阅读说明：本技术 起搏输出k因子改进 (Pace making output K factor improvement ) 是由 A·W·施罗克 J·W·布萨克 K·E·鲍姆加特 M·L·赫兹亚克 J·D·瑞恩克 J·D 于 2018-03-02 设计创作，主要内容包括：一种植入式医疗设备(IMD)包括：保持电容器,所述保持电容器被配置为递送电治疗脉冲；以及电荷泵电路系统,所述电荷泵电路系统被配置为将能量从电池转移到所述保持电容器。所述电荷泵电路系统包括：多个电容器；以及开关电路系统,所述开关电路系统被配置为通过打开和闭合连接到所述多个电容器的开关组合来将所述电荷泵电路系统置于从一组K因子模式中选择的K因子模式下。(An Implantable Medical Device (IMD) comprising: a holding capacitor configured to deliver an electrical therapy pulse; and charge pump circuitry configured to transfer energy from a battery to the holding capacitor. The charge pump circuitry includes: a plurality of capacitors; and switching circuitry configured to place the charge pump circuitry in a K factor mode selected from a set of K factor modes by opening and closing a combination of switches connected to the plurality of capacitors.)

1. An Implantable Medical Device (IMD) comprising:

one or more memory devices;

one or more processing circuits;

a battery;

a holding capacitor configured to deliver an electrical therapy pulse; and

charge pump circuitry configured to transfer energy from the battery to the holding capacitor, wherein the charge pump circuitry comprises:

a plurality of capacitors; and

switching circuitry configured to place the charge pump circuitry in a K factor mode selected from a set of K factor modes by opening and closing a combination of switches connected to the plurality of capacitors, wherein the set of K factor modes includes both a plurality of charging modes and a plurality of pumping modes, wherein the switching circuitry is configured to connect a first capacitor of the plurality of capacitors to the holding capacitor in a first orientation to enter a first charging mode and to connect the first capacitor to the holding capacitor in an opposite orientation from the first orientation to enter a second charging mode.

2. The IMD of claim 1, further comprising:

a two-phase clock configured to drive the charge pump circuitry.

3. The IMD of claim 1 or 2, wherein the one or more memory devices are configured to store a K-factor mode lookup table.

4. The IMD of any of claims 1-3, wherein the one or more processing circuits are configured to:

determining a voltage of the battery;

determining a voltage of the electrical therapy pulse;

determining a K factor mode from the set of K factor modes based on the determined voltage of the battery and the determined voltage of the electrical therapy pulse; and

cause the switching circuitry of the charge pump circuitry to place the charge pump circuitry in the determined K factor mode.

5. The IMD of claim 3, wherein the one or more processing circuits are configured to:

determining that the IMD has entered a high current mode;

in response to determining that the IMD has entered the high current mode, determining a K factor mode from the set of K factor modes based on a default voltage of the battery; and

cause the switching circuitry of the charge pump circuitry to place the charge pump circuitry in the selected K factor mode.

6. The IMD of claims 3 and 4 or claims 3 and 5, wherein to determine the K factor mode from the set of K factor modes, the one or more processing circuits are configured to select the K factor mode from the K factor mode lookup table.

7. The IMD of claim 1, wherein the first charging mode comprises a 0.75-fold charging mode.

8. The IMD of claim 1, wherein the second charging mode comprises a 1.25-fold charging mode.

9. The IMD of claim 1, wherein the charge pump circuitry is configured to operate in a 0.75-fold pumping mode.

10. The IMD of claim 1, wherein the charge pump circuitry is configured to operate in a 1.25-fold pumping mode.

Technical Field

The present disclosure relates to implantable medical devices, and more particularly to implantable medical devices that deliver cardiac pacing.

Background

Various implantable medical devices for delivering therapy or monitoring physiological conditions have been clinically implanted or proposed for clinical implantation into a patient. In some cases, an Implantable Medical Device (IMD) delivers electrical stimulation therapy and/or monitors physiological signals via one or more electrodes or sensor elements, which may be included as part of one or more elongate implantable medical leads. Implantable medical leads may be configured to allow electrodes or sensors to be positioned at desired locations in order to sense or deliver stimulation. For example, an electrode or sensor may be carried at a distal portion of the lead. The proximal portion of the lead may be coupled to an implantable medical device housing, which may contain electronic circuitry such as stimulation generation circuitry and/or sensing circuitry.

For example, an implantable medical device, such as a cardiac pacemaker or implantable cardioverter defibrillator, provides therapeutic stimulation to the heart by delivering electrical therapy signals, such as pulses for pacing, or shocks for cardioversion or defibrillation, via electrodes of one or more implantable leads. In some cases, such implantable medical devices may sense intrinsic depolarizations of the heart and control delivery of such signals to the heart based on the sensing. When an abnormal rhythm is detected (which may be bradycardia, tachycardia or fibrillation), one or more appropriate electrical signals may be delivered to restore the normal rhythm. For example, in some cases, the implantable medical device may deliver a pacing signal, a cardioversion signal, or a defibrillation signal to the patient's heart when ventricular tachycardia is detected and a defibrillation electrical signal to the patient's heart when ventricular fibrillation is detected. Pacing signals typically have lower energy than cardioversion or defibrillation signals.

In some cases, patients with heart failure are treated with Cardiac Resynchronization Therapy (CRT). CRT is a form of cardiac pacing. In some examples, CRT involves the delivery of pacing pulses to both ventricles in order to synchronize their contractions. In other examples, CRT involves the delivery of pacing pulses to one ventricle so that the contraction of the ventricle is synchronized with the contraction of the other ventricle, such as pacing the left ventricle to synchronize its contraction with the contraction of the right ventricle. CRT is one example of various cardiac pacing modes in which stimulation is delivered to one chamber or location at an interval of time before or after an event at another chamber or location. An event at a chamber or location may be the delivery of a pacing pulse to the chamber or location, or the detection of an intrinsic cardiac depolarization at the chamber or location.

In some examples, a first electrode pair delivers a pacing pulse to the chamber and the same or a different electrode pair detects an electrical signal indicative of capture in the chamber (e.g., evoked response). In other examples, the device detects mechanical contraction of the heart at the target site by pacing stimulation as evidence of capturing the heart. In general, capture threshold determination or management involves delivering pacing stimulus at progressively increasing or decreasing amplitudes (e.g., voltage amplitude or current amplitude or pulse width) and identifying the amplitude at which capture or loss of capture occurs.

Drawings

Fig. 1 is a conceptual diagram illustrating an example system that may be used to provide therapy to and/or monitor a patient's heart.

Fig. 2 is a conceptual diagram illustrating an example Implantable Medical Device (IMD) and lead of the system shown in fig. 1 in greater detail.

Fig. 3 is a block diagram illustrating an example configuration of an implantable medical device.

Fig. 4 is a block diagram showing an overview of the charge pump.

Fig. 5A is a schematic diagram illustrating a more detailed implementation of the charge pump of fig. 4.

Fig. 5B shows an example of the operation of the charge pump and non-overlapping pump phases.

Fig. 6 is a table showing the k-factors for each charging mode and pumping mode and the respective switch closures for these modes for implementing the charge pump of fig. 5A.

Fig. 7A-7P illustrate different switch configurations for various modes in which the charge pump of fig. 5A may be configured to implement.

Fig. 8 is a functional datagram illustrating a discharge mode.

Fig. 9 is a flow chart illustrating an example of an algorithm that may be used to select a K factor for a charge pump in accordance with the techniques of this disclosure.

Fig. 9.1, 9.2 and 9.3 are enlarged versions of fig. 9.

FIG. 10 is an example implementation illustrating techniques for the present disclosureBy way of selected pacing amplitude (V)_{Amplitude of vibration}) And a table of minimum supply voltages required for the k-factor.

FIG. 11 is a functional block diagram illustrating an example configuration of the programmer of FIG. 1.

Fig. 12 is a block diagram illustrating an example system including a server and one or more computing devices coupled to the IMD and programmer shown in fig. 1 via a network.

Detailed Description

Cardiac pacemakers provide therapeutic stimulation to the heart by delivering electrical therapy signals, such as electrical pulses for pacing. A charge pump in the cardiac pacemaker delivers pacing pulse energy from the battery to the holding capacitor, and the holding capacitor delivers therapy signals to the heart chamber. The voltage required by the therapy signal to effectively pace the heart may vary from patient to patient as well as from the patient's chamber. The voltage required to effectively pace the heart may vary over time, even within the same chamber of the same patient. In addition, the output voltage of a battery in a pacemaker typically varies with time.

The charge pump supplies a voltage to the holding capacitor equal to the battery voltage multiplied by the K factor. The relationship between the battery voltage and the charge pump voltage is shown by the following equation 1, and the relationship between the battery current and the charge pump current is shown by the following equation 2.

V_{Charge pump}＝V_{Battery with a battery cell}×K_Factor(s) (1)

I_{Battery with a battery cell}＝I_{Charge pump}×K_Factor(s) (2)

The K factor may be less than, equal to, or greater than 1. For example, a 3V battery produces a pacing voltage of 1V at a K-factor of 1/3 without any system losses. As another example, a 3V battery produces a pacing voltage of 4.5V at a K-factor of 3/2 without any system losses. The charge pump typically outputs a voltage that is higher than the target pacing voltage. Thus, higher pacing voltages require a higher K-factor, while lower pacing voltages require a lower K-factor.

For a typical pacemaker, the current from the battery for pacing is the most important load on the battery, particularly for CRT, heart failure patients who pace at a large percentage of time and at relatively high voltages. The most efficient K-factor (i.e., the K-factor that minimizes battery drain and maximizes battery life) is the K-factor that provides the required pacing output voltage for the minimum current. For example, without any system losses, a pacing voltage of 1V may be generated from a 3V battery with a K factor of 1/3, resulting in a reduction in the current drain of the battery to 1/3 compared to charging the hold capacitor directly from the battery.

In view of the above-described pacing voltage variations and battery voltage variations, charge pumps are typically designed to operate in a plurality of discrete modes, where each mode corresponds to a different K-factor. In the prior art, the number of modes (i.e., the number of K-factor ratios) is typically limited, largely due to the added capacitor components and IC switches required to implement these ratios in the charge pump circuitry. An advantage of having an increased mode is the ability to use a K-factor that more closely matches the output pacing voltage to the available battery voltage, potentially reducing current drain on the battery and thus increasing battery life.

Typically, the charge pump is configured to implement the increments of¹/₂In the range of¹/₂To a K factor of 4. The charge pump architecture of the present disclosure is designed to achieve a larger number of k-factor multipliers than previous architectures while minimizing the number of external components required. More specifically, the present disclosure describes techniques for adding 0.75-fold and 1.25-fold K-factors. The techniques of this disclosure utilize a 2-phase clock to provide increased ratios with minimal additional capacitors or added clock phases. About 2.0V is a common pacing voltage. A new battery may have an output voltage slightly above 3.0V, where the output voltage remains above 2.8V during most of the battery's life, making 0.75 times the preferred K-factor for many common pacing scenarios. As the battery ages, the output voltage may drop sufficiently, so the remaining battery capacity requires a K factor of 1.25. Thus, the added K-factors of 0.75 and 1.25 times can achieve a considerably larger K-factor than existing charge pumps that provide only K-factors of 1.0, 1.5 and 2.0 timesBattery current consumption savings and increased life.

This disclosure also describes techniques for implementing automatic switching of the K-factor based on the charged hold capacitor voltage. By minimizing the battery current by selecting the minimum k-factor multiplier that will still achieve the target pacing voltage, more k-factors can achieve better current drain optimization.

Fig. 1 is a conceptual diagram illustrating an example system 10 that may be used to monitor a heart 12 of a patient 14 and/or provide therapy to the heart of the patient. The patient 14 is typically, but not necessarily, a human. System 10B includes IMD16 coupled to leads 18, 20, and 22 and programmer 24. IMD16 may be, for example, an implantable pacemaker, cardioverter, and/or defibrillator that provides electrical signals to heart 12 via electrodes coupled to one or more of leads 18, 20, and 22.

Leads 18, 20, 22 extend into heart 12 of patient 16 to sense electrical activity of heart 12 and/or deliver electrical stimulation to heart 12. In the example shown in fig. 1, Right Ventricular (RV) lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and right atrium 26 and into right ventricle 28. Left Ventricular (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of left ventricle 32 of heart 12. Right Atrial (RA) lead 22 extends through one or more veins and the vena cava, and into right atrium 26 of heart 12. The techniques of this disclosure are not limited to IMDs having a particular number of leads and may be implemented in devices using more or fewer leads. For example, the techniques of this disclosure may also be implemented in single or dual chamber devices that use fewer leads than IMD 16. The techniques of this disclosure may also be implemented in an extravascular device that does not use a lead in the heart and uses only a subcutaneous or substernal lead. The techniques of this disclosure may also be implemented in an intracardiac device, such as a transcatheter pacemaker, that lacks a lead extending from the device.

IMD16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes (not shown in fig. 1) coupled to at least one of leads 18, 20, 22. In some examples, IMD16 provides pacing pulses to heart 12 (e.g., for bradycardia pacing (CRT), or anti-tachycardia pacing (ATP)) based on electrical signals sensed within heart 12. The configuration of electrodes used by IMD16 for sensing and pacing may be unipolar or bipolar. IMD16 may also provide defibrillation therapy and/or cardioversion therapy via electrodes located on at least one of leads 18, 20, 22. IMD16 may detect arrhythmias of heart 12, such as fibrillation of ventricles 28 and 32, and deliver defibrillation therapy to heart 12 in the form of electrical pulses. In some examples, IMD16 may be programmed to deliver a progression of therapy, e.g., pulses with elevated energy levels, until fibrillation of heart 12 ceases. IMD16 detects fibrillation using one or more fibrillation detection techniques known in the art.

In some examples, programmer 24 may be a handheld computing device or a computer workstation. A user (such as a physician, technician, or other clinician) may interact with programmer 24 to communicate with IMD 16. For example, a user may interact with programmer 24 to retrieve physiological or diagnostic information from IMD 16. A user may also interact with programmer 24 to program IMD16, e.g., select values for operating parameters of the IMD.

For example, a user may use programmer 24 to retrieve information from IMD16 regarding the rhythm of heart 12, trends in the heart rhythm over time, or arrhythmic events. As another example, the user may use programmer 24 to retrieve information from IMD16 regarding other sensed physiological parameters of patient 14, such as intracardiac or intravascular pressure, activity, posture, respiration, or thoracic impedance. As another example, a user may retrieve information from IMD16 regarding the performance or integrity of IMD16 or other components of system 10 (e.g., leads 18, 20, and 22 or a power source of IMD 16) using programmer 24. The user may use programmer 24 to program therapy progression, select electrodes for delivering defibrillation pulses, select waveforms for defibrillation pulses, or select or configure a fibrillation detection algorithm for IMD 16. The user may also use programmer 24 to program aspects of other therapies provided by IMD14, such as cardioversion therapies or pacing therapies.

IMD16 and programmer 24 may communicate via wireless communication using any technique known in the art. Examples of communication techniques may include, for example, low frequency or Radio Frequency (RF) telemetry, although other techniques are also contemplated. In some examples, programmer 24 may include a programming head that may be placed proximate to the patient's body near the IMD16 implantation site in order to improve the quality or safety of communication between IMD16 and programmer 24.

Fig. 2 is a conceptual diagram illustrating IMD16 and leads 18, 20, and 22 of therapy system 10 in greater detail. Leads 18, 20, 22 may be electrically coupled to signal generator and sensing circuitry of IMD16 via connector block 34.

Each of the leads 18, 20, 22 includes an elongated insulated lead body carrying one or more conductors. Electrodes 40 and 42 are positioned adjacent the distal end of lead 18, and electrodes 48 and 50 are positioned adjacent the distal end of lead 22. In some example configurations, lead 20 may be a quadrupolar lead, and thus include four electrodes, electrodes 44A-44D, positioned adjacent to the distal end of lead 20. Electrodes 40, 44A through 44D and 48 may take the form of ring electrodes, and electrodes 42 and 50 may take the form of extendable helix tip electrodes mounted retractably within insulative electrode heads 52 and 56, respectively.

Leads 18 and 22 also include elongated intracardiac electrodes 62 and 66, respectively, which may take the form of coils. Additionally, one of the leads 18, 20, 22 (e.g., lead 22 as seen in fig. 2) may include a Superior Vena Cava (SVC) coil 67 for delivering electrical stimulation (e.g., transvenous defibrillation). For example, lead 22 may be inserted through the superior vena cava, and SVC coil 67 may be placed, for example, in the right atrium/SVC junction (low SVC) or the left subclavian vein (high SVC). Each electrode 40, 42, 44A-44D, 48, 50, 62, 66, and 67 may be electrically coupled to a corresponding conductor within the lead body of its associated lead 18, 20, 22, and thereby be individually coupled to signal generator and sensing circuitry of IMD 16.

In some examples, as illustrated in fig. 2, IMD16 includes one or more housing electrodes (such as housing electrode 58) that may be integrally formed with an outer surface of hermetic housing 60 of IMD16 or otherwise coupled to housing 60. In some examples, housing electrode 58 is defined by an uninsulated portion of an outward facing portion of housing 60 of IMD 16. Other distinctions between insulated and non-insulated portions of the housing 60 may be employed to define two or more housing electrodes. In some examples, the housing electrode 58 includes substantially all of the housing 60.

IMD16 may sense electrical signals attendant to the depolarization and repolarization of heart 12 via electrodes 40, 42, 44A-44D, 48, 50, 58, 62, 66, and 67. These electrical signals are conducted to IMD16 via corresponding leads 18, 20, 22, or in the case of housing electrode 58, via conductors coupled to the housing electrode. IMD16 may sense such electrical signals via any combination of electrodes 40, 42, 44A-44D, 48, 50, 58, 62, 66, and 67. Further, any of the electrodes 40, 42, 44A-44D, 48, 50, 58, 62, 66 and 67 may be used in combination with the housing electrode 58 for unipolar sensing.

In some examples, IMD16 delivers pacing pulses via a combination of electrodes 40, 42, 44A through 44D, 48, and 50 to produce depolarization of cardiac tissue of heart 12. In some examples, IMD16 delivers pacing pulses via any one of electrodes 40, 42, 44A-44D, 48, and 50 in combination with housing electrode 58 in a unipolar configuration. For example, RV pacing may be delivered to heart 12 using electrodes 40, 42, and/or 58. Additionally or alternatively, LV pacing may be delivered to heart 12 using electrodes 44A-44D and/or 58, and RA pacing may be delivered to heart 12 using electrodes 48, 50, and/or 58.

Furthermore, IMD16 may deliver defibrillation pulses to heart 12 via any combination of elongate electrodes 62, 66, and 67 and housing electrode 58. Cardioversion pulses may also be delivered to heart 12 using electrodes 58, 62, and 66. Electrodes 62, 66 and 67 may be made of any suitable electrically conductive material, such as, but not limited to, platinum alloys, or other materials known to be useful in implantable defibrillation electrodes.

The configuration of the therapy system 10 illustrated in fig. 1 and 2 is merely one example. In other examples, the treatment system may include epicardial leads and/or patch electrodes instead of or in addition to the transvenous leads 18, 20, 22 illustrated in fig. 1 and 2. Further, IMD16 need not be implanted within patient 14. In examples where IMD16 is not implanted within patient 14, IMD16 may deliver defibrillation pulses and other therapies to heart 12 via a percutaneous lead that extends through the skin of patient 14 to various locations within or outside heart 12.

Additionally, in other examples, the therapy system may include any suitable number of leads coupled to IMD16, and each lead may extend to any location within or adjacent to heart 12. For example, other examples of treatment systems may include three transvenous leads positioned as illustrated in fig. 1 and 2, and additional leads positioned within or adjacent to the left atrium 36. Further, in some examples, the therapy system includes a leadless (e.g., transcatheter and/or intracardiac) pacemaker configured to deliver pacing pulses to the heart without a lead, e.g., via an electrode formed on or as part of its housing. Such leadless pacemakers may be configured to implement the pacing circuitry and techniques described herein.

Fig. 3 is a block diagram illustrating one example configuration of IMD 16. The techniques of this disclosure are not limited to a particular type of IMD, and may be implemented as a variety of IMDs, including IMDs that include features not described with respect to IMD16, as well as IMDs that do not include certain features of IMD 16. For example, although IMD16 is an intravascular IMD, the techniques of the present disclosure may also be implemented in an extravascular IMD.

In the example illustrated in fig. 3, IMD16 includes a battery 78, a processor 80, a memory 82, a signal generator 84, inductive circuitry 86, and telemetry circuitry 88. IMD16 further includes capture detection circuitry 90, which itself includes evoked response detection circuitry 94 and timer circuitry 96. Memory 82 may include computer readable instructions that, when executed by processor 80, cause IMD16 and processor 80 to perform various functions attributed throughout this disclosure to IMD16, processor 80, or capture detection circuitry 90. The computer readable instructions may be encoded within the memory 82. The memory 82 may include computer-readable storage media including any volatile, non-volatile, magnetic, optical, or electrical media, such as Random Access Memory (RAM), read-only memory (ROM), non-volatile RAM (nvram), electrically erasable programmable ROM (eeprom), flash memory, or any other digital media.

Battery 78 supplies energy to IMD16, including energy used to generate pacing signals. Although battery 78 is shown in fig. 3 as being connected to signal generator 84 only, it should be understood that battery 78 may provide all of the power for all of the functions of IMD 16.

The processor 80 may comprise any one or more of a microprocessor, controller, Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA), or equivalent discrete or integrated logic circuitry. In some examples, processor 80 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processor 80 herein may be embodied as software, firmware, hardware, or any combination thereof. In one example, capture detection circuitry 90, evoked response detection circuitry 94, and timer circuitry 96 may be stored or encoded as instructions in memory 82 that are executed by processor 80.

Processor 80 controls signal generator 84 to deliver stimulation therapy, such as cardiac pacing or CRT, to heart 12 according to the selected one or more therapy programs, which may be stored in memory 82. Signal generator 84 is electrically coupled to electrodes 40, 42, 44A-44D, 48, 50, 58, 62, and 66, for example, via conductors of corresponding leads 18, 20, 22, or, in the case of housing electrode 58, via electrical conductors disposed within housing 60 of IMD 16. Signal generator 84 is configured to generate and deliver electrical stimulation therapy to heart 12 via selected combinations of electrodes 40, 42, 44A-44D, 48, 50, 58, 62, and 66. In some examples, signal generator 84 is configured to deliver cardiac pacing pulses. In other examples, signal generator 84 may deliver pacing or other types of stimulation in the form of other signals, such as sine waves, square waves, or other substantially continuous time signals.

Signal generation circuitry 84 may include, for example, voltage conversion circuitry, charge pump circuitry, and one or more capacitors, for example, for delivering pacing pulses. Signal generator 84 may also include switching circuitry (not shown) and processor 80 may use the switching circuitry to select (e.g., via a data/address bus) which of the available electrodes are used to deliver pacing pulses. The processor 80 may also control which of the electrodes 40, 42, 44A-44D, 48, 50, 58, 62 and 66 is coupled to the signal generator 84 for generating stimulation pulses, e.g., via switching circuitry. The switching circuitry may include a switch array, a switch matrix, a multiplexer, or any other type of switching device suitable for selectively coupling signals to selected electrodes.

Electrical sensing circuitry 86 monitors signals from at least one of electrodes 40, 42, 44A-44D, 48, 50, 58, 62, or 66 to monitor electrical activity of heart 12. The electrical sensing circuitry 86 may include, for example, filters and amplifiers to condition the electrical signals sensed at the electrodes and/or to detect particular characteristics within the signals. The electrical sensing circuitry 86 may also include switching circuitry to select which of the available electrodes are used to sense cardiac activity. In some examples, processor 80 selects an electrode or sensing vector to act as a sensing electrode via switching circuitry within electrical sensing circuitry 86.

Electrical sensing circuitry 86 includes a plurality of detection channels, each of which may be selectively coupled to a corresponding combination of electrodes 40, 42, 44A-44D, 48, 50, 58, 62, or 66 in order to detect electrical activity of a particular chamber of heart 12. Each detection channel may include an amplifier that outputs an indication to processor 80 in response to detecting an event, such as a depolarization in a corresponding chamber of heart 12. In this manner, processor 80 may detect the occurrence of R-waves and P-waves in the various chambers of heart 12.

Memory 82 stores intervals, counters, or other data used by processor 80 to control signal generator 84 to deliver pacing pulses. Such data may include intervals and counters used by processor 80 to control the delivery of pacing pulses to one or both of the left and right ventricles for CRT. In some examples, these intervals and/or counters are used by processor 80 to control the timing of the delivery of pacing pulses relative to, for example, intrinsic or pacing events in another chamber.

In one example, capture detection circuitry 90 uses signals from electrical sensing circuitry 86 to detect capture and/or insufficient capture when signal generator 84 delivers a pacing pulse. Via switching circuitry, processor 80 may control which of electrodes 40, 42, 44A-44D, 48, 50, 58, 62, and 66 is coupled to electrical sensing circuitry 86 to detect an evoked response after delivery of a pacing pulse to a chamber (e.g., the LV) in order to determine whether the pacing pulse captured the chamber. Memory 82 may store predetermined intervals or voltage thresholds that define whether the detected signal has sufficient amplitude and is properly timed with respect to the pacing pulse to be considered an evoked response. In some examples, the channel of inductive circuitry 86 used to detect capture includes an amplifier that provides an indication to processor 80 when the detected signal has sufficient amplitude.

Processor 80 controls the selection of electrode configurations for delivering pacing pulses and for detecting capture and/or loss of capture. For example, processor 80 may communicate with signal generator 84 to select two or more stimulation electrodes in order to generate one or more pacing pulses for delivery to a selected chamber of heart 12. Processor 80 may also communicate with electrical sensing circuitry 86 to select two or more sensing electrodes for capture detection based on the chamber to which the pacing pulse is delivered by signal generator 84.

In the example of fig. 3, capture detection circuitry 90 is capable of detecting capture and LOC during a capture detection test. Capture detection circuitry 90 uses timer circuitry 96 to determine when to deliver a pacing pulse. Additionally, as seen in fig. 3, capture detection circuitry 90 further includes evoked response detection circuitry 94 for detecting the amplitude and timing of the evoked response.

Using certain techniques of this disclosure, capture detection circuitry 90 may determine a pacing capture threshold for each of a plurality of pacing vectors by delivering pacing pulses at various voltage levels and determining the voltage at which capture/loss of capture (LOC) occurs for each of the vectors.

The signal generator 84 may include a charge pump in accordance with the techniques of this disclosure. Fig. 4 shows an example of a charge pump 100 that may be included in the signal generator 84. Charge pump 100 is connected to battery 78 and is at C_HoldingProduces an output voltage equal to the voltage of the battery 78 multiplied by a factor K.

Fig. 5A illustrates a more detailed implementation of the charge pump 100 in accordance with the techniques of this disclosure. Charge pump 100 is connected to battery 78 and to hold capacitor 104 (C)_Holding104) An output voltage is delivered. The charge pump 100 includes capacitors CP1, CP2, CP3, and CP4, and switches S1 to S20. It should be appreciated that fig. 5A represents a simplified version of an actual charge pump for ease of illustration. For example, in real world implementations, C_Holding104 may actually be implemented as four holding capacitors, with any switch (any of switches S1-S20) implemented as four switches between the common node and the respective holding capacitors. The four holding capacitors may correspond to four chambers of the heart, such as the atrium (a), Right Ventricle (RV), Left Ventricle (LV), and holder (S). A holder (S) holding capacitor may sometimes be used in parallel with another holding capacitor to provide a higher current capacity during fast pacing demands, such as ATP, and in cases where a fourth amplitude value different from the amplitude value in the pacing chamber is required, such as during higher amplitude backup pacing during a pacing threshold test. For single-chamber equipment or dual chambersChamber equipment, less than four holding capacitors may be used. In addition, C_HoldingThe forward connector of 104 may be connected to VSS and B via a switch not explicitly shown in FIG. 5A_plus。

The holder capacitor may be configured to pace through the switch matrix to any other chamber. One purpose of the holder capacitor is: during RV capture management, IMD16 may perform 3 pacing steps on the holder capacitor through the RV lead, followed by a test pace on the RV hold capacitor, followed by a backup step on the holder capacitor. One purpose of the sequence is to make the holder voltage high enough to ensure capture of cardiac tissue while varying the test pacing amplitude during the capture routine to determine the voltage at which capture occurs or is lost. If the test pace does not capture the heart, then the purpose of the backup pace is to capture the heart. If the test pace did capture the heart, the backup pace occurs during the refractory interval so the backup pace does not capture the myocardium or begin another pace.

Fig. 6 shows a table that demonstrates the k-factor for each charging mode and pumping mode and the corresponding switch closures of the charge pump 100 of fig. 5A. In the table of fig. 6, X means that the switches of the corresponding column are closed when the mode of the corresponding row is implemented. The score in the pattern name represents the K factor of this pattern. For example, pumping mode A1/2 times corresponds to a K factor of¹/₂Pumping mode a. As another example, pumping pattern B4 times corresponds to pumping pattern B with a K-factor of 4.

The charge pump 100 is configured to operate in two primary modes (referred to herein as mode a and mode B), where each primary mode has a plurality of sub-modes, and each sub-mode corresponds to a different K-factor. Mode a is designed to have more fractional k-factors but a lower maximum multiplier (i.e., 3 times in fig. 6). Mode B has a higher maximum multiplier (4 times in fig. 6) but has fewer fractional values. While mode a may generally provide improved battery life, some patients may require mode B if one of their four heart chambers requires 7/2 times or 4 times the K-factor to provide sufficient pacing voltage.

The charge pump 100 may also operate in a direct mode (CM _1x) implemented by a set of individual switches that charge the holding capacitor directly from the BPLUS. Since the charge pump is shared between the pacing hold capacitors, the charging modes are mutually exclusive, i.e., all pacing hold capacitor charging must be done in the same charging mode and the k-factor must be selected from such charging modes. Because the voltage on the pump capacitor may need to change at a high rate, switching between charge mode a and charge mode B on a chamber-by-chamber basis may waste current due to charge transfer that may occur as a result of the switching between charge modes.

As a further illustration of the charging mode, all modes of charging mode a are compatible, so if one capacitor requires a k-factor of 3/4 times and the other one 5/4 times, the charge pump does not consume additional current. Further, the 1-time charging mode may be used together with the charging mode a or the charging mode B.

The charge pump 100 operates with a pacing output capDAC amplitude comparator to pump and monitor the voltage on the hold capacitor. During the initial pumping time, the charge pump 100 may be in a "fast" mode (e.g., 2kHz or 8kHz pumping clock) until the voltages of all holding capacitors are met. The charge pump 100 may then enter a maintenance mode (e.g., 256Hz pump clock) to maintain the voltage.

The purpose of a pacing charge pump is to efficiently generate a regulated voltage on a pacing hold capacitor, which is then used to deliver (current) energy to the heart via an output circuit switch. The pacing charge pump may include a capacitive charge pump as shown in fig. 5A for generating a voltage proportional to the battery voltage, the 1x charge and discharge switch, and the pacing amplitude comparator. The pacing amplitude comparator indicates when the holding capacitor is fully charged to turn off the charge pump to prevent excessive voltage from being applied across the holding capacitor. The pacing charge pump is implemented with 4 hold capacitors (LV) that can each be programmed to different pacing amplitudes_{c hold}、A_{c hold}、RV_{c hold}And S_{c hold}) And multiplexing between them.

The charge pump 100 is configured to operate in both a charging mode and a pumping mode. The charging mode corresponds to a first phase in which the switch on the battery is closed to the holding capacitor. The pumping mode corresponds to a second phase in which the pump capacitor is connected to the holding capacitor.

Fig. 5A shows a charge pump switch matrix structure. Note that C_HoldingRepresents one or more (e.g., four) holding capacitors, and any switches connected to the holding capacitors represent one or more (e.g., four) switches between a common node and the respective holding capacitors: atrium (a), Right Ventricle (RV), Left Ventricle (LV), and holder (S). Fig. 6 shows the k-factor and the corresponding switch closure for each charging mode and pumping mode. CP 1-CP 4 represent 4 pacing charge pump capacitors. In one embodiment of the charge pump 100, the capacitance of CP 1-CP 3 is 100nF, and the capacitance of CP4 is 470nF, although many capacitance values may also be used.

The basic switching clock for the pacing charge pump may be referred to as CP _ CLK. The charging phase of the circuit is in phase with CP _ CLK, while the pumping phase is out of phase with CP _ CLK. The non-overlapping clock generator is used to generate non-overlapping CHG and PMP signals from CP _ CLK. The non-overlap prevents crowbar current between BPLUS and VSS (e.g., ground) through the charge pump switch. Although the frequency of the clock may not be specified, each duty cycle phase generally needs to be of sufficient duration to transfer the entire charge through each phase. The frequency needs to be large enough to complete the entire charge transfer. Also, the voltage driving the switch needs to be greater than the pumping or holding voltage to ensure that the switching function has a minimum switching impedance. The pumping frequency can be adjusted to provide higher rate and higher voltage therapy, such as ATP. ATP typically requires a maximum pacing energy that is substantially limited by battery output impedance, switch impedance, and charge transfer duration.

The signal names in the table of fig. 6 indicate that the switch is closed and whether the switch is used in the charging mode or the pumping mode. For example, S4C represents control of pacing charge pump switch 4 in charging mode. The switch control signal is anded with the corresponding CHG signal or PMP signal. If the switch can be active in either the charging mode or the pumping mode, the ANDed signals are ORed together to drive the switch control signal. Note that the or of the and can be done using only NAND gates as DeMorgan equivalent functions.

Controlling the switches in this manner allows both the charging mode and the pumping mode to be set, and allows only CP _ CLK to be triggered during a set of charging intervals of the holding capacitor. Due to the non-overlapping clocks, the switches operate in "break before make" mode, so that the time for which all switches are open at the transition from charging mode to pumping mode and from pumping mode to charging mode occurs is short. All switch drive signals are level shifted to drive the final MOSFET switch.

Fig. 5B shows an example of the operation of the charge pump and non-overlapping pump phases. FIG. 5B shows the capacitor C being held_hAn example of 2 times the voltage. During phase 1(F1), S1 and S2 are closed, which closes C_pFrom V_{Battery with a battery cell}Is connected to ground. During phase 2(F2), S3 and S4 are closed, which transfers charge to C_h. Maximum voltage (V) that can be generated_ch) Twice the battery voltage.

The clock phases Phi 1 and Phi 2 cannot be active simultaneously, so they are implemented as non-overlapping clocks. Below the circuit diagram in fig. 5B, the clock CP _ CLK is used to generate charge (chg) and pump (pmp). The CHARGE phase corresponds to PHI 1 and the PUMP phase corresponds to PHI 2. FIG. 5B also shows C when charge is transferred from the pump capacitor to the hold capacitor_HoldingHow the voltage (measured across the capacitor) increases. The time constant of each step is caused by the effective capacitance and resistance of the switch. When C is present_hThe number of steps is greatest when the voltage across is small, since almost all the charge is from C_pTransfer to C_h. With C_hIncreasing, less charge is transferred and the step size is decreased. This goes into the quantization step in the description. If several hundred steps are combined together, the step size of each step is reduced, and the entire envelope looks like the order of the RC charge curveLadder version, where R is a function of the effective pump capacitance and frequency (which is all taus in the description).

Fig. 7A-7P illustrate various modes in which the charge pump 100 may be configured to implement. In other words, fig. 7A-7P illustrate the operation of the charge pump 100 with different switch configurations corresponding to different modes.

During times when pacing is not being delivered using the hold capacitor, the top plate of the hold capacitor is connected to the BPLUS through a low impedance switch (approximately 5 to 20 ohms). The 1-fold charge pumping mode "pumps" the hold capacitor using a PMOS FET switch connected in series between the hold capacitor bottom plate and VSS. The size of the 1x series charge switch is adapted to each charge pump operating clock frequency (256Hz, 2048Hz, and 8192Hz) so that the quantization error at each frequency is similar to the previous Brady platform with capture management functionality. The charge time constant is the hold capacitor times the effective switch impedance. The effective switch impedance is the switch "on" impedance divided by the switch duty cycle. For a 50% duty cycle, the effective switch impedance is 2 times the switch "on" impedance.

Fig. 7A is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set (i.e., opened or closed) to implement charge mode a. In charge mode A (e.g., FIG. 7A), CP1 and CP2 are connected in series across BPLUS, charging each capacitor to 1/2B_plus. During charging, CP4 is connected across BPLUS to obtain the full 1-fold B_plus. The CP3 is only used for CMA _3_4_ x (0.75 times) and CMA _5_4_ x (1.25 times) pumping modes in mode a, so for these pumping modes the CP3 is connected to the hold capacitor, as shown in fig. 7A. When the voltage on the hold capacitor approaches zero, CP3 will quickly charge to near full B_plusVoltage because the capacitance of CP3 is 100 times lower than the holding capacitor. When the holding capacitor is charged, CP3 charges to a lower voltage until steady state B is 1/4 times_plus. For other charging mode a configurations, CP3 is not used.

Fig. 7B is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement charge mode B. In charging mode B, CP1 and CP2 are connected in seriesConnected across the BPLUS such that each capacitor is charged to 1/2B across_plus. During charging, CP3 and CP4 were connected across BPLUS to obtain a full 1-fold B_plus。

Fig. 7C is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the charging mode a 1/2 times. For the CMA 1/2 times pumping mode, CP1 and CP2 are connected in parallel to the holding capacitor as shown in FIG. C. The estimated hold capacitor voltage is shown by equation 3 below.

Fig. 7D is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode a 3/4. For the CMA 3/4-fold pumping mode, CP1 and CP2 are connected in parallel and in series with CP3 across the holding capacitor, as shown in fig. 7D. The estimated hold capacitor voltage is shown by equation 4 below.

The factor "m" in the denominator of the time constant is due to the connection of CP3 to the hold capacitor during the charging phase, which effectively pumps the hold capacitor during this time. Since the hold capacitor is "pumped" during both phases, the overall time constant is the combination of the parallel/series pump capacitor seen in fig. 7D and CP3 seen only in fig. 14, with hold capacitor charging occurring on both clock phases. When two phases are used, the effective impedance of CP3 is half the effective impedance of a single-phase pump. In some embodiments, "m" may be equal to 4.

Fig. 7E is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode a 5/4. For the CMA 5/4-fold pumping mode, CP1 and CP2 are connected in parallel and in series with CP3 across the holding capacitor, as shown in fig. 7E. The estimated hold capacitor voltage is shown by equation 5 below.

The factor "m" in the denominator of the time constant is due to the connection of CP3 to the hold capacitor during the charging phase, which effectively pumps the hold capacitor during this time. Since the hold capacitor is "pumped" during both phases, the overall time constant is the combination of the parallel/series pump capacitor seen in fig. 7D and CP3 just as seen in fig. 7A, with hold capacitor charging occurring on both clock phases. When two phases are used, the effective impedance of CP3 is half the effective impedance of a single-phase pump. For this design, "m" is 4. The pump phase shows how a k-factor greater than 1 times introduces the pump capacitor to VSS.

For both the 3/4-fold mode and the 5/4-fold mode described above, the hold capacitor is "pumped" during both the charging phase and the pumping phase, or alternatively, the hold capacitor becomes the charging voltage of CP 3. This applies to 3/4 times and 5/4 times, where only the configuration of CP3 differs during the charging phase. Using a two-phase clock enables more pumping per unit time, and thus faster charging of the holding capacitor. When sharing a charge pump, fast charging may be desirable, especially when the pacing rate increases and the time between paces decreases.

Fig. 7F is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode a 3/2 times. For the CMA 3/2 times pumping mode, CP1 and CP2 are connected in parallel to the holding capacitor as shown in FIG. 7F. The estimated hold capacitor voltage is shown by equation 6 below.

Fig. 7G is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode A2 times. For the CMA 2-fold pumping mode, the series combination of CP1 and CP2 is connected to the holding capacitor in parallel with CP4, as shown in FIG. 7G. The estimated hold capacitor voltage is shown by equation 7 below.

Fig. 7H is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode a 5/2 times. For the CMA 5/2-fold pumping mode, the parallel combination of CP1 and CP2 is connected to the holding capacitor in series with CP3, as shown in fig. 7H. The estimated hold capacitor voltage is shown by equation 8 below.

Fig. 7I is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode A3 times. For the CMA 3-fold pumping mode, the series combination of CP1, CP2, and CP3 is connected to the hold capacitor, as shown in FIG. 7I. The estimated hold capacitor voltage is shown by equation 9.

Fig. 7J is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B1/2. For the CMB 1/2 times pumping mode, CP1 and CP2 are connected in parallel to the holding capacitor, as shown in FIG. 7J. The estimated hold capacitor voltage is shown in equation 10 below.

Fig. 7K is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B3/2. For the CMB 3/2 times pumping mode, CP1 and CP2 are connected in parallel to the holding capacitor as shown in FIG. 7K. The estimated hold capacitor voltage is shown by equation 11 below.

Fig. 7L is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B2 times. For CMB 2 times pumping mode, CP3 and CP4 are connected in parallel to the hold capacitor, as shown in FIG. 7L. The estimated hold capacitor voltage is shown by equation 12 below.

Fig. 7M is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B5/2. For the CMB 5/2-fold pumping mode, the parallel combination of CP1 and CP2 is connected to the holding capacitor in series with CP4, as shown in FIG. 7M. The estimated hold capacitor voltage is shown by equation 13 below.

Fig. 7N is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B3 times. For the CMB 3-fold pumping mode, the series combination of CP3 and CP4 is connected to the hold capacitor, as shown in FIG. 7N. The estimated hold capacitor voltage is shown by equation 14 below.

Fig. 7O is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B7/2. For the CMB 7/2-fold pumping mode, the parallel combination of CP1 and CP2 is connected to the holding capacitor in series with CP3 and CP4, as shown in FIG. 7O. The estimated hold capacitor voltage is shown by equation 15 below.

Fig. 7P is a functional diagram illustrating the operation of the charge pump 100 when the switches of the charge pump 100 are set to implement the pumping mode B4 times. For the CMB 4-fold pumping mode, CP1, CP2, CP3, and CP4 are connected in series to the holding capacitor, as shown in FIG. 7P. The estimated hold capacitor voltage is shown by equation 16 below.

Fig. 8 is a functional datagram illustrating a discharge mode. It is sometimes desirable to discharge the hold capacitor to a lower pacing voltage. The hold capacitor discharges during the normal "pumping" window and continues to discharge (e.g., Sd and Shp are closed) until the pacing amplitude comparator determines C_HoldingThe voltage is at an acceptable voltage level. The discharge switch may be clocked like the other pump switches, so that measurements may be taken between each discharge "pump".

The magnitude of the voltage step on the pacing hold capacitor due to the "pumping" phase may be important because the voltage step is the maximum value that the hold capacitor should exceed its intended pacing amplitude target. The pacing amplitude comparator measures the holding capacitor when it is not being pumped (particularly the "charging" phase of the pump capacitor) and expects the voltage to be stable during this measurement, and then determines whether additional pumping is needed based on this measured voltage. Thus, if the amplitude is just below the voltage required to trigger the (trip) comparator, the hold capacitor will receive one additional pump before the target amplitude is reached. The expected quantization voltage set for each K factor is determined by the following equation 17.

Wherein:

C_{pump and method of operating the same}Effective pump capacitance set for the charge pump k-factor (see time constant in the k-factor description, multiplier of frequency in denominator is effective pump capacitance)

C_HoldingPacing hold capacitance.

Pacing k factor multiplier

V_bplusBattery voltage.

V_{c hold}The pacing before being "pumped" maintains the capacitor voltage.

The worst case quantization step occurs at the minimum pacing amplitude setting for a particular k-factor.

One potential design goal of a pacing charge pump switch is a sufficiently low impedance such that the voltage during the charging phase and the pumping phase has stabilized during the charging interval or the pumping interval. This means that any impedance calculation or time constant calculation can be based only on the capacitor value and the clock frequency without having to take into account incomplete charge transfer. The individual switches are grouped in the following by embodiment and identified according to the switch number, as shown in fig. 5A.

Switches S1, S15, and S19 connect the charge pump capacitor to B_plus. Switches S2, S6, S9, S13, S16, and S18 connect the charge pump capacitor to VSS. For example, these switches may be made up of larger HV PMOS switches whose gates are driven to BPLUS to turn off and to N3VDD to turn on. During the ATP boost mode, which may increase the pacing pulse amplitude and/or frequency, another larger PMOS switch is coupled in parallel to lower the switch impedance.

Switches S3, S4, S5, S10, S11, S14, and S20 connect the charge pump capacitors to each other. The switch is an array of ballasted NMOS switch elements (identical to the pacing switch elements) that are turned on by driving their gate voltage to the BPLUS/VDD supply voltage and turned off by driving their gate voltage to the N3VDD of the switch element or the lower supply voltage of the well. The well itself uses the well switching function of the switching element to select the lowest voltage of the switch terminals. During the ATP boost mode, another switching element is connected in parallel to reduce the switching impedance.

Switches S7, S8, S12, and S17 connect the charge pump capacitor to the holding capacitor. At each switch position shown in fig. 5A, there is a separate switch for each holding capacitor. For example, S7 connects the CP2 bottom plate to the bottom plate of the holding capacitor. Each switch is designated by the holding capacitor to which it is connected, such as S7A, S7RV, S7LV, and S7S for the atrial capacitor, right ventricular capacitor, left ventricular capacitor, and holder holding capacitor, respectively.

The switches may use the same configuration as cross-coupled switches. During the ATP boost mode, another larger switching element is coupled in parallel with S17 to reduce the switching impedance.

The charge pump 100 can operate under a variety of use conditions. Examples of such use conditions are normal pacing, capture management, and high current conditions such as charging, ATP, or telemetry. In normal pacing, the goal is to maximize battery life by monitoring battery voltage and optimizing k-factor selection. For capture management, it is more emphasized to have a high enough margin in the charge pump to meet the target amplitude. Under high current conditions, the battery may be significantly pulled down from the nominal measured voltage, so the k-factor selection should assume the minimum battery voltage at the time of k-factor selection. While margins or k-factor multipliers that increase capture management and high current conditions may consume more current than normal pacing optimization, these are short-term events, so the increase in battery current is not significant over the life of the device.

One challenge in designing the k-factor selection algorithm is to provide sufficient additional margin between the multiplied battery voltage and the target pacing voltage to account for variations in battery voltage, pacing switch loss variations, pacing voltage measurement variations, and component process variations. In an "open loop" system without feedback, this requires an increase in margin, which may result in a higher k-factor being selected than necessary and consuming more current.

For the hardware/firmware implementation described in this disclosure, the optimal k-factor is selected as a function of battery voltage, programmed pacing amplitude, and nominal pacing switching loss. Pacing output hardware has increased the ability to monitor whether the target voltage is being gradually met. If the target voltage is not met, the pacing hardware sends a "100% not met" interrupt to the firmware selection algorithm, which automatically increments the pacing hardware to the next higher k-factor. This functionality compensates for the previously mentioned variations, knowing that the system will only select a higher k-factor when necessary, so that the initially calculated k-factor can be for typical values rather than worst case values.

To prevent transient high current events from incrementing the k-factor long term and increasing current drain, the firmware recalculates the optimal k-factor with reprogramming of any pacing amplitude or after a planned battery voltage measurement. After this procedure, the system returns to the pacing amplitude monitoring mode.

The charge pump 100 may be configured to periodically adjust the K factor in order to select the battery that maximizes the K factor. The formula for the selection of the k factor is given by equation (18).

V_PacingRepresents a programmed pacing voltage, and the ACF represents an amplitude correction factor (also referred to as an overcharge ratio) that compensates for losses in the pacing switch path. V_PacingThe x ACF corresponds to a target voltage of the holding capacitor. The margin is a minimum voltage level above a target voltage at which the transition occurs, and V_{Battery with a battery cell}Is the measured cell voltage. Tables 1 and 2 below show hexadecimal values used to encode the K-factor in the pacing output K-factor register. K-factor encoding is mapped such that K-factor ordering can be done by incrementing K-factor. The 1-fold mode is decoded twice: once in mode a and once in mode B.

MSIC delta 3K factor encoding

Factor K	Hexadecimal code (4 bit)
		CMA_1_2x	0x0h
CMA_3_4x	0x1h
		CMA_1x	0x2h
CMA_5_4x	0x3h
		CMA_3_2x	0x4h
CMA_2x	0x5h
		CMA_5_2x	0x6h
CMA_3x	0x7h
		CMB_1_2x	0x8h
CMB_1x	0x9h
		CMB_3_2x	0xAh
CMB_2x	0xBh
		CMB_5_2x	0xCh
CMB_3x	0xDh
		CMB_7_2x	0xEh
CMB_4x	0xFh

The selection of the k-factor will also utilize a pacing output interrupt or POINT. This interrupt may be activated for pacing amplitude monitoring and effective recharge rate monitoring. For pacing amplitude monitoring, an interrupt may be configured to trigger after pacing occurs if the target holding capacitor amplitude of 90% is not met (conventional operation) or if the target amplitude of 100% is not met. A 100% failure indicates to the firmware that the charge pump never reached the target voltage when pacing occurred, and therefore the pump never left fast mode. By using interrupts that are 100% unsatisfied, the pacing charge pump can essentially "fine tune" by calculating the optimal k-factor and incrementing to the next value when an interrupt occurs. This allows us to set the margin voltage to 0 because the interrupt and delta loops compensate for any changes in the pacing amplitude comparator in process, voltage and temperature.

The switching between 90% not-met and 100% not-met is controlled by the interrupt mask register. Setting this bit generates an interrupt if the amplitude comparator dac (ampdac) has not detected a 100% complete condition on the chamber being paced. Clearing this bit generates an interrupt if the ampDAC has not detected a 90% completion condition on the chamber being paced.

The ability to determine whether 90% or 100% of the target amplitude is reached may allow the system or user to trade off between maximizing battery efficiency (lifetime) and maximizing pacing amplitude accuracy. Also, wider tolerance (i.e., 90%) amplitude measurements may be used to trigger fault/exception handling logic to rule out the possibility of out-of-specification amplitudes that might otherwise affect the operation of sensitive operations, such as capture threshold testing.

The k-factor selection algorithm should first attempt to select from charge mode a. If any chamber needs to jump to charge mode B due to k-factor capacity depletion (i.e. a k-factor higher than 3 times is needed), all chamber k-factors must be recalculated for charge mode B.

In high current conditions and capture management, the battery voltage in the equation is set to the minimum expected voltage rather than using the last measured battery voltage. This will depend on the battery used in the system. Using the lithium anode/hybrid CFx + SVO cathode chemistry battery chemistry, a minimum battery voltage of 2.2V can be used to calculate the k-factor. All other parameters selected (mode a and mode B, etc.) remain the same as those used for conventional pacing.

Fig. 9 shows an example of an algorithm that may be used to select the K factor for the charge pump 100. The algorithm of fig. 9 may be implemented, for example, in computer readable instructions (e.g., software or firmware) stored in memory 82 and executed by processor 80. The selection of the K factor may be based on the table in fig. 10, for example. The table of fig. 10 may be generated according to the formula in equation (18) above, where ACF takes into account losses in the IPG and the margin is 0V. Since POINT "100% not met" enables the auto-trim function, the margin may be set to 0V.

FIG. 10 is a table showing selected pacing amplitudes (V)_{Amplitude of vibration}) And the minimum supply voltage required for the k factor. To limit the size of the lookup table, the pacing amplitude may be limited to a user programmable value, but may also be calculated in real time. Any intermediate amplitude that may be accessed during a function such as the VCM is considered the next higher user programmable value.

To use the table, the last battery voltage measurement will be read. If no battery measurement has occurred, such as after POR, the algorithm uses a default minimum battery voltage of 2.2V. Note that for this algorithm, BattVolt is a variable used by the k-factor algorithm and may represent the actual measured battery voltage or may be set to a default voltage for a particular use case.

For each programmed amplitude, the table mode _ a is read through from the amplitude and the minimum k-factor for which the supply voltage is less than the measured battery voltage is found. If the k factor for mode _ a is not found, then switch to table mode _ b. Note that all k-factors must be in the table for the same mode. If any k-factor must use mode _ b, then all k-factors must be calculated using the table mode _ b.

If the minimum voltage of the selected k-factor is less than 2.2V, no further action will be taken until the next amplitude programming or battery measurement, at which point the algorithm recalculates all k-factors.

Several use cases will now be described. One example use case is normal operation (auto-tweak). In normal operation, the k-factor is recalculated when a battery measurement occurs or when the chamber amplitude is programmed. For each chamber amplitude, a table mode _ a is used in conjunction with the cell voltage to determine the k-factor. If any chamber requires a higher k-factor than is available in mode _ a, all k-factors must be selected from the table mode _ b. By configuring the registers in the processor 80, 100% unsatisfied interrupts are enabled for all chambers.

When a 100% unsatisfied interruption occurs during normal operation, the k-factor of the chamber generating the interruption is incremented to the next higher value. If the k-factor is at the highest mode _ a and an interruption occurs, then table mode _ b is used and all chambers are converted to a value of mode _ b. If the chamber reaches the k-factor of the highest mode b, no further incrementing occurs.

After POR, the variable BattVolt is set to 2.2V and the k-factor is selected based on this voltage. All other operations in this state are the same as normal operations. Once a valid battery measurement occurs, BattVolt is set to the latest battery voltage and enters normal operating state. Note that in all use cases, BattVolt defaults to 2.2V if no valid battery measurements are available.

High current operation is defined as a set of use cases requiring a greater amount of current. This includes bluetooth telemetry sessions and ATP. At the beginning of high current operation, BattVolt is set to a minimum level (less than 2.1V), pacing interrupt is disabled, and a k-factor is selected from mode _ b based on this minimum voltage. Once high current operation is complete, the algorithm changes BattVolt to 2.2V, re-enables pacing interrupts, selects the k-factor from the table mode _ b and remains in the extended high current operating state until the high current timer expires. This allows the battery to recover from high current operation before returning to normal operation. Upon expiration of the high current timer, BattVolt reverts to the last valid battery measurement and normal operation resumes.

After entering capture management operations, the PO interrupt is set to 90% unsatisfied mode. This is to match the capture management requirements, i.e., the delivered pacing is at least 90% of the expected value. BattVolt is set to 2.2V and a k factor is selected from the table mode _ b based on this voltage. The k-factor is recalculated each time a new test pacing amplitude is written. If an interrupt that does not meet 90% is generated, the interrupt is sent to a capture management routine for management at the capture management routine. At the end of capture management, BattVolt reverts to the last valid battery measurement and normal operation resumes.

Writing to the following hardware registers affects the operation of the pacing output pacing charge pump state machine:

PO_A_kf

PO_RV_kf

PO_LV_kf

PO_S_kf

PO_Aamp

PO_RVamp

PO_LVamp

PO_Samp

writing to any of these registers triggers the measurement and charging cycle of the charge pump state machine so that the charge pump state machine can establish a new value. In this HW implementation, there is an indication that the hold capacitor has been charged to or above a certain level, but there is no indication of whether the hold capacitor has dropped below a certain level. The voltage regulation may be effectively unidirectional. In other words, if the capacitor voltage on the holding capacitor is not high enough, the holding capacitor may be pumped up until the target value is met. Once this occurs, IMD16 may enter a maintenance mode and examine at a frequency of 256 Hz. If the capacitor is too low, the capacitor can be pumped once without repeated inspection. During the next 256Hz interval, the capacitor may be checked again. However, there may not be a charge pumping pattern for gradual pump down to prevent trying to find a target value up and down "servo (serving)". The discharge pattern may be aggressive (e.g., large jumps per "pump") in order to discharge the capacitor to a level well below 100%.

Due to this measurement capability, when writing to one of the above registers, the measurement result showing that the level has been met does not indicate whether the hold capacitor was previously charged to a higher voltage and is now well above the new programmed amplitude, or whether the hold capacitor is at an appropriate level for the new programmed value. Thus, if one of these registers is written and the measurement status indicates that the voltage has been met, the hold capacitor enters a drain mode to drain charge from the capacitor so that the hold capacitor will approach the final value from below the amplitude measurement trigger point.

One of the methods for reducing the impact of soft errors corrupting hardware registers is to periodically flush registers by writing values. In the case of the PO register mentioned here, even writing the same value triggers a drain/charge sequence, wasting current, affecting life. To reduce the current consumption caused by register refresh, the following sequence may be followed:

1) the firmware may retain a mirror copy of the amplitude and kf registers of the hardware,

2) if any of the four hardware kf registers are not identical to the firmware image, the four hardware kf registers may be written to by the firmware copy,

3) if any of the four hardware amplitude registers are different from the firmware image, the four HW amplitude registers will be written by the FW copy.

This difference in FW comparison versus HW comparison may occur algorithmically according to fig. 9, or due to the occurrence of soft errors affecting HW.

During the refresh sequence of soft errors, the pacing output amplitude and k-factor registers should be refreshed only if the values read from the hardware registers differ from the values in the corresponding firmware registers. This sequence is referred to as "read before write".

In an example embodiment, the processor may control a user interface (e.g., user interface 114 of programmer 24 of fig. 11) to provide a "check box" or some other graphic that may receive input from a user. Using a checkbox, the clinician may provide input to programmer 24 if an undesired muscle and/or nerve stimulation of a particular vector occurs. In other words, if undesired muscle and/or nerve stimulation occurs, the clinician may label the vector. Providing input in this manner may allow tagged vectors to rank lower than untagged vectors. The tagged vectors may be transmitted back to the IMD, for example, via telemetry circuitry 116 of programmer 24 of fig. 11, so that the IMD will be able to provide this information to other programmers at a later date, allowing the clinician to choose to exclude vectors with an undesirable stimulation history in future test runs.

In other example embodiments, the clinician may specify that only some of the available vectors should be tested. For example, for a quadrupolar lead, although there are sixteen possible vectors, the clinician may only be interested in the ten most commonly used vectors or some other subset of the total available vectors. In this way, the clinician may specify, for example using programmer 24, the particular vectors that should be tested for pacing capture thresholds. In some examples, the clinician may save their preference vectors for a given lead and then use these to load and run the test.

In another example embodiment, processor 80 and electrical sensing circuitry 86 may perform impedance measurements for each vector during pacing capture threshold testing. Processor 80 may control electrical sensing circuitry 86 to perform an impedance measurement test in parallel with the pacing capture threshold test. At the end of the test, these impedance values may be displayed to the clinician, e.g., via programmer 24, along with pacing capture thresholds.

In one example embodiment, the clinician may specify that only vectors with certain characteristics (e.g., certain voltages and impedances) should be displayed upon completion of a pacing capture threshold test. For example, the clinician may specify, e.g., using programmer 24, that only vectors with capture thresholds less than about 3V and impedances less than about 10 ohms should be displayed.

Telemetry circuitry 88 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as programmer 24 (fig. 1). Telemetry circuitry 88 may receive downlink telemetry from and transmit uplink telemetry to programmer 24, via an antenna, which may be internal and/or external, under the control of processor 80. Processor 80 may provide data to be transmitted upstream to programmer 24 and receive data from programmer 24 via telemetry circuitry 88.

Fig. 11 is a functional block diagram illustrating an example configuration of programmer 24. As shown in fig. 11, programmer 24 may include a processor 110, a memory 112, a user interface 114, telemetry circuitry 116, and a power supply 118. Programmer 24 may be a dedicated hardware device with dedicated software for programming of IMD 16. Alternatively, programmer 24 may be an off-the-shelf computing device running an application that enables programmer 24 to program IMD 16.

The user may use programmer 24 to select a therapy program (e.g., multiple sets of stimulation parameters), generate a new therapy program, modify a therapy program through individual or global adjustments, or transmit a new program to a medical device such as IMD16 (fig. 1). The clinician may interact with programmer 24 via user interface 114, which may include a display for presenting a graphical user interface to the user and a keypad or another mechanism for receiving input from the user. A user (e.g., a clinician) may define or select a vector to be tested and/or input vector impedance values via the user interface 114.

User interface 114 may display the vectors to be tested and the results of the pacing capture threshold test to the clinician. As described above, user interface 114 may display each tested vector and its associated pacing capture threshold voltage in some order that may be selected or adjusted by the clinician. In some examples, the impedance of each test vector may also be displayed. The results of the test may also be stored in the memory 112.

The processor 110 may take the form of one or more microprocessors, DSPs, ASICs, FPGAs, programmable logic circuitry, etc., and the functions attributed to the processor 110 herein may be embodied as hardware, firmware, software, or any combination thereof. Memory 112 may store instructions that cause processor 110 to provide the functionality attributed to programmer 24 herein as well as information used by processor 110 to provide the functionality attributed to programmer 24 herein. Memory 112 may include any fixed or removable magnetic, optical, or electrical media, such as RAM, ROM, CD-ROM, hard or floppy disks, EEPROM, flash memory, or the like. The memory 112 may also include a removable memory portion that may be used to provide memory updates or increases in memory capacity. The removable memory may also allow patient data to be easily transferred to another computing device or removed before programmer 24 is used to program another patient's treatment.

Programmer 24 may communicate wirelessly with IMD16, such as using RF communication or near-end inductive interaction. Such wireless communication is possible through the use of telemetry circuitry 116 which may be coupled to an internal antenna or an external antenna. An external antenna coupled to programmer 24 may correspond to a programming head that may be placed on heart 12 as described above with reference to fig. 1. Telemetry circuitry 116 may be similar to telemetry circuitry 88 (fig. 3) of IMD 16.

The telemetry circuitry 116 may also be configured to communicate with another computing device via wireless communication techniques or via direct communication through a wired connection. Examples of local wireless communication techniques that may be used to facilitate communication between programmer 24 and another computing device include RF communication according to the 802.11 or bluetooth specification sets, infrared communication, for example, according to the IrDA standard, or other standard or proprietary telemetry protocols. In this manner, other external devices may be able to communicate with programmer 24 without establishing a secure wireless connection. An additional computing device in communication with programmer 24 may be a networked device, such as a server capable of processing information retrieved from IMD 16.

In some examples, programmer 24 and/or one or more networked computers may enable a user to program aspects of the performance of an implantable medical device according to the techniques described herein.

Fig. 12 is a block diagram illustrating an example system 219 including one or more computing devices 230A-230N and an external device (such as a server 224) coupled to IMD16 and programmer 24 shown in fig. 1 via a network 222. In this example, IMD16 may use its telemetry circuitry 88 to communicate with programmer 24 via a first wireless connection and to communicate with access point 220 via a second wireless connection. In the example of fig. 12, access point 220, programmer 24, server 224, and computing devices 230A-230N are interconnected and capable of communicating with each other over network 222. In some cases, one or more of access point 220, programmer 24, server 224, and computing devices 230A-230N may be coupled to network 222 through one or more wireless connections. IMD16, programmer 24, server 224, and computing devices 230A-230N may each include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, programmable logic circuitry, and the like, that may perform various functions and operations, such as those described herein.

Access point 220 may include devices that connect to network 222 via any of a variety of connections, such as telephone dial-up, Digital Subscriber Line (DSL), or cable modem connections. In other examples, access point 220 may be coupled to network 222 through different forms of connections (including wired or wireless connections). In some examples, the access point 220 may be co-located with the patient 14 and may include one or more programming units and/or computing devices (e.g., one or more monitoring units) that may perform the various functions and operations described herein. For example, access point 220 may include a home monitoring unit that is co-located with patient 14 and may monitor activity of IMD 16.

In some cases, server 224 may be configured to provide a secure storage site for data that has been collected from IMD16 and/or programmer 24. The network 222 may include a local area network, a wide area network, or a global network, such as the internet. In some cases, programmer 24 or server 224 may assemble data in a web page or other document for viewing by a trained professional (such as a clinician) via a viewing terminal associated with computing devices 230A-230N. The illustrated system of fig. 12 may, in some aspects, utilize a force of Medtronic similar to that developed by Medtronic, inc

Network-provided general network technologies and functions.

Examples of the present disclosure have been described. These and other examples are within the scope of the following claims.