CN117138230A - Coordinating the use of power-saving battery switch hardware features through multiple firmware features - Google Patents

Abstract

The present invention provides an exemplary implantable neurostimulator that includes a battery configured to provide power to the implantable neurostimulator, a battery switch configured to open or close, and a plurality of firmware modules. At least two of the plurality of firmware modules are configured to generate and transmit one or more corresponding requests. The implantable neurostimulator also includes power domain firmware configured to receive the one or more corresponding requests, determine whether to open or close the switch in response to the one or more corresponding requests, and respond Based on this determination, the battery switch is controlled to be turned off or kept closed.

Description

Coordinate the use of power-saving battery switch hardware features through multiple firmware features

Technical field

The present disclosure relates to power saving features in devices, such as devices configured to deliver therapy to patients.

Background technique

Illness, age, and injury can impair a patient's physiological functions. In some cases, physiological functions are completely impaired. In other examples, physiological functions may operate adequately at some times or under some conditions, and insufficiently at other times or under other conditions. In one example, bladder dysfunction such as overactive bladder, urinary urgency, or urinary incontinence is a problem that can affect people of all ages, genders, and races. Various muscles, nerves, organs, and ducts within the pelvic floor work together to collect, store, and release urine. A variety of disorders can impair urinary tract performance and lead to overactive bladder, urinary urgency, or incontinence that interfere with normal physiological function. Many disorders can be associated with aging, injury or disease.

Urinary incontinence can include urge incontinence and stress incontinence. In some examples, urge incontinence can be caused by disorders of the peripheral or central nervous system that control the bladder's micturition reflex. Some patients may also have neurological disorders that prevent the normal triggering and operation of the bladder, sphincter muscles or lead to overactive bladder activity or urge incontinence. In some cases, urinary incontinence can be attributed to abnormal sphincter function in the internal or external urethral sphincter.

Contents of the invention

Generally, the present disclosure relates to devices, systems, and techniques for controlling power delivery in devices such as implantable medical devices (IMDs), such as implantable stimulation devices (implantable neurostimulators). For example, this disclosure describes examples of devices, systems, and techniques for reducing power consumption in battery-powered devices, such as IMDs. Although primarily discussed herein for use in IMDs, the techniques of the present disclosure can be used in any device that has a battery as a power source.

For many stimulation treatments, excitatory, patterned, pulsed or cyclic stimulation pulses have periods of time that inhibit the delivery of stimulation to the body. During certain periods of suppressive therapy, much of the IMD's electronics can be disconnected from battery power or any power source derived from the battery. Such a state may be referred to herein as sleep mode. When power is disconnected from most of the IMD's electronics, power can remain connected to some portion of the IMD, such as a power domain circuit that can close a battery switch to restore power to the rest of the device. Such power domain circuitry may have firmware counterparts that may moderate, mediate, or arbitrate requests to open the battery switch or keep the battery switch closed. The power domain firmware may control the position of the battery switch to open or remain closed based on requests received by the power domain firmware from multiple firmware modules within the IMD. The plurality of firmware modules may be referred to herein as modules because at least two of the plurality of firmware modules may send a request on behalf of the corresponding hardware or for itself as to whether to open the battery switch or keep the battery switch closed. In some examples, even though the multiple firmware modules are referred to as multiple firmware modules, the multiple firmware modules may be implemented as a single piece of firmware. In some examples, the single piece of firmware may include power domain firmware. The power domain firmware may moderate, mediate, or arbitrate the requests such that the battery switch is turned off only if each of the requests received by the power domain firmware indicates that the battery switch can be turned off.

For battery-powered implantable stimulators, energy consumption from the battery results from a combination of the stimulation current delivered to the nervous system and the energy required to operate the support electronics. Supporting electronics may include processor circuitry such as a microprocessor, telemetry circuitry, sensors, timing circuitry, etc. In some cases, the support electronics can draw as much current from the battery as the stimulation current. Thus, by entering sleep mode, much of the battery drain can be eliminated, e.g., when stimulation therapy is turned off, greatly extending the stimulator's battery life and/or increasing the recharge interval (e.g., the length of time between recharges) .

In one example, the present disclosure relates to an implantable neurostimulator including: a battery configured to provide power to the implantable neurostimulator; a battery switch, the battery a switch configured to open and remove power from one or more components of the implantable neurostimulator, or to close to provide power to each component of the implantable neurostimulator that requires power to operate; and a processing circuit configured to: execute a plurality of firmware modules configured to execute corresponding functions of the implantable neurostimulator, at least two of the plurality of firmware modules being Configured to determine whether the corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function, and to perform the corresponding function based on whether the corresponding hardware component requires power or whether power is required during the corresponding time period. the determination to generate and transmit one or more corresponding requests; and execute power domain firmware that configures the processing circuit to: receive the one or more corresponding requests; respond to the one or more corresponding requests determine whether to open the battery switch or keep the battery switch closed upon request; and control the battery switch to open or keep the battery switch closed in response to the determination.

In another example, the present disclosure relates to a method that includes, via power domain firmware executing on a processing circuit and receiving one or more corresponding requests from at least two of a plurality of firmware modules, the plurality of firmware modules At least two of the firmware modules execute on the processing circuitry and are configured to determine whether a corresponding corresponding hardware component requires power or whether power is required during a corresponding time period to perform a corresponding function of the implantable neurostimulator, and The one or more corresponding requests are generated and transmitted based on the determination of whether the corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function; in response to the one or more corresponding requests by The power domain firmware determines whether to open the battery switch or keep the battery switch closed; and in response to the determination, the power domain firmware controls the battery switch to open or remain closed.

In another example, the present disclosure relates to a non-transitory computer-readable storage medium including instructions including a plurality of firmware modules and power domain firmware that when executed causing the processing circuit of the implantable neurostimulator to: perform a corresponding function of the implantable neurostimulator; determine whether a corresponding hardware component requires power or whether power is required during a corresponding time period to perform the corresponding function; based on the the determination of whether a corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function to generate and transmit one or more corresponding requests; receive the one or more corresponding requests; respond Determine whether to open the battery switch or keep the battery switch closed in response to the one or more corresponding requests; and control the battery switch to open or keep the battery switch closed in response to the determination.

In another example, the present disclosure relates to an implantable neurostimulator including: means for a firmware module to receive one or more corresponding requests, at least two of the plurality of firmware modules executing on the processing circuit and configured to determine whether the corresponding corresponding hardware component requires power or whether it is required during a corresponding time period power to perform a corresponding function of the implantable neurostimulator, and generating and transmitting the one or more functions based on the determination of whether the corresponding hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period. a corresponding request; means for determining, by the power domain firmware, whether to open the battery switch or to keep the battery switch closed in response to the one or more corresponding requests; and for controlling by the power domain firmware in response to the determination The battery switch opens or holds a closed device.

The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

The above summary is not intended to describe each illustrated example or every implementation of the disclosure.

Description of the drawings

Figure 1A is a schematic diagram illustrating an exemplary leadless neurostimulation device.

Figure IB is a conceptual diagram illustrating a leg with a leadless nerve stimulation device implanted near the tibial nerve.

1C is a conceptual diagram illustrating an exemplary system for managing delivery of nerve stimulation to a patient to manage bladder dysfunction such as overactive bladder, urinary urgency, or urinary incontinence.

Figure 2 is a block diagram illustrating an exemplary configuration of an implantable medical device (IMD).

3 is a block diagram illustrating an exemplary configuration of an external programmer.

4 is a block diagram illustrating an exemplary neurostimulation device having multiple firmware modules in accordance with the techniques of the present disclosure.

Figure 5 is a conceptual diagram illustrating example requests that multiple firmware modules may send to power domain firmware.

6 is a flow diagram illustrating an example technique for controlling power delivery in a device in accordance with one or more aspects of the present disclosure.

7A-7D are flow diagrams illustrating example techniques for opening a battery switch in accordance with one or more aspects of the present disclosure.

8A-8B are flow diagrams illustrating example techniques for recovery after closing a battery switch in accordance with one or more aspects of the present disclosure.

Detailed ways

The present disclosure relates to devices, systems, and techniques for reducing current draw or power consumption of devices such as IMDs. The techniques of the present disclosure may increase battery life and/or recharge intervals (eg, time between recharges) of devices implementing such techniques. In some examples, these technologies can be used with neurostimulators that can provide treatment for a variety of dysfunctions, diseases, or conditions. For purposes of illustration and not limitation, use of the techniques of the present disclosure will be described below with respect to bladder dysfunction. Bladder dysfunction generally refers to a condition in which the bladder or urethra functions abnormally, and may include, for example, overactive bladder, urinary urgency, or urinary incontinence. Overactive bladder (OAB) is a patient condition that may include symptoms such as urinary urgency with or without urinary incontinence. Urinary urgency is a sudden, irresistible desire to urinate, and can often, although not always, be associated with urinary incontinence. Urinary incontinence refers to the condition of the involuntary loss of urine and may include urge incontinence, stress incontinence, or stress and urge incontinence which may be referred to as mixed incontinence. As used in this disclosure, the term "urinary incontinence" includes disorders in which urination occurs when undesired, such as stress or urge incontinence. Other bladder dysfunctions may include disorders such as non-obstructive urinary retention.

One type of therapy for treating bladder dysfunction involves delivering continuous electrical stimulation to a target tissue site in the patient's body to induce a therapeutic effect during the delivery of the electrical stimulation. For example, electrical stimulation is delivered from the IMD to a target treatment site (e.g., stimulation is delivered to modulate the tibial nerve, spinal nerve (e.g., sacral nerve), pudendal nerve, dorsal genital nerve, inferior rectal nerve, perineal nerve, or branches of any of the foregoing nerves). tissue site) may provide immediate therapeutic effects for bladder dysfunction, such as a desired reduction in frequency of bladder contractions. In some cases, electrical stimulation of the tibial nerve can modulate afferent nerve activity to restore urinary function during electrical stimulation. However, continuous electrical stimulation (which may include pulsed stimulation) or other types of neurostimulation (e.g., drug delivery treatments) can provide neurostimulation during unnecessary phases of the menstrual cycle, which can lead to undesirable side effects, adaptations, undesirable Too focused treatment and an increase in the energy used by the IMD to deliver the treatment.

In contrast to this type of continuous neurostimulation therapy, the exemplary devices, systems, and techniques described in this disclosure involve managing the delivery of neurostimulation therapy in a discontinuous manner, which may include on-cycle and Off-cycle. For example, an IMD may deliver neurostimulation therapy for a specified period of time, followed by a specified period of time when the IMD does not deliver neurostimulation (eg, inhibits delivery of neurostimulation). During periods when the IMD is not delivering neurostimulation, the IMD may enter a sleep mode to further reduce the amount of power or current drawn on the battery powering the IMD. As described herein, the period of time during which stimulation is delivered (on-cycle) may include an on-period and an off-period (e.g., a duty cycle or burst of pulses), where even short inter-pulse durations when no pulses are delivered Still considered part of stimulation delivery. In some examples, when not delivering pulses, IMD 16 may not enter sleep mode during the short inter-pulse duration of the on-cycle. For example, short inter-pulse durations when no pulses are delivered during the on cycle are still considered part of the stimulation delivery, but during the off cycle, the IMD16 can be considered to be not delivering stimulation.

This disclosure includes a discussion of various examples, aspects, and features. Unless otherwise stated, various examples, aspects and features are contemplated for use together in different combinations. For ease of discussion and in practice, not every possible combination of features is explicitly recited.

In some examples, a system may be configured to provide stimulation at a neural target located distally from the affected end organ. For example, the stimulation site may be located at a relatively large distance from the bladder or bowel, such as the tibial nerve. The system may include multiple devices (eg, implanted sensors and implanted stimulation devices) having wireless communication circuitry that allows wireless communication of information between the devices, which may provide sensing or therapeutic stimulation. For example, wireless circuits can be designed to use near field communications, or other wireless protocols for communication.

To facilitate discussion, various examples are discussed in relation to bladder function. It should be recognized that bladder function is only one possible application. Aspects of the present disclosure may also be used in conjunction with urinary, bowel, and general pelvic floor dysfunction. For the sake of brevity, each type of dysfunction is not repeated for every characteristic or example discussed in this article.

As mentioned above, constant or continuous stimulation can lead to undesirable side effects, accommodation, less focused treatment, and an increase in energy used by the medical device delivering the treatment. Therefore, stimulation can be cycled on and off. When stimulation is cycled off, the neurostimulation device can enter a sleep mode in which very little current is drawn from the battery powering the neurostimulation device. This can translate into longer recharge intervals and/or longer replacement intervals.

A device such as an IMD can implement the techniques described in this disclosure and deliver stimulation therapy to at least one nerve (eg, tibial nerve, sacral nerve, spinal nerve, or pelvic floor nerve) via at least one electrode electrically connected to the IMD to modulate the activity of the nerve. Electrical stimulation may be configured to modulate contraction of the patient's detrusor muscle to cause a decrease in the frequency of bladder contractions (to reduce incontinence) or an increase in the frequency of bladder contractions (to promote voiding). A reduction in the frequency of bladder contractions may reduce the urgency to void and may reduce urinary urgency and/or incontinence, thereby at least partially relieving bladder dysfunction.

Neurostimulation as described herein may be aimed at managing bladder dysfunction such as overactive bladder, urinary urgency, urinary incontinence, or even non-obstructive urinary retention. For example, stimulation can be delivered to target tissue sites commonly used to alleviate these types of dysfunction. Although techniques for managing bladder dysfunction are primarily described in this disclosure, these techniques may also be applied to the management of other pelvic floor disorders or disorders associated with other organs, tissues, or nerves in the patient. For example, alternatively or additionally, the devices, systems, and techniques described in this disclosure may be used to manage sexual dysfunction, pelvic pain, fecal urgency, or fecal incontinence. Exemplary nerves that may be targeted for treatment include the tibial nerve, sacral nerve, pudendal nerve, dorsal nerve of the penis or clitoris, sural nerve, sciatic nerve, inferior rectal nerve, and peroneal or perineal nerve. Exemplary organ systems that may be treated for dysfunction may include the large and small intestines, stomach and/or intestines, liver, and spleen, which may be administered directly to the organ, to one or more nerves innervating the organ, and/or to the blood supply to the organ. Delivery of neural stimulation to regulate. In other examples, treatments can target the spinal cord to relieve pain. In other examples, treatments can target the brain to treat Parkinson's disease or epileptic seizure disorders.

Various examples are discussed with respect to one or more stimulation devices. It is recognized that stimulation devices may include features and functions other than electrical stimulation. This article discusses many of these additional features explicitly. Several example features include, but are not limited to, different types of sensing capabilities and different types of wireless communication capabilities. For ease of discussion, this disclosure does not explicitly recite every conceivable combination of additional features, such as by repeating each feature structure each time a different example and use of a stimulation device is discussed. Furthermore, the techniques described herein for controlling power delivery within a device may be used in any device powered by a battery.

Figure 1A is a schematic diagram illustrating an exemplary leadless neurostimulation device. The leadless neurostimulation device 1 includes a housing 2 containing components configured for delivering neurostimulation treatments therein, a head unit 3 including one or more main electrodes 4, and a mounting plate 5. This mounting plate couples the housing 2 to the head unit 3 . The head unit 3 includes at least one main electrode 4 forming part of the outer surface of the head unit 3 . The housing 2 includes a secondary electrode 6 which forms part of the outer surface of the housing 2 and is located on the same side of the device 1 as the main electrode 4 . In an alternative embodiment not depicted, the main electrode 4 and the secondary electrode 6 may be arranged on opposite sides of the device 1 .

The primary electrode 4 and the secondary electrode 6 operate in conjunction with each other to provide stimulation therapy to a target treatment site (eg, the tibial nerve). The secondary electrode 6 may also be called a shell electrode, a can electrode or a reference electrode. In one example, the main electrode 4 may include a cathode, and the secondary electrode 6 may include an anode. In some examples, primary electrode 4 and secondary electrode 6 may be characterized as a bipolar pair or system.

The terms "primary" and "secondary" are used to distinguish two or more electrodes configured to transmit electrical signals between them. These terms are not used to imply the layers between electrodes, the positive and negative terminals, the total number of electrodes, or the directionality of signal transmission between electrodes.

Additional information regarding the leadless neurostimulation device 1 can be found in US Patent Publication 2022/0096845A1, which is incorporated herein by reference in its entirety.

Figure IB is a conceptual diagram illustrating a leg with a leadless nerve stimulation device implanted near the tibial nerve. In the example of FIG. 1B , the leadless nerve stimulation device 1 is implanted in the patient's leg 8 near the tibial nerve 7 . For example, the leadless neurostimulation device 1 can deliver neurostimulation to a patient to manage bladder dysfunction, such as overactive bladder, urinary urgency, or urinary incontinence. The leadless nerve stimulation device 1 may be configured to deliver nerve stimulation to the tibial nerve 7 in a cyclic manner and to be placed when the nerve stimulation is not actively being delivered (eg, inhibiting) (eg, shutting off circulation). in sleep mode.

1C is a conceptual diagram illustrating an exemplary system 10 that manages the delivery of nerve stimulation to a patient 14 to manage bladder dysfunction such as overactive bladder, urinary urgency, or urinary incontinence. As described above, system 10 may be configured to deliver neurostimulation to patient 14 in a cyclic manner, and to implantable medical device (IMD) 16 when not actively delivering (eg, suppressing) neurostimulation (eg, shutting down circulation). Put into sleep mode.

As shown in the example of FIG. 1C , treatment system 10 includes IMD 16 (eg, an exemplary medical device) coupled to leads 18 , 20 , and 28 and sensor 22 . System 10 also includes an external programmer 24 configured to communicate with IMD 16 via wireless communications. Although not shown in FIGS. 1A-1B , the external programmer 24 may be configured to communicate with the leadless neurostimulation device 1 .

The IMD 16 is typically used as a treatment device that delivers targeted tissue sites proximal to, for example, the sacral nerve, tibial nerve, spinal nerve, pudendal nerve, dorsal genital nerve, lower rectal nerve, perineal nerve, or other pelvic nerves, or branches of any of the foregoing nerves. Deliver electrical nerve stimulation. IMD 16 works by generating and delivering programmable electrical stimulation signals (eg, in the form of electrical pulses or waveforms) proximate lead 28 and, more specifically, electrodes 29A-29D disposed proximate the distal end of lead 28 ( (collectively referred to as "electrodes 29") to provide electrical stimulation to patient 14 at the target treatment site.

IMD 16 may be surgically implanted within patient 14 at any suitable location within patient 14, such as proximate the pelvis. In some examples, IMD 16 may be implanted in a subcutaneous location in the side of the lower abdomen or lower back or upper buttocks. The IMD 16 has a biocompatible shell that can be formed from titanium, stainless steel, liquid crystal polymer, etc. The proximal ends of leads 18, 20, and 28 are electrically and mechanically coupled to IMD 16, such as directly or indirectly via respective lead extensions. Electrical conductors disposed within the lead bodies of leads 18, 20, and 28 electrically connect sensing electrodes (eg, electrodes 19A, 19B, 21A, and 21B) and stimulation electrodes (such as electrode 29) to sensing circuitry within IMD 16 and Stimulus delivery circuitry (e.g., stimulus generator). In the example of Figure 1C, leads 18 and 20 carry electrodes 19A, 19B (collectively "electrode 19") and electrodes 21A, 21B (collectively "electrode 21"), respectively. As described in greater detail below, electrodes 19 and 21 may be positioned to sense the impedance of bladder 12, which may increase as the volume of urine within bladder 12 increases. In some examples, system 10 may include electrodes (such as electrodes 19 and 21 ), strain gauges, one or more accelerometers, ultrasonic sensors, optical sensors, or be capable of detecting contractions of bladder 12 , pressure or volume of bladder 12 , or Any other sensors for the filling cycle of the bladder 12 and/or any other indication of possible bladder dysfunction status.

In other examples, system 10 may use sensors other than electrodes 19 and 21 to sense bladder volume, or use no sensors at all. For example, external programmer 24 may receive user input identifying voiding events, perceived fullness, etc. User input may be in the form of voiding logs analyzed by the external programmer 24 or IMD 16 or individual user input associated with corresponding voiding events, leaks, or any other events related to the phase of the menstrual cycle. External programmer 24 and/or IMD 16 may use this user input to generate estimated filling cycles and determine when to deliver stimulation and exit sleep mode and when to suppress stimulation and enter sleep mode. User input may be used in addition to or instead of sensors such as electrodes 19A and 21A to detect physiological markers.

One or more medical leads (eg, leads 18, 20, and 28) may be connected to the IMD 16 and surgically or transcutaneously tunneled to place one or more electrodes carried by the distal end of the respective lead at the desired location. At a nerve or muscle site, for example, at one of the previously listed target treatment sites (such as a tissue site proximate the sacral nerve, tibial nerve, spinal nerve, or pudendal nerve). For example, lead 28 may be positioned such that electrode 29 delivers electrical stimulation to the sacral nerve, tibial nerve, sacral nerve, or pudendal nerve to reduce the frequency and/or magnitude of bladder 12 contractions. Additional electrodes on lead 28 and/or electrodes on another lead may also provide additional stimulation treatments to other nerves or tissues. In Figure 1C, leads 18 and 20 are placed in first and second positions, respectively, proximate the outer surface of the wall of bladder 12. In other examples of treatment system 10 , IMD 16 may be coupled to more than one lead, including for delivering electrical stimulation to different stimulation sites within patient 14 (e.g., to target different nerves). ) electrode.

In the example shown in Figure 1C, leads 18, 20, 28 are cylindrical. The electrodes 19, 20, 29 of the leads 18, 20, 28, respectively, may be ring electrodes, segmented electrodes, partial ring electrodes, or any suitable electrode configuration. The segmented electrodes and partial annular electrodes each extend along an arc of less than 360 degrees (eg, 90 degrees - 120 degrees) around the outer perimeter of the respective lead 18, 20, 28. In some examples, segmented electrodes 29 of lead 28 may be used to target different fibers of the same or different nerves to produce different physiological effects (eg, therapeutic effects). In examples, one or more of leads 18, 20, 28 may be at least partially paddle-shaped (eg, "paddle" leads) and may include an array of electrodes located on a common surface that may Is or may not be substantially flat.

In some examples, one or more of electrodes 19, 20, 29 may be a snap-on electrode configured to extend at least partially around the nerve (eg, extend axially around an outer surface of the nerve). Delivery of electrical stimulation via one or more snap-on electrodes and/or segmented electrodes may help achieve a more uniform electrical field or activation field distribution relative to the nerve, which may help reduce symptoms of patient 14 resulting from the delivery of electrical stimulation. Discomfort is minimized. The electric field can define the volume of tissue affected when electrodes 19, 20, 29 are activated. The activation field represents the neurons in the neural tissue close to the activation electrode that will be activated by the electric field.

The illustrated numbers and configurations of leads 18, 20, and 28 and electrodes carried by leads 18, 20, and 28 are exemplary only. Other configurations of leads and electrodes, such as number and location, are also contemplated. For example, in other implementations, IMD 16 may be coupled to additional leads or lead segments having one or more electrodes positioned at various locations in the spinal cord or pelvic region proximate patient 14 . Additional leads may be used to deliver different stimulation treatments or other electrical stimulation to corresponding stimulation sites within the patient 14 , or to monitor at least one physiological marker of the patient 14 .

According to some examples of the present disclosure, IMD 16 delivers stimulation procedure-based electrical stimulation to at least one of a sacral nerve, a tibial nerve, a spinal nerve, a pudendal nerve, a dorsal genital nerve, a lower rectal nerve, or a perineal nerve to provide relief or Therapeutic effects in eliminating dysfunctional conditions such as overactive bladder. The desired therapeutic effect may be an inhibitory physiological response associated with patient 14 voiding, such as a reduction in bladder contraction frequency by a desired level or degree (eg, a percentage).

A stimulation program may define various parameters of the stimulation waveform and electrode configuration that result in the delivery of a predetermined stimulation intensity to the targeted nerve or tissue. In some examples, the stimulation program defines parameters of at least one of: current or voltage amplitude of the stimulation signal, frequency or pulse rate of the stimulation, shape of the stimulation waveform, duty cycle of the stimulation, pulse width of the stimulation, and/or or the combination of electrodes 29 used to deliver stimulation and the corresponding polarity of a subset of electrodes 29. Together, these stimulation parameter values can be used to define stimulation intensity (also referred to herein as stimulation intensity level). In some examples, if stimulation pulses are delivered in the form of pulse trains, the pulse train duty cycle may also contribute to stimulation intensity. Furthermore, regardless of intensity, the specific pulse width and/or pulse rate may be selected from a range suitable to elicit the desired therapeutic effect after terminating stimulation and optionally during stimulation. Additionally, as described herein, the periods during which stimulation is delivered may include on-periods and off-periods (e.g., duty cycles or bursts of pulses), where even short inter-pulse durations when no pulses are delivered are still considered stimulation part of the delivery. In some examples, IMD 16 may not enter sleep mode during short inter-pulse durations when pulses are not being delivered. For example, short interpulse durations when no pulses are delivered during the on cycle are still considered part of the stimulation delivery, but during the off cycle, the IMD 16 may be considered to be delivering no stimulation.

The stimulation program may also define the time periods during which the IMD 16 delivers stimulation (eg, on-cycle) and the time periods during which the IMD 16 inhibits stimulation delivery (eg, off-cycle). The time period during which the IMD 16 inhibits stimulation delivery is the time period in which there is no stimulation program activity for the IMD 16 (eg, the IMD 16 is not tracking pulse durations or inter-pulse durations that occur as part of the electrical stimulation delivery regimen). During such times, the IMD 16 may enter sleep mode. Typically, the time period during which IMD 16 inhibits neural stimulation is on the order of weeks, days, minutes, or hours, rather than tens of seconds or seconds.

These time periods (eg, a time period for on-cycle and a time period for off-cycle) may be programmed as absolute or associated with triggers such as sensor signals or telemetry circuit signals. In some examples, IMD 16 may be configured to deliver different types of stimulation treatments at different times during the patient's 14 menstrual cycle. For example, IMD 16 may deliver stimulation configured to reduce or eliminate bladder contractions to promote urinary retention and/or increase bladder capacity, and then deliver stimulation configured to promote urination in response to a user-requested voiding event or once it is detected that a voiding event has begun ( For example, stimulation that increases the frequency or magnitude of bladder contractions).

In some examples, sleep mode includes multiple sleep periods in a sequence, with brief periods outside of sleep mode. For example, if the results of diagnostic tests or requests to connect to external devices are OK, the IMD 16 can exit sleep mode to run diagnostic tests or advertise telemetry before re-entering sleep mode. In some examples, the sleep time may be altered by an algorithm that monitors treatment efficacy (eg, using implanted or external sensors) and adjusts the dose of treatment stimulation.

System 10 may also include an external programmer 24, as shown in Figure 1C. The external programmer 24 may be a clinician programmer or a patient programmer. In some examples, external programmer 24 may be a wearable communication device in which treatment request input is integrated into a key fob or wrist watch, a handheld computing device, a smartphone, a computer workstation, or a networked computing device. External programmer 24 may include a user interface configured to receive input from a user (eg, patient 14, patient caregiver, or clinician). In some examples, the user interface includes, for example, a keypad and a display, which may be, for example, a liquid crystal display (LCD) or a light emitting diode (LED) display. The keypad may take the form of an alphanumeric keypad or a reduced set of keys associated with a specific function. Additionally or alternatively, the external programmer 24 may include a peripheral pointing device, such as a mouse, via which a user may interact with the user interface. In some examples, the display of external programmer 24 may include a touch screen display, and a user may interact with external programmer 24 via the display. It should be noted that the user may also interact with external programmer 24 and/or IMD 16 remotely via a networked computing device. In some examples, external programmer 24 may be configured to interoperate with leadless neurostimulation device 1 of Figures 1A-1B.

A user such as a physician, technician, surgeon, electrophysiologist, or other clinician may also interact with external programmer 24 or another separate programmer (not shown) such as a clinician programmer to communicate with IMD 16 . Such users can interact with the programmer to retrieve physiological or diagnostic information from the IMD16. The user may also interact with the programmer to program IMD 16, e.g., select stimulation parameter values with which IMD 16 generates and delivers stimulation and/or other operating parameters of IMD 16 (such as the magnitude of stimulation energy, user-requested stimulation period or period of protection against irritation or any other such user treatment customization) value. As discussed herein, the user may also provide input to the external programmer 24 indicating physiological events such as bladder fill level sensing and voiding events.

For example, the user may use the programmer to retrieve information from the IMD 16 regarding contraction frequency and/or voiding events of the bladder 12 . As another example, a user may use a programmer to retrieve information from IMD 16 regarding the performance or integrity of IMD 16 or other components of system 10 such as leads 18 , 20 and 28 or the power source of IMD 16 . In some examples, if a system condition is detected that could affect the efficacy of the treatment, this information can be presented to the user as an alert.

The patient 14 may request the IMD 16 to deliver or terminate electrical stimulation, for example, using the keypad or touch screen of the external programmer 24 , such as when the patient 14 senses that a leak episode may be imminent or when an impending voiding may benefit from promoting urinary retention. When terminating treatment. In this manner, the patient 14 may use the external programmer 24 to provide treatment requests to control the delivery of electrical stimulation "on demand" (eg, when the patient 14 deems stimulation treatment is needed). In the event that the patient 14 uses the external programmer 24 to request the IMD 16 to deliver therapy, the IMD 16 may exit sleep mode in order to deliver electrical stimulation. In some examples, patient 14 may use external programmer 24 to request IMD 16 to terminate electrical stimulation. In the event that the patient 14 uses the external programmer 24 to terminate electrical stimulation, the IMD 16 may enter sleep mode. The patient 14 may also use the external programmer 24 to provide other information to the IMD 16, such as information indicative of the phase of the menstrual cycle, such as the occurrence of voiding events.

External programmer 24 may provide notification to patient 14 when electrical stimulation is being delivered, or notify patient 14 of expected termination of electrical stimulation. Additionally, termination notification may be helpful so that the patient 14 is aware that a voiding event may be more likely, and/or that the filling cycle is coming to an end such that the bladder should be emptied (eg, the patient 14 should go to the bathroom). In such examples, external programmer 24 may display a visible message, emit an audible alarm signal, or provide a somatosensory alarm (eg, by causing the housing of external programmer 24 to vibrate). In other examples, the notification may indicate when treatment is available during the menstrual cycle (eg, a countdown in minutes, or an indication that treatment is ready). In this manner, the external programmer 24 may wait for input from the patient 14 before terminating electrical stimulation that relieves bladder contractions or otherwise promotes urinary retention. Patient 14 may enter input that confirms the termination of electrical stimulation, causing treatment to cease for voiding purposes; confirms that the system should maintain therapy delivery until patient 14 can void; and/or confirms that patient 14 is ready to proceed during voiding events A different stimulation treatment that promotes excretion.

In the event that no input is received within a specific time frame in anticipation of a voiding event, external programmer 24 may wirelessly transmit a signal to IMD 16 indicating the absence of patient input. The IMD 16 may then choose to continue stimulation until patient input is received, or to terminate stimulation to avoid tissue damage based on the programming of the IMD 16 .

IMD 16 and external programmer 24 may communicate via wireless communications using any technique known in the art. Examples of communication technologies may include, for example, low frequency, radio frequency (RF) telemetry, or inductive coupling, although other technologies are also contemplated. In some examples, external programmer 24 may include programming leads that may be placed proximate the patient's 14 body near the IMD 16 implantation site in order to improve the quality or safety of communications between IMD 16 and external programmer 24 sex.

In one example described herein, a device (eg, IMD 16) includes a battery configured to provide power to the device. The apparatus includes power domain firmware configured to determine when to open the battery switch or keep the battery switch closed based on one or more of a plurality of requests that the power domain firmware may receive from a plurality of firmware modules. When the battery switch is open, the device is in the above-described sleep mode and power is not supplied to many components of the device, whereas when the battery switch is closed, power is supplied to all components of the device that require power. The device includes a battery switch and multiple firmware modules. In examples where the device includes a stimulation circuit, the stimulation circuit is not powered by the battery when the medical device is in sleep mode (eg, battery switch is off).

Unlike other technologies that enter or exit sleep mode, implantable neurostimulators such as the leadless neurostimulation device 1 or the IMD 16 may include multiple firmware modules executing on processing circuitry as well as power domain circuitry executing on the power domain circuitry. Firmware module. Each of the plurality of firmware modules is configured to perform a corresponding function of the device (eg, therapy delivery, telemetry, etc.). At least two of the plurality of firmware modules are configured to determine whether corresponding hardware components (eg, therapy delivery circuitry, telemetry circuitry, etc.) require power or require power during corresponding time periods to perform corresponding functions. At least two of the plurality of firmware modules are further configured to generate and transmit one or more corresponding requests based on a determination of whether the corresponding hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period. The power domain firmware module is configured to receive one or more corresponding requests and determine whether to open the battery switch or keep the battery switch closed in response to the one or more corresponding requests. The power domain firmware module is further configured to control the battery switch to open or remain closed in response to the determination.

As mentioned above, different physiological markers can be present. As an example, the magnitude of the filling level may be a physiological marker of the bladder filling cycle. In one example, system 10 may detect the magnitude of the filling level by detecting the pressure level of bladder 12 (eg, via sensor 22). For example, one or more pressure or stretch sensors may be attached to the exterior of bladder 12 or implanted within the bladder. As another example, system 10 may detect the magnitude of the filling level by detecting the impedance level of bladder 12, such as by monitoring the impedance between electrodes 19 and 21 of Figure 1C.

IMD 16 may detect contraction of bladder 12 using any suitable technique such as based on one or more sensed physiological parameters that may be physiological markers of the menstrual cycle. In one example, the physiological marker is the impedance of the bladder 12 . In the example shown in Figure 1, IMD 16 may determine the impedance of bladder 12 using a four-wire (or Kelvin) measurement technique. In other examples, IMD 16 may measure bladder impedance using a two-wire sensing arrangement. In either case, IMD 16 may transmit electrical measurement signals, such as electrical current, through bladder 12 via leads 18 and 20 and determine the impedance of bladder 12 based on the transmitted electrical signals. This impedance measurement may be used to determine the fullness of bladder 12, etc.

In the exemplary four-wire arrangement shown in FIG. 1C , electrodes 19A and 21A and electrodes 19B and 21B may be positioned substantially opposite each other relative to the center of bladder 12 . For example, electrodes 19A and 21A may be placed on opposite sides of bladder 12, ie, front and back or left and right. In FIG. 1C , electrodes 19 and 21 are shown positioned proximate the outer surface of the wall of bladder 12 . In some examples, electrodes 19 and 21 may be sutured or otherwise attached to the bladder wall. In other examples, electrodes 19 and 21 may be implanted within the bladder wall. To measure the impedance of bladder 12, IMD 16 may provide an electrical signal, such as a current, via lead 18 to electrode 19A, while electrode 21A via lead 20 receives the electrical signal. IMD 16 may then determine the voltage between electrode 19B and electrode 21B via leads 18 and 20, respectively. IMD 16 determines the impedance of bladder 12 using known values of the electrical signal derived from the determined voltage.

In other examples, electrodes 19 and 21 may be used to detect EMG of the detrusor muscle. This EMG can be used to determine the bladder contraction frequency and physiological markers of patient 14. In some examples, EMG can also be used to detect the strength of bladder contractions. As an alternative to or in addition to EMG, strain gauges or other devices may be used to detect the status of the bladder 12, such as by sensing forces indicative of bladder contraction.

In the example of FIG. 1C , IMD 16 also includes sensor 22 for detecting changes in contraction of bladder 12 . Sensors 22 may include, for example, pressure sensors for detecting changes in bladder pressure, electrodes for sensing tibial, pudendal or sacral afferent nerve signals, urethral sphincter EMG signals (or where the system 10 provides therapy to manage stool In the example of acute or fecal incontinence, anal sphincter EMG signals) electrodes or any combination thereof. In the example where sensor 22 is a pressure sensor or a stretch sensor, sensor 22 may be a remote sensor that transmits signals wirelessly to IMD 16 , or may be carried on leads 18 , 20 , or 28 or additional leads coupled to IMD 16 On one of them. In some examples, IMD 16 may determine whether a frequency of contractions of bladder 12 has occurred based on the pressure signal generated by sensor 22 .

In examples where sensor 22 includes one or more electrodes for sensing incoming neural signals, the sensing electrodes may be carried on one of leads 18 , 20 , or 28 or additional leads coupled to IMD 16 . In examples where sensor 22 includes one or more sensing electrodes for generating urethral sphincter EMG, the sensing electrodes may be carried on one of leads 18 , 20 , or 28 or additional leads coupled to IMD 16 . In any event, in some examples, IMD 16 may control the timing of delivery of electrical stimulation based on input received from sensor 22 .

Sensors 22 may include patient motion sensors, such as accelerometers, that generate signals indicative of the patient's activity level or postural status. In some examples, IMD 16 may terminate or resume delivery of electrical stimulation to patient 14 upon detecting a patient activity level below or above a certain threshold based on signals from the motion sensor. For example, a patient activity level that is greater than or equal to a threshold (which may be stored in the memory of IMD 16) may indicate an increased probability that an inadvertent voiding event will occur and, therefore, system 10 should exit sleep mode and begin delivering electrical stimulation. In other examples, IMD 16 may use sensor 22 to identify postural states known to require a desired therapeutic effect. For example, the patient 14 may be more susceptible to inadvertent voiding events when the patient 14 is in an upright position compared to a lying position. In any event, electrodes 19 and 21 and sensor 22 may be configured to detect voiding events and/or the magnitude of the filling level of bladder 12 during a filling cycle.

As discussed above, system 10 can monitor the filling cycle of bladder 12 by detecting subsequent voiding events over time. In some examples, system 10 may detect a voiding event by receiving user input indicating the occurrence of a voiding event (eg, via external programmer 24). In other words, the external programmer 24 may receive input from the user that identifies the occurrence of a voiding event, the beginning of a voiding event, and/or the end of a voiding event. In other examples, system 10 may automatically detect voiding events without receiving user input via external programmer 24 . Rather, the system 10 may detect bladder pressure, urine flow from the bladder, wetness of the patient's 14 external body, bladder volume, electromyography (EMG) signals, neural recordings, postural changes, patient's 14 position in a patient's 14 home, such as a residential or nursing facility. Excretion events are detected at least one of a physical location within the structure or a bathroom usage event. Some sensors outside the patient's 14 body may communicate with the external programmer 24 and/or the IMD 16 to provide such information indicative of possible voiding events. For example, humidity may be detected by a moisture sensor (eg, electrical impedance or chemical sensor) embedded in underwear worn by patient 14 and transmitted to IMD 16 or external programmer 24 . Similarly, the lavatory may include a presence sensor (eg, an infrared sensor, a thermal sensor, or a pressure sensor) that detects when patient 14 is using the lavatory and transmits a signal indicating the presence of patient 14 to IMD 16 or external programmer 24 . In this manner, non-invasively acquired data can provide information indicative of excretion events without implanted sensors, and such information can be used to determine when to enter or exit sleep mode.

Figure 2 is a block diagram illustrating an exemplary configuration of an IMD. As shown in Figure 2, IMD 32 (which may be an example of leadless neurostimulation device 1 or IMD 16) includes sensor 30, processor circuit 53, therapy delivery circuit 52, impedance circuit 54, memory 56, telemetry circuit 58, power Domain circuit 70, battery switch 72 and power supply 60. In some examples, sensor 30 may be similar to sensor 22 of Figure 1C. In other examples, IMD 32 may include a greater or lesser number or different components. For example, where the IMD 32 represents a leadless neurostimulation device 1 , the IMD 32 does not include leads, but electrodes are disposed on the surface of the IMD 32 .

Generally speaking, IMD 32 may include any suitable hardware arrangement, alone or in combination with software and/or firmware, for performing techniques attributed to IMD 32 and components of IMD 32 . In various examples, processor circuitry 53 of IMD 32 may include one or more processors, such as one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gates array (FPGA) or any other equivalent integrated or discrete logic circuit, and any combination of such components. In various examples, IMD 32 may also include memory 56 such as random access memory (RAM), synchronous RAM (SRAM), ferroelectric RAM (FRAM), nonvolatile memory, read only memory (ROM), Programmable Read-Only Memory (PROM), Erasable Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM), Flash Memory, which memory includes means for causing one or more processors to execute Executable instructions for their actions. In some examples, memory 56 includes non-volatile memory 74 , which may be used to store values (such as state and memory information 68 ) used by components, such as firmware components. Power may not be supplied when battery switch 72 is open in order to preserve such values.

Although processor circuit 53 , therapy delivery circuit 52 , impedance circuit 54 , and telemetry circuit 58 are described as separate circuits, in some examples processor circuit 53 , therapy delivery circuit 52 , impedance circuit 54 , and telemetry circuit 58 are functionally integrated. In some examples, processor circuit 53, treatment delivery circuit 52, impedance circuit 54, and telemetry circuit 58 correspond to separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit. In further examples, any of processor circuit 53, treatment delivery circuit 52, impedance circuit 54, and telemetry circuit 58 may correspond to multiple separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit.

Memory 56 stores a treatment program 66 that specifies stimulation parameter values and electrode combinations for electrical stimulation provided by IMD 32 . The therapy program 66 may also store information regarding the determination and use of physiological parameters, information regarding menstrual cycles and/or dysfunctional states, or any other information needed for the IMD 32 to deliver stimulation therapy. In some examples, the stimulation treatment is based on one or more physiological parameters of patient 14 . In some examples, memory 56 also stores bladder data 69 that processor circuitry 53 can use to control the timing of electrical stimulation delivery (eg, phases of the menstrual cycle that define when stimulation is delivered and inhibited). For example, bladder data 69 may include a threshold or baseline value for at least one of bladder impedance, bladder pressure, afferent nerve signals, bladder contraction frequency, or external urethral sphincter EMG template that serves as a physiological marker of the associated physiological cycle. Bladder data 69 may also include timing information and physiological markers associated with physiological events such as voiding events.

Memory 56 may also store status and memory information 68. In some examples, non-volatile memory 74 may store status and memory information 68 such that status and memory information 68 is stored even when battery switch 72 is open. For example, when IMD 32 is about to enter sleep mode, processor circuitry 53, power domain circuitry 70, or power domain firmware (not shown in FIG. 2) may store certain state and memory information in state and memory information 68. The battery switch 72 can then be opened. Then, when IMD 32 is exiting sleep mode, status and memory information 68 may be accessed by various components of IMD 32 (such as firmware, processor circuitry 53, etc.), which may be used to restore IMD 32 to a normal operating state. Status and memory information 68 may include time information indicating when to enter sleep mode, the desired exit time from sleep mode, the length of time last therapy was delivered, etc. Status and memory information 68 may include diagnostic information, such as images and logs, and/or usage information. Status and memory information 68 may also include information regarding sensor acquisition and treatment sequences. Status and memory information 68 may include algorithm status and data for ongoing assessments, such as bladder filling calculations or therapy titration calculations. Status and memory information 68 may also include diagnostic data for device status, such as battery voltage, electrode impedance, and/or telemetry logs. It should be noted that when battery switch 72 is closed, status and memory information 68 may be stored in other types of memory 56 , such as RAM, SRAM, FRAM, etc., rather than non-volatile memory 74 .

In some examples, power domain circuit 70 may remain powered when battery switch 72 is open. In some examples, power domain circuit 70 may cause battery switch 72 to close to repower other components of IMD 32 . For example, power domain circuitry 70 may close battery switch 72 in response to detecting incoming telemetry, detecting recharge energy, or after a defined period of time (eg, a period of time received from power domain firmware). In some examples, when battery switch 72 is open, in addition to a real-time clock (not shown) and circuitry or firmware that may be configured to detect incoming telemetry transmissions and/or recharge energy for recharging the battery. Additionally, each of the other components of the IMD 32 is powered down.

Information related to sensed bladder contractions, bladder impedance, and/or posture of patient 14 may be stored in bladder data 69 . Bladder data 69 may be retrieved by the user and/or used by processor circuitry 53 to adjust stimulation parameters (eg, amplitude, pulse width, and pulse rate). In some examples, memory 56 includes separate memory for storing instructions, electrical signal information, treatment procedures 66 , status and memory information 68 , and bladder data 69 . In some examples, processor circuit 53 selects new stimulation parameters for treatment program 66 or selects a new stimulation program from treatment program 66 for electrical stimulation delivery based on patient input or sensor signals. In some examples, processor circuitry 53 may use bladder data 69 to determine the efficacy of the treatment program and may adjust the period of stimulation and the suppression period of stimulation and associated operating modes based on the determined efficacy of the treatment program. Sleep mode.

Generally speaking, treatment delivery circuit 52 generates and delivers electrical stimulation under the control of processor circuit 53 . As used herein, controlling the delivery of electrical stimulation may also include controlling the termination of stimulation to achieve different stimulation and non-stimulation phases. In some examples, processor circuit 53 controls therapy delivery circuit 52 by accessing memory 56 to selectively access and load at least one of therapy programs 66 into therapy delivery circuit 52 . For example, in operation, processor circuit 53 may access memory 56 to load one of treatment programs 66 into treatment delivery circuit 52 . In other examples, treatment delivery circuitry 52 may access memory 56 and load one of the treatment programs 66 .

By way of example, processor circuit 53 may access memory 56 to load one of treatment programs 66 to treatment delivery circuit 52 for delivery of electrical stimulation to patient 14 . The clinician or patient 14 may select a specific one of the treatment procedures 66 from the list using a programming device such as an external programmer 24 or a clinician programmer. Processor circuit 53 may receive the selection via telemetry circuit 58 . The treatment delivery circuit 52 delivers electrical stimulation to the patient 14 according to the selected procedure for an extended period of time, such as minutes, hours, days, weeks, or until the patient 14 or the clinician manually stops or changes the procedure.

Treatment delivery circuit 52 delivers electrical stimulation according to stimulation parameters. In some examples, treatment delivery circuit 52 delivers electrical stimulation in the form of electrical pulses. In such examples, relevant stimulation parameters may include voltage amplitude, current amplitude, pulse rate, pulse width, duty cycle, or combination of electrodes 29 used by therapy delivery circuit 52 to deliver stimulation signals. In other examples, treatment delivery circuit 52 delivers electrical stimulation in the form of a continuous waveform. In such examples, relevant stimulation parameters may include voltage or current amplitude, frequency, the shape of the stimulation signal, the duty cycle of the stimulation signal, or the combination of electrodes 29 used by the therapy delivery circuit 52 to deliver the stimulation signal.

In some examples, stimulation parameters of treatment program 66 may be selected to cause bladder 12 to relax upon termination of electrical stimulation, for example, to reduce the frequency of bladder 12 contractions. Exemplary ranges of stimulation parameters for electrical stimulation that may be effective in treating bladder dysfunction (e.g., when applied to the tibial, spinal, sacral, pudendal, dorsal genital, lower rectal, or perineal nerves) are as follows:

1. Frequency or pulse rate: between about 0.5 Hz and about 500 Hz, such as between about 1 Hz and about 250 Hz, between about 1 Hz and about 20 Hz, or about 10 Hz.

2. Amplitude: between about 0.1 volts and about 50 volts, such as between about 0.5 volts and about 20 volts, or between about 1 volt and about 10 volts. Alternatively, the amplitude may be between about 0.1 milliamps (mA) and about 50 mA, such as between about 0.5 mA and about 20 mA, or between about 1 mA and about 10 mA.

3. Pulse width: between about 10 microseconds (μs) and about 5000 μs, such as between about 100 μs and about 1000 μs, or between about 100 μs and about 200 μs.

While the IMD 32 monitors the filling level of the bladder to determine the status of the bladder filling cycle, the processor circuit 53 may monitor the impedance of the bladder 12 for a predetermined duration to detect contraction of the bladder 12 and detect contraction of the bladder 12 by determining the resistance of the bladder 12 for the predetermined duration. The number of contractions is used to determine the baseline contraction frequency of the bladder 12. In other examples, electrodes 19 or 21 may be used to detect EMG of the detrusor muscle to identify bladder contraction frequency. Alternatively, strain gauge sensor signal output or other measures of changes in bladder contraction may be used to detect physiological markers of bladder 12 . In some examples, each of these alternative methods of monitoring bladder 12 filling levels and/or voiding events may be used.

In the example shown in FIG. 2 , the impedance circuit 54 includes a voltage measurement circuit 62 and a current source 64 , and may include an oscillator (not shown) for generating an alternating signal, or the like. In some examples, impedance circuit 54 may use a four-wire or Kelvin arrangement, as described above with respect to FIG. 1C. For example, processor circuit 53 may periodically control current source 64 to provide a current signal through electrode 19A and receive a current signal through electrode 21A, for example. In some examples, to collect impedance measurements, current source 64 may deliver current signals (eg, sub-threshold signals) to bladder 12 that are affected by, for example, the amplitude or width of such signals and/or the delivery of such signals. of timing without delivering stimulation treatments. Impedance circuit 54 may also include switching circuitry (not shown) for selectively coupling electrodes 19A, 19B, 21A, and 21B to current source 64 and voltage measurement circuit 62. Voltage measurement circuit 62 can measure the voltage between electrodes 19B and 21B. Voltage measurement circuit 62 may include a sample and hold circuit or other suitable circuit for measuring voltage amplitude. Processor circuit 53 determines the impedance value based on the measured voltage value received from voltage measurement circuit 62 .

In other examples, processor circuit 53 may monitor signals received from sensor 22 to detect contractions of bladder 12 and determine a baseline contraction frequency. In some examples, sensor 22 may be a pressure sensor for detecting changes in pressure of bladder 12 , and processor circuitry 53 may correlate pressure changes with contractions of bladder 12 . Processor circuit 53 may determine a pressure value based on the signal received from sensor 22 and compare the determined pressure value to a threshold value stored in bladder data 69 to determine whether the signal indicates contraction of bladder 12 . In some implementations, processor circuit 53 monitors the pressure of bladder 12 to detect contractions of bladder 12 within a predetermined duration, and determines the frequency of contractions of bladder 12 by counting the number of contractions of bladder 12 within a predetermined time period.

In some examples, processor circuitry 53 may cause contraction frequency information to be stored in memory 56 as bladder data 69 and changes in contraction frequency may be utilized to track filling levels of the bladder filling cycle or otherwise track phases of the filling cycle. In some implementations, processor circuit 53 may determine the frequency of contractions during the filling cycle automatically or under user control. Processor circuit 53 may determine that an increase in contraction frequency indicates an advanced stage of the filling cycle. In some examples, processor circuit 53 may use patient 14's EMG signals to track bladder contractions. In some implementations, sensor 22 may include an EMG sensor, and processor circuit 53 may generate EMG from the received signal generated by sensor 22 . Sensor 22 may be implanted near a muscle that is active when bladder 12 contracts, such as, for example, the detrusor muscle. Processor circuitry 53 may compare the EMG collected during the second time period to an EMG template (eg, a short-term running average) stored as bladder data 69 to determine whether contractions of bladder 12 indicate a particular phase of the bladder filling cycle.

In other examples, sensor 22 may be a pressure sensor, and processor circuitry 53 may monitor signals received from sensor 22 during at least a portion of the second period of time to detect contraction of bladder 12 . In some examples, processor circuit 53 substantially continuously monitors the pressure of bladder 12 during at least the second period of time to detect contractions of bladder 12 and determines the number of contractions of bladder 12 by determining the number of contractions of bladder 12 within the specified time period. Contraction frequency. Sensor 22 may also provide longer-term pressure changes to track bladder filling status (eg, increased bladder volume may correspond to increased bladder pressure).

In the example of FIG. 2 , treatment delivery circuit 52 drives electrodes on a single lead 28 . Specifically, treatment delivery circuit 52 delivers electrical stimulation to the tissue of patient 14 via selected electrodes 29A-29D carried by leads 28 . The proximal end of lead 28 extends from the housing of IMD 32 and the distal end of lead 28 extends to a target treatment site such as the tibial nerve, a spinal nerve (eg, S3 nerve), or a treatment site within the pelvic floor such as proximate the sacral nerves , pudendal nerve, dorsal genital nerve, inferior rectal nerve, perineal nerve, hypogastric nerve, urethral sphincter, or tissue site of any combination thereof. In other examples, therapy delivery circuit 52 may deliver electrical stimulation utilizing electrodes on more than one lead, and each of the leads may carry one or more electrodes. The leads may be configured as axial leads with ring electrodes or segmented electrodes and/or as paddle leads with electrode pads arranged in a two-dimensional array. The electrodes may operate in a bipolar or multipolar configuration with other electrodes, or may operate in a monopolar configuration with the electrodes carried by the device housing or "can" of the IMD 32.

As previously mentioned, sensor 22 may include a pressure sensor configured to detect changes in bladder pressure, electrodes for sensing pudendal or sacral afferent nerve signals, or for sensing external urethral sphincter EMG signals (or where IMD 32 Examples of providing treatment for fecal urgency or fecal incontinence are electrodes such as anal sphincter signals), or any combination thereof. Additionally or alternatively, sensor 22 may include a motion sensor such as a dual-axis accelerometer, a three-axis accelerometer, one or more gyroscopes, pressure transducers, piezoelectric crystals, or sensors that generate changes in response to the patient's activity level or posture state. changes in the signal of other sensors. Processor circuit 53 may detect physiological markers indicative of points during the bladder filling cycle. Sensor 22 may also be a motion sensor that responds to a tap on the skin over IMD 32 (eg, by patient 14). Processor circuit 53 may be configured to record patient input using this tapping method (eg, tapping may indicate that a voiding event is occurring). Alternatively or in addition, processor circuit 53 may control therapy circuit 52 to deliver or terminate electrical stimulation delivery in response to a tap or certain tap pattern.

In examples where sensor 22 includes a motion sensor, processor circuit 53 may determine the patient activity level or postural state based on signals generated by sensor 22 . The patient activity level may be, for example, sitting, exercising, working, running, walking, or any other activity of the patient 14. For example, processor circuit 53 may determine the patient activity level by sampling the signal from sensor 22 and determining the number of activity counts during the sampling period, with each of a plurality of activity levels associated with a corresponding activity count. In one example, processor circuit 53 compares the signal generated by sensor 22 to one or more amplitude thresholds stored within memory 56 and identifies each threshold crossing as an activity count. Physical activity may indicate filling levels, voiding events, or any other physiological marker associated with the bladder filling cycle.

In some examples, processor circuit 53 may control therapy delivery circuit 52 to deliver or terminate electrical stimulation. The power domain circuit 70 can control the battery switch 72 to enter or exit the sleep mode.

Telemetry circuitry 58 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device such as external programmer 24 (FIG. 1C). Under the control of processor circuit 53 , telemetry circuit 58 may receive downlink telemetry (eg, patient input) from external programmer 24 and transmit uplink telemetry (eg, alarms) to the external programmer 24 via an antenna that Can be internal and/or external. Processor circuit 53 may provide data to be uplinked to external programmer 24 and control signals for telemetry circuitry within telemetry circuit 58 and receive data from telemetry circuit 58 .

Generally speaking, processor circuitry 53 may control telemetry circuitry 58 to exchange information with external programmer 24 and/or another device external to IMD 32 . Processor circuit 53 may transmit operational information and receive stimulation programs or stimulation parameter adjustments via telemetry circuit 58 . Furthermore, in some examples, IMD 32 may communicate with other implanted devices such as stimulators, control devices, or sensors via telemetry circuitry 58 .

Power supply 60 delivers operating power to the components of IMD 32 . Power supply 60 may include batteries and power generation circuitry for generating operating power. In some examples, the battery may be rechargeable to allow long-term operation. Recharging can be achieved through near-side inductive interaction between an external charger and the inductive charging coil within the IMD 32.

Power domain circuitry 70 (and/or power domain firmware not shown in FIG. 2 ) may be configured to remove power normally provided by power supply 60 from various components of IMD 32 . In some examples, power domain firmware 100 executing on processing circuitry such as power domain circuitry 70 may be configured to determine whether IMD 32 should enter sleep mode based on requests from multiple firmware modules (not shown in Figure 2) (eg, open battery switch 72 or keep battery switch 72 closed). For example, power domain circuit 70 may be configured to receive a notification from the power domain firmware that battery switch 72 may be turned off, and in response to the notification, respond to the notification from processor circuit 53 , therapy delivery circuitry, by turning off battery switch 72 and entering sleep mode. 52 and/or impedance circuit 54 remove power. In some examples, power domain circuitry 70 may also be configured to restore power to such components upon exiting sleep mode. For example, power domain circuitry 70 may close battery switch 72 in response to detecting incoming telemetry, detecting recharge energy, or after a defined period of time (eg, a period of time received from power domain firmware).

FIG. 3 is a block diagram illustrating an exemplary configuration of external programmer 24. Although external programmer 24 may generally be described as a handheld computing device, external programmer 24 may be, for example, a laptop computer, smartphone, or workstation. As shown in FIG. 3 , external programmer 24 may include processor circuitry 90 , memory 92 , user interface 94 , telemetry circuitry 96 , and power source 98 . Memory 92 may store program instructions that, when executed by processor circuit 90, cause processor circuit 90 and external programmer 24 to provide the functionality ascribed to external programmer 24 throughout this disclosure.

Generally speaking, external programmer 24 includes any suitable technology that, alone or in combination with software and/or firmware, performs the techniques attributed to external programmer 24 and processor circuitry 90 , user interface 94 , and telemetry circuitry 96 of external programmer 24 Hardware layout. In various examples, external programmer 24 may include one or more processors, such as one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as the functionality of such components. random combination. In various examples, external programmer 24 may also include memory 92, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard drive, CD-ROM, that includes a memory 92 for causing one or more processors to perform the Executable instructions for their actions. Additionally, although processor circuit 90 and telemetry circuit 96 are described as separate circuits, in some examples, processor circuit 90 and telemetry circuit 96 may be functionally integrated. In some examples, processor circuit 90 and telemetry circuits 96 and 58 correspond to separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit. In other examples, processor circuit 90 and any of telemetry circuits 96 and 58 may correspond to multiple separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit.

Memory 92 may store program instructions that, when executed by processor circuit 90, cause processor circuit 90 and external programmer 24 to provide the functionality ascribed to external programmer 24 throughout this disclosure. In some examples, memory 92 may also include program information, such as stimulation programs defining neural stimulation similar to those stored in memory 56 of IMD 32 . Stimulation programs stored in memory 92 may be downloaded into memory 56 of IMD 32.

In some examples, the system includes a user interface 94 that allows the patient 14 to provide input. IMD32 can respond to patient-provided data from the user interface by changing treatments. For example, the patient 14 may use an external programmer 24 (eg, a handheld device) to record (by pushing a button) physiological events of interest. The processor circuitry 53 of the IMD 32 may respond by turning therapy on or off and exiting or entering sleep mode, or by adjusting therapy (eg, stimulation intensity), or by changing the therapy program. Referring to the urology application discussed herein, when the bladder is emptying, the patient 14 can push a button on an external programmer 24 (eg, their smartphone). For example, this may signal the IMD 32 to shut down and enter a sleep mode for a preprogrammed period of time based on the voiding characteristics of the patient 14 .

User interface 94 may include buttons or keypad, lights, speakers for voice commands, a display such as a liquid crystal (LCD), light emitting diode (LED), or cathode ray tube (CRT). In some examples, the display may be a touch screen. As discussed in this disclosure, processor circuitry 90 can present and receive information related to electrical stimulation and resulting therapeutic effects via user interface 94. For example, processor circuit 90 may receive patient input via user interface 94 . Input may be in the form of, for example, pressing a button on a keypad or selecting an icon from a touch screen.

Processor circuitry 90 may also present information to patient 14 in the form of alerts via user interface 94 related to the delivery of electrical stimulation to patient 14 or a caregiver, as described in greater detail below. Although not shown, external programmer 24 may additionally or alternatively include a data or network interface to another computing device to facilitate communication with the other device and to facilitate presentation and electrical stimulation via the other device. and information related to the effects of treatment after discontinuation of electrical stimulation.

Under the control of processor circuit 90 , telemetry circuit 96 supports wireless communication between IMD 32 and external programmer 24 . Telemetry circuitry 96 may also be configured to communicate with another computing device via wireless communication technology, or directly with another computing device through a wired connection. In some examples, telemetry circuitry 96 may be substantially similar to telemetry circuitry 58 of IMD 32 described above, providing wireless communication via a radio frequency or near-side sensing medium. In some examples, telemetry circuitry 96 may include an antenna, which may take many forms, such as an internal antenna or an external antenna.

Examples of local wireless communication technologies 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 set, infrared communication according to, for example, the IrDA standard or other standards or proprietary telemetry protocols. In this manner, other external devices are able to communicate with programmer 24 without establishing a secure wireless connection.

Power supply 98 delivers operating power to the components of programmer 24 . Power source 98 may include batteries and power generation circuitry for generating operating power. In some examples, the battery may be rechargeable to allow long-term operation.

4 is a block diagram illustrating an exemplary neurostimulation device having multiple firmware modules in accordance with the techniques of the present disclosure. IMD 32 includes power domain firmware 100. Power domain firmware 100 may execute within power domain circuitry 70 . IMD 32 may include multiple firmware modules. For example, IMD 32 may include non-volatile memory firmware 102 , device time firmware 104 , telemetry firmware 106 , therapy delivery firmware 108 , fuel gauge firmware 110 (which may be configured to provide control of the remaining charge of the battery powering IMD 32 estimation), and/or device recharging firmware 112 (which may be configured to manage battery recharging sessions), each of which may be referred to as a firmware module, whether they are implemented individually or together as one or more firmware. In some examples, the telemetry circuitry of IMD 32 may be configured to use multiple channels. In such cases, IMD 32 may also include channel firmware 107 that may be associated with multiple channels. In examples where IMD 32 includes sensing circuitry (such as impedance circuit 54 and/or sensor 30 of FIG. 2 ), IMD 32 may include sensing firmware 114 . Although not depicted in Figure 4, IMD 32 may include corresponding hardware (eg, circuitry) for one or more of the plurality of firmware modules. For example, IMD 32 may include non-volatile memory 74 (FIG. 2) which may correspond to non-volatile memory firmware 102, telemetry circuitry 58 which may correspond to and execute telemetry firmware 106, therapy delivery firmware 108 The treatment delivery circuit 52, etc. In some examples, there may be no hardware corresponding to a particular firmware module, or multiple firmware modules may use the same set of hardware (eg, circuitry). Although specific firmware modules are depicted in Figure 4, in some examples, fewer, more, or different firmware modules may be included in a device in accordance with the techniques of this disclosure.

In some examples, IMD 32 may be a neurostimulator that includes power domain hardware capabilities that facilitate the ability to hibernate firmware features on IMD 32 to conserve power. IMD 32 may include firmware (eg, power domain firmware 100) that allocates and manages power consumption requests to ensure that IMD 32 has power available when needed but sleeps when possible. For example, IMD 32 firmware logic can enable prioritized scheduling and timing of firmware features. Unlike other technologies for entering or exiting sleep mode, implantable neurostimulators such as IMD 32 may include multiple firmware modules executing on processing circuitry (eg, processor circuitry 53, telemetry circuitry 58, therapy delivery circuitry 52) (e.g., non-volatile memory firmware 102 , device time firmware 104 , telemetry firmware 106 , therapy delivery firmware 108 , fuel gauge firmware 110 , device recharge firmware 112 , and/or other firmware modules) and executing on power domain circuitry 70 The power domain firmware module 100. Each of the plurality of firmware modules is configured to perform a corresponding function of the device (eg, therapy delivery, telemetry, etc.). At least two of the plurality of firmware modules are configured to determine whether corresponding hardware components (eg, therapy delivery circuit 52, telemetry circuit 58, etc.) require power or require power during corresponding time periods to perform corresponding functions. At least two of the plurality of firmware modules are further configured to generate and transmit one or more corresponding requests based on a determination of whether the corresponding hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period. Power domain firmware 100 is configured to receive one or more corresponding requests and determine whether to open battery switch 72 or keep battery switch 72 closed in response to the one or more corresponding requests. Power domain firmware 100 is also configured to control battery switch 72 to open or remain closed in response to this determination.

Power domain firmware 100 may be configured to operate from multiple firmware modules (eg, non-volatile memory firmware 102, device time firmware 104, telemetry firmware 106, therapy delivery firmware 108, fuel gauge firmware 110, device recharge firmware 112, and or other firmware module not shown in FIG. 4 ) receives input as to whether battery switch 72 can be opened or held closed by power domain firmware 100 . Power domain firmware 100 may moderate, mediate, or arbitrate whether and for how long to open battery switch 72 (FIG. 2) based on input from multiple firmware modules.

For example, power domain firmware 100 may receive a request from telemetry firmware 106 to prevent battery switch 72 from turning off until further notice, and may receive a request from therapy delivery firmware 108 to allow battery switch 72 to turn off until further notice. In this case, power domain firmware 100 may determine to keep battery switch 72 closed and control the battery switch to remain closed because telemetry firmware 106 has indicated that battery switch 72 should remain closed. In such examples, telemetry firmware 106 and/or telemetry circuitry 58 still require power, for example, to perform telemetry operations. In another example, power domain firmware 100 may receive a request from therapy delivery firmware 108 to prevent battery switch 72 from being opened until a first time period expires (eg, 5 minutes from now), and a request from telemetry firmware 106 The request allows the battery switch 72 to be opened now, but requires the battery switch 72 to be closed when the second time period expires (eg, 5 minutes from now). In such examples, power domain firmware 100 may determine to keep battery switch 72 closed and control the battery switch to remain closed until at least power domain firmware 100 receives a request from telemetry firmware 106 to allow battery switch 72 to open. In this manner, power domain firmware 100 does not control battery switch 72 to turn off unless all received requests indicate that it is okay to turn battery switch 72 off, and then as long as all received requests indicate that it is okay to keep battery switch 72 off. Can.

Power domain firmware 100 is configured to control battery switch 72 to open or close based on requests from multiple firmware modules, such as firmware requests or hardware interrupts. In this manner, power domain firmware 100 may act as an arbiter or mediator for requests received from multiple firmware modules. For example, when battery switch 72 is closed, IMD 32's battery (eg, power supply 60) may provide power to components of IMD 32 that require power, and IMD 32 may be said to be in an operating mode. When battery switch 72 is open, the battery provides power to less than all components of IMD 32 that require power to operate, thereby reducing power consumption. In this case, it can be said that the IMD 32 is in sleep mode.

In some examples, power domain firmware 100 may store information about why battery switch 72 is closed and why battery switch 72 is open. In some examples, power domain firmware 100 may send messages to multiple firmware modules indicating why battery switch 72 is to be turned off before battery switch 72 is turned off. In some examples, instead of opening battery switch 72 , power domain firmware 100 may send a message instructing power domain circuit 70 ( FIG. 2 ) to open battery switch 72 , and power domain circuit 70 may open in response to the message. Battery switch 72.

In some examples, power domain firmware 100 may periodically perform analysis of requests received from multiple firmware modules. For example, power domain firmware 100 may perform such analysis every predetermined amount of time. This predetermined amount of time may include 5 seconds, 10 seconds, 15 seconds, 16 seconds, 20 seconds, 30 seconds, or any other predetermined amount of time. In other examples, power domain firmware 100 may perform analysis of received requests continuously and in real time. The result of this analysis may be to turn off battery switch 72 and, in some examples, how long to keep battery switch 72 off. Alternatively, the result of this analysis may be to keep battery switch 72 closed. In some examples, the maximum length of time that battery switch 72 can be open may be limited. By limiting the maximum length of time that battery switch 72 can be off, IMD 32 can be in an operating mode when incoming telemetry or therapy delivery is expected.

In some examples, power domain firmware 100 may send a notification to each of the plurality of firmware modules before turning off battery switch 72 to allow time to store data used by the plurality of firmware modules before turning off battery switch 72 In non-volatile memory 74 (FIG. 2), since opening battery switch 72 can result in data loss if the data is only stored in volatile memory, such as RAM. In some examples, power domain firmware 100 may commit data from multiple firmware modules to non-volatile memory 74 rather than each of the multiple firmware modules performing the commit. In some examples, each of the plurality of firmware modules may retrieve its own stored data from non-volatile memory 74 when battery switch 72 is reclosed. Notification that the switch is about to open may also allow any of the plurality of firmware modules to send a request to keep battery switch 72 closed until battery switch 72 opens.

In some examples, the power domain firmware 100 allows other portions of the firmware (eg, multiple firmware modules) to have input into when the battery switch may be opened and closed. In some examples, power domain firmware 100 may receive a scheduling request from any of the plurality of firmware modules. This scheduling request can be limited to one of four types of requests. For example, at least two firmware modules among a plurality of firmware modules (excluding power domain firmware 100) may transmit requests to power domain firmware 100 while the plurality of firmware modules are powered. Such requests may include: a) allowing the battery switch 72 to be disconnected at any time until further notice; b) not allowing (e.g., preventing) the battery switch 72 from disconnecting at all until further notice; c) not allowing (e.g., blocking) the battery Switch 72 is open until X seconds from now; or d) allow battery switch 72 to be open now, but close the switch and make the firmware fully operational within Y seconds.

Power domain firmware 100 may periodically (or alternatively, continuously) evaluate the conditions of all requests from multiple firmware modules, and if all requests received by power domain firmware 100 indicate that battery switch 72 may be opened immediately, then Power domain firmware 100 may turn off battery switch 72 for an appropriate length of time. The appropriate length of time may be based on requests received from multiple firmware modules. For example, if the therapy delivery firmware 108 requests that the battery switch 72 may open, but needs to close within 8 seconds for the firmware to be fully operational, and any other received request indicates that the battery switch 72 may open for these 8 seconds, then the power domain Firmware 100 may open battery switch 72 and power domain circuit 70 may close battery switch 72 once such that therapy delivery firmware 108 is fully operational 8 seconds after receiving the request from therapy delivery firmware 108 . It should be noted that this 8 second period can be shortened by detecting incoming telemetry or battery recharge energy. For example, if IMD 32 detects incoming telemetry or battery recharge energy after battery switch 72 is turned off, power domain circuitry 70 , telemetry circuitry 58 , or other circuitry may respond to detecting incoming telemetry before 8 seconds have expired. Telemetry or recharging energy to close the switch.

In some examples, power domain firmware 100 may maintain lifetime device values that any of the plurality of firmware modules may reference as needed or desired. For example, power domain firmware 100 may maintain a lifetime count for the cumulative amount of time that IMD 32 has left battery switch 72 open and a lifetime count for the cumulative amount of time that IMD 32 has left battery switch 72 closed. The lifetime count may include a count over the lifetime of the device (eg, IMD 32).

Non-volatile memory firmware 102 can manage the power needs of non-volatile memory 74 (FIG. 2) by generating and sending requests to power domain firmware 100. Non-volatile memory 74 may be configured to store data in such a manner that when not powered, the data is retained even when non-volatile memory 74 or other components of IMD 32 are not powered. In some examples, this data may include diagnostic information, such as images and logs, which may be stored in state and memory 56 . Non-volatile memory firmware 102 may be configured to track standard device time. In some examples, this standard device time may include the total number of device resets and a count of seconds since the most recent reset. In some examples, the non-volatile memory firmware 102 may also maintain a predetermined number (eg, 10) of the most recently reset diagnostic logs.

The fuel gauge firmware 110 may be configured to use voltage measurements, coulomb counter ticks, and battery charge curves to provide an estimate of remaining battery charge. Device recharge firmware 112 may be configured to manage battery recharge sessions.

Power domain circuit 70 may close battery switch 72 that is open due to incoming telemetry, incoming recharge energy, or after a defined interval (eg, a period of time determined by power domain firmware 100 to keep the battery switch open). Power domain firmware 100 may be configured to reliably and robustly determine the duration for which battery switch 72 is open regardless of how battery switch 72 is closed. If a request from one or more of the plurality of firmware modules indicates that battery switch 72 should be prevented from turning off, any preparatory action taken by power domain firmware 100 to turn off battery switch 72 may be canceled, causing the issuance of The requested one or more firmware modules of the plurality of firmware modules will continue to be powered and may continue to operate.

For example, while non-volatile memory 74 is updating diagnostic information, non-volatile memory 74 may request that battery switch 72 remains closed. At other times, non-volatile memory 74 may not issue a request to keep the battery switch closed. For example, non-volatile memory 74 may not require power during times when diagnostic information is not updated. Therefore, non-volatile memory 74 may issue a request to open the switch. Prior to turning off battery switch 72, all important data may be written to non-volatile memory 74 for persistent storage during a power outage event. In some examples, because it may be desirable to not generate new data after writing important data to non-volatile memory 74 before battery switch 72 is turned off, IMD 32 may write the data to non-volatile memory 74 after And prevent any firmware module from executing normally until the battery switch 72 is turned off.

Device time firmware 104 may update the device time, and power domain firmware 100 may store the device time in an image of non-volatile memory 74 just before the battery switch is turned off. If the battery switch 72 does not open for some reason, the device time system (not shown) may be restarted, of which the device time firmware 104 may be a part.

Telemetry firmware 106 may require battery switch 72 to be closed during downlink, processing, or uplink of any telemetry message because telemetry circuitry 58 may otherwise be powered down. In some examples, telemetry firmware 106 may require battery switch 72 to be closed for a certain period of time after each telemetry message and may issue appropriate requests to keep the battery switch closed until the first period of time expires. In other words, the telemetry firmware 106 may issue a request to prevent the battery switch 72 from turning off until the first time period expires. In other cases, the telemetry firmware 106 may issue a request to allow the battery switch 72 to be disconnected at any time until further notice. In some examples, telemetry firmware 106 may utilize power domain hardware (eg, power domain circuitry 70 of FIG. 2) to detect incoming telemetry while maintaining control of the telemetry. In some examples, power domain firmware 100 may be powered down when battery switch 72 is open. In such examples, power domain circuitry 70 may be configured to close battery switch 72 when incoming telemetry is detected. For example, power domain circuitry 70 may detect energy on an antenna or coil used for telemetry to detect incoming telemetry.

Treatment delivery firmware 108 may request battery switch 72 to remain closed any time stimulation is delivered. The therapy delivery firmware 108 may issue a request to allow the battery switch 72 to open any time therapy is off or during long cycle off durations when therapy is on but no stimulation is currently being delivered. If the battery switch 72 was opened during the long cycle off period, the therapy delivery firmware 108 may issue a request to allow the battery switch to be opened now, but require the battery switch to be closed when the second period expires. In this manner, the battery switch 72 can be closed and the therapy delivery firmware 108 (and/or other firmware modules) can be fully restarted before the next cycle on period. Similarly, if battery switch 72 is opened during a long cycle off period, battery switch 72 can be closed and therapy delivery firmware 108 (and/or other firmware modules) can be fully restarted before the next cycle on period. . In some examples, treatment delivery firmware 108 may perform some cleaning actions before battery switch 72 is turned off. When the battery switch 72 is closed and the therapy delivery firmware 108 restarts, the therapy delivery firmware 108 may use the saved therapy data and a lifetime count of the cumulative amount of open/close switch time to determine when therapy delivery should resume.

Fuel gauge firmware 110 may issue a request allowing power domain firmware 100 to turn off battery switch 72 at any time. When the fuel gauge firmware 110 is running, battery discharge can be tracked in at least two ways: via a coulomb counter interrupt that occurs every predetermined amount of battery discharge; or via a firmware timer that accounts for overhead discharges that are not measured by the hardware. When the power domain firmware 100 is about to open the battery switch 72, the fuel gauge firmware 110 can read the coulomb counter register (not shown) to see how much charge has been used since the last coulomb counter interrupt. The information read can be saved to the power image in non-volatile memory 74 (FIG. 2) to be later added to the discharge total. The fuel gauge firmware 110 may also read the overhead discharge firmware timer and save the read information to the power image so that it can be used when the timer is restarted when the fuel gauge firmware 110 reboots. In some examples, when battery switch 72 is closed, fuel gauge firmware 110 may use the switch off duration to estimate the discharge that occurs when battery switch 72 is open. For example, a technician may determine the amount of discharge that occurs in IMD 32 over time, such as in a laboratory, and fuel gauge firmware 110 may use such information to estimate the discharge that occurs when battery switch 72 is open.

Device recharge firmware 112 may require battery switch 72 to remain closed during a commanded recharge session or during an automatic passive recharge session that occurs when untimed non-power domain firmware 100 battery switch closure occurs. In some examples, when device recharge firmware 112 issues a request to keep battery switch 72 closed, IMD 32 may determine that the battery voltage is very low and IMD 32 needs to be recharged. In some examples, IMD 32 is configured to accept recharge energy and remain in the powered battery switch 72 closed mode for several minutes or until a first telemetry command is received. Because it may not be appropriate to open battery switch 72 during a battery recharge session or during an active telemetry session. Accordingly, device recharge firmware 112 and/or telemetry firmware 106 may be configured to request that the battery switch remains closed (eg, thereby preventing the battery switch from opening) until after the recharge session has ended and/or after the telemetry session has been completed.

For example, power domain firmware 100 may not allow battery switch 72 to open, such as until 10 seconds from when power domain firmware 100 first begins, to give the firmware sufficient time to initialize and receive telemetry before battery switch 72 opens again. For example, telemetry firmware 106 may issue a request that power domain firmware 100 does not allow battery switch 72 to open until, for example, 60 seconds from now. Telemetry firmware 106 may do this each time a telemetry message is received. By issuing such a request, the telemetry firmware 106 can ensure that the battery switch 72 is closed and the telemetry firmware remains ready for more telemetry messages. For example, the treatment delivery firmware 108 may issue a request that the power domain firmware 100 allows the battery switch 72 to open at any time until further notice that the treatment delivery firmware 108 is not delivering treatment. The therapy delivery firmware 108 may issue a request to prevent the battery switch 72 from being opened until further notice, for example, while therapy is being delivered. The therapy delivery firmware 108 may issue a request to allow the battery switch 72 to be opened now, but require the battery switch 72 to be closed upon expiration of the second time period, for example, when at the beginning of a long cycle shutdown period or when it will be later. The post time point occurs before the treatment delivery session when treatment is enabled.

For example, device recharge firmware 112 may issue a request to prevent battery switch 72 from re-opening until further notice. Device recharge firmware 112 may issue such a request at the beginning of a commanded recharge session. Device recharge firmware 112 may issue a request to allow battery switch 72 to open at any time until further notification at the end of a commanded recharge session or at the end of an automatic passive recharge session. The device recharge firmware 112 may issue a request to prevent the battery switch 72 from opening until, for example, 120 seconds from now when an automatic passive recharge session is initiated on the untimed, non-power domain firmware 100 battery Occurs when switch closure occurs.

Figure 5 is a conceptual diagram illustrating example requests that multiple firmware modules may send to power domain firmware. For example, at least two of the plurality of firmware modules may send one or more requests to the power domain firmware 100 .

The request of Figure 5 may include a first request 120 to allow battery switch 72 to be opened at any time until further notice. For example, when the therapy delivery functionality of IMD 32 is turned off, therapy delivery firmware 108 may send first request 120 to power domain firmware 100 . The request may also include a second request 122 to prevent the battery switch 72 from being opened until further notice. For example, when therapy is being actively delivered by IMD 32, therapy delivery firmware 108 may send second request 122 to power domain firmware 100.

The request may also include a third request 124 to prevent the battery switch 72 from turning off until the first time period expires. The first period of time may be a specified amount of time (eg, by a firmware module) or a predetermined amount of time. For example, telemetry firmware 106 may send a third request to power domain firmware 100 after receiving an incoming telemetry message, in the event that another incoming telemetry message is received or if telemetry circuitry 58 must respond to an incoming telemetry message. The telemetry circuit 58 and the processor circuit 53 are kept powered on. As mentioned above, in some examples, the time period is predetermined and not necessarily included within the third request 124 . For example, the predetermined time period may be 60 seconds. In some examples, this time period is specified by the firmware sending the request. For example, telemetry firmware 106 may send a third request 124 that includes a period of time (eg, 60 seconds) that telemetry firmware 106 indicates that battery switch 72 should close or remain closed.

These requests may also include a fourth request 126 to allow the battery switch 72 to be opened now, but require the battery switch 72 to be closed when the second time period expires. The second period of time may be a specified amount of time (eg, by a firmware module) or a predetermined amount of time. For example, when therapy delivery is scheduled to begin at a second designated time or at the end of a second predetermined time, therapy delivery firmware 108 may send a fourth request 126 to power domain firmware 100 . As mentioned above, in some examples, the time period is predetermined and not necessarily included within the fourth request 126 . For example, the predetermined time period may be 10 minutes. In some examples, this time period is specified by the firmware sending the request. For example, treatment delivery firmware 108 may send a fourth request 126 that includes a period of time (eg, 10 minutes) that treatment delivery firmware 108 indicates that battery switch 72 should be closed or remain closed. The first time period may be the same as or different from the second time period.

In some examples, multiple firmware modules may send only the first request 120 , the second request 122 , the third request 124 and/or the fourth request 126 to the power domain firmware 100 . In other words, in some examples, each request sent to power domain firmware 100 by any of the plurality of firmware modules is selected from the group consisting of first request 120 , second request 122 , third request 124 , and fourth request 126 list of. For example, power domain firmware 100 may receive one or more requests from multiple firmware modules. In some examples, this one or more requests may be selected by one or more of a plurality of firmware modules from a list consisting of: a) a request to allow battery switch 72 to be disconnected at any time until further notice , b) a request to prevent the battery switch 72 from opening (or to keep the battery switch 72 closed) until further notice, c) a request to prevent the battery switch 72 from opening (or to keep the battery switch 72 closed) until the first time period expires, or d) A request that allows the battery switch 72 to open now but requires the battery switch 72 to close when the second time period expires.

For example, the power domain firmware 100 may receive a second request 122 from the telemetry firmware 106 to prevent the battery switch 72 from being turned off until further notification to a therapy delivery circuit that allows the battery switch 72 to be turned off until further notification. In this case, power domain firmware 100 may determine to keep battery switch 72 closed and control the battery switch to remain closed because telemetry firmware 106 has indicated that battery switch 72 should remain closed. In such examples, telemetry firmware 106 and/or telemetry circuitry 58 still require power, for example, to perform telemetry operations. In another example, power domain firmware 100 may receive a request 124 from therapy delivery firmware 108 to prevent battery switch 72 from being opened until a first time period expires (eg, 5 minutes from now), and from telemetry firmware 106 Request 126 allows the battery switch 72 to be opened now, but requires the battery switch 72 to be closed when the second time period expires (eg, 5 minutes from now). In such examples, power domain firmware 100 may determine to keep battery switch 72 closed and control the battery switch to remain closed until at least power domain firmware 100 receives a request from telemetry firmware 106 to allow battery switch 72 to open. In this manner, power domain firmware 100 does not control battery switch 72 to turn off unless all received requests indicate that it is okay to turn battery switch 72 off, and then as long as all received requests indicate that it is okay to keep battery switch 72 off. Can.

Figure 6 is a flowchart illustrating an example battery switch control technique in accordance with one or more aspects of the present disclosure. Although described primarily with respect to the IMD 32 of FIG. 4, the technique of FIG. 6 may be performed by any battery powered device having a battery switch.

Power domain firmware 100 may receive one or more corresponding requests from multiple firmware modules (150). For example, power domain firmware 100 may be configured from non-volatile memory firmware 102 , device timing firmware 104 , telemetry firmware 106 , therapy delivery firmware 108 , fuel gauge firmware 110 , device recharge firmware 112 , and/or others not depicted in FIG. 4 Any one of the firmware modules receives the request. In some examples, the one or more corresponding requests include at least one of the following: a) a request to allow battery switch 72 to disconnect at any time until further notice; b) to prevent battery switch 72 from disconnecting until further notice a request; c) a request that prevents the battery switch 72 from opening until the first time period expires; or d) a request that allows the battery switch 72 to open now but requires the battery switch 72 to close when the second time period expires.

Power domain firmware 100 may determine whether to open battery switch 72 or keep battery switch 72 closed in response to one or more corresponding requests (152). For example, power domain firmware 100 may periodically or continuously monitor requests and evaluate the requests to determine whether each request that power domain firmware 100 has received authorizes disconnection of battery switch 72 or whether any of the received requests Battery switch 72 is required to remain closed.

Power domain firmware 100 may control battery switch 72 to open or remain closed in response to this determination (154). For example, if all received requests allow battery switch 72 to be turned off at a first given time, power domain firmware 100 (or power domain circuitry 70) may control battery switch 72 to turn off. If at least one of the received requests requires battery switch 72 to remain closed, power domain firmware 100 may control battery switch 72 to remain closed. In some examples, power domain firmware 100 controls battery switch 72 via power domain circuit 70 rather than directly. For example, when battery switch 72 is to be turned off, power domain firmware 100 may directly turn off battery switch 72 or may send a message to power domain circuit 70 to turn off battery switch 72 , and in some examples, turn off battery switch 72 for for how long.

In some examples, the one or more corresponding requests each allow battery switch 72 to open, and in those examples, the determination is to open the battery switch. In some examples, at least one of the one or more corresponding requests includes a request to prevent the battery switch from opening, and wherein the determination is to keep the battery switch closed.

In some examples, the power domain firmware 100 is further configured to control the battery switch 72 only during the given time period when each of the plurality of firmware modules has not requested to prevent the battery switch 72 from turning off during the given time period. disconnected. In some examples, the plurality of firmware modules includes at least one of: non-volatile memory firmware; device timer firmware; fuel gauge firmware; device recharger firmware; therapy delivery firmware; or telemetry firmware.

In some examples, treatment delivery circuitry 52 (Fig. 2) generates electrical stimulation signals and telemetry circuitry 58 communicates with another device (eg, external programmer 24 of Fig. 1C). In some examples, power domain firmware 100 stores in memory a lifetime count for the cumulative amount of time that battery switch 72 is closed and a lifetime count for the cumulative amount of time that battery switch 72 is open.

7A-7D are flow diagrams illustrating example techniques for opening a battery switch. Although described primarily with respect to IMD 32 of FIG. 4, the techniques of FIGS. 7A-7D may be performed by any battery powered device having a battery switch.

Power domain firmware 100 may evaluate the open switch condition and determine how long battery switch 72 should be open (200). For example, power domain firmware 100 may determine that all requests received from multiple firmware modules allow battery switch 72 to open. If one or more requests received from multiple firmware modules do not allow battery switch 72 to turn off, power domain firmware 100 may not turn off battery switch 72 at this time.

Power domain firmware 100 may notify multiple firmware modules that battery switch 72 is about to open (202). For example, power domain firmware 100 may send a message to each of the plurality of firmware modules to notify the plurality of firmware modules that battery switch 72 is about to open. By notifying multiple firmware modules that battery switch 72 is about to open, power domain firmware 100 can provide each of the multiple firmware modules with an assessment of the need for power and possibly send a new request to power domain firmware 100 to prevent battery switch 72 Opportunity to disconnect. The notification also provides each of the multiple firmware modules to read the module-specific portion of the updated data and prepare for shutdown. Each of the multiple firmware modules can update logs and images as needed to ensure that once the battery switch 72 is closed and power is restored, all data can be restored and operations continue.

Power domain firmware 100 may re-evaluate the open battery switch condition and determine how long battery switch 72 should be open (204). For example, in response to notifying multiple firmware modules that battery switch 72 is about to open, power domain firmware 100 may receive a further request from any of the multiple firmware modules that may warrant a re-evaluation or change that battery switch 72 should open. length of time. If the re-evaluation indicates that battery switch 72 should not be disconnected, power domain firmware 100 may send a notification to each of the plurality of firmware modules that battery switch 72 will not be disconnected at this time and cancel the battery switch disconnect operation.

Power domain firmware 100 may determine settings of power domain firmware 100 (including, for example, timer settings) and save power domain firmware 100 register values used in the power domain firmware 100 image in non-volatile memory 74 (206), Because these settings and values can be used later when the battery switch 72 is closed again.

Power domain firmware 100 may read the power domain firmware 100 real-time clock and store the current value of the power domain firmware 100 real-time clock in the power domain firmware 100 image in non-volatile memory 74 (208). The real-time clock value can be used later when the battery switch 72 is closed again. In some examples, if an error occurs reading the real-time clock, power domain firmware 100 may store the zero value of the real-time clock in the power domain firmware 100 image in non-volatile memory 74 .

Power domain firmware 100 may disable interrupts (210). For example, power domain firmware 100 may prevent other modules (eg, hardware and/or firmware) from interrupting the disconnected battery switching process.

As shown in Figure 7B, the power domain firmware 100 may determine which power domain firmware 100 switch closure external interrupts should be masked or unmasked (212). For example, power domain firmware 100 may ignore masked interrupts when battery switch 72 is open, but not ignore unmasked interrupts.

Power domain firmware 100 may determine if there are any real-time interrupt sources that are currently asserted or any interrupts that power domain firmware 100 should handle before continuing (214). If the power domain firmware 100 determines that there are any real-time interrupt sources that are currently asserted or any interrupts that the power domain firmware 100 should handle before continuing ("YES" path from block 214), the power domain firmware 100 may proceed to block 7C 234 and cancel the disconnection of battery switch 72. For example, the power domain firmware may prevent the opening of the battery switch 72 or may reassert the close battery switch event. This may be performed to avoid a situation where the power domain firmware 100 only opens the battery switch 72 so that the power domain circuit 70 immediately closes the battery switch 72 .

If the power domain firmware 100 determines that there are no currently asserted real-time interrupt sources or interrupts that the power domain firmware 100 should handle before continuing ("NO" path from block 214 ), the power domain firmware 100 may delay opening the battery switch 72 for a predetermined period of time, such as 5 milliseconds, 10 milliseconds, 20 milliseconds, 30 milliseconds, 40 milliseconds, 50 milliseconds, 60 milliseconds, 70 milliseconds, or other predetermined time period to allow the battery to recover in the event of a low battery voltage (216).

Power domain firmware 100 or any firmware module of the plurality of firmware modules may write all logs queued in RAM to non-volatile memory 74 (218). Power domain firmware 100 or any firmware module of the plurality of firmware modules may write all diagnostic or usage-related data queued in RAM to non-volatile memory 74 (220). In this manner, such data can be obtained when battery switch 72 is closed again.

Power domain firmware 100 may write the determined duration for which battery switch 72 should be open (see blocks 200 and 204 of Figure 7A) into the power domain firmware 100 system timer (222).

As shown in Figure 7C, in some examples, power domain firmware 100 may determine whether the write operation was successful (224). If the write operation is unsuccessful ("NO" path from block 224), the power domain firmware 100 may cancel the battery switch disconnect and cancel the entire process and move to block 236 of Figure 7D.

If the write operation is successful (YES path from block 224), the power domain firmware 100 may start the system timer of the power domain firmware 100 in a repeating mode (226). For example, repeating patterns can be used for robustness. In repetitive mode, if the battery switch 72 is not closed when the power domain firmware 100 system timer expires, the power domain firmware 100 system timer will expire again until the battery switch 72 is closed.

As determined in block 212 of Figure 7B, the power domain firmware 100 may set interrupt masking (228). Power domain firmware 100 may recheck to determine if there are any real-time interrupt sources that are currently asserted or any interrupts that power domain firmware 100 should handle before continuing to determine whether any unmasked interrupts are currently asserted (230). If there are no currently asserted real-time interrupt sources or interrupts that the power domain firmware 100 should handle before continuing ("NO" path from block 230), the power domain firmware 100 may control the battery switch 72 to open (232). The power domain firmware 100 may read the hardware battery switch status conditions for the next x intervals (eg, the next predetermined number of intervals) (234). Power domain firmware 100 may determine whether the battery switch status condition is still closed (236). If the battery switch status condition still does not close ("NO" path from block 236), the battery is disconnected and the sequence may end. If the battery switch status condition is still closed (YES path from block 236), the power domain firmware 100 may restore the original power domain firmware 100 interrupt mask (238). For example, the power domain firmware 100 may restore the power domain firmware 100 interrupt mask that existed before the power domain interrupt mask was set in block 228 . In some examples, if the battery switch 72 does not open due to the IMD's hardware and firmware being out of sync, the power domain firmware 100 may stay in the loop until a watchdog timer triggers a device reset.

If there are any real-time interrupt sources that are currently asserted or any interrupts that the power domain firmware 100 should handle before continuing ("YES" path from block 230), the power domain firmware 100 may restore the original power domain firmware 100 interrupt masking (238) .

As shown in Figure 7D, the power domain firmware 100 may clear the power domain firmware 100 system timer settings (240). Power domain firmware 100 may enable interrupts (242). For example, power domain firmware 100 may enable interrupts that are not currently masked. Power domain firmware 100 may clear the power domain firmware interrupt request source (244). For example, some power domain firmware interrupt request sources may be a by-product of a battery switch close event and may be cleared. Power domain firmware 100 may notify multiple firmware modules that battery switch 72 will not open (246). In some examples, in response to receiving notification that battery switch 72 will not turn off, each of the plurality of firmware modules may undo any action they took to prepare for shutdown, such as restarting a device timer.

8A-8B are flowcharts of example techniques for closing a battery switch in accordance with one or more aspects of the present disclosure. Power domain firmware 100 may, for example, read the power domain firmware 100 register values from non-volatile memory 74 (300). This can happen as quickly as possible upon firmware startup of the power domain firmware 100 . This value may be used in conjunction with the value written to the power domain firmware register of non-volatile memory 74 (stored in the power domain firmware 100 image) before the battery switch 72 is turned off.

Power domain firmware 100 may mask all power domain firmware 100 interrupts (302). Such power domain firmware 100 interrupts may be unmasked if desired while firmware execution of the IMD 32 continues.

Power domain firmware 100 may turn off the power domain firmware 100 system timer (304). Power domain circuit 70 may configure telemetry-based switch closing hardware (306). Power domain firmware 100 may clear the system timer interrupt source (308).

Power domain firmware 100 may assert a power-on reset any time battery switch 72 is open (310).

As shown in Figure 7B, power domain firmware 100 may restore the power domain firmware 100 image from non-volatile memory 74 (312). For example, power domain firmware 100 may load the power domain firmware 100 image from non-volatile memory 74 .

Power domain firmware 100 may determine whether battery switch 72 is open under firmware control (314). For example, the power domain firmware 100 may use the startup power domain firmware 100 register value and the power domain firmware 100 value saved prior to disconnection from the battery switch 72 to determine whether the battery switch 72 was opened under firmware control.

Power domain firmware 100 may determine the number of seconds that battery switch 72 was open (316). For example, power domain firmware 100 may use the power domain firmware 100 real-time clock to determine the number of seconds that battery switch 72 is open. In some examples, if there is an error reading the real-time clock of the power domain firmware 100 before or after turning off the battery switch 72 , the power domain firmware 100 may respond based on the startup value in the power domain firmware 100 system timer and the value in the battery switch 72 The initial timer value set before turning off determines the number of seconds the battery switch 72 is turned off.

Power domain firmware 100 may update the lifetime count for the cumulative amount of time that battery switch 72 has been off (318).

The plurality of firmware modules can continue to recover from the battery switch off condition. For example, treatment delivery firmware 108 may determine if and when treatment should be resumed and may schedule the resumption of such treatment. The fuel gauge 110 may adjust the estimate of the state of charge based on the off-switch duration and/or partial discharge coulomb counter information stored prior to the battery switch 72 being open. The firmware of non-volatile memory 74 may update the reset diagnostics (or not) based on whether battery switch 72 is opened by power domain firmware 100 for dielectric or for another purpose (such as as determined by the system design). ).

The present disclosure includes the following non-limiting examples.

Embodiment 1. An implantable neurostimulator, the implantable neurostimulator comprising: a battery configured to provide power to the implantable neurostimulator; a battery switch, the battery switch configured to open and remove power from one or more components of the implantable neurostimulator, or to close to provide power to each component of the implantable neurostimulator that requires power to operate; and Processing circuitry configured to execute a plurality of firmware modules configured to perform corresponding functions of the implantable neurostimulator, at least two of the plurality of firmware modules configured to determine whether the corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function, and to perform the corresponding function based on whether the corresponding hardware component requires power or whether power is required during the corresponding time period. the determination of functionality to generate and transmit one or more corresponding requests; and executing power domain firmware that configures the processing circuit to: receive the one or more corresponding requests; respond to the one or more corresponding requests Determine whether to open the battery switch or keep the battery switch closed in response to the request; and control the battery switch to open or keep the battery switch closed in response to the determination.

Embodiment 2. The implantable neurostimulator of claim 1, wherein the one or more corresponding requests include at least one of: a request to allow the battery switch to be disconnected at any time until further notice ;a request to prevent the battery switch from opening until further notice; a request to prevent the battery switch from opening until expiration of a first time period; or allowing the battery switch to open now but requiring the battery switch to open at a second time A request to close when the segment expires.

Embodiment 3. The implantable neurostimulator of claim 1 or 2, wherein the one or more corresponding requests each allow the battery switch to be turned off, and wherein the determination is to turn off the battery switch. .

Embodiment 4. The implantable neurostimulator of claim 3, wherein treatment delivery is in an off cycle.

Embodiment 5. The implantable neurostimulator of any one of claims 1 to 4, wherein at least one of the one or more corresponding requests includes a request to prevent the battery switch from opening, and wherein said determining is to keep said battery switch closed.

Embodiment 6. The implantable neurostimulator of any one of claims 1 to 5, wherein the power domain firmware further configures the processing circuitry to operate in each of the plurality of firmware modules. When there is no request to prevent the battery switch from turning off during a given time period, the battery switch is controlled to turn off only during the given time period.

Embodiment 7. The implantable neurostimulator of any one of claims 1 to 6, wherein the plurality of firmware modules includes at least one of the following firmware modules: non-volatile memory firmware; device time Firmware; fuel gauge firmware; device recharger firmware; therapy delivery firmware; telemetry firmware; or sensing firmware.

Embodiment 8. The implantable neurostimulator of any one of claims 1 to 7, further comprising: a stimulation circuit configured to generate an electrical stimulation signal; and telemetry circuitry configured to communicate with another device.

Embodiment 9. The implantable neurostimulator of any one of claims 1 to 8, wherein the power domain firmware further configures the processing circuit to store in memory a cumulative amount of time the battery switch is closed. The life count and the life count of the cumulative amount of time the battery switch has been off.

Embodiment 10. The implantable neurostimulator of any one of claims 1 to 9, wherein the one or more corresponding requests include one or more interrupts.

Embodiment 11. A method comprising: through power domain firmware executing on a processing circuit and receiving one or more corresponding requests from at least two of a plurality of firmware modules, the plurality of firmware modules At least two of the firmware modules execute on the processing circuit and are configured to determine whether a corresponding corresponding hardware component requires power or whether power is required during a corresponding time period to perform a corresponding function of the implantable neurostimulator, and based on the the determination of whether a corresponding hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period to generate and transmit the one or more corresponding requests; in response to the one or more corresponding requests The power domain firmware determines whether to turn off the battery switch or keep the battery switch closed; and in response to the determination, the power domain firmware controls the battery switch to turn off or keep the battery switch closed.

Embodiment 12. The method of claim 11, wherein the one or more corresponding requests include at least one of: a request to allow the battery switch to be disconnected at any time until further notice; to prevent the battery from being disconnected. A request to open the switch until further notice; a request to prevent the battery switch from opening until expiration of a first time period; or to allow the battery switch to open now but require the battery switch to close when a second time period expires. request.

Embodiment 13. The method of claim 11 or 12, wherein the one or more corresponding requests each allow the battery switch to be turned off, and wherein the determining is to turn off the battery switch.

Embodiment 14. The method of claim 13, wherein treatment delivery is in an off cycle.

Embodiment 15. The method of any one of claims 11 to 14, wherein at least one of the one or more corresponding requests includes a request to prevent the battery switch from being disconnected, and wherein the determining is Keep the battery switch closed.

Embodiment 16. The method of any one of claims 11 to 15, further comprising: blocking the battery during a given period of time when each firmware module of the plurality of firmware modules has not requested When the switch is turned off, the power domain firmware controls the battery switch to turn off only during the given time period.

Embodiment 17. The method of any one of claims 11 to 16, wherein the plurality of firmware modules includes at least one of the following firmware modules: non-volatile memory firmware; device time firmware; fuel gauge firmware ; device recharger firmware; therapy delivery firmware; telemetry firmware or sensing firmware.

Embodiment 18. The method of claim 17, further comprising: generating an electrical stimulation signal by the stimulation circuit; and communicating with another device via the telemetry circuit.

Embodiment 19. The method of any one of claims 11 to 18, further comprising storing, by the power domain firmware, a life count of the cumulative amount of time the battery switch is closed and the battery in memory. A life count of the cumulative amount of time the switch has been off.

Embodiment 20. The method of any one of claims 11 to 19, wherein the one or more corresponding requests include one or more interrupts.

Embodiment 21. A non-transitory computer-readable storage medium, the non-transitory computer-readable storage medium including instructions including a plurality of firmware modules and power domain firmware, the instructions when executed enable A processing circuit of an implanted neurostimulator: performs a corresponding function of the implantable neurostimulator; determines whether a corresponding hardware component requires power or whether power is required during a corresponding time period to perform the corresponding function; based on the correspondence the determination of whether a hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period to generate and transmit one or more corresponding requests; receive the one or more corresponding requests; respond to The one or more corresponding requests determine whether to open the battery switch or keep the battery switch closed; and in response to the determination, control the battery switch to open or keep the battery switch closed.

Embodiment 22. An implantable neurostimulator, the implantable neurostimulator comprising: configured to pass power domain firmware executing on a processing circuit and receive a or a plurality of correspondingly requested devices, at least two of the plurality of firmware modules executing on the processing circuit and configured to determine whether the corresponding corresponding hardware component requires power or whether power is required to perform during the corresponding time period a corresponding function of the implantable neurostimulator, and generating and transmitting the corresponding function based on the determination of whether the corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function. one or more corresponding requests; means for determining, by the power domain firmware, in response to the one or more corresponding requests, whether to open the battery switch or to keep the battery switch closed; and in response to the determination, by the power domain firmware Domain firmware controls the device that opens or holds the battery switch closed.

It should be noted that the technology of the present disclosure is not limited to IMDs or medical devices. These techniques can be applied to any device with a battery and battery switch. It should also be noted that system 10 and the techniques described herein may not be limited to the treatment or monitoring of human patients. In alternative examples, system 10 may be implemented in non-human patients (eg, primates, canines, horses, porcines, and felines). These other animals may undergo clinical or research treatments that may benefit from the disclosed subject matter.

The techniques of this disclosure may be implemented in a wide range of computing devices, medical devices, or any combination thereof. Any described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Describing different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be implemented by separate hardware, firmware or software components. Rather, the functions associated with one or more circuits or units may be performed by separate hardware, firmware, or software components, or may be integrated within common or separate hardware, firmware, or software components.

The present disclosure contemplates a computer-readable storage medium including instructions that cause a processor to perform any of the functions and techniques described herein. Computer-readable storage media may take the exemplary form of any volatile, nonvolatile, magnetic, optical, or electrical media such as RAM, ROM, NVRAM, EEPROM, or tangible flash memory. Computer-readable storage media may be referred to as non-transitory. The server, client computing device, or any other computing device may also include more portable removable memory types to enable easy data transfer or offline data analysis.

The techniques described in this disclosure, including those attributed to various circuits and various constituent components, may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of these technologies may be implemented within one or more processors including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated discrete logic circuitry or other processor circuitry, and any combination of such components, remote servers, remote client devices, or other devices. The term "processor circuit" or "processor circuit" may generally refer to any of the foregoing logic circuits or any other equivalent circuit, alone or in combination with other logic circuits.

Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. Furthermore, any described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Describing different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be implemented by separate hardware or software components. Rather, the functions associated with one or more circuits or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. For example, any circuit described herein may include circuitry configured to perform characteristics attributed to that particular circuit, such as fixed-function processor circuitry, programmable processor circuitry, or combinations thereof.

The techniques described in this disclosure may also be embedded or encoded in an article of manufacture including computer-readable media encoded with instructions. Instructions embedded or encoded in an article of manufacture including encoded computer-readable storage media may cause one or more programmable processors or other processors to implement one or more of the techniques described herein, such as in an article including or encoded When the instructions in the computer-readable storage medium are executed by one or more processors. Exemplary computer-readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EPROM), Programmable read-only memory (EEPROM), flash memory, hard disk, compact disk ROM (CD-ROM), floppy disk, magnetic tape cassette, magnetic media, optical media, or any other computer-readable storage device or tangible computer-readable medium. Computer-readable storage media may also be referred to as storage devices.

In some examples, computer-readable storage media includes non-transitory media. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or propagated signal. In some examples, non-transitory storage media may store data that may change over time (eg, in RAM or cache).

Various examples have been described in this article. Any combination of the described operations or functions is contemplated. These and other embodiments are within the scope of the appended claims. Based on the above discussion and illustrations, it has been recognized that various modifications and changes may be made to the disclosed examples in ways that do not necessarily require strict adherence to the examples and applications illustrated and described herein. Such modifications do not depart from the true spirit and scope of all aspects of the disclosure, including those set forth in the claims.

Claims (20)

1. An implantable neurostimulator, the implantable neurostimulator comprising: a battery configured to provide power to the implantable neurostimulator; A battery switch configured to open and remove power from one or more components of the implantable neurostimulator, or to close to provide power to one or more components of the implantable neurostimulator that require power to operate. Each component provides power; and processing circuit, the processing circuit being configured to: Executing a plurality of firmware modules configured to perform corresponding functions of the implantable neurostimulator, at least two of the plurality of firmware modules being configured to determine whether the corresponding hardware component Power is required or is required during a corresponding time period to perform the corresponding function, and the determination is based on whether the corresponding hardware component requires power or is required during the corresponding time period to perform the corresponding function. to generate and transmit one or more corresponding requests; and Execute power domain firmware that configures the processing circuitry to: receive the one or more corresponding requests; determining whether to turn off the battery switch in response to the one or more corresponding requests; and The battery switch is controlled to be turned off in response to the determination. 2. The implantable neurostimulator of claim 1, wherein the one or more corresponding requests include at least one of the following: A request to allow said battery switch to be disconnected at any time until further notice; A request to prevent said battery switch from being disconnected until further notice; A request to prevent the battery switch from opening until the first requested time period has expired; or A request that allows the battery switch to open now but requires the battery switch to close when the second request time period expires. 3. The implantable neurostimulator of claim 1, wherein the one or more corresponding requests each allow the battery switch to open, and wherein the determination is to open the battery switch. 4. The implantable neurostimulator of claim 3, wherein treatment delivery is in an off cycle. 5. The implantable neurostimulator of claim 1, wherein at least one of the one or more corresponding requests includes a request to prevent the battery switch from being disconnected, and wherein the determining is to maintain the The battery switch is closed. 6. The implantable neurostimulator of claim 1, wherein the power domain firmware further configures the processing circuitry to operate when each of the plurality of firmware modules is not requested during a given time period. When the battery switch is prevented from being turned off, the battery switch is controlled to turn off only during the given time period. 7. The implantable neurostimulator of claim 1, wherein the plurality of firmware modules includes at least one of: Non-volatile memory firmware; device time firmware; Fuel Gauge Firmware; Device recharger firmware; treatment delivery firmware; Telemetry firmware; or Sensing firmware. 8. The implantable neurostimulator of claim 1, further comprising: a stimulation circuit configured to generate an electrical stimulation signal; and Telemetry circuitry configured to communicate with another device. 9. The implantable neurostimulator of claim 1, wherein the power domain firmware further configures the processing circuitry to determine the maximum time for which the battery switch remains open in response to the one or more corresponding requests. duration. 10. The implantable neurostimulator of claim 1, wherein the power domain firmware further configures the processing circuit to store in memory a lifetime count of the cumulative amount of time the battery switch is closed and the battery switch Life count of the cumulative amount of time off. 11. A method comprising: by power domain firmware executing on the processing circuitry and receiving one or more corresponding requests from at least two firmware modules of a plurality of firmware modules executing on the processing circuitry and configured to determine whether a corresponding corresponding hardware component requires power or whether power is required during a corresponding time period to perform a corresponding function of the implantable neurostimulator, and based on whether the corresponding hardware component requires power or during the corresponding time generating and transmitting the one or more corresponding requests during said determination of whether power is required to perform said corresponding function; determining, by the power domain firmware, whether to turn off a battery switch in response to the one or more corresponding requests; and The battery switch is controlled to open by the power domain firmware in response to the determination. 12. The method of claim 11, wherein the one or more corresponding requests include at least one of: A request to allow said battery switch to be disconnected at any time until further notice; A request to prevent said battery switch from being disconnected until further notice; A request to prevent the battery switch from opening until the first requested time period has expired; or A request that allows the battery switch to open now but requires the battery switch to close when the second request time period expires. 13. The method of claim 11, wherein the one or more corresponding requests each allow the battery switch to be turned off, and wherein the determining is to turn off the battery switch. 14. The method of claim 13, wherein treatment delivery is in an off cycle. 15. The method of claim 11, wherein at least one of the one or more corresponding requests includes a request to prevent the battery switch from opening, and wherein the determining is to keep the battery switch closed. 16. The method of claim 11, further comprising: preventing the battery switch from turning off during a given period of time when each firmware module of the plurality of firmware modules does not request that the battery switch be prevented from turning off. Power domain firmware controls the battery switch to open only during the given time period. 17. The method of claim 11, wherein the plurality of firmware modules includes at least one of: Non-volatile memory firmware; device time firmware; Fuel Gauge Firmware; Device recharger firmware; treatment delivery firmware; Telemetry firmware; or Sensing firmware. 18. The method of claim 17, further comprising: Generating electrical stimulation signals by stimulation circuitry; and Communicates with another device via telemetry circuitry. 19. The method of claim 11, further comprising storing, by the power domain firmware, a lifetime count of the cumulative amount of time the battery switch is closed and a cumulative amount of time the battery switch is open in memory. Life count. 20. A non-transitory computer-readable storage medium comprising instructions including a plurality of firmware modules and power domain firmware that when executed enable implantable Neurostimulator processing circuit: Perform corresponding functions of the implantable neurostimulator; determining whether the corresponding hardware component requires power or whether power is required during the corresponding time period to perform the corresponding function; generating and transmitting one or more corresponding requests based on the determination of whether the corresponding hardware component requires power or whether power is required to perform the corresponding function during the corresponding time period; receive the one or more corresponding requests; determining whether to turn off the battery switch in response to the one or more corresponding requests; and The battery switch is controlled to be turned off in response to the determination.