Abstract: Methods for monitoring an infection in proximity to an implantable medical device include monitoring a first indicator of infection in proximity to a medical device implanted in a patient; monitoring a second patient parameter; and determining whether the combination of the first indicator and the second parameter are indicative of infection in proximity to the implanted device. If a determination is made that the combination of the first indicator and the second parameter are indicative of infection, an alert may be issued.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate fecal or urinary incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: A method includes monitoring infection in proximity to a rechargeable implantable medical device; determining whether an event associated with recharging of the device has occurred; and blanking the monitoring if the event has occurred.

Abstract: The disclosure describes an external sensor attached to an undergarment worn by a patient that detects voiding information. The sensor stores the voiding information in a voiding log and transmits the voiding log to an external device. The external device includes a user interface that displays the voiding log to the patient for review. The patient may correct any incorrect voiding information that was logged in error or due to a non-voiding event. A user, such as a clinician or the patient, may use the voiding information to diagnose a condition of the patient. In addition, the voiding information of the voiding log may be used by the user to adjust a stimulation therapy or the external device to automatically adjust stimulation therapy. The undergarment may be disposable or washable after patient use.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate urinary or fecal incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: The disclosure describes an external sensor attached to an undergarment worn by a patient that detects voiding information. The sensor stores the voiding information in a voiding log and transmits the voiding log to an external device. The external device includes a user interface that displays the voiding log to the patient for review. The patient may correct any incorrect voiding information that was logged in error or due to a non-voiding event. A user, such as a clinician or the patient, may use the voiding information to diagnose a condition of the patient. In addition, the voiding information of the voiding log may be used by the user to adjust a stimulation therapy or the external device to automatically adjust stimulation therapy. The undergarment may be disposable or washable after patient use.

Abstract: In general, the disclosure is directed to an implantable neurostimulator and system capable of providing adaptive neurostimulation therapy to alleviate urinary or fecal incontinence. The neurostimulator operates according to a set of stimulation parameters stored in memory. During operation, information is obtained from the patient, the implanted neurostimulator, one or more implanted sensors, or some combination thereof. A processor analyzes the information to automatically generate proposed adjustments to the stimulation parameters applied by the neurostimulator. The adjustments provide an adaptive neurostimulation therapy that supports or enhances therapeutic efficacy based on the information.

Abstract: Methods include determining whether an infection is in proximity to an implanted rechargeable medical device. If an infection is determined to be present, the recharge process is allowed to sufficiently heat the device to facilitate clearing of the infection. Additional methods include monitoring temperature in proximity to an implantable rechargeable device in connection with recharging the device. If the monitored temperature falls outside a desired range, one or more parameters associated with recharge energy are modified to cause the temperature to reside within the desired range. The desired temperature range, may be a range that can facilitate treatment of a condition in proximity to the implanted device without causing undesired damage to the patient's tissue surrounding the implanted device.

Abstract: Systems and methods for determining whether an involuntary voiding event was attributable to stress or urge incontinence include determining an activity level of a patient that coincides with the occurrence of the involuntary voiding event or the activity level within a certain time range of the involuntary voiding event. Patient activity data may be collected via a signal that varies as a function of patient activity. The signal may be generated with one or more sensors that detect motion, such as an accelerometer or a piezoelectric crystal, and/or one or more sensors that monitor a physiological parameter of the patient that varies as a function of patient activity, such as heart rate, respiratory rate, electrocardiogram morphology, respiration rate, respiratory volume, core temperature, muscular activity level or subcutaneous temperature of the patient.

Abstract: An implantable medical device (IMD) is configured to operate as an automatic voiding diary for logging urinary and/or fecal voiding events. The IMD detects urinary and/or fecal voiding events and generates data that identifies detected events as voluntary or involuntary events. In particular, the IMD generates the identification data based on a patient defined action. In one embodiment, the patient defined action is the patient tapping on the skin located above the IMD. The IMD may generate the identification data based on one or more characteristics of the tapping, e.g., the number, frequency, duration, or pattern of taps. The IMD may also generate the identification data based on a lack of input during a specific range of time after a detected voiding event. In some embodiments, the identification data may be used to identify a false positive, i.e., an event that was incorrectly detected by the IMD.

Abstract: A device that may be used as an automatic voiding diary detects urinary and/or fecal voiding events and records voiding information indicative of the voiding events without the need for significant patient interaction. The device includes a microphone that captures internal and/or external sounds that are associated with voiding events and generates an electrical signal based the sounds. The device processes the electrical signal to determine whether the signal is indicative of the occurrence of a voiding event (i.e., the device detects voiding events) by, for example, comparing the electrical signal to a signal template or comparing an amplitude of the signal to a threshold. The device may be a device implanted within the patient or an external device that can be carried or attached to the body or clothing of the patient.

Abstract: Systems and methods for determining a number of interruptions in a sleep state of a patient attributable to an urge or need to void during a sleep event include monitoring an activity level of the patient. The urge or need to void may be attributable to fecal or urinary incontinence. The patient activity level may be determined with one or more sensors that detect motion and/or one or more sensors that monitor a physiological parameter of the patient that varies as a function of patient activity. In one embodiment, a clinician selects a therapy parameter set for the patient based on the severity of the patient's incontinence. In another embodiment, the number of interruptions in the sleep state is associated with a therapy parameter set that was implemented during the sleep state in order to evaluate the efficacy of the therapy parameter set.

Abstract: An implantable medical lead includes at least one stimulation electrode and at least one sensor configured to generate an electrical signal that varies as a function of a parameter associated with a voiding event of a patient. In some embodiments, the sensor may be at least one of a microphone that captures sounds associated with voiding events, a pressure sensor, a flow sensor, a strain gauge, a physiological parameter sensing electrode or a temperature sensor. The electrical signal generated by the sensor may used to detect an occurrence of a voiding event. Thus, the lead may be coupled wirelessly or via a wired connection to a device that processes the electrical signal from the sensor, generates voiding information based on the electrical signal, and in some cases, records the voiding information for later retrieval and analysis.

Abstract: Techniques for controlling therapy delivery based on the relative orientation and/or motion of a device accelerometer and a lead accelerometer are described. In one embodiment, a therapy system includes an electrical stimulator and a lead. The electrical stimulator comprises a processor that controls delivery of a therapy to a target stimulation site in a patient and a device accelerometer coupled to the electrical stimulator. The lead is coupled to the electrical stimulator to deliver the therapy from the electrical stimulator to the target stimulation site in the patient, and includes a lead accelerometer. The processor compares signals from the accelerometers, and controls delivery of the therapy to the patient based on the comparison. In this manner, the processor may adjust stimulation to, for example, address movement of electrodes relative to target tissue when a patient changes postures.

Abstract: The invention is directed to controlling therapy delivery based on a relative motion between a first and second activity sensor. The relative motion between the activity sensors is representative of the relative motion between the locations of the body of the patient at which the respective activity sensors are located. The use of relative motion, however, may substantially remove motion experienced by both the activity sensors, e.g., motion caused by the environment in which patient is located, thus providing a new reference frame from which to analyze the motion measurements. The relative motion may be used to detect a condition of a movement disorder and/or control delivery of the therapy delivered to patient to treat or reduce the condition.

Abstract: Systems and methods for adjusting a therapy delivered to a patient include detecting a value of at least one sensed patient parameter and adjusting a therapy program to accommodate different patient parameter values. A data structure including a plurality of patient parameter values and associated therapy programs may be stored within a medical device or a programming device. Upon detecting a patient parameter value, an associated therapy program from the data structure may be selected. If no therapy program is associated with the detected patient parameter value, an intermediate program that best suits the detected patient parameter value may be generated by interpolating between the most recently implemented therapy program and a stored therapy program. In some embodiments, the rate of shifting between parameters of two stored or interpolated therapy programs may be based on the rate of change of the patient parameter value over time.

Abstract: Systems and methods for adjusting a therapy delivered to a patient include detecting a value of at least one sensed patient parameter and adjusting a therapy program to accommodate different patient parameter values. A data structure including a plurality of patient parameter values and associated therapy programs may be stored within a medical device or a programming device. Upon detecting a patient parameter value, an associated therapy program from the data structure may be selected. If no therapy program is associated with the detected patient parameter value, an intermediate program that best suits the detected patient parameter value may be generated by interpolating between the most recently implemented therapy program and a stored therapy program. In some embodiments, the rate of shifting between parameters of two stored or interpolated therapy programs may be based on the rate of change of the patient parameter value over time.

Abstract: A system includes an implantable medical device and an implantable therapy delivery element. The device includes a housing, electronics disposed in the housing, and a first temperature sensor operably coupled to the electronics and located in proximity to the housing. The element has a proximal end portion configured to be operably couplable to the device and a distal end portion configured to be placed in a patient at a location removed from the device. A second temperature sensor located on the element between the proximal end and the distal end. The second temperature sensor is operably couplable to the electronics. The electronics are configured to compare a value associated with the first temperature sensed by the first temperature sensor to a value associated with the second temperature sensed by the second temperature sensor. The system may be used for monitoring an infection in proximity to the device.

Abstract: An implantable medical device includes a housing and electronics disposed in the housing. The device also includes a heating element disposed in proximity to the housing and operably coupled to the electronics. The electronics are configured to control heating of the heating element to heat tissue in proximity to the housing to aid in the treatment of a condition of the patient in proximity to the device when implanted. The device may further include a temperature sensor disposed in proximity to the housing and operably coupled to the electronics. In such embodiments, the electronics may be configured to control the amount of heat generated by the heating element based on information transmitted from the temperature sensor.

Abstract: A method includes obtaining a baseline value for an indicator of infection in proximity to an implantable medical device and monitoring the indicator of infection in proximity to the device. The method further includes determining whether the monitored indicator is indicative of infection in proximity to the device. The determination as to whether the monitored indicator is indicative of infection includes comparing a value associated with the monitored indicator to the baseline value.