Direction detection device and direction detection method of implantable medical instrument

Abstract

The invention discloses a direction detection device and a direction detection method of an implantable medical instrument. An angle detection module in the direction detection device is used for detecting a first relative angle between the direction of a plane where the implantable medical instrument is located and a magnetic field direction of the implantable medical instrument in a preset magnetic field when a user is at a preset position. The control module is used for sending out first prompt information when the difference value between the first relative angle and a preset relative angle is larger than a first preset value, and the preset relative angle is the relative angle between the initial direction of the plane where the user implants the medical instrument at the preset position and the magnetic field direction. Thus, by arranging the direction detection device, whether the current position of the implantable medical instrument deflects relative to the standard position or not can be detected, the standard position is the initial position of the implantable medical instrument after implantation, and prompting is carried out when deflection occurs, so that a user can conveniently and timely discover abnormity, and operation is easy and convenient.

Description

Technical Field

[0001] The present application relates to the technical field of medical equipment, and in particular to a direction detection device and a direction detection method for an implantable medical instrument. Background Art

[0002] Implantable medical devices include implantable neural stimulation systems, implantable cardiac stimulation systems (also known as pacemakers), implantable drug delivery systems (IDDS), and lead adapter systems. An implantable neural stimulation system consists of a stimulator implanted in the user's body (i.e., an implantable neural stimulator) and a programmable device located outside the user's body.

[0003] The electronic architecture of the charging circuit uses energy coupling between coils to transfer electrical energy. This charging architecture is highly dependent on the alignment between the receiving coil of the implanted medical device and the charging coil of the charger. It is usually required that the side where the receiving coil is located faces outward during implantation to ensure that the coils are aligned. However, when the user performs common actions in life such as turning over, kneading, and pressing, there is a certain possibility that the implanted medical device will be deflected, which will cause the alignment of the receiving coil and the charging coil to deviate, thereby reducing the charging efficiency of the implanted medical device. Currently, the existing technology is to perform X-ray detection to see if there is any deviation, but the detection cost is relatively high and it is harmful to the patient himself.

[0004] Based on this, there is an urgent need for a direction detection device and a direction detection method for an implantable medical instrument to solve the above-mentioned technical problems. Summary of the Invention

[0005] The present application provides a direction detection device and a direction detection method for an implantable medical instrument. By comparing a first relative angle with a preset relative angle, it can be detected whether the current position of the implantable medical instrument is deflected compared to a standard position, wherein the standard position is the initial position of the implantable medical instrument when it is implanted, and a prompt is given when deflection occurs to facilitate the user to detect abnormalities in a timely manner. The operation is simple and convenient.

[0006] In a first aspect, the present application provides a direction detection device for an implantable medical instrument.

[0007] The direction detection device includes an angle detection module and a control module, wherein the angle detection module is used to detect a first relative angle between the direction of the plane where the implantable medical device is located at a preset position of the user and the magnetic field direction of the implantable medical device under a preset magnetic field;

[0008] The control module is electrically connected to the angle detection module, and is used to obtain the first relative angle detected by the angle detection module, and to issue a first prompt message when the difference between the first relative angle and a preset relative angle is greater than a first preset value, wherein the preset relative angle is the relative angle between the initial direction of the implantable medical instrument and the magnetic field direction when the user is in the preset position.

[0009] Optionally, the preset position includes an angle of a set value between the orientation direction of the user and the magnetic field direction of the magnetic field where the user is located.

[0010] Optionally, the preset rule includes that the angle between the orientation direction of the user and the magnetic field direction of the magnetic field where the user is located is 90°.

[0011] Optionally, the implantable medical instrument includes a receiving coil, and the first relative angle includes an angle between a plane direction where the receiving coil is located and the direction of the magnetic field.

[0012] Optionally, the angle detection module is further configured to detect a plurality of second relative angles between the direction of the plane where the implantable medical device is located and the magnetic field direction of the implantable medical device under the preset magnetic field under a preset rule;

[0013] The control module is further configured to obtain a plurality of second relative angles detected by the angle detection module, determine whether the implantable medical device is unstable based on the plurality of second relative angles, and issue a second prompt message when it is determined that the implantable medical device is unstable, wherein the preset rule is that the user moves along a set direction.

[0014] Optionally, the control module is configured to determine whether the implantable medical device is unstable through the following steps:

[0015] determining an angle difference between any two second relative angles based on the plurality of second relative angles obtained at the plurality of detection time points;

[0016] When the angle difference between any two second relative angles exceeds a preset difference value, it indicates that the implantable medical device is not stably fixed in the user's body.

[0017] Optionally, the control module is used to issue an alarm when the difference between the first relative angle and the preset relative angle is greater than a second preset value, wherein the second preset value is greater than the first preset value, and the second preset value is greater than or equal to 90°.

[0018] Optionally, the angle detection module includes a magnetic field sensor.

[0019] In a second aspect, the present application further provides a method for detecting the direction of an implantable medical instrument, which is applied to a direction detection device for an implantable medical instrument according to any of the above embodiments, wherein the direction detection device for the implantable medical instrument comprises:

[0020] Obtaining a first relative angle between a direction of a plane where the implantable medical device is located at a preset position of the user and a magnetic field direction of the implantable medical device under a preset magnetic field;

[0021] A first prompt message is issued when the difference between the first relative angle and the preset relative angle is greater than a first preset value, wherein the preset relative angle is the relative angle between the initial direction of the implantable medical device and the magnetic field direction at the preset position of the user.

[0022] In a third aspect, the present application further provides an implantable medical instrument, comprising the direction detection device according to any one of the first aspects;

[0023] The direction detection device is arranged on the implantable medical instrument.

[0024] In a fourth aspect, the present application further provides a direction detection system for an implantable medical instrument, comprising a magnetic field generator for generating a magnetic field with a preset magnetic field direction;

[0025] The implantable medical device according to the third aspect is implanted in a user's body, and the implantable medical device determines the position information of the implantable medical device in the user's body through a direction detection device.

[0026] In a fifth aspect, the present application further provides an implantable medical system, comprising:

[0027] The implantable medical device according to the third aspect is implanted into a user's body;

[0028] a charger, configured to charge the implantable medical device via the receiving coil;

[0029] The program-controlled device is used to send program-controlled instructions to the implantable medical instrument and receive first prompt information sent by the implantable medical instrument.

[0030] The beneficial effects of this application are:

[0031] The present application provides a direction detection device and a direction detection method for an implantable medical instrument. The direction detection device includes an implantable medical instrument and a direction detection device, the direction detection device includes an angle detection module and a control module, the angle detection module is used to detect the direction of the plane where the implantable medical instrument is located in the preset position of the user, and the first relative angle with the magnetic field direction of the implantable medical instrument under the preset magnetic field, the control module is used to obtain the first relative angle detected by the angle detection module, and issue a first prompt message when the difference between the first relative angle and the preset relative angle is greater than the first preset value. In this way, by comparing the first relative angle with the preset relative angle, it is possible to detect whether the current position of the implantable medical instrument is deflected compared to the standard position, wherein the standard position is the initial position of the implantable medical instrument after implantation, and a prompt is issued when deflection occurs, so that the user can find abnormalities in time, and the operation is simple and convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 This is a simplified structural diagram of a direction detection device for an implantable medical instrument provided by the present application;

[0033] Figure 2 is a schematic diagram of a magnetic field direction provided by this application;

[0034] Figure 3 This is a schematic diagram of the relationship between the position of a user with an implantable medical device and a magnetic field provided by the present application;

[0035] Figure 4 This is a schematic diagram of the relationship between the position of a user with an implantable medical device and a magnetic field provided by the present application;

[0036] Figure 5 This is a flow chart of a method for detecting the direction of an implantable medical device provided by the present application;

[0037] Figure 6 This is a structural diagram of an implantable medical system provided by this application. DETAILED DESCRIPTION

[0038] To make the purpose, technical solutions, and advantages of this application more clear, the technical solutions of this application will be fully described below in conjunction with the drawings in the embodiments of this application through specific implementation methods. Obviously, the described embodiments are part of the embodiments of this application, not all of them. Based on the embodiments of this application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts shall fall within the scope of protection of this application.

[0039] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects and are not necessarily used to describe a specific order or sequential order. It should be understood that the data used in this way can be interchangeable where appropriate, so that the embodiments of the present application described herein can be implemented in a sequence other than those illustrated or described herein. In addition, the terms "including" and "having" and any of their variations are intended to cover non-exclusive inclusions, 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 that are not clearly listed or inherent to these processes, methods, products or devices.

[0040] Below, we first briefly describe one of the application fields of the embodiment of the present invention (i.e., implantable devices). The implantable neural stimulation system (an implantable medical system) mainly includes a stimulator implanted in the patient's body and a programmable device arranged outside the patient's body. The existing neural regulation technology mainly implants electrodes in specific structures (i.e., targets) in the body through stereotactic surgery, and the stimulator implanted in the patient's body emits discharge pulse width to the target through the electrodes, regulates the electrical activity and function of the corresponding neural structure and network, thereby improving symptoms and alleviating pain. Among them, the stimulator can be any one of an implantable neural electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), an implantable drug delivery system (IDDS) and a lead adapter. Examples of implantable neurostimulation devices include deep brain stimulation (DBS), cortical nerve stimulation (CNS), spinal cord stimulation (SCS), sacral nerve stimulation (SNS), and vagus nerve stimulation (VNS).

[0041] In some embodiments, the stimulator may include an implantable pulse generator (IPG), an electrode wire, and an extension wire arranged between the implantable pulse generator and the electrode wire, and data interaction between the implantable pulse generator and the electrode wire is achieved through the extension wire, and the implantable pulse generator is arranged in the patient's body. In response to the program-controlled instructions sent by the program-controlled device, the sealed battery and circuit are used to provide controllable electrical stimulation energy to the tissue in the body, and one or two controllable specific electrical stimulations are delivered to specific areas of the tissue in the body through the implanted extension wire and the electrode wire. The extension wire is used in conjunction with the implantable pulse generator as a transmission medium for the electrical stimulation signal, and transmits the electrical stimulation signal generated by the implantable pulse generator to the electrode wire. The electrode wire delivers electrical stimulation to specific areas of the tissue in the body through the electrode contacts thereon. The stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire.

[0042] In other embodiments, the stimulator may include only an implantable pulse generator and electrode leads. The implantable pulse generator may be embedded in the patient's skull, and the electrode leads may be implanted in the patient's skull. In this case, the implantable pulse generator and the electrode leads are directly connected, without the need for extension leads.

[0043] The electrode wire can be a nerve stimulation electrode, and the electrode wire delivers electrical stimulation to a specific area of ​​tissue in the body through a plurality of electrode contacts. The stimulator is provided with one or more electrode wires on one side or both sides, and a plurality of electrode contacts are provided on the electrode wire, and the electrode contacts can be arranged uniformly or non-uniformly in the circumference of the electrode wire. 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 circumference of the electrode wire. The electrode contacts may include stimulation contacts and / or collection contacts. The electrode contacts can, for example, be in the shape of sheets, rings, dots, etc.

[0044] In some possible embodiments, the stimulated tissue in the body 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 type is different, the stimulated site is generally different, and the number of stimulation contacts used (single source or multiple sources), the use of one or more (single channel or multiple channels) 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, multi-channel (multi-channel), a larger amount of data will be generated compared to a single source, single channel.

[0045] The embodiments of the present invention do not limit the types of diseases that can be treated with DBS, which can be any of the types of diseases that can be treated with deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, or functional electrical stimulation. The types of diseases that DBS can be used to treat or manage include, but are not limited to, spastic disorders (e.g., epilepsy), pain, migraine, mental illness (e.g., major depressive disorder (MDD)), bipolar disorder, anxiety, post-traumatic stress disorder, depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and impairments.

[0046] Stimulation parameters may include: stimulation frequency (for example, the number of electrical stimulation pulse width signals within a unit time of 1s, in Hz), pulse width (the duration of each pulse width, in μs), current amplitude (generally expressed in voltage, that is, the intensity of each pulse width, in 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), one or more of the upper and lower limits controlled by the doctor (the range that the doctor can adjust) and the upper and lower limits controlled by the patient (the range that the patient can adjust independently).

[0047] Figure 1 This is a simplified structural diagram of a direction detection device for an implantable medical instrument provided by this application. Figure 1 The direction detection device 20 includes an angle detection module 210 and a control module 220. The angle detection module 210 is used to detect a first relative angle between the direction of the plane where the implantable medical device 10 is located at a preset position of the user and the direction of the magnetic field of the implantable medical device 10 under a preset magnetic field. The control module 220 is electrically connected to the angle detection module 210 and is used to obtain the first relative angle detected by the angle detection module 210 and issue a first prompt message when the difference between the first relative angle and a preset relative angle is greater than a first preset value, wherein the preset relative angle is the relative angle between the initial direction of the plane where the implantable medical device 10 is located at the preset position of the user and the direction of the magnetic field.

[0048] Specifically, such as Figure 1As shown, the implantable medical device 10 can be a stimulator, which can include an implantable pulse generator. The implantable pulse generator can provide the user with parameter-controllable refined electrical stimulation therapy, sending electrical pulses to the target point through electrodes, regulating the electrical activity and function of the corresponding neural structures and networks, thereby improving symptoms and alleviating pain. It is understood that the embodiments of the present application are only illustratively described using the implantable medical device 10 as a stimulator, but are not limited to this. In other embodiments, other implantable medical devices can also be used.

[0049] In addition, the implantable medical device 10 needs to be implanted in the user's body, for example, a groove is made in the user's skull, and then the implantable medical device 10 is installed in the groove of the skull, or implanted in the user's chest, which is not limited in this application. When charging the implantable medical device 10, wireless charging is usually used, and the wireless charging method is very dependent on the alignment between the receiving coil of the implantable medical device 10 and the charging coil of the charger. Furthermore, it is usually required that the receiving coil of the implantable medical device 10 is facing the outside of the human body during implantation, so as to ensure that the receiving coil of the implantable medical device 10 and the charging coil of the charger can be aligned. However, when the user performs common actions in life such as turning over, kneading, and pressing, there is a certain possibility that the implantable medical device may be deflected, which will cause the alignment of the receiving coil and the charging coil to deviate, thereby reducing the charging efficiency of the implantable medical device.

[0050] To this end, an embodiment of the present application may provide a direction detection device 20 on the implantable medical instrument 10. In one embodiment, the direction detection device 20 may be provided on the outer shell of the implantable medical instrument 10, but the present application is not limited thereto. In other embodiments, the direction detection device 20 may also be provided inside the implantable medical instrument 10, and those skilled in the art may provide the device as needed. The direction detection device 20 includes an angle detection module 210 and a control module 220. The angle detection module 210 may detect the direction of the plane where the implantable medical instrument 10 is located at the user's preset position, and a first relative angle with the magnetic field direction of the implantable medical instrument 10 under a preset magnetic field. The preset position may be understood as the user facing a certain direction under the action of a magnetic field after implanting the implantable medical instrument 10 provided with the angle detection module 210, so that the angle detection module 210 may detect the direction of the plane where the implantable medical instrument 10 is located, and a first relative angle with the magnetic field direction of the implantable medical instrument 10 under a preset magnetic field.

[0051] It should be noted that the above-mentioned magnetic field can be the earth's magnetic field or an external artificial magnetic field. This application is not limited to this, and those skilled in the art can set it as needed.

[0052] In addition, the control module 220 is electrically connected to the angle detection module 210. The control module 220 can obtain the first relative angle detected by the angle detection module 210. The control module 220 itself stores a preset relative angle, which is the relative angle between the initial direction of the plane where the implantable medical device 10 is located and the direction of the magnetic field when the user is in the preset position, wherein the initial direction of the plane where the implantable medical device 10 is located is the direction of the plane where the implantable medical device 10 is located after the device is first implanted, and the initial direction is actually the direction of the implantable medical device relative to the user's body. In addition, the preset relative angle corresponds to the first relative angle, that is, under the same magnetic field, the user's orientation when determining the preset relative angle is the same as the user's orientation when detecting the first relative angle. In other words, the first relative angle and the preset relative angle are determined based on the same preset position of the user.

[0053] It can be understood that the preset relative angle is the standard position of the implantable medical device 10 under the magnetic field and the preset position. The standard position can be understood as the initial position of the implantable medical device 10 after the first implant. In this way, the control module 220 can compare the first relative angle with the preset relative angle. If the difference between the first relative angle and the preset relative angle is greater than the first preset value, it means that the deflection angle of the current implantable medical device 10 is larger than the standard position of the implantable medical device 10. If the position is not adjusted, the charging efficiency of the implantable medical device 10 may be affected, and then a first prompt message is sent to prompt the user or doctor to adjust the position of the implantable medical device 10 in time. If the difference between the first relative angle and the preset relative angle is less than the first preset value, it means that the position deflection angle of the implantable medical device 10 is not large or even not deflected. At this time, it has little impact on the charging efficiency of the implantable medical device 10, and no prompt is given, and monitoring is maintained.

[0054] The difference between the first relative angle and the preset relative angle can be an absolute value, ensuring the reliability and accuracy of subsequent comparisons. It should be noted that in other embodiments, the direction detection device 20 can also include a switch module (not shown in the figure), and the switch module can wirelessly communicate with the magnetic field detection device 210. Then, the magnetic field detection device 210 will only detect the first relative angle when the switch module is turned on, thereby facilitating user use and improving the user experience.

[0055] In summary, the direction detection device in the present application includes an implantable medical instrument and a direction detection device. The direction detection device includes an angle detection module and a control module. The angle detection module is used to detect the direction of the plane where the implantable medical instrument is located in the preset position of the user, and the first relative angle with the magnetic field direction of the implantable medical instrument under the preset magnetic field. The control module is used to obtain the first relative angle detected by the angle detection module and issue a first prompt message when the difference between the first relative angle and the preset relative angle is greater than the first preset value. In this way, by comparing the first relative angle with the preset relative angle, it is possible to detect whether the current position of the implantable medical instrument is deflected compared to the standard position, wherein the standard position is the initial position of the implantable medical instrument after implantation, and to issue a prompt when deflection occurs, so that the user can find abnormalities in time, and the operation is simple and convenient.

[0056] Optionally, based on the above embodiment, continue to refer to Figure 2 The control module 220 is used to issue an alarm when the difference between the first relative angle and the preset relative angle is greater than a second preset value, wherein the second preset value is greater than the first preset value, and the second preset value is greater than or equal to 90°.

[0057] Specifically, if the control module 220 detects that the difference between the first relative angle and the preset relative angle is greater than the second preset value, it indicates that the position deflection of the implantable medical device 10 is relatively serious. If it is not adjusted in time, it is easy to damage human health and needs to be adjusted as soon as possible. For example, if the control module 220 detects that the difference between the first relative angle and the preset relative angle is greater than 90°, it indicates that the position of the implantable medical device 10 has been reversed compared to the standard position, that is, the receiving coil of the implantable medical device 10 is facing into the user's body. During charging, the receiving coil of the implantable medical device 10 and the charging coil of the charger cannot correspond, the charging efficiency is the lowest, and it is easy to overheat and damage human health. Therefore, the control module 220 directly issues an alarm to prompt the user or doctor to adjust the position of the implantable medical device 10 as soon as possible.

[0058] Optionally, based on the above embodiment, Figure 2 This is a schematic diagram of the magnetic field direction provided by this application. Figure 2, the preset position includes an angle of a set value between the user's orientation direction and the magnetic field direction of the magnetic field where the user is located. Specifically, when the user's orientation direction and the magnetic field direction of the magnetic field where the user is located have an angle of a set value, the angle detection module 210 located in the magnetic field can detect the first relative angle. It is understandable that when the angle between the user's orientation direction and the magnetic field direction of the magnetic field where the user is located changes, the first relative angle will change, and then the first relative angle detected at the same preset position and the preset relative angle determined at the same preset position need to be compared to ensure the accuracy of the measurement.

[0059] It should be noted that, continue to refer to Figure 2 The preset position includes a 90° angle between the user's orientation and the magnetic field direction of the user's magnetic field. Specifically, the angle between the user's orientation and the magnetic field direction of the user's magnetic field is 90°, that is, the user's orientation is perpendicular to the direction of the magnetic field lines of the user's magnetic field. This facilitates the user's detection work and avoids the situation where the user's standing orientation deviates from the standing orientation in the preset position, which may cause measurement errors.

[0060] For example, Figure 3 As shown, the implantable medical device 10 is implanted into the body of the user 100, and when implanted, the overall plane direction of the implantable medical device 10 is consistent with the main body plane of the user 100, that is, this position is the initial position of the implantable medical device 10 in the body of the user 100, and the user 100 stands in the magnetic field 200, and the direction of the magnetic field is perpendicular to the plane of the user's body. At this time, the preset relative angle is α.

[0061] As the user 100 goes about his daily life, the position of the implantable medical device 10 in the user's body will change to a certain extent. The longer the time, the greater the possibility and amplitude of the position change. Figure 4 As shown, the position of the implantable medical device 10 in the user 100 after a certain period of time has passed (the figure is a schematic diagram, and the implantable medical device is generally completely implanted in the user's body). At this time, the position of the user 100 in the magnetic field 200 remains unchanged, while the direction of the implantable medical device 10 relative to the magnetic field has changed. At this time, the first relative angle is β. Therefore, by comparing the angle difference between α and β, the position change of the implantable medical device and whether to issue a prompt are determined.

[0062] Based on the above embodiment, the implantable medical device 10 includes a receiving coil, and the first relative angle comprises the angle between the plane direction of the receiving coil and the magnetic field direction. Specifically, the direction of the plane of the implantable medical device 10 is the direction of the plane of the receiving coil. Based on this, the initial direction of the plane of the implantable medical device in the user's preset position is the direction of the plane of the implantable medical device when the receiving coil is facing outside the user's body. That is, in this initial direction, the receiving coil of the implantable medical device 10 is aligned with the charging coil of the charger.

[0063] Optionally, based on the above embodiment, continue to refer to Figure 1 and Figure 2 The angle detection module 210 is further configured to detect a plurality of second relative angles between the direction of the plane on which the implantable medical device 10 is located and the direction of the magnetic field of the implantable medical device 10 under a preset magnetic field under a preset rule. The control module 220 is further configured to obtain the plurality of second relative angles detected by the angle detection module 210, determine whether the implantable medical device 10 is unstable based on the plurality of second relative angles, and issue a second prompt message when it is determined that the implantable medical device 10 is unstable, wherein the preset rule is that the user moves in a set direction.

[0064] For example, Figure 2 In the embodiment shown, the preset rule may be that the user moves in a direction perpendicular to the direction of the magnetic field lines for a certain period of time. The control module 220 acquires multiple second relative angles detected at different times in real time. Under normal circumstances, since the user's movement direction has not changed, the multiple second relative angles should be the same within this time period. Furthermore, if it is detected that the multiple second relative angles at different times are different, it indicates that the implantable medical device 10 is unstable. In this case, the position of the implantable medical device 10 is extremely prone to deflection. Therefore, if the control module 220 detects that the multiple second relative angles at different times have changed, a second prompt message is issued to indicate to the user or doctor that the implantable medical device 10 is unstable, so as to facilitate adjustment.

[0065] Optionally, based on the above embodiment, the control module 220 is configured to determine whether the implantable medical device 10 is unstable by the following steps: determining the angular difference between any two second relative angles based on multiple second relative angles obtained at multiple detection time points; when the angular difference between any two second relative angles exceeds a preset difference value, it indicates that the implantable medical device 10 is unstable in the user's body. The preset difference value can be 5°, 10°, etc., and when the angular difference between any two second relative angles exceeds 5°, it indicates that the implantable medical device 10 is unstable. In this case, the position of the implantable medical device 10 is extremely prone to deflection, and a second prompt message is issued to indicate to the user or doctor that the implantable medical device 10 is unstable, so as to facilitate adjustment.

[0066] Optionally, based on the above embodiment, the angle detection module 210 includes a geomagnetic sensor. Specifically, if the user is in the geomagnetic field, the angle detection module 210 can detect a first relative angle between the direction of the plane in which the receiving coil of the implantable medical device 10 is located and the direction of the magnetic field of the implantable medical device 10 in the geomagnetic field when the user is in a preset position. The control module 220 can then issue a first prompt message when the difference between the first relative angle and the preset relative angle exceeds a first preset value. This eliminates the need for an additional magnetic field generator on the angle detection module 210, thereby reducing costs and the size of the direction detection device 20.

[0067] Based on the same application concept, the present application also provides a direction detection device for an implantable medical instrument, which is applied to the above-mentioned direction detection device for an implantable medical instrument. Figure 5 This is a flow chart of a method for detecting the direction of an implantable medical device provided by the present application. Figure 5 As shown, the direction detection method includes:

[0068] S110. Obtain a first relative angle between a direction of a plane where the implantable medical device is located at a preset position of the user and a magnetic field direction of the implantable medical device under a preset magnetic field.

[0069] Specifically, the angle detection module can detect the direction of the plane where the user's implantable medical device is located at a preset position, and the first relative angle with the direction of the magnetic field of the implantable medical device under a preset magnetic field. The control module is electrically connected to the angle detection module, and then the first relative angle is obtained through the control module. Among them, the preset angle can be understood as the user facing a certain direction after the implantable medical device provided with the angle detection module is implanted, under the action of the magnetic field, so that the angle detection module can detect the direction of the plane where the receiving coil is located, and the current first relative angle with the direction of the magnetic field of the implantable medical device 10 under the preset magnetic field. It should be noted that the above-mentioned magnetic field can be the earth's magnetic field, or it can be the magnetic field provided by the angle detection module itself. This application is not limited to this, and those skilled in the art can set it as needed.

[0070] S120: Issue a first prompt message when the difference between the first relative angle and the preset relative angle is greater than a first preset value.

[0071] Specifically, the control module can obtain a first relative angle detected by the angle detection module. The control module itself stores a preset magnetic field direction, where the preset relative angle corresponds to the first relative angle. That is, under the same magnetic field, the user's orientation when determining the preset relative angle is the same as the user's orientation when detecting the first relative angle. In other words, the first relative angle and the preset relative angle are determined based on the same preset user position. It can be understood that the preset magnetic field direction is the standard position of the implantable medical device under the magnetic field and the preset position. The standard position can be understood as the initial position of the implantable medical device after implantation. In this way, the control module can compare the first relative angle with the preset relative angle. If the difference between the first relative angle and the preset relative angle is greater than the first preset value, it indicates that the current deflection angle of the implantable medical device is larger than the standard position of the implantable medical device. If the position is not adjusted, the charging efficiency of the implantable medical device may be affected. Then, a first prompt message is sent to prompt the user or doctor to adjust the position of the implantable medical device in a timely manner. If the difference between the first relative angle and the preset relative angle is less than the first preset value, it indicates that the position deflection angle of the implantable medical device is not large or even not deflected, which has little impact on the charging efficiency of the implantable medical device. No prompt will be given and monitoring will be maintained.

[0072] It should be noted that, in other embodiments, the direction detection device may also be provided to include a switch module, which may communicate wirelessly with the magnetic field detection device. Then, only when the switch module is turned on, the magnetic field detection device will detect the first relative angle, thereby facilitating user use and improving the user experience.

[0073] In summary, the present application obtains a first relative angle between the direction of the plane of the implantable medical device in the user's preset position and the direction of the magnetic field of the implantable medical device in the preset magnetic field, and issues a first prompt message when the difference between the first relative angle and the preset relative angle is greater than a first preset value. In this way, by comparing the first relative angle with the preset relative angle, it is possible to detect whether the current position of the implantable medical device has deflected from the standard position, where the standard position is the initial position of the implantable medical device after implantation. A prompt is issued when deflection occurs, allowing the user to promptly detect abnormalities, and the operation is simple and convenient.

[0074] Based on the same inventive concept, the present application also provides an implantable medical instrument, which includes the direction detection device of any of the above embodiments. The direction detection device can be set on the implantable medical instrument.

[0075] Based on the same inventive concept, the present application also provides a direction detection system for an implantable medical instrument, the direction detection system comprising:

[0076] A magnetic field generator, used to generate a magnetic field with a preset magnetic field direction;

[0077] The implantable medical device according to any of the above embodiments is implanted in the user's body, and the implantable medical device determines the position information of the implantable medical device in the user's body through the direction detection device.

[0078] Specifically, a magnetic field generator is used to generate a magnetic field, and the implantable medical device is located in the magnetic field generated by the magnetic field generator. The magnetic field detector may include an accelerometer sensor, etc., for detecting the orientation of a plane containing a receiving coil in the implantable medical device when the user is in a preset position, and a first relative angle between the orientation of the plane and the magnetic field direction of the implantable medical device under the preset magnetic field. To ensure that the implantable medical device is located within a stable magnetic field, the magnetic field generator may be positioned in a fixed position so that the implantable medical device is located within the magnetic field generated by the magnetic field generator.

[0079] Based on the same inventive concept, the present application also provides an implantable medical system. Figure 6 This is a schematic diagram of the structure of an implantable medical system provided by this application. Figure 6 As shown, the implantable medical system includes an implantable medical device 10 and a charger 30. The implantable medical device 10 is implanted in the user's body, and the charger 30 is used to charge the implantable medical device through a receiving coil;

[0080] The program-controlled device is used to send program-controlled instructions to the implantable medical device and receive first prompt information sent by the implantable medical device.

[0081] Note that the above are only preferred embodiments of the present application and the technical principles employed. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and that various obvious changes, readjustments, and substitutions can be made by those skilled in the art without departing from the scope of protection of the present application. Therefore, although the present application has been described in more detail through the above embodiments, the present application is not limited to the above embodiments and may include many other equivalent embodiments without departing from the scope of the present application. The scope of the present application is determined by the scope of the appended claims.

Claims

1. A direction detection device for an implantable medical instrument, characterized in that: The direction detection device includes an angle detection module and a control module, wherein the angle detection module is used to detect a first relative angle between the direction of the plane where the implantable medical device is located at a preset position of the user and the magnetic field direction of the implantable medical device under a preset magnetic field; The control module is electrically connected to the angle detection module, and is used to obtain the first relative angle detected by the angle detection module, and to issue a first prompt message when the difference between the first relative angle and a preset relative angle is greater than a first preset value, wherein the preset relative angle is the relative angle between the initial direction of the plane where the implantable medical instrument is located and the direction of the magnetic field when the user is in the preset position.

2. The direction detection device according to claim 1, wherein The preset position includes an angle of a set value between the orientation direction of the user and the magnetic field direction of the magnetic field where the user is located.

3. The direction detection device according to claim 2, wherein: The preset position includes an angle of 90° between the user's orientation direction and the magnetic field direction of the magnetic field where the user is located.

4. The direction detection device according to claim 1, wherein The implantable medical instrument includes a receiving coil, and the first relative angle includes an angle between a plane direction where the receiving coil is located and the direction of the magnetic field.

5. The direction detection device according to claim 1, wherein The angle detection module is further configured to detect a plurality of second relative angles between the direction of the plane where the implantable medical device is located and the magnetic field direction of the implantable medical device under the preset magnetic field under a preset rule; The control module is further configured to obtain a plurality of second relative angles detected by the angle detection module, determine whether the implantable medical device is unstable based on the plurality of second relative angles, and issue a second prompt message when it is determined that the implantable medical device is unstable, wherein the preset rule is that the user moves along a set direction.

6. The direction detection device according to claim 5, characterized in that The control module is configured to determine whether the implantable medical device is unstable through the following steps: determining an angle difference between any two second relative angles based on the plurality of second relative angles obtained at the plurality of detection time points; When the angle difference between any two second relative angles exceeds a preset difference value, it indicates that the implantable medical device is not stably fixed in the user's body.

7. The direction detection device according to claim 1, wherein The control module is used to issue an alarm when the difference between the first relative angle and the preset relative angle is greater than a second preset value, wherein the second preset value is greater than the first preset value, and the second preset value is greater than or equal to 90°.

8. The direction detection device according to claim 1, wherein The angle detection module includes a magnetic field sensor.

9. A method for detecting the direction of an implantable medical device, applied to the device for detecting the direction of an implantable medical device according to any one of claims 1 to 8, characterized in that: The direction detection method comprises: Obtaining a first relative angle between a direction of a plane where the implantable medical device is located at a preset position of the user and a magnetic field direction of the implantable medical device under a preset magnetic field; A first prompt message is issued when the difference between the first relative angle and the preset relative angle is greater than a first preset value, wherein the preset relative angle is the relative angle between the initial direction of the implantable medical device and the magnetic field direction at the preset position of the user.

10. An implantable medical device, characterized in that: comprising the direction detection device according to any one of claims 1 to 7; The direction detection device is arranged on the implantable medical instrument.

11. A direction detection system for an implantable medical device, characterized in that: The direction detection system comprises: A magnetic field generator, used to generate a magnetic field with a preset magnetic field direction; The implantable medical device according to claim 10 is implanted in a user's body, wherein the implantable medical device determines the position information of the implantable medical device in the user's body through a direction detection device.

12. An implantable medical system, characterized in that: The implantable medical system comprises: The implantable medical device according to claim 10, wherein the implantable medical device is implanted into a user's body; a charger, configured to charge the implantable medical device via the receiving coil; The program-controlled device is used to send program-controlled instructions to the implantable medical instrument and receive first prompt information sent by the implantable medical instrument.

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