阅读说明：本技术 具有用于可植入医疗系统中植入物到植入物通信的偏移量校正的始终开启接收器 (Receiver is always on the offset correction communicated for implantation material in implantable medical system to implantation material ) 是由 K.J.卡罗尔 于 2018-04-19 设计创作，主要内容包括：本文公开了包括接收器和电池的可植入医疗设备(IMD)以及与其一起使用的方法。接收器包括第一和第二差分放大器,每个差分放大器在被使能的时候监视频率范围内的预定信号并消耗来自电池的电力,而在未被使能时基本上不消耗来自所述电池的电力。为了去除不期望的输入偏移电压,所述差分放大器中的每一个在被使能时候被选择性地置于偏移校正阶段,在此期间,该差分放大器无法检测到所述预定信号。在任何给定时间,所述第一和第二差分放大器中的至少一个被使能而不处于所述偏移校正阶段,使得所述差分放大器中的至少一个始终监视所述预定信号。以这种方式,所述接收器永远不会对由另一个IMD发送的信号,包括所述预定信号,是盲目的。(Implantable medical device (IMD) and the method that is used therewith disclosed herein is including receiver and battery.Receiver includes the first and second difference amplifiers, prearranged signals and consumption electric power from battery of each difference amplifier when being enabled within the scope of monitoring frequency, and does not consume the electric power from the battery substantially when not being enabled.In order to remove undesirable input off-set voltage, each of the difference amplifier is selectively placed on the offset correction stage when being enabled, and during this period, which can not detect the prearranged signals.At any given time, at least one of described first and second difference amplifier is enabled and is not at the offset correction stage, so that at least one of described difference amplifier monitors the prearranged signals always.In this way, the receiver is blindness never to the signal sent by another IMD, including the prearranged signals.)

1. a kind of implantable medical device (IMD), comprising:

Receiver, including the first and second difference amplifiers, each difference amplifier are selectively enabled, each differential amplification Device includes differential input end, and each difference amplifier includes output end；And

Battery is electrical when the electric component (including described first and second difference amplifier) of the IMD is enabled Component power supply；

Each of described first and second difference amplifier is configured as within the scope of monitoring frequency when being enabled Prearranged signals；

Each of described first and second difference amplifier consumes electric current when being enabled, and to which consumption comes from The electric power of the battery；

Each of described first and second difference amplifier does not consume electric current substantially when not being enabled, and because This does not consume the electric power from the battery substantially；And

Each of described first and second difference amplifier can be selectively placed on offset school when being enabled Positive stage, during this period, the difference amplifier cannot detect the prearranged signals；

Wherein, at any given time, at least one of first and second difference amplifier of the receiver is made Can and be not at the offset correction stage so that at least one of described first and second difference amplifier monitors always The prearranged signals in the frequency range.

2. IMD as described in claim 1, in which:

It is only enabling in the time less than 20% of one time in first and second difference amplifier, is enabling simultaneously First and second difference amplifier；And

For at least most of time that first and second difference amplifier is simultaneously enabled, first and second difference One of amplifier is in the offset correction stage.

3. IMD as claimed in claim 2, in which:

For only enabling the time for being less than 10% of one time in first and second difference amplifier, enable simultaneously First and second difference amplifier.

4. IMD as described in claim 1, further includes:

First and second electrodes；

Wherein the differential input end of each of described first and second difference amplifier is coupled to described first and Two electrodes.

5. IMD as claimed in claim 4, the receiver including first and second difference amplifier includes the One receiver, and wherein each of first and second difference amplifier of first receiver is configured as supervising Depending on the prearranged signals include the wake-up signal within the scope of first frequency, and the wherein IMD further include:

Second receiver is coupled to first and second electrode；

The first frequency range is detected in response to one of first and second difference amplifier of first receiver The interior wake-up signal, selectively enables the second receiver；

The second receiver, which is configured as receiving when the second receiver is enabled, is being higher than the first frequency One or more implantation materials within the scope of the second frequency of range are to implantation material (i2i) signal of communication；And

When the second receiver is enabled, the second receiver consumes more function than first receiver Rate.

6. IMD as claimed in claim 5, wherein the IMD includes no lead pacemaker, the no lead pacemaker includes branch Support first and second electrode and in the airtight housing for wherein disposing first and second receivers and the battery.

7. IMD as claimed in claim 5 further includes OR gate circuit system, which, which has, is coupled to described the The input terminal of the output end of first and second difference amplifier of one receiver, and have and be coupled to second reception The output end of the enabled terminal of device, and wherein pulse regulating circuit is optionally coupled in the described defeated of the OR gate circuit system Between outlet and the enabled terminal of the second receiver.

8. IMD according to any one of claims 1 to 7, in which:

When first difference amplifier is enabled and is in the offset correction stage, second differential amplification Device is enabled and is not at the offset correction stage；And

When second difference amplifier is enabled and is in the offset correction stage, first differential amplification Device is enabled and is not at the offset correction stage.

9. IMD according to any one of claims 1 to 7, wherein each in first and second difference amplifier A includes auto zero difference amplifier, and wherein the offset correction stage includes the auto zero stage.

10. IMD according to any one of claims 1 to 7, wherein each in first and second difference amplifier A difference amplifier including chopped wave stabilizing, and wherein the offset correction stage includes the chopped wave stabilizing stage.

11. a kind of method for being used together with the implantable medical device (IMD) for including receiver, wherein the receiver Including the first and second difference amplifiers, wherein each of described first and second difference amplifier includes differential input end And output end, and wherein each of described first and second difference amplifier can be by selectivity when being enabled Ground is placed in the offset correction stage, this method comprises:

First and second difference amplifier is selectively enabled, so that at any given time, enabling described first and At least one of two difference amplifiers；

First and second difference amplifier is selectively placed in the offset correction stage, so that in first differential amplification When device is enabled and is in the offset correction stage, second difference amplifier is enabled and is not at the offset Calibration phase, and make when second difference amplifier is enabled and is in the offset correction stage, it is described First difference amplifier is enabled and is not at the offset correction stage；And

Always carry out the prearranged signals within the scope of monitoring frequency using at least one of described first and second difference amplifier.

12. method as claimed in claim 11 enables wherein executing the selectivity, so that for only enabling first He The time less than 20% of one time in second difference amplifier, while enabling first and second differential amplification Device.

13. method as claimed in claim 11, wherein each of described first and second difference amplifier includes automatic Be zeroed difference amplifier, and wherein the offset correction stage includes the auto zero stage.

14. method as claimed in claim 11, wherein each of described first and second difference amplifier includes copped wave Stable difference amplifier, and wherein the offset correction stage includes the chopped wave stabilizing stage.

15. the method as described in any one of claim 11 to 14, including first and second difference amplifier The receiver include the first receiver, and wherein the prearranged signals include within the scope of first frequency wake-up letter Number, and this method further include:

In response to being detected by one of first and second difference amplifier of first receiver in the first frequency The wake-up signal and enabled second receiver in range；And

When enabling the second receiver, is received using the second receiver and be higher than the first frequency range One or more implantation materials within the scope of second frequency are to implantation material (i2i) signal of communication；

Wherein, when enabling the second receiver, the second receiver is more more than first receiver consumption Power.

16. a kind of implantable medical device (IMD), comprising:

First difference amplifier, including the first differential input end and the first output end export first in first output The differential signal of amplification；And

Second difference amplifier, including the second differential input end and second output terminal export second at the second output terminal The differential signal of amplification；

Wherein first and second difference amplifier is enabled and auto zero, so that at any time described first and second At least one of difference amplifier is enabled and not by auto zero；And

Wherein, at any given time, one of the differential signal of first and second amplification is used in response to described first Be enabled and do not detected by a difference amplifier of auto zero pre- in frequency range in the second difference amplifier Determine signal, and the component of selectively enabled IMD.

17. IMD as claimed in claim 16, in which:

It is only enabling in the time less than 20% of one time in first and second difference amplifier, is enabling simultaneously First and second difference amplifier；And

For enabling at least most of time of first and second difference amplifier simultaneously, first and second difference is put One of big device is by auto zero.

18. the IMD as described in claim 16 or 17, in which:

First and second difference amplifier is a part of the first receiver of the IMD；And

The component for the IMD being enabled in response to detecting the prearranged signals includes the second receiver of IMD, institute It states second receiver and consumes more power than first receiver when being enabled.

19. IMD as claimed in claim 18, wherein the IMD includes cardiac stimulation device, and it is described first and second poor The electrode for dividing the differential input end of each of amplifier to be connected to the cardiac stimulation device, the electrode is for selecting It delivers to selecting property cardiac stimulation and is also used to sense the conduction sent by least one of another IMD or external programmer Signal of communication.

20. IMD as claimed in claim 19, wherein first and second difference amplifier is configured as the described pre- of monitoring Determining signal includes wake-up signal, and the wake-up signal is initiated in response to the IMD for triggering via the electricity in another IMD The interval timer of pole delivering pacemaker impulse and before sending event message, sent by another described IMD.

21. IMD as claimed in claim 19, wherein the IMD be configured as being implanted within atrial wall or on, and from Its another described IMD for receiving the wake-up signal and event message be configured as being implanted within ventricle wall or on.

Technical field

Embodiment described herein the method and systems for generally relating to the communication between implantable medical device.

Background technique

Implantable medical device and system often depend upon communication appropriate and carry out correct operation.For example, in biventricular pacemaker (pacemaker) in system, implantation material to implantation material (i2i) communicates the accurate synchronization for system and operates most important.This Kind system can use conduction (conductive) communication, thus using the identical electricity for sensing and/or delivering pacing therapy Extremely send and receive i2i signal of communication.In the case where conductive communication is used for i2i communication, the signal received may have There is short arc, for example, amplitude is lower than 1mV.Thus, in such systems, using conventional differential amplifier as receiver is not have It is useful because the input off-set voltage of conventional differential amplifier is typically larger than 1mV, for example, at any time with the variation of temperature It may be 10mV or bigger.In addition, conventional differential amplifier is highly susceptible to the influence of input off-set voltage drift, this is being tasted It is undesirable when examination detection short arc i2i signal.

Summary of the invention

This document describes implantable medical device (IMD) and its application methods.This IMD can be configured as the implantation heart In room or ventricle cavity wall or on wall without lead pacemaker (LP), but not limited to this.

According to some embodiments, IMD especially includes receiver and battery.Receiver includes the first and second differential amplifications Device, each difference amplifier are selectively enabled, and each difference amplifier includes differential input end, and each differential amplification Device includes output end.When the electric component (including first and second difference amplifiers) of IMD is enabled, battery is these Electric component power supply.Each of first and second difference amplifiers are configured as within the scope of monitoring frequency when being enabled Prearranged signals.Prearranged signals can be the wake-up signal in such as frequency range.More specifically, wake-up signal can be in example Low frequency wake-up pulse in low-frequency range such as from 1kHz to 100kHz.Each of first and second difference amplifiers are in quilt Electric current is all consumed when enabled, thus electric power of the consumption from battery.In contrast, each in the first and second difference amplifiers It is a not consume electric current substantially when being not enabled on, therefore do not consume the electric power from battery substantially.It is short as used in this article Language, substantially without electric current and there is no electric power respectively and mean it is consumed when enabled difference amplifier compared with it is at least few 100 times of electric current and at least lack 100 times of electric power.In order to remove for example due to input off-set voltage drift caused by it is undesirable Input off-set voltage, each of first and second difference amplifiers can be selectively placed on offset school when being enabled In the positive stage, prearranged signals (for example, wake-up pulse) can not be detected by difference amplifier during this period.According to certain of this technology A little embodiments, at any given time, first and second that receiver is enabled in the case where being not at the offset correction stage are poor At least one of point amplifier, so that at least one of first and second difference amplifiers are always within the scope of monitoring frequency Prearranged signals.In this way, receiver never to sent by another IMD (such as another LP) message (including wake up Signal) it is blindness.

According to the specific embodiment of this technology, lacking for one time in the first and second difference amplifiers is only being enabled In 20% time, while enabled first and second difference amplifiers.In addition, enabling the first and second difference amplifiers at the same time Time at least most of time in, one in the first and second difference amplifiers is in the offset correction stage.In order into One step saves battery electric power, according to the specific embodiment of this technology, is only enabling one in the first and second difference amplifiers Time less than in 10% time, while enabled first and second difference amplifiers.

According to the specific embodiment of this technology, IMD further includes being coupled to each of first and second difference amplifiers Differential input end the first and second electrodes.In this way, electrode can be used to receive implantation material to implantation material (i2i) Signal of communication.Electrode may be utilized for sending i2i signal of communication.Identical electrode can also be used to deliver cardiac stimulation arteries and veins Punching, and for sensing intrinsic or induction cardiomotility.

According to the specific embodiment of this technology, the receiver including the first difference amplifier and the second difference amplifier is One receiver, and IMD further includes second receiver, nominally the second receiver is maintained at disabled status when not in use, To save power.In such embodiments, each of the first and second difference amplifiers of the first receiver are configured It can be the wake-up signal in first frequency range (for example, from 1kHz to 100kHz) (for example, waking up for the prearranged signals of monitoring Pulse).It detects and calls out within the scope of first frequency in response to one in the first and second difference amplifiers of the first receiver Awake signal, selectively enables to be also coupled to the second receiver of the first and second electrodes.Second receiver is configured as One or more i2i communication letter is received when two receivers are enabled within the scope of the second frequency for being higher than first frequency range Number.When enabled second receiver, second receiver consumes more power than the first receiver, therefore, in addition to needing Except when wanting, it is beneficial that holding second receiver, which is disabling,.According to the specific embodiment of this technology, IMD includes OR Circuit system, the input terminal of the OR gate circuit system are coupled to the output of the first and second difference amplifiers of the first receiver End, and output end is coupled to the enabled terminal of second receiver.Pulse regulating circuit is optionally coupled in OR gate circuit system Output end and second receiver enabled terminal between.

According to the specific embodiment of this technology, IMD is a kind of no lead pacemaker (LP) comprising support first electrode and The air tight enclosure of second electrode, and it is deployed with the first receiver and second receiver and battery wherein.

According to the specific embodiment of this technology, enabled first difference amplifier and in the offset correction stage when It waits, enables the second difference amplifier and be not at the offset correction stage.On the contrary, in enabled second difference amplifier and deviating When in calibration phase, enables the first difference amplifier and be not at the offset correction stage.In this way, first and second At least one of difference amplifier is enabled always and is not at the offset correction stage, therefore, can monitor and detect always Prearranged signals (for example, wake-up signal).This is why it may be said that including the receiver beginning of the first and second difference amplifiers The reason of opening eventually.

According to the specific embodiment of this technology, each of first and second difference amplifiers are that auto zero difference is put Big device, and the offset correction stage is the auto zero stage.Alternatively, each of first and second difference amplifiers can To be the difference amplifier of chopped wave stabilizing, in this case, the offset correction stage is the chopped wave stabilizing stage.It is other variation be also It is possible and embodiment described herein in the range of.

Certain embodiments of the present technology are related to and have the implantable of the receiver including the first and second difference amplifiers The method that Medical Devices (IMD) are used together, wherein each of first and second difference amplifiers include differential input end And output end, and wherein each of first and second difference amplifiers can be optionally disposed in offset when being enabled Calibration phase.This method may include selectively enabled first and second difference amplifier, so that at any given time, At least one of enabled first and second difference amplifiers.This method can also include selectively poor by first and second Point amplifier is placed in the offset correction stage, so that in enabled first difference amplifier and when in the offset correction stage, It enables the second difference amplifier and is not at the offset correction stage, and in enabled second difference amplifier and in offset correction When in stage, enables the first difference amplifier and be not at the offset correction stage.In addition, this method can also include beginning The prearranged signals come within the scope of monitoring frequency using at least one of first and second difference amplifiers eventually (is believed for example, waking up Number).

According to some embodiments, in order to save power, the selectivity for executing the first and second difference amplifiers is enabled, so that The time that first and second difference amplifiers are simultaneously enabled is enabled less than only one in the first and second difference amplifiers 20% (even more preferably less than 10%) of time.

Receiver including the first and second difference amplifiers can be the first receiver, and prearranged signals can be Wake-up signal within the scope of first frequency.In such an embodiment, this method may be responsive to by the first receiver At least one of first and second difference amplifiers detect the wake-up signal within the scope of first frequency and enabled second connects Device is received, wherein second receiver consumes power more more than the first receiver when second receiver is enabled.The party Method can also include, and when enabled second receiver, received using second receiver and be higher than the of first frequency range One or more implantation materials in two frequency ranges are to implantation material (i2i) signal of communication.

The content of present invention is not intended to be fully described by the embodiment of this technology.In conjunction with drawings and claims, from Under elaborate in the description of preferred embodiment, the other feature and advantage of the embodiment of this technology will become obvious.

Detailed description of the invention

By reference to the following description and drawings, can be best understood and structurally and operationally method both related skills The embodiment of art, wherein run through several views, similar appended drawing reference indicates similar element:

Fig. 1 instantiates the system of the implantation heart formed according to certain embodiments herein.

Fig. 2A is the block diagram according to the single LP of certain embodiments herein.

Fig. 2 B is provided according to the additional of one of the receiver of LP of reference Fig. 2A introduction of certain embodiments of the present technology Details.

Fig. 2 C is according to the enabled and inclined of this technology some embodiments and each difference amplifier for being supplied to receiver The associated exemplary timing chart of correction signal, wherein the details of receiver is described with reference to Fig. 2 B.

Fig. 3 instantiates the LP according to certain embodiments herein.

Fig. 4 is to show the implementation communicated for the implantation material of pace events (paced event) to implantation material (i2i) The timing diagram of example.

Fig. 5 is the timing diagram of one embodiment of the i2i communication for the event for sensing that shows.

Fig. 6 is the high level flow chart for summarizing the method according to this technology some embodiments.

Specific embodiment

As mentioned above, in the case where conductive communication is used for i2i communication, the signal received may have low Amplitude, for example, amplitude is lower than 1mV.Thus, in such systems, the use of conventional differential amplifier is otiose, because with The variation of time and temperature, the input off-set voltage of integrated amplifier will be generally greater than 1mV, for example, it may be possible to be 10mV or more It is high.In addition, traditional difference amplifier is highly susceptible to the influence of input off-set voltage drift, this is attempting to detect short arc It is undesirable when i2i signal.

Instead of using difference amplifier, single-ended amplifier can be alternatively used.But since the power supply of single-ended topology presses down System is than excessively poor, therefore this will require to use very quiet power supply for receiver.Such receiver is to power supply noise It is very sensitive and may the false triggering due to power supply and other noise sources.

Instead of using conventional differential amplifier or single-ended amplifier, the difference amplifier of auto zero can be used to eliminate Input off-set voltage problem.But during the auto zero time (also referred to as auto zero stage (phase)), amplifier pair In i2i message will be " blindness ", it means that the difference amplifier of auto zero possibly can not detect when by auto zero To i2i message.This may be unacceptable in biventricular pacemaker system, because this will lead to two implantable medical devices Between synchronization loss, this will lead to dangerous situation.

Certain embodiments of the present technology are related to a kind of parallel fully differential automatic back-zero system of redundancy, which combines low Input off-set voltage, therefore the high sensitivity of low shifting difference system is combined, but not since auto zero function causes The system " blindness " period.More generally, certain embodiments of the present invention utilizes a pair of of differential input amplifier, It is enabled that ground selectivity is inverted in a manner of only consuming the slightly more electric current of electric current consumed by than one differential input amplifier (enable) and selectively offset correction.

Before the additional detail that this technology specific embodiment above-mentioned is provided, it will be described with reference to Fig. 1-5 first In can be used this technology embodiment exemplary system.More specifically, Fig. 1-5 will be used to describe Exemplary cardiac It fights system, wherein pace-making and sensing operation can be executed by multiple Medical Devices, the multiple Medical Devices may include one Or multiple leadless cardiac pacemakers, ICD (such as subcutaneous ICD) and/or reliably, safely coordinate pace-making and/or sensing operation Programmable device.

Fig. 1 instantiates the system 100 being configured as in implantation heart 101.System 100 includes the different chamber positioned at heart In two or more without lead pacemaker (Leadless pacemaker, LP) 102 and 104.LP 102 is located at atrium dextrum, And LP 104 is located at right ventricle.LP 102 and LP 104 communicate with one another, to notify various local physiological activities, such as local each other Intrinsic event, local pace events etc..LP 102 and 104 can be constructed in a similar way, but be based on LP 102 or 104 Which operated differently in chamber.

In certain embodiments, LP 102 and 104 passes through via the identical electrodes for sensing and/or delivering pacing therapy Conductive communication communicated to communicate with one another, and/or with ICD 106.LP 102 and 104 can also be able to use conductive communication come with External equipment (for example, programmable device 109) communication, the external equipment have the skin for being placed on the patient for implanting LP 102 and 104 Electrode on skin.(and not preferably as this will increase the size of LP 102 and 104) although not shown, but LP 102 and 104 can potentially include antenna and/or telemetry coil, this will allow them to using RF or inductive communication each other, with ICD 106 and/or and external device communication.

In some embodiments, one or more leadless cardiac pacemakers 102 and 104 can be multiple with implantable heart Defibrillator (ICD) 106 is restrained to be implanted into altogether.Each leadless cardiac pacemaker 102,104 is interior, upper or interior using pacemaker shell is located at Two or more electrodes in several centimetres of portion, to be paced and be sensed at the chambers of the heart, for each other, with programmable device 109 and Two-way communication is carried out with ICD 106.

According to some embodiments, provide for coordinate in the different chamber positioned at heart without lead pacemaker (LP) it Between operation device and method.These device and method enable local LP to receive message from long-range LP by conductive communication.

Although method described herein, equipment and system are mainly included in the example in the context of LP, but it is understood that , method described herein, equipment and system can be used together with various other outsides with implantation equipment.For example, The method, equipment and system can be coordinated to be implanted into the intracorporal various implantable medical devices (IMD) of people, rather than just LP, Between operation.Some embodiments enable the first IMD to connect by the conductive communication at least the first channel from least the 2nd IMD Reception breath.It should also be understood that being not limited solely to embodiment described herein the communication that can be used between multiple IMD Communication between first IMD and the 2nd IMD.The method, equipment and system can be also used for two be implanted into the same chamber Communication between a or more IMD, the IMD can be the IMD of same type or can be different types of IMD.Institute Stating method, apparatus and system can be also used for communication between two or more IMD in system, and the system comprises at least One implantation but it is not located in the chambers of the heart (such as the external membrane of heart, transmural, intravascular (for example, coronary sinus), subcutaneous (for example, S-ICD) etc. Deng) IMD.

With reference to Fig. 2A, block diagram shows being configured to supply through sensing/pace-making of the electronic device in LP 102,104 The embodiment of the part of the conductive communication of electrode.One or more of LP 102 and 104 includes at least two without lead electrode 108, it is configured for delivering cardiac pacing pulse, sensing induces and/or natural cardiac electric signals and unidirectional or double To communication.

LP 102,104 includes the first and second receivers 120 and 122, their common restrictions (inter alia) are in LP The first and second communication channels 105 and 107 (Fig. 1) separated between 102 and 104.Depicted in an arrangement that the first and second receivers 120 and 122, but in other embodiments, LP 102,104 can only include the first receiver 120, or may include removing Other receivers except first and second receivers 120 and 122.As will be described in more detail, impulse generator 116 It may be used as the transmitter that i2i signal of communication is sent using electrode 108.In certain embodiments, LP 102 and 104 can be not only Only communicated by the first and second communication channels 105 and 107.In certain embodiments, LP 102 and 104 can be at one It is communicated in common communication channel 105.More specifically, LP 102 and 104 can believe via identical electrode 108 in public physics It is conductively communicated on road, which is also used to deliver pacemaker impulse.Carrying out communication using electrode 108 makes one or more without lead Pacemaker 102 and 104 is able to carry out no antenna and the communication without telemetry coil.

Receiver 120 and 122 can also be known respectively as low frequency (LF) receiver 120 and high frequency (HF) receiver 122, because One or more signals in monitoring rather low-frequency range (for example, being lower than 100kHz) are configured as receiver 120, and are connect Receive one or more signals that device 122 was configured as in monitoring relative high frequency range (for example, being higher than 100kHz).In certain realities It applies in example, receiver 120 (and more specifically, at least part of it) is always enabled, and monitors in particular low frequency model The wake-up notice in (for example, between 1kHz and 100kHz) is enclosed, wake-up notice can be simply wake-up pulse；And it connects Device 120 is received selectively to be enabled by receiver 122.When the first and second receivers are all enabled, receiver 120 is configured as Less power is consumed than receiver 122.Thus, receiver 120 can also be referred to as low power receiver (low power Receiver) 120, and receiver 122 can also be referred to as high power receiver (high power receiver) 122.Root According to certain embodiments of the present technology, the additional detail of receiver 120 is further described below with reference to Fig. 2 B and 2C.Low-power reception Device 120 cannot receive the signal in relative high frequency range (for example, be higher than 100kHz), but the power consumed considerably less than High power receiver 122.In this way, low power receiver 120 can monitor wake-up notice always, without significantly exhausting The battery (for example, 114) of LP.According to some embodiments, wake-up notice, low-power are received in response to low power receiver 120 Receiver 120 selectively enables high power receiver 122, so that high power receiver 122 can receive the letter of higher frequency Number, higher data throughout needed for thus disposing effective i2i communication, without unnecessary and promptly exhaust the electricity of LP Pond (if high power receiver 122 is enabled always, it would be possible that can be in this way).

It is right when one of LP 102 and LP 104 sense intrinsic event or delivering pace events according to some embodiments The LP 102,104 answered sends implantation event message to another of LP 102,104.For example, when atrium LP 102 is sensed/is risen When atrial event of fighting, atrium LP 102 sends implantation material event message, which includes indicating the event flag (example of event property Such as, intrinsic/atrial event sensed, pace-making property atrial event).When 104 sensings of ventricle LP/pace-making ventricular cardiac event, ventricle LP 104 sends implantation event message, the message include indicate event property event flag (for example, intrinsic/heart that senses Room event, pace-making property ventricular cardiac event).In certain embodiments, LP 102,104 will be implanted into event before practical pacemaker impulse Message is sent to another of LP 102,104, and long-range LP is allowed to keep its sensing defeated in that expected long-range pacemaker impulse Enter blank (blank) (prevent unsuitable crosstalk from sensing).

Implantation event message can format in various ways.As an example, each event message may include with The leading trigger pulse of event flag (also referred to as LP wakes up notice, wake-up pulse or wake-up signal).Notification triggers pulse ( Referred to as wake up notice, wake-up pulse or wake-up signal) it is sent on the first channel (for example, the pulse duration is about 10 μ S to about 1ms, and/or within the scope of the base frequency of about 1kHz to about 100kHz).Notification triggers pulse indicates event Label will be sent on a second channel (for example, in lower frequency range).Then thing can be sent on a second channel Part label.

Event flag may include indicating the data of one or more events (for example, for the sensing for the LP for being located at atrium The intrinsic atrial activation arrived is activated for being located at the intrinsic ventricle of LP sensed of ventricle).Event flag may include being used for Intrinsic and pace events not isolabelings.Event flag also can indicate that beginning for timer or end time (for example, AV Interval, blank spaces etc.).Optionally, implantation event message may include message segment, which includes additional/auxiliary Information.

Optionally, logical to implantation material (i2i) from another LP (or other IMD) or from any implantation material of external equipment reception The LP (or other IMD) of letter can send instruction and receive the reception confirmation that LP/IMD receives i2i message etc..

Event message enables LP 102,104 to deliver synchronous treatment and additional supported feature (for example, measurement etc.). In order to maintain synchronous treatment, when event occurs in the chamber comprising a LP 102,104, make in LP 102 and 104 Another (passing through event message) knows.Certain embodiments described herein, which provides, efficiently and reliably to be handled, to maintain LP Synchronization between 102 and 104, without maintaining the continuous communiction between LP 102 and 104.According to some embodiments herein, Low power event message/signaling synchronously or can be maintained asynchronously between LP 102 and LP 104.

For synchronous event signaling, LP 102 and 104 remains synchronous and with specific interval periodic communication.Synchronous event signaling Allow the transmitters and receivers in each LP 102,104 using limited (or minimum) power, because of each LP 102,104 Only it is being powered with sending and receiving in the related sub-fraction time.For example, LP 102,104 can be 10- in the duration Transmission/reception (Tx/Rx) message in the time slot of 20 μ s, wherein Tx/Rx time slot is that periodically (for example, every 10-20ms) occurs.

Even in synchronous event signaling schemes, LP 102 and 104 can also lose synchronous.It as will be explained herein, can be with In the feature synchronous with including maintenance equipment in LP 104 of LP 102, and when synchronization loss, the experience of LP 102 and 104 is restored Synchronous operation.Moreover, synchronous event message/signal can introduce delay between transmissions, this can receive LP 102,104 Cause response lag in place.As a result, it is possible to achieve solving the feature of response lag.

During asynchronous event signaling, LP 102 and 104 does not maintain communication synchronization.During asynchronous event signaling, LP One or more of 102 and 104 receiver 120 and 122 " can be always on " and (be waken always) to search for incoming biography It is defeated.But LP receiver 120,122 is maintained at " being always on " state that (wakes always) and proposes challenge, because due to suffering from The decaying of high channel caused by the anatomical structure of person, the signal level received are usually low.It will be than can in addition, receiver is maintained to wake Battery 114 is quickly exhausted with desired.

Asynchronous event signaling method is avoided loses synchronous associated risk between equipment.But asynchronous event is believed Method is enabled to utilize additional receiver electric current between transmissions.For illustration purposes only, non-limiting example is described below.Example Such as, fading channel can be estimated as to the gain with 1/500 to 1/10000.Gain factor can be 1/1000.Except receiver Outside electric current, sending electric current is also design factor.As an example, the implantation communication current budget of half can be dispatched to send out by system Send device (for example, each transmitter is 0.5 μ A).When transmitter is maintained the state of being continuously switched on and electrode load by LP 102,104 When being 500 ohm, the voltage of transmission can be 2.5V.When event signal is sent with 2.5V, event signal can decline when propagating Subtract, and will occur at LP 102,104 receivers, amplitude is about 0.25mV.

In order to overcome reception power limit above-mentioned, pulsatile delivery scheme can use, wherein occurring relevant to event Communications.For example, it can simplify pulsatile delivery scheme, so that each transmission constitutes the list with selected amplitude and width A pulse.

According to some embodiments herein, LP 102 and 104, which can use, realizes that classification receiver wakes up the more of scheme Grade receiver, to improve reliability and to keep power-efficient.Each of LP 102 and 104 may include with different 120 He of the first and second receivers that first and second activated protocols and the first and second different reception channels are operated 122.For example, can distribute the first activated protocol to the first receiver 120, first activated protocol " being always on " is (also referred to as Always wake) and with distribute to the second reception channel base frequency range (for example, be greater than each pulse of 100kHz/ it is small In 10 μ s) compared to have lower base frequency range/pulse duration (such as.1kHz to 100kHz/10 μ s to about 1ms) First reception channel on monitored.

According to some embodiments, the first receiver 120 can institute's having time (including when second channel it is inactive (sleep) When) maintain the first channel active (waking), to monitor the message from long-range LP.The can be distributed to second receiver 122 Two activated protocols, second activated protocol are the agreements being triggered, and wherein second receiver 122 is in response to receiving channel first On detect trigger event and become active and (wake) (for example, when incoming signal and LP wake up notice to it is corresponding when to activate Second channel of local LP).Term active (active) wakes (awake) and enables to be used interchangeably herein.

A still referring to Figure 2, each LP 102,104 are shown as including processor or controller 112 and impulse generator 116.Processor or controller 112 may include that such as microprocessor (or equivalent control circuit system), RAM and/or ROM are deposited Reservoir, logic and timing circuitry, state machine circuitry and I/O circuit system, but not limited to this.Processor or controller 112 can also include such as timing control circuit system, to control boost pulse (for example, the delay of pacing rate, chamber (AV), the heart In room conduct (A-A) delay or compartment space conduction (V-V) delay etc.) timing.This timing control circuit system can also be used In refractory period, blank spaces, noise detection window, the response window of induction, alarm interval, label channel timing etc. determine When.Processor or controller 112 can also include other special circuit systems and/or firmware/software component, help to monitor The various situations of patient's heart simultaneously manage pacing therapy.Processor or controller 112 and impulse generator 116 can be configured as Event message is sent via electrode 108 in a manner of heart in the chamber locating for the not error capture LP 102,104, such as works as phase When associated chamber is not at refractory state.In addition, the LP 102,104 for receiving event message can disappear in the event of receiving Enter " event is not answered " state (or event space state) after breath.Event can not be answered/space state is set as receiving Extend the determining period after to event message, accidentally another signal detection disappears for event to avoid LP 102,104 is received Breath, otherwise this will cause retriggered.For example, receive LP 102,104 can detecte from LP 102,104 another or compile The measurement pulse of journey device 109.

According to some embodiments herein, programmable device 109 can be sharp with LP 102,104 on the channel of programmable device to LP It is communicated with identical communication plan.External programmer can monitor the event message sent between LP 102,104, and Keep programmable device synchronous to carry out implantation communication, so that programmable device 109 is until completing implantation material to implantation material messaging sequence Signal of communication 113 is just sent later.

According to some embodiments, LP 102,104 can will send operation and be combined with treatment.Sending event flag can be by It is configured to that there is characteristic similar with pacemaker impulse on amplitude and pulse width, and LP 102,104 can be used event and disappear Energy in breath helps to capture heart.For example, pacemaker impulse can usually be risen with 2.5V amplitude, 500 ohmages, 60bpm The pacing parameter delivering for rate, the 0.4ms pulse width of fighting.The current drain (draw) of aforementioned pacing parameter and about 1.9 μ A is right It answers.Identical LP 102,104 can use with about for the corresponding amplitude of the current drain of 0.5 μ A, pulse sent it is wide The event signaling parameter of degree, pulse rate etc. realizes event message.

LP 102,104 can combine event message transmission with pacemaker impulse.For example, LP 102,104 can be used The 50 μ s that amplitude is 2.5V, which wake up, sends pulse, and for 500 ohm of electrode load, which will be consumed 250nC (receive coulomb). Event message can be followed after the pulse for sending event message, a series of short duration pulse (examples of the event message Such as 16,2 μ s ON/OFF bytes) coding, this will consume additional 80nC.Then, event message pulse, which will follow, reaches nominal Residual impulse width needed for the equivalent quantity of electric charge of 0.4ms pacemaker impulse.In this case, electric current base needed for sending label It is free on this, because it is all used to realize necessary pace-making capture anyway.It in this way, can be reception Device budget sends the saving of electric current, or can prolong the service life.

When LP 102 or 104 senses intrinsic event, it can send qualitative similar event pulse sequence (but indicate The event sensed), without adding pacemaker impulse remainder.Since 100% temporally being delivered based on LP 102,104 Fight treatment hypothesis come design LP 102,104 service life calculated, therefore send the another of LP 102,104 for intrinsic event flag It is a to will not affect that the LP service life nominally calculated.

In some embodiments, LP 102,104 can deliver pacemaker impulse with relatively low amplitude.When use short arc When pacemaker impulse, the power budget of event message can be revised as to the major part of whole equipment energy budget.With pace-making Pulse amplitude reduce closer to event message amplitude, LP 102,104 as pacing therapy a part and increase LP 102, the degree (also referred to as shared " capture charge " and " sending charge ") of 104 use event messages.As an example, if nominal Pace-making vector can be reduced to < 1.25V, then " supply halves " pace-making charging circuit, which can consume battery current, to be reduced about 50%.1.25V pacemaker impulse will save the pacemaker current budget of 1.5 μ A.For lower pulse amplitude, LP 102,104 can be with Use bigger pulse width.

It is paced by combination event message and low-power, the additional service life may be implemented in LP 102,104.The current service life Standard regulation, is specified when the service life must be based on 100% pace-making using the therapy of 2.5V amplitude, 0.4ms pulse.Optionally, New standard can be established compared with the pacemaker impulse of short arc and/or shorter pacemaker impulse based on delivering.

Although it is not shown, communication capacitor can be provided in LP 102,104.Communication capacitor can be used for for Event message pulse, which is sent, has the event signal of high voltage to improve communication, such as when the experience of LP 102 and 104 is difficult to feel When the event message of survey.The implantation material that high voltage event signaling can be used to have high RST to decay, or retrying ARQ (automatic repeat request) is shaken hands and is used in the case where scheme.

In some embodiments, individual LP 102 may include: the shell 110 of sealing, be configured to be placed on or attached It is connected to the internal or external of the chambers of the heart；And at least two electrodes 108 without lead, close to shell 110 and be configured to 106 two-way communication of at least one other equipment in or beyond body.

Fig. 2A depicts single LP 102 (or 104), and shows the function element of LP, they are substantially enclosed in airtight In shell 110.LP 102 (or 104) has at least two to be located in shell 110, on or near electrode 108, for heart The intramuscular delivery pacemaker impulse of chamber simultaneously senses its electrical activity, and with the two-way each other of at least one equipment in or beyond body Letter.Airtight feedthrough (feedthrough) 130,131 passes through 110 conducting electrode signal of shell.Shell 110 includes one-shot battery (primary battery) 114, for being applied to the electric power (power) of pace-making, sensing and communication.Shell 110 is also comprising being used for The circuit 132 that cardiomotility is sensed from electrode 108, for receiving connecing for information from least one other equipment via electrode 108 Device 120,122 is received, and for generating pacemaker impulse to deliver and be also used to via electrode 108 at least via electrode 108 One other equipment sends the impulse generator 116 of information.Shell 110 can also include the circuit for supervision equipment health, Such as battery current monitor 136 and cell voltage monitor 138, and may include for controlling operation in a predefined manner Circuit.

Electrode 108 can be configured as the two-way between multiple leadless cardiac pacemakers and/or the ICD of implantation 106 Letter coordinates pacemaker impulse delivering and optionally other treatments or diagnostic characteristic to use message, and the message identification is initiated Event at the individual pacemaker of message and the pacemaker of reception message is made such as message instruction according to the source of message Reaction.The LP 102,104 for receiving event message makes a response as message indicates according to the source or position of message.In In some embodiments or situation, two or more be can be configured as in one or more without lead electrode 108 without the lead heart Two-way communication between dirty pacemaker 102 and/or ICD 106, and transmission includes the thing for being detected or being created by individual pacemaker The data of the appointment codes of part.Each pacemaker can be configured, it is corresponding with event type and the transmission position of pacemaker to issue Unique code.

In some embodiments, individual LP 102,104 can be configured as delivering rising in wherein coded event message It fights pulse, wherein distributing code according to pacemaker location and the pacemaker impulse that is configured as encoding via event message is to one Or a number of other leadless cardiac pacemakers send message.The one or more pacemakers for receiving the message are suitable for according to event Type and position respond the message in a predefined manner.

Moreover, the information transmitted on incoming channel can also include the event from another leadless cardiac pacemaker Message, which indicates that another leadless cardiac pacemaker has sensed heartbeat or delivered pacemaker impulse, and knows Not Chu another pacemaker position.For example, LP 104 can receive event message from LP 102 and be relayed to programmable device. Similarly, the information that transmits can also include to another or multiple leadless cardiac pacemakers or ICD on outflow channel Message, the message indicate that sending leadless cardiac pacemaker senses heartbeat at the position for sending pacemaker or delivered It fights pulse.

Referring again to Fig. 1 and Fig. 2, in addition to being configured for being implanted into electrical contact with the chambers of the heart and for combining implantable ICD Except 106 leadless cardiac pacemaker 102,104 to execute cardiac rhythm management function, cardiac pacing system 100 can also include Implantable cardiac cardioverter defibrillators (ICD) 106.Implantable ICD 106 and one or more leadless cardiac pacemakers 102,104 It is configured as according to the Information Conduction discussed in this article by via bodily tissue and/or between transmitter and receiver Wireless transmission is to realize that no lead is in communication with each other.

In another embodiment, cardiac pacing system 100 includes at least one leadless cardiac pacemaker 102,104, It is configured as being implanted into and be configured as to combine the implantable cardiac conversion defibrillation being implanted into jointly in electrical contact with heart chamber Device (ICD) 106 executes heart pace-making function.One or more leadless cardiac pacemakers 102 include at least two without lead Electrode 108, this at least two is configured for delivering cardiac pacing pulse without lead electrode 108, sensing induces and/or natural Cardiac electric signals, and will send information to the ICD 106 being implanted into jointly.

As shown in the illustrated embodiment, leadless cardiac pacemaker 102,104 may include that two or more nothings are drawn Line electrode 108, be configurable for delivering cardiac pacing pulse, sensing induces and/or natural cardiac electric signals and With 106 two-way communication of ICD being implanted into jointly.

LP 102,104 can be configured as during fabrication and/or when being programmed by external programmer in specific position It is operated in specific function.Two-way communication between multiple leadless cardiac pacemakers can be arranged the heartbeat that will be sensed Or the notice of pacemaker impulse event and the type of coding of event that deliver and position are transmitted to of another or multiple implantation It fights device.102, the 104 pairs of information of LP for receiving communication are decoded and according to the positions and scheduled system function for receiving pacemaker It is responded.

In some embodiments, LP 102 and 104 is configured as in any chamber of implantable cardiac, that is, any atrium (RA, LA) or any ventricle (RV, LV).In addition, configuring for dual chamber, it can be implanted into multiple LP jointly (for example, one in RA It is a, one in RV, one in RV, one in the coronary sinus near LV).Certain pacemaker parameters and function depend on (or hypothesis) wherein (therefore, LP is interacted implantable pacemaker；For example, pace-making and/or sensing) chamber knowledge.It is some non- Limitative examples include: sensing sensitivity, the response algorithm of induction, use AF inhibition, blank and refractory period in local chamber Deng.Thus, each LP needs to know the identity for being wherein implanted into the chamber of LP, and it is related to each LP that automatic identification may be implemented The processing of the local chamber of connection.

Processing for chamber identification also can be applied to the subcutaneous pacemaker with lead etc., ICD.With one or more The chamber of the equipment for being implanted into conducting wire, identification and/or confirmation lead implantation therein can be useful in several associated scenarios.Example Such as, can be mitigated by clinician and inadvertently can plant the insertion of V lead for DR or CRT equipment, automatic identification and confirmation A possibility that port A of Medical Devices, vice versa.As another example, for SR equipment, the cavity that is implanted it is automatic Identification can enable equipment and/or programmable device select and the appropriate subset (for example, AAI or VVI) of pacing mode is presented, and Allow IPG using setting appropriate and algorithm set (for example, V-AutoCapture is relative to ACap-Confirm, sensing sensitivity Deng).

And show in fig. 2, one-shot battery 114 has positive terminal 140 and negative terminal 142.From one-shot battery The electric current of 114 positive terminal 140 flows through current divider 144 and reaches regulator circuit 146, is suitable for pacemaker 102 with creation The positive voltage supply 148 of remaining circuit system power supply.Current divider 144 enables battery current monitor 136 to mention to processor 112 The indirect instruction of instruction and equipment health for battery current drain.Exemplary power can be one-shot battery 114.

In various embodiments, LP 102,104 can manage power consumption thus to reduce from the limited electric power of battery consumption Equipment volume.It can be with each circuit in designing system to avoid big peak point current.For example, can be by making across pacing electrode Energy-storage capacitor (not shown) discharges to realize cardiac pacing.Recharging for energy-storage capacitor is usually controlled by charge pump circuit. In a particular embodiment, charge pump circuit is throttled, to be charged from battery with constant power to energy-storage capacitor.

In some embodiments, the processor in a leadless cardiac pacemaker 102 or the accessible electricity of controller 112 Signal on pole 108, and can check the output pulse width from another pacemaker, for use as determining touching The signature also, the signature for being reached in predetermined limit of photos and sending messages validity, in the delay of scheduled zero or more millisecond The delivering of pacemaker impulse is activated later.Predetermined delay can preset during fabrication, can program via external programmer, or Person is determined by adaptively monitoring to promote to identify trigger signal and distinguish trigger signal and noise.In some embodiments In or in some cases, processor or controller 112 can check the output arteries and veins from another leadless cardiac pacemaker Waveform is rushed, for use as the signature for determining triggering effectiveness of information also, the signature for reaching in predetermined limit, pre- The delivering of pacemaker impulse is activated after the delay of zero or more fixed millisecond.

Fig. 3 shows LP 102,104.LP may include the gas-tight shell of the electrode 108a and 108b with deployment on it Body 202.It is surrounded as shown, electrode 108a can be separated with fixed mechanism 205 but is fixed 205 part of mechanism, and electrode 108b can be deployed on shell 202.It is special that fixed mechanism 205 can be fixed helix, multiple hooks, barb or other attachments Sign, is configured to for pacemaker to be attached to tissue (such as heart tissue).Electrode 108a and 108b are shown above with reference to Fig. 2A Out and discuss electrode 108 example.

Shell can also be included in the intracorporal electronic device compartment 210 of shell, which grasps comprising pacemaker Electronic component necessary to making, including such as impulse generator, receiver, battery and for the processor of operation.Airtight housing 202 may be adapted to be implanted into human heart on or in which, and for example can for cylinder, rectangle, spherical shape or it is any other properly Shape.

Shell may include conduction, biocompatible, inert and safe anode material, and such as titanium, 316L is stainless Steel or other similar materials.Shell can also include being deployed in the insulator that electrode 108a and 108b is separated in conductive material. Insulator can be the insulating coating in a part of shell between the electrodes, and may include such as silicone resin, poly- ammonia Ester, Parylene or the material commonly used in another biocompatibility electrical insulator of implantable medical device etc.In In the embodiment of Fig. 3, single insulator 208 along shell the partial deployment between electrode 108a and 108b.In some realities It applies in example, shell itself may include insulator rather than conductor, such as aluminium oxide ceramics or other similar materials, and electrode It can be deployed on shell.

As shown in Figure 3, pacemaker can also include head assembly 212 so that 108a and 108b is isolated.Head assembly 212 can To be made of PEEK, cyclobutane or another biocompatible plastic, and it may include feedthrough component, glass of the ceramics to metal To the feedthrough component or other suitable feed-through insulators known in the art of metal.

Electrode 108a and 108b may include pace-making/sensing electrode or refurn electrode.Hypopolarization coating can be applied to electricity On extremely, the platinum, platinoiridita, iridium, yttrium oxide, titanium nitride, carbon or the other materials commonly used in reducing polarization effect that are such as sintered.In In Fig. 3, electrode 108a can be pace-making/sensing electrode, and electrode 108b can be refurn electrode.Electrode 108b can be conduction Shell 202 do not include insulator 208 a part.

Inner wall or outer wall that shell 202 is attached to heart by several technologies and structure can be used.Spiral fixed mechanism 205 can enable a device to be inserted into the intracardiac or external membrane of heart by guiding catheter.Coilable conduit can be used to rotate shell, And fixed equipment is forced to enter heart tissue, thus the tissue that makes fixed equipment (and electrode 108a in Fig. 3) and can stimulate Contact.Electrode 108b may be used as the indifference different electrode for sensing and pacing.Fixed mechanism can partly or entirely apply coated with Just it is electrically insulated, and can include steroids eluting matrix in equipment or near it to minimize fiberization, this is normal It is known in the pacing electrode lead of rule.

Implantation material is transmitted to event message

LP 102 and 104 can be communicated by event message using implantation material to (i2i), be coordinated in various ways mutual Operation.Term " i2i communication ", " i2i event message " and " i2i event flag " is used interchangeably herein, and refers to from being planted Enter equipment send and be directed to event related news that another is implanted equipment and message relevant to IMD/IMD operation (though Right external equipment (for example, programmable device) also can receive i2i event message).In certain embodiments, LP 102 and LP 104 makees It is operated for two independent no lead pacemakers, to maintain dual chamber function by shooting via " master/slave " operative configuration.For retouching The purpose stated, ventricle LP 104 will be referred to as " vLP ", and atrium LP 102 will be referred to as " aLP ".It is designated as main equipment (example Such as, vLP) LP 102,104 all or most of dual chamber diagnosing and treatings may be implemented determine algorithm.For following explanation, Assuming that vLP is " master " equipment, and aLP is " from " equipment.Alternatively, aLP can be appointed as to main equipment, and vLP is specified For from equipment.Most of main equipment planning or all decisions and timing determination (including for example rate response changes).

According to some embodiments, provide for being configured as being fully implanted in the first and second chambers indoor of heart One and second method without coordinated manipulation between lead pacemaker (LP).A kind of method passes through fixed via the shell along the first LP The conductive communication of the electrode of position sends event flag, which indicates one of local pace-making or event for sensing.It should By sensing channels, the detecting event at the 2nd LP marks method.This method is based on being configured as indicating that interested event exists The preassigned pattern that occurs in long-range chamber identifies the event flag at the 2nd LP.It is operated in response to identification, this method is second Relevant action is initiated in LP.

Fig. 4 is timing diagram 400, demonstrates an example of the i2i communication for pace events.It can be for example from LP 102 send i2i communication to LP 104.As shown in Figure 4, in this embodiment, i2i transmission 402 be send LP (for example, LP 102) transmission before of delivering pacemaker impulse 404.This prepare reception LP (for example, LP 104) can to pacemaker impulse Remote delivery.I2i transmission 402 includes envelope 406, may include one or more individual pulses.For example, in this reality It applies in example, envelope 406 includes low-frequency pulse 408, is followed by high-frequency pulse string 410.408 sustained periods of time of low-frequency pulse Ti2iLF, and 410 sustained periods of time Ti2iHF of high-frequency pulse string.The end of low-frequency pulse 408 and the starting quilt of high-frequency pulse string 410 Space period Ti2iGap is separated.

As shown in Figure 4, i2i transmits 402 sustained periods of time Ti2iP, and 404 sustained periods of time Tpace of pacemaker impulse.i2i The end of transmission 402 and the period TdelayP that starts to be delayed by of pacemaker impulse 404 are separated.Delay periods can be for example about Between 0.0 and 10.0 millisecond (ms), especially between about 0.1ms and 2.0ms, and more particularly about 1.0ms.Such as Used herein, term " about " is meant to refer to +/- the 10% of definite value.

Fig. 5 is an exemplary timing diagram 500 of the i2i communication for the event for sensing of demonstrating.It can be for example from LP 102 send i2i communication to LP 104.As shown in Figure 5, in this embodiment, when the intrinsic activation 502 sensed is across sense When the threshold value 504 measured, sends LP (for example, LP 102) and detect the event sensed.When predetermined delay after a test Section TdelayS sends LP and sends the i2i transmission 506 for continuing predetermined period Ti2iS.Delay periods can be for example in about 0.0 He Between 10.0 milliseconds (ms), especially between about 0.1ms and 2.0ms, and more particularly about 1.0ms.

As i2i transmission 402, i2i transmission 506 may include envelope, which may include one or more Independent pulse.For example, being similar to envelope 406, the envelope of i2i transmission 506 may include low-frequency pulse, be followed by high frequency arteries and veins Punching string.

Optionally, wherein the first LP is located in atrium and the 2nd LP is located in ventricle, the first LP generates AS/AP event mark Note is to indicate to have occurred atrial sense (AS) event or auricular pacemaking (AP) event or will occur in the near future.For example, can To send AS and AP event flag after corresponding AS or AP event.Alternatively, the first LP can be slightly in delivering atrium AP event flag is sent before pacemaker impulse.Alternatively, wherein the first LP is located in atrium, the 2nd LP is located in ventricle, the Two LP initiate Atrioventricular septum after receiving AS or AP event flag from the first LP；And AP event mark is being received from the first LP The interval post atrial blanking period (PAVB) is initiated after note.

Optionally, the first and second LP can be operated with " pure " master-slave relationship, wherein main LP is other than " event " marks Or replace " event " label also delivering " order " label.Command Flags instruction executes the dynamic of delivering pacemaker impulse etc. from LP Make.For example, with pure master-slave relationship, being ordered when receiving AP from main LP when being located in atrium from LP and main LP is located in ventricle When enabling label, atrium LP will be delivered to by pacemaker impulse immediately from LP.

According to some embodiments, via the communication of label/order progress in event message (according to i2i communication protocol) Come realize the communication between aLP and vLP with it is synchronous.As explained above, the communication of progress may include from sensing/pace-making electricity The event message that pole is sent with the frequency except RF or Wi-Fi frequency range.The following drawings and corresponding description illustrate can be The non-limiting example of the label sent in event message.The following drawings and corresponding description further include the description of label and are connecing Receive the example of the result occurred in the LP of event message.Table 1 indicates that the exemplary event that vLP is sent to from aLP marks, and table 2 Indicate the exemplary event label that aLP is sent to from vLP.In master/slave configuration, atrium blank phase (PVAB) after ventricle every time When detecting atrial event except the ventricle blank interval of interval or certain other restrictions, all AS event flag can be sent from aLP. When each aLP delivers pacemaker impulse in atrium, AP event flag will be sent from aLP.ALP can limit the biography of AS label It is defeated, as a result, when the atrial refractory period (PVARP) except the interval PVAB and after ventricle or the atrium of some other alternative restrictions When all detecting atrial event in refractory period, aLP sends AS event flag.Alternatively, aLP can be not based on PVARP limitation The transmission of AS event flag, but AS event flag is instead sent when sensing atrial event every time.

Table 1

As shown in table 1, when aLP sends the event message including AS event flag, (instruction aLP senses intrinsic atrium thing Part) when, vLP initiates AV intervalometer.If aLP sends AS event flag for all events sensed, vLP will Determine that the interval PVAB or PVARP is inactive first preferably before initiating AV intervalometer.But if aLP only when AS event flag is just sent when detecting intrinsic signal except the interval PVAB or PVARP, then vLP can receive AS event AV intervalometer is initiated after label, without first checking PVAB or PVARP situation.When aLP sends the (instruction of AP event flag ALP to atrium delivering or will transmit pacemaker impulse to atrium) when, if the interval PVARP is inactive, then vLP is initiated PVAB timer and AV interval time.VLP can also make its sensing amplifier blank, with prevent to by aLP deliver it is long-range Pulse of fighting carries out possible crosstalk sensing.

Table 2

As shown in table 2, when vLP senses ventricular cardiac event, vLP sends the event message including VS event flag, makees For response, aLP can initiate PVARP intervalometer.When vLP is delivered in ventricle or intends to deliver pacemaker impulse, vLP hair Send VP event flag.When aLP receives VP event flag, aLP initiates PVAB intervalometer and the timing of the interval PVARP Device.ALP can also make its sensing amplifier blank, to prevent from carrying out possible crosstalk to the long-range pacemaker impulse delivered by vLP Sensing.VLP can also send event message, which includes AP Command Flags, to exist receiving order post command aLP Delivered in atrium immediately pacemaker impulse without postpone.

Aforementioned events label can be used for showing for the label subset for making aLP and vLP be able to maintain that complete dual chamber function Example.In one embodiment, vLP can execute all dual chamber algorithms, and aLP can execute that the local in aLP realizes based on The hardware-related function in atrium, such as PVAB.In this embodiment, aLP is effectively treated as long-range " wireless " atrium Pace-making/sensing electrode.In another embodiment, vLP can execute dual chamber algorithm that is most of but being not all of, and aLP can To execute the subset of diagnosing and treating algorithm.In alternative embodiments, vLP and aLP can equally execute diagnosing and treating calculation Method.In certain embodiments, Decision-making Responsibility can be separately divided into one of aLP or vLP.In other embodiments, decision is blamed Joint input and responsibility can be related to by appointing.

In embodiment, in order to provide safer treatment, pace-making and sensing function based on ventricle are not dependent on any I2i communication.For example, in the case where LP to LP (i2i) communication loss (for a long time or of short duration), when vLP equipment is currently running institute When having required algorithm independently to realize these functions, system 100 be automatically moved back to the safe pace-making based on ventricle/ Sensing function.For example, since vLP is not dependent on, i2i communication is movable to execute ventricular pacemaking/sensing, and vLP can be restored to Vvi mode.Once having restored i2i communication, system 100 can restore dual chamber function automatically.

Receiver is always on offset correction

As described above, each of LP 102,104 includes the first and second receivers 120 in the discussion of Fig. 2A With 122, they can also be known respectively as LF and HF receiver 120 and 122 or low-power and 120 He of high power receiver 122.According to some embodiments, LF receiver 120 is configured as monitoring in relatively low frequency range (for example, lower than 100kHz) Interior wake-up signal, and receiver 122 (when enabled) is configured as monitoring in relative high frequency range (for example, being higher than Event message signal in 100kHz).In certain embodiments, receiver 120 (and more specifically, at least part of it) It is always enabled and monitors that the wake-up in particular low frequency range (for example, between 1kHz and 100kHz) notifies, the wake-up Notice can be simply wake-up pulse；And receiver 122 is selectively enabled by receiver 120.It connects when first and second When receipts device is all enabled, receiver 120 is configured as consuming less power than receiver 122.For example, receiver 122 makes About 50 μ A can be consumed when energy, and receiver 120 averagely can only consume about 0.3 μ A.

According to some embodiments, receiver 120 is configured as monitoring and the wake-up signal that detects have can be lower than 1mV Short arc.Thus, realize that receiver 120 will be otiose using conventional differential amplifier, because of conventional differential amplifier Input off-set voltage will be generally greater than 1mV (for example, it may be possible to 10mV or higher, as time and temperature have additional change Change).In addition, conventional differential amplifier is highly susceptible to the influence of input off-set voltage drift, this is in trial detection 1mV or more It is undesirable when small low-amplitude signal.

Receiver 120 is realized instead of using conventional differential amplifier, and single-ended amplifier can be used.But due to list End topology has excessively poor power supply rejection ratio, therefore this will undesirably require to use very quiet electricity for receiver 120 Source.This quiet power supply is difficult to realize in such as IMD of LP 102,104 etc.

Another selection will be that receiver 120 is realized using the difference amplifier of auto zero, this can eliminate input Offset voltage problem.But during the auto zero stage, the difference amplifier of auto zero will be unable to detection from another LP The signal of transmission, therefore be blindness to the wake-up signal sent from another LP (or from external programmer 109).This is in dual chamber It is unacceptable in pacemaker system, because synchronizing between two LP 102 and 104 may lose, so as to cause potential Dangerous situation.

According to the certain embodiments of the present technology that initial reference Fig. 2 B is described, two auto zeros are used parallel and anti-phase Difference amplifier (or more generally, can be by the difference amplifier of selectively offset correction) Lai Shixian receiver 120. To avoid receiver 120 to wake-up signal blindness during the auto zero stage (or more generally, offset correction stage) Mode, such embodiment provide low input off-set voltage, and thus provide the high sensitivity of low shifting difference system.Under It may be better understood in the discussion of Fig. 2 B.

With reference to Fig. 2 B, receiver 120 is shown as including two difference amplifiers 124a and 124b, each difference amplifier packet Include differential input end and output end.Difference amplifier 124a and 124b may be collectively termed as difference amplifier 124, or respectively by Referred to as difference amplifier 124.Each of difference amplifier 124 includes enabling terminal accordingly, allows difference amplifier Each of 124 are selectively enabled.Each of difference amplifier 124 consumes electric current when being enabled (for example, about 300nA), and thus it powers from battery.On the contrary, each of difference amplifier 124 does not consume substantially when not being enabled Electric current (that is, being less than 10nA), therefore do not consume the electric power (that is, being less than 20nA) of battery 114 substantially.In difference amplifier 124 Each further include corresponding offset correction terminal, which makes each of difference amplifier 124 (when being enabled) It can be by selectively offset correction.Depending on embodiment, each of difference amplifier 124 can be configured as response The signal at terminal is enabled in it to be HIGH (signal for or alternatively, enabling in response to it at terminal is LOW) and made Energy.Depending on embodiment, each of difference amplifier 124 be can be configured as in response at its offset correction terminal Signal is HIGH (or in response to the signal at its offset correction terminal be LOW) and is shifted by correction (when being enabled).When Not when enabled difference amplifier 124, it may also be said to which the difference amplifier 124 is disabled.Be enabled when difference amplifier 124 and Not in its offset correction stage (that is, not carrying out offset correction), it may be said that difference amplifier 124 is in it and normally senses and put The big stage.

According to some embodiments, each of difference amplifier 124 is implemented as the difference amplifier of auto zero, In In this case, the more specifically auto zero stage in offset correction stage, at this stage period, difference amplifier 124 is by certainly Dynamic zero is to remove input off-set voltage.According to alternate embodiment, it is steady to be implemented as copped wave for each of difference amplifier 124 Fixed difference amplifier, in this case, the more specifically chopped wave stabilizing stage in offset correction stage.Other variations are also can Can, and in the range of the embodiment of this technology described herein.

According to some embodiments, each of difference amplifier 124 is configured as monitoring wake-up signal when being enabled. As above with reference to explaining Fig. 4, wake-up signal can be short arc (for example, 1mV) and low-frequency pulse 408 (is followed behind Short arc and high-frequency pulse string 410).For more specific example, wake-up signal can be the 1mV arteries and veins with 20 μ s pulse widths Punching, in such a case, it is possible to specially be tuned to each of difference amplifier, to monitor and detect with 20 μ s arteries and veins Rush the 1mV wake-up pulse of width.

The signal exported from each of difference amplifier 124 can be referred to as the differential signal of amplification.Depending on reality Apply mode, each of difference amplifier 124 can be configured as the differential signal of nominally output LOW amplification (when not examining When measuring wake-up pulse) and the differential signal of HIGH amplification is exported in response to detecting wake-up pulse.Alternatively, although It is less likely, but each of difference amplifier 124 can be configured as the differential signal of nominally output HIGH amplification (when wake-up pulse is not detected) and the differential signal of LOW amplification is exported in response to detecting wake-up pulse.For this The rest part of discussion, it will be assumed that each of difference amplifier 124 is configured as nominally exporting the differential signal of LOW amplification (when wake-up pulse is not detected) and the differential signal of HIGH amplification is exported in response to detecting wake-up pulse.

During its offset correction stage (for example, auto zero stage or chopper stabilization sub stage), difference amplifier 124 It can not detect that difference amplifier 124 is configured as the signal (for example, wake-up pulse) of monitoring, therefore, in difference amplifier 124 The differential signal of amplification that generates of output would not indicate whether difference amplifier 124 detects prearranged signals (for example, calling out Awake pulse).For example, when difference amplifier 124 is in its offset correction stage, the amplification that is exported by difference amplifier 124 Differential signal approximately half of between LOW and HIGH output level can hover.Thus, according to some embodiments, when difference is put When big device 124 is in its offset correction stage (for example, its auto zero stage or chopper stabilization sub stage), ignores and put by difference The differential signal for the amplification that big device 124 exports.In other words, according to some embodiments, when difference amplifier 124 is in its offset When calibration phase, ignore the output of difference amplifier 124.

B still referring to Figure 2, the output for showing difference amplifier 124a and 124b are provided to the corresponding of OR gate circuit 126 Input terminal, the OR gate circuit 126 be used to combine the output of difference amplifier 124a and 124b.More specifically, in response to OR At least one of the input of gate circuit 126 becomes HIGH, and the output of OR gate circuit 126 will become HIGH.Work as difference amplifier When one of 124a and 124b detect wake-up signal (for example, wake-up pulse) that difference amplifier 124a and 124b are respectively monitored, One of input of OR gate circuit 126 will be HIGH.Thus, detect them just in response to one of difference amplifier 124a and 124b HIGH will be become in the output of the wake-up signal of monitoring, OR door 126, and receiver 122 is made to be enabled.The output of OR gate circuit 126 It can be supplied directly to the enabled terminal of receiver 122.Alternatively, optional pulse regulating circuit 128 is located at OR gate circuit Between 126 output end and the enabled terminal of receiver 122.Pulse regulating circuit 128 can for example will be defeated by OR gate circuit 126 Pulse out is broadened to desired pulse width.Alternatively, pulse regulating circuit 128 can be configured as in response to pulse tune Economize on electricity road 128 input from LOW become HIGH and at least predetermined time period keep HIGH and export particular amplitude and The pulse of pulse width.Other variations are also possible, and in the range of the embodiment of this technology.More generally, it removes Using other than OR gate circuit 126, the output of difference amplifier 124a and 124b is combined into the other way of a signal It is possible, and in the range of embodiments of the present techniques described herein.

According to certain embodiments of the present technology, at any given time, enable receiver 120 difference amplifier 124a and At least one of 124b and be not in offset correction stage (for example, auto zero stage or chopper stabilization sub stage).This It monitor at least one of difference amplifier 124a and 124b can always and be expected the wake-up in low-frequency range at it Signal.More specifically, according to certain embodiments of the present technology, each of difference amplifier 124a and 124b are by periodicity Ground offset correction, during this period, another in difference amplifier 124a and 124b are enabled and are not shifted by correction, and Thus it is monitored wake-up signal.Thus, it is to be appreciated that there are difference amplifier 124a and 124b be simultaneously enabled when Between, and therefore difference amplifier 124a and 124b consumes electric current and thus consumes the time of electric power from battery 114.

In order to substantially minimize the electric power that receiver 120 is consumed from battery 114, two difference amplifiers 124a and 124b The time quantum being all enabled should keep low and be preferably minimized.According to some embodiments, for two differential amplifications At least most of time that device 124a and 124b are enabled, one of difference amplifier 124a and 124b are shifted by correction.For example, Assuming that completing the offset correction stage needs 3ms.If the time quantum that difference amplifier 124a and 124b are enabled is each follows Ring period (for example, every 100ms) 4ms, then at least most of time being all enabled for difference amplifier 124a and 124b For, one of difference amplifier 124a and 124b are shifted by correction.Preferably, in order to make to include difference amplifier 124a and 124b Receiver 120 consume electric power substantially minimize, so that difference amplifier 124a and 124b is all enabled without in them Any one carry out offset correction time quantum substantially minimize.According to some embodiments, difference amplifier is only being enabled In time less than 20% (being preferably less than 10%) of the time of 124a and 124b at the same enabled difference amplifier 124a and 124b。

For example, it is assumed that each of difference amplifier 124a and 124b are selectively in each 64ms cycle period Be enabled 36ms.It is also supposed that difference amplifier a 124a and 124b is only made to enable 28ms in each 64ms cycle period, and And two difference amplifiers are enabled 4ms during each 64ms cycle period.In this illustration, it is recycled in each 64ms During period, difference amplifier 124a and 124b only enable difference amplifier a 124a and 124b time about 14% Inside it is simultaneously enabled (i.e. 4ms/28ms=0.14286).This will meet claimed below: only enable difference amplifier 124a and In the time less than 20% of the time of one of 124b, while enabled difference amplifier 124a and 124b.

Fig. 2 C be provided separately to difference amplifier 124a enabled terminal and offset correction terminal Enable_A and Offset_correct_A signal, and it is respectively supplied to the enabled terminal and offset correction terminal of difference amplifier 124b The exemplary timing chart of Enable_B and Offset_correct_B signal.In this illustration, in each 100ms cycle period Period, each of the difference amplifier 124a and 124b 54ms that is selectively enabled, during each 100ms cycle period Only one difference amplifier 124a and 124b are enabled 46ms, and two differential amplifications during each 100ms cycle period Device is all enabled 4ms.Thus, in this illustration, in each 100ms cycle period, difference amplifier 124a and 124b exist Only enable about 8.7% (that is, 4ms/46ms=0.08696) of one time in difference amplifier a 124a and 124b It is simultaneously enabled in time.This is claimed below by meeting: only enabling lacking for the time of one of difference amplifier 124a and 124b In enabled difference amplifier 124a and 124b simultaneously in 20% time.In fact, in this illustration, difference amplifier 124a 10% of the time being simultaneously enabled with 124b less than only one enable time in difference amplifier 124a and 124b.Preferably, The time quantum that two difference amplifiers 124a and 124b are simultaneously enabled is minimized, and will depend, at least partially, on difference How soon amplifier 124 can be shifted by the length of correction and cycle period.Processor or controller 112 (in fig. 2) can be with It is used to generate signal shown in Fig. 2 C.Alternatively or additionally, clock circuitry (not specifically illustrated) can by with In the potentially signal shown in generation Fig. 2 C under the control of processor or controller 112.Embodiment described herein In range, other variations are also possible.

According to certain embodiments of the present technology, (by receiver 120, in response to receiver after enabled receiver 122 120 detect wake-up signal), receiver 122 may be received in the frequency that the frequency range of wake-up signal is received higher than receiver 120 One or more i2i signals of communication within the scope of rate.More generally, receiver 122 be once enabled can than receive Device 120 can receive the inscribed collection of letters number of the higher frequency range of frequency range of signal.It can will be received by receiver 122 (one or more) i2i signal of communication is supplied to processor or controller 112, and is used for by processor or controller 112 Dynamic intervalometer (for example, AV intervalometer), the intervalometer be used to trigger pacemaker impulse passing via electrode 108 It send.This pacemaker impulse can be generated by impulse generator 116.Other variations are also possible and in implementations described herein In the range of example.

Fig. 6 is the high level flow chart for summarizing the method according to this technology some embodiments.Such method can be with tool There is the implantable medical device (IMD) of the receiver including the first and second difference amplifiers to be used together, wherein first and Each of two difference amplifiers include differential input end and output end, and wherein in the first and second difference amplifiers Each can be optionally disposed in the offset correction stage when being enabled.The example for the IMD that such method executes can be used It is 102,104 LP above with reference to described in Fig. 2A -2C.More specifically, Fig. 2 B as described above is provided including two difference The exemplary details of the receiver 120 of amplifier 124a and 124b, described two difference amplifier 124a and 124b include difference Input terminal and output end, and the offset correction stage can be optionally disposed in when being enabled.

With reference to Fig. 6, step 602 is related to selectively enabling the first and second difference amplifiers, so that when any given Between, enable at least one of first and second difference amplifiers.According to discussed above is its exemplary some embodiments, execute Step 602, so that in the time less than 20% for only enabling one time in the first and second difference amplifiers simultaneously Enabled first and second difference amplifiers.

Referring still to Fig. 6, step 604 is related to that the first and second difference amplifiers are selectively placed in offset correction rank Section so that when the first difference amplifier is enabled and is in the offset correction stage, the second difference amplifier be enabled and It is not at the offset correction stage, and is made when the second difference amplifier is enabled and is in the offset correction stage, the One difference amplifier is enabled and is not at the offset correction stage.Having shown and described above with reference to Fig. 2 C can be used for executing step Rapid 604 and step 602 exemplary timing chart.According to some embodiments, each of the first and second difference amplifiers It is all auto zero difference amplifier, in this case, the offset correction stage is the auto zero stage.According to other implementations Example, each of first and second difference amplifiers are the difference amplifier of chopped wave stabilizing, in this case, offset correction Stage is the chopped wave stabilizing stage.

Step 606 is related to coming within the scope of monitoring frequency using at least one of first and second difference amplifiers always Prearranged signals.According to some embodiments, prearranged signals is wake-up signal, and more specifically, can be wake-up pulse.According to Some embodiments are wherein monitoring that the frequency range of wake-up signal is in low-frequency range, which can for example exist Between 1kHz and 100kHz, but not limited to this.

Step 608 is related to detecting in frequency range using one of first and second difference amplifiers of receiver (for example, the One frequency range) in prearranged signals (for example, wake-up signal).

Step 610 is related in response to detecting the prearranged signals in frequency range by one of first and second difference amplifiers And another component of enabled IMD.According to some embodiments, the receiver including the first and second difference amplifiers can be One receiver (for example, receiver 120 in Fig. 2A and 2B).In addition, as described above, difference amplifier is configured as monitoring and examine The prearranged signals of survey can be the wake-up signal within the scope of first frequency.In such embodiments, step 610 can be related to responding In by least one of the first and second difference amplifiers of the first receiver detect the wake-up within the scope of first frequency believe Number and it is enabled second receiver (for example, receiver 122 in Fig. 2A).

Step 612 is related to executing predetermined function using another component enabled at step 610.For example, step 612 It can be related to detecting when second receiver is enabled using second receiver (for example, receiver 122 in Fig. 2A) One or more implantation materials within the scope of the second frequency for being higher than first frequency range are to implantation material (i2i) signal of communication.Such as Explained above, when second receiver is enabled, this second receiver (for example, 122) the first receiver (example of ratio Such as, more power 120) are consumed.

Step 614 is related to disabling this another after having used another component to execute its predetermined function at step 612 Component (for example, receiver 122 in Fig. 2A).In order to save the electricity for the battery powered for the electronic component for IMD in IMD Power, and in order to power when second receiver is enabled for it, this disabling in step 614 is executed, the component removes it It especially may include the first and second difference amplifiers of the first receiver outside its component.

Unless the result of a step is used by another step or be used to trigger the beginning of another step, otherwise not The step with reference to described in Fig. 6 must be executed with described definite order.For example, step 602,604 and 606 or its at least partly It can execute parallel.Conversely, because in response to step 608 execution and execute step 610, therefore step 610 must occur After step 608.

Although many embodiments of above-mentioned this technology are described as being used together with LP type IMD, this technology Embodiment can also be used together with the other types of IMD in addition to LP.Thus, unless being clearly limited to make together with LP With otherwise claims should not necessarily be limited by is used together with LP type IMD.

It should be understood that theme described herein be not limited to be described herein in its application described in or in its attached drawing Shown in structure detail and component arrangement.Theme described herein can have other embodiments and can be with various sides Formula is practiced or carried out.Furthermore, it is to be understood that phraseology and terminology employed herein is for purposes of illustration, without answering When being considered restrictive.The use of "include", "comprise" herein or " having " and its variant is intended to list thereafter Project and its equivalent and addition item.Again, it should be noted that unless otherwise stated, terms used herein " being based on " should be interpreted the meaning being at least partially based on, it is meant that there may be the one or more made decision based on it Additive factor etc..For example, if it is determined that being based on comparison result, then the decision other than based on comparison result, is gone back It can other factors based on one or more.

It should be understood that above description be intended to it is illustrative and not restrictive.For example, above-described embodiment (and/or Its aspect) it can be in combination with one another.In addition, in the case where not departing from this technology range, can make it is many modify so that Specific condition or material adapt to the introduction of the embodiment of this technology.Although the dimension of material described herein and coating, type purport In the parameter for the embodiment for limiting this technology, but they are by no means limitative, but exemplary embodiment.It is retouched more than looking back After stating, many other embodiments will be apparent those skilled in the art.Therefore, the model of the embodiment of this technology It encloses and should refer to the full scope of the equivalent that appended claims and these claims are assigned to determine.In In appended claims, term " includes " and the general English for " wherein " being used as corresponding term " comprising " and " wherein " are equivalent Object.Moreover, in following following claims, term " first ", " second " and " third " etc. are used only as label, and are not intended to it Object applies numerical requirements.In addition, the limitation of following claims is not to add the format writing of function with device, and not It is intended to explain based on 35U.S.C. § 112 (f), unless the limitation of such claim clearly " is used for ... using phrase Device " is followed by the function statement of no further structure.