Implantable medical devices

Abstract

The present invention discloses an implantable medical device, comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair for sensing; wherein the control device is configured to perform the following steps during operation: obtaining a first in-vivo near-field myocardial electrocardiogram based on the first electrode pair; obtaining a first sensing time and a second sensing time; wherein the first sensing time is the sensing time of the R wave in the far-field electrocardiogram, and the second sensing time is the sensing time corresponding to the sensing event in the first in-vivo near-field myocardial electrocardiogram; determining the ventricular excitation source of the heartbeat based on the difference between the first sensing time and the second sensing time, without using atrial time information, without waiting until the ventricular excitation is completed, and without using a morphological algorithm, the classification method is simple and will not affect the energy consumption generated by the implantable medical device.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implantable medical device. Background Art

[0002] In medical devices that provide cardiac therapy, it is crucial to understand whether the source of ventricular activation is atrial or ventricular. Knowing whether a particular ventricular beat or group of beats is SR (sinus rhythm), PAC (premature atrial contraction), or PVC (premature ventricular contraction), or whether ventricular activation is caused by ventricular pacing, is clinically important for cardiac rhythm diagnosis and treatment. Therefore, methods for automatically classifying the source of ventricular activation for each heartbeat as atrial or ventricular, are essential for various clinical applications.

[0003] Typically, information about the timing of the current ventricular excitation relative to the previous excitation (RR interval) compared to periods of relatively stable sinus rhythm is combined with information about the morphology of the cardiac activity for that particular excitation to identify whether a premature beat has occurred and its source (atrial or ventricular). Specifically, the duration of the ventricular excitation (i.e., R-wave width) is used to distinguish PVCs from sinus beats or PACs, as ventricular excitation originating from the atria typically has an R-wave morphology similar to that seen during sinus rhythm, compared to the abnormalities (wider) typically seen in ventricular excitation originating from the ventricles (such as PVCs). In existing ICDs (implantable cardioverter defibrillators), distinguishing between VT (ventricular tachycardia) and SVT (supraventricular tachycardia) in similar high ventricular rate regions is of great significance, and typically requires a wider R-wave width or a different morphology than during sinus rhythm.

[0004] However, using automated classification methods such as R-wave width or morphology not only requires special hardware and relatively cumbersome calculations for far-field ECG signals, but also requires that calculations wait until ventricular activation is complete, as is the case with ICDs. Furthermore, in some medical devices and clinical applications, R-wave width or morphology cannot be calculated in some situations, such as when an ECG (surface electrocardiogram) or far-field intracardiac electrocardiogram (EGM) is unavailable. Furthermore, if treatment needs to be initiated before ventricular activation is complete, such as in CCM (cardiac contractility modulation) therapy, R-wave width methods cannot always be relied upon due to time constraints.

[0005] Several methods exist in the prior art for confirming or verifying capture in pacing systems, including evoked potentials and impedance. This capability allows for automated measurement and / or monitoring of pacing thresholds over time, allowing the pacing system to deliver sufficient and appropriate energy based on the threshold to ensure capture while conserving energy, maintaining effectiveness, safety, and efficiency over time and minimizing the need for physician intervention. Confirming capture typically requires specialized hardware and software, increasing device complexity. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide an implantable medical device in order to overcome the above-mentioned defects in the prior art.

[0007] The present invention solves the above technical problems through the following technical solutions:

[0008] A first aspect of the present invention provides an implantable medical device comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair for sensing;

[0009] The control device is configured to perform the following steps during operation:

[0010] acquiring a first in vivo near-field myocardial electrocardiogram based on the first electrode pair;

[0011] Obtaining a first perception time and a second perception time; wherein the first perception time is the perception time of an R wave in a far-field electrocardiogram, and the second perception time is the perception time corresponding to a perception event in the first in-vivo near-field myocardial electrocardiogram; the R wave in the far-field electrocardiogram and the perception event in the first in-vivo near-field myocardial electrocardiogram correspond to the same heartbeat;

[0012] The ventricular excitation source of the heartbeat is determined according to the difference between the first sensing time and the second sensing time, wherein the ventricular excitation source includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

[0013] Optionally, the step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes:

[0014] If the difference between the first difference and the second difference is greater than a first threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium;

[0015] Among them, the first difference is the difference between the first perception time and the second perception time, and the second difference is determined according to the difference between the third perception time and the fourth perception time; the third perception time is the perception time of the R wave in the far-field electrocardiogram obtained within the preset period, and the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period; the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

[0016] Optionally, the second difference is determined based on the difference between the third perception time and the fourth perception time corresponding to multiple heartbeats.

[0017] Optionally, the step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes:

[0018] If the difference between the first sensing time and the second sensing time is greater than a second threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium.

[0019] Optionally, the at least one ventricular electrode lead is further configured with a second electrode pair for sensing;

[0020] The control device is further configured to perform the following steps during operation: acquiring a second in-vivo near-field myocardial electrocardiogram based on the second electrode pair;

[0021] The step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes: determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time and the difference between the first sensing time and the fifth sensing time;

[0022] Among them, the fifth perception time is the perception time corresponding to the perception event in the second body near-field myocardial electrocardiogram, and the perception event in the second body near-field myocardial electrocardiogram and the R wave in the far-field electrocardiogram correspond to the same heartbeat.

[0023] A second aspect of the present invention provides an implantable medical device, comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair and a second electrode pair for sensing;

[0024] The control device is configured to perform the following steps during operation:

[0025] Acquire a first in-vivo near-field myocardial electrocardiogram based on the first electrode pair, and acquire a second sensing time; wherein the second sensing time is a sensing time corresponding to a sensing event in the first in-vivo near-field myocardial electrocardiogram;

[0026] acquiring a second in-vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquiring a fifth sensing time; wherein the fifth sensing time is a sensing time corresponding to a sensing event in the second in-vivo near-field myocardial electrocardiogram, and the sensing event in the second in-vivo near-field myocardial electrocardiogram and the sensing event in the first in-vivo near-field myocardial electrocardiogram correspond to the same heartbeat;

[0027] The ventricular excitation source of the heartbeat is determined according to the difference between the second sensing time and the fifth sensing time, wherein the ventricular excitation source includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

[0028] Optionally, the step of determining the ventricular excitation source of the heartbeat according to the difference between the second sensing time and the fifth sensing time specifically includes:

[0029] If the difference between the third difference and the fourth difference is greater than a third threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium;

[0030] Among them, the third difference is the difference between the second perception time and the fifth perception time, and the fourth difference is determined based on the difference between the fourth perception time and the sixth perception time; the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period, and the sixth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair within the preset period; the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

[0031] Optionally, the fourth difference is determined based on the difference between the fourth perception time and the sixth perception time corresponding to multiple heartbeats.

[0032] Optionally, the step of determining the ventricular excitation source of the heartbeat according to the difference between the second sensing time and the fifth sensing time specifically includes:

[0033] If the difference between the second sensing time and the fifth sensing time is greater than a fourth threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium.

[0034] Optionally, the control device is further configured to perform the following steps during operation:

[0035] The length of the R-wave perception time window corresponding to the R-wave in the far-field electrocardiogram acquired within a preset period is determined according to the ventricular excitation source of the heartbeat.

[0036] A third aspect of the present invention provides an implantable medical device, comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair for sensing;

[0037] The control device is configured to perform the following steps during operation:

[0038] Acquire a first sensing time and a first delivery time; wherein the first sensing time is the sensing time of the R wave in the far-field electrocardiogram, and the first delivery time is the time when the pacing pulse is delivered through the first electrode pair;

[0039] Whether the ventricle is captured is determined based on the difference between the first discharge time and the first sensing time.

[0040] Optionally, the step of determining whether the ventricle is captured based on the difference between the first sensing time and the first releasing time specifically includes: if the difference between the fifth difference and the sixth difference is less than a fifth threshold, determining that the ventricle is captured; otherwise, determining that the ventricle is not captured;

[0041] Among them, the fifth difference is the difference between the first emission time and the first perception time, and the sixth difference is determined based on the difference between the second emission time and the seventh perception time; the seventh perception time is the perception time of the R wave in the far-field electrocardiogram obtained during the period of ventricular pacing capture within the preset period, and the second emission time is the time when the pacing pulse is emitted by the first electrode pair during the period of ventricular pacing capture within the preset period.

[0042] Optionally, the sixth difference is determined according to the difference between the second emission time and the seventh perception time corresponding to multiple heartbeats.

[0043] Optionally, the step of determining whether to capture the ventricle based on the difference between the first release time and the first sensing time specifically includes:

[0044] If the difference between the first discharge time and the first sensing time is a positive number and is smaller than a sixth threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured.

[0045] A fourth aspect of the present invention provides an implantable medical device, comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair and a second electrode pair for sensing;

[0046] The control device is configured to perform the following steps during operation:

[0047] Acquiring a first delivery time; wherein the first delivery time is the time when a pacing pulse is delivered through the first electrode pair;

[0048] Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquire an eighth perception time; wherein the eighth perception time is a perception time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram;

[0049] Whether the ventricle is captured is determined based on the difference between the eighth sensing time and the first firing time.

[0050] Optionally, the step of determining whether to capture the ventricle according to the difference between the eighth sensing time and the first releasing time specifically includes:

[0051] If the ratio between the seventh difference and the eighth difference is greater than a seventh threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured;

[0052] Among them, the seventh difference is the difference between the eighth perception time and the first emission time, and the eighth difference is determined based on the difference between the sixth perception time and the fourth perception time; the sixth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair within the preset period, and the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period, and the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

[0053] Optionally, the step of determining whether to capture the ventricle according to the difference between the eighth sensing time and the first releasing time specifically includes:

[0054] If the difference between the seventh difference and the ninth difference is less than an eighth threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured;

[0055] Among them, the seventh difference is the difference between the eighth perception time and the first delivery time, and the ninth difference is determined based on the difference between the ninth perception time and the second delivery time; the ninth perception time is the perception time of ventricular muscle activation corresponding to the pacing event in the in vivo near-field myocardial electrocardiogram obtained by the second electrode pair during the period of ventricular pacing capture within the preset period, and the second delivery time is the time for delivering pacing pulses through the first electrode pair during the period of ventricular pacing capture within the preset period.

[0056] A fifth aspect of the present invention provides an implantable medical device comprising a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a second electrode pair for sensing;

[0057] The control device is configured to perform the following steps during operation:

[0058] Acquire a first perception time; wherein the first perception time is a perception time of an R wave in a far-field electrocardiogram;

[0059] Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquire an eighth perception time; wherein the eighth perception time is a perception time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram;

[0060] Whether the ventricle is captured is determined based on the difference between the first sensing time and the eighth sensing time.

[0061] Optionally, the step of determining whether to capture the ventricle according to the difference between the first sensing time and the eighth sensing time specifically includes:

[0062] If the difference between the tenth difference value and the eleventh difference value is less than the ninth threshold value, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured;

[0063] Among them, the tenth difference is the difference between the eighth perception time and the first perception time, and the eleventh difference is determined based on the difference between the ninth perception time and the seventh perception time; the ninth perception time is the perception time of ventricular muscle activation corresponding to the pacing event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair during the period of ventricular pacing capture within the preset period, and the seventh perception time is the perception time of the R wave in the far-field electrocardiogram obtained during the period of ventricular pacing capture within the preset period.

[0064] Optionally, the step of determining whether to capture the ventricle according to the difference between the first sensing time and the eighth sensing time specifically includes:

[0065] If the ratio between the tenth difference value and the twelfth difference value is greater than a tenth threshold value, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured;

[0066] Among them, the tenth difference is the difference between the eighth perception time and the first perception time, and the twelfth difference is determined based on the difference between the sixth perception time and the third perception time; the sixth perception time is the perception time corresponding to the perception event in the near-field myocardial electrocardiogram in the body obtained based on the second electrode pair within a preset period, and the third perception time is the perception time of the R wave in the far-field electrocardiogram obtained within a preset period, and the preset period corresponds to ventricular excitation originating from the atrium.

[0067] Optionally, the control device is configured to perform the following steps during operation:

[0068] After a first preset number of heartbeats into the running period, the control device is configured to perform the following steps.

[0069] Optionally, the control device is further configured to perform the following steps during operation:

[0070] For the second preset number of heartbeats, if it is determined that the ventricle is captured for a third preset number of heartbeats, it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle is being captured;

[0071] Wherein, the third preset number of times is less than or equal to the second preset number of times.

[0072] On the basis of conforming to the common sense in this field, the above optional conditions can be arbitrarily combined to obtain the preferred embodiments of the present invention.

[0073] The positive progressive effect of the present invention is that the implantable medical device provided by the present invention can classify the sources of ventricular excitation of the running heartbeat only by using the time information of the ventricles, without using the time information of the atria, without waiting until the ventricular excitation is completed, and without using morphological algorithms. The classification method is simple and will not affect the energy consumption required by the implantable medical device.

[0074] The implantable medical device provided by the present invention can determine whether the ventricle is captured during operation by only using the time information of the ventricle. The determination method is simple and does not affect the energy consumption required by the implantable medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] Figure 1A Schematic diagram of the far-field electrocardiogram of ventricular excitation originating from the atria and the near-field myocardial electrocardiogram in vivo.

[0076] Figure 1B Schematic diagram of the far-field electrocardiogram of ventricular excitation originating from the ventricle and the near-field myocardial electrocardiogram in vivo.

[0077] Figure 2A Schematic diagram of the far-field electrocardiogram, the first in-vivo near-field myocardial electrocardiogram, and the second in-vivo near-field myocardial electrocardiogram of ventricular excitation originating from the atrium.

[0078] Figure 2B Schematic diagram of the far-field electrocardiogram, the first in-vivo near-field myocardial electrocardiogram, and the second in-vivo near-field myocardial electrocardiogram originating from the ventricular excitation.

[0079] Figure 3 This is a flow chart of a control method for an implantable medical device provided in Example 1 of the present invention.

[0080] Figure 4 This is a flow chart of a control method for an implantable medical device provided in Example 2 of the present invention.

[0081] Figure 5 Schematic diagram of the far-field electrocardiogram and the in vivo near-field myocardial electrocardiogram provided in Example 2 of the present invention.

[0082] Figure 6 This is a flow chart of a control method for an implantable medical device provided in Example 3 of the present invention.

[0083] Figure 7 This is a flow chart of a control method for an implantable medical device provided in Example 4 of the present invention.

[0084] Figure 8 This is a flow chart of a control method for an implantable medical device provided in Example 5 of the present invention. DETAILED DESCRIPTION

[0085] The present invention is further described below by way of examples, but the present invention is not limited to the scope of the examples.

[0086] The far-field electrocardiogram (FVEG) is used to sense the overall electrical activity of the heart. The R-wave time window (RTW) corresponds to the time window of the overall ventricular activation seen in the far-field electrocardiogram (FF-EGM). This means that all ventricular activation signals measured from the various local myocardiums of the ventricles should fall within the RTW. As can be seen, Figure 1A The ventricular excitation signal LS1 in the in vivo near-field myocardial electrocardiogram (NF-EGM) of the ventricular excitation originating from the atrium falls within the RTW. Figure 1B The ventricular excitation signal LS1 in the near-field myocardial electrocardiogram of the ventricular excitation originating from the ventricle also falls within the RTW. Figure 2A The ventricular excitation signal LS1 in the first internal near-field myocardial electrocardiogram and the ventricular excitation signal LS2 in the second internal near-field myocardial electrocardiogram of the ventricular excitation originating from the atrium both fall within the RTW. Figure 2B The ventricular excitation signal LS1 in the first in-vivo near-field myocardial electrocardiogram and the ventricular excitation signal LS2 in the second in-vivo near-field myocardial electrocardiogram originating from the ventricular excitation of the ventricle also fall within the RTW.

[0087] It should be noted that the implantable medical devices involved in the embodiments of the present invention may specifically be implantable single-chamber pacemakers, dual-chamber pacemakers, single-chamber ICDs, dual-chamber ICDs, CRT-Ds (cardiac resynchronization therapy defibrillators), CRT-Ps (cardiac resynchronization therapy pacemakers), CCMs, etc., and may also be temporary or long-term in vitro medical devices with similar single and / or combined functions.

[0088] The set-up period (SUP) involved in the embodiments of the present invention is the period during which the implantable medical device is not actually in operation, and the operational period (OP) is the period during which the implantable medical device is actually in operation. In the embodiments of the present invention, parameters obtained during the set-up period (e.g., sensing time) may be values ​​calculated over multiple cardiac cycles under a certain, relatively stable cardiac rhythm, such as average values, median values, or other statistical values. Optionally, data from the set-up period may also be updated and used during the operational period.

[0089] The in vivo near-field myocardial electrocardiogram (ECG) involved in the embodiments of the present invention is also called the L-EGM (Local Electrogram, sometimes also called the Near-field Electrogram), and the far-field ECG is also called the FF-EGM (Far-Field Electrogram). The R wave in the far-field ECG refers to the electrical signal recorded in the far field during the depolarization process of the ventricular myocardium, corresponding to the QRS wave in the surface electrocardiogram (ECG).

[0090] In embodiments of the present invention, the difference between two differences generally refers to the absolute value of the difference between the absolute values ​​of the two differences, and the ratio between two differences generally refers to the ratio between the absolute values ​​of the two differences. In a specific example, the difference between a first difference and a second difference refers to ||first difference|-|second difference||, and the ratio between the first difference and the second difference refers to ||first difference| / |second difference|.

[0091] Example 1

[0092] Figure 3 This embodiment provides a flow chart of a control method for an implantable medical device. The control method can be executed by a control device of the implantable medical device during operation. The control device can be implemented by software and / or hardware, and the control device can be a part of the implantable medical device.

[0093] The implantable medical device in this embodiment includes a control device and at least one ventricular electrode lead, and the at least one ventricular electrode lead is configured with a first electrode pair for sensing. In one specific example, the implantable medical device includes one ventricular electrode lead, and the ventricular electrode lead is configured with a first electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and each ventricular electrode lead is configured with a first electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and only one ventricular electrode lead is configured with a first electrode pair for sensing.

[0094] like Figure 3 As shown, the control method of the implantable medical device provided in this embodiment may include the following steps S101 to S103:

[0095] Step S101: Acquire a first in-vivo near-field myocardial electrocardiogram based on the first electrode pair.

[0096] Step S102: Acquire a first perception time and a second perception time. The first perception time is the perception time of an R wave in a far-field electrocardiogram, and the second perception time is the perception time corresponding to a perception event in the first in-vivo near-field myocardial electrocardiogram; the R wave in the far-field electrocardiogram and the perception event in the first in-vivo near-field myocardial electrocardiogram correspond to the same heartbeat.

[0097] Step S103: Determine the source of the ventricular excitation of the heartbeat according to the difference between the first sensing time and the second sensing time, wherein the source of the ventricular excitation includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

[0098] Assuming that the first sensing time obtained during the operation period is GS_OP and the second sensing time is LS1_OP, this embodiment determines whether the source of ventricular excitation of the operating heartbeat is from the ventricular excitation of the atrium or from the ventricle based on GS_OP-LS1_OP. That is, only the time information of the ventricle can be used to classify the source of ventricular excitation of the operating heartbeat. There is no need to use the time information of the atrium, nor to wait until the ventricular excitation is completed, and there is no need to use a morphological algorithm. The classification method is simple and will not affect the energy consumption required for the implantable medical device.

[0099] Furthermore, when it is determined that the source of ventricular excitation of the operational heartbeat is ventricular excitation originating from the atria, the implantable medical device can be controlled to provide cardiac treatment to the patient, such as emitting CCM pulses, thereby improving the efficacy and patient safety.

[0100] In an optional embodiment of step S103, if the difference between the first difference and the second difference is greater than a first threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the ventricles; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the atria. The first difference is the difference between the first perception time and the second perception time, and the second difference is determined based on the difference between the third perception time and the fourth perception time; the third perception time is the perception time of the R wave in the far-field electrocardiogram obtained within a preset period, and the fourth perception time is the perception time corresponding to the perception event in the near-field myocardial electrocardiogram in the body obtained based on the first electrode pair within the preset period; the source of the ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atria.

[0101] Assume that the first sensed time obtained during the operation period is GS_OP, the second sensed time is LS1_OP, the first difference is GS_OP-LS1_OP, and the third sensed time obtained during the preset period is GS_SUP, the fourth sensed time is LS1_SUP, and the second difference is GS_SUP-LS1_SUP. If the difference between the first difference and the second difference is greater than a first threshold, that is, ||GS_OP-LS1_OP|-|GS_SUP-LS1_SUP|| is greater than the first threshold, then it is determined that the source of ventricular excitation of the heartbeat is ventricular excitation from the ventricle; if the difference between the first difference and the second difference is less than or equal to the first threshold, that is, ||GS_OP-LS1_OP|-|GS_SUP-LS1_SUP|| is less than or equal to the first threshold, then it is determined that the source of ventricular excitation of the heartbeat is ventricular excitation from the atrium. The first threshold value can be set according to actual conditions, for example, it can be set to 10ms, and the first threshold value can also be obtained in other ways, for example, by a doctor inputting through an external device (such as a programmer) to modify the preset value and directly program the first threshold value.

[0102] In this embodiment, the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium. If the difference between the first difference calculated during the running period and the second difference calculated during the preset period is greater than the first threshold, it means that the first difference calculated during the running period is significantly different from the second difference calculated during the preset period. At this time, it is determined that the source of ventricular excitation of the heartbeat during the running period is ventricular excitation originating from the ventricles. Otherwise, it is determined that the source of ventricular excitation of the heartbeat during the running period is ventricular excitation originating from the atria.

[0103] In a specific implementation, the second difference GS_SUP-LS1_SUP calculated in the preset period may be a value calculated in multiple cardiac cycles, such as an average value, a median value, a quartile, or other statistical values.

[0104] In another optional embodiment of step S103, if the difference between the first perception time and the second perception time is greater than a second threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the atrium.

[0105] Assuming that the first sensed time obtained during the operation period is GS_OP and the second sensed time is LS1_OP, if GS_OP-LS1_OP is greater than a second threshold, indicating that the difference between the first sensed time and the second sensed time is large, it is determined that the source of ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the ventricles; otherwise, it is determined that the source of ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the atria. The second threshold can be set according to actual conditions, for example, it can be set to 100ms, and the second threshold can also be obtained in other ways, for example, by a doctor inputting a modification of a preset value through an external device (such as a programmer) to directly program the second threshold.

[0106] In an optional embodiment, in the above-mentioned implantable medical device, the at least one ventricular electrode lead is further configured with a second electrode pair for sensing; the above-mentioned control method further includes the following steps: obtaining a second in-vivo near-field myocardial electrocardiogram based on the second electrode pair. In this embodiment, the above-mentioned step S103 specifically includes: determining the ventricular excitation source of the heartbeat based on the difference between the first sensing time and the second sensing time and / or the difference between the first sensing time and the fifth sensing time. The fifth sensing time is the sensing time corresponding to the sensing event in the second in-vivo near-field myocardial electrocardiogram, and the sensing event in the second in-vivo near-field myocardial electrocardiogram and the R wave in the far-field electrocardiogram correspond to the same heartbeat.

[0107] Assuming that the first perception time obtained during the operation period is GS_OP, the second perception time is LS1_OP, and the fifth perception time is LS2_OP, determine whether the source of ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the ventricles or ventricular excitation originating from the atria based on GS_OP-LS1_OP and / or GS_OP-LS2_OP. Specifically, the source of ventricular excitation of the heartbeat during the operation period can be determined based on GS_OP-LS1_OP alone, or based on GS_OP-LS2_OP alone, or based on GS_OP-LS1_OP and GS_OP-LS2_OP together to determine the source of ventricular excitation of the heartbeat during the operation period. In a specific example, if it is determined that the ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the ventricles based on GS_OP-LS1_OP, then the heartbeat can be ultimately determined as having a source of ventricular excitation originating from the ventricles. In another specific example, if it is determined according to GS_OP-LS1_OP that the ventricular excitation of the heartbeat during the running period is ventricular excitation originating from the atrium, the source of the ventricular excitation of the heartbeat can also be finally determined according to GS_OP-LS2_OP.

[0108] It should be noted that, in the example where the implantable medical device includes one ventricular electrode lead and the ventricular electrode lead is configured with a first electrode pair for sensing, the ventricular electrode lead is also configured with a second electrode pair for sensing. In the example where the implantable medical device includes two ventricular electrode leads and each ventricular electrode lead is configured with a first electrode pair for sensing, each ventricular electrode lead is also configured with a second electrode pair for sensing. In the example where the implantable medical device includes two ventricular electrode leads and only one ventricular electrode lead is configured with the first electrode pair for sensing, the ventricular electrode lead configured with the first electrode pair is also configured with a second electrode pair for sensing, or the other ventricular electrode lead is configured with a second electrode pair for sensing.

[0109] Example 2

[0110] Figure 4 This embodiment provides a flow chart of a control method for an implantable medical device. The control method can be executed by a control device of the implantable medical device during operation. The control device can be implemented by software and / or hardware, and the control device can be a part of the implantable medical device.

[0111] The implantable medical device in this embodiment includes a control device and at least one ventricular electrode lead, and the at least one ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In one specific example, the implantable medical device includes one ventricular electrode lead, and the ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and each ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and only one ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and one ventricular electrode lead is configured with a first electrode pair for sensing, and the other ventricular electrode lead is configured with a second electrode pair for sensing.

[0112] like Figure 4 As shown, the control method of the implantable medical device provided in this embodiment may include the following steps S201 to S203:

[0113] Step S201: Acquire a first in-vivo near-field myocardial electrocardiogram based on the first electrode pair, and acquire a second sensing time, wherein the second sensing time is the sensing time corresponding to a sensing event in the first in-vivo near-field myocardial electrocardiogram.

[0114] Step S202: Acquire a second intrabody near-field myocardial electrocardiogram based on the second electrode pair, and acquire a fifth sensing time. The fifth sensing time is the sensing time corresponding to a sensing event in the second intrabody near-field myocardial electrocardiogram, where the sensing event in the second intrabody near-field myocardial electrocardiogram and the sensing event in the first intrabody near-field myocardial electrocardiogram correspond to the same heartbeat.

[0115] Step S203: Determine the source of the ventricular excitation of the heartbeat according to the difference between the second sensing time and the fifth sensing time, wherein the source of the ventricular excitation includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

[0116] Assuming that the second sensing time obtained during the operation period is LS1_OP and the fifth sensing time is LS2_OP, this embodiment determines whether the source of ventricular excitation of the heartbeat during the operation period is from the ventricular excitation of the atrium or from the ventricle based on LS1_OP-LS2_OP. That is, only the time information of the ventricle can be used to classify the source of ventricular excitation of the heartbeat during the operation period. There is no need to use the time information of the atrium, no need to wait until the ventricular excitation is completed, no need to refer to the far-field electrocardiogram, and no need to use morphological algorithms. The classification method is simple and will not affect the energy consumption required for implantable medical devices.

[0117] Furthermore, when it is determined that the source of ventricular excitation of the operational heartbeat is ventricular excitation originating from the atria, the implantable medical device can be controlled to provide cardiac treatment to the patient, such as emitting CCM pulses, thereby improving the efficacy and patient safety.

[0118] In an optional embodiment of step S203, if the difference between the third difference and the fourth difference is greater than the third threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the ventricles; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the atria. The third difference is the difference between the second perception time and the fifth perception time, and the fourth difference is determined based on the difference between the fourth perception time and the sixth perception time; the fourth perception time is the perception time corresponding to the perception event in the near-field myocardial electrocardiogram in the body obtained based on the first electrode pair within the preset period, and the sixth perception time is the perception time corresponding to the perception event in the near-field myocardial electrocardiogram in the body obtained based on the second electrode pair within the preset period; the source of the ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atria.

[0119] Assume that the second sensed time obtained during the operation period is LS1_OP, the fifth sensed time is LS2_OP, the third difference is LS1_OP-LS2_OP, and the fourth sensed time obtained during the preset period is LS1_SUP, the sixth sensed time is LS2_SUP, and the fourth difference is LS1_SUP-LS2_SUP. If the difference between the third difference and the fourth difference is greater than a third threshold, that is, ||LS1_OP-LS2_OP|-|LS1_SUP-LS2_SUP|| is greater than the third threshold, then it is determined that the source of ventricular excitation of the heartbeat is ventricular excitation from the ventricle; if the difference between the third difference and the fourth difference is less than or equal to the third threshold, that is, |LS1_OP-LS2_OP|-|LS1_SUP-LS2_SUP| is less than or equal to the third threshold, then it is determined that the source of ventricular excitation of the heartbeat is ventricular excitation from the atrium. Among them, the third threshold can be set according to actual conditions, for example, it can be set to 10ms, and the third threshold can also be obtained in other ways, for example, through an external device (such as a programmer) by a doctor inputting to modify the preset value and directly programming the third threshold.

[0120] In this embodiment, the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium. If the difference between the third difference calculated during the running period and the fourth difference calculated during the preset period is greater than the third threshold, it means that the third difference calculated during the running period is significantly different from the fourth difference calculated during the preset period. At this time, it is determined that the source of ventricular excitation of the heartbeat during the running period is ventricular excitation originating from the ventricles. Otherwise, it is determined that the source of ventricular excitation of the heartbeat during the running period is ventricular excitation originating from the atria.

[0121] In another optional embodiment of step S203, the source of the ventricular excitation of the heartbeat can also be determined based on the ratio between the third difference and the fourth difference. Specifically, if the ratio between the third difference and the fourth difference is not within a preset range, it means that the third difference calculated during the operational period is significantly different from the fourth difference calculated during the preset period. In this case, the source of the ventricular excitation of the heartbeat during the operational period is determined to be ventricular excitation from the ventricles. Otherwise, the source of the ventricular excitation of the heartbeat is determined to be ventricular excitation from the atria. The preset range can be set according to specific circumstances, for example, it can be set to 0.95 to 1.05.

[0122] In a specific implementation, the fourth difference LS1_SUP-LS2_SUP calculated in the preset period can be determined based on the difference between the fourth perception time and the sixth perception time corresponding to multiple heartbeats. For example, it can be the average, median, quartile or other statistical value of multiple differences.

[0123] In another optional implementation of step S203, if the difference between the second perception time and the fifth perception time is greater than a fourth threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation originating from the atrium.

[0124] Assuming that the second sensed time obtained during the operation period is LS1_OP and the fifth sensed time is LS2_OP, if LS1_OP-LS2_OP is greater than a fourth threshold, indicating that the difference between the second sensed time and the fifth sensed time is large, it is determined that the source of ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the ventricles; otherwise, it is determined that the source of ventricular excitation of the heartbeat during the operation period is ventricular excitation originating from the atria. The fourth threshold can be set according to actual conditions, for example, to 90 ms. The fourth threshold can also be obtained by other means, such as by directly programming the fourth threshold by having a doctor input a preset value through an external device (such as a programmer) to modify the fourth threshold.

[0125] In an optional embodiment, the above control method further includes the following steps: determining the length of the R wave perception time window corresponding to the R wave in the far-field electrocardiogram obtained within a preset period according to the ventricular excitation source of the heartbeat.

[0126] Among them, the R wave perception time window can also be called RTW, which corresponds to the window of ventricular excitation seen from the far-field electrocardiogram and is characterized by its start time and length. Figure 5 The ventricular activation signal LS1 of the near-field myocardial electrocardiogram in the body falls within the RTW, and the length of the RTW is Wd.

[0127] In one specific example, if the source of ventricular excitation during the running heartbeat is ventricular excitation originating from the atria, the R wave width in the far-field electrocardiogram is normal, typically less than 120 ms, and the length of the R wave sensing time window can be set to 90-100 ms. In another specific example, if the source of ventricular excitation during the running heartbeat is ventricular excitation originating from the ventricles, the R wave in the far-field electrocardiogram is relatively wide, typically between 160 and 250 ms, and the length of the R wave sensing time window can be set to 200-250 ms.

[0128] Example 3

[0129] Figure 6 This embodiment provides a flow chart of a control method for an implantable medical device. The control method can be executed by a control device of the implantable medical device during operation. The control device can be implemented by software and / or hardware, and the control device can be a part of the implantable medical device.

[0130] The implantable medical device in this embodiment includes a control device and at least one ventricular electrode lead, and the at least one ventricular electrode lead is configured with a first electrode pair for sensing. In one specific example, the implantable medical device includes one ventricular electrode lead, and the ventricular electrode lead is configured with a first electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and each ventricular electrode lead is configured with a first electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and only one ventricular electrode lead is configured with a first electrode pair for sensing.

[0131] like Figure 6 As shown, the control method of the implantable medical device provided in this embodiment may include the following steps S301-S302:

[0132] Step S301: Acquire a first sensing time and a first delivery time, wherein the first sensing time is the sensing time of the R wave in the far-field electrocardiogram, and the first delivery time is the time when the pacing pulse is delivered through the first electrode pair.

[0133] Step S302: Determine whether to capture the ventricle according to the difference between the first delivery time and the first sensing time.

[0134] Assuming that the first sensing time obtained during the operation period is GS_OP and the first release time is LS1_OP, this embodiment determines whether the ventricle is captured during the operation period based on LS1_OP-GS_OP. That is, only the time information of the ventricle can be used to determine whether the ventricle is captured during the operation period. The judgment method is simple and does not affect the energy consumption required by the implantable medical device.

[0135] In an optional embodiment of step S302, if the difference between the fifth difference and the sixth difference is less than a fifth threshold, ventricular capture is determined; otherwise, ventricular non-capture is determined. The fifth difference is the difference between the first delivery time and the first sensing time, and the sixth difference is determined based on the difference between the second delivery time and the seventh sensing time; the seventh sensing time is the sensing time of an R wave in a far-field electrocardiogram acquired during ventricular capture by pacing within a preset period, and the second delivery time is the time at which a pacing pulse is delivered via the first electrode pair during ventricular capture by pacing within the preset period.

[0136] Assume that the first sensing time obtained during the operation period is GS_OP, the first dispensing time is LS1_OP, and the fifth difference is LS1_OP-GS_OP. Assume that the seventh sensing time GS_SUP and the second dispensing time LS1_SUP are obtained during the preset period, and the sixth difference is LS1_SUP-GS_SUP-. If the difference between the fifth and sixth differences is less than a fifth threshold, i.e., ||LS1_OP-GS_OP|-|LS1_SUP-GS_SUP|| is less than the fifth threshold, then ventricular capture is determined. If the difference between the fifth and sixth differences is greater than or equal to the fifth threshold, i.e., ||LS1_OP-GS_OP|-|LS1_SUP-GS_SUP|| is greater than or equal to the fifth threshold, then ventricular non-capture is determined. The fifth threshold can be set according to actual circumstances, for example, to 5 ms. The fifth threshold can also be obtained by other means, such as by directly programming the fifth threshold by a physician through an external device (e.g., a programmer) to modify a preset value.

[0137] In this embodiment, the preset period corresponds to pacing and ventricular capture. If the difference between the fifth difference calculated during the running period and the sixth difference calculated during the preset period is less than the fifth threshold, it means that the fifth difference calculated during the running period is close to the sixth difference calculated during the preset period. In this case, it is determined that the ventricle is captured during the running period. Otherwise, it is determined that the ventricle is not captured during the running period.

[0138] In a specific implementation, the sixth difference calculated in the preset period can be determined based on the difference between the second emission time and the seventh perception time corresponding to multiple heartbeats, for example, it can be the average, median, quartile or other statistical value of multiple differences.

[0139] In another optional implementation of step S302, if the difference between the first delivery time and the first sensing time is a positive number and is smaller than a sixth threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured.

[0140] Assuming that the first sensing time obtained during the operational phase is GS_OP and the first delivery time is LS1_OP, if LS1_OP minus GS_OP is a positive number and less than a sixth threshold, indicating that the first sensing time occurs after the first delivery time, and the difference between the first sensing time and the first delivery time is small, it is determined that ventricular pacing during the operational phase was performed by the ventricle, i.e., ventricular capture was achieved. Otherwise, it is determined that the ventricle was not captured. The sixth threshold can be set based on actual circumstances, for example, to 40 ms. The sixth threshold can also be obtained by other means, such as by using the sixth difference, or by directly programming the sixth threshold by having a physician input a preset value via an external device (e.g., a programmer).

[0141] In an optional embodiment, the control device is configured to execute the above-described control method after a first preset number of heartbeats have occurred during the operational phase. The first preset number of heartbeats can be set based on practical circumstances, for example, to 5. In this embodiment, after the first preset number of heartbeats have occurred during the operational phase, it indicates that the heartbeat and capture have stabilized. Re-testing for ventricular capture at this time can improve detection accuracy.

[0142] In an optional embodiment, for the second preset number of heartbeats, if it is determined that the ventricle has been captured for a third preset number of heartbeats, then it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle is being captured. It should be noted that the ventricle can be captured continuously or discontinuously for the third preset number of heartbeats.

[0143] Wherein, the third preset number of times is less than or equal to the second preset number of times, and can be set according to actual conditions. In a specific example, the second preset number of times is 12 times, and the third preset number of times is 9 times. In order to eliminate false positives or minimize false positives, the third preset number of times can be set to be equal to the second preset number of times.

[0144] Example 4

[0145] Figure 7 This embodiment provides a flow chart of a control method for an implantable medical device. The control method can be executed by a control device of the implantable medical device during operation. The control device can be implemented by software and / or hardware, and the control device can be a part of the implantable medical device.

[0146] The implantable medical device in this embodiment includes a control device and at least one ventricular electrode lead, and the at least one ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In one specific example, the implantable medical device includes one ventricular electrode lead, and the ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and each ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and only one ventricular electrode lead is configured with a first electrode pair and a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and one ventricular electrode lead is configured with a first electrode pair for sensing, and the other ventricular electrode lead is configured with a second electrode pair for sensing.

[0147] like Figure 7 As shown, the control method of the implantable medical device provided in this embodiment may include the following steps S401 to S403:

[0148] Step S401: Acquire a first delivery time, wherein the first delivery time is the time when the pacing pulse is delivered through the first electrode pair.

[0149] Step S402: Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair and acquire an eighth sensing time, wherein the eighth sensing time is the sensing time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram.

[0150] Step S403: Determine whether to capture the ventricle according to the difference between the eighth sensing time and the first release time.

[0151] Assuming that the first emission time obtained during the operation period is LS1_OP and the eighth sensing time is LS2_OP, this embodiment determines whether the ventricle is captured during the operation period based on LS2_OP-LS1_OP. That is, only the time information of the ventricle can be used to determine whether the ventricle is captured during the operation period, without referring to the far-field electrocardiogram. The judgment method is simple and will not affect the energy consumption generated by the implantable medical device.

[0152] In an optional embodiment of step S403, if the ratio between the seventh difference and the eighth difference is greater than a seventh threshold, then it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle has not been captured. The seventh difference is the difference between the eighth perception time and the first release time, and the eighth difference is determined based on the difference between the sixth perception time and the fourth perception time; the sixth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram acquired by the second electrode pair within a preset period, the fourth perception time is the perception time of ventricular myocardial activation corresponding to the perception event in the in vivo near-field myocardial electrocardiogram acquired by the first electrode pair within a preset period, and the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

[0153] Assuming that the first dispensing time obtained during the operation period is LS1_OP, the eighth sensing time is LS2_OP, and the seventh difference is LS2_OP-LS1_OP, and the sixth sensing time obtained during the preset period is LS2_SUP, the fourth sensing time is LS1_SUP, and the eighth difference is LS2_SUP-LS1_SUP. If the ratio of the seventh difference to the eighth difference is greater than a seventh threshold, that is, |LS2_OP-LS1_OP| / |LS2_SUP-LS1_SUP| is greater than the seventh threshold, then ventricular capture is determined. If the ratio of the seventh difference to the eighth difference is less than or equal to the seventh threshold, that is, |LS2_OP-LS1_OP| / |LS2_SUP-LS1_SUP| is less than or equal to the seventh threshold, then ventricular non-capture is determined. Among them, the seventh threshold can be set according to actual conditions, for example, it can be set to 1.3, and the seventh threshold can also be obtained in other ways, such as obtaining the ratio of the eighth difference between ventricular activity originating from ventricular pacing and ventricular activity originating from the atrium during a preset period, or the doctor can input through an external device (such as a programmer) to modify the preset value and directly program the seventh threshold.

[0154] In this embodiment, the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium. If the ratio between the seventh difference calculated during the running period and the eighth difference calculated during the preset period is greater than the seventh threshold, it means that the seventh difference calculated during the running period is significantly different from the eighth difference calculated during the preset period. At this time, it is determined that the ventricles are captured during the running period; otherwise, it is determined that the ventricles are not captured during the running period.

[0155] In another optional implementation of step S403, whether the ventricle is captured can also be determined based on the difference between the seventh difference and the eighth difference. Specifically, if the difference between the seventh difference and the eighth difference is greater than a certain threshold, it means that the seventh difference calculated during the running period is significantly different from the eighth difference calculated during the preset period. In this case, it is determined that the ventricle is captured during the running period; otherwise, it is determined that the ventricle is not captured during the running period.

[0156] In another optional embodiment of step S403, if the difference between the seventh difference and the ninth difference is less than an eighth threshold, it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle has not been captured. The seventh difference is the difference between the eighth sensing time and the first delivery time, and the ninth difference is determined based on the difference between the ninth sensing time and the second delivery time. The ninth sensing time is the sensing time of ventricular myocardial activation corresponding to a pacing event in an in vivo near-field myocardial electrocardiogram acquired by the second electrode pair during ventricular capture by pacing within a preset period, and the second delivery time is the time of delivery of a pacing pulse via the first electrode pair during ventricular capture by pacing within the preset period.

[0157] Assume that the first dispensing time obtained during the operation period is LS1_OP, the eighth sensing time is LS2_OP, and the seventh difference is LS2_OP-LS1_OP. The ninth sensing time obtained during the preset period is LS2_SUP, the second dispensing time is LS1_SUP, and the ninth difference is LS2_SUP-LS1_SUP. If the difference between the seventh and ninth differences is less than an eighth threshold, i.e., |LS2_OP-LS1_OP|-|LS2_SUP-LS1_SUP| is less than the eighth threshold, then ventricular capture is determined. If the difference between the seventh and ninth differences is greater than or equal to the eighth threshold, i.e., |LS2_OP-LS1_OP|-|LS2_SUP-LS1_SUP| is greater than or equal to the eighth threshold, then ventricular non-capture is determined. The eighth threshold can be set based on actual conditions, for example, to 5 ms. Alternatively, the eighth threshold can be obtained by other means, such as by directly programming the eighth threshold by having a physician input a preset value via an external device (e.g., a programmer).

[0158] In this embodiment, the preset period corresponds to pacing and ventricular capture. If the difference between the seventh difference calculated during the running period and the ninth difference calculated during the preset period is less than the eighth threshold value, indicating that the seventh difference calculated during the running period is close to the ninth difference calculated during the preset period, it is determined that the ventricle is captured during the running period. Otherwise, it is determined that the ventricle is not captured during the running period.

[0159] In an optional embodiment, the control device is configured to execute the above-described control method after a first preset number of heartbeats have occurred during the operational phase. The first preset number of heartbeats can be set based on actual conditions, for example, to 5. In this embodiment, after the first preset number of heartbeats have occurred during the operational phase, the heartbeat has stabilized, and detecting ventricular capture at this time can improve detection accuracy.

[0160] In an optional embodiment, for the second preset number of heartbeats, if it is determined that the ventricle has been captured for a third preset number of heartbeats, then it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle is being captured. It should be noted that the ventricle can be captured continuously or discontinuously for the third preset number of heartbeats.

[0161] Wherein, the third preset number of times is less than or equal to the second preset number of times, and can be set according to actual conditions. In a specific example, the second preset number of times is 12 times, and the third preset number of times is 9 times. In order to eliminate false positives or minimize false positives, the third preset number of times can be set to be equal to the second preset number of times.

[0162] Example 5

[0163] Figure 8 This embodiment provides a flow chart of a control method for an implantable medical device. The control method can be executed by a control device of the implantable medical device during operation. The control device can be implemented by software and / or hardware, and the control device can be a part of the implantable medical device.

[0164] The implantable medical device in this embodiment includes a control device and at least one ventricular electrode lead, and the at least one ventricular electrode lead is configured with a second electrode pair for sensing. In one specific example, the implantable medical device includes one ventricular electrode lead, and the ventricular electrode lead is configured with a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and each ventricular electrode lead is configured with a second electrode pair for sensing. In another specific example, the implantable medical device includes two ventricular electrode leads, and only one ventricular electrode lead is configured with a second electrode pair for sensing.

[0165] like Figure 8 As shown, the control method of the implantable medical device provided in this embodiment may include the following steps S501 to S503:

[0166] Step S501: Acquire a first sensing time, wherein the first sensing time is the sensing time of an R wave in a far-field electrocardiogram.

[0167] Step S502: Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair and acquire an eighth sensing time, wherein the eighth sensing time is the sensing time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram.

[0168] Step S503: Determine whether to capture the ventricle according to the difference between the first sensing time and the eighth sensing time.

[0169] Assuming that the first sensing time obtained during the operation period is GS_OP and the eighth sensing time is LS2_OP, this embodiment determines whether the ventricle is captured during the operation period based on GS_OP-LS2_OP. That is, only using the time information of the ventricle and only one non-pacing electrode pair, it is possible to determine whether the ventricle is captured during the operation period. The judgment method is simple and will not affect the energy consumption generated by the implantable medical device.

[0170] In an optional embodiment of step S503, if the difference between the tenth difference and the eleventh difference is less than a ninth threshold, then ventricular capture is determined; otherwise, ventricular non-capture is determined. The tenth difference is the difference between the eighth perception time and the first perception time, and the eleventh difference is determined based on the difference between the ninth perception time and the seventh perception time; the ninth perception time is the perception time of ventricular myocardial activation corresponding to a pacing event in an in vivo near-field electrocardiogram acquired based on the second electrode pair during ventricular capture by pacing within a preset period; and the seventh perception time is the perception time of an R wave in a far-field electrocardiogram acquired during ventricular capture by pacing within a preset period.

[0171] Assume that the first sensed time obtained during the run period is GS_OP, the eighth sensed time is LS2_OP, and the tenth difference is LS2_OP-GS_OP. The ninth sensed time obtained during the preset period is LS2_SUP, the seventh sensed time is GS_SUP, and the eleventh difference is LS2_SUP-GS_SUP. If the difference between the tenth and eleventh differences is less than a ninth threshold, i.e., |LS2_OP-GS_OP|-|LS2_SUP-GS_SUP| is less than the ninth threshold, then ventricular capture is determined. If the difference between the tenth and eleventh differences is greater than or equal to the ninth threshold, i.e., |LS2_OP-GS_OP|-|LS2_SUP-GS_SUP| is greater than or equal to the ninth threshold, then ventricular non-capture is determined. The ninth threshold can be set based on actual conditions, for example, to 5 ms. Alternatively, the ninth threshold can be obtained by other means, such as by directly programming the ninth threshold by a physician inputting a modified preset value via an external device (e.g., a programmer).

[0172] In this embodiment, the preset period corresponds to pacing and ventricular capture. If the difference between the tenth difference calculated during the running period and the eleventh difference calculated during the preset period is less than the ninth threshold value, indicating that the tenth difference calculated during the running period is close to the eleventh difference calculated during the preset period, it is determined that the ventricle is captured during the running period. Otherwise, it is determined that the ventricle is not captured during the running period.

[0173] In another optional embodiment of step S503, if the ratio between the tenth difference and the twelfth difference is greater than a tenth threshold, then ventricular capture is determined; otherwise, ventricular non-capture is determined. The tenth difference is the difference between the eighth perception time and the first perception time, and the twelfth difference is determined based on the difference between the sixth perception time and the third perception time; the sixth perception time is the perception time corresponding to a perception event in an in vivo near-field myocardial electrocardiogram acquired by the second electrode pair within a preset period, and the third perception time is the perception time of an R wave in a far-field electrocardiogram acquired within a preset period, wherein the preset period corresponds to ventricular activation originating from the atria.

[0174] Assuming that the first sensed time obtained during the operation period is GS_OP, the eighth sensed time is LS2_OP, and the tenth difference is LS2_OP-GS_OP, and the sixth sensed time obtained during the preset period is LS2_SUP, the third sensed time is GS_SUP, and the twelfth difference is LS2_SUP-GS_SUP, if the ratio of the tenth difference to the twelfth difference is greater than a tenth threshold, that is, the ratio |LS2_OP-GS_OP| / |LS2_SUP-GS_SUP| is greater than the tenth threshold, then ventricular capture is determined. If the difference between the tenth difference and the twelfth difference is less than or equal to the tenth threshold, that is, |LS2_OP-GS_OP| / |LS2_SUP-GS_SUP| is less than or equal to the tenth threshold, then ventricular non-capture is determined. Among them, the tenth threshold can be set according to actual conditions, for example, it can be set to 1.3, and the tenth threshold can also be obtained in other ways, such as obtaining the ratio of the eighth difference between ventricular activity originating from ventricular pacing and ventricular activity originating from the atrium during a preset period, or the doctor can input through an external device (such as a programmer) to modify the preset value and directly program the tenth threshold.

[0175] In this embodiment, the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium. If the ratio between the tenth difference value calculated during the running period and the twelfth difference value calculated during the preset period is greater than the tenth threshold value, it means that the tenth difference value calculated during the running period is significantly different from the twelfth difference calculated during the preset period. At this time, it is determined that the ventricles are captured during the running period; otherwise, it is determined that the ventricles are not captured during the running period.

[0176] In another optional implementation of step S503, whether the ventricle is captured can also be determined based on the difference between the tenth difference and the twelfth difference. Specifically, if the difference between the tenth difference and the twelfth difference is greater than a certain threshold, indicating that the tenth difference calculated during the running period is significantly different from the twelfth difference calculated during the preset period, it is determined that the ventricle is captured during the running period. Otherwise, it is determined that the ventricle is not captured during the running period.

[0177] In an optional embodiment, the control device is configured to execute the above-described control method after a first preset number of heartbeats have occurred during the operational phase. The first preset number of heartbeats can be set based on actual conditions, for example, to 5. In this embodiment, after the first preset number of heartbeats have occurred during the operational phase, the heartbeat has stabilized, and detecting ventricular capture at this time can improve detection accuracy.

[0178] In an optional embodiment, for the second preset number of heartbeats, if it is determined that the ventricle has been captured for a third preset number of heartbeats, then it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle is being captured. It should be noted that the ventricle can be captured continuously or discontinuously for the third preset number of heartbeats.

[0179] Wherein, the third preset number of times is less than or equal to the second preset number of times, and can be set according to actual conditions. In a specific example, the second preset number of times is 12 times, and the third preset number of times is 9 times. In order to eliminate false positives or minimize false positives, the third preset number of times can be set to be equal to the second preset number of times.

[0180] Although specific embodiments of the present invention have been described above, those skilled in the art will appreciate that these are merely illustrative and that the scope of the present invention is defined by the appended claims. Those skilled in the art may make various changes or modifications to these embodiments without departing from the principles and essence of the present invention, and such changes and modifications are intended to fall within the scope of the present invention.

Claims

1. An implantable medical device, characterized in that: The device comprises a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair for sensing; The control device is configured to perform the following steps during operation: acquiring a first in vivo near-field myocardial electrocardiogram based on the first electrode pair; Obtaining a first perception time and a second perception time; wherein the first perception time is the perception time of an R wave in a far-field electrocardiogram, and the second perception time is the perception time corresponding to a perception event in the first in-vivo near-field myocardial electrocardiogram; the R wave in the far-field electrocardiogram and the perception event in the first in-vivo near-field myocardial electrocardiogram correspond to the same heartbeat; The ventricular excitation source of the heartbeat is determined according to the difference between the first sensing time and the second sensing time; wherein the ventricular excitation source includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

2. The implantable medical device according to claim 1, wherein The step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes: If the difference between the first difference and the second difference is greater than a first threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium; Among them, the first difference is the difference between the first perception time and the second perception time, and the second difference is determined according to the difference between the third perception time and the fourth perception time; the third perception time is the perception time of the R wave in the far-field electrocardiogram obtained within the preset period, and the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period; the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

3. The implantable medical device according to claim 2, wherein: The second difference is determined according to the difference between the third perception time and the fourth perception time corresponding to the plurality of heartbeats.

4. The implantable medical device according to claim 1, wherein The step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes: If the difference between the first sensing time and the second sensing time is greater than a second threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium.

5. The implantable medical device according to claim 1, wherein: The at least one ventricular electrode lead is further provided with a second electrode pair for sensing; The control device is further configured to perform the following steps during operation: acquiring a second in-vivo near-field myocardial electrocardiogram based on the second electrode pair; The step of determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time specifically includes: determining the ventricular excitation source of the heartbeat according to the difference between the first sensing time and the second sensing time and / or the difference between the first sensing time and the fifth sensing time; Among them, the fifth perception time is the perception time corresponding to the perception event in the second body near-field myocardial electrocardiogram, and the perception event in the second body near-field myocardial electrocardiogram and the R wave in the far-field electrocardiogram correspond to the same heartbeat.

6. An implantable medical device, characterized in that: The device comprises a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair and a second electrode pair for sensing; The control device is configured to perform the following steps during operation: Acquire a first in-vivo near-field myocardial electrocardiogram based on the first electrode pair, and acquire a second sensing time; wherein the second sensing time is a sensing time corresponding to a sensing event in the first in-vivo near-field myocardial electrocardiogram; acquiring a second in-vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquiring a fifth sensing time; wherein the fifth sensing time is a sensing time corresponding to a sensing event in the second in-vivo near-field myocardial electrocardiogram, and the sensing event in the second in-vivo near-field myocardial electrocardiogram and the sensing event in the first in-vivo near-field myocardial electrocardiogram correspond to the same heartbeat; The ventricular excitation source of the heartbeat is determined according to the difference between the second sensing time and the fifth sensing time; wherein the ventricular excitation source includes ventricular excitation originating from the atrium and ventricular excitation originating from the ventricle.

7. The implantable medical device according to claim 6, wherein: The step of determining the ventricular excitation source of the heartbeat according to the difference between the second sensing time and the fifth sensing time specifically includes: If the difference between the third difference and the fourth difference is greater than a third threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium; Among them, the third difference is the difference between the second perception time and the fifth perception time, and the fourth difference is determined based on the difference between the fourth perception time and the sixth perception time; the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period, and the sixth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair within the preset period; the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

8. The implantable medical device according to claim 7, wherein: The fourth difference is determined according to the difference between the fourth perception time and the sixth perception time corresponding to the plurality of heartbeats.

9. The implantable medical device according to claim 6, wherein: The step of determining the ventricular excitation source of the heartbeat according to the difference between the second sensing time and the fifth sensing time specifically includes: If the difference between the second sensing time and the fifth sensing time is greater than a fourth threshold, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the ventricle; otherwise, it is determined that the source of the ventricular excitation of the heartbeat is ventricular excitation from the atrium.

10. The implantable medical device according to any one of claims 1 to 9, wherein: The control device is further configured to perform the following steps during operation: The length of the R-wave perception time window corresponding to the R-wave in the far-field electrocardiogram acquired within a preset period is determined according to the ventricular excitation source of the heartbeat.

11. An implantable medical device, characterized in that: The device comprises a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair for sensing; The control device is configured to perform the following steps during operation: Acquire a first sensing time and a first delivery time; wherein the first sensing time is the sensing time of the R wave in the far-field electrocardiogram, and the first delivery time is the time when the pacing pulse is delivered through the first electrode pair; Whether the ventricle is captured is determined based on the difference between the first discharge time and the first sensing time.

12. The implantable medical device according to claim 11, wherein: The step of determining whether the ventricle is captured based on the difference between the first sensing time and the first releasing time specifically includes: if the difference between the fifth difference and the sixth difference is less than a fifth threshold, determining that the ventricle is captured; otherwise, determining that the ventricle is not captured; Among them, the fifth difference is the difference between the first emission time and the first perception time, and the sixth difference is determined based on the difference between the second emission time and the seventh perception time; the seventh perception time is the perception time of the R wave in the far-field electrocardiogram obtained during the period of ventricular pacing capture within the preset period, and the second emission time is the time when the pacing pulse is emitted by the first electrode pair during the period of ventricular pacing capture within the preset period.

13. The implantable medical device according to claim 12, wherein: The sixth difference is determined according to the difference between the second emission time and the seventh sensing time corresponding to the plurality of heartbeats.

14. The implantable medical device according to claim 11, wherein The step of determining whether to capture the ventricle according to the difference between the first release time and the first sensing time specifically includes: If the difference between the first discharge time and the first sensing time is a positive number and is smaller than a sixth threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured.

15. An implantable medical device, characterized in that: The device comprises a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a first electrode pair and a second electrode pair for sensing; The control device is configured to perform the following steps during operation: Acquiring a first delivery time; wherein the first delivery time is the time when a pacing pulse is delivered through the first electrode pair; Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquire an eighth perception time; wherein the eighth perception time is a perception time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram; Whether the ventricle is captured is determined based on the difference between the eighth sensing time and the first firing time.

16. The implantable medical device according to claim 15, wherein: The step of determining whether to capture the ventricle based on the difference between the eighth sensing time and the first releasing time specifically includes: If the ratio between the seventh difference and the eighth difference is greater than a seventh threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured; Among them, the seventh difference is the difference between the eighth perception time and the first emission time, and the eighth difference is determined based on the difference between the sixth perception time and the fourth perception time; the sixth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair within the preset period, and the fourth perception time is the perception time corresponding to the perception event in the in vivo near-field myocardial electrocardiogram obtained based on the first electrode pair within the preset period, and the source of ventricular excitation of the heartbeat corresponding to the preset period is ventricular excitation originating from the atrium.

17. The implantable medical device according to claim 15, wherein: The step of determining whether to capture the ventricle based on the difference between the eighth sensing time and the first releasing time specifically includes: If the difference between the seventh difference and the ninth difference is less than an eighth threshold, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured; Among them, the seventh difference is the difference between the eighth perception time and the first delivery time, and the ninth difference is determined based on the difference between the ninth perception time and the second delivery time; the ninth perception time is the perception time of ventricular muscle activation corresponding to the pacing event in the in vivo near-field myocardial electrocardiogram obtained by the second electrode pair during the period of ventricular pacing capture within the preset period, and the second delivery time is the time for delivering pacing pulses through the first electrode pair during the period of ventricular pacing capture within the preset period.

18. An implantable medical device, characterized in that: The device comprises a control device and at least one ventricular electrode lead, wherein the at least one ventricular electrode lead is provided with a second electrode pair for sensing; The control device is configured to perform the following steps during operation: Acquire a first perception time; wherein the first perception time is a perception time of an R wave in a far-field electrocardiogram; Acquire an in vivo near-field myocardial electrocardiogram based on the second electrode pair, and acquire an eighth perception time; wherein the eighth perception time is a perception time of ventricular myocardial activation corresponding to a pacing event in the in vivo near-field myocardial electrocardiogram; Whether the ventricle is captured is determined based on the difference between the first sensing time and the eighth sensing time.

19. The implantable medical device according to claim 18, wherein The step of determining whether to capture the ventricle according to the difference between the first sensing time and the eighth sensing time specifically includes: If the difference between the tenth difference value and the eleventh difference value is less than the ninth threshold value, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured; Among them, the tenth difference is the difference between the eighth perception time and the first perception time, and the eleventh difference is determined based on the difference between the ninth perception time and the seventh perception time; the ninth perception time is the perception time of ventricular muscle activation corresponding to the pacing event in the in vivo near-field myocardial electrocardiogram obtained based on the second electrode pair during the period of ventricular pacing capture within the preset period, and the seventh perception time is the perception time of the R wave in the far-field electrocardiogram obtained during the period of ventricular pacing capture within the preset period.

20. The implantable medical device according to claim 18, wherein The step of determining whether to capture the ventricle according to the difference between the first sensing time and the eighth sensing time specifically includes: If the ratio between the tenth difference value and the twelfth difference value is greater than a tenth threshold value, it is determined that the ventricle is captured; otherwise, it is determined that the ventricle is not captured; Among them, the tenth difference is the difference between the eighth perception time and the first perception time, and the twelfth difference is determined based on the difference between the sixth perception time and the third perception time; the sixth perception time is the perception time corresponding to the perception event in the near-field myocardial electrocardiogram in the body obtained based on the second electrode pair within a preset period, and the third perception time is the perception time of the R wave in the far-field electrocardiogram obtained within a preset period, and the preset period corresponds to ventricular excitation originating from the atrium.

21. The implantable medical device according to any one of claims 11 to 20, wherein: The control device is configured to perform the following steps during operation: After a first preset number of heartbeats into the running period, the control device is configured to perform the following steps.

22. The implantable medical device according to any one of claims 11 to 20, wherein: The control device is further configured to perform the following steps during operation: For the second preset number of heartbeats, if it is determined that the ventricle is captured for a third preset number of heartbeats, it is determined that the ventricle has been captured; otherwise, it is determined that the ventricle is being captured; Wherein, the third preset number of times is less than or equal to the second preset number of times.

Images