signal of the implantable pulse generator in response to the in vitro control signal;

determining a respiratory cycle of the human body in response to the respiratory information, to generate an in-vivo stimulation start signal at an end of expiration of the respiratory cycle, and to generate an in-vivo stimulation end signal at an end of inspiration of the respiratory cycle;

Generating an in vivo stimulation parameter adjustment signal in response to the sleep posture information;

wherein the in vivo stimulation control signal comprises: the on signal, the off signal, the stimulation intensity signal, the in vivo stimulation start signal, the in vivo stimulation end signal, and the in vivo stimulation parameter adjustment signal.

10. The nerve stimulation method according to claim 8 or 9, wherein the implantable pulse generator acquires sleep posture information and respiration information of a human body, comprising:

the implanted pulse generator acquires the sleeping posture information and the breathing information through a gyroscope and an accelerometer which are integrated in a shell of the implanted pulse generator;

or the implantable pulse generator acquires the sleeping posture information and the breathing information through an electrode lead of a cardioverter defibrillator which is positioned outside the shell and connected with the shell.