Sealing detection method and device of implantable pulse generator and storage medium

Abstract

The embodiment of the invention discloses a sealing detection method and device for an implantable pulse generator and a storage medium, and the method comprises the steps: obtaining internal gas parameters of the implantable pulse generator implanted into a user body, and the gas parameters comprise a gas pressure parameter and a gas component parameter; and determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold. By adopting the technical scheme, the sealing condition of the implantable pulse generator is detected in real time, the timeliness and accuracy of the sealing detection of the implantable pulse generator are ensured, and the adverse effect on the body of a patient caused by the sealing failure of the implantable pulse generator is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a method, device, and storage medium for detecting the seal of an implantable pulse generator. Background Art

[0002] Deep Brain Stimulation (DBS) systems are widely used to treat or manage various disease types, including but not limited to Parkinson's disease, spastic diseases (e.g., epilepsy), pain, migraine, mental diseases, etc. The system mainly includes an Implantable Pulse Generator (IPG), which can provide refined electrostimulation treatment with controllable parameters for patients. The IPG belongs to class III medical devices implanted in the human body. To ensure biocompatibility with the human body, epoxy resin and a titanium shell are used as the contact surface with the human body. Inside the titanium shell, there are circuit boards, batteries, coils, and other devices. To ensure tightness, these devices can work properly. In addition, an inert gas needs to be filled inside the titanium shell, and the water vapor and hydrogen components need to be controlled below a certain standard to ensure the normal operation of the internal circuit devices.

[0003] Currently, the titanium shell of the IPG uses a laser welding solution + helium leak detection method to ensure the tightness of the internal cavity of the titanium shell. This method cannot be detected during the entire life cycle, and only the tightness can be confirmed during the inspection process. There are still risks of seal failure in subsequent process steps such as sandblasting and polishing. Therefore, the existing detection methods cannot ensure real-time seal detection during the entire life cycle of the IPG product. Summary of the Invention

[0004] Embodiments of the present invention provide a method, device, and storage medium for detecting the seal of an implantable pulse generator, ensuring the timeliness of the seal detection of the implantable pulse generator to improve the use safety of the implantable pulse generator.

[0005] In a first aspect, embodiments of the present invention provide a method for detecting the seal of an implantable pulse generator, including:

[0006] Obtaining internal gas parameters of the implantable pulse generator implanted in a user, where the gas parameters include air pressure parameters and gas component parameters;

[0007] Determining the seal state of the implantable pulse generator according to the gas parameters and gas parameter thresholds.

[0008] Optionally, the gas parameter thresholds include a preset air pressure threshold range and a preset gas component threshold range;

[0009] Determining the seal state of the implantable pulse generator according to the gas parameters and gas parameter thresholds includes:

[0010] Determine the preset air pressure threshold range and the preset gas composition threshold range;

[0011] If the air pressure parameter exceeds the preset air pressure threshold range, determine the sealing state of the implantable pulse generator as an unsealed state;

[0012] If the gas composition parameter exceeds the preset gas composition threshold range, determine the sealing state of the implantable pulse generator as an unsealed state.

[0013] Optionally, the gas composition parameter includes a gas type parameter and a proportion parameter of each gas, and the preset gas composition threshold range includes a preset gas type parameter threshold range and a preset gas proportion parameter threshold range;

[0014] If the gas composition parameter exceeds the preset gas composition threshold range, determining the sealing state of the implantable pulse generator as an unsealed state includes:

[0015] If the gas type parameter exceeds the preset gas type parameter threshold range, and / or the proportion parameter of each gas exceeds the preset gas proportion parameter threshold range, determine the sealing state of the implantable pulse generator as an unsealed state.

[0016] Optionally, determining the preset air pressure threshold range and the preset gas composition threshold range includes:

[0017] Obtain the usage duration of the implantable pulse generator;

[0018] Determine the preset air pressure threshold range and the preset gas composition threshold range according to the usage duration of the implantable pulse generator; wherein, there is a corresponding relationship between the usage duration and the preset air pressure threshold range, and there is a corresponding relationship between the usage duration and the preset gas composition threshold range.

[0019] Optionally, determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold includes:

[0020] Determine the ambient gas parameter of the implantable pulse generator, and the ambient gas parameter is the gas parameter inside the body of a user implanted with the implantable pulse generator;

[0021] Determine the sealing state of the implantable pulse generator according to the similarity between the gas parameter and the ambient gas parameter.

[0022] Optionally, the ambient gas parameter includes an ambient air pressure parameter and an ambient gas composition parameter;

[0023] Determine the sealing state of the implantable pulse generator according to the similarity between the gas parameters and the ambient gas parameters, including:

[0024] If the similarity between the air pressure parameter and the ambient air pressure parameter is within a first preset range, and / or if the similarity between the gas composition parameter and the ambient gas composition parameter is within a second preset range, then determine the sealing state of the implantable pulse generator as an unsealed state.

[0025] Optionally, obtain the internal gas parameters of the implantable pulse generator implanted in the user, including:

[0026] Obtain multiple internal gas parameters of the implantable pulse generator implanted in the user at preset intervals;

[0027] Determine the sealing state of the implantable pulse generator according to the gas parameters and the gas parameter threshold, including:

[0028] Determine the air pressure change rate according to multiple air pressure parameters, and determine the gas composition change rate according to multiple gas composition parameters;

[0029] Determine the sealing state of the implantable pulse generator according to the air pressure change rate and / or the gas composition change rate.

[0030] Optionally, the sealing detection method further includes:

[0031] Determine the service life of the implantable pulse generator according to the air pressure change rate and / or the gas composition change rate;

[0032] Perform a first warning reminder according to the service life.

[0033] Optionally, obtain the internal gas parameters of the implantable pulse generator implanted in the user, including:

[0034] Obtain the body parameters of the user; the body parameters include electroencephalogram signals, heart rate or blood pressure;

[0035] If the body parameters of the user are in an abnormal state, then obtain the internal gas parameters of the implantable pulse generator implanted in the user.

[0036] Optionally, the sealing detection method further includes:

[0037] When the implantable pulse generator is in an unsealed state, send a second warning reminder to the user.

[0038] Second aspect, an embodiment of the present invention further provides a sealing detection device for an implantable pulse generator, including: an acquisition module and a determination module;

[0039] The acquisition module is configured to acquire internal gas parameters of the implantable pulse generator implanted into a user's body;

[0040] The determination module is configured to determine the sealing state of the implantable pulse generator according to the gas parameters and a gas parameter threshold.

[0041] Third aspect, an embodiment of the present invention further provides a computer-readable storage medium, on which a computer program is stored, and when the program is executed by a processor, it implements the sealing detection method for the implantable pulse generator according to any embodiment of the present invention.

[0042] Fourth aspect, an embodiment of the present invention further provides an implantable pulse generator, and the implantable pulse generator includes:

[0043] A housing implanted into a user's body, and a gas sensor and a controller disposed inside the housing;

[0044] The gas sensor is configured to collect the internal gas parameters of the housing;

[0045] The controller is configured to execute the sealing detection method for the implantable pulse generator according to any embodiment of the present invention according to the gas parameters.

[0046] Fifth aspect, an embodiment of the present invention further provides an implantable medical system, and the implantable medical system includes:

[0047] The implantable pulse generator as provided in the embodiment of the fourth aspect of the present invention;

[0048] A stimulation electrode, connected to the implantable pulse generator and configured to be implanted into a user's target biological tissue;

[0049] A programming device, communicatively connected to the implantable pulse generator, and sending a programming instruction to the implantable pulse generator according to an operator's operation instruction, so that the stimulation electrode delivers a stimulation pulse to the target biological tissue.

[0050] In this embodiment, by obtaining the internal gas parameters of an implantable pulse generator implanted in a user and determining the sealing state of the implantable pulse generator according to the gas parameters and the gas parameter threshold, the implantable pulse generator is detected to realize real-time detection of the sealing condition of the implantable pulse generator, ensuring the timeliness and accuracy of the sealing detection of the implantable pulse generator. It enables the user to timely understand the sealing condition of the implantable pulse generator. In case of sealing failure, corresponding measures can be taken in a timely manner, improving the use safety and treatment effect of the implantable pulse generator, extending the service life of the implantable pulse generator, and avoiding adverse effects on the patient's body due to the sealing failure of the implantable pulse generator.

[0051] It should be understood that the content described in this part is not intended to identify the key or important features of the embodiments of the present invention, nor is it used to limit the scope of the present invention. Other features of the present invention will become easily understandable through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for the description of the embodiments. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0053] Figure 1 is a schematic structural diagram of a sealing detection system for an implantable pulse generator provided by an embodiment of the present invention;

[0054] Figure 2 is a flowchart of a method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention;

[0055] Figure 3 is a flowchart of another method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention;

[0056] Figure 4 is a flowchart of another method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention;

[0057] Figure 5 is a flowchart of another method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention;

[0058] Figure 6 is a flowchart of yet another method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention;

[0059] Figure 7 is a schematic structural diagram of a sealing detection device for an implantable pulse generator provided by an embodiment of the present invention;

[0060] Figure 8 It is a schematic structural diagram of an implantable pulse generator provided by an embodiment of the present invention;

[0061] Figure 9 It is a schematic structural diagram of a sealing detection device for an implantable pulse generator provided by an embodiment of the present invention.

[0062] Figure 10 It is a schematic structural diagram of an implantable medical system provided by an embodiment of the present invention. Detailed implementation manners

[0063] In order to enable those skilled in the art to better understand the solution of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0064] It should be noted that the terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged under appropriate circumstances so that the embodiments of the present invention described herein can be implemented in an order different from those illustrated or described herein. In addition, the terms "comprising" and "having" and any variations thereof are intended to cover non-exclusive inclusion. For example, a process, method, system, product or device comprising a series of steps or units is not necessarily limited to those steps or units clearly listed, but may include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0065] First, a brief description will be given to one of the application fields of the embodiments of the present invention (i.e., the implantable nerve stimulation system).

[0066] An implantable nerve stimulation system (an implantable medical system) mainly includes a stimulator implanted in a patient's body and a programming device arranged outside the patient's body. Existing nerve regulation technologies mainly implant electrodes in specific structures (i.e., target points) in the body through stereotactic surgery, and the stimulator implanted in the patient's body sends electrical pulses to the target points through the electrodes to regulate the electrical activities and functions of the corresponding nerve structures and networks, thereby improving symptoms and relieving pain. Among them, the stimulator can be any one of an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a cardiac pacemaker), an implantable drug delivery device (Implantable Drug Delivery System, IDDS), and a wire transfer device. The implantable nerve electrical stimulation device is, for example, a deep brain stimulation system (Deep Brain Stimulation, DBS), an implantable cortical nerve stimulation system (Cortical Nerve Stimulation, CNS), an implantable spinal cord stimulation system (Spinal Cord Stimulation, SCS), an implantable sacral nerve stimulation system (Sacral Nerve Stimulation, SNS), an implantable vagus nerve stimulation system (Vagus Nerve Stimulation, VNS), etc.

[0067] In some embodiments, the stimulator may include an implantable pulse generator (IPG), electrode leads, and an extension lead arranged between the pulse generator and the electrode leads. Data interaction between the pulse generator and the electrode leads is achieved through the extension lead, and the pulse generator is arranged in the patient's body. In response to the programming instructions sent by the programming device, it provides controllable electrical stimulation energy to the internal tissues by relying on a sealed battery and a circuit, and delivers one or two controllable specific electrical stimulations to a specific area of the internal tissues through the implanted extension lead and electrode leads. The extension lead is used in cooperation with the pulse generator as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the pulse generator to the electrode leads. The electrode leads deliver electrical stimulation to a specific area of the internal tissues through the electrode contacts thereon. The stimulator is provided with one or more electrode leads on one or both sides, and multiple electrode contacts are arranged on the electrode leads.

[0068] In some other embodiments, the stimulator may only include a pulse generator and electrode leads. Among them, the pulse generator can be embedded in the patient's skull, and the electrode leads are implanted in the patient's intracranial cavity. At this time, the pulse generator is directly connected to the electrode leads without an extension lead.

[0069] The electrode lead can be a nerve stimulation electrode. Through multiple electrode contacts, the electrode lead delivers electrical stimulation to a specific area of the body tissue. The stimulator is provided with one or more electrode leads on one side or both sides. Multiple electrode contacts are arranged on the electrode lead, and the electrode contacts can be evenly arranged or unevenly arranged in the circumferential direction of the electrode lead. As an example, the electrode contacts can be arranged in an array of 4 rows and 3 columns (a total of 12 electrode contacts) in the circumferential direction of the electrode lead. The electrode contacts can include stimulation contacts and / or acquisition contacts. The electrode contacts can adopt shapes such as sheet-shaped, ring-shaped, and dot-shaped, for example.

[0070] In some possible ways, the stimulated body tissue can be the patient's brain tissue, and the stimulated site can be a specific site of the brain tissue. When the patient's disease types are different, generally the stimulated sites are different, and the number of stimulation contacts (single-source or multi-source), the use of one or more (single-channel or multi-channel) specific electrical stimulation signals, and the stimulation parameter data are also different. It can be considered that when the stimulation contacts used are multi-source and multi-channel (multi-channel), a larger amount of data will be generated compared to single-source and single-channel.

[0071] The embodiments of the present invention do not limit the applicable disease types, which can be the disease types applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the disease types that DBS can be used to treat or manage include but are not limited to: spastic diseases (such as epilepsy), pain, migraine, mental diseases (such as major depressive disorder (MDD)), bipolar disorder, anxiety disorder, post-traumatic stress disorder, dysthymia, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (such as essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0072] The stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals within 1 second of unit time, with the unit of Hz), pulse width (the duration of each pulse, with the unit of μs), amplitude (generally expressed by voltage, that is, the intensity of each pulse, with the unit of V), timing (for example, it can be continuous or triggered), stimulation mode (including one or more of current mode, voltage mode, timed stimulation mode, and cyclic stimulation mode), doctor control upper and lower limits (the adjustable range by the doctor), and patient control upper and lower limits (the range that the patient can adjust independently).

[0073] Figure 1 It is a schematic structural diagram of a sealing detection system for an implantable pulse generator provided by the embodiments of the present invention; Figure 2It is a flowchart of a method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention. This embodiment is applicable to the situation of detecting whether the seal of the implantable pulse generator fails. This method can be executed by a seal detection device of the implantable pulse generator, and the detection device can be implemented in the form of hardware and / or software. As Figure 1 shown, the seal detection system of the implantable pulse generator provided by the embodiment of the present invention includes: a pressure sensor 1, a gas composition sensor 2, a processing unit 3, and a terminal 4. Among them, the processing unit 3 is respectively connected to the pressure sensor 1, the gas composition sensor 2, and the terminal 4. Exemplarily, the connection between the processing unit 3 and the pressure sensor 1 and the gas composition sensor 2 can be realized based on a Controller Area Network (CAN), a Local Interconnect Network (LIN), or an Ethernet, and the connection between the processing unit 3 and the terminal 4 can be realized wirelessly based on radio frequency, Bluetooth, or near-field communication technology, so as to transmit the seal detection data and results of the implantable pulse generator to the user.

[0074] The processing unit can be an MCU inside the IPG, and through the pre-configured working logic, it acquires and processes the acquisition information of the pressure sensor 1 and the gas composition sensor 2.

[0075] The terminal 4 can be an external programmer, such as a patient programmer or a doctor programmer, which can enable the patient or doctor to timely understand the internal seal situation of the IPG, facilitating the timely collection of corresponding processing strategies. Of course, it can also be other devices of the patient or doctor, such as mobile terminals like mobile phones and tablets.

[0076] As Figure 2 shown, the method for detecting the seal of the implantable pulse generator based on the above structure includes the following steps:

[0077] S110. Obtain the internal gas parameters of the implantable pulse generator implanted in the user's body. The gas parameters include pressure parameters and gas composition parameters.

[0078] Among them, the implantable pulse generator is a device implanted in the human body that can convert the electrical energy provided by the battery into electrical pulse signals and transmit the electrical pulse signals to specific body parts through electrode wires. These electrical pulses can stimulate nerves, muscles, or other tissues, so as to achieve the purpose of treating diseases or regulating physiological functions.

[0079] Specifically, the processing unit 3 can obtain the air pressure parameter inside the implantable pulse generator at this time through the air pressure sensor 1, and obtain the gas composition parameter inside the implantable pulse generator at this time through the gas composition sensor 2, so as to obtain the internal gas parameter of the implantable pulse generator implanted into the user's body. Exemplarily, the air pressure sensor 1 can be a device composed of a thin film, a thimble and a flexible resistor. The air pressure inside the implantable pulse generator causes the thin film to deform and drives the thimble to move, changing the resistance value of the flexible resistor, thereby converting the air pressure into a changing resistance value and presenting it in the form of an electrical signal to obtain the air pressure parameter inside the implantable pulse generator at this time; the gas composition sensor 2 can be a device based on the semiconductor principle, and uses the change in resistivity when a metal oxide semiconductor material contacts a specific gas to detect the gas composition parameter inside the implantable pulse generator at this time.

[0080] S120. Determine the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold.

[0081] Specifically, the implantable pulse generator is usually designed as a sealed system. During the production process of its product, a certain air pressure and mixed gas are filled into its internal cavity to ensure the normal operation of the internal circuit equipment of the implantable pulse generator. During long-term operation, if the implantable pulse generator fails to seal, resulting in too high or too low air pressure inside it, and the presence of corrosive gases may affect the movement of the internal mechanical structure or the performance of electronic components. Therefore, the air pressure parameter and gas composition parameter inside the cavity of the implantable pulse generator can characterize the sealing state of the implantable pulse generator. The processing unit 3 can determine the environment inside the cavity of the implantable pulse generator at this time according to the air pressure parameter and gas composition parameter obtained in real time, and thus determine the sealing state of the implantable pulse generator by comparing the gas parameter with the gas parameter threshold. The processing unit 3 can also send the air pressure parameter, gas composition parameter and sealing state to the terminal 4 through wireless communication technology, so that the user can timely understand the sealing situation of the implantable pulse generator.

[0082] In this embodiment, by obtaining the internal gas parameter of the implantable pulse generator implanted into the user's body and determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold, the implantable pulse generator is detected to realize the real-time detection of the sealing situation of the implantable pulse generator, ensuring the timeliness and accuracy of the sealing detection of the implantable pulse generator. It enables the user to timely understand the sealing situation of the implantable pulse generator. In case of sealing failure, corresponding measures can be taken in a timely manner, improving the use safety and treatment effect of the implantable pulse generator, extending the service life of the implantable pulse generator, and avoiding adverse effects on the patient's body due to the sealing failure of the implantable pulse generator.

[0083] On the basis of the above embodiment,Figure 3 It is a flowchart of another method for detecting the seal of an implantable pulse generator provided by an embodiment of the present invention. Figure 3 The seal detection method shown explains how to determine the seal state of the implantable pulse generator based on gas parameters and gas parameter thresholds. As Figure 1 and Figure 3 shown, the seal detection method of the implantable pulse generator includes the following steps:

[0084] S210. Obtain the internal gas parameters of the implantable pulse generator implanted in the user's body, where the gas parameters include air pressure parameters and gas component parameters.

[0085] S220. Determine a preset air pressure threshold range and a preset gas component threshold range;

[0086] Among them, the gas parameter threshold includes a preset air pressure threshold range and a preset gas component threshold range.

[0087] Specifically, based on device performance and safety requirements, different implantable pulse generators will have a normal operating air pressure range and gas composition during design and manufacturing. Considering that the device may be affected by factors such as temperature changes and altitude changes during operation, a reasonable air pressure and gas component fluctuation range can be set as the preset air pressure threshold range and the preset gas component threshold range respectively. The preset gas component threshold range includes a preset gas type parameter threshold range and a preset gas proportion parameter threshold range. The preset gas type parameter threshold range can be the number range of gas types allowed to be contained in the cavity on the premise of ensuring the normal operation of the implantable pulse generator. Each gas proportion parameter can be the proportion range of the content of each gas allowed to account for all the gas content in the cavity on the premise of ensuring the normal operation of the implantable pulse generator. The preset air pressure threshold range and the preset gas component threshold range can be pre-stored in the processing unit 3. When it is necessary to detect the seal of the implantable pulse generator, the processing unit 3 can determine the preset air pressure threshold range and the preset gas component threshold range by reading data, or by the user inputting in the terminal 4, so as to provide a data comparison basis for the seal detection of the implantable pulse generator. This embodiment does not make specific limitations on this.

[0088] Exemplarily, during the manufacturing process of the implantable pulse generator, after the hermetic welding is completed, the internal device circuit performs calibration and verification work. At this time, the air pressure parameters and gas composition parameters sampled by the air pressure sensor 1 and the gas composition sensor 2 are the initial data of the implantable pulse generator. After performing floating data verification of ±20% on the two data respectively, a preset air pressure threshold range and a preset gas composition threshold range are formed and stored inside the processing unit 3 for use as the original reference data for hermeticity detection.

[0089] S230: If the air pressure parameter exceeds the preset air pressure threshold range, the hermetic state of the implantable pulse generator is determined to be an unsealed state.

[0090] Specifically, when the hermetic seal of the implantable pulse generator fails, air leakage or air intake may occur inside it, resulting in a change in the air pressure parameter of the implantable pulse generator. If the air pressure parameter obtained by the processing unit 3 through the air pressure sensor 1 is not within the preset air pressure threshold range, it indicates that the air pressure of the implantable pulse generator is not a normal data fluctuation caused by reasonable objective factors (such as temperature, altitude, etc.) under the hermetic state, but an abnormal air pressure data caused by the hermetic seal failure, causing the air pressure parameter to exceed the preset air pressure threshold range. By comparing the air pressure parameter with the preset air pressure threshold range, if the air pressure parameter is within the preset air pressure threshold range, the hermetic state of the implantable pulse generator is determined to be a sealed state; if the air pressure parameter exceeds the preset air pressure threshold range, the hermetic state of the implantable pulse generator is determined to be an unsealed state. The patient can perform an intervention operation on the implantable pulse generator based on the unsealed state to correct the hermeticity of the implantable pulse generator, ensure personal safety, and prevent further damage to the implantable pulse generator.

[0091] Exemplarily, the preset air pressure threshold range can be 100000 Pa - 101325 Pa. If the air pressure parameter obtained by the processing unit 3 is 110000 Pa, this value exceeds the preset air pressure threshold range, and the hermetic state of the implantable pulse generator is determined to be an unsealed state.

[0092] S240: If the gas composition parameter exceeds the preset gas composition threshold range, the hermetic state of the implantable pulse generator is determined to be an unsealed state.

[0093] Specifically, when the seal of the implantable pulse generator fails, air leakage or air intake may occur inside it, resulting in a change in the gas composition parameters of the implantable pulse generator. If the gas composition parameters obtained by the processing unit 3 through the gas composition sensor 1 are not within the preset gas composition threshold range, it indicates that the gas composition of the implantable pulse generator is not the normal data fluctuation caused by reasonable objective factors (such as temperature, altitude, etc.) under the sealed state, but the abnormal gas composition data caused by the seal failure, making the gas composition parameters exceed the preset gas composition threshold range. By comparing the gas composition parameters with the preset gas composition threshold range, if the gas composition parameters are within the preset gas composition threshold range, the seal state of the implantable pulse generator is determined to be the sealed state; if the gas composition parameters exceed the preset gas composition threshold range, the seal state of the implantable pulse generator is determined to be the unsealed state. The user can perform an intervention operation on the implantable pulse generator according to the unsealed state to correct the seal of the implantable pulse generator, ensure personal safety, and prevent further damage to the implantable pulse generator.

[0094] In this embodiment, the air pressure parameters are compared with the preset air pressure threshold range, the gas type parameters are compared with the preset gas type parameter threshold range, and each gas proportion parameter is compared with the preset gas proportion parameter threshold range respectively, so as to determine the seal state of the implantable pulse generator, improve the efficiency and accuracy of seal detection, and avoid adverse effects on the patient's body due to untimely detection of the seal failure of the implantable pulse generator.

[0095] Optionally, the gas composition parameters include gas type parameters and each gas proportion parameter, and the preset gas composition threshold range includes the preset gas type parameter threshold range and the preset gas proportion parameter threshold range;

[0096] If the gas composition parameters exceed the preset gas composition threshold range, determining the seal state of the implantable pulse generator as the unsealed state includes:

[0097] If the gas type parameters exceed the preset gas type parameter threshold range, and / or, each gas proportion parameter exceeds the preset gas proportion parameter threshold range, then the seal state of the implantable pulse generator is determined to be the unsealed state.

[0098] Among them, the processing unit 3 obtains the gas type parameters and each gas proportion parameter in the cavity of the current implantable pulse generator through the gas composition sensor 2. The gas type parameters can be the number of gas types in the cavity, and each gas proportion parameter can be the proportion of the content of each gas in the total gas content in the cavity.

[0099] Specifically, when the seal of the implantable pulse generator fails, air leakage or air intake may occur inside it. A certain gas in the implantable pulse generator will diffuse outward or a certain gas outside will enter the implantable pulse generator, resulting in a change in the gas type parameter and / or the proportion parameter of each gas in the implantable pulse generator. If the gas type parameter obtained by the processing unit 3 through the gas composition sensor 2 is not within the preset gas type parameter threshold range, and / or the proportion parameter of each gas is not within the preset gas proportion parameter threshold range, it indicates that the gas type parameter and / or the proportion parameter of each gas in the implantable pulse generator are not normal data fluctuations caused by reasonable objective factors (such as temperature, altitude, etc.) under the sealed state, but abnormal gas composition data caused by seal failure, causing the gas type parameter to exceed the preset gas type parameter threshold range, and / or the proportion parameter of each gas to exceed the preset gas proportion parameter threshold range. By comparing the gas type parameter with the preset gas type parameter threshold range and the proportion parameter of each gas with the preset gas proportion parameter threshold range, if the gas type parameter is within the preset gas type parameter threshold range and the proportion parameter of each gas is within the preset gas proportion parameter threshold range, the seal state of the implantable pulse generator is determined to be the sealed state; if the gas type parameter exceeds the preset gas type parameter threshold range, and / or the proportion parameter of each gas exceeds the preset gas proportion parameter threshold range, the seal state of the implantable pulse generator is determined to be the unsealed state. The patient can perform an intervention operation on the implantable pulse generator according to the unsealed state to correct the seal of the implantable pulse generator, ensure personal safety, and prevent further damage to the implantable pulse generator.

[0100] Exemplarily, the preset gas type parameter threshold range can be 6 - 10, and the preset gas proportion parameter threshold range for helium is 20% - 30%. If the gas type parameter obtained by the processing unit 3 is 11, and / or the helium proportion parameter is 18%, it indicates that at least one of the gas type parameter and the proportion parameter of each gas exceeds the reasonable numerical fluctuation range, and the seal state of the implantable pulse generator is determined to be the unsealed state.

[0101] Optionally, determining the preset air pressure threshold range and the preset gas composition threshold range includes:

[0102] Obtaining the usage duration of the implantable pulse generator;

[0103] Determining the preset air pressure threshold range and the preset gas composition threshold range according to the usage duration of the implantable pulse generator; wherein, there is a corresponding relationship between the usage duration and the preset air pressure threshold range, and there is also a corresponding relationship between the usage duration and the preset gas composition threshold range.

[0104] Specifically, since there are electrical components inside the implantable pulse generator, during the operation of the implantable pulse generator, it is actually a power consumption process of the electrical components, which may bring changes in gas components or air pressure. Therefore, the preset air pressure threshold range and the preset gas component threshold range under the sealed condition are different for different usage durations of the implantable pulse generator. According to the aging characteristics of the electrical component materials and the known aging rate, the corresponding relationships between different usage durations and the preset air pressure threshold range and the preset gas component threshold range can be preset and stored in the processing unit 3, so as to match the corresponding preset air pressure threshold range and preset gas component threshold range according to the usage duration during the seal detection, and correct and adjust the reference data for the seal detection to determine a reasonable parameter comparison threshold range. When performing a seal detection on the implantable pulse generator, the processing unit 3 can obtain the usage duration of the implantable pulse generator through a timer, and match the corresponding preset air pressure threshold range and preset gas component threshold range at this usage duration as the comparison reference data for determining the seal state of the implantable pulse generator based on the air pressure parameters and gas component parameters, improving the accuracy of the seal detection and avoiding false alarms and missed alarms in the seal detection.

[0105] Exemplarily, the electrical components of the implantable pulse generator may generate excess gas during operation. In the case of good sealing, the air pressure inside may increase, the types of gases may become more, or the proportion of a certain gas may increase. Therefore, a positive correlation relationship can be set between the preset air pressure threshold range and the preset gas component threshold range and the usage duration of the implantable pulse generator, so that when performing a seal detection on the implantable pulse generator, a reasonable threshold range can be matched according to the usage duration for comparison with the real-time data, improving the accuracy of the seal detection. The positive correlation relationship between the preset air pressure threshold range and the preset gas component threshold range and the usage duration of the implantable pulse generator can be as follows: taking the initial data of the implantable pulse generator as the starting time, when the usage duration is 1 month, the data with ±1% of the initial air pressure is used as the preset air pressure threshold range; when the usage duration is 2 months, the data with ±2% of the initial air pressure is used as the preset air pressure threshold range; when the usage duration is 3 months, the data with ±3% of the initial air pressure is used as the preset air pressure threshold range, and so on.

[0106] Optionally, the seal detection method further includes:

[0107] When the implantable pulse generator is in an unsealed state, a second warning reminder is sent to the user.

[0108] Specifically, when the implanted pulse generator is in an unsealed state, the processing unit 3 can send a second warning reminder to the terminal 4 through wireless communication, informing the user that the implanted pulse generator has experienced a seal failure, so as to take emergency measures in a timely manner to ensure their physical safety. The second warning reminder can include, but is not limited to, at least one of voice reminder, beeping reminder, light-emitting reminder, etc., and this embodiment does not make specific limitations on this.

[0109] Based on the above embodiments, Figure 4 is a flowchart of another method for detecting the seal of an implanted pulse generator provided by an embodiment of the present invention. Figure 4 The seal detection method shown further illustrates how to determine the seal state of the implanted pulse generator according to the gas parameters and the gas parameter threshold. As Figure 1 and Figure 4 shown, the seal detection method of the implanted pulse generator includes the following steps:

[0110] S310. Obtain the internal gas parameters of the implanted pulse generator implanted in the user's body, where the gas parameters include air pressure parameters and gas component parameters.

[0111] S320. Determine the environmental gas parameters where the implanted pulse generator is located, and the environmental gas parameters are the gas parameters inside the user's body where the implanted pulse generator is implanted.

[0112] Specifically, the environmental gas parameters refer to the gas-related parameters inside the user's body where the implanted pulse generator is located. In the internal environment of the human body, the environmental gas parameters involve gas components in tissue fluid (such as oxygen, carbon dioxide, etc.), local pressure, and humidity and other factors. The gas parameters may vary in different tissue environments, and appropriate sensors or detection methods are needed to obtain the relevant gas parameters of the environment where the implanted pulse generator is implanted in the user's body. Exemplarily, biomedical sensors can be used or the environmental gas parameters can be obtained by analyzing tissue samples.

[0113] S330. Determine the seal state of the implanted pulse generator according to the similarity degree between the gas parameters and the environmental gas parameters.

[0114] Specifically, compare and analyze the internal gas parameters of the implanted pulse generator collected and the environmental gas parameters where the implanted pulse generator is located. The similarity degree between them can be determined by calculating the difference value, ratio between the parameters or using a specific similarity algorithm. For example, when the internal gas parameters are highly similar to the environmental gas parameters, it means that the seal structure of the implanted pulse generator is incomplete, and there are situations such as leakage or penetration, allowing external substances to enter the device interior. At this time, the implanted pulse generator can be determined to be in an unsealed state.

[0115] In this embodiment, the gas parameters and the ambient gas parameters are compared respectively, and whether the implantable pulse generator has leakage is judged according to the similarity between the two, so as to determine the sealing state of the implantable pulse generator, improve the efficiency and accuracy of the sealing detection, and avoid adverse effects on the patient's body due to untimely detection of the sealing failure of the implantable pulse generator.

[0116] Optionally, the ambient gas parameters include ambient air pressure parameters and ambient gas composition parameters;

[0117] Determining the sealing state of the implantable pulse generator according to the similarity between the gas parameters and the ambient gas parameters includes:

[0118] If the similarity of the ratio of the air pressure parameters to the ambient air pressure parameters is within a first preset range, and / or if the similarity of the gas composition parameters to the ambient gas composition parameters is within a second preset range, the sealing state of the implantable pulse generator is determined to be an unsealed state.

[0119] Wherein, the gas composition parameters may include gas type parameters and the proportion parameter of each gas, and the ambient gas composition parameters may include ambient gas type parameters and the proportion parameter of each ambient gas. The processing unit 3 obtains the gas type parameters and the proportion parameter of each gas in the cavity of the current implantable pulse generator through the gas composition sensor 2. The gas type parameter may be the number of gas types in the cavity, and the proportion parameter of each gas may be the proportion of the content of each gas in the total gas content in the cavity.

[0120] Specifically, the working environment of the implantable pulse generator is inside the patient's body. For the implantable pulse generator, the air pressure and gas composition of each part of the human body are the ambient air pressure parameters and the ambient gas composition parameters, and the air pressure and gas composition of different parts of the human body are different. For example, the air pressure in the chest cavity is small, the gas types are many, and the oxygen proportion is high. Therefore, the ambient gas parameters corresponding to the implantable pulse generator implanted in different biological tissues are different. The processing unit 3 can detect the air pressure and gas composition of the implanted part through the air pressure sensor 1 and the gas composition sensor 2 respectively, as the ambient air pressure parameters and the ambient gas composition parameters of the implantable pulse generator. The ambient gas composition parameters include ambient gas type parameters and the proportion parameter of each ambient gas, so as to improve the accuracy of the sealing detection.

[0121] Further, when the seal of the implantable pulse generator fails, due to penetration or leakage, the internal air pressure parameter and / or gas component parameter thereof will gradually approach the ambient air pressure parameter and ambient gas component parameter. Based on the principle of whether the internal air pressure parameter of the implantable pulse generator is similar or identical to the ambient air pressure parameter of its implantation site and / or whether the gas component parameter is similar or identical to the ambient gas component parameter, it is possible to detect whether the implantable pulse generator has a seal failure. If the similarity degree between the air pressure parameter and the ambient air pressure parameter is within the first preset range and / or the similarity degree between the gas component parameter and the ambient gas component parameter is within the second preset range, it indicates that the implantable pulse generator has a seal failure at this time, resulting in the similarity or identity between the air pressure parameter and the ambient air pressure parameter and / or between the gas component parameter and the ambient gas component parameter. Then, the seal state of the implantable pulse generator is determined to be an unsealed state. It should be understood that in the initial state of the implantable pulse generator (i.e., the factory state), the similarity degree between the internal air pressure parameter and the ambient air pressure parameter of the corresponding part where it is implanted or to be implanted into the patient is not within the first preset range, and / or the similarity degree between the internal gas component parameter and the ambient gas component parameter of the corresponding part where it is implanted or to be implanted into the patient is not within the second preset range. In this way, it is possible to determine whether there is a possibility of air leakage during subsequent acquisition and monitoring. Exemplarily, in the initial state, the similarity degree between the internal air pressure parameter of the implantable pulse generator and the air pressure parameter inside the chest cavity where it is implanted is 0.5, then the first preset range can be 0.8 to 1.2; the similarity degree between the internal gas component parameter of the implantable pulse generator and the gas component parameter inside the chest cavity where it is implanted is 0.6, then the second preset range can be 0.9 to 1.3. It should be noted that the first preset range and the second preset range can be the same or different, and this embodiment does not make specific limitations thereon.

[0122] Optionally, if the ratio of the gas type parameter to the ambient gas type parameter is within the third preset range and / or the ratio of each gas proportion parameter to the corresponding ambient gas proportion parameter of each type is within the fourth preset range, then the seal state of the implantable pulse generator is determined to be an unsealed state.

[0123] Specifically, when the seal of the implantable pulse generator fails, the internal gas type parameter will gradually approach the ambient gas type parameter due to osmotic pressure, and / or each gas proportion parameter will gradually approach each ambient gas proportion parameter due to osmotic pressure. Based on the principle of whether the internal gas type parameter of the implantable pulse generator is similar or identical to the ambient gas type parameter of its implantation site and / or whether each gas proportion parameter is similar or identical to each ambient gas proportion parameter of its implantation site, it is possible to detect whether the implantable pulse generator has a seal failure.

[0124] Further, if the ratio of the gas type parameter to the ambient gas type parameter is within a third preset range, and / or the ratio of each gas proportion parameter to the corresponding ambient gas proportion parameter of each type is within a fourth preset range, it indicates that the seal of the implantable pulse generator fails at this time, resulting in the similarity or identity of the gas type parameter and the ambient gas type parameter, and / or the similarity or identity of each gas proportion parameter and the corresponding ambient gas proportion parameter of each type. Then, the seal state of the implantable pulse generator is determined to be an unsealed state.

[0125] Exemplarily, the third preset range can be 0.7 to 1.3, and the fourth preset range can be 0.8 to 1.3. It should be noted that the first preset range, the second preset range, the third preset range, and the fourth preset range can be the same or different, as long as the ratio of the two data can be approximated to 1. Those skilled in the art can adjust the first preset range, the second preset range, the third preset range, and the fourth preset range according to the actual situation, and this embodiment does not make specific limitations on this.

[0126] Based on the above embodiment, Figure 5 is a flowchart of another seal detection method for an implantable pulse generator provided by an embodiment of the present invention. Figure 5 The seal detection method is described as follows. As Figure 1 and Figure 5 shown, the seal detection method for the implantable pulse generator includes the following steps:

[0127] S410. Obtain multiple internal gas parameters of the implantable pulse generator implanted in the user's body at preset intervals.

[0128] Specifically, the gas parameters can include air pressure parameters and gas component parameters. The processing unit 3 can obtain multiple air pressure parameters inside the implantable pulse generator through the air pressure sensor 1 at preset time intervals, and obtain multiple gas component parameters inside the implantable pulse generator through the gas component sensor 2.

[0129] S420. Determine the air pressure change rate according to the multiple air pressure parameters, and determine the gas component change rate according to the multiple gas component parameters.

[0130] Specifically, the processing unit 3 can determine the air pressure acquisition duration according to the preset time and the number of air pressure parameters obtained, and then determine the change amount of the air pressure parameters during the air pressure acquisition duration through the multiple air pressure parameters, and calculate the air pressure change rate by dividing the change amount by the air pressure acquisition duration. The processing unit 3 can also determine the gas component acquisition duration according to the preset time and the number of gas component parameters obtained, and then determine the change amount of the gas component parameters during the gas component acquisition duration through the multiple gas component parameters, and calculate the gas component change rate by dividing the change amount by the gas component acquisition duration.

[0131] S430. Determine the sealing state of the implantable pulse generator according to the rate of change of air pressure and / or the rate of change of gas composition.

[0132] Specifically, considering that the device may be affected by factors such as temperature change and altitude change during operation, a reasonable fluctuation range of the rate of change of air pressure and the rate of change of gas composition can be set as the preset air pressure change rate threshold range and the preset gas composition change rate threshold range respectively. The preset gas composition change rate threshold range can include the preset gas type change rate threshold range and the preset gas proportion change rate threshold range. The preset gas type change rate threshold range can be the range of the rate of change of the number of gas types allowed to be contained in the cavity on the premise of ensuring the normal operation of the implantable pulse generator. Each gas proportion parameter can be the range of the rate of change of the proportion of the content of each gas in the total gas content in the cavity allowed on the premise of ensuring the normal operation of the implantable pulse generator. The preset air pressure change rate threshold range and the preset gas composition change rate threshold range can be pre-stored in the processing unit 3. When it is necessary to detect the sealing performance of the implantable pulse generator, the processing unit 3 can determine the preset air pressure change rate threshold range and the preset gas composition change rate threshold range by reading data, or determine the preset air pressure change rate threshold range and the preset gas composition change rate threshold range by the input of the user at the terminal 4, so as to provide a data comparison basis for the sealing detection of the implantable pulse generator. In this embodiment, the acquisition method of the preset air pressure change rate threshold range and the preset gas composition change rate threshold range is not specifically limited.

[0133] In this embodiment, by obtaining a plurality of air pressure parameters and a plurality of gas composition parameters of the implantable pulse generator at preset time intervals respectively, and then determining the rate of change of air pressure and the rate of change of gas composition, and determining the sealing state of the implantable pulse generator according to the rate of change of air pressure and / or the rate of change of gas composition, the efficiency and accuracy of the sealing detection are improved, and the adverse impact on the patient's body caused by the untimely detection of the sealing failure of the implantable pulse generator is avoided.

[0134] Optionally, the sealing detection method further includes:

[0135] Determine the service life of the implantable pulse generator according to the rate of change of air pressure and / or the rate of change of gas composition;

[0136] Perform a first warning reminder according to the service life.

[0137] Specifically, the processing unit 3 can determine the air pressure difference based on the air pressure parameter of the implantable pulse generator at this time and the preset air pressure threshold range. The upper limit and the lower limit of the preset air pressure threshold range can be the critical values for seal failure. When the air pressure parameter exceeds the upper limit or the lower limit, the implantable pulse generator fails to seal and cannot be used normally. Dividing the air pressure difference by the air pressure change rate can calculate the failure time of the implantable pulse generator, realizing the prediction of the service life of the implantable pulse generator. And / or, the processing unit 3 determines the gas component difference based on the gas component parameter at this time and the preset gas component threshold range, and dividing the gas component difference by the gas component change rate can calculate the failure time of the implantable pulse generator, realizing the prediction of the service life of the implantable pulse generator, avoiding the seal failure of the implantable pulse generator when performing seal detection, and improving the user's use safety.

[0138] When detecting the service life of the implantable pulse generator, the processing unit 3 can send a first warning reminder to the terminal 4 through wireless communication, informing the user that the implantable pulse generator may have a seal failure, so as to take warning measures in time to ensure the user's physical safety. The first warning reminder can include but is not limited to at least one of voice reminder, beep reminder, light reminder, etc. This embodiment does not make specific limitations on this. It should be noted that the first warning reminder is different from the second warning reminder to facilitate the user to distinguish the state of the implantable pulse generator through the types of warning reminders. The user can prevent the failure risk of the implantable pulse generator in advance, reduce the occurrence of accidents, and the user can take preventive measures in time to ensure the continuity of treatment, improving the user's use safety and experience.

[0139] Based on the above embodiments, Figure 6 is a flowchart of another seal detection method for an implantable pulse generator provided by an embodiment of the present invention. Figure 6 The seal detection method shown explains how to obtain the air pressure parameter and the gas component parameter of the implantable pulse generator respectively. As Figure 1 and Figure 6 shown, the seal detection method for the implantable pulse generator includes the following steps:

[0140] S510. Obtain the user's body parameters; the body parameters include electroencephalogram signal, heart rate or blood pressure.

[0141] Specifically, the processing unit 3 can record the user's electroencephalogram signal through an electroencephalogram sensor, obtain the user's heart rate change through a heart rate sensor or measure the user's blood pressure through a blood pressure sensor.

[0142] S520. If the user's body parameters are in an abnormal state, obtain the internal gas parameters of the implantable pulse generator implanted in the user's body.

[0143] Specifically, the internal battery of the implantable pulse generator is generally a rechargeable battery. However, its internal battery capacity is small, and the number of cyclic charge-discharge cycles is limited. Periodic data sampling of gas parameters also consumes a large amount of power, resulting in frequent charging and affecting the patient's usage experience. Moreover, the implantable pulse generator generally operates continuously for a long time, that is, continuously outputs electrical pulse stimuli to the patient's target point, enabling the patient to always be in a better state. Therefore, it is possible to determine whether to start sampling of air pressure parameters and gas component parameters based on the actual state of the patient. After the processing unit 3 obtains the user's body parameters, it compares the user's body parameters with the normal parameters. If the body parameters are abnormal, it indicates that the implantable pulse generator is not in a normal working state. At this time, it may be due to abnormal air pressure parameters or gas component parameters that cause the implantable pulse generator to malfunction. Therefore, at this time, a seal detection can be started to obtain the internal gas parameters of the implantable pulse generator implanted in the user's body, so as to determine whether the implantable pulse generator has a seal failure, thereby realizing precise detection and prompting and improving the utilization efficiency of electric energy.

[0144] S530. Determine the seal state of the implantable pulse generator according to the gas parameters and the gas parameter threshold.

[0145] In this embodiment, by obtaining the user's body parameters and obtaining the internal gas parameters of the implantable pulse generator implanted in the user's body when the body parameters are in an abnormal state, it is possible to determine whether the implantable pulse generator has a seal failure, thereby realizing precise detection, improving the utilization efficiency of electric energy, and enhancing the user's usage experience.

[0146] Based on the same inventive concept, Figure 7 is a schematic structural diagram of a seal detection device for an implantable pulse generator provided by an embodiment of the present invention, as Figure 7 shown. The seal detection device for the implantable pulse generator includes: an acquisition module 610 and a determination module 620;

[0147] The acquisition module 610 is configured to acquire the internal gas parameters of the implantable pulse generator implanted in the user's body;

[0148] The determination module 620 is configured to determine the seal state of the implantable pulse generator according to the gas parameters and the gas parameter threshold.

[0149] The seal detection device for the implantable pulse generator provided by the embodiment of the present invention can execute the seal detection method for the implantable pulse generator provided by any embodiment of the present invention, and has corresponding functional modules and beneficial effects for executing the method.

[0150] Figure 8 is a schematic structural diagram of an implantable pulse generator provided by an embodiment of the present invention, asFigure 8 As shown in the figure, the implantable pulse generator 700 includes:

[0151] A housing 710 implanted into a user's body, and a gas sensor 720 and a controller disposed inside the housing 710;

[0152] The gas sensor 720 is used to collect gas parameters inside the housing 710;

[0153] The controller is used to perform the seal detection method of the implantable pulse generator 700 provided in any embodiment of the present invention according to the gas parameters.

[0154] The implantable pulse generator provided in the embodiment of the present invention can execute the seal detection method of the implantable pulse generator provided in any embodiment of the present invention, and has corresponding functional modules and beneficial effects for executing the method.

[0155] Figure 9 The structural schematic diagram of an electronic device 80 that can be used to implement the embodiments of the present invention is shown. The electronic device is intended to represent various forms of digital computers, such as, laptop computers, desktop computers, workstations, personal digital assistants, servers, blade servers, mainframe computers, and other suitable computers. The electronic device can also represent various forms of mobile devices, such as, personal digital processors, cellular phones, smart phones, wearable devices (such as helmets, glasses, watches, etc.) and other similar computing devices. The components shown herein, their connections and relationships, and their functions are merely examples and are not intended to limit the implementation of the present invention described and / or claimed herein.

[0156] As Figure 9 shown, the electronic device 80 includes at least one processor 81, and a memory communicatively connected to the at least one processor 81, such as a read-only memory (ROM) 82, a random access memory (RAM) 83, etc. Among them, the memory stores a computer program executable by the at least one processor. The processor 81 can perform various appropriate actions and processes according to the computer program stored in the read-only memory (ROM) 82 or the computer program loaded from the storage unit 88 into the random access memory (RAM) 83. In the RAM 83, various programs and data required for the operation of the electronic device 80 can also be stored. The processor 81, the ROM 82, and the RAM 83 are connected to each other through a bus 84. The input / output (I / O) interface 85 is also connected to the bus 84.

[0157] Multiple components in the electronic device 80 are connected to the I / O interface 85, including: an input unit 86, such as a keyboard, a mouse, etc.; an output unit 87, such as various types of displays, speakers, etc.; a storage unit 88, such as a magnetic disk, an optical disc, etc.; and a communication unit 89, such as a network card, a modem, a wireless communication transceiver, etc. The communication unit 89 allows the electronic device 80 to exchange information / data with other devices through a computer network such as the Internet and / or various telecommunication networks.

[0158] The processor 81 can be various general-purpose and / or special-purpose processing components with processing and computing capabilities. Some examples of the processor 81 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various dedicated artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, a digital signal processor (DSP), and any suitable processor, controller, microcontroller, etc. The processor 81 executes the various methods and processes described above, such as the sealing detection method of the implantable pulse generator.

[0159] In some embodiments, the sealing detection method of the implantable pulse generator can be implemented as a computer program, which is tangibly contained in a computer-readable storage medium, such as the storage unit 88. In some embodiments, part or all of the computer program can be loaded and / or installed onto the electronic device 80 via the ROM 82 and / or the communication unit 89. When the computer program is loaded into the RAM 83 and executed by the processor 81, one or more steps of the sealing detection method of the implantable pulse generator described above can be executed. Alternatively, in other embodiments, the processor 81 can be configured to execute the sealing detection method of the implantable pulse generator in any other suitable manner (e.g., by means of firmware).

[0160] Various embodiments of the systems and techniques described above herein can be implemented in digital electronic circuit systems, integrated circuit systems, field-programmable gate arrays (FPGA), application-specific integrated circuits (ASIC), application-specific standard products (ASSP), systems-on-a-chip (SOC), complex programmable logic devices (CPLD), computer hardware, firmware, software, and / or combinations thereof. These various embodiments can include: being implemented in one or more computer programs, which can be executed and / or interpreted on a programmable system including at least one programmable processor, which can be a dedicated or general-purpose programmable processor, and can receive data and instructions from a storage system, at least one input device, and at least one output device, and transmit the data and instructions to the storage system, the at least one input device, and the at least one output device.

[0161] A computer program for implementing the method of the present invention can be written in any combination of one or more programming languages. These computer programs can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, such that when the computer programs are executed by the processor, the functions / operations specified in the flowchart and / or block diagram are implemented. The computer programs can be executed entirely on the machine, partially on the machine, executed partially on the machine and partially on a remote machine as an independent software package, or executed entirely on a remote machine or server.

[0162] In the context of the present invention, a computer-readable storage medium can be a tangible medium that can contain or store a computer program for use by or in connection with an instruction execution system, apparatus, or device. The computer-readable storage medium can include, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination of the foregoing. Alternatively, the computer-readable storage medium can be a machine-readable signal medium. More specific examples of the machine-readable storage medium would include an electrical connection based on one or more wires, a portable computer disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

[0163] To provide interaction with a user, the systems and techniques described herein can be implemented on an electronic device having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user; and a keyboard and a pointing device (e.g., a mouse or a trackball) through which the user can provide input to the electronic device. Other kinds of devices can also be used to provide interaction with the user; for example, the feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including acoustic input, voice input, or tactile input).

[0164] The systems and techniques described herein can be implemented in a computing system including backend components (e.g., as a data server), or a computing system including middleware components (e.g., an application server), or a computing system including frontend components (e.g., a user computer having a graphical user interface or a web browser through which a user can interact with an implementation of the systems and techniques described herein), or a computing system including any combination of such backend components, middleware components, or frontend components. The components of the system can be interconnected to each other by digital data communication in any form or medium (e.g., a communication network). Examples of communication networks include: local area network (LAN), wide area network (WAN), blockchain network, and the Internet.

[0165] A computing system can include a client and a server. The client and the server are generally remote from each other and typically interact through a communication network. The client-server relationship is created by computer programs running on respective computers and having a client-server relationship with each other. The server can be a cloud server, also known as a cloud computing server or a cloud host, which is a host product in the cloud computing service system, solving the defects of difficult management and weak business scalability existing in traditional physical hosts and VPS services.

[0166] Figure 10 It is a schematic structural diagram of an implantable medical system provided by an embodiment of the present invention, as Figure 10 shown. An embodiment of the present invention also provides an implantable medical system, including:

[0167] An implantable pulse generator 700;

[0168] A stimulating electrode 910, connected to the implantable pulse generator 700 and configured to be implanted into a user's target biological tissue;

[0169] A programming device 920, communicatively connected to the implantable pulse generator 700 and sending a programming instruction to the implantable pulse generator according to an operator's operation instruction, so that the stimulating electrode delivers a stimulating pulse to the target biological tissue.

[0170] It should be understood that various forms of processes shown above can be used, reordering, adding, or deleting steps. For example, the steps recited in the present invention can be executed in parallel, sequentially, or in a different order, as long as the desired results of the technical solution of the present invention can be achieved, and no limitation is made herein.

[0171] The above specific embodiments do not constitute a limitation to the protection scope of the present invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A sealing detection method for an implantable pulse generator, characterized in that: include: Acquiring internal gas parameters of an implantable pulse generator implanted in a user's body, wherein the gas parameters include gas pressure parameters and gas composition parameters; The sealing state of the implantable pulse generator is determined according to the gas parameter and the gas parameter threshold.

2. The sealing detection method of the implantable pulse generator according to claim 1, characterized in that: The gas parameter threshold includes a preset gas pressure threshold interval and a preset gas composition threshold interval; Determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold comprises: Determining the preset air pressure threshold interval and the preset gas composition threshold interval; If the air pressure parameter exceeds the preset air pressure threshold interval, determining the sealing state of the implantable pulse generator as an unsealed state; If the gas composition parameter exceeds the preset gas composition threshold range, the sealing state of the implantable pulse generator is determined to be an unsealed state.

3. The sealing detection method of the implantable pulse generator according to claim 2, characterized in that: The gas composition parameter includes a gas type parameter and a gas proportion parameter of each gas, and the preset gas composition threshold interval includes a preset gas type parameter threshold interval and a preset gas proportion parameter threshold interval; If the gas composition parameter exceeds the preset gas composition threshold range, determining the sealing state of the implantable pulse generator as an unsealed state includes: If the gas type parameter exceeds the preset gas type parameter threshold range, and / or the each gas proportion parameter exceeds the preset gas proportion parameter threshold range, the sealing state of the implantable pulse generator is determined to be an unsealed state.

4. The sealing detection method of the implantable pulse generator according to claim 2, characterized in that: Determining the preset air pressure threshold interval and the preset gas composition threshold interval includes: Obtaining the usage time of the implantable pulse generator; The preset air pressure threshold interval and the preset gas composition threshold interval are determined according to the usage time of the implantable pulse generator; wherein the usage time and the preset air pressure threshold interval are in a corresponding relationship, and the usage time and the preset gas composition threshold interval are in a corresponding relationship.

5. The sealing detection method of the implantable pulse generator according to claim 1, characterized in that: Determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold comprises: Determine the environmental gas parameters of the implantable pulse generator, wherein the environmental gas parameters are gas parameters inside the body of a user in which the implantable pulse generator is implanted; The sealing state of the implantable pulse generator is determined according to the similarity between the gas parameter and the ambient gas parameter.

6. The sealing detection method of the implantable pulse generator according to claim 5, characterized in that: The ambient gas parameters include ambient air pressure parameters and ambient gas composition parameters; Determining the sealing state of the implantable pulse generator according to the similarity between the gas parameter and the ambient gas parameter includes: If the similarity between the air pressure parameter and the ambient air pressure parameter is within a first preset range, and / or if the similarity between the gas composition parameter and the ambient gas composition parameter is within a second preset range, the sealing state of the implantable pulse generator is determined to be an unsealed state.

7. The sealing detection method of the implantable pulse generator according to claim 1, characterized in that: Obtain the internal gas parameters of the implantable pulse generator implanted in the user's body, including: Acquire multiple internal gas parameters of an implantable pulse generator implanted in a user's body at preset intervals; Determining the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold comprises: Determining a rate of change of air pressure according to the plurality of air pressure parameters, and determining a rate of change of gas composition according to the plurality of gas composition parameters; The sealing state of the implantable pulse generator is determined based on the rate of change of the gas pressure and / or the rate of change of the gas composition.

8. The sealing detection method of the implantable pulse generator according to claim 7, characterized in that: The sealing detection method further comprises: Determining the service life of the implantable pulse generator according to the rate of change of the gas pressure and / or the rate of change of the gas composition; A first warning reminder is given according to the service life.

9. The sealing detection method of the implantable pulse generator according to claim 1, characterized in that: Obtain the internal gas parameters of the implantable pulse generator implanted in the user's body, including: Acquiring the user's physical parameters; the physical parameters include electroencephalogram signals, heart rate or blood pressure; If the user's body parameters are in an abnormal state, the internal gas parameters of the implantable pulse generator implanted in the user's body are obtained.

10. The sealing detection method of the implantable pulse generator according to claim 1, characterized in that: The sealing detection method further comprises: When the implantable pulse generator is in an unsealed state, a second warning reminder is issued to the user.

11. A sealing detection device for an implantable pulse generator, characterized in that: include: Get module and determine module; The acquisition module is used to acquire internal gas parameters of an implantable pulse generator implanted in a user's body; The determination module is used to determine the sealing state of the implantable pulse generator according to the gas parameter and the gas parameter threshold.

12. A computer-readable storage medium having a computer program stored thereon, characterized in that: When the program is executed by a processor, the sealing detection method for an implantable pulse generator as described in any one of claims 1 to 10 is implemented.

13. An implantable pulse generator, characterized in that: The implantable pulse generator comprises: A housing implanted in a user's body, and a gas sensor and a controller disposed inside the housing; The gas sensor is used to collect gas parameters inside the shell; The controller is used to execute the sealing detection method of the implantable pulse generator as described in any one of claims 1-10 according to the gas parameters.

14. An implantable medical system, characterized in that: The implantable medical system comprises: The implantable pulse generator as claimed in claim 13; a stimulation electrode connected to the implantable pulse generator and configured to be implanted into a target biological tissue of a user; The programmable control device is connected to the implantable pulse generator for communication and sends programmable control instructions to the implantable pulse generator according to the operation instructions of the operator, so that the stimulation electrode delivers the stimulation pulse to the target biological tissue.

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