Systems and methods for remote control of an implantable device

Abstract

Provided herein are systems and methods for remotely controlling an implantable device using an external magnet. The implantable device may be an implantable pulse generator, and the external magnet can be used for on demand electrical stimulation of target tissue. The implantable device may comprise a magnetic field sensor of a first type, one or more magnetic field sensors of a second type, a latching load switch and a stimulation circuit. A user of the implantable device may place the external magnet in proximity to the implantable device and, using one or more predetermined gestures, manipulate the magnetic field around the implantable device. The implantable device may detect the gesture using the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type, and, in response, electrically stimulate or stop electrically stimulating target tissue using the stimulation circuit.

Description

Attorney Docket No: 78895-20043.40 SYSTEMS AND METHODS FOR REMOTE CONTROL OF AN IMPLANTABLE DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 761,727, filed February 21, 2025, the entire contents of which are incorporated herein by reference for all purposes.FIELD

[0002] This disclosure relates generally to devices, systems, and methods of controlling implantable devices using an external magnet.BACKGROUND

[0003] Underactive Bladder (UAB) is a complex of lower urinary tract symptoms caused by one or more disruptions to the normal storage or voiding mechanisms of a bladder. These disruptions may be caused by injury or disease that affect either the bladder muscle, bladder nerves, or both. The complex of symptoms associated with UAB include slow urinary streams, difficulty initiating urination, difficulty maintaining the urinary stream, and the sensation of incomplete bladder emptying. Additionally, incomplete bladder emptying may lead to bladder urgency as well as unusual daytime and nighttime urination frequency.

[0004] The complex of lower urinary tract symptoms characteristic of UAB relate to detrusor underactivity. The detrusor is the muscular layer surrounding the bladder. Detrusor underactivity is characterized by contractions of reduced strength or duration that result in prolonged bladder emptying or a failure to achieve complete bladder emptying in a normal time span.

[0005] Conventional methods of treating UAB prioritize reducing the amount of urine that is chronically retained. These methods include behavioral modifications, catheterization, urethral pumps, medication, and surgical intervention. These methods are not universally effective and can result in unwanted side effects.

[0006] Electrical stimulation of target tissue, such as nervous tissue and / or muscle tissue, has shown increased therapeutic promise in recent years. Implantable pulse generators, for example, have been developed to treat numerous ailments. For example, UAB or overactive bladder (OAB) may be treated through direct bladder wall stimulation or sacral1MF-367063050Attorney Docket No: 78895-20043.40 neuromodulation. Additionally, implantable pulse generators can be used to alleviate pain due to various neurological conditions by stimulating regions of the spinal cord or nerve structures. Activating or deactivating the implantable pulse generator should generally be carefully controlled to ensure therapy is applied at the desired time.SUMMARY

[0007] Described herein are systems and methods for remotely controlling an implantable device, such as an implantable pulse generator, using an external magnet. The implantable device may be used, for example, for the treatment of an underactive bladder such as by sacral neuromodulation or direct bladder wall stimulation. Alternatively, the implantable device may be used, for example, for the alleviation of pain. As further described herein, a user may place an external magnet in proximity to an implantable device and, by moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, manipulate the magnetic field around the implantable device to control it. The implantable device may detect the magnetic field gesture and, in response, electrically stimulate or stop electrically stimulating target tissue. The electrical stimulation may target tissue that controls bladder voiding. Thus, through the use of an external magnet, the user may cause bladder voiding.

[0008] The implantable device may comprise an energy storage circuit, a magnetic field sensor of a first type, one or more magnetic field sensors of a second type, one or more controllers, and a stimulation circuit. The magnetic field sensor of a first type may, upon detecting a magnetic field, activate the one or more magnetic field sensors of a second type and the one or more controllers. The magnetic field sensors of a second type may detect one or more characteristics of a magnetic field. The one or more characteristics of a magnetic field may comprise a flux density and / or a magnetic flux of the magnetic field. The one or more controllers may receive the detected characteristics of the magnetic field as a function of time. Based on the characteristics of the magnetic field, the one or more controllers may synthesize a series of magnetic field events. The magnetic field events of the series of magnetic field events may comprise a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and / or a motion of the magnetic field with respect to the implantable device.

[0009] The detected magnetic field and / or changes in the magnetic field may be caused by the presence and / or movement of an external magnet. The external magnet may be positioned such that the magnetic field sensor of a first type and magnetic field sensors of a 2MF-367063050Attorney Docket No: 78895-20043.40 second type can detect changes or disturbances to the magnetic field caused by the external magnet. The external magnet may be moved in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein each magnetic field gesture may correspond to an action for the implantable device. The one or more controllers may identify one or more magnetic field gestures made by the external magnet based on the series of magnetic field events. Based on the identified magnetic field gesture, the one or more controllers may cause the implantable device to execute the action corresponding to the identified magnetic field gesture. For example, the one or more controllers may cause the implantable device to electrically stimulate or stop electrically stimulating target tissue. The electrical stimulation may target tissue that controls bladder voiding, thus causing bladder voiding.

[0010] In some embodiments, an implantable device is provided comprising: an energy storage circuit configured to power the implantable device; a magnetic field sensor of a first type configured to detect a presence of a magnetic field; one or more magnetic field sensors of a second type configured to activate in response to a magnetic field being detected by the magnetic field sensor of a first type and sense one or more magnetic field characteristics; and one or more controllers configured to control the implantable device based on the sensed one or more magnetic field characteristics.

[0011] In some embodiments, the implantable device is an implantable pulse generator comprising a stimulation circuit, wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from the one or more sensed magnetic field characteristics, and wherein the first magnetic gesture corresponds to initiating stimulation.

[0012] In some embodiments, the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a first predetermined period of time. In some embodiments, the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture from the one or more sensed magnetic field characteristics, wherein the second magnetic field gesture corresponds to stopping stimulation. In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes bladder voiding. In some embodiments, the magnetic field sensor of a first type is passive. In some embodiments, the magnetic field sensor of a first type is a Reed switch. In some embodiments, the magnetic field sensor of a first type is an electromagnetic induction antenna.3MF-367063050Attorney Docket No: 78895-20043.40

[0013] In some embodiments, the one or more magnetic field sensors of a second type comprise at least one of one or more Hall-effect sensors, one or more magnetometers, one or more magnetoresistive sensors, one or more micro electromechanical systems (MEMS) sensors, one or more magnetic fluxgate sensors, one or more Reed switches, one or more electromagnetic induction antennas, one or more magnetoelectric sensors and one or more spin electronic sensors. In some embodiments, the one or more controllers and the stimulation circuit are configured to be activated upon detection of the magnetic field by the magnetic field sensor of a first type. In some embodiments, the implantable device further comprises a load switch configured to transfer power from the energy storage circuit to the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit.

[0014] In some embodiments, upon detection of the magnetic field, the magnetic field sensor of a first type is configured to activate the load switch. In some embodiments, the load switch is configured to latch and remain activated after activation by the magnetic field sensor of a first type. In some embodiments, the load switch is configured to stop transferring power from the energy storage circuit to the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit upon deactivation of the load switch. In some embodiments, at least one of the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit are configured to be deactivated upon deactivation of the load switch. In some embodiments, the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch.

[0015] In some embodiments, the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device. In some embodiments, the load switch is configured to deactivate after a second predetermined period of time. In some embodiments, the one or more magnetic field characteristics detected by the magnetic field sensors of a second type comprise at least one of a magnetic flux, and a magnetic flux density of the magnetic field. In some embodiments, the implantable device further comprises a converter configured to convert one or more analog signals received from the one or more magnetic field sensors of a second type to one or more digital signals, and wherein the one or more controllers are configured to receive the one or more digital signals. In some embodiments, the one or more controllers are configured to receive the sensed magnetic field characteristics as a function of time and synthesize a series of magnetic field events based on the sensed magnetic field characteristics. In some 4MF-367063050Attorney Docket No: 78895-20043.40 embodiments, the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

[0016] In some embodiments, the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein the magnetic field gestures of the set of predetermined magnetic field gestures correspond to one or more actions for the implantable device. In some embodiments, the implantable device further comprises one or more leads coupled with the implantable device, wherein the one or more leads are configured to stimulate target tissue by transmitting one or more electric pulses from the stimulation circuit to the target tissue. In some embodiments, the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads. In some embodiments, the energy storage circuit comprises a non-rechargeable battery. In some embodiments, the energy storage circuit comprises a rechargeable battery.

[0017] In some embodiments, a method of operating an implantable device is provided, comprising: detecting, using a magnetic field sensor of a first type, the presence of a magnetic field; activating one or more magnetic field sensors of a second type in response to the detected magnetic field; sensing, using the one or more magnetic field sensors of a second type, one or more magnetic field characteristics; identifying one or more actions based on the one or more magnetic field characteristics; and operating the implantable device according to the identified one or more actions.

[0018] In some embodiments, the magnetic field sensor of a first type is passive. In some embodiments, activating the one or more magnetic field sensors of a second type in response to the magnetic field comprises: activating, upon detection of the magnetic field by the magnetic field sensor of a first type, a load switch; and transferring power, by the load switch, from an energy storage circuit to the one or more magnetic field sensors of a second type and a stimulation circuit. In some embodiments, the method further comprises deactivating the one or more magnetic field sensors of a second type. In some embodiments, deactivating the one or more magnetic field sensors of a second type comprises deactivating the load switch after a first predetermined period of time. In some embodiments, the method further comprises deactivating the load switch by transmitting an unlatch signal to the load switch. In some embodiments, the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device.5MF-367063050Attorney Docket No: 78895-20043.40

[0019] In some embodiments, detecting one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field. In some embodiments, the method further comprises positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type. In some embodiments, the method further comprises moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type during the one or more gestures. In some embodiments, the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of: holding the external magnet stationary for a second predetermined period of time; moving the external magnet laterally; moving the external magnet circularly; and switching which pole of the external magnet is directed towards the magnetic field sensor of a first type and magnetic field sensors of a second type.

[0020] In some embodiments, the method further comprises synthesizing a series of magnetic field events based on the detected one or more magnetic field characteristics. In some embodiments, the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device. In some embodiments, identifying one or more actions based on the one or more magnetic field characteristics comprises: identifying one or more magnetic field gestures based on the series of magnetic field events; and identifying the corresponding one or more actions based on the identified one or more magnetic field gestures. In some embodiments, the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue. In some embodiments, the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue.6MF-367063050Attorney Docket No: 78895-20043.40

[0021] In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding. In some embodiments, operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a third predetermined period of time. In some embodiments, the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses. In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding. In some embodiments, an implantable device is provided comprising: an energy storage circuit configured to power the implantable device; one or more magnetic field sensors configured to detect a presence of a magnetic field; and one or more controllers configured to control the implantable device based on the detected magnetic field presence over a first predetermined period of time. In some embodiments, the implantable device is an implantable pulse generator comprising a stimulation circuit and wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from detected magnetic field presence over the first predetermined period of time, wherein the first magnetic gesture corresponds to initiating stimulation.

[0022] In some embodiments, the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a second predetermined period of time. In some embodiments, the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture from the detected magnetic field presence over the first predetermined period of time, wherein the second magnetic field gesture corresponds to stopping stimulation. In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes a bladder to void. In some embodiments, the one or more magnetic field sensors are passive sensors. In some embodiments, at least one of the one or more magnetic field sensors is a Reed switch. In some embodiments, at least one of the one or more magnetic field sensors is an electromagnetic induction antenna. In some embodiments, the one or more controllers and the stimulation circuit are configured to be activated upon detection of the magnetic field by the one or more magnetic field sensors. In some embodiments, the implantable device further 7MF-367063050Attorney Docket No: 78895-20043.40 comprises a load switch configured to transfer power from the energy storage circuit to the one or more controllers and the stimulation circuit.

[0023] In some embodiments, upon detection of the magnetic field, the one or more magnetic field sensors are configured to activate the load switch. In some embodiments, the load switch is configured to latch and remain activated after activation by the one or more magnetic field sensors. In some embodiments, the load switch is configured to stop transferring power from the energy storage circuit to the one or more controllers and the stimulation circuit upon deactivation of the load switch. In some embodiments, the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch. In some embodiments, the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device. In some embodiments, the load switch is configured to deactivate after a third predetermined period of time. In some embodiments, the one or more controllers are configured to synthesize a series of magnetic field events based on the detected presence of a magnetic field over the first predetermined period of time.

[0024] In some embodiments, the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a directional motion of the magnetic field with respect to the implantable device. In some embodiments, the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein the magnetic field gestures of the set of predetermined magnetic field gestures correspond to one or more actions for the implantable device. In some embodiments, the implantable device further comprises one or more leads coupled with the implantable device, wherein the one or more leads are configured to stimulate target tissue by transmitting one or more electric pulses from the stimulation circuit to the target tissue. In some embodiments, the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads. In some embodiments, the energy storage circuit comprises a non-rechargeable battery. In some embodiments, the energy storage circuit comprises a rechargeable battery. In some embodiments, a method of operating an implantable device is provided, comprising: detecting, using one or more magnetic field sensors, the presence of a magnetic field; activating the implantable device in response to the detected magnetic field; detecting, using the one or more magnetic field sensors, the presence of the magnetic field over a first predetermined period of time; identifying one or more actions based on the8MF-367063050Attorney Docket No: 78895-20043.40 detected presence of the magnetic field over the first predetermined period of time; and operating the implantable device according to the identified one or more actions.

[0025] In some embodiments, the one or more magnetic field sensors are passive sensors. In some embodiments, activating the implantable device in response to the detection of the magnetic field comprises: activating, upon detection of the magnetic field, a load switch; and transferring power, by the load switch, from an energy storage circuit to a stimulation circuit and one or more controllers. In some embodiments, the method further comprises deactivating the implantable device. In some embodiments, deactivating the implantable comprises deactivating the load switch after a second predetermined period of time. In some embodiments, the method further comprises deactivating the load switch by transmitting an unlatch signal to the load switch. In some embodiments, the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device. In some embodiments, detecting one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field. In some embodiments, the method further comprises positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors.

[0026] In some embodiments, the method further comprises moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors during the one or more gestures. In some embodiments, the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of: holding the external magnet stationary for a third predetermined period of time; moving the external magnet laterally; moving the external magnet circularly; moving the magnet towards the implantable device; and moving the magnet away from the implantable device. In some embodiments, the method further comprises synthesizing a series of magnetic field events based on the detected presence of the magnetic field over the first predetermined period of time. In some embodiments, the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device. In some embodiments, identifying one or more actions based on the one or more magnetic field characteristics comprises: identifying one or more magnetic field gestures based on the series of magnetic field events;9MF-367063050Attorney Docket No: 78895-20043.40 and identifying the corresponding one or more actions based on the identified one or more magnetic field gestures. In some embodiments, the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue.

[0027] In some embodiments, the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue. In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding. In some embodiments, operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a fourth predetermined period of time. In some embodiments, the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses. In some embodiments, the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding.BRIEF DESCRIPTION OF THE FIGURES

[0028] Various aspects of the disclosed systems and methods are set forth with particularity in the appended claims. A better understanding of the features and advantages of the disclosed systems and methods will be obtained by reference to the detailed description of illustrative embodiments and the accompanying drawings.

[0029] FIG. 1 shows an exemplary system for remotely controlling an implantable device, which includes the implantable device and an external magnet, according to some embodiments.

[0030] FIG. 2 shows a block diagram of an exemplary device that can be remotely controlled using an external magnet, according to some embodiments.

[0031] FIG. 3 shows a block diagram of another exemplary device that can be remotely controlled using an external magnet, according to some embodiments.10MF-367063050Attorney Docket No: 78895-20043.40

[0032] FIG. 4A shows a cross sectional view of an exemplary external magnet for remotely controlling an implantable device, according to some embodiments.

[0033] FIG. 4B shows a top view of an exemplary external magnet for remotely controlling an implantable device, according to some embodiments.

[0034] FIG. 5 shows an exemplary method for remotely controlling an implantable device using a magnet, according to some embodiments.

[0035] FIG. 6 shows an exemplary gesture of an external magnet, according to some embodiments.

[0036] FIG. 7 shows a block diagram of another exemplary device that can be remotely controlled using an external magnet, according to some embodiments.

[0037] FIG. 8 shows another exemplary method for remotely controlling an implantable device using a magnet, according to some embodiments.

[0038] FIG. 9 shows a block diagram of an exemplary load switch and latching circuit, according to some embodiments.DETAILED DESCRIPTION

[0039] Described herein are systems and methods for using an external magnet to control an implantable device. The implantable device may be, for example, an implantable pulse generator. The external magnet can be used to cause the implantable pulse generator to start stimulating or stop stimulating target tissue. By placing an external magnet in proximity to an implantable device, a user can manipulate the magnetic field around the implantable device. For example, a user may move the magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein each magnetic field gesture corresponds to one or more actions by the implantable device. The implantable device can sense characteristics of the manipulated magnetic field, identify the magnetic field gestures based on the characteristics, and execute the corresponding one or more actions. In this manner, a user can control an implantable device, such as an implantable pulse generator, using an external magnet. For example, the user may cause the implantable pulse generator to stimulate or stop stimulating target tissue on demand.

[0040] Various disorders, such as underactive bladder (UAB) or overactive bladder (OAB), may be treated by electrical stimulation of target tissue. Methods of administering such electrical stimulation may utilize an implantable pulse generator. However, the implantable pulse generator should generally be carefully controlled to ensure the stimulation is applied at desired times. For example, for the treatment of UAB, stimulation of tissues that cause bladder voiding should only occur when the patient is seeking to void their bladder and 11MF-367063050Attorney Docket No: 78895-20043.40 not at other times. Accordingly, there is a need for on-demand electrical stimulation of target tissue for the treatment of a variety of disorders or disease states. The systems and methods disclosed herein meet that need by enabling a user to wirelessly control an implantable device, such as an implantable pulse generator, using an external magnet. Using the external magnet, the user may be able to start or stop electrical stimulation at desired times.

[0041] The systems and methods disclosed may be advantageous for controlling an implantable device because the external magnet may be portable, hand-held, and / or easy to clean. Additionally, the systems and methods disclosed herein may be advantageous for controlling implantable devices because the external magnet may not require power, which removes the need for charging or replacement of a battery. Further, the systems and methods disclosed herein may not be limited for use with implantable devices at certain implantation depths as the magnetic field may not attenuate to a noticeable extent as the magnetic field permeates tissue. It is to be understood by one of ordinary skill in the art that the systems and methods for magnetically controlling an implantable device disclosed herein are not limited to treatment of bladder disorders and may be used to stimulate other target tissue on demand. For example, the systems and methods disclosed herein may be used to treat neurological disorders by providing on demand neuromodulation or neurostimulation. Further, it is to be understood that the systems and methods disclosed herein are not limited to implantable pulse generators and may be used to control other implantable devices.

[0042] The systems and methods disclosed herein may reduce the risk of harm to a subject by providing safety features and fail-safe mechanisms for the implantable device. For example, components of the implantable device (e.g., a stimulation circuit of an implantable pulse generator) may automatically shut down after a predetermined period of time (e.g., to prevent damage to target tissue). Additionally or alternatively, the implantable device may comprise hardware fail-safe mechanisms to recognize an emergency predetermined gesture and control the device based on the recognized predetermined gesture even if firmware or software of the implantable device has failed. Additionally or alternatively, the implantable device may comprise one or more fault detection sensors that may power down the device in response to detected fault conditions.

[0043] An exemplary implantable device may comprise a magnetic field sensor of a first type configured to detect a magnetic field. In some implementations, the magnetic field sensor of a first type may be a passive sensor that does not consume power or allow current to pass until the magnetic field sensor of a first type detects a magnetic field. For example, the magnetic field sensor of a first type may be a Reed switch, a magnetoelectric sensor, or an 12MF-367063050Attorney Docket No: 78895-20043.40 electromagnetic induction antenna. The exemplary implantable device may further comprise one or more magnetic field sensors of a second type configured to activate in response to the magnetic field being detected by the magnetic field sensor of a first type and sense one or more magnetic field characteristics. In some implementations, the one or more magnetic field sensors of a second type may comprise at least one of one or more Hall-effect sensors, one or more magnetometers, one or more magnetoresistive sensors, one or more micro electromechanical systems (MEMS) magnetic sensors, one or more magnetic fluxgate sensors, one or more Reed switches, one or more electromagnetic induction antennas, one or more magnetoelectric sensors and / or one or more spin electronic sensors. The exemplary implantable device may further comprise one or more controllers configured to control the implantable device based on the sensed one or more magnetic field characteristics. In some implementations, the exemplary implantable device may be an implantable pulse generator and may comprise a stimulation circuit configured to generate electrical pulses. The one or more controllers may be configured to cause the implantable device to stimulate a target tissue using the stimulation circuit based on an identification of a magnetic field gesture from the one or more detected magnetic field characteristics. The exemplary implantable device may comprise an energy storage circuit configured to power the implantable device. In some implementations, the exemplary implantable device may comprise a load switch configured to transfer power from an energy storage circuit to the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit.

[0044] An exemplary method for operating an implantable device may comprise detecting, using a magnetic field sensor of a first type, a presence of a magnetic field; activating one or more magnetic field sensors of a second type in response to the detected magnetic field; detecting, using the one or more magnetic field sensors of a second type, one or more magnetic field characteristics; identifying one or more actions based on the one or more magnetic field characteristics; and operating the implantable device according to the identified one or more actions. The detected magnetic field may be manipulated by an external magnet. In some implementations of the method, the method may further comprise moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type. Each of the magnetic field gestures from the set of predetermined magnetic field gestures may correspond to one or more actions for the implantable device. In some examples of the method, the method may comprise synthesizing 13MF-367063050Attorney Docket No: 78895-20043.40 a series of magnetic field events based on the detected one or more magnetic field characteristics. In some examples of the method, identifying one or more actions based on the one or more magnetic field characteristics may comprise identifying one or more magnetic field gestures based on the series of magnetic field events and identifying one or more actions based on the identified one or more magnetic field gestures.Definitions

[0045] As used herein, the singular forms “a,” “an,” and “the” include the plural reference unless the context clearly dictates otherwise.

[0046] Reference to “about” a value or parameter herein includes (and describes) variations that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X.”

[0047] It is understood that aspects and variations of the invention described herein include “consisting” and / or “consisting essentially of’ aspects and variations.

[0048] When a range of values is provided, it is to be understood that each intervening value between the upper and lower limit of that range, and any other stated or intervening value in that stated range, is encompassed within the scope of the present disclosure. Where the stated range includes upper or lower limits, ranges excluding either of those included limits are also included in the present disclosure.

[0049] The section headings used herein are for organizational purposes only and are not to be construed as limiting the subject matter described. The description is presented to enable one of ordinary skill in the art to make and use the invention and is provided in the context of a patent application and its requirements. Various modifications to the described embodiments will be readily apparent to those persons skilled in the art and the generic principles herein may be applied to other embodiments. Thus, the present invention is not intended to be limited to the embodiment shown but is to be accorded the widest scope consistent with the principles and features described herein.

[0050] The figures illustrate processes according to various embodiments. In the exemplary processes, some blocks are, optionally, combined, the order of some blocks is, optionally, changed, and some blocks are, optionally, omitted. In some examples, additional steps may be performed in combination with the exemplary processes. Accordingly, the operations as illustrated (and described in greater detail below) are exemplary by nature and, as such, should not be viewed as limiting.14MF-367063050Attorney Docket No: 78895-20043.40

[0051] The entire disclosure of the patents and publications referred in this application are hereby incorporated herein by reference for all purposes. To the extent that any reference incorporated by reference conflicts with the instant disclosure, the instant disclosure shall control.Magnetically Controlled Implantable Devices and Systems

[0052] FIG. 1 shows a schematic of a system 100 configured to control an implantable device 102 using an external magnet 106, in accordance with some embodiments.Implantable device 102 may be configured to be implanted in a subject (e.g., in a subcutaneous pocket in the abdomen of the subject). Implantable device 102 may comprise a plurality of sensors comprising a magnetic field sensor of a first type configured to detect a magnetic field and one or more magnetic field sensors of a second type configured to sense one or more characteristics of the magnetic field.

[0053] In some embodiments, system 100 may comprise an external magnet 106. By moving the magnet in one or more magnetic field gestures from a predetermined set of magnetic field gestures, a user of the system 100 may manipulate the magnetic field around implantable device 102. Using the plurality of sensors, implantable device 102 may be configured to detect the presence of the magnetic field and / or characteristics of the magnetic field. In some embodiments, implantable device 102 may be configured to sense changes in the characteristics of the magnetic field caused by movements of external magnet 106. Based on the sensed characteristics of the magnetic field, the implantable device 102 may be configured to identify the one or more magnetic field gestures made by the user. In some embodiments, each of the magnetic field gestures from the set of predetermined magnetic field gestures may correspond to one or more actions for the implantable device 102.Identification of the one or more magnetic field gestures made by the user may cause implantable device 102 to execute the one or more corresponding actions. In this manner, implantable device 102 may be controlled by external magnet 106.

[0054] In some embodiments, implantable device 102 may be an implantable pulse generator comprising a stimulation circuit configured to emit electrical pulses for electrical stimulation of target tissue. For example, a first magnetic field gesture may correspond to stimulating target tissue and identification of the first magnetic field gesture by implantable device 102 may cause the stimulation circuit to emit electrical pulses, enabling implantable device 102 to start stimulating target tissue. A second magnetic field gesture may correspond to stopping stimulation of target tissue and identification of the second magnetic field gesture 15MF-367063050Attorney Docket No: 78895-20043.40 by implantable device 102 may cause implantable device 102 to stop stimulating target tissue. Additionally or alternatively, implantable device 102 may be configured to provide timed stimulation and may stop stimulation after a predetermined period of time. The predetermined amount of time may be determined based on the amount of stimulation time desired for a given treatment. For example, for treatment of UAB, the predetermined amount of time may be determined based on the amount of tissue stimulation time likely to result in complete bladder voiding (e.g., between about 30 seconds and about 45 seconds).

[0055] The stimulation circuit of implantable device 102 may be coupled to one or more leads 104 configured to transmit electrical pulses from the implantable device 102 to target tissue. The one or more leads 104 may comprise one or more electrodes at one or more distal tips of the one or more leads. The one or more leads 104 may be similar in size, material, construction methods, contact geometry, etc. to leads commonly used in the field. For example, the one or more leads 104 may be 1-2 mm in diameter, comprise ethylene tetrafluoroethylene copolymer (ETFE) conductive wire insulation material, and / or 55D urethane lead body material.

[0056] In some embodiments, the system 100 may be configured to treat bladder disorders (e.g., UAB or OAB) by stimulating tissue that controls bladder voiding.Implantable device 102 may be configured to be implanted in a subcutaneous pocket above the fascia in the lower lateral abdominal quadrant of the subject. The one or more leads 104 may extend from the implantable device 102 to target tissue that controls bladder voiding through one or more subcutaneous tunnels.

[0057] In some embodiments, implantable device 102 may comprise an energy storage circuit comprising a battery. In some embodiments, the battery may be rechargeable. In some embodiments, the battery is non-rechargeable (e.g., a primary battery). Implantable device 102 may be configured to reduce power consumption when not in use. For example, implantable device 102 may be configured to stay in a powered-down state, wherein power consumption by implantable device 102 is minimal, until the magnetic field sensor of a first type 202 of implantable device 102 detects a magnetic field. In some embodiments, upon detection of the magnetic field, implantable device 102 may remain powered for a predetermined period of time before returning to the powered-down state. In some embodiments, upon detection of the magnetic field, implantable device 102 may remain powered until implantable device 102 identifies a predetermined gesture corresponding to powering down implantable device 102. Additionally or alternatively, upon detection of the16MF-367063050Attorney Docket No: 78895-20043.40 magnetic field, implantable device 102 may remain powered until detection of one or more fault conditions of implantable device 102 (e.g., overheating of implantable device 102).

[0058] FIG. 2 shows a block diagram of an exemplary implantable device, in accordance with some embodiments. With reference to FIG. 2, the solid lines represent the flow of power, and the dashed lines represent communication and / or control signals.

[0059] Implantable device 200 may comprise any one or more features of implantable device 102 disclosed herein with respect to FIG. 1. External magnet 204 may be used to affect the magnetic field around implantable device 200. The implantable device 200 may comprise a magnetic field sensor of a first type 202 configured to detect a magnetic field. Magnetic field sensor of a first type 202 may be a passive sensor that does not consume power or allow current to pass until a magnetic field is detected. In some embodiments, magnetic field sensor of a first type 202 may be a passive electromechanical switch configured to activate whenever a sufficiently strong magnetic field of either polarity is detected. For example, the magnetic field sensor of a first type 202 may be a Reed switch. In some embodiments, magnetic field sensor of a first type 202 may be an electromagnetic inductance antenna configured to generate an electric current proportional to detected changes in the magnetic field. For example, magnetic field sensor of a first type 202 may be a loop antenna.

[0060] Magnetic field sensor of a first type 202 may be electrically connected to an energy storage circuit 208. Energy storage circuit 208 may comprise a battery and may be configured to store and distribute energy to implantable device 200 and components thereof. The battery of energy storage circuit 208 may be rechargeable. The battery of energy storage circuit 208 may be non-rechargeable. To minimize power consumption and maximize the longevity of energy storage circuit 208, magnetic field sensor of a first type 202 may be configured to draw power from energy storage circuit 208 only once a magnetic field is detected. For example, magnetic field sensor of a first type 202 may be a normally-open Reed switch such that no power is drawn from energy storage circuit 208 by the magnetic field sensor of the first type 202 (e.g., because of the open circuit caused by the open Reed switch) until the Reed switch detects a magnetic field and the Reed switch closes, which may complete the circuit and enable current flow from energy storage circuit 208. In this manner, energy storage circuit 208 may power only necessary components of the implantable device (e.g., a real time clock) until the magnetic field sensor of a first type 202 detects a magnetic field. The energy storage circuit 208 may comprise a fuse (e.g., a slow -blow fuse) configured to protect the battery of energy storage circuit 208 from overcurrent caused by a short circuit.17MF-367063050Attorney Docket No: 78895-20043.40 In some embodiments, when magnetic field sensor of a first type 202 generates an electrical signal based on electromagnetic inductance, (e.g., when magnetic field sensor of a first type 202 is an electromagnetic inductance antenna or a loop antenna), magnetic field sensor of a first type 202 may not be electrically connected to energy storage circuit 208.

[0061] Magnetic field sensor of a first type 202 may be electrically coupled to a control input of load switch 206. Upon activation by magnetic field sensor of a first type 202, load switch 206 may be configured to transfer power from energy storage circuit 208 to other components of implantable device 200 (e.g., magnetic field sensor of a second type 210, converter 212, one or more controllers 214 and / or stimulation circuit 216). To minimize power consumption and maximize longevity of energy storage circuit 208, load switch 206 may be deactivated such that little or no power (e.g., less than about 1 pW) is drawn from energy storage circuit 208 by components of implantable device 200 until magnetic field sensor of a first type 202 detects a magnetic field. For example, until magnetic field sensor of a first type 202 detects a magnetic field, load switch 206 may be deactivated and power consumed from energy storage circuit 208 by implantable device 200 may be as little as any leakage current through load switch 206 (e.g., from about 150 nA to about 250 nA).

[0062] Magnetic field sensor of a first type 202 may be configured to activate load switch 206 when magnetic field sensor of a first type 202 detects a magnetic field. For example, magnetic field sensor of a first type 202 may be a normally open Reed switch configured to close upon detection of a magnetic field and provide an activation signal to load switch 206 (e.g., by completing the circuit and creating a current path between energy storage circuit 208 and load switch 206). In some embodiments, magnetic field sensor of a first type 202 may be a loop antenna configured to generate an electric current in response to detecting the changing magnetic field. Load switch 206 may be configured to activate upon receiving a voltage at the control input of load switch 206. In some embodiments, load switch 206 may be a normally open load switch, and, upon activation, may be configured to close and create a current path from energy storage circuit 208 to other components of implantable device 200 (e.g., magnetic field sensor of a second type 210, converter 212, one or more controllers 214 and / or stimulation circuit 216.)

[0063] Load switch 206 may be configured to latch upon activation by magnetic field sensor of a first type 202. For example, once activated, load switch 206 may be configured to remain activated after magnetic field sensor of a first type 202 no longer detects a magnetic field (e.g., if external magnet 204 has moved out of the detection range of magnetic field sensor of a first type 202). FIG. 9 shows a block diagram of an exemplary load switch and 18MF-367063050Attorney Docket No: 78895-20043.40 latching circuit, according to some embodiments. While FIG. 9 shows magnetic field sensor of a first type 202 as a switch (e.g., a Reed Switch), magnetic field sensor of a first type 202 may be any passive sensor that does not consume power or allow current to pass until a magnetic field is detected. In some embodiments, the latching behavior of load switch 206 may be implemented by a feedback loop connecting the output of load switch 206 back to the control input of load switch 206. In this manner, the control input of load switch 206 may be configured to operate as a logical “OR” function between the signal from magnetic field sensor of a first type 202 and the output of load switch 206. The logical “OR” function may be implementable in hardware by using diodes. In some embodiments, the latching behavior of load switch 206 may be implemented by an explicit latch. The explicit latch may be powered by the output of the load switch, such that the explicit latch does not consume power until the load switch is latched.

[0064] Latching behavior of load switch 206 may enable implantable device 200 and components thereof to remain powered after the external magnet 204 is no longer detected by magnetic field sensor of a first type 202. This behavior may be desirable if magnetic field gestures for controlling implantable device 200 require the external magnet 204 to be moved away from the implantable device 200. Magnetic field gestures will be described in more detail below, with respect to FIGS. 4 and 6. Additionally or alternatively, the latching behavior may enable the implantable device to stimulate tissue without sensing external magnet 204 for the entire duration of stimulation. For example, once stimulation is triggered, external magnet 204 may not need to be positioned near the implantable device for stimulation to continue.

[0065] Load switch 206 may be configured to unlatch (or deactivate) such that load switch 206 no longer transfers power from energy storage circuit 208 to other components of implantable device 200. Unlatching of load switch 206, and subsequent deactivation of implantable device 200 and components thereof, may be desirable to minimize power consumption and maximize the longevity of energy storage circuit 208. In some embodiments, load switch 206 may unlatch after implantable device 200 has completed one or more actions. For example, load switch 206 may unlatch after implantable device 200 has completed a timed stimulation. In some embodiments, load switch 206 may be configured to unlatch in response to a received unlatch signal. The unlatch signal may be received by a transistor located on the feedback path of the load switch 206, which may break the feedback path allowing the control signal to load switch 206 to be de-asserted. Generation of unlatch signals are described in more detail below. Additionally or alternatively, load switch 206 may 19MF-367063050Attorney Docket No: 78895-20043.40 unlatch after a predetermined amount of time measured from the time of activation of load switch 206. With reference to FIG. 2, implantable device 200 may comprise hardware delays 218 configured to unlatch load switch 206 after the predetermined amount of time. In some embodiments, the hardware delays 218 may comprise resistor-capacitor delays. The hardware delays 218 may be additionally configured to create a shutdown notification signal to one or more components of implantable device 200 such that implantable device 200 may be configured to handle any shutdown procedures before load switch 206 is deactivated and implantable device 200 is subsequently unpowered.

[0066] Implantable device 200 may comprise at least one magnetic field sensor of a second type 210 configured to sense one or more characteristics of a magnetic field. The one or more characteristics of a magnetic field may comprise one or more of a magnetic flux and a magnetic flux density of the magnetic field. In some embodiments, magnetic field sensor of a second type 210 may be an active integrated sensor with an output proportional to magnetic flux density of a detected magnetic field. Magnetic field sensor of a second type 210 may be able to sense magnetic fields with higher sensitivity than magnetic field sensor of a first type 202. Magnetic field sensor of a second type 210 may be a Hall-effect sensor, a magnetometer, a magnetoresistive sensor, a MEMS sensor, a magnetic fluxgate sensor, a Reed switch, an electromagnetic induction antenna, an magnetoelectric sensors or a spin electronic sensor. The magnetic field sensor of a second type 210 may sense changes in the one or more characteristics of the magnetic field in response to movements of external magnet 204. In some embodiments, magnetic field sensor of a second type 210 may be a passive electromechanical switch configured to activate whenever a sufficiently strong magnetic field of either polarity is detected (e.g., a Reed switch or a magnetic inductance antenna).

[0067] Magnetic field sensor of a second type 210 may be configured to be activated upon detection of a magnetic field by magnetic field sensor of a first type 202. For example, magnetic field sensor of a second type 210 may be configured to receive energy from energy storage circuit 208 through load switch 206, once load switch 206 is activated by magnetic field sensor of a first type 202. Magnetic field sensor of a second type 210 may consume higher power than magnetic field sensor of a first type 202. Accordingly, magnetic field sensor of a second type 210 may remain unpowered until detection of a magnetic field by magnetic field sensor of a first type 202 to conserve energy.

[0068] Magnetic field sensor of a second type 210 may be configured to output the sensed one or more characteristics of the magnetic field as a plurality of electrical signals. In some embodiments, magnetic field sensor of a second type 210 may be connected to20MF-367063050Attorney Docket No: 78895-20043.40 converter 212. Converter 212 may be configured to receive the sensed one or more characteristics of the magnetic field in as plurality of electrical signals from magnetic field sensor of a second type 210, convert the sensed one or more characteristics of the magnetic field into a plurality of digital signals, and input the plurality of digital signals into one or more controllers 214. Converter 212 may be a window comparator with two fixed thresholds configured to reduce the plurality of electrical signals into a two-bit digital signal. The two bits may represent the polarity of the detected magnetic field. For example, one of the two bits may indicate the presence of the north pole of external magnet 204 and the other bit may represent the presence of the south pole of external magnet 204. The thresholds may be symmetrical and may be chosen according to external magnet 204, such that the threshold is met or exceeded when the external magnet 204 is near the implantable device. For example, if the implantable device 200 is implanted in a subject, the threshold may be set such that it is met or exceeded when the external magnet 204 is placed near the skin of the subject external to the implantable device 200. In some embodiments, converter 212 may be an analog to digital converter configured to digitize the sensed one or more characteristics of the magnetic field to a scalar number representation.

[0069] Implantable device 200 may comprise one or more controllers 214 configured to receive the sensed characteristics of the magnetic field as a plurality of digital signals from converter 212. The one or more controllers may comprise at least one of software or firmware. The one or more controllers 214 may be configured to receive the sensed characteristics of the magnetic field as a function of time and synthesize a series of magnetic field events based on the received sensed characteristics of the magnetic field. In some embodiments, magnetic field events of the series of magnetic field events may comprise one or more of a presence, an absence, a polarity, a change in polarity, a rate of change of magnetic flux, and / or a velocity of the magnetic field with respect to the implantable device.

[0070] Synthesizing the series of magnetic field events may comprise the one or more controllers 214 taking a moving average of the plurality of digital signals over a fixed window of time and determining when the average exceeds a fixed threshold. For example, when the moving average of detected flux density exceeds a fixed threshold, the sequence of magnetic field characteristics as a function of time may indicate that one of two magnetic poles of external magnet 204 is detected, and when the moving average of detected flux density drops below the fixed threshold, the sequence of magnetic field characteristics as a function of time may indicate that the pole is no longer detected. Utilizing a moving average in synthesizing the sequence of magnetic field characteristics as a function of time may 21MF-367063050Attorney Docket No: 78895-20043.40 reduce noise caused by imperfect positioning of external magnet 204. Imperfect positioning of external magnet 204 may be caused by uncertainty of the exact location of implantable device 200, which may be hidden beneath skin of a subject. For example, the disclosed system may tolerate minor intermptions in detection of the magnetic field due to unintentional movements bringing the external magnet out of range of the magnetic field sensor of a first type 202 or magnetic field sensor of a second type 210.

[0071] In some embodiments, the fixed window of time may be determined based on the level of uncertainty of the exact location of implantable device 200. For example, if there is less uncertainty and a user can reliably position external magnet 204 such that it can be detected by implantable device 200, the fixed window of time may be shorter (e.g., about 0.5 seconds to about 3 seconds). If there is more uncertainty and a user cannot reliably position external magnet 204 such that it can be detected by implantable device 200, the fixed window of time may be longer (e.g., about 3 seconds to about 8 seconds). In some embodiments, the fixed threshold may be set high enough such that the implantable device 200 can tolerate imperfect positioning of external magnet 204 yet low enough that the implantable device 200 does not ignore gestures made by the external magnet 204. In some embodiments, interruptions in detection of the magnetic field may be reduced by selecting external magnet 204 based on the size of implantable device 200, such that the spatial area where implantable device 200 can detect external magnet 204 is increased.

[0072] The one or more controllers 214 may be configured to control implantable device 200 based on the synthesized series of magnetic field events. For example, the one or more controllers 214 may be configured to identify one or more magnetic field gestures from a predetermined set of magnetic field gestures from the series of magnetic field events. Each of the magnetic field gestures from the set of predetermined magnetic field gestures may correspond to one or more actions for the implantable device 200. Upon identifying one or more magnetic field gestures, the one or more controllers 214 may cause the implantable device 200 to execute the one or more corresponding actions. For example, the identified one or more magnetic field gesture may correspond to shutting down implantable device 200, and the one or more controllers 214 may generate an unlatch signal to deactivate load switch 206, causing implantable device 200 to shut down.

[0073] Implantable device 200 may be an implantable pulse generator comprising a stimulation circuit 216 configured to generate electrical pulses for stimulating target tissue. For example, the identified one or more magnetic field gestures may correspond to the implantable device 200 beginning stimulation of target tissue, and the one or more controllers 22MF-367063050Attorney Docket No: 78895-20043.40 214 may cause stimulation circuit 216 of implantable device 200 to begin generating electrical pulses. In some embodiments, the implantable device 200 may stop generating pulses after a predetermined period of time. The predetermined amount of time may be determined based on the amount of stimulation time desired for a given treatment. For example, for treatment of UAB, the predetermined amount of time may be determined based on the amount of tissue stimulation time likely to result in complete bladder voiding (e.g., about 30 seconds to about 45 seconds). In some embodiments, the identified one or more magnetic field gestures may correspond to the implantable device 200 stopping stimulation, and the one or more controllers 214 may cause stimulation circuit 216 of implantable device 200 to stop generating electrical pulses. In some embodiments, the power provided from energy storage circuit 208 to the stimulation circuit 216 of the implantable device 200 may be controlled by load switch 206, such that unlatching load switch 206 shuts down the stimulation circuit 216 of implantable device 200.

[0074] The one or more controllers 214 may be configured to unlatch load switch 206 and return implantable device 200 to an unpowered state after the implantable device 200 has completed executing the one or more actions. For example, the one or more controllers 214 may generate an unlatch signal after the implantable device has completed a timed stimulation or after the implantable device has stopped stimulating tissue in response to identifying one or more magnetic field gestures corresponding to stopping stimulation. In some embodiments, the one or more controllers may generate an unlatch signal if no magnetic field gestures from the predetermined set of magnetic field gestures are identified based on the series of magnetic field events for a predetermined measurement period of time. The predetermined measurement period of time may be about 10 seconds to about 20 seconds. For example, the predetermined measurement period of time may be about 16 seconds.

[0075] Stimulation circuit 216 may comprise a current source 226. In some embodiments, current source 226 may be an application-specific integrated circuit configured to generate electrical pulses. Stimulation circuit 216 may comprise one or more capacitors 224 configured to provide power to current source 226. The one or more capacitors 224 may be configured to provide stimulation currents that exceeds the power density (or current delivery capability) of energy storage circuit 208. The one or more capacitors 224 may be configured to be empty (e.g., have no power stored) when implantable device 200 is in an unpowered state (e.g., load switch 206 is deactivated). When the one or more controllers 214 identify one or more predetermined magnetic field characteristics corresponding to beginning stimulation,23MF-367063050Attorney Docket No: 78895-20043.40 the one or more controllers 214 may be configured to cause the one or more capacitors of stimulation circuit 216 to draw energy from energy storage circuit 208, charging the one or more capacitors 224 with stored energy. Stimulation circuit 216 may be coupled to one or more leads 220. The one or more leads 220 may comprise any one or more features of leads 104 as described herein with reference to FIG. 1. The one or more leads 220 may each comprise one or more electrodes 222 at distal ends of the one or more leads 220. Once charged, the one or more capacitors 224 may be configured to discharge the stored energy to the current source, which may use the energy to generate electrical pulses. The current source may transmit electrical pulses to one or more electrical leads 220, thereby emitting electrical pulses at the one or more electrodes 222 of the one or more electrical leads 220. In this manner, the one or more controllers 214 may be configured to cause implantable device 200 to stimulate target tissue. Stimulation circuit 216 may be configured to stop transmitting electrical pulses to the one or more electrical leads 220 after a predetermined period of time. Additionally or alternatively, one or more controllers 214 may cause stimulation circuit 216 to stop generating electrical pulses after identification of one or more magnetic field gestures corresponding to stopping stimulation.

[0076] The stimulation circuit 216 may be configured to implement one or more safety features. For example, the one or more capacitors 224 may still contain stored energy after the stimulation circuit 216 stops transmitting electrical pulses (e.g., because the stimulation circuit 216 has completed a timed stimulation or because the one or more controllers 214 identify one or more magnetic field gestures corresponding to stopping stimulation). To prevent unintentional stimulation due to discharge of stored energy in one or more capacitors 224, stimulation circuit 216 may comprise one or more dissipation elements configured to dissipate the remaining stored energy in capacitors 224 such that the stored energy is not discharged into the target tissue. For example, stimulation circuit 216 may comprise one or more resistors configured to dissipate the remaining stored energy as heat energy.

[0077] The one or more controllers 214 may be configured to implement one or more safety features. In some embodiments, the one or more controllers 214 may comprise one or more hardware components configured to cause implantable device 200 to implement a failsafe emergency action if firmware or software of the controllers 214 have failed. In other words, an emergency set of one or more magnetic field gestures may be identifiable by the one or more hardware components, which may be able to control implantable device 200 to take a predetermined emergency action. For example, the emergency set of one or more magnetic field gestures may comprise detection of a south pole of external magnet 204, the 24MF-367063050Attorney Docket No: 78895-20043.40 predetermined emergency action may be to shut down implantable device 200, and the hardware components may comprise a connection between a south-pole output of a window comparator of converter 212 and the unlatch input of the load switch 206, such that when the window comparator indicates the south pole of external magnet 204 is detected, the load switch unlatches and shuts down implantable device 200.

[0078] In some embodiments, the one or more controllers 214 may be configured to receive sensor data from one or more emergency sensors on implantable device 200. For example, implantable device 200 may comprise sensors to detect fault conditions (e.g., temperature sensors to detect overheating, overcurrent sensors, undervoltage sensors, or other emergency sensors). The one or more controllers 214 may, based on the detection of fault conditions by the emergency sensors, generate and provide an unlatch signal for the load switch 206, causing implantable device 200 to shut down. Alternatively or additionally, the one or more controllers 214 may, based on the detection of fault conditions, cause the stimulation circuit 216 to stop stimulating.

[0079] In some embodiments, as a fail-safe, the one or more controllers 214 may be configured to unlatch load switch 206, causing implantable device 200 to shut down after a predetermined fail-safe period of time. This predetermined fail-safe period of time may be longer than the predetermined period of time for a timed stimulation and the predetermined measurement period of time. In some embodiments, the predetermined fail-safe period of time may be selected from a range of about 45 seconds to about 2 minutes. For example, the predetermined fail-safe period of time may be 65 seconds.

[0080] The one or more controllers may comprise an application-specific integrated circuit (ASIC), a low-power microcontroller, and / or a field programmable gate array configured to control the ASIC and other electronic components of the implantable device 200. In some embodiments, the one or more controllers 214 may be configured to host digital application logic that implements identification of predetermined magnetic field characteristics, identification of corresponding actions by the implantable device 200, operation of the implantable device 200 in accordance with the corresponding actions, and stimulation parameters for stimulation circuit 216. The application logic may be stored in a non-volatile memory chip, wherein the application logic may be loaded onto the one or more controllers 214 upon activation.

[0081] In some embodiments, the one or more controllers 214 may be located on a printed circuit board (PCB) assembly. The PCB may comprise one or more monitoring circuits which may comprise the one or more emergency sensors. In some embodiments, the 25MF-367063050Attorney Docket No: 78895-20043.40 one or more monitoring circuits may be configured to operate independently of the one or more controllers 214 such that the monitoring circuits are configured to shut down the implantable device 200 upon detection of a fault condition. For example, a monitoring circuit may be implemented in hardware such that an output of an emergency detector may be connected to the unlatch input of the load switch 206.

[0082] FIG. 3 shows a block diagram of a second exemplary implantable device 300, in accordance with some embodiments. With reference to FIG. 3, the solid lines represent the flow of power, and the dashed lines represent communication and / or control signals.Implantable device 300 may comprise any one or more features of implantable device 102 or 200 described herein with respect to FIG. 1 or FIG. 2. For example, magnetic field sensor of a first type 302 may comprise any one or more features of magnetic field sensor of a first type 202 described herein with respect to FIG. 2. Load switch 306 may comprise any one or more features of load switch 206 described herein with respect to FIGS. 2 or 9. Energy storage circuit 308 may comprise any one or more features of energy storage circuit 208 described herein with respect to FIG. 2. Converter 312 may comprise any one or more features of converter 212 described herein with respect to FIG. 2. One or more controllers 314 may comprise any one or more features of one or more controllers 214 described herein with respect to FIG. 2. Stimulation circuit 316, one or more capacitors 324, and / or current source 326 may comprise any one or more features of stimulation circuit 216, one or more capacitors 224, and / or current source 226, respectively, described herein with respect to FIG. 2. One or more leads 320 may comprise any one or more features of one or more leads 104 and / or one or more leads 220 described herein with respect to FIGS. 1 or 2, respectively. One or more electrodes 322 may comprise any one or more features of one or more electrodes 222 described herein with respect to FIG. 2.

[0083] FIG. 3 can demonstrate an implantable device 300 in which components of implantable device 300 may be distributed in different geographical areas of implantable device 300 to enable a more robust set of predetermined magnetic field gestures. Implantable device 300 may comprise a plurality of magnetic field sensors of a second type 310a, 310b, 310c, 31 Od (hereinafter, for simplicity collectively referred to as magnetic field sensors of a second type 310). Each of the plurality of magnetic field sensors of a second type 310 may be similar to or may comprise any one or more components described herein with respect to magnetic field sensor of a second type 210 of implantable device 200 shown in FIG. 2. While four magnetic field sensors of a second type 310 are shown in FIG. 3, implantable device 300 may comprise any number of magnetic field sensors of a second type 310. For example, the 26MF-367063050Attorney Docket No: 78895-20043.40 device may comprise 2, 3, 4, 5, 6, or more magnetic field sensors of a second type 310. In some embodiments, each of the magnetic field sensors of a second type 310 may be positioned at different geographical locations of implantable device 300. In some embodiments, the plurality of magnetic field sensors of a second type 310 may enable identification of a more robust predetermined set of magnetic field gestures by sensing one or more magnetic field characteristics at distinct geographical locations on implantable device 300. For example, magnetic field sensors of a second type 310 may enable one or more controllers 314 of implantable device 300 to identify directional movement of a magnetic field (e.g., caused by directional movement of external magnet 304) based on the magnetic field characteristics sensed at distinct geographical locations.

[0084] In some embodiments, converter 312 may be configured to receive the sensed one or more magnetic field characteristics as a plurality of electrical signals from each of the magnetic field sensors of a second type 310, representing the one or more magnetic field characteristics at the distinct geographical locations. Converter 312 may convert the sensed magnetic field characteristics into a plurality of digital signals and input the converted one or more magnetic field characteristics into one or more controllers 314 (e.g., similarly to converter 212 of implantable device 200 as shown in FIG. 2). In some embodiments, implantable device 300 may comprise a plurality of converters 312. Implantable device 300 may comprise a converter 312 connected to each of the plurality of magnetic field sensors of a second type 310. The plurality of converters 312 may each convert the one or more magnetic field characteristics received from the corresponding magnetic field sensor of a second type 310 to a plurality of digital signals, and transmit the converted one or more magnetic field characteristics to the one or more controllers 314.

[0085] One or more controllers 314 may be configured to receive the one or more magnetic field characteristics as a function of time and synthesize a series of magnetic field events based on the one or more magnetic field characteristics (e.g., similarly to one or more controllers 214 of implantable device 200 of FIG. 2). In some embodiments, events of the series of magnetic field events may comprise a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, a position, and / or a directional motion of the magnetic field with respect to the implantable device.

[0086] By utilizing magnetic field characteristics from different geographical locations of implantable device 300 to synthesize the series of magnetic field events, the one or more controllers 314 may be able to determine a direction of motion of the magnetic field (e.g., as caused by movement of external magnet 304 in relation to implantable device 300). This may 27MF-367063050Attorney Docket No: 78895-20043.40 enable the identification of a more robust and complex set of predetermined magnetic field gestures. For example, with reference to FIG. 3, if the series of magnetic field events comprises the presence of a pole of the magnetic field at the location of magnetic field sensor of a second type 310a, then an absence of the pole of the magnetic field at the location of magnetic field sensor of a second type 310a, then the presence of the pole of the magnetic field at the location of magnetic field sensor of a second type 310c, the one or more controllers 314 may identify that the magnetic field has moved (e.g., because external magnet 304 has moved) in a direction from magnetic field sensor of a second type 310a to magnetic field sensor of a second type 310c (e.g., from left to right). Enabling detection of a more robust set and / or complex set of predetermined magnetic field gestures (e.g., by enabling identification of directional movement of the magnetic field and / or external magnet 304) may reduce the risk of unintended actions of the implantable device (e.g., unintended stimulation) due to disturbances in the magnetic field that may be caused by other environmental conditions (e.g., disturbances to the magnetic fields produced by a household magnet rather than external magnet 304).

[0087] FIGS. 4A and 4B show an exemplary external magnet 402 for controlling an implantable device, according to some embodiments. External magnet 402 may comprise any one or more features of external magnet 106, external magnet 204, and / or external magnet 304 described herein with respect to FIG. 1, FIG. 2, and FIG. 3, respectively. External magnet 402 may be used to control an implantable device similar to implantable device 102 of FIG. 1, implantable device 200 of FIG. 2, and / or implantable device 300 of FIG. 3.

[0088] FIG. 4A shows a cross sectional view of an external magnet 402, according to some embodiments. External magnet 402 may be polarized through thickness and may comprise a north pole 408 on one side of external magnet 402 and a south pole 410 on the opposite side of external magnet 402. In some embodiments, external magnet 402 may be a passive permanent magnet. Use of a passive permanent magnet may be convenient for a user because it does not comprise electronics which may malfunction and does not need to be recharged or powered by battery. In some embodiments, external magnet 402 may be an active magnet configured to emit a magnetic field produced by an electrical current.

[0089] External magnet 402 may be selected such that it is light weight and portable. External magnet 402 may be sized to be easily carried in a subject’s hand. External magnet 402 may be robust to a wide range of environmental conditions (e.g., being submerged in water or exposure to any temperatures, pressures, and / or humidity reasonably expected in habitable environments). In some embodiments, external magnet 402 may be selected such 28MF-367063050Attorney Docket No: 78895-20043.40 that it may be easily replaced by a user if external magnet 402 is lost (e.g., replaceable by commonly available magnets). External magnet 402 may comprise a molding 406. Molding 406 may increase durability of external magnet 402 (e.g., by increasing shock absorption). Molding 406 may make it easier for a subject to hold external magnet 402. In some embodiments, molding 406 may comprise a rubberized plastic material. External magnet 402 may be selected such that external magnet 402 emits a magnetic field with detectable field strength at a distance at least equal to a maximum implantation depth of an implantable device. External magnet 402 may comprise neodymium.

[0090] FIG. 4B shows a schematic of external magnet 402, according to some embodiments. External magnet 402 may include one or more indicators 404 on the surface of external magnet 402. One or more indicators 404 may indicate the polarity of each side of external magnet 402. In some embodiments, the one or more indicators 404 may indicate what action the corresponding pole of external magnet 402 may control when used to control an implantable device (e.g., implantable device 102 of FIG. 1, implantable device 200 of FIG.2, or implantable device 300 of FIG. 3). In some embodiments, one or more indicators 404 may provide instructions for using external magnet 402 to control an implantable device. For example, as shown in FIG. 4B, indicator 404 may indicate which orientation external magnet 402 should be facing with respect to the subject’s skin to stop an implantable device from functioning. While FIG. 4B shows indicator 404 as comprising text, one or more indicators 404 may comprise any form of indicator to communicate how to use the magnet (e.g., colors, symbols, indentations, protrusions, Braille, and / or textured patterns). Further, while FIG. 4B shows indicators 404 on one side of the magnet, external magnet 402 may comprise one or more indicators on each side of external magnet 402.Methods for Magnetically Controlling an Implantable Device

[0091] FIG. 5 shows a method 500 for controlling an implantable device using an external magnet, in accordance with some embodiments. For example, the method 500 may be used to control an implantable pulse generator to stimulate target tissue (e.g., a bladder wall). In some examples of the method, method 500 may be performed using a system (e.g., system 100 disclosed herein with respect to FIG. 1) comprising an implantable device (e.g., implantable device 200 or implantable device 300, disclosed herein with respect to FIGS. 2 and 3, respectively) and an external magnet (e.g., external magnet 106, 204, 304, or 402, disclosed herein with respect to FIGS. 1, 2, 3, or 4 respectively).29MF-367063050Attorney Docket No: 78895-20043.40

[0092] At step 502, the method 500 may comprise detecting the presence of a magnetic field using a magnetic field sensor of a first type of the implantable device. The detected magnetic field may be caused by an external magnet. For example, the method may comprise positioning the external magnet such that changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of a first type of the implantable device. The magnetic field sensor of a first type may be a passive sensor that does not consume power or allow current to pass until a magnetic field is detected. In some embodiments, the magnetic field sensor of a first type may be a passive electromechanical switch configured to activate whenever a sufficiently strong magnetic field of either polarity is detected. For example, the magnetic field sensor of a first type may be a Reed switch. In some embodiments, the magnetic field sensor of a first type may be an electromagnetic induction antenna configured to generate an electrical current proportional to detected changes in the magnetic field. For example, the magnetic field sensor of a first type may be a loop antenna. In some examples of the method, the implantable device may be in a powered-down state until the magnetic field is detected by the magnetic field sensor of a first type.

[0093] At step 504, the method 500 may comprise activating the one or more magnetic field sensors of a second type of the implantable device in response to the detection of the magnetic field by the magnetic field sensor of a first type. The one or more magnetic field sensors of a second type of the implantable device may be unpowered prior to detection of the magnetic field. In some examples of the method, activating the one or more magnetic field sensors of a second type may comprise activating a load switch upon detection of the magnetic field by the magnetic field sensor of a first type, and transferring power, by the load switch, from an energy storage circuit to the one or more magnetic field sensors of a second type. In some examples of the method, activating the load switch may provide power to other components of the implantable device (e.g., one or more controllers and / or a stimulation circuit of the implantable device).

[0094] In some examples of the method, the method may comprise latching the load switch such that the load switch remains activated after the magnet is no longer in proximity to the implantable device. In some examples, the method may comprise deactivating the load switch after a predetermined period of time. In some examples, the method may comprise deactivating the load switch in response to an unlatch signal generated by one or more controllers of the implantable device. Deactivating the load switch may comprise stopping the provision of power from the energy storage circuit to components of the implantable device.30MF-367063050Attorney Docket No: 78895-20043.40

[0095] At step 506, the method 500 may comprise sensing, by the one or more magnetic field sensors of a second type, one or more magnetic field characteristics. In some examples of the method, sensing one or more magnetic field characteristics may comprise sensing one or more of a magnetic flux and / or a magnetic flux density of the magnetic field. In some embodiments, the one or more magnetic field sensors of a second type may be an active integrated sensor with an output proportional to magnetic flux density of a detected magnetic field. The one or more magnetic field sensors of a second type may be able to detect magnetic fields with higher sensitivity than the magnetic field sensor of a first type. The one or more magnetic field sensors of a second type may comprise one or more Hall-effect sensors, one or more magnetometers, one or more magnetoresistive sensors, one or more MEMS sensors, one or more Reed switches, one or more magnetic fluxgate sensors, one or more electromagnetic induction antennas, one or more magnetoelectric sensors, and / or one or more spin electronic sensors. The one or more magnetic field sensors of a second type may sense changes in the one or more characteristics of the magnetic field in response to movements of the external magnet.

[0096] In some examples of the method, the method may comprise moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein changes to the magnetic field caused by the external magnet can be detected and / or sensed by the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type during the one or more gestures. Each magnetic field gesture of the set of predetermined magnetic field gestures may correspond to one or more actions of the implantable device. Each of the magnetic field gestures may comprise one or more of holding the external magnet stationary for a second predetermined period of time, moving the external magnet laterally, moving the external magnet circularly, and / or switching which pole of the external magnet is directed towards the magnetic field sensor of a first type and magnetic field sensors of a second type. Moving the external magnet in one or more magnetic field gestures may cause changes in the magnetic field around the implantable device, which the one or more magnetic field sensors of a second type may sense.

[0097] At step 508, the method 500 may comprise identifying one or more actions for the implantable device based on the one or more magnetic field characteristics. In some examples, the method may further comprise receiving the sensed one or more magnetic field characteristics as a function of time and synthesizing a series of magnetic field events based on the one or more magnetic field characteristics. Magnetic field events of the series of magnetic field events may comprise one or more of a presence, an absence, a polarity, a 31MF-367063050Attorney Docket No: 78895-20043.40 change in polarity, a rate of change of magnetic flux, and / or a velocity of the magnetic field with respect to the implantable device. In some examples of the method, synthesizing the series of magnetic field events is done by one or more controllers of the implantable device. In some examples of the method, identifying one or more actions for the implantable device based on the one or more magnetic field characteristics comprises identifying one or more magnetic field gestures based on the series of the magnetic field events and identifying one or more corresponding actions for the implantable device based on the identified one or more magnetic field gestures.

[0098] At step 510, the method 500 may comprise operating the implantable device according to the one or more actions. For example, the method may comprise moving the magnet in a predetermined gesture corresponding to shutting down the implantable device, identifying the predetermined gestures based on the sequence of magnetic field characteristics, and causing the implantable device to shut down by generating an unlatch signal for the load switch and shutting of the supply of power to the implantable device.

[0099] In some examples of the method, the implantable device may be an implantable pulse generator comprising a stimulation circuit for stimulating target tissue. The method may comprise moving the external magnet in a first magnetic field gesture corresponding to stimulating target tissue, identifying the first magnetic field gesture based on the series of magnetic field events, identifying the corresponding action for the implantable device as stimulating target tissue, and operating the implantable device to generate, by the stimulation circuit of the implantable device, one or more electrical pulses to stimulate target tissue. In some examples, the implantable pulse generator may comprise one or more leads (e.g., one or more leads 104, one or more leads 220, or one or more leads 320 described herein with respect to FIGS. 1, 2, and 3, respectively). Generating electrical pulses to stimulate target tissue may comprise transmitting one or more electrical pulses from the stimulation circuit to the target tissue using the one or more leads. In some examples, the method may further comprise stopping generation of electrical pulses after a predetermined period of time. In some examples, the method may further comprise moving the external magnet in a second magnetic field gesture corresponding to stopping stimulation of target tissue, identifying the second magnetic field gesture based on the series of magnetic field events, identifying the corresponding action for the implantable device as stopping stimulation, and operating the implantable device to stop generating electrical pulses. In some examples of the method, the target tissue may comprise tissue controlling voiding of a bladder (e.g., a bladder wall), and32MF-367063050Attorney Docket No: 78895-20043.40 stimulating the target tissue may cause the bladder to void, and stopping stimulation of the target tissue may cause the bladder to stop voiding.

[0100] FIG. 6 shows a schematic of an exemplary magnetic field gesture of an external magnet for controlling an implantable device, according to some embodiments. FIG. 6 shows predetermined gesture 600 and graph 616 representing a synthesis of an exemplary series of magnetic field events based on sensed magnetic field characteristics as a function of time (e.g., synthesized by controllers 214, controllers 314, or as part of method 500 as disclosed herein with respect to FIGS. 2, 3, and 5 respectively). While FIG 6. shows the magnetic field characteristics comprising magnetic flux density, the magnetic field characteristics may comprise other magnetic field characteristics (e.g., magnetic flux of a magnetic field). While FIG. 6 shows the series of magnetic field events comprising a pole presence event 618, a pole absence event 620, and an opposite pole presence event 622, the series of magnetic field events may comprise other types of events (e.g., a presence, an absence, a polarity, a change of polarity, a velocity, a rate of change of magnetic flux, and / or a directional movement of the magnetic field with respect to the implantable device) and / or may comprise any different quantities of events (e.g., 1, 2, 3, 4, 5, 6, or more events). Further, while graph 616 shows the magnetic field characteristics as sensed by one sensor at one location (e.g., magnetic field sensor of a second type 210 as disclosed herein with respect to FIG. 2) on implantable device 602, the magnetic field characteristics may be sensed by more than one sensor at multiple geographical locations (e.g., magnetic field sensors of a second type 310 as disclosed herein with respect to FIG. 3) on implantable device 602.

[0101] Magnetic field gesture 600 may be selected from a predetermined set of magnetic field gestures. Each magnetic field gesture in the predetermined set of magnetic field gestures may correspond to one or more actions (e.g., starting stimulation of target tissue) for implantable device 602 (e.g., implantable device 102 disclosed herein with respect to FIG. 1, implantable device 200 disclosed herein with respect to FIG. 2, implantable device 300 disclosed herein with respect to FIG. 3, or the implantable device of method 500 disclosed herein with respect to FIG. 5). A user of the implantable device may move an external magnet (e.g., external magnet 106 disclosed herein with respect to FIG. 1, external magnet 204 disclosed herein with respect to FIG. 2, external magnet 402 disclosed herein with respect to FIG. 3, external magnet 402 disclosed herein with respect to FIGS. 4A-B, or the external magnet of method 500 disclosed herein with respect to FIG. 5.) in magnetic field gesture 600 to cause implantable device 602 to execute the corresponding action.33MF-367063050Attorney Docket No: 78895-20043.40

[0102] Implantable device 602 may be implanted in a subject (e.g., in a subcutaneous pocket). External magnet 604 may comprise two poles, 608 and 610. The magnetic field gesture 600 may comprise moving external magnet 604 close to the skin of a subject external to implantable device 602 such that sensors of implantable device 602 can detect and / or sense changes to the magnetic field caused by pole 608 of external magnet 604. At the corresponding times, the magnetic flux density as a function of time may exceed predetermined threshold 612. One or more controllers of implantable device 602 (e.g., controllers 214 or controllers 314 as described herein with respect to FIGS. 2 and 3, respectively) may identify a first magnetic field event in the series of magnetic field events as pole presence event 618 based on the magnetic flux density exceeding predetermined threshold 612.

[0103] Magnetic field gesture 600 may further comprise flipping the orientation of external magnet 604. In some embodiments, flipping external magnet 604 may be done away from the skin of the subject, such that the sensors of implantable device 602 cannot detect changes to the magnetic field caused by external magnet 604. At the corresponding times, the magnetic flux density as a function of time may drop below predetermined threshold 612. One or more controllers of implantable device 602 may identify a second magnetic field event in the series of magnetic field events as pole absence event 620 based on the magnetic flux density dropping below threshold 612.

[0104] Magnetic field gesture 600 may further comprise positioning external magnet 604 such that such that sensors of the implantable device 602 can detect and / or sense changes to the magnetic field caused by pole 610 of the external magnet 604 within a predetermined amount of time after pole absence event 620. At the corresponding time, the magnetic flux density as a function of time may drop below predetermined threshold 614. One or more controllers of implantable device 602 may identify a third magnetic field event in the series of magnetic field events as opposite pole presence event 620 based on the magnetic flux density dropping below threshold 614.

[0105] One or more controllers of implantable device 602 may identify magnetic field gesture 600 based on the synthesized series of magnetic field events, determine that magnetic field gesture 600 corresponds to one or more actions (e.g., starting stimulation of target tissue), and operate implantable device 602 to perform the one or more actions.

[0106] FIG. 6 shows one exemplary magnetic field gesture for controlling implantable device 602. Implantable device 602 may be configured to be controlled by a set of predetermined magnetic field gestures, wherein each magnetic field gesture in the set of 34MF-367063050Attorney Docket No: 78895-20043.40 magnetic field gestures corresponds to one or more actions for implantable device 602. Magnetic field gestures may comprise more or less steps and / or directional movements (e.g., moving external magnet from left to right and / or from top to bottom with respect to implantable device 602). More complex magnetic field gestures may reduce the risk of unintended actions by the implantable device 602.Magnetically Controlled Implantable Device Having Passive Magnetic Field Sensors

[0107] FIG. 7 shows a block diagram of a third exemplary implantable device 700, in accordance with some embodiments. With reference to FIG. 7, the solid lines represent the flow of power, and the dashed lines represent communication and / or control signals.Implantable device 700 may comprise any one or more features of implantable device 102, 200, and / or 300 as described herein with respect to FIG. 1, FIG. 2, or FIG. 3. For example, load switch 706 may comprise any one or more features of load switch 206 and / or 306 described herein with respect to FIG. 2, FIG. 9, or FIG. 3. Energy storage circuit 708 may comprise any one or more features of energy storage circuit 208 and / or 308 described herein with respect to FIG. 2 or FIG. 3. One or more controllers 714 may comprise any one or more features of one or more controllers 214 and / or 314 described herein with respect to FIG. 2 or FIG. 3. Stimulation circuit 716, one or more capacitors 724, and / or current source 726 may comprise any one or more features of stimulation circuit 216 or 316, one or more capacitors 224 or 324, and / or current source 226 or 326, respectively, described herein with respect to FIG. 2 or FIG. 3. One or more leads 720 may comprise any one or more features of one or more leads 104, one or more leads 220, or one or more leads 320 described herein with respect to FIGS. 1, 2, or 3, respectively. One or more electrodes 722 may comprise any one or more features of one or more electrodes 222 or 322 described herein with respect to FIGS.2 or 3. External magnet 704 may comprise any one or more features of external magnet 106, 204, 304, or 402.

[0108] FIG. 7 can demonstrate an implantable device 700 comprising one or more passive magnetic field sensors, which may reduce complexity, power consumption, and / or cost of implantable device 700 in comparison to implantable devices comprising active magnetic field sensors. Implantable device 700 may comprise a magnetic field sensor 702a. In some embodiments, implantable device 700 may further comprise one or more magnetic field sensors. For example, implantable device 700 may comprise a second magnetic field sensor 702b in a different geographical location from magnetic field sensor 702a (e.g., to enable detection of a more robust set of magnetic field gestures by enabling detection of 35MF-367063050Attorney Docket No: 78895-20043.40 directional movement of the external magnet, as described in FIG. 3). Magnetic field sensor 702a and second magnetic field sensor 702b (hereinafter, for simplicity collectively referred to as magnetic field sensors 702) may comprise any one or more features of magnetic field sensor of a first type 202 or 302 as described herein with respect to FIG. 2 or FIG. 3. While only two magnetic field sensors 702 are shown in FIG. 7, implantable device 700 may comprise any number of magnetic field sensors 702. For example, implantable device 700 may comprise 1, 3, 4, 5, or 6 magnetic field sensors 702. In some embodiments, magnetic field sensor 702a and / or second magnetic field sensor 702b may be connected to load switch 706 such that magnetic field sensor 702a and / or second magnetic field sensor 702b are configured to latch load switch 706 upon detection of a magnetic field.

[0109] Magnetic field sensors 702 may be connected to one or more controllers 714. In some embodiments, magnetic field sensors 702 may be a passive electromechanical switch configured to activate whenever a sufficiently strong magnetic field of either polarity is detected and to send a magnetic field detection signal to one or more controllers 714 upon each activation. In some embodiments, magnetic field sensors 702 may be connected to one or more converters 712 configured to convert the signals from magnetic field sensors 702 into a plurality of digital signals, and input the plurality of digital signals into one or more controllers 714. One or more controllers 714 may be configured to receive the magnetic field detection signals over a predetermined measurement period of time measured from the first magnetic field detection signal. For example, the predetermined measurement period of time may be between about 10 seconds and about 25 seconds. For example, the predetermined measurement period of time may be about 16 seconds. The one or more controllers 714 may be configured to synthesize a series of magnetic field events based on the received magnetic field detection signals (e.g., similarly to one or more controllers 214 or 314 of implantable device 200 or 300 of FIGS. 2 or 3). In some embodiments, events of the series of magnetic field events may comprise a presence, absence, velocity, a rate of change of magnetic flux and / or directional motion of the magnetic field with respect to the implantable device 700.Method for Magnetically Controlling an Implantable Device Having Passive Magnetic Field Sensors

[0110] FIG. 8 shows a method 800 for controlling an implantable device using an external magnet, in accordance with some embodiments. For example, the method 800 may be used to control an implantable pulse generator to stimulate target tissue (e.g., a bladder wall, a sacral nerve, and / or a pudendal nerve). In some examples of the method, method 80036MF-367063050Attorney Docket No: 78895-20043.40 may be performed using a system (e.g., system 100 disclosed herein with respect to FIG. 1) comprising an implantable device (e.g., implantable device 102, 200, 300, or 700, disclosed herein with respect to FIGS. 1, 2, 3 or 7) and an external magnet (e.g., external magnet 106, 204, 304, 402, or 704 disclosed herein with respect to FIGS. 1, 2, 3, 4 or 7 respectively).

[0111] At step 802, the method 800 may comprise detecting the presence of a magnetic field using one or more magnetic field sensor. The detected magnetic field may be caused by an external magnet. For example, the method may comprise positioning the external magnet such that changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors of the implantable device. The one or more magnetic field sensors may be passive sensors that do not consume power or allow current to pass until a magnetic field is detected. In some embodiments, the one or more magnetic field sensors may be passive electromechanical switches configured to activate whenever a sufficiently strong magnetic field of either polarity is detected. For example, at least one of the one or more magnetic field sensors may be a Reed switch. In some embodiments, at least one of the one or more magnetic field sensors may be an electromagnetic induction antenna configured to generate an electrical current proportional to detected changes in the magnetic field. For example, at least one of the one or more magnetic field sensors may be a loop antenna. In some examples of the method, the implantable device may be in a powered-down state until the magnetic field is detected by the one or more magnetic field sensors.

[0112] At step 804, the method 800 may comprise activating the implantable device in response to the detection of the magnetic field by the one or more magnetic field sensors. In some examples of the method, activating the implantable device may comprise activating a load switch upon detection of the magnetic field, and transferring power, by the load switch, from an energy storage circuit to one or more components of the implantable device (e.g., one or more controllers and / or a stimulation circuit of the implantable device).

[0113] In some examples of the method, the method may comprise latching the load switch such that the load switch remains activated after the external magnet is no longer in proximity to the implantable device. In some examples, the method may comprise deactivating the load switch after a predetermined measurement period of time. In some examples, the method may comprise deactivating the load switch in response to an unlatch signal generated by one or more controllers of the implantable device. Deactivating the load switch may comprise stopping the provision of power from the energy storage circuit to components of the implantable device.37MF-367063050Attorney Docket No: 78895-20043.40

[0114] At step 806, the method 800 may comprise detecting, by the one or more magnetic field sensors, the presence or absence of the magnetic field over the predetermined measurement period of time. In some examples of the method, the method may comprise moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein changes to the magnetic field caused by the external magnet can be detected and / or sensed by the one or more magnetic field sensors during the one or more gestures. Each magnetic field gesture of the set of predetermined magnetic field gestures may correspond to one or more actions of the implantable device. Each of the magnetic field gestures may comprise one or more of holding the external magnet stationary for a predetermined period of time or moving the magnet towards or away from the implantable device. Moving the external magnet in one or more magnetic field gestures may cause changes in the magnetic field around the implantable device, which the one or more magnetic field sensors may sense.

[0115] At step 808, the method 800 may comprise identifying one or more actions for the implantable device based on the presence or absence of the magnetic field over the predetermined measurement period of time. In some examples, the method may further comprise synthesizing a series of magnetic field events based on the presence or absence of the magnetic field over the predetermined measurement period of time. Magnetic field events of the series of magnetic field events may comprise one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and / or a directional movement of the magnetic field with respect to the implantable device. In some examples of the method, synthesizing the series of magnetic field events is done by one or more controllers of the implantable device. In some examples of the method, identifying one or more actions for the implantable device based on the one or more magnetic field characteristics comprises identifying one or more magnetic field gestures based on the series of the magnetic field events and identifying one or more corresponding actions for the implantable device based on the identified one or more magnetic field gestures.

[0116] At step 810, the method 800 may comprise operating the implantable device according to the one or more actions. For example, the method may comprise moving the magnet in a predetermined gesture corresponding to shutting down the implantable device, identifying the predetermined gestures based on the sequence of magnetic field characteristics, and causing the implantable device to shut down by generating an unlatch signal for the load switch and shutting of the supply of power to the implantable device.38MF-367063050Attorney Docket No: 78895-20043.40

[0117] In some examples of the method, the implantable device may be an implantable pulse generator comprising a stimulation circuit for stimulating target tissue. The method may comprise moving the external magnet in a first magnetic field gesture corresponding to stimulating target tissue, identifying the first magnetic field gesture based on the series of magnetic field events, identifying the corresponding action for the implantable device as stimulating target tissue, and operating the implantable device to generate, by the stimulation circuit of the implantable device, one or more electrical pulses to stimulate target tissue. In some examples, the implantable pulse generator may comprise one or more leads (e.g., one or more leads 104, one or more leads 220, or one or more leads 320 described herein with respect to FIGS. 1, 2, and 3, respectively). Generating electrical pulses to stimulate target tissue may comprise transmitting one or more electrical pulses from the stimulation circuit to the target tissue using the one or more leads. In some examples, the method may further comprise stopping generation of electrical pulses after a predetermined period of time. In some examples, the method may further comprise moving the external magnet in a second magnetic field gesture corresponding to stopping stimulation of target tissue, identifying the second magnetic field gesture based on the series of magnetic field events, identifying the corresponding action for the implantable device as stopping stimulation, and operating the implantable device to stop generating electrical pulses. In some examples of the method, the target tissue may comprise tissue controlling voiding of a bladder (e.g., a bladder wall, a sacral nerve, and / or a pudendal nerve), and stimulating the target tissue may cause the bladder to void, and stopping stimulation of the target tissue may cause the bladder to stop voiding.EXEMPLARY EMBODIMENTS

[0118] The following embodiments are exemplary and are not intended to limit the scope of any invention described herein.

[0119] Embodiment 1. An implantable device comprising:an energy storage circuit configured to power the implantable device;a magnetic field sensor of a first type configured to detect a presence of a magnetic field;one or more magnetic field sensors of a second type configured to activate in response to a magnetic field being detected by the magnetic field sensor of a first type and sense one or more magnetic field characteristics; and39MF-367063050Attorney Docket No: 78895-20043.40 one or more controllers configured to control the implantable device based on the sensed one or more magnetic field characteristics.

[0120] Embodiment 2. The implantable device of embodiment 1, wherein the implantable device is an implantable pulse generator comprising a stimulation circuit, wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from the one or more sensed magnetic field characteristics, and wherein the first magnetic gesture corresponds to initiating stimulation.

[0121] Embodiment 3. The implantable device of embodiment 2, wherein the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a first predetermined period of time.

[0122] Embodiment 4. The implantable device of embodiment 2 or embodiment 3, wherein the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture from the one or more sensed magnetic field characteristics, wherein the second magnetic field gesture corresponds to stopping stimulation.

[0123] Embodiment 5. The implantable device of any one of embodiments 2-4, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes bladder voiding.

[0124] Embodiment 6. The implantable device of any one of embodiments 1-5, wherein the magnetic field sensor of a first type is passive.

[0125] Embodiment 7. The implantable device of any one of embodiments 1-6, wherein the magnetic field sensor of a first type is a Reed switch.

[0126] Embodiment 8. The implantable device of any one of embodiments 1-7, wherein the magnetic field sensor of a first type is an electromagnetic induction antenna.

[0127] Embodiment 9. The implantable device of any one of embodiments 1-8, wherein the one or more magnetic field sensors of a second type comprise at least one of one or more Hall-effect sensors, one or more magnetometers, one or more magnetoresistive sensors, one or more micro electromechanical systems (MEMS) sensors, one or more magnetic fluxgate sensors, one or more Reed switches, one or more electromagnetic induction antennas, one or more magnetoelectric sensors and one or more spin electronic sensors

[0128] Embodiment 10. The implantable device of any one of embodiments 1-9, wherein the one or more controllers and the stimulation circuit are configured to be activated upon detection of the magnetic field by the magnetic field sensor of a first type.40MF-367063050Attorney Docket No: 78895-20043.40

[0129] Embodiment 11. The implantable device of any one of embodiments 1-10, further comprising a load switch configured to transfer power from the energy storage circuit to the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit.

[0130] Embodiment 12. The implantable device of embodiment 11, wherein, upon detection of the magnetic field, the magnetic field sensor of a first type is configured to activate the load switch.

[0131] Embodiment 13. The implantable device of embodiment 11 or embodiment 12, wherein the load switch is configured to latch and remain activated after activation by the magnetic field sensor of a first type.

[0132] Embodiment 14. The implantable device of any one of embodiments 11-13, wherein the load switch is configured to stop transferring power from the energy storage circuit to the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit upon deactivation of the load switch.

[0133] Embodiment 15. The implantable device of any one of embodiments 11-14, wherein at least one of the one or more magnetic field sensors of a second type, the one or more controllers, and the stimulation circuit are configured to be deactivated upon deactivation of the load switch.

[0134] Embodiment 16. The implantable device of any one of embodiments 11-15, wherein the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch.

[0135] Embodiment 17. The implantable device of embodiment 16, wherein the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device.

[0136] Embodiment 18. The implantable device of any one of embodiments 11-17, wherein the load switch is configured to deactivate after a second predetermined period of time.

[0137] Embodiment 19. The implantable device of any one of embodiments 1-18, wherein the one or more magnetic field characteristics detected by the magnetic field sensors of a second type comprise at least one of a magnetic flux, and a magnetic flux density of the magnetic field.

[0138] Embodiment 20. The implantable device of any one of embodiments 1-19, further comprising a converter configured to convert one or more analog signals received from the41MF-367063050Attorney Docket No: 78895-20043.40 one or more magnetic field sensors of a second type to one or more digital signals, and wherein the one or more controllers are configured to receive the one or more digital signals.

[0139] Embodiment 21. The implantable device of embodiments 1-20, wherein the one or more controllers are configured to receive the sensed magnetic field characteristics as a function of time and synthesize a series of magnetic field events based on the sensed magnetic field characteristics.

[0140] Embodiment 22. The implantable device of embodiments 1-21, wherein the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

[0141] Embodiment 23. The implantable device of any one of embodiments 1-22, wherein the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein each of the magnetic field gestures of the set of predetermined magnetic field gestures corresponds to one or more actions for the implantable device.

[0142] Embodiment 24. The implantable device of any one of embodiments 1-23, further comprising one or more leads coupled with the implantable device, wherein the one or more leads are configured to stimulate target tissue by transmitting one or more electric pulses from the stimulation circuit to the target tissue.

[0143] Embodiment 25. The implantable device of any one of embodiments 1-24, wherein the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads.

[0144] Embodiment 26. The implantable device of any one of embodiments 1-25, wherein the energy storage circuit comprises a non-rechargeable battery.

[0145] Embodiment 27. The implantable device of any one of embodiments 1-25, wherein the energy storage circuit comprises a rechargeable battery.

[0146] Embodiment 28. A method of operating an implantable device, comprising:detecting, using a magnetic field sensor of a first type, the presence of a magnetic field;activating one or more magnetic field sensors of a second type in response to the detected magnetic field;sensing, using the one or more magnetic field sensors of a second type, one or more magnetic field characteristics;42MF-367063050Attorney Docket No: 78895-20043.40 identifying one or more actions based on the one or more magnetic field characteristics; andoperating the implantable device according to the identified one or more actions.

[0147] Embodiment 29. The method of embodiment 28, wherein the magnetic field sensor of a first type is passive.

[0148] Embodiment 30. The method of embodiment 28 or embodiment 29, wherein activating the one or more magnetic field sensors of a second type in response to the magnetic field comprises:activating, upon detection of the magnetic field by the magnetic field sensor of a first type, a load switch; andtransferring power, by the load switch, from an energy storage circuit to the one or more magnetic field sensors of a second type and a stimulation circuit.

[0149] Embodiment 31. The method of any one of embodiments 28-30, further comprising deactivating the one or more magnetic field sensors of a second type.

[0150] Embodiment 32. The method of embodiment 31, wherein deactivating the one or more magnetic field sensors of a second type comprises deactivating the load switch after a first predetermined period of time.

[0151] Embodiment 33. The method of any one of embodiments 30-32, further comprising deactivating the load switch by transmitting an unlatch signal to the load switch.

[0152] Embodiment 34. The method of embodiment 33, wherein the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device.

[0153] Embodiment 35. The method of any one of embodiments 28-34, wherein detecting one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field.

[0154] Embodiment 36. The method of any one of one of embodiments 28-35, further comprising positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of a first type and the one or more magnetic field sensors of a second type.

[0155] Embodiment 37. The method of embodiment 36, further comprising moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic43MF-367063050Attorney Docket No: 78895-20043.40 field sensor of a first type and the one or more magnetic field sensors of a second type during the one or more gestures.

[0156] Embodiment 38. The method of embodiment 37, wherein the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of: holding the external magnet stationary for a second predetermined period of time; moving the external magnet laterally;moving the external magnet circularly; andswitching which pole of the external magnet is directed towards the magnetic field sensor of a first type and magnetic field sensors of a second type.

[0157] Embodiment 39. The method of any one of embodiments 28-38, further comprising synthesizing a series of magnetic field events based on the detected one or more magnetic field characteristics.

[0158] Embodiment 40. The method of embodiment 39, wherein the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

[0159] Embodiment 41. The method of any one of embodiments 37-40, wherein identifying one or more actions based on the one or more magnetic field characteristics comprises:identifying one or more magnetic field gestures based on the series of magnetic field events; andidentifying the corresponding one or more actions based on the identified one or more magnetic field gestures.

[0160] Embodiment 42. The method of any one of embodiments 28-41, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue.

[0161] Embodiment 43. The method of embodiment 42, wherein the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue.44MF-367063050Attorney Docket No: 78895-20043.40

[0162] Embodiment 44. The method of embodiment 42 or embodiment 43, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding.

[0163] Embodiment 45. The method of any one of embodiments 42-44, wherein operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a third predetermined period of time.

[0164] Embodiment 46. The method of any one of embodiments 28-41, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses.

[0165] Embodiment 47. The method of embodiment 46, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding.

[0166] Embodiment 48. An implantable device comprising:an energy storage circuit configured to power the implantable device;one or more magnetic field sensors configured to detect a presence of a magnetic field; andone or more controllers configured to control the implantable device based on the detected magnetic field presence over a first predetermined period of time.

[0167] Embodiment 49. The implantable device of embodiment 48, wherein the implantable device is an implantable pulse generator comprising a stimulation circuit and wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from detected magnetic field presence over the first predetermined period of time, wherein the first magnetic gesture corresponds to initiating stimulation.

[0168] Embodiment 50. The implantable device of embodiment 48 or 49, wherein the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a second predetermined period of time.

[0169] Embodiment 51. The implantable device of any one of embodiments 48-50, wherein the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture45MF-367063050Attorney Docket No: 78895-20043.40 from the detected magnetic field presence over the first predetermined period of time, wherein the second magnetic field gesture corresponds to stopping stimulation.

[0170] Embodiment 52. The implantable device of any one of embodiments 48-51, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes a bladder to void.

[0171] Embodiment 53. The implantable device of any one of embodiments 48-52, wherein the one or more magnetic field sensors are passive sensors.

[0172] Embodiment 54. The implantable device of any one of embodiments 48-53, wherein at least one of the one or more magnetic field sensors is a Reed switch.

[0173] Embodiment 55. The implantable device of any one of embodiments 48-54, wherein at least one of the one or more magnetic field sensors is an electromagnetic induction antenna.

[0174] Embodiment 56. The implantable device of any one of embodiments 48-55, wherein the one or more controllers and the stimulation circuit are configured to be activated upon detection of the magnetic field by the one or more magnetic field sensors.

[0175] Embodiment 57. The implantable device of any one of embodiments 48-55, further comprising a load switch configured to transfer power from the energy storage circuit to the one or more controllers and the stimulation circuit.

[0176] Embodiment 58. The implantable device of embodiment 57, wherein, upon detection of the magnetic field, the one or more magnetic field sensors are configured to activate the load switch.

[0177] Embodiment 59. The implantable device of embodiment 57 or embodiment 58, wherein the load switch is configured to latch and remain activated after activation by the one or more magnetic field sensors.

[0178] Embodiment 60. The implantable device of any one of embodiments 57-59, wherein the load switch is configured to stop transferring power from the energy storage circuit to the one or more controllers and the stimulation circuit upon deactivation of the load switch.

[0179] Embodiment 61. The implantable device of any one of embodiments 57-60 wherein the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch.

[0180] Embodiment 62. The implantable device of embodiment 61, wherein the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device.46MF-367063050Attorney Docket No: 78895-20043.40

[0181] Embodiment 63. The implantable device of any one of embodiments 55-62, wherein the load switch is configured to deactivate after a third predetermined period of time.

[0182] Embodiment 64. The implantable device of embodiments 48-63, wherein the one or more controllers are configured to synthesize a series of magnetic field events based on the detected presence of a magnetic field over the first predetermined period of time.

[0183] Embodiment 65. The implantable device of embodiments 48-64, wherein the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a directional motion of the magnetic field with respect to the implantable device.

[0184] Embodiment 66. The implantable device of any one of embodiments 48-65, wherein the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein the magnetic field gestures of the set of predetermined magnetic field gestures correspond to one or more actions for the implantable device.

[0185] Embodiment 67. The implantable device of any one of embodiments 48-66, further comprising one or more leads coupled with the implantable device, wherein the one or more leads are configured to stimulate target tissue by transmitting one or more electric pulses from the stimulation circuit to the target tissue.

[0186] Embodiment 68. The implantable device of any one of embodiments 48-67, wherein the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads.

[0187] Embodiment 69. The implantable device of any one of embodiments 48-68, wherein the energy storage circuit comprises a non-rechargeable battery.

[0188] Embodiment 70. The implantable device of any one of embodiments 48-68, wherein the energy storage circuit comprises a rechargeable battery.

[0189] Embodiment 71. A method of operating an implantable device, comprising:detecting, using one or more magnetic field sensors, the presence of a magnetic field; activating the implantable device in response to the detected magnetic field; detecting, using the one or more magnetic field sensors, the presence of the magnetic field over a first predetermined period of time;identifying one or more actions based on the detected presence of the magnetic field over the first predetermined period of time; andoperating the implantable device according to the identified one or more actions.47MF-367063050Attorney Docket No: 78895-20043.40

[0190] Embodiment 72. The method of embodiment 71, wherein the one or more magnetic field sensors are passive sensors.

[0191] Embodiment 73. The method of embodiment 71 or embodiment 72, wherein activating the implantable device in response to the detection of the magnetic field comprises:activating, upon detection of the magnetic field, a load switch; andtransferring power, by the load switch, from an energy storage circuit to a stimulation circuit and one or more controllers.

[0192] Embodiment 74. The method of embodiments 71-73, further comprising deactivating the implantable device.

[0193] Embodiment 75. The method of embodiment 74, wherein deactivating the implantable comprises deactivating the load switch after a second predetermined period of time.

[0194] Embodiment 76. The method of any one of embodiments 73-75, further comprising deactivating the load switch by transmitting an unlatch signal to the load switch.

[0195] Embodiment 77. The method of embodiment 76, wherein the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device.

[0196] Embodiment 78. The method of any one of embodiments 71-73, wherein detecting one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field.

[0197] Embodiment 79. The method of any one of one of embodiments 71-74, further comprising positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors.

[0198] Embodiment 80. The method of embodiment 75, further comprising moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors during the one or more gestures.

[0199] Embodiment 81. The method of embodiment 76, wherein the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of:holding the external magnet stationary for a third predetermined period of time; moving the external magnet laterally;moving the external magnet circularly;moving the magnet towards the implantable device; and48MF-367063050Attorney Docket No: 78895-20043.40 moving the magnet away from the implantable device.

[0200] Embodiment 82. The method of any one of embodiments 71-81, further comprising synthesizing a series of magnetic field events based on the detected presence of the magnetic field over the first predetermined period of time.

[0201] Embodiment 83. The method of embodiment 82, wherein the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

[0202] Embodiment 84. The method of embodiment 82 or 83, wherein identifying one or more actions based on the one or more magnetic field characteristics comprises:identifying one or more magnetic field gestures based on the series of magnetic field events; andidentifying the corresponding one or more actions based on the identified one or more magnetic field gestures.

[0203] Embodiment 85. The method of any one of embodiments 71-84, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue.

[0204] Embodiment 86. The method of embodiment 85, wherein the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue.

[0205] Embodiment 87. The method of embodiment 85 or embodiment 86, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding.

[0206] Embodiment 88. The method of any one of embodiments 85-87, wherein operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a fourth predetermined period of time.

[0207] Embodiment 89. The method of any one of embodiments 71-84, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device49MF-367063050Attorney Docket No: 78895-20043.40 according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses.

[0208] Embodiment 90. The method of embodiment 89, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding.

[0209] The foregoing description, for the purpose of explanation, has been described with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various embodiments with various modifications as are suited to the particular use contemplated.

[0210] Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims.50MF-367063050

Claims

1. Attorney Docket No: 78895-20043.40CLAIMSWhat is claimed is:

1. An implantable device comprising:an energy storage circuit configured to power the implantable device;a magnetic field sensor of a first type configured to detect a presence of a magnetic field;one or more magnetic field sensors of a second type configured to activate in response to a magnetic field being detected by the magnetic field sensor of the first type and sense one or more magnetic field characteristics; andone or more controllers configured to control the implantable device based on the sensed one or more magnetic field characteristics.

2. The implantable device of claim 1, wherein the implantable device is an implantable pulse generator comprising a stimulation circuit, wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from the one or more sensed magnetic field characteristics, and wherein the first magnetic gesture corresponds to initiating stimulation.

3. The implantable device of claim 2, wherein the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a first predetermined period of time.

4. The implantable device of claim 2 or claim 3, wherein the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture from the one or more sensed magnetic field characteristics, wherein the second magnetic field gesture corresponds to stopping stimulation.

5. The implantable device of any one of claims 2-4, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes bladder voiding.51MF-367063050Attorney Docket No: 78895-20043.40 6. The implantable device of any one of claims 1-5, wherein the magnetic field sensor of the first type is passive.

7. The implantable device of any one of claims 1-6, wherein the magnetic field sensor of the first type is a Reed switch.

8. The implantable device of any one of claims 1-7, wherein the magnetic field sensor of the first type is an electromagnetic induction antenna.

9. The implantable device of any one of claims 1-8, wherein the one or more magnetic field sensors of the second type comprise at least one of one or more Hall-effect sensors, one or more magnetometers, one or more magnetoresistive sensors, one or more micro electromechanical systems (MEMS) sensors, one or more magnetic fluxgate sensors, one or more Reed switches, one or more electromagnetic induction antennas, one or more magnetoelectric sensors and one or more spin electronic sensors.

10. The implantable device of any one of claims 1-9, wherein the one or more controllers and a stimulation circuit are configured to be activated upon detection of the magnetic field by the magnetic field sensor of the first type.

11. The implantable device of any one of claims 1-10, further comprising a load switch configured to transfer power from the energy storage circuit to the one or more magnetic field sensors of the second type, the one or more controllers, and a stimulation circuit.

12. The implantable device of claim 11, wherein, upon detection of the magnetic field, the magnetic field sensor of the first type is configured to activate the load switch.

13. The implantable device of claim 11 or claim 12, wherein the load switch is configured to latch and remain activated after activation by the magnetic field sensor of the first type.

14. The implantable device of any one of claims 11-13, wherein the load switch is configured to stop transferring power from the energy storage circuit to the one or more magnetic field sensors of the second type, the one or more controllers, and the stimulation circuit upon deactivation of the load switch.52MF-367063050Attorney Docket No: 78895-20043.4015. The implantable device of any one of claims 11-14, wherein at least one of the one or more magnetic field sensors of the second type, the one or more controllers, and the stimulation circuit are configured to be deactivated upon deactivation of the load switch.

16. The implantable device of any one of claims 11-15, wherein the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch.

17. The implantable device of claim 16, wherein the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device.

18. The implantable device of any one of claims 11-17, wherein the load switch is configured to deactivate after a second predetermined period of time.

19. The implantable device of any one of claims 1-18, wherein the one or more magnetic field characteristics detected by the magnetic field sensors of the second type comprise at least one of a magnetic flux, and a magnetic flux density of the magnetic field.

20. The implantable device of any one of claims 1-19, further comprising a converter configured to convert one or more analog signals received from the one or more magnetic field sensors of a second type to one or more digital signals, and wherein the one or more controllers are configured to receive the one or more digital signals.

21. The implantable device of claims 1-20, wherein the one or more controllers are configured to receive the sensed magnetic field characteristics as a function of time and synthesize a series of magnetic field events based on the sensed magnetic field characteristics.

22. The implantable device of claim 21, wherein the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.53MF-367063050Attorney Docket No: 78895-20043.4023. The implantable device of claim 21 or 22, wherein the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein each of the magnetic field gestures of the set of predetermined magnetic field gestures corresponds to one or more actions for the implantable device.

24. The implantable device of any one of claims 1-23, further comprising one or more leads coupled with the implantable device, wherein the one or more leads are configured to stimulate target tissue by transmitting one or more electric pulses from a stimulation circuit to the target tissue.

25. The implantable device of claim 24, wherein the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads.

26. The implantable device of any one of claims 1-25, wherein the energy storage circuit comprises a non-rechargeable battery.

27. The implantable device of any one of claims 1-25, wherein the energy storage circuit comprises a rechargeable battery.

28. A method of operating an implantable device, comprising:detecting, using a magnetic field sensor of a first type, a presence of a magnetic field; activating one or more magnetic field sensors of a second type in response to the detected magnetic field;sensing, using the one or more magnetic field sensors of the second type, one or more magnetic field characteristics;identifying one or more actions based on the one or more magnetic field characteristics; andoperating the implantable device according to the identified one or more actions.

29. The method of claim 28, wherein the magnetic field sensor of the first type is passive.54MF-367063050Attorney Docket No: 78895-20043.40 30. The method of claim 28 or claim 29, wherein activating the one or more magnetic field sensors of the second type in response to the magnetic field comprises:activating, upon detection of the magnetic field by the magnetic field sensor of the first type, a load switch; andtransferring power, by the load switch, from an energy storage circuit to the one or more magnetic field sensors of the second type and a stimulation circuit.

31. The method of any one of claims 28-30, further comprising deactivating the one or more magnetic field sensors of the second type.

32. The method of claim 31, wherein deactivating the one or more magnetic field sensors of the second type comprises deactivating a load switch after a first predetermined period of time.

33. The method of claim 32, further comprising deactivating the load switch by transmitting an unlatch signal to the load switch.

34. The method of claim 33, wherein the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device.

35. The method of any one of claims 28-34, wherein detecting the one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field.

36. The method of any one of claims 28-35, further comprising positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of the first type and the one or more magnetic field sensors of the second type.

37. The method of claim 36, further comprising moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the magnetic field sensor of the first type 55MF-367063050Attorney Docket No: 78895-20043.40 and the one or more magnetic field sensors of the second type during the one or more gestures.

38. The method of claim 37, wherein the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of:holding the external magnet stationary for a second predetermined period of time; moving the external magnet laterally;moving the external magnet circularly; andswitching which pole of the external magnet is directed towards the magnetic field sensor of the first type and magnetic field sensors of the second type.

39. The method of any one of claims 28-38, further comprising synthesizing a series of magnetic field events based on the detected one or more magnetic field characteristics.

40. The method of claim 39, wherein the series of magnetic field events comprises one or more of a presence, an absence, a polarity, a change in polarity, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

41. The method of claim 39 or 40, wherein identifying one or more actions based on the one or more magnetic field characteristics comprises:identifying one or more magnetic field gestures based on the series of magnetic field events; andidentifying the corresponding one or more actions based on the identified one or more magnetic field gestures.

42. The method of any one of claims 28-41, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue.

43. The method of claim 42, wherein the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to56MF-367063050Attorney Docket No: 78895-20043.40 stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue.

44. The method of claim 42 or claim 43, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding.

45. The method of any one of claims 42-44, wherein operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a third predetermined period of time.

46. The method of any one of claims 28-41, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses.

47. The method of claim 46, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding.

48. An implantable device comprising:an energy storage circuit configured to power the implantable device;one or more magnetic field sensors configured to detect a presence of a magnetic field; andone or more controllers configured to control the implantable device based on the detected magnetic field presence over a first predetermined period of time.

49. The implantable device of claim 48, wherein the implantable device is an implantable pulse generator comprising a stimulation circuit and wherein the one or more controllers are configured to cause the implantable device to stimulate a target tissue based on an identification of a first magnetic field gesture from detected magnetic field presence over the first predetermined period of time, wherein the first magnetic gesture corresponds to initiating stimulation.57MF-367063050Attorney Docket No: 78895-20043.40 50. The implantable device of claim 49, wherein the stimulation circuit of the implantable device is configured to stop stimulating the target tissue after a second predetermined period of time.

51. The implantable device of any one of claims 49-50, wherein the one or more controllers are configured to cause the implantable device to stop stimulating the target tissue based on an identification of a second magnetic field gesture from the detected magnetic field presence over the first predetermined period of time, wherein the second magnetic field gesture corresponds to stopping stimulation.

52. The implantable device of any one of claims 49-51, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and wherein stimulating the target tissue causes a bladder to void.

53. The implantable device of any one of claims 48-52, wherein the one or more magnetic field sensors are passive sensors.

54. The implantable device of any one of claims 48-53, wherein at least one of the one or more magnetic field sensors is a Reed switch.

55. The implantable device of any one of claims 48-54, wherein at least one of the one or more magnetic field sensors is an electromagnetic induction antenna.

56. The implantable device of any one of claims 48-55, wherein the one or more controllers and a stimulation circuit are configured to be activated upon detection of the magnetic field by the one or more magnetic field sensors.

57. The implantable device of any one of claims 48-55, further comprising a load switch configured to transfer power from the energy storage circuit to the one or more controllers and a stimulation circuit.

58. The implantable device of claim 57, wherein, upon detection of the magnetic field, the one or more magnetic field sensors are configured to activate the load switch.58MF-367063050Attorney Docket No: 78895-20043.40 59. The implantable device of claim 57 or claim 58, wherein the load switch is configured to latch and remain activated after activation by the one or more magnetic field sensors.

60. The implantable device of any one of claims 57-59, wherein the load switch is configured to stop transferring power from the energy storage circuit to the one or more controllers and the stimulation circuit upon deactivation of the load switch.

61. The implantable device of any one of claims 57-60 wherein the one or more controllers are configured to deactivate the load switch by transmitting an unlatch signal to the load switch.

62. The implantable device of claim 61, wherein the one or more controllers are configured to generate the unlatch signal in response to one or more detected unsafe conditions of the implantable device.

63. The implantable device of any one of claims 57-62, wherein the load switch is configured to deactivate after a third predetermined period of time.

64. The implantable device of any one of claims 48-63, wherein the one or more controllers are configured to synthesize a series of magnetic field events based on the detected presence of a magnetic field over the first predetermined period of time.

65. The implantable device of claim 64, wherein the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a directional motion of the magnetic field with respect to the implantable device.

66. The implantable device of claim 64 or 65, wherein the one or more controllers are configured to identify one or more magnetic field gestures from a set of predetermined magnetic field gestures based on the series of magnetic field events, wherein the magnetic field gestures of the set of predetermined magnetic field gestures correspond to one or more actions for the implantable device.

67. The implantable device of any one of claims 48-66, further comprising one or more leads coupled with the implantable device, wherein the one or more leads are configured to59MF-367063050Attorney Docket No: 78895-20043.40 stimulate target tissue by transmitting one or more electric pulses from a stimulation circuit to the target tissue.

68. The implantable device of claim 67, wherein the one or more leads comprise one or more electrodes at one or more distal tips of the one or more leads.

69. The implantable device of any one of claims 48-68, wherein the energy storage circuit comprises a non-rechargeable battery.

70. The implantable device of any one of claims 48-68, wherein the energy storage circuit comprises a rechargeable battery.

71. A method of operating an implantable device, comprising:detecting, using one or more magnetic field sensors, a presence of a magnetic field; activating the implantable device in response to the detected magnetic field; detecting, using the one or more magnetic field sensors, the presence of the magnetic field over a first predetermined period of time;identifying one or more actions based on the detected presence of the magnetic field over the first predetermined period of time; andoperating the implantable device according to the identified one or more actions.

72. The method of claim 71, wherein the one or more magnetic field sensors are passive sensors.

73. The method of claim 71 or claim 72, wherein activating the implantable device in response to the detection of the magnetic field comprises:activating, upon detection of the magnetic field, a load switch; andtransferring power, by the load switch, from an energy storage circuit to a stimulation circuit and one or more controllers.

74. The method of claims 71-73, further comprising deactivating the implantable device.

75. The method of claim 74, wherein deactivating the implantable comprises deactivating a load switch after a second predetermined period of time.60MF-367063050Attorney Docket No: 78895-20043.4076. The method of any one of claims 73-75, further comprising deactivating the load switch by transmitting an unlatch signal to the load switch.

77. The method of claim 76, wherein the unlatch signal is generated in response to one or more detected unsafe conditions of the implantable device.

78. The method of any one of claims 71-73, wherein detecting one or more magnetic field characteristics comprises detecting at least one of a magnetic flux and a magnetic flux density of the magnetic field.

79. The method of any one of claims 71-74, further comprising positioning an external magnet, wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors.

80. The method of claim 79, further comprising moving the external magnet in one or more magnetic field gestures from a set of predetermined magnetic field gestures, wherein the magnetic field gestures from the set of predetermined magnetic field gestures correspond to one or more actions of the implantable device, and wherein changes to the magnetic field caused by the external magnet can be detected by the one or more magnetic field sensors during the one or more gestures.

81. The method of claim 80, wherein the magnetic field gestures from the set of predetermined magnetic field gestures comprise at least one of:holding the external magnet stationary for a third predetermined period of time; moving the external magnet laterally;moving the external magnet circularly;moving the magnet towards the implantable device; andmoving the magnet away from the implantable device.

82. The method of any one of claims 71-81, further comprising synthesizing a series of magnetic field events based on the detected presence of the magnetic field over the first predetermined period of time.61MF-367063050Attorney Docket No: 78895-20043.40 83. The method of claim 82, wherein the series of magnetic field events comprises one or more of a presence, an absence, a velocity, a rate of change of magnetic flux, and a motion of the magnetic field with respect to the implantable device.

84. The method of claim 82 or 83, wherein identifying one or more actions based on the detected presence of the magnetic field comprises:identifying one or more magnetic field gestures based on the series of magnetic field events; andidentifying the corresponding one or more actions based on the identified one or more magnetic field gestures.

85. The method of any one of claims 71-84, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stimulating target tissue, and operating the implantable device according to the identified one or more actions comprises generating one or more electrical pulses using the implantable pulse generator to stimulate the target tissue.

86. The method of claim 85, wherein the implantable pulse generator comprises one or more leads and wherein generating electrical pulses using the implantable pulse generator to stimulate the target tissue comprises transmitting, using the one or more leads, the one or more electrical pulses from the implantable pulse generator to the target tissue.

87. The method of claim 85 or claim 86, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stimulating the target tissue causes bladder voiding.

88. The method of any one of claims 85-87, wherein operating the implantable device according to the identified one or more actions further comprises stopping the implantable pulse generator from generating electrical pulses after a fourth predetermined period of time.

89. The method of any one of claims 71-84, wherein the implantable device is an implantable pulse generator, wherein the identified one or more actions comprise stopping stimulation of target tissue, and operating the implantable device according to the identified one or more actions comprises stopping the implantable pulse generator from generating electrical pulses.62MF-367063050Attorney Docket No: 78895-20043.4090. The method of claim 89, wherein the target tissue comprises at least one of a bladder wall, a pudendal nerve, and a sacral nerve, and stopping stimulation of the target tissue causes cessation of bladder voiding.63MF-367063050

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