Implantable electrical stimulation equipment and control method, device and system thereof

Abstract

The invention provides implantable electrical stimulation equipment and a control method, device and system thereof, the equipment comprises a controller, an impedance detection device, a stimulation circuit, a switching circuit and an acquisition circuit, and the controller is configured to obtain a characteristic value of a waveform of an ECAP signal of a body of a patient in a current posture; measuring a first impedance value of a body, between the first electrode contact and the second electrode contact, of the patient through an impedance detection device, and determining contact conditions of the first electrode contact and the second electrode contact with the body of the patient based on the first impedance value; and determining whether to switch different electrode contacts to transmit pulses according to the contact condition and the characteristic value. When the electrode contacts are twisted and are in poor contact with the body of a patient, a proper electrode contact is switched in time to output a treatment pulse, so that the treatment part is accurately stimulated, and the accuracy and the treatment effect of the treatment process are ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to an implantable electrical stimulation device and a control method, device and system thereof. Background Art

[0002] With the development of medical technology, implantable electrical stimulation has become a common treatment method for pain symptoms. Implantable medical devices usually contact the patient's nervous system or nervous system through electrode contacts on the electrode leads, and then deliver stimulation pulses to relieve the patient's pain and achieve the purpose of treatment.

[0003] Considering that in actual applications, the position of the electrode contacts relative to the patient's nervous system may move as the patient's posture changes, the contact site between the electrode contacts and the patient's nervous system may change, resulting in inaccurate stimulation and affecting the patient's treatment effect and experience.

[0004] Therefore, how to improve the accuracy of electrical stimulation of implantable electrical stimulation devices is a technical problem that needs to be solved urgently by those skilled in the art. Summary of the invention

[0005] In view of this, the embodiments of the present invention are directed to providing an implantable electrical stimulation device and a control method, apparatus and system thereof, aiming to improve the accuracy of electrical stimulation.

[0006] In the first aspect, the present invention provides an implantable electrical stimulation device, comprising: a controller, an impedance detection device, connected to the controller, for detecting the impedance value between electrode contacts; a stimulation circuit, configured to generate pulses and output pulses through the electrode contacts on the electrode leads; a switching circuit, connected between the controller and the electrode leads, configured to, under the control of the controller, connect the electrode contacts to the stimulation circuit to switch different electrode contacts to output pulses; an acquisition circuit, electrically connected to the controller, configured to receive an evoked compound action potential (ECAP) signal generated by the pulses emitted by the stimulation circuit to stimulate the patient's body after the controller controls the stimulation circuit and the acquisition circuit to connect to the electrode contacts.

[0007] The controller is configured to perform the following steps:

[0008] Acquire the characteristic value of the waveform of the ECAP signal of the patient's body based on the current posture; measure the first impedance value between the first electrode contact and the second electrode contact on the electrode lead of the implantable electrical stimulation device in real time through an impedance detection device, wherein the first impedance value is the actual impedance value of the patient's body located between the first electrode contact and the second electrode contact, and the first electrode contact and the second electrode contact are located in different electrode contact groups for outputting pulses; determine the contact status of the first electrode contact and the second electrode contact with the body based on the first impedance value; determine whether to switch different electrode contacts to output pulses according to the contact status and the characteristic value; and in the case of determining to switch different electrode contacts, switch to the third electrode contact and the fourth electrode contact through the switching circuit to transmit pulses to the body.

[0009] In one embodiment provided by the present invention, determining the contact status of the first electrode contact and the second electrode contact with the body based on the first impedance value includes: comparing the first impedance value with a first threshold value, wherein the first threshold value is a threshold range of the impedance between the first electrode contact and the second electrode contact; when the first impedance value is greater than the first threshold value, determining that at least one of the first electrode contact and the second electrode contact has poor contact with the body.

[0010] In one embodiment provided by the present invention, when the first impedance value is greater than a first threshold value, it is determined that at least one of the first electrode contact and the second electrode contact has poor contact with the body, including: when the first impedance value is greater than the first threshold value and less than the second threshold value, it is determined that at least one of the first electrode contact and the second electrode contact partially contacts the body, or at least one of the first electrode contact and the second electrode contact partially contacts the body, and at the same time, one of the other electrode contacts in the corresponding electrode contact group partially contacts the body; when the first impedance value is greater than the second threshold value, it is determined that at least one of the first electrode contact and the second electrode contact does not contact the body.

[0011] In one embodiment provided by the present invention, determining whether to switch different electrode contacts to output pulses based on contact conditions and characteristic values ​​includes: when the first impedance value is greater than the second threshold, determining to switch different electrode contacts to deliver pulses; when the first impedance value is greater than the first threshold and less than the second threshold, comparing the characteristic value with the third threshold, and when the characteristic value is greater than the third threshold, determining to switch different electrode contacts to deliver pulses.

[0012] In one embodiment provided by the present invention, switching different electrode contacts to deliver pulses includes: determining a new electrode contact for outputting pulses based on the impedance values ​​of other electrode contacts in the electrode contact group where the electrode contact currently outputting the pulse is located; and switching the electrode contact currently outputting the therapeutic pulse to the electrode contact for the new output pulse.

[0013] In one embodiment provided by the present invention, the controller is further configured to: measure a second impedance value between a first electrode contact and a fifth electrode contact on an electrode lead of an implantable electrical stimulation device by means of an impedance measuring device, wherein the second impedance value is an actual impedance value of the patient's body located between the first electrode contact and the fifth electrode contact, and the first electrode contact and the fifth electrode contact are located in different electrode contact groups for outputting pulses; compare the second impedance value with a first threshold value, and when the second impedance value is not greater than the first threshold value, determine that the second electrode contact is in poor contact with the body.

[0014] In one embodiment provided by the present invention, the controller is further configured to: when the second impedance value is greater than the first threshold value, measure the third impedance value between the second electrode contact and the fifth electrode contact on the electrode lead of the implantable electrical stimulation device by an impedance measuring device, wherein the third impedance value is the actual impedance value of the patient's body located between the second electrode contact and the fifth electrode contact, and the second electrode contact and the fifth electrode contact are located in different electrode contact groups; compare the third impedance value with the first threshold value; when the third impedance value is not greater than the first threshold value, determine that the first electrode contact is in poor contact with the body; when the third impedance value is greater than the first threshold value, determine that both the first electrode contact and the second electrode contact are in poor contact with the body.

[0015] In one embodiment provided by the present invention, obtaining characteristic values ​​of the waveform of the ECAP signal of the patient's body based on the current stimulation parameter value includes: determining the waveform of the ECAP signal of the patient's body in the current posture; and extracting the characteristic values ​​of the waveform based on a deep learning algorithm.

[0016] In one embodiment provided by the present invention, real-time measurement of a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of an implantable electrical stimulation device includes: measuring a measured voltage value between the first electrode contact and the second electrode contact; measuring a measured current value between the first electrode contact and the second electrode contact; and obtaining an impedance value between the first electrode contact and the second electrode contact based on the measured voltage value and the measured current value.

[0017] In a second aspect, the present invention provides a control method for the implantable electrical stimulation device described in the first aspect, comprising: obtaining a characteristic value of a waveform of an ECAP signal of a patient's body based on a current posture; measuring in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device, wherein the first impedance value is an actual impedance value of the patient's body between the first electrode contact and the second electrode contact, and the first electrode contact and the second electrode contact are located in different electrode contact groups for outputting pulses; determining a contact condition between the first electrode contact and the second electrode contact and the body based on the first impedance value; determining whether to switch different electrode contacts to output pulses according to the contact condition and the characteristic value; and in the case of determining to switch different electrode contacts, switching to the third electrode contact and the fourth electrode contact to deliver pulses to the body.

[0018] In a third aspect, the present invention provides a control device for the implantable electrical stimulation device described in the first aspect, the device comprising: an acquisition module, the acquisition module is configured to acquire a characteristic value of the waveform of an ECAP signal of a patient's body in a current posture; a measurement module, the measurement module is configured to measure in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device, the first impedance value being an actual impedance value of the patient's body located between the first electrode contact and the second electrode contact, the first electrode contact and the second electrode contact being located in different electrode contact groups for outputting pulses; a determination module, the determination module is configured to determine a contact condition between the first electrode contact and the second electrode contact and the body based on the first impedance value, and to determine whether it is necessary to switch different electrode contacts to output pulses according to the contact condition and the characteristic value; an adjustment module: the adjustment module is configured to switch to the third electrode contact and the fourth electrode contact to transmit pulses to the body when it is determined that different electrode contacts are switched to output pulses.

[0019] In a fourth aspect, the present invention provides an implantable electrical stimulation system, comprising: the implantable electrical stimulation device described in the first aspect; and electrode leads connected to the implantable electrical stimulation device for delivering pulses to the patient's body.

[0020] The embodiment of the present invention provides an implantable electrical stimulation device and a control method, device and system thereof. The device includes: a controller, an impedance detection device, a stimulation circuit, a switching circuit and an acquisition circuit. The controller is configured to: obtain the characteristic value of the waveform of the ECAP signal of the patient's body in the current posture; measure the first impedance value of the patient's body between the first electrode contact and the second electrode contact through the impedance detection device, and determine the contact between the first electrode contact and the second electrode contact and the patient's body based on the first impedance value; determine whether to switch different electrode contacts to deliver pulses according to the contact situation and the characteristic value. When the electrode contact is twisted and has poor contact with the patient's body, it is promptly switched to a suitable electrode contact to output a treatment pulse to achieve precise stimulation of the treatment site, ensuring the accuracy of the treatment process and the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0022] Figure 1 A schematic diagram of an implantable electrical stimulation system provided by an embodiment of the present invention.

[0023] Figure 2 A schematic diagram of the structure of an implantable electrical stimulation device provided by one embodiment of the present invention.

[0024] Figure 3 A schematic diagram of the structure of an electrode lead provided in one embodiment of the present invention.

[0025] Figure 4 An embodiment of the present invention provides Figure 2 The electrode lead shown is a cross-sectional view taken along the longitudinal direction (direction A).

[0026] Figure 5 A schematic flow chart of a control method for an implantable electrical stimulation device provided by an exemplary embodiment of the present invention.

[0027] Figure 6 A schematic flow chart of a method for determining contact between an electrode contact and a patient's body provided in one embodiment of the present invention.

[0028] Figure 7 A schematic structural diagram of the contact between an electrode contact and a patient's body provided by an embodiment of the present invention.

[0029] Figure 8A schematic structural diagram of another contact situation between an electrode contact and a patient's body provided by an embodiment of the present invention.

[0030] Fig. 9 A schematic structural diagram of another contact situation between an electrode contact and a patient's body provided by an embodiment of the present invention.

[0031] Fig.10 A flowchart of a method for determining electrode contacts that have poor contact with a patient's body is provided in accordance with an embodiment of the present invention.

[0032] Fig.11 A schematic diagram of system modules of a control device for an implantable electrical stimulation device provided in one embodiment of the present invention.

[0033] Fig.12 A schematic diagram of the structure of an implantable electrical stimulation device provided by one embodiment of the present invention. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] Figure 1 FIG. 1 is a schematic diagram of the structure of an implantable electrical stimulation system 100 provided in one embodiment of the present invention. Figure 1 In the figure, reference numeral SC is used to indicate the patient's spinal cord, and reference numeral SK is used to indicate the patient's skin. In addition, the implantable electrical stimulation system provided by the present invention can also be used for electrical stimulation treatment of other parts besides the spinal cord, such as the brain, waist, legs, etc. This embodiment is only described by taking the electrical stimulation system for the spinal cord as an example, and does not mean that the implantable electrical stimulation system provided by the present invention is limited to the spinal cord.

[0036] In order to avoid mis-stimulation of areas that do not need treatment, achieve precise stimulation, and reduce battery consumption, such as Figure 3 As shown, in the related art, the multiple electrode contacts on the electrode lead are designed to be distributed at equal intervals, that is, the electrode contacts in the same electrode contact group are not continuous and there are gaps G.

[0037] In actual applications, when the patient's body posture changes (for example, from lying to sitting, from sitting to standing, or bending, squatting, coughing, etc.), the electrode contacts on the electrode leads may move with the body's nerve fibers, thereby changing the contact site between the electrode contacts and the patient's body's nerve fibers. For example, there is a situation where the electrode contacts partially contact the patient's body's nerve fibers, and the gaps between the electrode contacts partially contact the nerve fibers (that is, the electrode contacts are not in contact with the nerve fibers). Accordingly, the degree to which the electrical stimulation pulse actually acts on the patient's body's nerve fibers will also change. If the previous electrode contacts are always used for electrical stimulation, at the same electrical stimulation pulse intensity, if the above-mentioned electrode contacts have poor contact with the patient's body, it may result in insufficient stimulation, thereby weakening the treatment effect, and the patient's symptoms cannot be effectively relieved.

[0038] In response to the above problems, the present invention creatively proposes to judge the contact condition between the electrode contacts and the patient's body based on the impedance value between the electrode contacts, and further combines the characteristic value of the ECAP waveform to timely switch the electrode contacts to output electrical stimulation pulses when the contact is poor, so as to achieve precise stimulation.

[0039] The following will refer to the attached Figure 1-12 Various non-limiting embodiments of the present invention will now be described in detail.

[0040] like Figure 1 As shown, the implantable electrical stimulation system 100 includes an electrode lead 10 and an implantable electrical stimulation device 20. Figure 2 As shown, the implantable electrical stimulation device 20 includes: a controller 21, a stimulation circuit 22, a collection circuit 23, a switch circuit 24 and an impedance detection device 25.

[0041] The electrode lead 10 is configured to be implanted into the patient's body, and to deliver electrical stimulation pulses (including therapeutic pulses and induced pulses) to the patient's body through electrode contacts on the electrode lead 10, such as electrode contact 11a1. The controller 21 can be configured to be implanted into the patient's body, or it can be configured to be located outside the patient's body, for generating electrical stimulation pulses. The controller 21 can be electrically connected to the electrode lead 10 through the switching circuit 24, and deliver the electrical stimulation pulses to the patient's body through the electrode lead 10 to achieve the purpose of treatment. The impedance detection device 25 is electrically connected to the controller, and can be configured to measure the impedance of the patient's body (biological tissue, such as nerve fibers) between the electrode contacts of the implantable electrical stimulation device.

[0042] The switch circuit 24 is connected between the controller 21 and the electrode lead 10, and is configured to execute the conduction and disconnection of the circuit between the electrode lead and the electrode contact under the control of the controller 21, so as to switch different electrode contacts to output electrical stimulation pulses when there is a problem in the contact between the current electrode contact and the body.

[0043] The acquisition circuit 23 is electrically connected to the controller and is configured to receive an evoked compound action potential (ECAP) signal generated by the electrical stimulation pulse emitted by the stimulation circuit 22 to stimulate the body when the controller controls the stimulation circuit and the acquisition circuit to be connected to the corresponding electrode contacts.

[0044] The controller 21 can accurately control the conduction between any electrode contact and the stimulation circuit and the acquisition circuit by controlling the switch circuit 24, without setting too many channels in the controller, which helps to reduce the size of the controller. This design allows the controller to flexibly control the electrode contacts by simply controlling the switch circuit, and the number of channels of the switch circuit can be flexibly designed according to the number of channels of the controller and the number of electrode contacts, thereby achieving precise control of a single electrode contact, which is more convenient. In addition, the implementation method of the switch circuit is relatively simple, which is conducive to reducing the manufacturing cost of the implantable neural stimulation device.

[0045] For example, Figure 1 As shown, an implantable electrical stimulation system 100 provided by an embodiment of the present invention can be used for electrical stimulation treatment of the spinal cord, wherein the electrode lead 10 is suitable for being placed in the spinal canal of the body to contact the spinal nerves of the body. By implanting the electrode lead 10 in the spinal canal of the body, the length direction of the electrode lead 10 can be substantially parallel to the spinal cord SC, as close to the spinal nerves as possible, thereby improving the effect of electrical stimulation.

[0046] Figure 3 Schematic diagram of the structure of the electrode lead 10. Figure 2 , arrow L may be used to indicate the length direction of the electrode lead 10 , and arrow A may be used to indicate the longitudinal direction perpendicular to the length direction.

[0047] Figure 4 yes Figure 3 A cross-sectional view taken along the longitudinal direction (direction A).

[0048] In some embodiments, Figure 3 and Figure 4 As shown, the electrode lead 10 may include a plurality of electrode contact groups 11 (11a, 11b, 11c, 11d, 11e, 11f, 11g, 11h), and the plurality of electrode contact groups 11 are distributed at intervals along the length direction of the electrode lead 10. Each electrode contact group includes three electrode contacts (e.g., 11a1, 11a2, 11a3). In one example, the three electrode contacts may be located on the same ring.

[0049] In some embodiments, the controller 20 can stimulate the human body through two electrode contacts of the same electrode contact group. Figure 2 As shown, the electrode lead 11 may include an electrode contact 11a1 and an electrode contact 11a2, and is configured to stimulate a human body, for example, a spinal cord SC of a human body, or other parts of a human body, which are not specifically limited here. The stimulation circuit 22 is configured to generate a first pulse signal, and apply the first pulse signal to the first electrode contact to stimulate the human body.

[0050] In some embodiments, the controller 20 may also use electrode contacts (eg, Figure 3 11a1, 11b1) shown in the figure sends therapeutic pulses to the patient's body, and sends inducing pulses to the patient's body through electrode contacts of at least two electrode contact groups among the multiple electrode contact groups (which can be 11a1, 11b1, or other electrode contacts, such as 11d1, 11e1, etc.).

[0051] In some embodiments, the controller 20 is further configured to collect ECAP signals through the electrode contacts in the plurality of electrode contact groups 11 .

[0052] It should be noted that Figure 3 In the illustrated embodiment, 8 electrode contact groups are shown as examples only, each electrode contact group includes 3 electrode contacts, and the number of electrode contact groups and the number of electrode contacts included in the electrode contact groups are not limited. The electrode lead 10 may also include other numbers of electrode contact groups 11, for example, 2, 3, 6, etc. Figure 4 The number of electrode contact groups in each electrode contact group shown may also be other numbers, which is not specifically limited here.

[0053] In some embodiments, the switch circuit can connect the electrode contacts to different circuits according to the instructions of the controller to perform the function switching of the electrode contacts and the conduction and disconnection of the electrode contacts. For example, the electrode contacts can deliver or stop delivering electrical stimulation pulses, such as treatment pulses or induced pulses. It should be understood that the present invention does not limit the implementation method of the function switching of the electrode contacts.

[0054] The therapeutic pulse is used to treat symptoms of the body, such as relieving pain in the body, so its stimulation parameter value (including other parameters besides pulse amplitude and pulse width, such as frequency) must be sufficient to effectively relieve symptoms of the body at the treatment site to achieve a therapeutic effect. The induced pulse is used to stimulate the ECAP signal, so its stimulation parameter value only needs to be sufficient to cause the body's nerve fibers to emit ECAP signals, and may not be involved in the therapeutic effect.

[0055] In the present invention, electrical stimulation pulses (including therapeutic pulses and / or inducing pulses) may refer to current pulses or voltage pulses, and the stimulation intensity may be adjusted by adjusting the stimulation parameter values ​​of the electrical stimulation pulses. Specifically, the electrical stimulation parameter values ​​may include the amplitude of the pulse and / or the pulse width of the pulse.

[0056] In the implantable electrical stimulation system provided by the present invention, the contact condition between the electrode contacts and the patient's body can be determined based on the result of comparing the impedance value of the patient's body between the electrode contacts detected in real time by the impedance detection device with a threshold value (the impedance range when the electrode contacts are in normal contact), so that different electrode contacts can be switched in time to output electrical stimulation pulses when the electrode contacts are in poor contact with the patient's body, thereby achieving precise stimulation of the treatment site.

[0057] Corresponding to the above system, the present invention provides a control method of an implantable electrical stimulation device 20 applied to the above system. Figure 5 Shown is a flow chart of a control method for an implantable electrical stimulation device provided by an exemplary embodiment of the present invention.

[0058] In some embodiments, Figure 5 The illustrated method may be performed by controller 20 .

[0059] like Figure 5 As shown, the method may include the following steps:

[0060] S210 , obtaining characteristic values ​​of the waveform of the ECAP signal of the patient's body in the current posture.

[0061] In some embodiments, therapeutic pulses and induction pulses can be emitted to the patient's body through electrode contacts in two electrode contact groups among the multiple electrode contact groups 11, for example, the first electrode contact in the first electrode contact group and the second electrode contact in the second electrode contact group, so that the multiple electrode contact groups on the electrode lead can deliver electrical stimulation pulses to the patient's body at different positions and directions, and by assigning different functions to the electrode contacts in the multiple electrode contact groups, more diversified treatment plans can be achieved.

[0062] Exemplarily, the first electrode contact and the second electrode contact may be two electrode contacts of adjacent electrode contact groups in a plurality of electrode contact groups, for example, Figure 2 As shown, the first electrode contact and the second electrode contact can be electrode contacts 11a1 and 11b1 respectively, the first electrode contact can be used to emit a positive phase pulse, and the second electrode contact can be used to emit a negative phase pulse; or the second electrode contact can be used to emit a positive phase pulse, and the first electrode contact can be used to emit a negative phase pulse, which is not specifically limited here.

[0063] In some embodiments, the ECAP signal emitted by the patient's body's nerve fibers can also be sensed by the collection electrode contact after the first electrode contact or the second electrode contact emits an induced pulse, and a certain distance is ensured between the first electrode contact and / or the second electrode contact and the collection electrode contact. That is, the ECAP signal is collected at a position far from the position where the treatment pulse and / or the induced pulse is emitted, for example, Figure 2 As shown, the collection electrode contact may be 11d1. Based on this, the degree to which the ECAP signal is affected by the stimulation pulse tail and the degree of distortion of the ECAP signal in long-distance transmission can be better balanced, thereby collecting more effective ECAP signals and ECAP signal waveforms, and improving the accuracy of electrical stimulation regulation.

[0064] In some embodiments, in order to facilitate the subsequent use of the waveform of the ECAP signal, the preprocessed ECAP signal can be standardized. Exemplarily, the characteristic values ​​of the waveform of the ECAP signal can be extracted based on a deep learning algorithm, wherein the characteristic values ​​of the waveform of the ECAP signal generally include a peak value P1, a peak value P2, and a valley value N1.

[0065] S220. Measure in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of an implantable electrical stimulation device.

[0066] The first impedance value may be an actual impedance of the patient between two electrode contacts for delivering electrical stimulation pulses measured in real time, for example, an impedance value of the patient's body between the first electrode contact and the second electrode contact.

[0067] In some embodiments, considering that the patient's posture may change continuously, if only a currently measured impedance value is used as a reference value, it may affect the accuracy of the impedance value judgment. For example, the average value of the impedance values ​​of 5 groups (including the current moment) before and after the current impedance value can be calculated as the first impedance value, so that the first impedance value is more accurate and more in line with actual needs.

[0068] S230: Determine contact conditions between the first electrode contact and the second electrode contact and the patient's body based on the first impedance value.

[0069] The contact condition can be the connection condition between the electrode contact for delivering electrical stimulation and the part to be stimulated (treatment part) of the patient. Specifically, the contact condition can be divided into good contact, partial contact and no contact. The contact condition between the electrode contact and the patient's body can reflect the probability (proportion) that the electrical stimulation pulse emitted in the electrode lead can be delivered to the patient's body to a certain extent. For example, when the area where the electrode contact contacts the patient's body (treatment part) accounts for 90% of the area of ​​the electrode contact, it can generally be considered that 90% of the electrical stimulation pulse emitted by the electrode contact is delivered to the treatment part.

[0070] In some embodiments, the current contact between the electrode contacts and the patient's body can be determined by measuring the impedance value (first impedance value) of the patient's body between the electrode contacts that deliver the electrical stimulation pulse. Figure 6 and related descriptions.

[0071] S240: Determine whether to switch different electrode contacts to output pulses according to the contact condition and the characteristic value of the waveform of the ECAP signal.

[0072] Considering that nerve fibers generally have a certain tolerance range for electrical stimulation pulses, that is, within a certain range of variation in the size of electrical stimulation, the electrical stimulation is considered to be suitable for the patient and does not need to be adjusted. Therefore, when it is determined in step S230 that the contact between the first electrode contact and the second electrode contact and the patient's body is poor, it is possible to determine whether the current stimulation is within the patient's tolerance range based on the characteristic value of the waveform of the ECAP signal, and then determine whether to switch different electrode contacts to output electrical stimulation pulses, and adjust the corresponding stimulation parameter values, so as to achieve precise stimulation, ensure the treatment effect, reduce the frequency of switching electrode contacts, and reduce energy consumption. For the specific contact determination process, please refer to Figure 6-Figure 9 and its related description.

[0073] Specifically, in some embodiments, the aforementioned S240 may include the following sub-steps:

[0074] S241. When the first impedance value is greater than the second threshold, determine to switch different electrode contacts to deliver pulses.

[0075] S242. When the first impedance value is greater than the first threshold value and less than the second threshold value, compare the characteristic value with the third threshold value, and when the characteristic value is greater than the third threshold value, determine to switch different electrode contacts to deliver pulses.

[0076] In some embodiments, a third threshold may be set, wherein the third threshold may be understood as a deviation range of the waveform of the ECAP signal that the patient's body can tolerate and accept (ie, a sensitivity range of the ECAP waveform).

[0077] In some embodiments, the characteristic value of the waveform of the ECAP signal in the current posture can be obtained, and the difference between the characteristic value of the waveform of the currently obtained ECAP signal and the characteristic value of the waveform of the target ECAP signal (the waveform of the ECAP signal fed back under the optimal stimulation parameters) is calculated. The specific method of obtaining the waveform of the target ECAP signal can refer to the relevant technology and will not be repeated here. After obtaining the difference, the difference is compared with the third threshold value. When the difference exceeds the third threshold value, it is considered that the stimulation pulse output under the current electrode contact makes the patient uncomfortable and has affected the treatment effect. It is determined that different electrode contacts need to be switched to output electrical stimulation pulses. Otherwise, it is considered that the current stimulation is still within the patient's tolerance range, which can make the patient comfortable and does not affect the treatment effect, and there is no need to switch the electrode contacts.

[0078] S250: When it is determined to switch to different electrode contacts, switch to the third electrode contact and the fourth electrode contact to transmit pulses to the body.

[0079] In some embodiments, the third electrode contact and the fourth electrode contact may be electrode contacts in the same electrode contact group as the first electrode contact group and the second electrode contact, wherein the third electrode contact and the fourth electrode contact may be the same as or different from the first electrode contact and the second electrode contact.

[0080] In some embodiments, the impedance value of the patient's body between the other electrode contacts of the electrode contact group where the electrode contact (first electrode contact and second electrode contact) currently outputting the electrical stimulation pulse is located can be obtained, and the third electrode contact and the fourth electrode contact, that is, the electrode contacts currently suitable for delivering the electrical stimulation pulse, can be determined based on the difference between the impedance value and a preset threshold.

[0081] For example, Figure 2 As shown, if the electrode contacts currently outputting electrical stimulation pulses are 11a1 and 11b1, if it is determined that electrode contact 11a1 is in poor contact with the patient's body, the impedance values ​​between electrode contact 11a2 and electrode contact 11b1, and between electrode contact 11a2 and electrode contact 11b1 in electrode contact group 11a can be measured respectively, and the respectively measured impedance values ​​can be compared with the first threshold value to determine the electrode contact currently in contact with the patient's body.

[0082] Considering that only the first electrode contact may have poor contact with the patient's body, in this case, the fourth electrode contact can be understood as the second electrode contact, that is, the second electrode contact is not switched. Similarly, when only the second electrode contact has poor contact with the patient's body, the third electrode contact can be understood as the first electrode contact.

[0083] In some embodiments, considering that the current stimulation parameter value may not be suitable for the patient after switching the new electrode contact, in some embodiments, the difference between the characteristic value of the current ECAP waveform and the second threshold value can be calculated, and then the stimulation parameter value can be adjusted based on the stimulation parameter value function in combination with the difference to make the patient comfortable. The specific adjustment process can be referred to the relevant technology.

[0084] In some embodiments, the stimulation parameter value function may be a linear function, a multi-time function, or a multi-segment function, which is not specifically limited herein.

[0085] In some embodiments, the measured voltage value between the first electrode contact and the second electrode contact can be measured, and the measured current value between the first electrode contact and the second electrode contact can be measured at the same time, and then the impedance value between the first electrode contact and the second electrode contact can be obtained based on the measured voltage value and the measured current value.

[0086] In order to improve the accuracy of the measurement result, the amplitude of the preset voltage may be adjusted, and the amplitude between the first electrode contact and the second electrode contact may be repeatedly measured.

[0087] According to the implantable electrical stimulation device provided by the embodiment of the present invention, the impedance value of the patient's body between the electrode contacts that deliver treatment pulses on the electrode leads of the implantable electrical stimulation device is measured in real time through an impedance detection device, and the actual impedance value measured is compared with the threshold value to further determine the contact status between the electrode contacts and the patient's body. According to the contact status and the characteristic value of the waveform of the ECAP signal obtained in the current posture, it is determined whether to switch to different electrode contacts to output pulses. Therefore, when the electrode contacts are twisted and have poor contact with the patient's body, they are promptly switched to suitable electrode contacts to output pulses, thereby achieving precise stimulation of the treatment site and ensuring the accuracy of the treatment process and the treatment effect.

[0088] In order to further explain in detail the process of determining the contact status between the electrode contacts and the patient's body, the present invention also provides a method for determining the contact status between the electrode contacts and the patient's body.

[0089] Figure 6 A flow chart of a method for determining the contact between an electrode contact and a patient's body provided by an exemplary embodiment of the present invention. In some embodiments, Figure 6 The illustrated method may be executed by a controller.

[0090] like Figure 6 As shown, the method may include the following steps:

[0091] S310: Compare the first impedance value with a first threshold.

[0092] S320: When the first impedance value exceeds a first threshold value, determine that at least one of the first electrode contact and the second electrode contact has poor contact with the body.

[0093] Specifically, S320 may include the following sub-steps:

[0094] S321: When the first impedance value is greater than a second threshold value, determine that at least one of the first electrode contact and the second electrode contact is not in contact with the body.

[0095] S322: When the first impedance value is greater than the first threshold and less than the second threshold, determine that at least one of the first electrode contact and the second electrode contact partially contacts the body, and at the same time, one of the other electrode contacts in the corresponding electrode contact group partially contacts the body.

[0096] When the patient's posture changes, the electrode contact twists relative to the patient's body, causing the contact portion between the electrode contact and the patient's body to change, resulting in poor contact. This poor contact may exist in a variety of contact situations. In order to more clearly compare good contact with poor contact, the present invention provides a method for Figure 2 The electrode contact group 11a in FIG. 1 is a schematic diagram showing the contact between three types of electrode contacts and the patient's body. Figure 7-Figure 9 ). Wherein, A may represent the portion of the electrode contact in contact with the patient's nerve fiber (SC).

[0097] Figure 7 It is a schematic diagram of the structure in which the electrode contacts are in good contact with the patient's body. Figure 7-Figure 8 Schematic diagram of the structure in which the electrode contact has poor contact with the patient's body. Exemplarily, the poor contact situation may be that at least one of the first electrode contact and the second electrode contact partially contacts the patient's body, specifically, Figure 7 As shown, the first electrode contact or the second electrode contact part contacts the patient's body, and Figure 7 Compared with the conventional method, the contact area between the electrode contacts and the patient's body becomes smaller; Fig. 9 As described above, it is also possible that the first electrode contact or the second electrode contact partially contacts the patient's body, while at the same time one of the other electrode contacts in the corresponding electrode contact group partially contacts the patient's body (i.e., two electrode contacts in the same electrode contact group partially contact the patient's body); it is also possible that the electrode contact and the patient's body are twisted to a large extent, resulting in a situation where there is no contact between the electrode contact and the patient's body.

[0098] In order to further determine whether the poor contact between the electrode contacts and the body's nerve fibers is partial contact (such as Figure 8 and Fig. 9The first threshold value can be used to determine whether the electrode contact is in contact with the body part, and the second threshold value can be used to determine whether the electrode contact is in contact with the body. Specifically, the specific value can be determined through early tests (i.e., actual feedback from the patient).

[0099] Specifically, the first impedance value can be compared with the first threshold value. If the first impedance value is greater than the first threshold value, it is considered that the first electrode contact and the second electrode contact are in poor contact with the patient's body. The first impedance value is further compared with the second threshold value. When the first impedance value is greater than the second threshold value, it is determined that one of the first electrode contact and the second electrode contact is disconnected from the body, that is, not in contact. When the first impedance value is less than the second threshold value (that is, the first impedance value is between the first threshold value and the second threshold value), it is determined that one of the first electrode contact and the second electrode contact is in partial contact with the body, that is, ( Figure 8 , Fig. 9 Considering that there may be errors in the actual application process, a floating range of 5%, namely, an error range, may exist during the comparison process to improve the accuracy of the judgment.

[0100] Exemplarily, the second threshold value may be 4k ohms (Ω), and the first threshold value may be 25% of the second threshold value, 1k ohms (Ω). Correspondingly, if the measured first impedance value is greater than 4k ohms, it is considered that the first electrode contact and the second electrode contact are not in contact with the body; if the first impedance value is greater than 1k ohms and less than 4k ohms, it is considered that the first electrode contact and the second electrode contact are in contact with part of the body.

[0101] In some embodiments, when it is detected that the resistance between the first electrode contact and the second electrode contact is less than 50 ohms (Ω), it can be directly determined that a short circuit occurs between the two electrode contacts.

[0102] After determining the contact conditions between different electrode contacts and the patient's body, it may be necessary to determine specific electrode contacts with poor contact according to different contact conditions. The present invention also provides a method for determining electrode contacts with poor contact.

[0103] Fig. 9 A flow chart of a method for adjusting electrode contacts for outputting therapeutic pulses provided by an exemplary embodiment of the present invention. In some embodiments, Fig. 9 The illustrated method may be executed by a controller.

[0104] like Fig.10 As shown, the method may include the following steps:

[0105] S410, measuring a second impedance value between a first electrode contact and a fifth electrode contact on an electrode lead of an implantable electrical stimulation device.

[0106] S420: Compare the second impedance value with the first threshold.

[0107] S430: When the second impedance value is not greater than the first threshold, determine that the second electrode contact is in poor contact with the patient's body.

[0108] S440. When the second impedance value is greater than the first threshold, measure a third impedance value between the second electrode contact and the fifth electrode contact on the electrode lead of the implantable electrical stimulation device.

[0109] S450: Compare the third impedance value with the first threshold value to determine whether the third impedance value exceeds the first threshold value.

[0110] S460: When the third impedance value is not greater than the first threshold, determine that the first electrode contact is in poor contact with the body.

[0111] S470: When the third impedance value is greater than the first threshold value, determine that both the first electrode contact and the second electrode contact are in poor contact with the body.

[0112] The fifth electrode contact may be an electrode contact in an electrode contact group different from the electrode contact group in which the first electrode contact and the second electrode contact are located.

[0113] The second impedance value may be an actual impedance value of the patient's body between the first electrode contact and the fifth electrode contact, and correspondingly, the third impedance value is an actual impedance value of the patient's body between the second electrode contact and the fifth electrode contact on the electrode lead.

[0114] Since the distance will also affect the impedance value to a certain extent, the fifth electrode contact can be selected from the electrode contact group adjacent to the first electrode contact group. For example, if the first electrode contact is an electrode contact in the electrode contact group 11b, then the electrode contact in the electrode contact group 11c can be selected as the fifth electrode contact as the reference electrode contact to reduce the error. The specific process of determining the contact status according to the impedance value can be seen in Figure 6-Figure 9 And the related description will not be repeated here.

[0115] Fig.11 This is a system module diagram of a control device for an implantable electrical stimulation device provided in some embodiments of the present application.

[0116] like Fig.10 As shown, the device 500 for controlling an implantable electrical stimulation device to output pulses may include an acquisition module 510 , a measurement module 520 , a determination module 530 and an adjustment module 540 .

[0117] The acquisition module 510 may be used to acquire characteristic values ​​of the waveform of the ECAP signal of the patient's body based on the current posture.

[0118] The measurement module 520 can be used to measure in real time the first impedance value between the first electrode contact and the second electrode contact on the electrode lead of the implantable electrical stimulation device, wherein the first impedance value is the actual impedance value of the patient's body located between the first electrode contact and the second electrode contact, and the first electrode contact and the second electrode contact are in different electrode contact groups for outputting pulses.

[0119] The determination module 530 may be used to determine the contact conditions between the first electrode contact and the second electrode contact and the patient's body based on the first impedance value, and determine whether to switch different electrode contacts to output pulses according to the contact conditions and the characteristic value;

[0120] The switching module 540 can be used to switch to the third electrode contact and the fourth electrode contact to transmit the pulse to the body when it is determined to switch to different electrode contacts to output the pulse.

[0121] In some embodiments, the measurement module 520 can also be used to measure the measured voltage value between the first electrode contact and the second electrode contact; measure the measured current value between the first electrode contact and the second electrode contact; and obtain the impedance value between the first electrode contact and the second electrode contact based on the measured voltage value and the measured current value.

[0122] In some embodiments, the acquisition module is used to obtain the characteristic value of the waveform of the ECAP signal in the current posture, calculate the difference between the characteristic value of the waveform of the currently acquired ECAP signal and the characteristic value of the waveform of the target ECAP signal (the waveform of the ECAP signal fed back under the optimal stimulation parameters), and the determination module 530 is used to compare the difference with a third threshold (the range that the patient can tolerate), which can be understood as the sensitivity range of the ECAP signal waveform. If the difference exceeds the third threshold, the switching module 540 is used to switch different electrode contacts to output electrical stimulation pulses, and the stimulation parameter value is adjusted accordingly to achieve precise stimulation, thereby ensuring the treatment effect while reducing the frequency of switching electrode contacts and reducing energy consumption.

[0123] In some embodiments, the determination module 530 can also be used to determine to switch different electrode contacts to output pulses when at least one of the first electrode contact and the second electrode contact is not in contact with the patient's body; and to compare the characteristic value with a third threshold value when at least one of the first electrode contact and the second electrode contact partially contacts the patient's body and one of the other electrode contacts in the corresponding electrode contact group partially contacts the patient's body.

[0124] In some embodiments, the determination module 530 can be used to compare the first impedance value with a first threshold; when the first impedance value is greater than the first threshold, it is determined that at least one of the first electrode contact and the second electrode contact is in poor contact with the patient's body.

[0125] In some embodiments, the determination module 530 can also be used to measure a second impedance value between a first electrode contact and a fifth electrode contact on an electrode lead of an implantable electrical stimulation device, wherein the second impedance value is an actual impedance value of the patient's body located between the first electrode contact and the fifth electrode contact, and the first electrode contact and the fifth electrode contact are in different electrode contact groups, for outputting pulses; comparing the second impedance value with a first threshold; when the second impedance value is not greater than the first threshold, determining that the second electrode contact is in poor contact with the body; when the second impedance value is greater than the first threshold, measuring a third impedance value between the second electrode contact and the fifth electrode contact on the electrode lead of the implantable electrical stimulation device, wherein the third impedance value is an actual impedance value of the patient's body located between the second electrode contact and the fifth electrode contact, and the second electrode contact and the fifth electrode contact are in different electrode contact groups, for outputting pulses; comparing the third impedance value with the first threshold; when the third impedance value is not greater than the first threshold, determining that the first electrode contact is in poor contact with the body; when the third impedance value is greater than the first threshold, determining that both the first electrode contact and the second electrode contact are in poor contact with the body.

[0126] It should be understood that the specific working processes and functions of the acquisition module 510, the measurement module 520, the determination module 530 and the switching module 540 in the above embodiment can refer to the above Figures 5 to 10 The description of the control method of the implantable electrical stimulation device provided in the embodiment will not be repeated here to avoid repetition.

[0127] Fig.12 An implantable electrical stimulation device 600 provided in one embodiment of the present application includes: a processor 610, and a storage medium 620, wherein the storage medium 620 stores a program, and when the program is executed by the processor 610, the processor 610 executes the method for controlling the output pulse of the implantable electrical stimulation device provided in the above embodiment.

[0128] An embodiment of the present disclosure further provides a storage medium storing a program, which, when executed by a processor, enables the processor to execute the method for controlling an implantable electrical stimulation device to output pulses provided in the above embodiment.

[0129] It should be understood that the term “including” and its variations used in the present disclosure are open inclusions, ie, “including but not limited to.” The term “one embodiment” means “at least one embodiment,” and the term “another embodiment” means “at least one additional embodiment.”

[0130] It should be noted that the various specific technical features (elements) described in the above specific embodiments can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present disclosure will not further describe various possible combinations.

[0131] Those of ordinary skill in the art will appreciate that the units or modules of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this disclosure.

[0132] In the several embodiments provided in the present disclosure, it should be understood that the disclosed systems and devices can be implemented in other ways. For example, the device embodiments described above are only schematic. For example, the division of the units or modules is only a logical function division. There may be other division methods in actual implementation, such as multiple units or modules can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, and the indirect coupling or communication connection of units or modules can be electrical or other forms.

[0133] In addition, each functional unit or module in each embodiment of the present disclosure may be integrated into one processing unit or module, or each unit or module may exist physically separately, or two or more units or modules may be integrated into one unit or module.

[0134] The above is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any changes or substitutions that can be thought of by any technician familiar with the technical field within the technical scope disclosed in the present disclosure should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

1. An implantable electrical stimulation device comprising: Controller, An impedance detection device, connected to the controller, for detecting the impedance value between the electrode contacts; a stimulation circuit configured to generate pulses and output the pulses through the electrode contacts on the electrode leads; A switch circuit, connected between the controller and the electrode lead, configured to connect the electrode contact to the stimulation circuit under the control of the controller to switch different electrode contacts to output pulses; The acquisition circuit is electrically connected to the controller and is configured to receive an evoked compound action potential (ECAP) signal generated by the pulse emitted by the stimulation circuit to stimulate the patient's body after the controller controls the stimulation circuit and the acquisition circuit to be connected to the electrode contact. Wherein, the controller is configured to perform the following steps: Acquire a characteristic value of a waveform of an ECAP signal of the patient's body in a current posture; The impedance detection device measures in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device, wherein the first impedance value is an actual impedance value of the patient's body located between the first electrode contact and the second electrode contact, and the first electrode contact and the second electrode contact are located in different electrode contact groups, for outputting pulses; determining contact conditions between the first electrode contact and the second electrode contact and the body based on the first impedance value; Determining whether to switch different electrode contacts to output the pulse according to the contact condition and the characteristic value; and When it is determined to switch different electrode contacts, the pulse is delivered to the body by switching to the third electrode contact and the fourth electrode contact through the switch circuit.

2. The implantable electrical stimulation device according to claim 1, characterized in that: The determining, based on the first impedance value, the contact status between the first electrode contact and the second electrode contact and the body comprises: comparing the first impedance value with a first threshold; When the first impedance value is greater than the first threshold value, it is determined that at least one of the first electrode contact and the second electrode contact is in poor contact with the body.

3. The implantable electrical stimulation device according to claim 2, characterized in that When the first impedance value is greater than the first threshold, determining that at least one of the first electrode contact and the second electrode contact has poor contact with the body includes: When the first impedance value is greater than the first threshold value and less than the second threshold value, it is determined that at least one of the first electrode contact and the second electrode contact partially contacts the body, or at least one of the first electrode contact and the second electrode contact partially contacts the body while one of the other electrode contacts in the corresponding electrode contact group partially contacts the body; When the first impedance value is greater than the second threshold, it is determined that at least one of the first electrode contact and the second electrode contact is not in contact with the body.

4. The implantable electrical stimulation device according to claim 3, characterized in that The determining whether to switch different electrode contacts to output the pulse according to the contact condition and the characteristic value comprises: When the first impedance value is greater than a second threshold, determining to switch different electrode contacts to deliver the pulse; When the first impedance value is greater than a first threshold value and less than a second threshold value, the characteristic value is compared with a third threshold value, and when the characteristic value is greater than the third threshold value, it is determined to switch different electrode contacts to deliver the pulse.

5. The implantable electrical stimulation device according to claim 4, characterized in that The switching of different electrode contacts to deliver the pulses comprises: Determine a new electrode contact for outputting the pulse according to the impedance values ​​of other electrode contacts of the electrode contact group where the electrode contact currently outputting the pulse is located; The electrode contact currently outputting the pulse is switched to the new electrode contact outputting the pulse.

6. The implantable electrical stimulation device according to claim 1, characterized in that The controller is also configured to: Measuring a second impedance value between the first electrode contact and the fifth electrode contact on the electrode lead of the implantable electrical stimulation device by the impedance measuring device, wherein the second impedance value is an actual impedance value of the patient's body located between the first electrode contact and the fifth electrode contact, and the first electrode contact and the fifth electrode contact are located in different electrode contact groups, for outputting pulses; comparing the second impedance value with the first threshold; When the second impedance value is not greater than the first threshold, it is determined that the second electrode contact is in poor contact with the body.

7. The implantable electrical stimulation device according to claim 6, characterized in that The controller is also configured to: When the second impedance value is greater than the first threshold value, measuring a third impedance value between the second electrode contact and the fifth electrode contact on the electrode lead of the implantable electrical stimulation device by the impedance measuring device, wherein the third impedance value is an actual impedance value of the patient's body located at the second electrode contact and the fifth electrode contact, and the second electrode contact and the fifth electrode contact are located in different electrode contact groups, and are used to output pulses; comparing a third impedance value with the first threshold; When the third impedance value is not greater than the first threshold value, determining that the first electrode contact is in poor contact with the body; When the third impedance value is greater than the first threshold value, it is determined that both the first electrode contact and the second electrode contact are in poor contact with the body.

8. The implantable electrical stimulation device according to claim 1, characterized in that The step of obtaining the characteristic value of the waveform of the ECAP signal of the patient's body in the current posture includes: Determining a waveform of an ECAP signal of the aircraft body in a current posture; The characteristic value of the waveform is extracted based on a deep learning algorithm.

9. The implantable electrical stimulation device according to claim 1, characterized in that The step of measuring in real time by the impedance measuring device a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device comprises: measuring a measured voltage value between the first electrode contact and the second electrode contact; measuring a measured current value between the first electrode contact and the second electrode contact; An impedance value between the first electrode contact and the second electrode contact is obtained based on the measured voltage value and the measured current value.

10. A control method for an implantable electrical stimulation device, characterized in that: include: Obtaining characteristic values ​​of the waveform of the ECAP signal of the patient's body in the current posture; measuring in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device, wherein the first impedance value is an actual impedance value of the patient's body located between the first electrode contact and the second electrode contact, and the first electrode contact and the second electrode contact are located in different electrode contact groups, for outputting pulses; determining contact conditions between the first electrode contact and the second electrode contact and the body based on the first impedance value; Determining whether to switch different electrode contacts to output the pulse according to the contact condition and the characteristic value; and When it is determined to switch different electrode contacts, the third electrode contact and the fourth electrode contact are switched to deliver the pulse to the body.

11. A control device for an implantable electrical stimulation device, characterized in that: The device comprises: An acquisition module, the acquisition module being configured to acquire a characteristic value of a waveform of an ECAP signal of a patient's body in a current posture; A measuring module, the measuring module being configured to measure in real time a first impedance value between a first electrode contact and a second electrode contact on an electrode lead of the implantable electrical stimulation device, the first impedance value being an actual impedance value of a body of the patient located between the first electrode contact and the second electrode contact, the first electrode contact and the second electrode contact being located in different electrode contact groups, and being used to output pulses; a determination module, the determination module being configured to determine a contact condition between the first electrode contact and the second electrode contact and the body based on the first impedance value, and to determine whether to switch different electrode contacts to output the pulse according to the contact condition and the characteristic value; Switching module: The switching module is configured to switch to the third electrode contact and the fourth electrode contact to transmit the pulse to the body when it is determined to switch to different electrode contacts to output the pulse.

12. An implantable electrical stimulation system, characterized in that: include: An implantable electrical stimulation device as claimed in claims 1 to 9; Electrode leads are connected to the implantable electrical stimulation device and are used to deliver pulses to the patient's body.

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