WO2023193564A1

WO2023193564A1 - Impedance measurement apparatus and system and computer-readable storage medium

Info

Publication number: WO2023193564A1
Application number: PCT/CN2023/080145
Authority: WO
Inventors: 陈晶华; 朱为然
Original assignee: 苏州景昱医疗器械有限公司
Priority date: 2022-04-08
Filing date: 2023-03-07
Publication date: 2023-10-12
Also published as: CN114732392A

Abstract

Provided are an impedance measurement apparatus (200) and system and a computer-readable storage medium for measuring an impedance of an organism tissue between electrode contacts of an implantable medical device. The impedance measurement apparatus (200) is configured for: setting the implantable medical device to output an electrical stimulation at a preset voltage in a voltage mode, the preset voltage enabling the normal output of a stimulation waveform (S101); measuring a measured voltage between a first electrode contact and a second electrode contact of the implantable medical device, the first electrode contact and the second electrode contact being located on electrode wires at the same side or electrode wires on different sides, or being respectively located on the electrode wire and a housing of a pulse generator (S102); measuring a current between the first electrode contact and the second electrode contact (S103); and on the basis of the measured voltage and the current, acquiring an impedance between the first electrode contact and the second electrode contact (S104). The acquired impedance can be used to determine The connectivity of an in-vivo conductive path, thus avoiding the communication fault of the device and enhancing the reliability.

Description

Impedance measurement device, system and computer-readable storage medium

This application claims priority to the Chinese patent with application number 202210370055.6 submitted on April 8, 2022. The above Chinese patent is incorporated by reference in full.

Technical field

The present application relates to the technical field of implantable medical devices, such as impedance measurement devices, systems and computer-readable storage media.

Background technique

After the electrodes of implantable medical devices are implanted in the brain, it is necessary to measure the impedance of the biological tissue between the electrode contacts to determine the connectivity of the conductive paths in the body (to determine whether there is a short circuit or open circuit); if the electrode contacts are in If there is a short circuit in the conductive path in the body, the electrical stimulation output by it may produce excessive current, which may cause damage to the biological tissues receiving specific stimulation or the tissues that directly contact the electrode contacts at the short circuit; if the electrode contacts are located When there is a break in the conductive path in the body, the electrical stimulation output by it will not be transmitted to the target area, but will be output directly at the electrode contact at the break, so it cannot produce effective treatment for the target biological tissue; in order to avoid implantable medical equipment If the conductive paths in the body where the electrode contacts are located have connectivity failures such as short circuit or open circuit, which will have adverse effects of ineffective treatment, it is very important to measure the impedance of the electrode contacts of implantable medical devices.

In the related art, the impedance measurement method of implantable medical equipment adopts a constant current measurement method. For example, the electrode circuit is fixedly outputting a current of 2 milliamperes (mA), and the amplitude of the voltage between the electrode contacts is measured. The resulting voltage amplitude The ratio to the fixed current value is the impedance value of the biological tissue between the electrode contacts; however, there is a deviation between the fixed current value used in the calculation of this measurement method and the true current value of the actual electrode circuit, so The obtained impedance value between the electrode contacts also has a certain error; secondly, the constant current measurement method has a small measurement range. For example, when the measured value of the voltage amplitude between the electrode contacts is greater than 2.5 k Ohm (KΩ), it is necessary to change the fixed output current value of the electrode circuit to 1mA for re-measurement, in order to increase the measurement range of the impedance value to the measurement range with the maximum impedance value of about 6.5KΩ; therefore, use constant current measurement This method of measuring the impedance of the electrode contacts has the disadvantages of having errors in the impedance value and a limited measurement range.

Patent CN111770774A discloses a neural interface device for stimulating nerves and measuring impedance. The system includes: a neural interface device including a plurality of electrodes for electrically contacting the nerves; voltage or electricity a current source operatively connected to at least a subset of the electrodes, wherein the voltage or current source is configured to generate an electrical signal to be applied to the subset of electrodes; an impedance measurement module operatively connected to at least a subset of the electrodes, wherein the impedance measurement module is configured to measure impedance between the subset of electrodes; and a controller arranged to measure impedance via the electrical conductor based on the measured impedance. The signal determines the amplitude of the action potential induced in the nerve, and the electrical signal is modulated so as to induce an action potential with a target amplitude. This technical solution does not consider whether the stimulation waveform can be output normally when the electrical signal is applied, and the measured impedance value may be under an abnormal stimulation waveform, and there is a certain deviation from the impedance value under the normal stimulation waveform.

Patent CN110325241A discloses a device and method for setting stimulation parameters of a cochlear implant system based on electrode impedance measurement values. The device includes: at least one physical computing component, and the at least one physical computing component indicates that the cochlear implant is included in the cochlear implant system. A cochlear implant within the system and implanted in the patient's body generates an electrical stimulation current at a predetermined current level and applies the electrical stimulation to the patient via electrodes coupled to the cochlear implant an electric current; while applying the electrical stimulation current to the patient via the electrode, instructing the cochlear implant to measure a voltage level associated with the electrode; based on a predetermined current level and a measured determining the impedance of the electrode by the voltage level; identifying a predetermined stimulation parameter adjustment constraint; and automatically adjusting an adjustment associated with the cochlear implant system based on the impedance of the electrode and in accordance with the predetermined stimulation parameter adjustment constraint associated stimulation parameters. This technical solution measures the impedance value in the constant current stimulation mode, but in the actual treatment process, the voltage mode is mostly used. There is a certain deviation between the impedance value under constant current stimulation and the impedance value under constant voltage stimulation.

Patent CN102917639B discloses a device for measuring interface impedance between the body and stimulation electrodes, including: a first electrode connected to some cells in the body; a second electrode connected to other cells in the body to provide the current applied by the stimulator to the first electrode through the cell; a measurement unit for selectively extracting the load on the first electrode depending on the current applied to the first electrode and the second electrode a voltage on the first electrode and the second electrode; a charge storage unit that stores a relative potential corresponding to the voltage difference between the first electrode and the second electrode to the charge storage unit; A /D conversion unit for converting a signal corresponding to the relative potential into a digital signal and for outputting the digital signal; and an impedance calculation unit for converting a signal corresponding to the relative potential into a digital signal based on the digital signal output from the A/D conversion unit. signal and the current applied to the second electrode to calculate the interface impedance of the first electrode and the second electrode. This technology utilizes induction at both ends of each electrode implanted in a living body. The voltage difference and the current stimulation signal applied to the pair of electrodes are used to measure the changes in the impedance of the electrodes in real time according to the implantation period and environment. It does not consider the use of interface impedance to detect whether there is a short circuit or connectivity failure such as a short circuit in the conductive path in the body.

Patent CN108635669A discloses an impedance measurement device and method based on deep brain stimulator electrodes, including a pulse emission circuit, a signal amplification circuit, an analog-to-digital conversion circuit, a processing controller, an electrode port selection module and several deep brain stimulator electrodes, wherein , the output end of the processing controller is connected to the control end of the pulse emission circuit and the control end of the electrode port selection module, the output end of the pulse emission circuit is connected to each deep brain stimulator electrode through the electrode port selection module, and the signal amplification circuit The input end is connected to each deep brain stimulator electrode through the electrode port selection module, and the output end of the signal amplifier circuit is connected to the processing controller through the analog-to-digital conversion circuit; the processing controller controls the pulse emission circuit to emit current through the deep brain stimulator electrodes. Pulse signal or voltage pulse signal, the processing controller collects the voltage signal or current signal on the deep brain stimulator electrode through the analog-to-digital conversion circuit and the signal amplification circuit to calculate the contact impedance value between the two electrodes and the brain tissue, the contact impedance value between the single electrode and the brain tissue. The contact impedance value between brain tissues and the impedance value between brain tissues determine the contact effect between the deep brain stimulator electrode and the brain tissue, and provide data support for setting stimulation parameters. However, this patent does not consider that the measurement method used has a small measurement range, and does not perform numerical division and re-measurement operations on the measured impedance values.

In order to avoid connectivity failures such as short circuits or open circuits in the body's conductive paths of implantable medical devices, which may lead to adverse effects of ineffective treatment, and at the same time reduce possible errors during the impedance measurement process and expand the measurement range, this application provides an impedance measurement device and method. and computer-readable storage media to enhance the stability and reliability of implantable medical devices.

Contents of the invention

The purpose of this application is to provide an impedance measurement device, system and computer-readable storage medium to avoid short circuits or open circuits and other connectivity failures in the body's conductive paths of implantable medical devices, resulting in the adverse effects of ineffective treatment, and at the same time reduce the risk of ineffective treatment during the impedance measurement process. Possible errors and expanded measurement range.

The purpose of this application is achieved using the following technical solutions:

In a first aspect, the present application provides an impedance measurement device for measuring the impedance of biological tissue between electrode contacts of an implantable medical device, the impedance measurement device being configured to:

The implantable medical device is configured to output electrical stimulation at a preset voltage value in voltage mode, and the preset voltage value enables normal output of the stimulation waveform;

Measure the actual voltage value between the first electrode contact and the second electrode contact of the implantable medical device, and the first electrode contact and the second electrode contact are located on the same side of the electrode lead or on the opposite side. The electrode lead on the side, or the first electrode contact and the second electrode contact are respectively located on the electrode lead and the housing of the pulse generator of the implantable medical device;

measuring the 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 current value, and the impedance value is one of the electrode contacts of the implantable medical device. impedance between biological tissues.

In a possible implementation, the first electrode contact and the second electrode contact are any two electrode contacts in one side of the electrode lead of the implantable medical device.

In a possible implementation, the impedance measurement device is further configured to:

If the measured voltage value is not within the floating range of the preset voltage value, the impedance value is set to a preset error identification value, and the error identification value is used to indicate an impedance measurement error this time.

Based on the preset impedance comparison value, obtain the comparison result between the impedance value and the impedance comparison value;

Based on the comparison result, the preset voltage value is adjusted, and the impedance value between the first electrode contact and the second electrode contact corresponding to the impedance value is re-measured.

Correct the impedance value;

The impedance value is written into the memory of the implantable medical device.

In a possible implementation, the impedance measuring device is further configured to correct the impedance value in the following manner:

Determine the current corresponding impedance offset value of the implantable medical device;

The impedance value is corrected based on the impedance offset value.

Impedance values between multiple groups of first electrode contacts and second electrode contacts are measured sequentially.

When the implantable medical device sets stimulation parameters, impedance measurement is performed, and the stimulation parameters include the working mode of the implantable medical device and its corresponding one or more working parameters; or,

Before the implantable medical device outputs electrical stimulation, an impedance measurement is performed.

In a second aspect, this application provides an impedance measurement system for measuring the impedance of biological tissue between electrode contacts of an implanted medical device. The impedance measurement system includes:

A device for setting the implantable medical device to output electrical stimulation at a preset voltage value in voltage mode, and the preset voltage value enables normal output of the stimulation waveform;

Device for measuring the measured voltage value between the first electrode contact and the second electrode contact of the implantable medical device, the first electrode contact and the second electrode contact being located on the same side The electrode lead or the electrode lead on the opposite side, or the first electrode contact and the second electrode contact are respectively located on the electrode lead and the housing of the pulse generator of the implantable medical device;

A device for measuring the current value between the first electrode contact and the second electrode contact;

Device for obtaining an impedance value between the first electrode contact and the second electrode contact based on the measured voltage value and the current value, the impedance value being the value of the implantable medical device The impedance of biological tissue between electrode contacts.

In a possible implementation, the impedance measurement system further includes:

A device for setting the impedance value to a preset error identification value when the actual measured voltage value is not within the floating range of the preset voltage value, and the error identification value is used to indicate an impedance measurement error this time .

A device for obtaining a comparison result between the impedance value and the impedance comparison value based on a preset impedance comparison value;

A device for adjusting the preset voltage value based on the comparison result, and re-testing the impedance value between the first electrode contact and the second electrode contact corresponding to the impedance value.

Device for correcting said impedance value;

Means for writing the impedance value into the memory of the implantable medical device.

In a possible implementation, the impedance measurement system further includes the following sub-device to correct the impedance value:

A device for determining the current corresponding impedance offset value of the implantable medical device;

Sub-means for correcting the impedance value based on the impedance offset value.

A device for sequentially measuring impedance values between multiple groups of first electrode contacts and second electrode contacts.

In a possible implementation, the impedance measurement device further includes:

A device for performing impedance measurement when the implantable medical device sets stimulation parameters, the stimulation parameters including the working mode of the implantable medical device and its corresponding one or more working parameters; or,

A device for measuring impedance before the implantable medical device outputs electrical stimulation.

In a third aspect, the present application provides a computer-readable storage medium that stores a computer program. When the computer program is executed by a processor, the function of any of the above devices is implemented.

Using the impedance measurement device, system and computer-readable storage medium provided by this application has at least the following advantages:

Using a fixed voltage measurement method, the implantable medical device outputs electrical stimulation at a fixed voltage value in voltage mode, and the stimulation chip of the implantable medical device is used to measure and feedback the current stimulation voltage, which is the The actual measured voltage value between the first electrode contact and the second electrode contact; and using a sampling resistor and a current amplification unit to measure and feedback the stimulation current of the stimulation circuit, that is, the first electrode contact and the second electrode contact. The current value between the second electrode contact points; and then the impedance value between the first electrode contact point and the second electrode contact point is calculated, which is the electrode contact point of the implantable medical device The impedance value of the biological tissue between them; in this measurement method, even if a fixed voltage is used to output electrical stimulation, the stimulation voltage and stimulation current of the implanted medical device in the current state will be measured as all the parameters used in the calculation. Describe the actual measured voltage value and the current value to reduce the error caused by the deviation between the theoretical value and the actual measured value, and ensure the accuracy of the calculated impedance value; judge the electrode wires located on the same side or on the opposite side through the impedance value Whether the conductive path in the body where the electrode contact is located, or the conductive path in the body between the electrode lead and the pulse generator housing has a short circuit or open circuit, etc., to avoid the occurrence of excessive current value due to short circuit of the electrode contact. Damage to biological tissue or electrical stimulation due to disconnection of electrode contacts cannot be transmitted to the target area and treatment is ineffective, etc., thereby enhancing the stability and reliability of implantable medical devices. For example, the implantable medical device may be provided with an IPG (pulse generator), multiple extension leads, and multiple electrode leads. The IPG has a housing, and the IPG and each electrode lead may be connected through an extension lead. The multiple electrode leads can be located in the same side or opposite side. Implantable medical devices are, for example, deep brain stimulators. When the number of electrode leads is greater than 1, the multiple electrode leads may be located on the same side (both on the left brain or both on the right brain) or on opposite sides (one on the left brain and one on the right brain). in the right brain). Both electrode contacts can be located on the electrode lead (whether on the same side or on opposite sides), or one can be located on the electrode lead and the other on the IPG housing.

Description of the drawings

The present application will be further described below in conjunction with the accompanying drawings and examples.

Figure 1 is a schematic diagram of the operation flow of an impedance measurement device provided by an embodiment of the present application;

Figure 2 is a schematic diagram of a partial operation flow of an impedance measurement device provided by an embodiment of the present application;

Figure 3 is a partial operational flow diagram of another impedance measurement device provided by an embodiment of the present application;

Figure 4 is a partial operational flow diagram of yet another impedance measurement device provided by an embodiment of the present application;

Figure 5 is a schematic flowchart of correcting an impedance value provided by an embodiment of the present application;

Figure 6 is a partial operational flow diagram of yet another impedance measurement device provided by an embodiment of the present application;

Figure 7 is a partial operational flow diagram of yet another impedance measurement device provided by an embodiment of the present application;

Figure 8 is a schematic structural diagram of an impedance measurement device provided by an embodiment of the present application;

FIG. 9 is a schematic structural diagram of a program product for implementing an impedance measurement device provided by an embodiment of the present application.

Detailed ways

Below, the present application will be further described with reference to the accompanying drawings and specific embodiments. It should be noted that, on the premise that there is no conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments. .

Below, one of the application fields of the embodiments of the present application (namely, the implantable neurostimulator) will be briefly described.

The implantable neurostimulation system (a type of neurostimulation system) mainly includes a stimulator implanted in the patient's body (i.e., an implantable neurostimulator, a type of neurostimulator) and a programmable controller installed outside the patient's body. Relevant neuromodulation technology mainly involves implanting electrodes in specific parts of the body's tissues (i.e., target points) through stereotaxic surgery, and a stimulator implanted in the patient's body sends electrical pulses to the target point through the electrodes to regulate the corresponding neural structures. And the electrical activity and functions of the network, thereby improving symptoms and relieving pain. Among them, the stimulator can be an implantable nerve electrical stimulation device, an implantable cardiac electrical stimulation system (also known as a pacemaker), or an implantable drug. Any one of the infusion device (Implantable Drug Delivery System, IDDS for short) and the lead adapter device. Implantable neuroelectric stimulation devices include, for example, Deep Brain Stimulation (DBS), Cortical Nerve Stimulation (CNS), and Spinal Cord stimulation systems. Stimulation, referred to as SCS), implanted sacral nerve electrical stimulation system (Sacral Nerve Stimulation, referred to as SNS), implanted vagus nerve electrical stimulation system (Vagus Nerve Stimulation, referred to as VNS), etc.

The stimulator may include an IPG and electrode module. The electrode module may include electrode leads and may also include extension leads. IPG (implantable pulse generator, implantable pulse generator) is installed in the patient's body. The IPG can include a control module and receive program control instructions sent by the program controller. IPG relies on sealed batteries and circuits to provide controllable electrical stimulation energy to biological tissues. Through implanted electrode modules, it delivers one or two controllable specific electrical stimulations to specific areas of biological tissues. The extension lead is used in conjunction with the IPG as a transmission medium for electrical stimulation signals to transmit the electrical stimulation signals generated by the IPG to the electrode leads. Electrode leads deliver electrical stimulation to specific areas of biological tissue through multiple electrode contacts. It can be understood that the stimulator is provided with one or more electrode leads on one or both sides, and multiple electrode contacts are provided on the electrode leads. The electrode contacts can be evenly or non-uniformly arranged in the circumferential direction of the electrode leads. As an example, the electrode contacts may be arranged in an array of 4 rows and 3 columns (12 electrode contacts in total) in the circumferential direction of the electrode lead. Electrode contacts may include stimulation contacts and/or collection contacts. The electrode contacts may be in the shape of, for example, a sheet, a ring, a dot, or the like.

In some possible ways, the stimulated biological tissue may be the patient's brain tissue, and the stimulated site may be a specific part of the brain tissue. When patients have different types of diseases, the stimulated parts are generally different, the number of stimulation contacts used (single source or multiple sources), one or more channels (single channel or multi-channel) specific electrical stimulation signals The application and stimulation parameter data are also different. The embodiments of this application do not limit the applicable disease types, which may be the disease types applicable to deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among them, the types of diseases that DBS can be used to treat or manage include, but are not limited to: spastic diseases (eg, epilepsy), pain, migraine, mental illness (eg, major depressive disorder (MDD)), bipolar disorder, anxiety disorder, Post-traumatic stress disorder, mild depression, obsessive-compulsive disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental status disorders, mobility disorders (e.g., essential tremor or Parkinson's disease), Huntington's disease, Alzheimer's disease Alzheimer's disease, drug addiction, autism or other neurological or psychiatric diseases and impairments.

In the embodiment of the present application, when the program controller and the stimulator establish a program-controlled connection, the program controller can be used to adjust the stimulation parameters of the stimulator (different stimulation parameters correspond to different electrical stimulation signals), and the stimulator can also be used to sense the deep brain of the patient. The bioelectrical activity is used to collect electrophysiological signals, and the stimulation parameters of the electrical stimulation signal of the stimulator can be continuously adjusted through the collected electrophysiological signals.

Stimulation parameters can include: frequency (for example, the number of electrical stimulation pulse signals per unit time 1 s, the unit is Hz), pulse width (the duration of each pulse, the unit is μs), amplitude (generally expressed in voltage, that is, The intensity of each pulse, 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), physician control upper limit One or more of the upper and lower limits (the range that the doctor can adjust) and the upper and lower limits of the patient's control (the range that the patient can adjust independently). In some possible ways, various stimulation parameters of the stimulator can be adjusted in current mode or voltage mode.

Referring to Figure 1, Figure 1 is a schematic diagram of the operation flow of an impedance measurement device provided by an embodiment of the present application. An embodiment of the present application provides an impedance measurement device for measuring the impedance of biological tissue between electrode contacts of an implantable medical device. The impedance measurement device is configured to:

Step S101: Set the implantable medical device to output electrical stimulation at a preset voltage value in voltage mode, and the preset voltage value can enable the stimulation waveform to be output normally;

Step S102: Measure the actual voltage value between the first electrode contact and the second electrode contact of the implantable medical device. The first electrode contact and the second electrode contact are located on the same side of the electrode. The wire or the electrode lead on the opposite side, or the first electrode contact and the second electrode contact are respectively located on the electrode lead and the housing of the pulse generator of the implantable medical device;

Step S103: Measure the current value between the first electrode contact and the second electrode contact;

Step S104: Obtain an impedance value between the first electrode contact and the second electrode contact based on the measured voltage value and the current value, where the impedance value is an electrode of the implantable medical device The resistance of biological tissue between contacts.

Using a fixed voltage measurement method, the implantable medical device outputs electrical stimulation at a fixed voltage value in voltage mode, and the stimulation chip of the implantable medical device is used to measure and feedback the current stimulation voltage, which is the The actual measured voltage value between the first electrode contact and the second electrode contact; and using a sampling resistor and a current amplification unit to measure and feedback the stimulation current of the stimulation circuit, that is, the first electrode contact and the second electrode contact. the current value between the second electrode contact; and then calculate the first electrode contact and the second electrode The impedance value between the electrode contacts is the impedance value of the biological tissue between the electrode contacts of the implantable medical device; in this measurement method, even if a fixed voltage is used to output electrical stimulation, all the parameters will be measured during the measurement. The stimulation voltage and stimulation current of the implantable medical device in the current state are used as the measured voltage value and the current value used in the calculation, thereby reducing the error caused by the deviation between the theoretical value and the actual measured value, and ensuring that all calculations are accurate. The accuracy of the impedance value; use the impedance value to determine whether the conductive path in the body where the electrode contact of the electrode lead on the same side or on the opposite side is located, or whether the conductive path in the body between the electrode lead and the pulse generator housing has a short circuit Or open circuit and other connectivity failures, to avoid the impact of excessive current value causing damage to biological tissues due to short circuit of electrode contacts, or ineffective treatment due to electrical stimulation being unable to be transmitted to the target area due to open circuit of electrode contacts, thereby enhancing implantation stability and reliability of implantable medical devices. For example, the implantable medical device may be provided with an IPG (pulse generator), multiple extension leads, and multiple electrode leads. The IPG has a housing, and the IPG and each electrode lead may be connected through an extension lead. The multiple electrode leads Can be on the same side or different sides. Implantable medical devices are, for example, deep brain stimulators. When the number of electrode leads is greater than 1, the multiple electrode leads may be located on the same side (both on the left brain or both on the right brain) or on opposite sides (one on the left brain and one on the right brain). in the right brain). Both electrode contacts can be located on the electrode lead (whether on the same side or on opposite sides), or one can be located on the electrode lead and the other on the IPG housing.

In some possible embodiments, the preset voltage value is, for example, 1 volt (V), 1.5V, 1.75V, 2V, etc.;

In a possible embodiment, the preset voltage value is, for example, 1 volt (V). When the voltage value of 1V is output, the impedance between the first electrode contact and the second electrode contact is measured. The value can not only ensure the normal output of the stimulation waveform, but also ensure the safety of the biological tissue receiving electrical stimulation when a connectivity failure occurs in the conductive path in the body.

In a possible embodiment, the impedance value between the first electrode contact and the second electrode contact is obtained based on the measured voltage value and the current value, and the measured voltage can be used The impedance value is obtained as the ratio of the value to the current value (V/I). In a possible embodiment, the first electrode contact and the second electrode contact are any two electrode contacts in one side of the electrode lead of the implantable medical device.

Therefore, the implantable medical device has one or more electrode leads on one or both sides, and multiple electrode contacts are provided on the electrode leads. The electrode contacts can, for example, be evenly arranged on the electrode leads. Circumferentially (for example, an array of 4 rows and 3 columns, a total of 12 electrode contacts); when measuring the impedance value, you can By selecting any two electrode contacts on one side of the electrode wire for measurement, the electrode contacts that require impedance measurement can be measured in a targeted manner to improve measurement efficiency; in addition, when troubleshooting electrode contact faults, you can Select a regular arrangement and combination of electrode contacts for measurement to achieve accurate investigation.

In a possible embodiment, the first electrode contact and the second electrode contact may be electrode contact No. 1 and electrode contact No. 3 in the right electrode lead of the implantable medical device ; It can be the No. 1 electrode contact and the No. 2 electrode contact in the left electrode lead of the implantable medical device; It can be the No. 4 electrode contact in the left second electrode lead of the implantable medical device and No. 5 electrode contacts, etc.

Referring to Figure 2, Figure 2 is a schematic diagram of a partial operation flow of an impedance measurement device provided by an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to:

Step S105: If the measured voltage value is not within the floating range of the preset voltage value, set the impedance value to a preset error identification value, and the error identification value is used to indicate an impedance measurement error this time.

Therefore, when measuring the actual measured voltage value, the actual measured voltage value is compared with the preset voltage value. If the actual measured voltage value is not within the floating range of the preset voltage value, that is, the When the error in the actual measured voltage value is too large, the impedance value is set to a preset error identification value to indicate an error in the impedance measurement without calculation of the impedance value, thereby ensuring that the measured impedance value is accurate. The error is within the expected error range to avoid misjudgment of the connectivity of the conductive path in the body due to extremely inaccurate impedance values.

In a possible embodiment, if the actual measured voltage value is within the floating range of the preset voltage value, step S103 and step S104 are continued.

In a possible embodiment, the floating range of the preset voltage value may be: based on the preset voltage value, floating up and down within 400 millivolts (mV); may be: based on the preset voltage value The value can be used as a benchmark, floating within 200mV or below 300mV; it can be based on the preset voltage value, and the floating value should not exceed 300mV, etc.

In a possible embodiment, the preset voltage value is 1V, and the floating range of the preset voltage value is: based on the preset voltage value, it floats up and down within 400 millivolts (mV). If the preset voltage value is If the actual measured voltage value is 1.5V, then the actual measured voltage value is not within the floating range of the preset voltage value. At this time, the impedance value is set to a preset error identification value, for example, the impedance value is Set to 0xEFFF to indicate this impedance measurement error.

Referring to Figure 3, Figure 3 is a schematic diagram of a partial operation flow of another impedance measurement device provided by an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to:

Step S106: Based on the preset impedance comparison value, obtain the comparison result between the impedance value and the impedance comparison value;

Step S107: Based on the comparison result, adjust the preset voltage value, and re-measure the impedance value between the first electrode contact and the second electrode contact corresponding to the impedance value.

Therefore, the preset voltage value is first used to measure the impedance value between the first electrode contact and the second electrode contact, the impedance value is compared with the preset impedance comparison value, and then the impedance value is adjusted. The amplitude of the preset voltage value is used to re-measure the impedance value between the first electrode contact and the second electrode contact; in this way, by dividing the re-measurement interval of the impedance, a sufficiently large value can be obtained The claimed impedance value measurement range is conducive to accurately and quickly determining the short circuit or open circuit failure of the conductive path in the body where the electrode contact is located.

In a possible embodiment, the preset impedance comparison value may be 1500 ohms (Ω), 1 kiloohms (KΩ), 10KΩ, etc.

In a possible embodiment, the preset impedance comparison value may be 1500Ω, and the impedance value is compared with 1500Ω. The comparison result is that the impedance value is >1500Ω, or the impedance value is ≤1500Ω; if the comparison The result is that the impedance value is >1500Ω, adjust the preset voltage value to 3V, and retest the impedance value between the first electrode contact and the second electrode contact with an impedance value >1500Ω; if The comparison result is that the impedance value is ≤1500Ω, the preset voltage value is adjusted to 1.5V, and the impedance value between the first electrode contact and the second electrode contact with an impedance value of ≤1500Ω is re-measured.

In a possible embodiment, when the preset voltage value is adjusted to 3V, the measurable impedance value can be measured in a range of 40KΩ, which is helpful for determining whether the conductive path in the body where the electrode contact is located exists. Broken connectivity failure.

In a possible embodiment, when the preset voltage value is adjusted to 1.5V, the measured current value is relatively large, which is helpful for determining whether there is a short-circuit connectivity failure in the conductive path in the body where the electrode contact is located. .

Referring to FIG. 4 , FIG. 4 is a schematic diagram of a partial operation flow of yet another impedance measurement device provided by an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to:

Step S108: Correct the impedance value;

Step S109: Write the impedance value into the memory of the implantable medical device.

Therefore, since the electrical stimulation output passes through electronic components such as switch chips, the measured impedance value includes this part of the impedance value, so this part of the impedance value needs to be eliminated; thus, after the measurement is completed, all the impedance values are corrected. to ensure the authenticity and accuracy of the measured impedance value, and then save the corrected impedance value. Stored in the memory of the implantable medical device, the memory may be a Flash register, so that the impedance value can be called when the implanted medical device performs other operations.

Referring to Figure 5, Figure 5 is a schematic flowchart of correcting an impedance value according to an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to perform the operation of step S108 in the following manner:

Step S201: Determine the current corresponding impedance offset value of the implantable medical device;

Step S202: Correct the impedance value based on the impedance offset value.

Thus, the impedance value is corrected based on the preset impedance offset value under the current impedance measurement condition of the implanted medical device; the preset impedance offset value is, for example, preset under monopolar stimulation. Impedance offset value, preset impedance offset value under bipolar stimulation, etc., to ensure the accuracy of the impedance value.

For example, when the implanted medical device currently uses unipolar stimulation, it is determined that the current corresponding impedance offset value of the implanted medical device is the preset impedance offset value under unipolar stimulation; When the implantable medical device currently uses bipolar stimulation, it is determined that the current corresponding impedance offset value of the implantable medical device is the preset impedance offset value under bipolar stimulation.

The unipolar stimulation in the embodiment of the present application means that one of the first electrode contact and the second electrode contact is located on the electrode lead, and the other is located on the housing; the bipolar stimulation in the embodiment of the present application means that the first electrode contact Points and second electrode contacts are located on the electrode leads.

In a possible embodiment, the preset impedance offset value under unipolar stimulation may be 50Ω, 60Ω, 70Ω, etc.; the preset impedance offset value under bipolar stimulation may be 80Ω, 90Ω, 100Ω, etc.;

In a possible embodiment, the corrected impedance value = the impedance value - the offset value.

Referring to FIG. 6 , FIG. 6 is a partial operational flow diagram of yet another impedance measurement device provided by an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to:

Step S110: Measure impedance values between multiple groups of first electrode contacts and second electrode contacts in sequence.

Therefore, the impedance measuring device can sequentially measure the impedance values between multiple groups of the first electrode contacts and the second electrode contacts in one measurement operation, or can also set a specific electrode contact combination sequence. The impedance value measurement is performed multiple times in sequence, and the combination of each group of first electrode contacts and second electrode contacts is different; thus, the impedance value measurement requirements under different situations can be met, The operation of impedance value measurement is simplified and the measurement efficiency of the impedance measurement device is improved.

In a possible embodiment, the impedance measuring device sequentially measures between No. 1 and No. 2 electrode contacts, between No. 1 and No. 3 electrode contacts, and between No. 1 and No. 4 electrode contacts in one measurement operation. between the impedance values.

In a possible embodiment, the impedance measuring device measures the impedance value between electrode contacts No. 1 and 2 for the first time and measures No. 1 for the second time based on a preset specific electrode contact combination sequence. and the impedance value between electrode contacts No. 3, and measure the impedance value between electrode contacts No. 1 and No. 4 for the third time.

Referring to FIG. 7 , FIG. 7 is a schematic diagram of a partial operation flow of yet another impedance measurement device provided by an embodiment of the present application. In a possible embodiment, the impedance measurement device is further configured to:

Step S111: Perform impedance measurement when the implantable medical device sets stimulation parameters. The stimulation parameters include the working mode of the implantable medical device and its corresponding one or more working parameters; or,

Step S112: Before the implantable medical device outputs electrical stimulation, perform impedance measurement.

Therefore, when the implanted medical device sets stimulation parameters (such as the working mode of the implanted medical device and its corresponding one or more working parameters), the impedance measurement can be performed to ensure that the detected electrodes While the contacts are in a normal state, use the impedance value to design stimulation parameters; or perform impedance measurement before the implantable medical device outputs electrical stimulation to ensure that there is no short circuit or short circuit in the conductive path in the body where the electrode contacts are located. Connectivity failures such as circuit breaks ensure that the output electrical stimulation reaches the target biological tissue normally and provides effective treatment.

In a possible embodiment, the implanted medical device performs impedance measurement when the current mode is converted to the voltage mode.

In a possible embodiment, if the switch chip configuration is changed in the current mode of the implanted medical device, the impedance measurement is performed before the implanted medical device outputs electrical stimulation.

In a possible embodiment, if the implanted medical device switches to the off stimulation mode in the current mode, no impedance measurement is performed.

The embodiments of the present application also provide an impedance measurement system. Possible embodiments thereof are consistent with the embodiments described in the above embodiments of the impedance measurement device and achieve the same technical effects, and some details will not be described again.

An embodiment of the present application provides an impedance measurement system for measuring the impedance of biological tissue between electrode contacts of an implanted medical device. The impedance measurement system includes:

A device for setting the implantable medical device to output electrical stimulation at a preset voltage value in voltage mode Setting, the preset voltage value can make the stimulation waveform output normally;

In a possible embodiment, the first electrode contact and the second electrode contact are any two electrode contacts in one side of the electrode lead of the implantable medical device.

In a possible embodiment, the impedance measurement system further includes:

Device for correcting said impedance value;

In a possible embodiment, the impedance measurement system further includes the following sub-device to correct the impedance value:

In a possible embodiment, the impedance measurement system further includes:

In a possible embodiment, the impedance measurement device further includes:

Referring to Figure 8, Figure 8 is a schematic structural diagram of an impedance measurement device 200 provided by an embodiment of the present application, including one or more memories 210, one or more processors 220, and a bus 230 connecting different platform systems.

Memory 210 may include readable media in the form of volatile memory, such as random access memory (RAM) 211 and/or cache memory 212, and may further include read only memory (ROM) 213.

The memory 210 also stores a computer program, and the computer program can be executed by the processor 220, so that the processor 220 performs the above steps in the embodiment of the present application. The embodiment is the same as the embodiment described in the embodiment of the impedance measurement device. The technical effects achieved are the same, and some contents will not be repeated again.

Memory 210 may also include utilities 214 having one or more program modules 215, such program modules 215 including, but not limited to: an operating system, one or more application programs, other program modules, and program data, each of these examples. One or some combination may include the implementation of a network environment.

Correspondingly, the processor 220 can execute the above-mentioned computer program, and can execute the utility tool 214.

Bus 230 may be a local bus representing one or more of several types of bus structures, including a memory bus or memory controller, a peripheral bus, a graphics acceleration port, a processor, or using any of a variety of bus structures.

The impedance measurement device 200 may also communicate with one or more external devices 240 such as a keyboard, a pointing device, a Bluetooth device, etc., and may also communicate with one or more devices capable of interacting with the impedance measurement device 200, and/or with the device that enables the impedance measurement device 200 to communicate with the impedance measurement device 200. Impedance measurement device 200 can communicate with any device that communicates with one or more other computing devices (eg, router, modem, etc.). This communication may occur through the input/output interface 250. Furthermore, the impedance measurement device 200 may also communicate with one or more networks (eg, a local area network (LAN), a wide area network (WAN), and/or a public network, such as the Internet) through a network adapter 260. Network adapter 260 may communicate with other modules of impedance measurement device 200 via bus 230. It should be understood that, although not shown in the figures, other hardware and/or software modules may be used in conjunction with the impedance measurement device 200, including but not limited to: microcode, device drivers, redundant processors, external disk drive arrays, RAID systems, tapes Drives and data backup storage platforms, etc.

Embodiments of the present application also provide a computer-readable storage medium. The computer-readable storage medium is used to store a computer program. When the computer program is executed, the above steps in the embodiments of the present application are implemented. The embodiments thereof are consistent with the above impedance. The technical effects achieved by the embodiments described in the embodiments of the measuring device are the same, and some contents will not be described again.

Referring to FIG. 9 , FIG. 9 is a schematic structural diagram of a program product 300 for implementing an impedance measurement device provided by an embodiment of the present application. The program product 300 for implementing the impedance measuring device may be a portable compact disk read-only memory (CD-ROM) and include program code, and may be run on a terminal device, such as a personal computer. However, the program product 300 in the embodiment of the present application is not limited thereto. In the embodiment of the present application, the readable storage medium may be any tangible medium containing or storing a program, and the program may be used by or in conjunction with an instruction execution system, device or device.

In conjunction with. Program product 300 may take the form of any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. The readable storage medium may be, for example, but not limited to, an electrical, magnetic, optical, electromagnetic, infrared, or semiconductor system, device or device, or any combination thereof. Examples (non-exhaustive list) of readable storage media include: electrical connection with one or more conductors, portable disk, hard disk, random access memory (RAM), read only memory (ROM), erasable programmable Read-only memory (EPROM or flash memory), optical fiber, portable compact disk read-only memory (CD-ROM), optical storage device, magnetic storage device, or any suitable combination of the above.

A computer-readable storage medium may include a data signal propagated in baseband or as part of a carrier wave carrying the readable program code therein. Such propagated data signals may take many forms, including but not limited to electromagnetic signals, optical signals, or any suitable combination of the above. A readable storage medium may also be any readable medium that can transmit, propagate, or transport the program for use by or in connection with an instruction execution system, apparatus, or device. Program code contained on a readable storage medium may be transmitted using any appropriate medium, including but not limited to wireless, wired, optical cable, RF, etc., or any suitable combination of the above. The program code for performing the operations of the embodiments of the present application can be written in any combination of one or more programming languages, including object-oriented programming languages such as Java, C++, etc., and also includes conventional procedural programs. Design language such as C language or similar programming language. The program code may execute entirely on the user's computing device, partly on an associated device, as a stand-alone software package, partly on the user's computing device and partly on a remote computing device, or Executed entirely on a remote computing device or server. In situations involving remote computing devices, the remote computing device may be connected to the user computing device through any kind of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computing device, such as provided by an Internet service. (business comes via Internet connection).

Claims

An impedance measuring device used to measure the impedance of biological tissue between electrode contacts of an implantable medical device, the impedance measuring device is configured to:

The implantable medical device is configured to output electrical stimulation at a preset voltage value in voltage mode, and the preset voltage value enables normal output of the stimulation waveform;

Measure the actual voltage value between the first electrode contact and the second electrode contact of the implantable medical device, and the first electrode contact and the second electrode contact are located on the same side of the electrode lead or on the opposite side. The electrode lead on the side, or the first electrode contact and the second electrode contact are respectively located on the electrode lead and the housing of the pulse generator of the implantable medical device;

measuring the 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 current value, and the impedance value is one of the electrode contacts of the implantable medical device. impedance of living tissue.
The impedance measurement device according to claim 1, wherein the first electrode contact and the second electrode contact are any two electrode contacts in one side of the electrode lead of the implantable medical device.
The impedance measuring device according to claim 1, wherein the impedance measuring device is further configured to:

If the measured voltage value is not within the floating range of the preset voltage value, the impedance value is set to a preset error identification value, and the error identification value is used to indicate an impedance measurement error this time.
The impedance measuring device according to claim 1, wherein the impedance measuring device is further configured to:

Based on the preset impedance comparison value, obtain the comparison result between the impedance value and the impedance comparison value;

Based on the comparison result, the preset voltage value is adjusted, and the impedance value between the first electrode contact and the second electrode contact corresponding to the impedance value is re-measured.
The impedance measuring device according to claim 1, wherein the impedance measuring device is further configured to:

Correct the impedance value;

The impedance value is written into the memory of the implantable medical device.
The impedance measuring device according to claim 5, wherein the impedance measuring device is further configured to correct the impedance value in the following manner:

Determine the current corresponding impedance offset value of the implantable medical device;

The impedance value is corrected based on the impedance offset value.
The impedance measuring device according to claim 1, wherein the impedance measuring device is further configured to:

Impedance values between multiple groups of first electrode contacts and second electrode contacts are measured sequentially.
The impedance measuring device according to claim 1, wherein the impedance measuring device is further configured to:

When the implantable medical device sets stimulation parameters, impedance measurement is performed, and the stimulation parameters include the working mode of the implantable medical device and its corresponding one or more working parameters; or,

Before the implantable medical device outputs electrical stimulation, an impedance measurement is performed.
An impedance measurement system for measuring the impedance of biological tissue between electrode contacts of an implantable medical device, the impedance measurement system includes:

A device for setting the implantable medical device to output electrical stimulation at a preset voltage value in voltage mode, and the preset voltage value enables normal output of the stimulation waveform;

Device for measuring the measured voltage value between the first electrode contact and the second electrode contact of the implantable medical device, the first electrode contact and the second electrode contact being located on the same side The electrode lead or the electrode lead on the opposite side, or the first electrode contact and the second electrode contact are respectively located on the electrode lead and the housing of the pulse generator of the implantable medical device;

A device for measuring the current value between the first electrode contact and the second electrode contact;

Device for obtaining an impedance value between the first electrode contact and the second electrode contact based on the measured voltage value and the current value, the impedance value being the value of the implantable medical device The impedance of biological tissue between electrode contacts.
A computer-readable storage medium stores a computer program. When the computer program is executed by a processor, the functions of the device described in claims 1-8 are implemented.