Pacing control method, pacing control device, and medical device

Abstract

The present invention discloses a pacing control method, a pacing control device, and a medical device, the pacing control method including: obtaining a patient's actual heart rate; and pacing the patient's heart at a preset pacing frequency when the actual heart rate meets a preset low heart rate condition, the preset low heart rate condition being used to indicate that the patient is in a life-threatening state. The present invention targets patients in need of pacing support who are in a life-threatening state, including severe bradycardia or cardiac arrest. The present invention can perform pacing at a high pacing frequency only when pacing is necessary, thereby achieving timely and effective pacing to support the patient's life. In daily use, the present invention can significantly avoid unnecessary pacing and pain caused by pacing stimulation. In particular, the present invention can avoid pacing in the event of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, thereby improving user acceptance and / or experience.

Description

Technical Field

[0005] , , , ,

[0004]

[0001] <Cross - reference to Related Applications> This application claims the priority of Chinese Patent Application No. 2020112229214 with a filing date of November 5, 2020. This application incorporates the full text of the above - mentioned Chinese patent application by reference.

[0002] The present invention relates to the technical field of medical devices, and particularly to a pacing control method, a pacing control device, and a medical device.

Background Art

[0003] Monitoring the patient's heart rate in real - time and promptly pacing the heart when the heart rate reaches the set pacing condition to prevent the heart beat from slowing down or stopping is the most basic purpose of a cardiac medical device. <00000​​​​​​Such pacing control methods are applicable to general endocardial / epidcardial pacing. However, in the case of transcutaneous pacing (electrical stimulation), for example, it can easily cause pain or unbearable pain to the patient. With existing pacing control methods, as described above, pacing is initiated as soon as the patient's heart rate drops to the preset lower limit, resulting in frequent pacing operations. Consequently, patients often experience pain from the pacing operations, leading to a poor user experience and reduced patient use of or compliance with the medical device / equipment. [Overview of the project]

[0006] The technical problem that this invention aims to solve is to overcome the drawback of prior art pacing control methods, which often result in patients experiencing pain due to frequent pacing, thus worsening the user experience, and to provide a pacing control method, a pacing control device, and a medical device.

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

[0008] The present invention provides a pacing control method, and the pacing control method is Steps to obtain the patient's actual heart rate, The procedure includes determining whether the actual heart rate meets a preset low heart rate condition, and if so, pacing the patient's heart at a preset pacing frequency, where the preset low heart rate condition is used to indicate that the patient is in a life-threatening condition.

[0009] Rather than targeting patients with bradycardia in the conventional sense of cardiac pacing therapy, this invention targets patients with severe bradycardia or cardiac arrest due to underlying heart disease or acute heart disease. Patients in the life-threatening condition described above are considered to require pacing support when there is a very high probability of death if pacing is not performed (the patient urgently needs rescue). In other words, the pacing operation in this invention is performed as a "last resort" / "life-saving measure".

[0010] Specifically, by pre-setting the conditions for initiating pacing, pacing can be performed at a high pacing frequency only when necessary, enabling timely and effective pacing to support the patient's life. At the same time, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided during the patient's daily use, improving user acceptance and / or experience.

[0011] Preferably, the step of determining whether the actual heart rate meets the preset low heart rate condition, and if this condition is met, pacing the patient's heart at the preset pacing frequency, This includes determining whether the actual heart rate falls below a preset low heart rate, and if so, pacing the patient's heart at the preset pacing frequency.

[0012] By monitoring the patient's heart rate in real time, it is possible to identify that the patient is in urgent need of rescue if it falls below a set preset low heart rate (much lower than the preset low heart rate in existing pacing control methods). This means that pacing can be activated only when the patient's heart rate is extremely low, enabling timely and effective pacing to sustain the patient's life.

[0013] Preferably, the step of determining whether the actual heart rate meets the preset low heart rate condition, and if this condition is met, pacing the patient's heart at the preset pacing frequency, The system includes determining whether the actual heart rate is below a preset low heart rate, and if so, obtaining a period of time during which the patient's heart is continuously below the preset low heart rate (i.e., a first low heart rate duration), and pacing the patient's heart at the preset pacing frequency when the first low heart rate duration reaches the preset duration.

[0014] The system monitors the patient's real-time heart rate in real time, and when the actual heart rate falls below the preset low heart rate, Actual heart rate By activating pacing only when the first low heart rate duration reaches the preset low heart rate duration, the patient's heart rate does not accidentally fall below the preset low heart rate, preventing unnecessary pacing interventions. This achieves superior pacing monitoring, ensuring patient safety while further enhancing the user experience.

[0015] Preferably, the preset pacing frequency, the preset low heart rate, and the preset low heart rate duration are parameters that can be reset by a healthcare professional according to the patient's condition.

[0016] Considering that each patient has a different physical condition and tolerance to pacing, we comprehensively consider multiple parameters such as each patient's medical history, current condition, medication use, and need for pacing in advance to ultimately determine the appropriate preset low heart rate, preset low heart rate duration, and preset pacing frequency for each patient, thereby ensuring patient safety and guaranteeing the best possible experience.

[0017] Preferably, the preset low heart rate is greater than 0 bpm and 40 bpm or less. The preset low heart rate is much lower than the preset lower heart rate limit in existing pacing control methods.

[0018] Preferably, the preset low heart rate duration includes 1 s to 60 s.

[0019] Preferably, the preset pacing frequency includes 40 bpm to 80 bpm.

[0020] Preferably, during the step of pacing the patient's heart at the preset pacing frequency, During the first pacing period, the patient's own heart rate Steps to obtain, Total number of patients corresponding to the set period heart rate a step of obtaining; Here, the total heart rate is the self heart rate and pacing heart rate and includes; the set period includes the first pacing period, and the duration corresponding to the set period is not less than the duration corresponding to the first pacing period, the self heart rate and the total heart rate a step of calculating a ratio therebetween; determining whether the ratio is not less than a first set threshold value, and if it is not less than the first set threshold value, controlling the stop of pacing, and if it is less than the first set threshold value, determining whether the ratio is not more than a second set threshold value, and if it is not more than the second set threshold value, continuously executing a step of pacing the patient's heart at a preset pacing frequency, and if it exceeds the second set threshold value and is less than the first set threshold value, reducing the preset pacing frequency to a first pacing frequency, and determining whether the first pacing frequency is less than a minimum pacing frequency, and if it is not less than the minimum pacing frequency, pacing the patient's heart at the first pacing frequency, and if it is less than the minimum pacing frequency, pacing the patient's heart at the minimum pacing frequency, for example, reducing the preset pacing frequency by 10 bpm and pacing the patient's heart at the reduced pacing frequency, and if the reduced pacing frequency is less than the minimum pacing frequency, pacing the patient's heart at the minimum pacing frequency, where the minimum pacing frequency is 40 bpm to 60 bpm, and generally 50 bpm.

[0021] Here, the ratio of the self heart rate and the total heart rate corresponding to the first set threshold value is high, and the ratio of the self heart rate and the total heart rate corresponding to the second set threshold value is low.

[0022] In order to perform timely and effective pacing control, after pacing at a preset pacing frequency, the patient's heart rateRe-evaluate. If the actual heart rate exceeds the preset pacing frequency (which can be regarded as a general heart rate), for example, 50 bpm or 60 bpm, and lasts for the set time, it indicates that pacing is effectively being performed at the current pacing frequency, restoring the patient's own heart rate and liberating the patient from the life crisis. At this point, stop the pacing operation on the patient and stop pacing in a timely manner to minimize the pain given to the patient.

[0023] If the actual heart rate is still below the first preset pacing frequency, that is, the general heart rate (50 bpm - 60 bpm, adjustable by the doctor), or only a slight heart rate exceeds the first preset pacing frequency, it indicates that the patient's heart rate does not increase / recover at the current pacing frequency, or does not increase / recover sufficiently to support proper blood circulation. At this point, continue pacing for the patient to further ensure the patient's safety.

[0024] The present invention also provides a pacing control device, and the pacing control device includes a heart rate acquisition module for acquiring the actual heart rate of the patient, a first judgment module for judging whether the actual heart rate meets the preset low heart rate condition, and if this condition is met, calling the pacing module to pace the patient's heart at the preset pacing frequency, where the preset low heart rate condition is used to indicate that the patient is in a life-threatening state.

[0025] Preferably, the first judgment module judges whether the actual heart rate is below the preset low heart rate, and if so, calls the pacing module to pace the patient's heart at the preset pacing frequency.

[0026] Preferably, the first judgment module judges whether the actual heart rate is below the preset low heart rate, and if so, calls the duration acquisition module to acquire the first low heart rate duration when the patient's heart is at the actual heart rate. The first decision module is also used to invoke the pacing module to pace the patient's heart at the preset pacing frequency when the first low heart rate duration reaches a preset low heart rate duration.

[0027] Preferably, the preset pacing frequency, the preset low heart rate, and the preset low heart rate duration are parameters that can be reset according to the patient's condition.

[0028] Preferably, the preset low heart rate is greater than 0 bpm and 40 bpm or less.

[0029] Preferably, the preset low heart rate duration is 1 s to 60 s.

[0030] Preferably, the preset pacing frequency is 40 bpm to 80 bpm.

[0031] Preferably, the pacing control device also, During the first pacing period, the patient's own heart rate Self to obtain heart rate Acquisition module and Total number of patients corresponding to the set period heart rate To obtain the total heart rate Acquisition module and Here, the setting period includes the first pacing period, and the duration corresponding to the setting period is greater than or equal to the duration corresponding to the first pacing period. The aforementioned self heart rate and the total heart rate A ratio calculation module for calculating the ratio of, Determine whether the ratio is greater than or equal to a first setting threshold. If it is greater than or equal to the first setting threshold, control the cessation of pacing. If it is less than the first setting threshold, determine whether the ratio is less than or equal to a second setting threshold. If it is less than or equal to the second setting threshold, continue the step of pacing the patient's heart at the preset pacing frequency. If it is greater than the second setting threshold but less than the first setting threshold, reduce the preset pacing frequency to the first pacing frequency and determine whether the first pacing frequency is less than the minimum pacing frequency. The system includes a second decision module for determining whether the patient's heart is pacing at the first pacing frequency if it is not less than the minimum pacing frequency, for example, by reducing the preset pacing frequency by 10 bpm and pacing the patient's heart at the reduced pacing frequency, and if the reduced pacing frequency is less than the minimum pacing frequency, pacing the patient's heart at the minimum pacing frequency, where the minimum pacing frequency is between 40 bpm and 60 bpm, and is generally 50 bpm.

[0032] Here, the self corresponding to the first setting threshold heart rate and total heart rate The ratio is high, and the self corresponding to the second setting threshold heart rate and total heart rate The ratio is low.

[0033] The present invention also provides a medical device, the medical device including the pacing control device described above.

[0034] Preferably, the medical device includes a wearable defibrillator (WCD), an external defibrillator (such as an AED), a fully implantable subcutaneous cardioverter-defibrillator (SICD), or a mechanical circulatory support system (MCS).

[0035] As long as it does not violate common sense in the art, the above preferred conditions can be arbitrarily combined to obtain each preferred embodiment of the present invention.

[0036] The positive progressive effects of this invention are as follows: This invention does not target patients with bradycardia in the conventional sense, but rather patients with life-threatening conditions such as severe bradycardia or cardiac arrest due to underlying heart disease or acute heart disease who require pacing support. By pre-setting the conditions for initiating pacing, pacing can be performed at a high pacing frequency only when necessary, enabling timely and effective pacing to support the patient's life. Pacing is terminated when the patient's own heart rate recovers to a certain level. Meanwhile, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided in the patient's daily use, improving the user's acceptance, compliance, and experience with the medical device. [Brief explanation of the drawing]

[0037] [Figure 1] This is a first flowchart of the pacing control method according to Embodiment 1 of the present invention. [Figure 2] This is a second flowchart of the pacing control method according to Embodiment 1 of the present invention. [Figure 3] This is a third flowchart of the pacing control method according to Embodiment 1 of the present invention. [Figure 4] This is a flowchart of the pacing control method according to Embodiment 2 of the present invention. [Figure 5] This is a schematic diagram of the first structure of the pacing control system according to Embodiment 3 of the present invention. [Figure 6] This is a schematic diagram of the second structure of the pacing control system according to Embodiment 3 of the present invention. [Figure 7] This is a schematic diagram of the structure of the pacing control system according to Embodiment 4 of the present invention. [Modes for carrying out the invention]

[0038] The present invention will be further described below with reference to embodiments, but this does not limit the present invention to the scope of these embodiments.

[0039] <Example 1> As shown in Figure 1, the pacing control method of this embodiment includes the following steps.

[0040] In S101, the patient's actual heart rate is obtained. In S102, it is determined whether the actual heart rate meets the preset low heart rate condition, and if this condition is met, S103 is executed. In S103, the patient's heart is paced at a preset pacing frequency, where a preset low heart rate condition is used to indicate that the patient is in a life-threatening condition.

[0041] Rather than targeting patients with bradycardia in the conventional sense, this invention targets patients with severe bradycardia or cardiac arrest due to underlying heart disease or acute heart disease, and identifies patients in the life-threatening condition described above as those who require pacing support when there is a very high probability of death if pacing is not performed (the patient urgently needs rescue). In other words, the pacing operation in this invention is performed as a "last resort" / "life-saving measure".

[0042] Specifically, by pre-setting the conditions for initiating pacing, pacing can be performed at a high pacing frequency only when necessary, enabling timely and effective pacing to support the patient's life. At the same time, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided during the patient's daily use, improving user acceptance, compliance, and experience with the medical device.

[0043] Specifically, as shown in Figure 2, step S102 includes the following steps.

[0044] In S1021, it is determined whether the actual heart rate falls below the preset low heart rate, and if it does, S103 is executed.

[0045] The system monitors the patient's heart rate in real time and identifies that the patient is in urgent need of rescue if it falls below a set preset low heart rate (much lower than the preset low heart rate in existing pacing control methods). This means that pacing can be initiated only when the patient's heart rate is extremely low, enabling timely and effective pacing to sustain the patient's life. Furthermore, as shown in Figure 3, step S102 includes the following steps.

[0046] In S1022, it determines whether the actual heart rate is below the preset low heart rate. If it is, it obtains the duration of the first low heart rate when the patient's heart is at the actual heart rate, and the duration of the first low heart rate is then set to the preset low heart rate. Low heart rate Determine whether the duration is reached, and if so, perform step S103.

[0047] The system monitors the patient's real-time heart rate in real time, and when the actual heart rate falls below the preset low heart rate, Actual heart rate By activating pacing only when the first low heart rate duration reaches the preset low heart rate duration, the patient's heart rate does not accidentally fall below the preset low heart rate, preventing unnecessary pacing interventions. This achieves superior pacing monitoring, ensuring patient safety while further enhancing the user experience.

[0048] In this embodiment, the preset low heart rate is greater than 0 bpm and 40 bpm or less, preferably 10 bpm to 30 bpm, and can be set to 20 bpm. The pacing control method of this embodiment is still applicable even when the patient is in cardiac arrest, i.e., when the real-time heart rate is 0 bpm, and it is important to note that timely pacing can be achieved in extreme conditions where there is no heartbeat, and the patient's life can be saved in a timely manner.

[0049] The preset low heart rate duration is 1 s to 5 min (i.e., 1 second to 5 minutes), and the preset low heart rate duration can be adjusted and determined according to the physical condition of different patients or other actual circumstances, and is within the scope of protection of the present invention as long as the preset low heart rate duration in the technical solution of the present invention is reasonably applicable during the actual pacing process.

[0050] Furthermore, the preset low heart rate duration is 1s to 60s, preferably 1s to 20s, and can also be set to 10s.

[0051] The preset pacing frequency is 35 bpm to 90 bpm, and the preset pacing frequency can be adjusted and determined according to the physical condition of different patients or other actual circumstances. Insofar as the preset pacing frequency in the technical solution of the present invention can be reasonably applied during the actual pacing process, it falls within the scope of protection of the present invention.

[0052] Furthermore, the preset pacing frequency is 40 bpm to 80 bpm, preferably 50 bpm to 65 bpm. Additionally, the preset pacing frequency can be set to 60 bpm.

[0053] In this embodiment, the preset pacing frequency, preset low heart rate, and preset low heart rate duration are parameters that can be reset according to the specific condition of different patients. Considering that patients have different physical conditions, and in order to ensure that each patient can receive targeted pacing therapy, multiple parameters such as each patient's medical history, current condition, medication use, and need for pacing are comprehensively considered in advance to ultimately determine the appropriate preset low heart rate, preset low heart rate duration, and preset pacing frequency for each patient, thereby ensuring patient safety and guaranteeing the best possible patient experience.

[0054] It should be noted that all parameter values ​​in this embodiment can be reset according to the actual situation.

[0055] In this embodiment, for patients with life-threatening conditions such as severe bradycardia or cardiac arrest, the conditions for initiating pacing operations are pre-set. This allows for pacing at a high frequency only when necessary, enabling timely and effective pacing to support the patient's life. Pacing is terminated once the patient's own heart rate recovers to a certain level. Meanwhile, in the patient's daily use, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided. In particular, pacing is not activated in cases of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, improving the user's acceptance, compliance, and experience with the medical device.

[0056] <Example 2> As shown in Figure 4, the pacing control method of this embodiment is a further improvement on Embodiment 1, and specifically, The following steps are also included after step S103.

[0057] In S104, the patient's own self-regulation occurs during the first pacing period. heart rate Obtain, At this time, the character was created. heart rate This is the patient's own heart rate , in other words, non-pacing heart rate That is the case.

[0058] In S105, the total number of patients corresponding to the set period heart rate Obtain, Here, the setting period includes the first pacing period, and the duration corresponding to the setting period is greater than or equal to the duration corresponding to the first pacing period, and of course, not only time, but also total heart rate It is also possible to limit (i.e., total heart rate is self heart rate That's all.

[0059] Both the duration corresponding to the first pacing period and the duration corresponding to the set period can be set and adjusted according to actual needs.

[0060] Innate heart rate, pacing heart rate and total heart rate The process for obtaining this is well known in the relevant technical field, so it will not be repeated here.

[0061] In S106, self heart rate and total heart rate The ratio was calculated, In S107, it is determined whether the ratio is equal to or greater than the first set threshold. If so, step S109 is executed; otherwise, step S108 is executed. In S108, it is determined whether the ratio is below the second set threshold. If so, step S103 is continued. Otherwise, the preset pacing frequency is reduced to the first pacing frequency. It is then determined whether the first pacing frequency is below the minimum pacing frequency. For example, the preset pacing frequency is reduced by 10 bpm, and the patient's heart is paced at the reduced pacing frequency. Otherwise, the patient's heart is paced at the first pacing frequency. If so, the patient's heart is paced at the minimum pacing frequency. Here, the minimum pacing frequency is between 40 bpm and 60 bpm, and is generally 50 bpm.

[0062] Here, the minimum pacing frequency is the preset pacing threshold, which can, of course, be redefined and adjusted according to actual needs.

[0063] Self corresponding to the first set threshold heart rate and total heart rate The ratio is high, and the self corresponding to the second setting threshold heart rate and total heart rate The ratio is low.

[0064] Here, steps S104 to S108 are continuously executed during the pacing process until pacing is stopped, thereby controlling pacing as timely and effectively as possible.

[0065] In S109, the pacing stoppage can be controlled, and during the pacing process described above, pacing can be manually terminated or adjusted in real time.

[0066] Specifically, the pacing operation can be controlled by program control and sustained for a set time, for example, one minute (specifically, it can be set and adjusted from a few seconds to a few minutes depending on the actual needs, and the pacing operation can be manually terminated by the program controller, operation buttons or other means of implementation depending on the actual usage requirements), and the patient's self during this period heart rate and total heart rate After summing up, the total number of patients during the pacing phase heart rate Self in heart rate The ratio is calculated, and if that ratio exceeds a specific set value (50-100%, preferably 90%, programmable), then pacing is effective and self heart rate If the patient's spontaneous heart rate has recovered to a state above the preset pacing frequency, and it is determined that pacing can be stopped, and the percentage falls below a specific setpoint (0-30%, preferably, for example, 10%, programmable), it indicates that the patient's spontaneous heart rate has not yet recovered and pacing support is still needed, and pacing is continued at the preset pacing frequency. Otherwise, the pacing frequency is reduced by 10 bpm for pacing, and the above process is continued until the pacing frequency reaches the initially set minimum pacing frequency (40-60 bpm, preferably, for example, 50 bpm).

[0067] To ensure timely and effective pacing control, the patient's own heart rate is collected when pacing is performed at a preset pacing frequency, and then, after a certain period of time, the patient's own heart rate is recorded. heart rateRe-evaluate the actual heart rate, and if it exceeds the preset pacing frequency (which can be considered a typical heart rate), for example, 50 bpm or 60 bpm, and this continues for the set time, it indicates that pacing is being performed effectively at the current pacing frequency, allowing the patient's own heart rate to recover and freeing the patient from life-threatening situations. At this point, pacing operations on the patient should be stopped in an appropriate manner to minimize pain to the patient.

[0068] If the actual heart rate is below the first preset pacing frequency, i.e., the normal heart rate (50 bpm to 60 bpm, adjustable by the physician), or if it is only slightly above the first preset pacing frequency, it indicates that the patient's heart rate will not increase / recover at the current pacing frequency, or will not increase / recover sufficiently to support adequate blood circulation. At this point, the patient should continue pacing to further ensure patient safety.

[0069] Of course, the above values ​​can be pre-set or adjusted according to the physician's judgment regarding the clinical situation, in order to suit different patients, meet their individual needs, and further improve the user experience.

[0070] It should be noted that all parameter values ​​in this embodiment can be reset according to the actual situation.

[0071] In this embodiment, for patients with life-threatening conditions such as severe bradycardia or cardiac arrest, the conditions for initiating pacing operations are pre-set. This allows for pacing at a high pacing frequency only when necessary, ensuring timely and effective pacing to support the patient's life. Pacing is terminated once the patient's own heart rate recovers to a certain level. Meanwhile, in the patient's daily use, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided. In particular, pacing is not initiated in cases of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, improving the user's acceptance, compliance, and experience with the medical device. Furthermore, after the pacing operation is performed, the effect of the pacing operation on the patient is monitored in a timely manner, and the pacing frequency is adaptively adjusted to ensure timely and effective ventricular capture to ensure patient safety.

[0072] <Example 3> As shown in Figure 5, the pacing control device of this embodiment includes a heart rate acquisition module 1, a decision module 2, and a pacing module 3.

[0073] Heart rate acquisition module 1 is used to acquire the patient's actual heart rate. Decision module 2 is used to determine whether the actual heart rate meets the preset low heart rate condition. If so, it calls pacing module 3 to pace the patient's heart at the preset pacing frequency, where the preset low heart rate condition is used to indicate that the patient is in a life-threatening condition.

[0074] Rather than targeting patients with bradycardia in the conventional sense, the present invention targets patients with severe bradycardia or cardiac arrest, where there is a very high probability of death if pacing is not performed (the patient is in urgent need of rescue). In other words, the pacing operation in this invention is performed as a "last resort" / "life-saving measure".

[0075] Specifically, by pre-setting the conditions for initiating pacing, pacing can be performed at a high pacing frequency only when necessary, enabling timely and effective pacing to support the patient's life. At the same time, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided during the patient's daily use. In particular, pacing can not be activated in cases of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, thereby improving the user's acceptance, compliance, and experience with the medical device.

[0076] Specifically, Decision Module 2 is used to determine whether the actual heart rate is below a preset low heart rate, and if so, it invokes Pacing Module 3 to pace the patient's heart at a preset pacing frequency.

[0077] The system monitors the patient's heart rate in real time and identifies that the patient is in urgent need of rescue if it falls below a set preset low heart rate (much lower than the preset low heart rate in existing pacing control methods). This means that pacing can be initiated only when the patient's heart rate is extremely low, enabling timely and effective pacing to sustain the patient's life. Furthermore, as shown in Figure 6, the pacing control device of this embodiment further includes a duration acquisition module 4.

[0078] Decision module 2 is used to determine whether the actual heart rate is below a preset low heart rate, and if so, it calls duration acquisition module 4 to obtain the first low heart rate duration when the patient's heart is at the actual heart rate. Decision module 2 is also used to invoke pacing module 3 to pace the patient's heart at a preset pacing frequency when the first low heart rate duration reaches a preset low heart rate duration.

[0079] The system monitors the patient's real-time heart rate in real time, and when the actual heart rate falls below the preset low heart rate, Actual heart rateBy activating pacing only when the duration of the first low heart rate is equal to or greater than the preset low heart rate duration, the patient's heart rate does not accidentally fall below the preset low heart rate, preventing unnecessary pacing interventions. This achieves superior pacing monitoring, ensuring patient safety while further enhancing the user experience.

[0080] In embodiments, the preset low heart rate is greater than 0 bpm and less than or equal to 40 bpm, and is much lower than the preset lower heart rate in existing pacing control methods, and is set so that the patient can be reliably captured by the ventricles after pacing. Preferably, the preset low heart rate is 10 bpm to 30 bpm, and can be further set to 20 bpm.

[0081] The preset low heart rate duration is 1 s to 5 min (i.e., 1 second to 5 minutes), and the preset low heart rate duration can be adjusted and determined according to the physical condition of different patients or other actual circumstances, and is within the scope of protection of the present invention as long as the preset low heart rate duration in the technical solution of the present invention is reasonably applicable during the actual pacing process. The pacing control method of this embodiment is still applicable even when the patient is in cardiac arrest, i.e., when the real-time heart rate is 0 bpm, and it is important to note that timely pacing can be achieved in extreme conditions without a heartbeat, and the patient's life can be saved in a timely manner.

[0082] The preset low heart rate duration is 1s to 60s, preferably 1s to 20s, and can also be set to 10s.

[0083] The preset pacing frequency is 35 bpm to 90 bpm, and the preset pacing frequency can be adjusted and determined according to the physical condition of different patients or other actual circumstances. Insofar as the preset pacing frequency in the technical solution of the present invention can be reasonably applied during the actual pacing process, it falls within the scope of protection of the present invention.

[0084] Furthermore, the preset pacing frequency is 40 bpm to 80 bpm, preferably 50 bpm to 65 bpm. Additionally, the preset pacing frequency can be set to 60 bpm.

[0085] In this embodiment, the preset pacing frequency, preset low heart rate, and preset low heart rate duration are parameters that can be reset according to the specific condition of different patients. Considering that patients have different physical conditions, and in order to ensure that each patient can receive targeted pacing therapy, multiple parameters such as each patient's medical history, current condition, medication use, and need for pacing are comprehensively considered in advance to ultimately determine the appropriate preset low heart rate, preset low heart rate duration, and preset pacing frequency for each patient, thereby ensuring patient safety and guaranteeing the best possible patient experience.

[0086] It should be noted that all parameter values ​​in this embodiment can be reset according to the actual situation.

[0087] In this embodiment, for patients with life-threatening conditions such as severe bradycardia or cardiac arrest, the conditions for initiating pacing operations are pre-set. This allows for pacing at a high frequency only when necessary, enabling timely and effective pacing to support the patient's life. Pacing is terminated once the patient's own heart rate recovers to a certain level. Meanwhile, in the patient's daily use, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided. In particular, pacing is not activated in cases of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, improving the user's acceptance, compliance, and experience with the medical device.

[0088] <Example 4> The pacing control system of this embodiment is a further improvement over Embodiment 3, and specifically, As shown in Figure 7, the pacing control system of this embodiment is self heart rate Acquired module 5, total heart rate It includes an acquisition module 6, a ratio calculation module 7, and a second judgment module 8.

[0089] self heart rate Acquisition module 5 is used to obtain the patient's own self during the first pacing period. heart rate Used to obtain, Total heart rate Acquisition module 6 retrieves the total number of patients corresponding to the set period. heart rate Used to obtain, Here, heart rate is, heart rate and pacing heart rate Includes, The set period includes the first pacing period, and the duration corresponding to the set period is equal to or greater than the duration corresponding to the first pacing period. The ratio calculation module 7 is self heart rate and total heart rate Used to calculate the ratio with, The second decision module 8 is used to determine whether the ratio is above or below the first set threshold. If it is above or below the first set threshold, it calls the pacing module 3 to control the cessation of pacing. If it is below the first set threshold, it determines whether the ratio is below or below the second set threshold. If it is below the second set threshold, it calls the pacing module 3 to continue pacing the patient's heart. If it is above the second set threshold but below the first set threshold, it calls the pacing module 3 to reduce the preset pacing frequency to the first pacing frequency. It then determines whether the first pacing frequency is below the minimum pacing frequency. For example, it reduces the preset pacing frequency by 10 bpm and paces the patient's heart at the reduced pacing frequency. Otherwise, it paces the patient's heart at the first pacing frequency. If it is below the first pacing frequency, it paces the patient's heart at the minimum pacing frequency. Here, the minimum pacing frequency is 40 bpm to 60 bpm, and is generally 50 bpm.

[0090] Here, the minimum pacing frequency is the preset pacing threshold, which can, of course, be redefined and adjusted according to actual needs.

[0091] Self corresponding to the first set threshold heart rate and total heart rate The ratio is high, and the self corresponding to the second setting threshold heart rate and total heart rate The ratio is low.

[0092] Specifically, the pacing operation can be controlled by program control and sustained for a set time, for example, 1 minute (specifically, the set time can be set and adjusted according to actual needs (from a few seconds to a few minutes), and the pacing operation can be manually terminated by the program controller, operation buttons or other means of implementation, according to actual usage requirements), and the patient's self during this period heart rate and total heart rate After summing up, the total number of patients during the pacing phase heart rate Self in heart rate The ratio is calculated, and if that ratio exceeds a specific set value (50-100%, preferably 90%, programmable), then pacing is effective and self heart rate If the system indicates that the patient's spontaneous heart rate has recovered to a level above the preset pacing frequency and it is determined that pacing can be stopped, and the percentage falls below a set value (0-30%, preferably, for example, 10%, programmable), it indicates that the patient's spontaneous heart rate has not yet recovered and pacing support is still needed, and pacing is continued at the preset pacing frequency. Otherwise, the pacing frequency is reduced by 10 bpm for pacing, and the above process is continued until the pacing frequency reaches the initially set minimum pacing frequency (40-60 bpm, preferably, for example, 50 bpm).

[0093] To ensure timely and effective pacing control, the patient's own heart rate is collected when pacing is performed at a preset pacing frequency, and then, after a certain period of time, the patient's own heart rate is recorded. heart rateRe-evaluate the actual heart rate, and if it exceeds the preset pacing frequency (which can be considered a typical heart rate), for example, 50 bpm or 60 bpm, and this continues for the set time, it indicates that pacing is being performed effectively at the current pacing frequency, allowing the patient's own heart rate to recover and freeing the patient from life-threatening situations. At this point, pacing operations on the patient should be stopped in an appropriate manner to minimize pain to the patient.

[0094] If the actual heart rate is below the first preset pacing frequency, i.e., the normal heart rate (50 bpm to 60 bpm, adjustable by the physician), or if it is only slightly above the first preset pacing frequency, it indicates that the patient's heart rate will not increase / recover at the current pacing frequency, or will not increase / recover sufficiently to support adequate blood circulation. At this point, the patient should continue pacing to further ensure patient safety.

[0095] Of course, the above values ​​can be pre-set or adjusted according to the physician's judgment regarding the clinical situation, in order to suit different patients, meet their individual needs, and further improve the user experience.

[0096] It should be noted that all parameter values ​​in this embodiment can be reset according to the actual situation.

[0097] In this embodiment, for patients in life-threatening conditions such as severe bradycardia or cardiac arrest, the conditions for initiating pacing operations are pre-set. This allows for pacing at a high pacing frequency only when necessary, enabling timely and effective pacing to support the patient's life. Pacing is terminated once the patient's own heart rate recovers to a certain level. Meanwhile, unnecessary pacing and pain caused by pacing stimuli can be significantly avoided in the patient's daily use, improving user acceptance, compliance, and experience with the medical device. Furthermore, after the pacing operation is performed, the effect of the pacing operation on the patient is monitored in a timely manner, and the pacing frequency is adaptively adjusted to ensure timely and effective ventricular capture to ensure patient safety.

[0098] <Example 5> The medical device of this embodiment includes the pacing control device of Embodiment 3 or 4. Here, the medical devices include, but are not limited to, wearable cardioverter-defibrillators (WCDs), external cardioverter-defibrillators (AEDs, etc.), fully implantable subcutaneous cardioverter-defibrillators (SICDs), mechanical circulatory support systems (MCSs), or other life support devices / equipment.

[0099] The hardware components and circuit structures required for the pacing control process described above are all existing structures of wearable defibrillators (WCDs), external defibrillators, fully implantable subcutaneous cardioverter-defibrillators (SICDs), or mechanical circulatory support devices (MCSs). In other words, how each component works together and how the circuit structure realizes the corresponding function is well known in the art, so it will not be repeated here.

[0100] The medical device of this embodiment uses the pacing control device described above and is primarily intended for patients in life-threatening conditions such as severe bradycardia or cardiac arrest. If the patient's heart rate remains below a preset very low heart rate for a certain period, the device determines that pacing is necessary and initiates pacing at a high pacing frequency, enabling timely and effective pacing to support the patient's life. On the other hand, it significantly avoids unnecessary pacing and pain caused by pacing stimuli during the patient's daily use. In particular, it does not activate pacing in cases of accidental bradycardia, non-severe bradycardia, or transient cardiac arrest, thereby improving the user's acceptance, compliance, and experience with the medical device.

[0101] Although specific embodiments of the present invention have been described above, those skilled in the art will understand that these are merely illustrative descriptions, and various changes and modifications can be made to these embodiments, provided that they do not contradict the principles of the present invention in substance. Therefore, the scope of protection of the present invention is limited by the appended claims.

Claims

1. A heart rate acquisition module for obtaining the patient's actual heart rate, Duration acquisition module, Pacing module and, Including the first decision module, The first decision module determines whether the actual heart rate meets the preset low heart rate conditions. The condition for determining whether the actual heart rate meets the preset low heart rate condition is to determine whether the actual heart rate is below the preset low heart rate, and the preset low heart rate is greater than 0 bpm and 40 bpm or less. If the actual heart rate falls below the preset low heart rate, the duration acquisition module is invoked to obtain the first low heart rate duration during which the patient's heart continues to have an actual heart rate below the preset low heart rate, and It is determined whether the first low heart rate duration has reached a preset low heart rate duration, and the preset low heart rate duration includes being 10 s to 5 min. The first decision module invokes the pacing module to pace the patient's heart at a preset pacing frequency when the first low heart rate duration reaches the preset low heart rate duration, where the preset low heart rate condition is used to indicate that the patient is in a life-threatening condition, and the first low heart rate duration is the time during which the actual heart rate is continuously below the preset low heart rate. A heart rate acquisition module for acquiring the patient's heart rate (number of beats) during the first pacing period, The total number of heartbeats is defined as the patient's heart rate corresponding to a set time, and a total heart rate acquisition module is used to obtain this total heart rate. Includes, Here, the set time includes the first pacing period, and the time corresponding to the set time is equal to the time corresponding to the first pacing period. A ratio calculation module for calculating the ratio of the aforementioned heart rate to the aforementioned total heart rate, A second decision module for determining whether the ratio is greater than or equal to a first set threshold, controlling the cessation of pacing if it is greater than or equal to the first set threshold, determining whether the ratio is less than or equal to a second set threshold, continuing the step of pacing the patient's heart at the preset pacing frequency if it is greater than the second set threshold and less than or equal to the first set threshold, reducing the preset pacing frequency, determining whether the preset pacing frequency is less than the minimum pacing frequency, pacing the patient's heart at the reduced preset pacing frequency if it is less than the minimum pacing frequency, and including, A pacing control device characterized by the following.

2. The pacing control device according to claim 1, characterized in that the preset pacing frequency, the preset low heart rate, and the preset low heart rate duration are parameters that can be reset according to the patient's condition.

3. The pacing control device according to claim 1, characterized in that the preset low heart rate is 10 bpm or more and 30 bpm or less.

4. The pacing control device according to claim 1, characterized in that the preset low heart rate time is 10s to 60s.

5. The pacing control device according to any one of claims 1 to 4, characterized in that the preset pacing frequency is 40 bpm to 80 bpm.

6. A pacing control device according to any one of claims 1 to 5, characterized in that the first setting threshold is 50 to 100%, the second setting threshold is 0 to 30%, and the minimum pacing frequency is 40 bpm to 60 bpm.

7. A medical device characterized by including a pacing control device according to any one of claims 1 to 6.

8. The medical device according to claim 7, characterized in that the medical device includes a wearable cardioverter-defibrillator (WCD), an external cardioverter-defibrillator, a fully implantable subcutaneous cardioverter-defibrillator (SICD), or a mechanical circulatory support device (MCS).

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