CN218774182U - Implantable pulse generator, circuit system thereof, stimulator and medical system - Google Patents
Implantable pulse generator, circuit system thereof, stimulator and medical system Download PDFInfo
- Publication number
- CN218774182U CN218774182U CN202221915761.6U CN202221915761U CN218774182U CN 218774182 U CN218774182 U CN 218774182U CN 202221915761 U CN202221915761 U CN 202221915761U CN 218774182 U CN218774182 U CN 218774182U
- Authority
- CN
- China
- Prior art keywords
- board
- stimulation
- pulse generator
- pcb
- chip
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 230000000638 stimulation Effects 0.000 claims abstract description 129
- 238000002513 implantation Methods 0.000 claims abstract description 6
- 230000005540 biological transmission Effects 0.000 claims description 18
- 210000004556 brain Anatomy 0.000 claims description 17
- 238000004891 communication Methods 0.000 claims description 11
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 11
- 201000010099 disease Diseases 0.000 claims description 9
- 208000021384 Obsessive-Compulsive disease Diseases 0.000 claims description 7
- 208000018737 Parkinson disease Diseases 0.000 claims description 6
- 208000024827 Alzheimer disease Diseases 0.000 claims description 4
- 206010003805 Autism Diseases 0.000 claims description 4
- 208000020706 Autistic disease Diseases 0.000 claims description 4
- 206010013663 drug dependence Diseases 0.000 claims description 4
- 206010015037 epilepsy Diseases 0.000 claims description 4
- 238000001727 in vivo Methods 0.000 claims description 4
- 208000011117 substance-related disease Diseases 0.000 claims description 4
- 206010044565 Tremor Diseases 0.000 claims description 3
- 150000003071 polychlorinated biphenyls Chemical class 0.000 abstract description 6
- 230000006870 function Effects 0.000 description 28
- LAHWLEDBADHJGA-UHFFFAOYSA-N 1,2,4-trichloro-5-(2,5-dichlorophenyl)benzene Chemical compound ClC1=CC=C(Cl)C(C=2C(=CC(Cl)=C(Cl)C=2)Cl)=C1 LAHWLEDBADHJGA-UHFFFAOYSA-N 0.000 description 12
- 230000009286 beneficial effect Effects 0.000 description 11
- BWWVXHRLMPBDCK-UHFFFAOYSA-N 1,2,4-trichloro-5-(2,6-dichlorophenyl)benzene Chemical compound C1=C(Cl)C(Cl)=CC(Cl)=C1C1=C(Cl)C=CC=C1Cl BWWVXHRLMPBDCK-UHFFFAOYSA-N 0.000 description 10
- 230000003993 interaction Effects 0.000 description 10
- 230000002093 peripheral effect Effects 0.000 description 10
- 210000001519 tissue Anatomy 0.000 description 10
- 238000013461 design Methods 0.000 description 9
- 208000002193 Pain Diseases 0.000 description 8
- 238000010586 diagram Methods 0.000 description 8
- 230000000694 effects Effects 0.000 description 6
- 230000008901 benefit Effects 0.000 description 5
- 239000003814 drug Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
- 238000000034 method Methods 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- 208000020016 psychiatric disease Diseases 0.000 description 4
- 208000019901 Anxiety disease Diseases 0.000 description 3
- 230000036506 anxiety Effects 0.000 description 3
- 210000005013 brain tissue Anatomy 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 210000005036 nerve Anatomy 0.000 description 3
- 230000007383 nerve stimulation Effects 0.000 description 3
- 239000003826 tablet Substances 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 239000002775 capsule Substances 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 208000035475 disorder Diseases 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 208000024714 major depressive disease Diseases 0.000 description 2
- 230000007257 malfunction Effects 0.000 description 2
- 238000007726 management method Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000001537 neural effect Effects 0.000 description 2
- 210000001009 nucleus accumben Anatomy 0.000 description 2
- 210000000278 spinal cord Anatomy 0.000 description 2
- 230000001360 synchronised effect Effects 0.000 description 2
- 230000007384 vagal nerve stimulation Effects 0.000 description 2
- 208000020925 Bipolar disease Diseases 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 208000023105 Huntington disease Diseases 0.000 description 1
- 208000026139 Memory disease Diseases 0.000 description 1
- 208000019695 Migraine disease Diseases 0.000 description 1
- 208000019022 Mood disease Diseases 0.000 description 1
- 208000016285 Movement disease Diseases 0.000 description 1
- 208000012902 Nervous system disease Diseases 0.000 description 1
- 208000025966 Neurological disease Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 230000003542 behavioural effect Effects 0.000 description 1
- 230000002146 bilateral effect Effects 0.000 description 1
- 208000028683 bipolar I disease Diseases 0.000 description 1
- 239000003990 capacitor Substances 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 230000001054 cortical effect Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 201000006517 essential tremor Diseases 0.000 description 1
- 210000001723 extracellular space Anatomy 0.000 description 1
- 230000005669 field effect Effects 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000014509 gene expression Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 210000001503 joint Anatomy 0.000 description 1
- 239000000696 magnetic material Substances 0.000 description 1
- 230000006996 mental state Effects 0.000 description 1
- 206010027599 migraine Diseases 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 230000000926 neurological effect Effects 0.000 description 1
- 230000005693 optoelectronics Effects 0.000 description 1
- 210000000578 peripheral nerve Anatomy 0.000 description 1
- 208000028173 post-traumatic stress disease Diseases 0.000 description 1
- 239000010453 quartz Substances 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 239000004065 semiconductor Substances 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicon dioxide Inorganic materials O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000000946 synaptic effect Effects 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
Images
Landscapes
- Electrotherapy Devices (AREA)
Abstract
The present application provides an implantable pulse generator and circuitry thereof, a stimulator, and a medical system, the implantable pulse generator for implantation in a patient, the circuitry comprising: a board-to-board connector; the first PCB and the second PCB are connected by the board-to-board connector; the control chip is arranged on the first PCB and used for generating a stimulation control signal and outputting the stimulation control signal through the board-to-board connector; the stimulation chip is arranged on the second PCB and used for receiving the stimulation control signal through the board-to-board connector, generating a stimulation pulse signal and outputting the stimulation pulse signal to the electrode lead so that the electrode lead can deliver electrical stimulation to the internal tissues of the patient. The control chip and the stimulation chip are respectively arranged on the two PCBs connected through the board-to-board connector, so that the volume of a single PCB is reduced, and the volume of the whole implanted pulse generator is reduced.
Description
Technical Field
The application relates to the technical field of implantable instruments and deep brain nerve stimulation, in particular to an implantable pulse generator and a circuit system thereof, a stimulator and a medical system.
Background
With the development of science and technology and social progress, patients are eager to improve the quality of life through various treatment means, wherein the application prospect of medical devices, especially implantable devices, is very wide. An implantable device refers to a medical device that enters the human body or into a cavity (mouth) completely or partially by means of an operation, or is used for replacing the epithelial surface or ocular surface of the human body, and is left in the human body for more than 30 days (inclusive) or is absorbed by the human body after the operation process is finished. A stimulator is one type of implantable device, which generally includes an IPG, extension leads, and electrode leads, and is commercially popular with many patients to provide a patient with parametrically controlled refined electrical stimulation therapy.
Its PCB (Printed Circuit Board) structure of pulse generator of prior art is the multiply wood constitution mostly, and maintainability is not high in research and development process, and is difficult for fault detection, if electronic components is more on the PCB, can make its area increase, causes whole product volume too big, can not be applicable to the application of implanted apparatus well.
Patent CN107952171a discloses a neural regulation external pulse generator, comprising: the circuit board comprises a front shell, a rear shell, an end cover, a battery cover, a wire interface end plug and a PCB (printed circuit board); the front shell, the rear shell and the end cover support the PCB in the shell; the PCB board includes: the PCB comprises a first PCB and a second PCB, wherein the first PCB and the second PCB are connected through a board-to-board connector, the first PCB is fixed in a front shell, and the second PCB is fixed in a rear shell and is connected with the board-to-board connector through an FPC (flexible printed circuit); the wire interface end plug is mounted on the second PCB. The non-implanted device of the external pulse generator cannot solve the problem of overlarge volume of the implanted pulse generator.
Based on this, the present application provides an implantable pulse generator and its circuit system, a stimulator and a medical system to solve the above-mentioned problems in the prior art.
Disclosure of Invention
The utility model aims at providing implanted pulse generator and circuit system, stimulator and medical system thereof sets up control chip and stimulation chip respectively in two PCB boards through board-to-board connector connection, reduces the volume of single PCB board to reduce whole implanted pulse generator's volume.
The purpose of the application is realized by adopting the following technical scheme:
in a first aspect, the present application provides circuitry for an implantable pulse generator for implantation in a patient, the circuitry comprising:
a board-to-board connector;
the first PCB and the second PCB are connected by the board-to-board connector;
the control chip is arranged on the first PCB and used for generating a stimulation control signal and outputting the stimulation control signal through the board-to-board connector;
the stimulation chip is arranged on the second PCB and used for receiving the stimulation control signal through the board-to-board connector, generating a stimulation pulse signal and outputting the stimulation pulse signal to the electrode lead so that the electrode lead delivers electrical stimulation to the internal tissue of the patient.
The technical scheme has the beneficial effects that: the control chip and the stimulation chip are respectively arranged on two PCBs connected through a board-to-board connector (BTB), so that the volume of a single PCB is reduced, the volume of a circuit system is reduced, and the volume of the whole implanted pulse generator is reduced. The circuit system adopts the appearance design and the circuit architecture design of BTB, reduces the overall size of an implanted pulse generator product, adopts a modular board dividing mode, and utilizes a first PCB and a second PCB to respectively set a control chip and an exciting chip, thereby improving the reliability and the maintainability of the product and simultaneously reducing the fault detection difficulty.
In some alternative embodiments, the number of board-to-board connectors is greater than 1;
the control chip and the stimulation chip realize the data transmission function between the control chip and the stimulation chip through one of the board-to-board connectors.
The technical scheme has the beneficial effects that: the circuit system can be provided with a plurality of board-to-board connectors for realizing the data transmission function among a plurality of components, wherein one board-to-board connector is used for realizing the data transmission function of the control chip and the stimulation chip, and the other board-to-board connectors can be used for realizing the power supply function between the power module and the stimulation chip, and the like.
In some optional embodiments, each of the board-to-board connectors satisfies:
the male seat of the board-to-board connector is arranged on the first PCB, and the female seat of the board-to-board connector is arranged on the second PCB; alternatively, the first and second electrodes may be,
the male seat of the board-to-board connector is arranged on the second PCB, and the female seat of the board-to-board connector is arranged on the first PCB.
The technical scheme has the beneficial effects that: for each board-to-board connector, the male socket and the female socket are respectively arranged on different PCB boards, that is, when the male socket is arranged on one PCB board, the female socket is arranged on the other PCB board, so that the data transmission function between the two PCB boards can be realized.
In some optional embodiments, the control chip and the stimulation chip communicate with each other through an SPI protocol.
The technical scheme has the beneficial effects that: the SPI is an abbreviation of a Serial Peripheral Interface (Serial Peripheral Interface), is a synchronous Serial Interface technology, and has the advantages of supporting full-duplex communication, simple communication, and a data transmission rate block.
In some optional embodiments, the circuitry further comprises:
and the power module is arranged on the first PCB and used for supplying power to the control chip and the stimulation chip.
The technical scheme has the beneficial effects that: the power module and the control chip are arranged on the same PCB, but not arranged on the same PCB together with the stimulation chip, so that the power module and the control part (comprising the control chip and the peripheral circuit) are arranged on the same PCB, the advantage of the power module and the control chip is that the peripheral circuit of the control chip is complex, the number of peripheral chips which need to be supplied with power independently is large, the number of circuits which are electrically connected between boards can be reduced, the requirement for the number of board-to-board connectors is reduced, and the complexity of wiring is reduced.
In some optional embodiments, the circuitry further comprises:
the external wake-up circuit is connected with the control chip in a communication mode and used for providing a timing function and resetting the control chip.
The technical scheme has the beneficial effects that: in the circuit structure of the implantable pulse generator in the prior art, when a control chip fails, the circuit system of the implantable pulse generator cannot realize automatic reset, specifically, after the implantable pulse generator is implanted into the body of a patient and when the implantable pulse generator encounters a chip failure, the implantable pulse generator cannot be awakened or reset in a conventional restarting mode such as an entity reset button of a manual operation product, and if the control chip cannot be automatically reset within a certain time, the circuit system is halted, electrical stimulation treatment fails, and pain is brought to the patient. When the implantable pulse generator breaks down, the electrostimulation treatment fails, in order to continue the electrostimulation treatment, the patient has to select to perform the operation again, the implantable pulse generator is implanted by the doctor, then replaced or maintained (awakening or resetting the control chip), and implanted again, so that the pain is brought to the patient, the expensive operation cost is caused, and the use experience of the patient is poor. By adopting the design of the external wake-up circuit, when the implantable pulse generator breaks down, as long as the external wake-up circuit works normally, the control chip of the implantable pulse generator can be restarted within a preset time, the automatic wake-up function can reduce the pain and the operation cost of a patient, and the experience of the patient is improved. For example, when a patient enters a Magnetic Resonance (MR) scanning room, the implanted pulse generator may malfunction due to a strong Magnetic field and cannot work normally, and the problem can be solved by the above circuit design.
In some optional embodiments, the external wake-up circuit employs a counter.
The technical scheme has the beneficial effects that: the counter is used as an external wake-up circuit, so that the circuit is simple, the operability is high, and the cost is low. The counting of the counter is continuously increased along with the time change, and when the counting of the counter reaches a preset value, a reset signal is automatically sent to the control chip, so that the automatic reset function of the control chip is realized. In a normal working state, the counter starts counting after being electrified, the control chip sends a zero clearing signal every preset time to control the counter to clear, when the control chip is dead or has other faults, the control chip cannot send the zero clearing signal in time to cause the value of the counter to be continuously increased, and when the value is increased to the preset value, the control chip sends a reset signal to the control chip to enable the control chip to be automatically reset. The advantage of this is that, the implanted pulse generator is provided with an automatic external reset function, when the control chip in the implanted pulse generator fails, the implanted pulse generator can be automatically reset in time, so that the implanted pulse generator can be reactivated. For example, when the zero clearing signal sent by the controller is not received within ten minutes of counting, the whole circuit system can be automatically reset, the control chip is restarted, the automatic reset of the implanted pulse generator is completed, and the electrical stimulation treatment is continuously provided for the patient.
In some optional embodiments, the external wake-up circuit is disposed on the first PCB.
The technical scheme has the beneficial effects that: because the external wake-up circuit needs to communicate with the control chip, the external wake-up circuit and the control chip are arranged on the same PCB, so that the electric connection between boards can be reduced, the overall complexity of a circuit system is reduced, and the volume of the whole circuit system is further reduced.
In a second aspect, the present application provides an implantable pulse generator comprising circuitry of any of the implantable pulse generators described above.
In a third aspect, the present application provides a stimulator for implantation in a patient, the stimulator comprising:
an implantable pulse generator according to any of the preceding claims;
at least one electrode lead, each of the electrode leads being communicatively coupled with a stimulation chip of circuitry of the implantable pulse generator, respectively.
In some optional embodiments, the stimulator further comprises:
the extension leads are connected with the electrode leads in a one-to-one correspondence manner, and each extension lead is arranged between the stimulation chip and the corresponding electrode lead and is used for realizing the data transmission function between the stimulation chip and the corresponding electrode lead.
The technical scheme has the beneficial effects that: the extension lead is utilized to realize the data transmission function between the stimulation chip and the electrode lead, and the implanted pulse generator and the electrode lead can be implanted into different parts in the body of a patient respectively, so that the number of implants at the same part is reduced, the flexibility degree is high, and the electrical stimulation treatment effect is further improved. For example, the implanted pulse generator can be implanted in the chest, and the electrode lead can be implanted in the cranium, and can be used for treating mental diseases such as obsessive compulsive disorder, depression and anxiety, parkinson's disease or assisting drug addicts in drug addicting, etc.
In some alternative embodiments, the number of electrode leads is greater than 1, at least one of the electrode leads being implanted in a left hemisphere of the patient's brain and at least one of the electrode leads being implanted in a right hemisphere of the patient's brain.
The technical scheme has the beneficial effects that: the left hemisphere and the right hemisphere of the brain of the patient are respectively provided with at least one electrode lead, so that combined electrical stimulation aiming at bilateral target spots of the brain can be realized, and the patient with serious illness state and large electrical stimulation energy is convenient to treat. It is medically prescribed that the electrical stimulation energy that can be delivered to a single target site (e.g., nucleus accumbens, anterior inner capsule, etc.) is limited, and thus, if more electrical stimulation energy is to be delivered simultaneously, multiple target sites on both left and right hemispheres of the patient's brain need to be stimulated simultaneously.
In some alternative embodiments, the patient's disease type comprises one or more of epilepsy, tremor, parkinson's disease, depression, obsessive compulsive disorder, alzheimer's disease, autism, and drug addiction.
The technical scheme has the beneficial effects that: the stimulator is suitable for treating various diseases and brings better treatment effect for more patients.
In a third aspect, the present application provides a medical system comprising:
a stimulator according to any of the above;
the programmable device is communicatively connected with the implantable pulse generator of the stimulator and is used for sending a stimulation control command to the implantable pulse generator so that the implantable pulse generator generates a corresponding stimulation control signal.
Drawings
The present application is further described below with reference to the accompanying drawings and embodiments.
Fig. 1 shows a block diagram of a medical system according to an embodiment of the present application.
Fig. 2 shows a block diagram of a stimulator according to an embodiment of the present disclosure.
Fig. 3 is a block diagram illustrating an implantable pulse generator according to an embodiment of the present disclosure.
Fig. 4 is a block diagram illustrating a circuit system of an implantable pulse generator according to an embodiment of the present disclosure.
In the figure: 10. a stimulator; 20. a program-controlled device; 11. an implantable pulse generator; 12. an electrode lead; 13. an extension wire; 100. circuitry; 101. a first PCB board; 102. a second PCB board; 103. a board-to-board connector; 104. a control chip; 105. a stimulation chip; 106. a power supply module; 107. an external wake-up circuit.
Detailed Description
The technical solutions in the present application will be described below with reference to the drawings and the detailed description of the present application, and it should be noted that, in the present application, new embodiments can be formed by any combination of the following described embodiments or technical features without conflict.
In the embodiments of the present application, "at least one" means one or more, "a plurality" means two or more. "and/or" describes the association relationship of the associated objects, meaning that there may be three relationships, e.g., a and/or B, which may mean: a exists alone, A and B exist simultaneously, and B exists alone, wherein A and B can be singular or plural. The character "/" generally indicates that the former and latter associated objects are in an "or" relationship. "at least one of the following" or similar expressions refer to any combination of these items, including any combination of the singular or plural items. For example, at least one (one) of a, b, or c, may represent: a, b, c, a and b, a and c, b and c, a and b and c, wherein a, b and c can be single or multiple. It is to be noted that "at least one item" may also be interpreted as "one or more item(s)".
It should also be noted that in the embodiments of the present application, words such as "exemplary" or "for example" are used to indicate examples, illustrations or descriptions. Any embodiment or design described herein as "exemplary" or "e.g.," is not necessarily to be construed as preferred or advantageous over other embodiments or designs. Rather, use of the word "exemplary" or "such as" is intended to present concepts related in a concrete fashion.
In the following, a brief description of one of the application areas (i.e. implantable devices) of the embodiments of the present application will be given first.
An implantable neurostimulation system (an implantable medical system) generally includes a stimulator implanted in a patient and a programming device disposed outside the patient. The existing nerve regulation and control technology is mainly characterized in that an electrode is implanted in a specific structure (namely a target spot) in a body through a three-dimensional directional operation, and a stimulator implanted in the body of a patient sends an electric pulse to the target spot through the electrode to regulate and control the electric activity and the function of a corresponding nerve structure and network, so that symptoms are improved, and pain is relieved. The stimulator may be any one of an Implantable nerve electrical stimulation device, an Implantable cardiac electrical stimulation System (also called a cardiac pacemaker), an Implantable Drug Delivery System (I DDS for short), and a lead switching device. Examples of the implantable neural electrical Stimulation device include Deep Brain Stimulation (DBS), cortical Brain Stimulation (CNS), spinal Cord Stimulation (SCS), sacral Nerve Stimulation (SNS), and Vagal Nerve Stimulation (VNS).
The stimulator may include an IPG (implantable pulse generator) disposed in the patient's body, an extension lead and an electrode lead, and is configured to provide controllable electrical stimulation energy to the tissue in the body by means of a sealed battery and a circuit, and to deliver one or two controllable specific electrical stimulations to a specific region of the tissue in the body through the implanted extension lead and electrode lead. The extension lead is used in cooperation with the IPG and is used as a transmission medium of the electrical stimulation signal to transmit the electrical stimulation signal generated by the IPG to the electrode lead. The electrode leads deliver electrical stimulation to specific areas of tissue within the body through a plurality of electrode contacts. The stimulator is provided with one or more paths of electrode leads on one side or two sides, a plurality of electrode contacts are arranged on the electrode leads, and the electrode contacts can be uniformly arranged or non-uniformly arranged on the circumference 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. The electrode contacts may include stimulation electrode contacts and/or collection electrode contacts. The electrode contact may have a sheet-like shape, an annular shape, a dot-like shape, or the like.
In some possible embodiments, the stimulated in vivo tissue may be brain tissue of a patient, and the stimulated site may be a specific site of the brain tissue. The sites stimulated are generally different when the patient's disease type is different, as are the number of stimulation contacts (single or multiple) used, the application of one or more (single or multiple) specific electrical stimulation signals, and stimulation parameter data. The present embodiment is not limited to the type of disease applicable, and may be the type of disease applicable to Deep Brain Stimulation (DBS), spinal Cord Stimulation (SCS), pelvic stimulation, gastric stimulation, peripheral nerve stimulation, and functional electrical stimulation. Among the types of diseases that DBS may be used for treatment or management include, but are not limited to: convulsive disorders (e.g., epilepsy), pain, migraine, psychiatric disorders (e.g., major Depressive Disorder (MDD)), manic depression, anxiety, post-traumatic stress disorder, depression, obsessive Compulsive Disorder (OCD), behavioral disorders, mood disorders, memory disorders, mental state disorders, movement disorders (e.g., essential tremor or parkinson's disease), huntington's disease, alzheimer's disease, drug addiction, autism, or other neurological or psychiatric diseases and injuries.
In the embodiment of the application, when the program control device is connected with the stimulator in a program control manner, the program control device can be used for adjusting stimulation parameters of the stimulator (different electrical stimulation signals corresponding to different stimulation parameters are different), the stimulator can sense bioelectricity activity of a deep part of the brain of a patient to acquire electrophysiological signals, and the stimulation parameters of the electrical stimulation signals of the stimulator can be continuously adjusted through the acquired electrophysiological signals.
The programming device may be a physician programming device (i.e., a programming device used by a physician) or a patient programming device (i.e., a programming device used by a patient). The doctor program control device may be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone, or other intelligent terminal device with program control software. The patient program control device may be, for example, an intelligent terminal device such as a tablet computer, a laptop computer, a desktop computer, or a mobile phone, which is loaded with program control software, or may be another electronic device with a program control function (for example, a charger with a program control function, or a data acquisition device).
The embodiment of the application does not limit data interaction between the doctor program control equipment and the stimulator, and when a doctor performs remote program control, the doctor program control equipment can perform data interaction with the stimulator through the server and the patient program control equipment. When the doctor goes offline and performs program control face to face with the patient, the doctor program control device can perform data interaction with the stimulator through the patient program control device, and the doctor program control device can also perform data interaction with the stimulator directly.
In some alternative embodiments, the patient-programmed device may include a master (in communication with the server) and a slave (in communication with the stimulator), with the master and slave being communicatively coupled. The doctor program control equipment can perform data interaction with the server through a 3G/4G/5G network, the server can perform data interaction with the host through the 3G/4G/5G network, the host can perform data interaction with the submachine through a Bluetooth protocol/WIFI protocol/USB protocol, the submachine can perform data interaction with the stimulator through a 401MHz-406MHz working frequency band/2.4 GHz-2.48GHz working frequency band, and the doctor program control equipment can perform data interaction with the stimulator directly through the 401MHz-406MHz working frequency band/2.4 GHz-2.48GHz working frequency band.
In addition to the application field of the implantable device, the embodiments of the present application may also be applied to the technical field of other medical devices, even non-medical devices, and the embodiments of the present application are not limited thereto, and may be applied to any occasion related to delivering electrical stimulation, and the command received by the implantable pulse generator may not be limited to the stimulation control command.
System implementation
Referring to fig. 1, fig. 1 shows a block diagram of a medical system according to an embodiment of the present application.
An embodiment of the present application provides a medical system, including:
a stimulator 10;
a programming device 20, the programming device 20 communicatively coupled with the implantable pulse generator of the stimulator 10, the programming device 20 configured to send stimulation control instructions to the implantable pulse generator to cause the implantable pulse generator to generate corresponding stimulation control signals.
The embodiments of the present application are not limited to implantable pulse generators, which are implanted in a patient, such as in the cranium or other internal body location.
The program control device 20 is not limited in this embodiment, and may be, for example, a tablet computer, a notebook computer, a desktop computer, a mobile phone, an intelligent wearable device, and the like.
In some alternative embodiments, the stimulator 10 may be further configured to collect electrophysiological signals of the patient and transmit the signals to the programming device 20, and the programming device 20 processes the received electrophysiological signals and displays the processed electrophysiological signals graphically.
The electrophysiological signal may be, for example, a single cell electrophysiological signal, or a Local Field Potential (i.e., LFP) of an in vivo tissue or nucleus, such as a brain tissue or other in vivo tissue. Local field potentials are a special class of electrophysiological signals. In a living body, dendritic synaptic activity in a certain volume of biological tissue induces a current, which, when flowing through an extracellular space with a certain impedance, forms a certain voltage distribution, and the local voltage value recorded at a certain point is called local field potential.
The stimulator 10 will be described below.
Stimulator embodiments
Referring to fig. 2, fig. 2 shows a block diagram of a stimulator according to an embodiment of the present disclosure.
The present application also provides a stimulator for implantation in a patient, the stimulator comprising:
an implantable pulse generator 11;
at least one electrode wire 12, each of the electrode wires 12 being communicatively connected to a stimulation chip of the circuitry of the implantable pulse generator 11.
In some optional embodiments, the stimulator may further include:
at least one extension lead 13, wherein the at least one extension lead 13 is connected with the at least one electrode lead 12 in a one-to-one correspondence manner, and each extension lead 13 is arranged between the stimulation chip and the corresponding electrode lead 12 and is used for realizing a data transmission function between the stimulation chip and the corresponding electrode lead 12.
Therefore, the extension lead 13 is utilized to realize the data transmission function between the stimulation chip and the electrode lead 12, the implanted pulse generator 11 and the electrode lead 12 can be implanted into different parts in the body of a patient respectively, the number of implants at the same part is reduced, the flexibility degree is high, and the electrical stimulation treatment effect is further improved. For example, the implanted pulse generator 11 may be implanted in the chest, and the electrode lead 12 may be implanted in the cranium for treating mental diseases such as obsessive compulsive disorder, depression and anxiety, parkinson's disease, and assisting drug addicts in drug addicts.
In some alternative embodiments, the number of the electrode leads 12 may be more than 1, at least one of the electrode leads 12 being implanted in a left hemisphere of the patient's brain, and at least one of the electrode leads 12 being implanted in a right hemisphere of the patient's brain.
Therefore, the left hemisphere and the right hemisphere of the brain of the patient are respectively provided with the at least one electrode lead 12, so that combined electrical stimulation aiming at target points on two sides of the brain can be realized, and the patient with serious illness state and large electrical stimulation energy is convenient to treat. It is medically prescribed that the electrical stimulation energy that can be delivered to a single target site (e.g., nucleus accumbens, anterior inner capsule, etc.) is limited, and thus, if more electrical stimulation energy is to be delivered simultaneously, multiple target sites on both left and right hemispheres of the patient's brain need to be stimulated simultaneously.
In some alternative embodiments, the patient's disease type may include one or more of epilepsy, tremor, parkinson's disease, depression, obsessive compulsive disorder, alzheimer's disease, autism, and drug addiction.
Therefore, the stimulator is suitable for treating various diseases and brings better treatment effect to more patients.
The implanted pulse generator 11 will be described below.
Implantable pulse generator embodiments
Referring to fig. 3, fig. 3 is a block diagram illustrating a structure of an implantable pulse generator according to an embodiment of the present disclosure.
The present embodiments also provide an implantable pulse generator that includes circuitry 100 for an implantable pulse generator.
The circuitry 100 of the implanted pulse generator will be described below.
Circuit implementation mode
Referring to fig. 4, fig. 4 is a block diagram illustrating a circuit system of an implantable pulse generator according to an embodiment of the present disclosure.
Embodiments of the present application further provide a circuit system of an implantable pulse generator, the implantable pulse generator being configured to be implanted in a patient, the circuit system including:
a board-to-board connector 103;
a first PCB 101 and a second PCB 102 connected by the board-to-board connector 103;
the control chip 104, the control chip 104 is disposed on the first PCB 101, and the control chip 104 is configured to generate a stimulation control signal and output the stimulation control signal through the board-to-board connector 103;
the stimulation chip 105 is disposed on the second PCB 102, and the stimulation chip 105 is configured to receive the stimulation control signal through the board-to-board connector 103, generate a stimulation pulse signal, and output the stimulation pulse signal to an electrode lead, so that the electrode lead delivers electrical stimulation to the internal tissue of the patient.
Thus, the control chip 104 and the stimulation chip 105 are respectively arranged on two PCBs (i.e., the first PCB 101 and the second PCB 102) connected by the board-to-board connector 103 (BTB), so that the volume of a single PCB is reduced, the volume of a circuit system is reduced, and the volume of the whole implantable pulse generator is reduced.
The circuit system adopts the appearance design and the circuit architecture design of BTB, reduces the overall size of an implanted pulse generator product, adopts a modular board dividing mode, and utilizes the first PCB board 101 and the second PCB board 102 to respectively arrange the control chip 104 and the stimulating chip 105, thereby improving the reliability and the maintainability of the product and simultaneously reducing the difficulty of fault detection.
In the embodiment of the present application, the number of the board-to-board connectors 103 may be 1, 2, 3, 5, and the like.
In the embodiment of the present application, the number of the control chips 104 may be 1 or 2, the number of the stimulation chips 105 may be 1, 2, 4, and the like, and the control chips 104 and the stimulation chips 105 may be in a one-to-one, one-to-many relationship, for example. Any group of control chips 104 and stimulation chips 105 which can communicate with each other perform data interaction through the board-to-board connector 103. The control chip 104 may be partially or entirely disposed on the first PCB 101, and the stimulation chip 105 may be partially or entirely disposed on the second PCB 102.
In some alternative embodiments, the number of board-to-board connectors 103 may be greater than 1;
the control chip 104 and the stimulation chip 105 implement a data transmission function between the two through one of the board-to-board connectors 103.
Therefore, the circuit system may be provided with a plurality of board-to-board connectors 103 for implementing a data transmission function between a plurality of components, where one board-to-board connector 103 is used for implementing a data transmission function between the control chip 104 and the stimulation chip 105, and the other board-to-board connectors 103 may be used for implementing, for example, a power supply function between the power module 106 and the stimulation chip 105, a data transmission function between other components located on two PCB boards, and the like.
In some alternative embodiments, each of the board-to-board connectors 103 may satisfy:
a male socket of the board-to-board connector 103 is disposed on the first PCB 101, and a female socket of the board-to-board connector 103 is disposed on the second PCB 102; alternatively, the first and second electrodes may be,
the male socket of the board-to-board connector 103 is disposed on the second PCB 102, and the female socket of the board-to-board connector 103 is disposed on the first PCB 101.
Therefore, for each board-to-board connector 103, the male socket and the female socket are respectively arranged on different PCBs, that is, when the male socket is arranged on one of the PCBs, the female socket is arranged on the other PCB, so that the data transmission function between the two PCBs can be realized.
In the embodiment of the present application, the shapes and functions of the control portion and the stimulation portion may be matched by the butt joint between the male socket and the female socket of the board-to-board connector 103. The control part comprises a first PCB 101 and a plurality of electronic components arranged on the first PCB 101, and the stimulation part comprises a second PCB 102 and a plurality of electronic components arranged on the second PCB 102. The electronic components may include, for example, one or more of chips, resistors, capacitors, inductors, potentiometers, transistors (including diodes, transistors, field effect transistors, thyristors, etc.), tubes, heat sinks, electromechanical components, connectors, semiconductor discrete devices, electro-acoustic devices, laser devices, electronic display devices, optoelectronic devices, sensors, power supplies, switches, micro-electro-mechanical devices, electronic transformers, relays, integrated circuits, piezoelectrics, crystals, quartz, ceramic magnetic materials, electronic functional process specific materials, electronic adhesive (tape) products, electronic chemical materials, and components.
In some optional embodiments, the control chip 104 and the stimulation chip 105 may communicate with each other through SPI protocol.
Therefore, the SPI is an abbreviation of Serial Peripheral Interface (Serial Peripheral Interface), is a synchronous Serial Interface technology, and has the advantages of supporting full-duplex communication, simple communication, and a data transmission rate block.
In other alternative embodiments, the control chip 104 and the stimulation chip 105 may communicate via a UART protocol or an I2C protocol.
Among them, the UART (Universal Asynchronous Receiver/Transmitter) protocol is a serial, asynchronous, full duplex communication protocol, and is widely applied in the embedded field.
I2C (also written as I) 2 C, inter-Integrated Circuit) literally means between Integrated circuits, which is actually I 2 C Bus, chinese name, is an integrated circuit Bus, is a serial communication BusA multi-master-slave architecture is used.
In some optional embodiments, the circuitry may further comprise:
a power module 106, wherein the power module 106 is disposed on the first PCB 101, and the power module 106 is configured to supply power to the control chip 104 and the stimulation chip 105.
Therefore, the power module 106 and the control chip 104 are arranged on the same PCB, but not arranged on one PCB together with the stimulation chip 105, so that the advantage is that the peripheral circuit of the control chip 104 is complex, and more peripheral chips need to be supplied with power independently, and the power module 106 and the control part (including the control chip 104 and the peripheral circuits) are arranged on one PCB, so that the number of circuits electrically connected between boards can be reduced, the requirement on the number of board-to-board connectors 103 is reduced, and the wiring complexity is reduced.
In some optional embodiments, the power module 106 may include a power management chip, a charge and discharge protection circuit, an overvoltage protection circuit, an ESD protection circuit, an overcurrent protection circuit, and the like.
In some optional embodiments, the circuitry may further comprise:
an external wake-up circuit 107, the external wake-up circuit 107 being communicably connected to the control chip 104, the external wake-up circuit 107 being configured to provide a timing function and reset the control chip 104.
Therefore, in the circuit structure of the implanted pulse generator in the prior art, when the control chip 104 fails, the circuit system of the implanted pulse generator cannot realize automatic reset, specifically, after the implanted pulse generator is implanted into the body of a patient, when the implanted pulse generator encounters a fault of the control chip 104, the implanted pulse generator cannot be awakened or reset in a conventional restarting mode such as an entity reset button of a manual operation product, and if the control chip 104 cannot be automatically reset within a certain time, the circuit system is halted, electrical stimulation treatment fails, and pain is brought to the patient.
When the implantable pulse generator fails, the electrical stimulation therapy fails, and in order to continue the electrical stimulation therapy, the patient has to choose to perform the operation again, and the implantable pulse generator is implanted by the doctor, then replaced or maintained (awakening or resetting the control chip 104), and then implanted again, so that the pain is brought to the patient, the expensive operation cost is caused, and the use experience of the patient is poor. By adopting the design of the external wake-up circuit 107, when the implantable pulse generator fails, as long as the external wake-up circuit 107 works normally, the control chip 104 of the implantable pulse generator is restarted within a preset time, and the automatic wake-up function can reduce the pain and the operation cost of a patient and improve the experience of the patient. For example, when a patient enters a Magnetic Resonance (MR) scanning room, the implantable pulse generator may malfunction due to a strong Magnetic field, and cannot work normally.
In some alternative embodiments, the external wake-up circuit 107 may employ a counter.
Therefore, the counter (namely, the counter reset chip) is adopted as the external wake-up circuit 107, so that the circuit is simple, the operability is strong, and the cost is low. The count of the counter is continuously increased along with the time change, and when the count of the counter reaches a preset value, a reset signal is automatically sent to the control chip 104, so that the automatic reset function of the control chip 104 is realized.
In a normal working state, the counter starts counting after being powered on, the control chip 104 sends a zero clearing signal every preset time to control the counter to clear, when the control chip 104 is halted or has other faults, the control chip 104 cannot send the zero clearing signal in time to cause the value of the counter to be continuously increased, and when the value is increased to the preset value, a reset signal is sent to the control chip 104 to enable the control chip 104 to be automatically reset.
This advantageously provides an automatic external reset function for the implanted pulse generator, which can automatically reset in time when the control chip 104 of the implanted pulse generator fails, so that the implanted pulse generator can be reactivated.
For example, when the zero clearing signal sent by the controller is not received within ten minutes of counting, the whole circuit system is automatically reset, the control chip 104 is restarted, the automatic reset of the implanted pulse generator is completed, and the electrical stimulation treatment is continuously provided for the patient.
In this embodiment of the application, the preset time period corresponding to the counter may be, for example, 1 minute, 3 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, and the like, and the preset value corresponding to the counter may be, for example, 5, 10, 15, 20, 30, 50, 100, 200, 300, 500, 1000, 10000, and the like.
In the embodiment of the present application, the counter may adopt a low power consumption counter or an ultra-low power consumption counter. In a standby state, the quiescent current of the counter can be not more than 100nA, and the requirement of ultra-low power consumption in the implantable medical device is met. Wherein, the output pin of the counter can be connected to the reset pin of the control chip 104.
In alternative embodiments, the external wake-up circuit 107 may employ a reset chip or other reset circuit other than a counter.
In some optional embodiments, the external wake-up circuit 107 may be disposed on the first PCB board 101.
Therefore, the external wake-up circuit 107 needs to communicate with the control chip 104, and therefore, the external wake-up circuit 107 and the control chip 104 are arranged on the same PCB, so that the electric connection between boards can be reduced, the overall complexity of the circuit system is reduced, and the volume of the whole circuit system is further reduced.
In other alternative embodiments, the external wake-up circuit 107 may be disposed on the second PCB board 102.
With continued reference to fig. 4, in one particular application scenario, the circuitry includes:
a board-to-board connector 103;
a first PCB 101 and a second PCB 102 connected by the board-to-board connector 103;
the control chip 104, the control chip 104 is disposed on the first PCB 101, and the control chip 104 is configured to generate a stimulation control signal and output the stimulation control signal through the board-to-board connector 103;
a stimulation chip 105, wherein the stimulation chip 105 is disposed on the second PCB 102, and the stimulation chip 105 is configured to receive the stimulation control signal through the board-to-board connector 103, generate a stimulation pulse signal, and output the stimulation pulse signal to an electrode lead, so that the electrode lead delivers electrical stimulation to the internal tissue of the patient;
the power module 106, the power module 106 is disposed on the first PCB 101, and the power module 106 is configured to supply power to the control chip 104 and the stimulation chip 105;
an external wake-up circuit 107, wherein the external wake-up circuit 107 is communicably connected to the control chip 104, and the external wake-up circuit 107 is configured to provide a timing function and reset the control chip 104; wherein the external wake-up circuit 107 employs a counter.
While the present application is described in terms of various aspects, including exemplary embodiments, the principles of the invention should not be limited to the disclosed embodiments, but are also intended to cover various modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
Claims (11)
1. Circuitry of an implantable pulse generator for implantation in a patient, the circuitry comprising:
a board-to-board connector;
the first PCB and the second PCB are connected by the board-to-board connector;
the control chip is arranged on the first PCB and used for generating a stimulation control signal and outputting the stimulation control signal through the board-to-board connector;
the stimulation chip is arranged on the second PCB and used for receiving the stimulation control signal through the board-to-board connector, generating a stimulation pulse signal and outputting the stimulation pulse signal to an electrode lead so that the electrode lead delivers electrical stimulation to the in-vivo tissue of the patient;
the number of the board-to-board connectors is 1 or more than 1; each board-to-board connector satisfies: the male seat of the board-to-board connector is arranged on the first PCB, and the female seat of the board-to-board connector is arranged on the second PCB; or, the male socket of the board-to-board connector is arranged on the second PC B board, and the female socket of the board-to-board connector is arranged on the first PCB board;
the control chip and the stimulation chip realize a data transmission function between the control chip and the stimulation chip through one of the board-to-board connectors; the control chip and the stimulation chip are communicated through an SPI protocol, a UART protocol or an I2C protocol.
2. The circuitry of the implantable pulse generator of claim 1, further comprising:
and the power module is arranged on the first PCB and used for supplying power to the control chip and the stimulation chip.
3. The circuitry of the implantable pulse generator of claim 1, further comprising:
the external wake-up circuit is connected with the control chip in a communication mode and used for providing a timing function and resetting the control chip.
4. The implantable pulse generator circuitry of claim 3, wherein the external wake-up circuit employs a counter.
5. The circuitry of the implantable pulse generator of claim 3, wherein the external wake-up circuit is disposed on the first PCB board.
6. An implantable pulse generator, comprising circuitry of the implantable pulse generator of any one of claims 1-5.
7. A stimulator for implantation in a patient, the stimulator comprising:
the implantable pulse generator of claim 6;
at least one electrode lead, each of the electrode leads being communicatively coupled with a stimulation chip of circuitry of the implantable pulse generator, respectively.
8. The stimulator of claim 7, further comprising:
the extension leads are connected with the electrode leads in a one-to-one correspondence mode, and each extension lead is arranged between the stimulation chip and the corresponding electrode lead and used for achieving a data transmission function between the stimulation chip and the corresponding electrode lead.
9. The stimulator of claim 7, wherein the number of electrode leads is greater than 1, at least one of the electrode leads is implanted in a left hemisphere of the patient's brain, and at least one of the electrode leads is implanted in a right hemisphere of the patient's brain.
10. The stimulator of claim 7, wherein the type of disease of the patient includes one or more of epilepsy, tremor, parkinson's disease, depression, obsessive compulsive disorder, alzheimer's disease, autism, and drug addiction.
11. A medical system, characterized in that the medical system comprises:
a stimulator according to any one of claims 7 to 10;
the implantable pulse generator comprises a programmable device which is connected with the implantable pulse generator of the stimulator in a communication way, and the programmable device is used for sending a stimulation control instruction to the implantable pulse generator so as to enable the implantable pulse generator to generate a corresponding stimulation control signal.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202221915761.6U CN218774182U (en) | 2022-07-21 | 2022-07-21 | Implantable pulse generator, circuit system thereof, stimulator and medical system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202221915761.6U CN218774182U (en) | 2022-07-21 | 2022-07-21 | Implantable pulse generator, circuit system thereof, stimulator and medical system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN218774182U true CN218774182U (en) | 2023-03-31 |
Family
ID=85707113
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202221915761.6U Active CN218774182U (en) | 2022-07-21 | 2022-07-21 | Implantable pulse generator, circuit system thereof, stimulator and medical system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN218774182U (en) |
-
2022
- 2022-07-21 CN CN202221915761.6U patent/CN218774182U/en active Active
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN202933393U (en) | Implantable medical equipment and system with wireless communication antenna | |
| JP5875706B2 (en) | Architecture for an implantable stimulator device having multiple electrode driver integrated circuits with shorted electrode outputs | |
| US20180369596A1 (en) | Systems and methods for providing an auxiliary electrical connection along an electrical stimulation system | |
| CN109173042B (en) | Vagus nerve stimulation device for weight reduction | |
| WO2023011491A1 (en) | In-vitro program controller, and control circuit and program control system thereof | |
| JP2013542836A (en) | Notification of start status of implantable nerve stimulator | |
| US20140343621A1 (en) | Probe system for brain applications | |
| EP2854941B1 (en) | Neurostimulation system with default mri-mode | |
| US20150360037A1 (en) | Leads, systems, and methods using external primary and internal secondary power sources | |
| WO2023061233A1 (en) | Charging control method for external charger, and related apparatus | |
| WO2023011492A1 (en) | Implantable stimulator and stimulation system | |
| CN109718470A (en) | The In-Ear noninvasive nervus auricularis vagi stimulation instrument of one kind and its pulse output method | |
| CN103845802B (en) | A kind of implantable medical device and system with radio antenna | |
| CN109045468B (en) | Vagus nerve stimulation system of ear and device thereof | |
| US20220104293A1 (en) | Adjustment of Advertising Interval in Communications Between an Implantable Medical Device and an External Device | |
| US20150165206A1 (en) | Apparatus, Method and System for Closed-Loop Neurostimulation | |
| WO2023151538A1 (en) | Nerve stimulator and nerve stimulation system | |
| WO2023124617A1 (en) | Implantable stimulation system | |
| CN218774182U (en) | Implantable pulse generator, circuit system thereof, stimulator and medical system | |
| WO2023151539A1 (en) | Brain medical analysis apparatus and control unit | |
| CN218793561U (en) | Circuit system of pulse generator, pulse generator and nerve stimulator | |
| WO2023138117A1 (en) | Remote diagnosis and treatment system and method based on implantation device | |
| CN202933392U (en) | Implantable medical equipment and system with wireless communication function | |
| US20140031908A1 (en) | System and method for enhancing large diameter nerve fiber stimulation using sequential activation of electrodes | |
| CN205516003U (en) | Device of treatment epilepsy |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 215000 building C16, bio nano Park, 218 Xinghu street, Suzhou Industrial Park, Jiangsu Province Patentee after: Jingyu Medical Technology (Suzhou) Co.,Ltd. Address before: 215000 building C16, bio nano Park, 218 Xinghu street, Suzhou Industrial Park, Jiangsu Province Patentee before: SCENERAY Co.,Ltd. |
|
| CP01 | Change in the name or title of a patent holder |