CN106110503B - A kind of implantable medical devices and its working method with MRI mode - Google Patents
A kind of implantable medical devices and its working method with MRI mode Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 60
- 230000002093 peripheral effect Effects 0.000 claims description 52
- 238000006243 chemical reaction Methods 0.000 claims description 26
- 238000001514 detection method Methods 0.000 claims description 23
- 230000006698 induction Effects 0.000 claims description 13
- 238000004146 energy storage Methods 0.000 claims description 9
- 238000004891 communication Methods 0.000 claims description 6
- 102220492605 Numb-like protein_S17A_mutation Human genes 0.000 claims description 4
- 230000005355 Hall effect Effects 0.000 claims description 3
- 229920006395 saturated elastomer Polymers 0.000 claims description 3
- 238000002595 magnetic resonance imaging Methods 0.000 description 77
- 210000004556 brain Anatomy 0.000 description 25
- 230000003902 lesion Effects 0.000 description 24
- 230000001939 inductive effect Effects 0.000 description 15
- 238000010586 diagram Methods 0.000 description 10
- 230000005611 electricity Effects 0.000 description 5
- 238000012544 monitoring process Methods 0.000 description 4
- 230000005311 nuclear magnetism Effects 0.000 description 3
- 230000004936 stimulating effect Effects 0.000 description 3
- 230000033228 biological regulation Effects 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 239000003990 capacitor Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 238000013421 nuclear magnetic resonance imaging Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 230000002459 sustained effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000013519 translation Methods 0.000 description 1
- 210000001186 vagus nerve Anatomy 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/16—Screening or neutralising undesirable influences from or using, atmospheric or terrestrial radiation or fields
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/37—Monitoring; Protecting
- A61N1/3718—Monitoring of or protection against external electromagnetic fields or currents
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Abstract
The present invention relates to a kind of working methods of implantable medical devices with MRI mode comprising following steps：Step S11 detects strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, S12 is entered step, if not, continuing to repeat step S11；Step S12, record detect the time of strong external magnetic field and the state of impulse generator, and label is in strong magnetic field circumstance, and enters step S13；Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step S14；Step S15, the state of time and impulse generator that record strong external magnetic field disappears, label leaves strong magnetic field circumstance, and enters step S16；And step S16, it is switched to normal mode, marks MRI mode switching event, and return step S11.The invention further relates to a kind of implantable medical devices.
Description
Technical field
The present invention relates to medical instrument correlative technology fields, in particular, being related to a kind of implantable medical devices
(Implantable Medical Device,IMD)。
Background technique
There are many implantable medical devices type, such as pacemaker and defibrillator, embedded nerve stimulator, implanted flesh
Meat stimulator etc..Implantable medical devices generally comprise et al. Ke device and outer control device, between the two by two-way
Wireless telecommunications exchange information.
In existing technology, implantable medical devices generally utilize battery to power, and are issued by pulse generating circuit special
The boost pulse for determining frequency stimulates specific target spot, so as to improve the symptom of patient.The pulse generating circuit is usual
Including a DC-DC voltage conversion circuit.However, under strong magnetic field circumstance, such as under magnetic resonance imaging (MRI) environment, the DC-DC
Core inductance in voltage change circuit causes inductance to decline due to core saturation, this will affect pulse generating circuit sending
Boost pulse, to influence to the therapeutic effect of patient and bring security risk.
Summary of the invention
The present invention provides a kind of working method of implantable medical devices that can detect strong magnetic field circumstance automatically and adopts
With the implantable medical devices of this method.
A kind of working method of the implantable medical devices with MRI mode, the implantable medical devices include one internal
Implanted device and a peripheral control unit, and the et al. Ke device includes the circuit element of a pair of outer high-intensity magnetic field sensitivity；The plant
The working method for entering formula medical instrument includes the method for controlling the et al. Ke device；Wherein, control et al. Ke device
Method include the following steps：
Step S11 detects strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, entering step
Rapid S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of et al. Ke device, and label is in high-intensity magnetic field
Environment, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step
S14；
Step S15, the state of time and et al. Ke device that record strong external magnetic field disappears, label leave high-intensity magnetic field ring
Border, and enter step S16；And
Step S16 is switched to normal mode, marks MRI mode switching event, and return step S11.
According to the working method of above-mentioned implantable medical devices, wherein the method for the control et al. Ke device is into one
Step includes the following steps：
Step S17 judges whether the inquiry instruction for receiving peripheral control unit, if so, S18 is entered step, if not,
Continue to repeat step S17；
Step S18 judges whether there is MRI mode switching event, if so, S19 is entered step, if it is not, then entering step
Rapid S22；
Step S19 sends MRI mode switching event relevant information to peripheral control unit, subsequently into step S20；
Step S20, waits the response of peripheral control unit, and enters step S21；
Step S21, resetting MRI mode switching event label, and enter step S22；And
Step S22 terminates.
According to the working method of above-mentioned implantable medical devices, wherein the working method of the implantable medical devices is also wrapped
Include the method for controlling the peripheral control unit；The method of the control peripheral control unit includes the following steps：
Step S23 sends inquiry instruction to et al. Ke device, and enters step S24；
Step S24 judges whether to receive the prompt of MRI mode switching event, if so, S25 is entered step, if not,
Enter step S29；
Step S25 receives MRI mode switching event relevant information, subsequently into step S26；
Step S26, display MRI mode switching event prompt warning, subsequently into step S27；
Step S27 waits user to check, and enters step S28；
Step S28 sends response to et al. Ke device, and enters step S29；And
Step S29 terminates.
A kind of working method of the implantable medical devices with MRI mode, the implantable medical devices include one internal
Implanted device and a peripheral control unit, and the et al. Ke device includes the circuit element of a pair of outer high-intensity magnetic field sensitivity；The plant
The working method for entering formula medical instrument includes the method for controlling the et al. Ke device；Wherein, control et al. Ke device
Method include the following steps：
Step S10 judges whether the detection instruction for receiving peripheral control unit, if so, S11 is entered step, if not,
Continue to repeat step S10；
Step S11 starts to detect strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, into
Enter step S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of et al. Ke device, and label is in high-intensity magnetic field
Environment, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step
S14；
Step S15, the state of time and et al. Ke device that record strong external magnetic field disappears, label leave high-intensity magnetic field ring
Border, and enter step S16；
Step S16 is switched to normal mode, marks MRI mode switching event, and enter step S17；And
Step S17 stops detection strong external magnetic field, and return step S10.
According to the working method of above-mentioned implantable medical devices, wherein in the step S17, the stopping detection is external
The method of high-intensity magnetic field includes the following steps：
Step S171 judges whether the stopping detection instruction for receiving peripheral control unit, if so, S173 is entered step,
If not, entering step S172；
Step S172, if more than a time threshold, if so, S173 is entered step, if not, return step S171；
And
Step S173 stops detection strong external magnetic field.
According to the working method of above-mentioned implantable medical devices, wherein the method for the control et al. Ke device is into one
Step includes the following steps：
Step S17A judges whether the inquiry instruction for receiving peripheral control unit, if so, S18 is entered step, if
It is no, continue to repeat step S17A；
Step S18 judges whether there is MRI mode switching event, if so, S19 is entered step, if it is not, then entering step
Rapid S22；
Step S19 sends MRI mode switching event relevant information to peripheral control unit, subsequently into step S20；
Step S20, waits the response of peripheral control unit, and enters step S21；
Step S21, resetting MRI mode switching event label, and enter step S22；And
Step S22 terminates.
According to the working method of above-mentioned implantable medical devices, wherein the working method of the implantable medical devices is also wrapped
Include the method for controlling the peripheral control unit；The method of the control peripheral control unit includes the following steps：
Step S23 sends inquiry instruction to et al. Ke device, and enters step S24；
Step S24 judges whether to receive the prompt of MRI mode switching event, if so, S25 is entered step, if not,
Enter step S29；
Step S25 receives MRI mode switching event relevant information, subsequently into step S26；
Step S26, display MRI mode switching event prompt warning, subsequently into step S27；
Step S27 waits user to check, and enters step S28；
Step S28 sends response to et al. Ke device, and enters step S29；And
Step S29 terminates.
A kind of implantable medical devices with MRI mode comprising：One peripheral control unit and et al. Ke dress
It sets；Include inside the et al. Ke device：One power module, a voltage-stablizer, a DC-DC voltage conversion circuit, a control electricity
Road, a magnetic field sensor and a communication module, wherein the working method of the implantable medical devices is implantation described above
Any one in the working method of formula medical instrument.
According to above-mentioned implantable medical devices, wherein the magnetic field sensor include a magnetic field induction element and one with
The judgment module of magnetic field induction element electrical connection；Detection data of the judgment module according to the magnetic field induction element, judgement
With the presence or absence of the magnetic field for the energy storage inductor saturation that can make in the DC-DC voltage conversion circuit.
According to above-mentioned implantable medical devices, wherein the magnetic field induction element is hall effect sensor；Or the magnetic
Field sensing element is the detecting element of the impulse generator internal circuit parameter of a detection et al. Ke device, by described
The presence of the variation presumption strong external magnetic field of impulse generator internal circuit parameter.
Compared to the prior art, implantable medical devices provided by the invention and its working method can detect strong magnetic automatically
Field environment avoids security risk to realize the switching of MRI mode and normal mode, improves safety.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of lesions located in deep brain device used in the embodiment of the present invention.
Fig. 2 is the structural block diagram of the impulse generator of lesions located in deep brain device provided in an embodiment of the present invention.
Fig. 3 is the structural block diagram of the magnetic field sensor of lesions located in deep brain device provided in an embodiment of the present invention.
Fig. 4 is the structural block diagram of another magnetic field sensor of lesions located in deep brain device provided in an embodiment of the present invention.
Fig. 5 is the structural block diagram of the DC-DC voltage conversion circuit of lesions located in deep brain device provided in an embodiment of the present invention.
Fig. 6 is that the inductive current of the DC-DC voltage conversion circuit of lesions located in deep brain device provided in an embodiment of the present invention exists
It works normally and comparing result when working under 3T nuclear-magnetism high-intensity magnetic field.
Fig. 7 is the feedback control circuit of DC-DC voltage conversion circuit used in the embodiment of the present invention.
Fig. 8 is the feedback of the DC-DC voltage conversion circuit used in the embodiment of the present invention including normal mode and MRI mode
Control circuit.
Fig. 9 is the work flow diagram of the impulse generator for the lesions located in deep brain device that the embodiment of the present invention 1 provides.
Figure 10 is the further workflow of the impulse generator for the lesions located in deep brain device that the embodiment of the present invention 1 provides
Figure.
Figure 11 is the work flow diagram of the peripheral control unit for the lesions located in deep brain device that the embodiment of the present invention 1 provides.
Figure 12 is the work flow diagram of the impulse generator for the lesions located in deep brain device that the embodiment of the present invention 2 provides.
Figure 13 is the work flow diagram of the impulse generator for the lesions located in deep brain device that the embodiment of the present invention 3 provides.
Figure 14 is the work flow diagram of the impulse generator for the lesions located in deep brain device that the embodiment of the present invention 4 provides.
Main element symbol description
Lesions located in deep brain device 10
External program control instrument 11
Impulse generator 12
Extension lead 14
Stimulating electrode 16
Electrode contacts 18
Power module 100
Voltage-stablizer 101
DC-DC voltage conversion circuit 102
Communication module 103
Magnetic field sensor 104
Control circuit 105
Battery 1001
Current-limiting resistance RS 1002
A/D 1003
Judgment module 1004
Magnetic field induction element 1005
Following specific embodiment will further illustrate the present invention in conjunction with above-mentioned attached drawing.
Specific embodiment
The present invention provides a kind of implantable medical devices and its control methods.Wherein the implantable medical devices can be
Pacemaker, defibrillator, lesions located in deep brain device, spinal stimulator, vagus nerve stimulator, stomach stimulator or other
Similar implantable medical devices.The present invention is only illustrated by taking lesions located in deep brain device as an example, in conjunction with attached drawing to the present invention into
One step explanation.
Referring to Figure 1, the lesions located in deep brain device 10 includes：One outside program control instrument 11 and the pulse to implant hair
Raw device 12, extension lead 14 and stimulating electrode 16 form.The external program control instrument 11 controls the impulse generator 12 for generating
The electric pulse of certain pattern is passed at the electrode contacts 18 of stimulating electrode 16 by the extension lead 14, passes through the electrode contacts
18 stimulation particular core groups can achieve the purpose for the treatment of disease.
Fig. 2 is referred to, includes inside the impulse generator 12：One power module 100, voltage-stablizer 101, DC-DC voltage
Translation circuit 102, control circuit 105, magnetic field sensor 104 and communication module 103 etc..The power module 100 passes through institute
It states voltage-stablizer 101 and generates constant voltage, the input voltage as the DC-DC voltage conversion circuit 102.The control circuit
105 for controlling the energy storage of inductance in DC-DC voltage conversion circuit 102 and releasing energy.The magnetic field sensor 104 is outer for detecting
The strong magnetic field circumstance in portion, and control circuit 105 is adjusted according to the result of feedback.The communication module 103 is used for and the outside
Communication between program control instrument 11.
The structure of the magnetic field sensor 104 is unlimited.Fig. 3 is referred to, the magnetic field sensor 104 generally includes magnetic field sense
The judgment module 1004 answering element 1005 and being electrically connected with the magnetic field induction element 1005.The judgment module 1004 is according to this
The detection data of magnetic field induction element 1005, judges whether there is strong external magnetic field, that is, with the presence or absence of can make the DC-DC
The magnetic field of energy storage inductor saturation in voltage conversion circuit 102.The magnetic field induction element 1005 can be the strong magnetic in special outside
Field sensing element, such as hall effect sensor, or the inspection of a detection 12 internal circuit parameter of impulse generator
Element is surveyed, the presence of the variation presumption strong external magnetic field of the 12 internal circuit parameter of impulse generator is passed through.The judgement mould
Block 1004 can be individual judgment module, be also possible to the one of the central control module (not shown) of the impulse generator 12
Part.If the judgment module 1004 is individual judgment module, central control module is required connect to.
Refer to Fig. 4, in the present embodiment, the power module 100 includes：Battery 1001, current-limiting resistance RS1002 and
A/D1003.The current-limiting resistance RS1002 for limiting the output electric current of the battery 1001, to protect battery 1001.It is described
A/D1003 is for monitoring current-limiting resistance RSThe voltage at 1002 both ends, thus the voltage of real-time monitoring battery 1001 and output electric current,
To monitor the working condition of battery 1001.The magnetic field sensor 104 includes：Current-limiting resistance RS1002, A/D1003 and with
The judgment module 1004 of the A/D1003 connection.The judgment module 1004 is according to the A/D1003 to the monitoring number of battery 1001
According to judging whether there is strong external magnetic field.
It is appreciated that under strong magnetic environment, energy storage inductor in the DC-DC voltage conversion circuit 102 due to saturation and
Inductance is caused to decline, so that the electric current for flowing through inductance increases.Since inductive current is from the output electricity of the battery 1001
Stream, the increase of the inductive current will necessarily cause the increase of the output electric current of the battery 1001.Therefore, by the battery
The energy storage inductor of 1001 actual output current and the battery 1001 in the DC-DC voltage conversion circuit 102 is saturated shape
Electric current under state compares, so that it may judge whether there is strong external magnetic field.The magnetic field sensor 104 of the embodiment of the present invention is logical
The function that monitoring 1001 electric current of battery achieves that magnetic field sensor is crossed, additional magnetic induction component is not needed.
It is appreciated that the magnetic field sensor 104 can work always, can also start under the control of peripheral control unit
Work or power cut-off.For example, the magnetic field sensor 104 can start after the detection instruction for receiving peripheral control unit
Work, in power cut-off after the stopping detection instruction for receiving the external program control instrument 11.The peripheral control unit can be
Other control equipment being connect with impulse generator 12 such as external program control instrument 11 or computer, mobile phone.In the present embodiment, the peripheral hardware control
Device processed is external program control instrument 11.
The impulse generator 12 has two kinds of operating modes of MRI mode and normal mode.The impulse generator 12 can
With the strong external magnetic field information that is detected according to the magnetic field sensor 104 or according to receiving from peripheral control unit
The mutual switching between MRI mode and normal mode is instructed, and records relevant handover information.The pulse hair introduced below
The MRI mode of raw device 12 and the difference and switching mode of normal mode.
Fig. 5 is referred to, by taking DC-DC Boost circuit as an example, the DC-DC voltage conversion circuit 102 includes：Energy storage inductor
L, inductance equivalent series resistance RL, switching tube M1, sustained diode 1 and filter capacitor Cload.Under normal conditions, in order to mention
The efficiency of high DC-DC voltage conversion circuit 102, energy storage inductor L are usually core inductance.At MRI, core saturation causes to store up
Energy inductance inductance value L declines in the order of magnitude, changes so as to cause the other parameters of circuit, most typical is exactly to cause inductive current
Increase at double.
Fig. 6 is referred to, inductive current is working normally and comparing result when working under 3T nuclear-magnetism high-intensity magnetic field, wherein
inormal(t) real-time current when working normally, i are indicatedpnormalIndicate current peak when working normally, imri(t) MRI is indicated
Real-time current when working under high-intensity magnetic field, ipmriIndicate current peak when working under MRI high-intensity magnetic field.It will be appreciated from fig. 6 that normal work
When making, the inductance value in DC-DC voltage conversion circuit 102 keeps normal value, inductive current peak ipnormalIt is smaller.In 3T nuclear-magnetism
Under, due to the saturation effect of magnetic core, core inductance declines close to hollow inductance, inductance value in the order of magnitude.Reduced inductance value,
Lead to inductive current peak ipmriIt is larger.On the one hand the increase of inductive current may damage circuit, on the other hand cause
The power consumption of circuit increases, and the efficiency of circuit is caused to reduce.
Now by taking DC-DC Boost circuit as an example, and assume that circuit works in discontinuous mode (DCM), it is strong in MRI
Under magnetic field, it is assumed that inductance value reduces N times, if not considering coil equivalent series circuit, the various resistance such as switch conduction resistance
It influences, inductive current peak will increase N times.In this way, the power consumption of DC-DC circuit significantly increases under MRI high-intensity magnetic field.In addition, electric
The root-mean-square value of inducing current is expressed as follows：
Wherein, IL,RMSIndicate inductive current root-mean-square value, Vo, IoOutput voltage and electric current are respectively indicated, M indicates output electricity
The ratio of pressure and input voltage, L indicate inductance value, fsIndicate switch regulation frequency.
Under MRI mode, it is assumed that the other parameters in formula (1) are constant, and inductance value L becomes smaller N times,
IL, RMS_MRI=N1/4IL, RMS_NMRI (2)
That is, the root-mean-square value of inductive current is inductive current root-mean-square value when working normally under MRI high-intensity magnetic field
N1/4Times.
In Boost circuit, since power supply is connected always with inductance, inductive current is consistent with electric power outputting current.Therefore,
Formula (2) means under MRI high-intensity magnetic field that the power consumption of DC-DC voltage conversion circuit 102 is N when working normally simultaneously1/4Times.Change sentence
It talks about, works under MRI high-intensity magnetic field 1 hour, be equivalent to and work normally N1/4Hour, that is to say, that under MRI high-intensity magnetic field and just
The efficiency ratio to work in normal situation is N1/4:1。。
Therefore under MRI high-intensity magnetic field, hidden danger existing for DC-DC switching circuit 102 is mainly the electricity by increasing exponentially
Caused by inducing current, for this purpose, can be improved to the DC-DC voltage conversion circuit 102 under MRI high-intensity magnetic field.Introduced below hair
It is bright how DC-DC voltage conversion circuit 102 to be improved under MRI high-intensity magnetic field, to realize MRI mode.
Fig. 7 is referred to, for the feedback control circuit for the DC-DC voltage conversion circuit 102 that the present invention uses.The DC-DC
The output voltage of voltage conversion circuit 102 is through divider resistance Rf1And Rf2The feedback voltage V obtained after partial pressurefbWith expected with reference to electricity
Press VrefIt is compared, obtains error signal, the error signal and control 201 co- controlling DC-DC voltage conversion circuit of pulse
The conducting and disconnection switched in 102.
The control pulse 201 generally includes two parameters of frequency and duty ratio, joins to adapt to circuit under MRI high-intensity magnetic field
The variation that number occurs, for this purpose, can be improved to this control pulse 201.Such as, shown in Fig. 8, in normal work, pulse is controlled
201 first clocks when can be used occur to control frequency f caused by circuit 301s1, when the generation of the clock signal is by external low frequency
Zhong Yuan is provided.Under MRI high-intensity magnetic field, it is higher that frequency caused by second clock generation circuit 302 can be used in control pulse 201
fs2It is controlled, which is provided by the internal clocking DCO of microcontroller.The benefit of this way is that circuit does not need to increase
Add additional device, the f under normal mode of operations1External clock reference offer, the f under MRI high-intensity magnetic field are provideds2It can be used micro-
Included digital dock, the highest frequency of the clock all in 10MHz magnitude, can be carried out simply by software inside controller
Frequency regulation.In addition, its duty ratio also can be changed, or change simultaneously except through changing the control frequency of control pulse 201
Control frequency and duty ratio.In this way, the conversion of normal mode Yu MRI mode can be realized.
The working method for dividing different embodiments to introduce the lesions located in deep brain device 10 below.
Embodiment 1
Referring to Fig. 9, in embodiment 1, the outside that the impulse generator 12 is detected according to the magnetic field sensor 104
High-intensity magnetic field information realizes the mutual switching between MRI mode and normal mode automatically.The magnetic field sensor 104 is constantly in work
Make state.Specifically, the workflow of the impulse generator 12 of the lesions located in deep brain device 10 includes the following steps：
Step S11 detects strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, entering step
Rapid S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of impulse generator 12, and label is in high-intensity magnetic field
Environment, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step
S14；
Step S15, the state of time and impulse generator 12 that record strong external magnetic field disappears, label leave high-intensity magnetic field ring
Border, and enter step S16；
Step S16 is switched to normal mode, marks MRI mode switching event, and return step S11.
It is appreciated that above-mentioned working method usually occurs to enter MRI sensing chamber in patient, indoor carry out MRI is detected in MRI
During detecting and leaving MRI sensing chamber.
With further reference to Figure 10, in embodiment 1, after patient leaves MRI sensing chamber (after i.e. strong external magnetic field disappears),
The workflow of the impulse generator 12 of the lesions located in deep brain device 10 can also include the following steps：
Step S17 judges whether the inquiry instruction for receiving peripheral control unit, if so, S18 is entered step, if not,
Continue to repeat step S17；
Step S18 judges whether there is MRI mode switching event, if so, S19 is entered step, if it is not, then entering step
Rapid S22；
Step S19 sends MRI mode switching event relevant information to peripheral control unit, subsequently into step S20；
Step S20, waits the response of peripheral control unit, and enters step S21；
Step S21, resetting MRI mode switching event label, and enter step S22；
Step S22 terminates.
With further reference to Figure 11, in embodiment 1, after patient leaves MRI sensing chamber (after i.e. strong external magnetic field disappears),
The workflow of the peripheral control unit of the lesions located in deep brain device 10 includes the following steps：
Step S23 sends inquiry instruction to impulse generator 12, and enters step S24；
Step S24 judges whether to receive the prompt of MRI mode switching event, if so, S25 is entered step, if not,
Enter step S29；
Step S25 receives MRI mode switching event relevant information, subsequently into step S26；
Step S26, display MRI mode switching event prompt warning, subsequently into step S27；
Step S27 waits user to check, and enters step S28；
Step S28 sends response to impulse generator 12, and enters step S29；
Step S29 terminates.
Further, the step S25 can also include：According under the battery current calculating MRI high-intensity magnetic field monitored and just
Often efficiency ratio when work.The step S26 can also include：The efficiency ratio is shown to user.
Embodiment 2
Referring to Figure 12, in example 2, the workflow of the impulse generator 12 of the lesions located in deep brain device 10 includes
Following steps：
Step S10 judges whether the detection instruction for receiving peripheral control unit, if so, S11 is entered step, if not,
Continue to repeat step S10；
Step S11 starts to detect strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, into
Enter step S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of impulse generator 12, and label is in high-intensity magnetic field
Environment, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step
S14；
Step S15, the state of time and impulse generator 12 that record strong external magnetic field disappears, label leave high-intensity magnetic field ring
Border, and enter step S16；
Step S16 is switched to normal mode, marks MRI mode switching event, and enter step S17；
Step S17 stops detection strong external magnetic field, and return step S10.
In the embodiment of the present invention 2, the magnetic field sensor 104 is started to work under peripheral control unit control or end work
Make.In the embodiment of the present invention 2, the working method and the embodiment of the present invention of the impulse generator 12 of the lesions located in deep brain device 10
The working method of impulse generator 12 is essentially identical in 1, and difference is, includes one judging whether to receive before step S11
The step S10 of the detection instruction of peripheral control unit；And not instead of return step S11 after step S16, enter step S17.
Further, the step S17 can be specifically included：
Step S171 judges whether the stopping detection instruction for receiving peripheral control unit, if so, S173 is entered step,
If not, entering step S172；
Step S172, if more than a time threshold, if so, S173 is entered step, if not, return step S171；
Step S173 stops detection strong external magnetic field.
It is appreciated that also may include working method described in above-mentioned Figure 10 and Figure 11 in the embodiment of the present invention 2.
Embodiment 3
Referring to Figure 13, in embodiment 3, the workflow of the impulse generator 12 of the lesions located in deep brain device 10 includes
Following steps：
Step S10, judge whether to receive peripheral control unit is switched to MRI mode instruction, if so, entering step
S11, if not, continuing to repeat step S10；
Step S11 is switched to MRI mode, and enters step S12；
Step S12 judges whether that the normal mode that is switched to for receiving peripheral control unit instructs, if so, entering step
S15, if not, entering step S13；
Step S13 judges whether to be more than time threshold, if so, S14 is entered step, if not, return step S12；
Step S14 is switched to normal mode, records overtime handover event, and enter step S15；
Step S15 judges whether the inquiry instruction for receiving peripheral control unit, if so, S16 is entered step, if not, into
Enter step S17；
Step S16 sends overtime handover event information to peripheral control unit, enters step S17；
Step S17 terminates.
In the embodiment of the present invention 3, by manual switching realize the impulse generator 12 MRI mode and normal mode it
Between switching.And MRI mode and normal mode of the above-described embodiment 1 and 2 by automatically switching the realization impulse generator 12
Switching between formula.
In the step S13, which is an empirical value, and usually patient enters MRI sensing chamber, is detected in MRI
Indoor carry out MRI detection and leave the time required for MRI sensing chamber.
It is appreciated that step S15 and S16 are optional step in the embodiment of the present invention 3.
Embodiment 4
Referring to Figure 14, in example 4, the workflow of the impulse generator 12 of the lesions located in deep brain device 10 includes
Following steps：
Step S10, judge whether to receive peripheral control unit is switched to MRI mode instruction, if so, entering step
S11, if not, continuing to repeat step S10；
Step S11 is switched to MRI mode, and enters step S12；
Step S12 starts to detect strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, into
Enter step S13, if not, continuing to repeat step S12；
Step S13, record detect the time of strong external magnetic field and the state of impulse generator 12, and label is in high-intensity magnetic field
Environment, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step
S14；
Step S15, the state of time and impulse generator 12 that record strong external magnetic field disappears, label leave high-intensity magnetic field ring
Border, and enter step S16；
Step S16 judges whether that the normal mode that is switched to for receiving peripheral control unit instructs, if so, entering step
S18, if not, entering step S17；
Step S17 judges whether to be more than time threshold, if so, S18 is entered step, if not, return step S16；
Step S18 stops detection strong external magnetic field, is switched to normal mode, records overtime handover event, and enter step
S19；
Step S19 judges whether the inquiry instruction for receiving peripheral control unit, if so, S20 is entered step, if not, into
Enter step S21；
Step S20 sends overtime handover event information to peripheral control unit, enters step S21；
Step S21 terminates.
In the embodiment of the present invention 4, the magnetic field sensor 104 is after the impulse generator 12 opens MRI mode, certainly
It is dynamic to start to work, and work is ended automatically after detecting that strong external magnetic field disappears.In the embodiment of the present invention 4, the brain deep
The working method of the impulse generator 12 of egersimeter 10 and the working method of impulse generator 12 in the embodiment of the present invention 3 are basic
Identical, difference is, increases the step of magnetic field sensor 104 detects strong external magnetic field, and will test outer
The step of working condition of portion's high-intensity magnetic field information and the impulse generator 12 under the strong external magnetic field is recorded.
It is appreciated that also may include working method described in above-mentioned Figure 10 and Figure 11 in the embodiment of the present invention 4.
Multiple embodiments of the invention are given above, it is to be understood that without departing from present disclosure essence
In the case where mind and range, it can make a variety of changes, replace and change, these embodiments are also in guarantor of the invention
It protects in range.
Claims (7)
1. a kind of working method of the implantable medical devices with MRI mode, which includes et al. Ke
Device and peripheral control unit, and the et al. Ke device includes magnetic field sensor；The working method packet of the implantable medical devices
Include the method for controlling the et al. Ke device；The method of the control et al. Ke device includes the following steps：
Step S11 detects strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, entering step
S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of et al. Ke device, and label is in high-intensity magnetic field ring
Border, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step S14；
Step S15, the state of time and et al. Ke device that record strong external magnetic field disappears, label leave strong magnetic field circumstance,
And enter step S16；And
Step S16 is switched to normal mode, marks MRI mode switching event, and return step S11；
It is characterized in that, the method for the control et al. Ke device further comprises the steps：
Step S17 judges whether the inquiry instruction for receiving peripheral control unit, if so, S18 is entered step, if not, continuing
Repeat step S17；
Step S18 judges whether there is MRI mode switching event, if so, S19 is entered step, if it is not, then entering step
S22；
Step S19 sends MRI mode switching event relevant information to peripheral control unit, subsequently into step S20；
Step S20, waits the response of peripheral control unit, and enters step S21；
Step S21, resetting MRI mode switching event label, and enter step S22；And
Step S22 terminates；
And the working method of the implantable medical devices further includes the method for controlling the peripheral control unit；The control peripheral control unit
Method include the following steps：
Step S23 sends inquiry instruction to et al. Ke device, and enters step S24；
Step S24 judges whether to receive the prompt of MRI mode switching event, if so, S25 is entered step, if not, into
Step S29；
Step S25 receives MRI mode switching event relevant information, subsequently into step S26；
Step S26, display MRI mode switching event prompt warning, subsequently into step S27；
Step S27 waits user to check, and enters step S28；
Step S28 sends response to et al. Ke device, and enters step S29；And
Step S29 terminates.
2. a kind of working method of the implantable medical devices with MRI mode, which includes integrated interplantation
Enter device and a peripheral control unit, and the et al. Ke device includes magnetic field sensor；The work side of the implantable medical devices
Method includes the method for controlling the et al. Ke device；The method of the control et al. Ke device includes the following steps：
Step S10 judges whether the detection instruction for receiving peripheral control unit, if so, S11 is entered step, if not, continuing
Repeat step S10；
Step S11 starts to detect strong external magnetic field and judges whether to detect the presence of strong external magnetic field, if so, entering step
Rapid S12, if not, continuing to repeat step S11；
Step S12, record detect the time of strong external magnetic field and the state of et al. Ke device, and label is in high-intensity magnetic field ring
Border, and enter step S13；
Step S13 is switched to MRI mode, marks MRI mode switching event, and enter step S14；
Step S14, judges whether strong external magnetic field disappears, if it is, S15 is entered step, if it is not, then repeating step S14；
Step S15, the state of time and et al. Ke device that record strong external magnetic field disappears, label leave strong magnetic field circumstance,
And enter step S16；
Step S16 is switched to normal mode, marks MRI mode switching event, and enter step S17；And
Step S17 stops detection strong external magnetic field, and return step S10；
It is characterized in that, the method for the control et al. Ke device further comprises the steps：
Step S17A judges whether the inquiry instruction for receiving peripheral control unit, if so, S18 is entered step, if not, after
It is continuous to repeat step S17A；
Step S18 judges whether there is MRI mode switching event, if so, S19 is entered step, if it is not, then entering step
S22；
Step S19 sends MRI mode switching event relevant information to peripheral control unit, subsequently into step S20；
Step S20, waits the response of peripheral control unit, and enters step S21；
Step S21, resetting MRI mode switching event label, and enter step S22；And
Step S22 terminates；
And the working method of the implantable medical devices further includes the method for controlling the peripheral control unit；The control peripheral control unit
Method include the following steps：
Step S23 sends inquiry instruction to et al. Ke device, and enters step S24；
Step S24 judges whether to receive the prompt of MRI mode switching event, if so, S25 is entered step, if not, into
Step S29；
Step S25 receives MRI mode switching event relevant information, subsequently into step S26；
Step S26, display MRI mode switching event prompt warning, subsequently into step S27；
Step S27 waits user to check, and enters step S28；
Step S28 sends response to et al. Ke device, and enters step S29；And
Step S29 terminates.
3. the working method of the implantable medical devices according to claim 2 with MRI mode, which is characterized in that the step
In rapid S17, the method for stopping detection strong external magnetic field includes the following steps：
Step S171 judges whether the stopping detection instruction for receiving peripheral control unit, if so, S173 is entered step, if
It is no, enter step S172；
Step S172, if more than a time threshold, if so, S173 is entered step, if not, return step S171；And
Step S173 stops detection strong external magnetic field.
4. a kind of implantable medical devices with MRI mode comprising：Peripheral control unit and et al. Ke device；It is described
Include inside et al. Ke device：Power module, voltage-stablizer, DC-DC voltage conversion circuit, control circuit, magnetic field sensor with
And communication module, which is characterized in that the working method of the implantable medical devices is such as claims 1 to 3 any one institute
The working method for the implantable medical devices stated.
5. the implantable medical devices according to claim 4 with MRI mode, which is characterized in that the magnetic field sensor packet
The judgment module for including magnetic field induction element and being electrically connected with the magnetic field induction element；The judgment module is according to the magnetic field induction
The detection data of element judges whether there is the magnetic field that the energy storage inductor in the DC-DC voltage conversion circuit can be made to be saturated.
6. the implantable medical devices according to claim 5 with MRI mode, which is characterized in that the magnetic field induction element
For hall effect sensor.
7. the implantable medical devices according to claim 4 with MRI mode, which is characterized in that the magnetic field sensor packet
It includes the detecting element for the impulse generator internal circuit parameter for detecting the et al. Ke device and is electrically connected with the detecting element
The judgment module connect；The judgment module is judged whether there is by the variation of the impulse generator internal circuit parameter can
The magnetic field for being saturated the energy storage inductor in the DC-DC voltage conversion circuit.
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