Prediction of remaining implant lifetime

Abstract

Devices, systems, and techniques for predicting the remaining lifetime of a medical device are disclosed. For example, a system may include an elongate member configured to be implanted within a patient, where the elongate member is configured to be coupled to an implantable medical device (IMD) configured to deliver therapy to the patient via the elongate member. A sensor may be carried by the elongate member and configured to provide a signal indicative of a deformation experienced by the elongate member. The IMD may generate an alert indicative of a predicted remaining device life and / or modify therapy delivery based on the signal indicative of deformation.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application 63 / 516,440, filed July 28, 2023, the entire contents of which are incorporated herein by reference.

[0002] This disclosure relates to medical devices, and more specifically to sensors for monitoring the use of medical devices. Background Technology

[0003] Implantable medical devices (IMDs) can be used to monitor a patient's condition and / or deliver therapy to the patient. Example IMDs may be implanted for symptoms related to chronic pain, tremor, Parkinson's disease, multiple sclerosis, spinal cord injury, cerebral palsy, amyotrophic lateral sclerosis, dystonia, torticollis, epilepsy, pelvic floor dysfunction, gastroparesis, muscle stimulation (e.g., functional electrical muscle stimulation (FES)), or obesity.

[0004] Current implanted systems typically include multiple devices, such as an electrical stimulator connected to one or more leads or a drug pump connected to one or more catheters. The implant lifespan of any of these devices can be anticipated based on battery life or component wear. In some cases, patients may require surgery to replace one or more components of the implanted system in order to continue receiving monitoring or treatment. Summary of the Invention

[0005] Generally, this disclosure relates to apparatus, systems, and techniques for predicting or estimating the lifespan of an implantable medical device (IMD) based on sensed data. The medical device (such as a catheter or medical lead) may include one or more sensors disposed along a portion of the implant, which may be subjected to strain and / or deformation when implanted in a patient. The sensors may be configured to sense mechanical exposures of the implant, such as flexion or bending, during implantation. Furthermore, an IMD attached to or in communication with an implant will be able to use information from the one or more sensors to generate metrics relating to the remaining lifespan of the implant, potential operational problems with the implant, etc., and to generate alerts and / or modify therapies in response to the predicted operational lifespan of the implant from the sensor data.

[0006] In some examples, one or more sensors may be mounted on the outer surface of the implanted device (e.g., a lead or catheter) or embedded within the implanted device. Each sensor may include a component configured to provide information about deformation or strain experienced by the implanted device. For example, the sensor may include a strain gauge or other mechanism that provides a signal indicating deformation over time. Alternatively, the sensor may include a component that breaks or otherwise undergoes structural change after a predetermined amount of deformation and / or a value of deformation. This structural change may be configured to occur before or prior to implanted device failure, allowing the information to predict impending device failure. IMD may use this information to generate alerts to users for intervention and / or adjustments to therapy delivery due to the predicted end of life of the implanted device.

[0007] In one example, a system includes: an elongated member configured to be implanted in a patient, wherein the elongated member is configured to be coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member; and a sensor carried by the elongated member and configured to provide a signal indicative of deformation experienced by the elongated member.

[0008] For example, one method includes: receiving a signal from a sensor carried by an elongated member by a processing circuit, wherein the elongated member is configured to be implanted in a patient and coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member, and wherein the signal indicates deformation experienced by the elongated member; and determining, by the processing circuit and based on the signal, the functional lifetime state of the elongated member implanted in the patient.

[0009] For example, a computer-readable storage medium includes instructions that, when executed by processing circuitry, cause the processing circuitry to: receive a signal from a sensor carried by an elongated member, wherein the elongated member is configured to be implanted in a patient and coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member, and wherein the signal indicates deformation experienced by the elongated member; and determine, based on the signal, the functional lifetime state of the elongated member implanted in the patient. Attached Figure Description

[0010] Figure 1A , Figure 1B and Figure 1C This is a conceptual diagram illustrating an example medical device system that includes an implantable medical device coupled to the implant.

[0011] Figure 2 This is a block diagram illustrating an example configuration of components of an IMD according to one or more technologies of this disclosure.

[0012] Figure 3 This is a block diagram illustrating an example configuration of the components of an external programmer according to one or more technologies of this disclosure.

[0013] Figure 4A and Figure 4B This is a conceptual diagram of an example sensor configured to detect deformation via component fracture.

[0014] Figure 5 This is a conceptual diagram of an example sensor configured to generate changes in electrical signals in response to deformation.

[0015] Figure 6A , Figure 6B and Figure 6C It is a cross-sectional view showing exemplary leads at different locations for the deformation sensor.

[0016] Figure 7 This is a conceptual diagram of an example sensor configured to detect deformation of a medical lead and the included energy source.

[0017] Figure 8 This is a flowchart illustrating an example technique for sensing the breakage of an IMD and generating an alarm according to one or more techniques of this disclosure.

[0018] Figure 9 This is a flowchart illustrating an example technique for generating an alarm in response to determining that the cumulative deformation exceeds a deformation threshold, according to one or more techniques of this disclosure. Detailed Implementation

[0019] Generally, this disclosure describes techniques for predicting the lifespan of medical devices configured for implantation in a patient. Some medical devices have relatively straightforward end-of-life predictions, such as those with batteries that eventually run out during operation. However, other medical devices may be used until mechanical components fail or degrade beyond their operating parameters. These failures may include metal fracture, plastic deformation of the material, delamination, material degradation from the bio-implant environment, or any other type of failure.

[0020] It is well known that, from a end-of-life perspective, the survival of therapeutic delivery components, such as medical leads carrying electrodes or drug delivery catheters, can be difficult to predict accurately after failure. To predict the lifespan of a mechanical component, the number of bend cycles per year can be estimated, and the amount of time the device can continue to function can be determined (e.g., a predetermined number of months or years). For example, if a catheter is estimated to experience 100,000 bends per year, a device with 700,000 bends would meet a 7-year implant lifespan expectation. However, each device experiences different events and frequencies of movement in different patients, which can make implant lifespan expectations inaccurate. Furthermore, there are few real-world studies tracking device survival to match predicted lifespan expectations with actual device survival. Device failure at implantation can prevent the delivery of effective therapies or potentially cause tissue damage or more complex device removal for the patient.

[0021] As described herein, systems, devices, and techniques can be configured to monitor mechanical exposure and predict the remaining lifespan of an implanted device. For example, an implanted device may include a lead or catheter with one or more sensors configured to monitor deformation of the device over time. An IMD or other processing device can use information from the sensors to generate and track metrics related to mechanical deformation over time or in response to a failure event. The IMD or other device may generate alerts indicating deformation or end of life, or adjust therapy delivery in response to deformation information.

[0022] In some examples, adding sensors to the IMD can have the benefits of monitoring therapy efficacy, ensuring patient safety, providing warning signs of a failing treatment system, and being incorporated into feedback loops to automatically adjust therapy or provide recommendations for therapy updates. For example, physiological metrics such as breathing or patient movement can also be monitored by the device's sensors. In one example, if an increase in respiratory rate is known to be associated with overtreatment or increased rapid movement as a sign of inadequate therapy, the system can use the deformed signal as feedback to control therapy delivery and / or monitor patient health.

[0023] The sensors described herein provide the additional benefit of a system capable of monitoring therapeutic efficacy, patient safety, and warning signs of a failing treatment system. The system can incorporate this sensed information into a feedback loop to automatically adjust the therapy and / or provide recommendations for updating the therapy. For example, measurements of respiration or movement can be virtually monitored by sensors in implanted devices that detect deformation. If an increase in respiratory rate is known to be associated with overtreatment or rapid movement as a sign of inadequate therapy, the system can be configured to vary one or more parameters defining the therapy until the sensed information indicates that the therapy may be effective or is no longer ineffective.

[0024] As described herein, there is an increasing need for technologies capable of more reliably predicting the remaining lifespan of implants based on the actual condition of the implanted device. By using the sensors described herein to increase the accuracy of implant lifespan prediction, systems can be configured to improve patient safety by alerting to or predicting failures that would otherwise manifest as symptom recurrence or other undesirable effects. Thus, implanted devices nearing failure can be replaced or considered before failure leads to negative outcomes for the patient.

[0025] Figure 1A , Figure 1B and Figure 1C These are conceptual diagrams illustrating example medical device systems 10A, 10B, and 10C (collectively, "Medical Device System 10") that include implantable medical devices coupled to implantable medical leads or catheters. Figure 1A In the example, medical system 10A includes an IMD 14A configured to deliver therapeutic effects to the brain 24 of patient 12A and / or sense physiological signals from the patient's brain via electrodes 20A and 20B of leads 16A (which may include multiple leads). More specifically, IMD 14A may be located via sensors (e.g., at one or more locations (or one or more lengths) along leads 16A. Figure 2 One or more sensors 220A and 220B are used to track mechanical exposure. Tracking / monitoring and signals can be conducted between sensors or generated by sensors located proximal to, between, or at multiple locations of electrodes 20A and / or 20B.

[0026] like Figure 1A As shown, the medical device system 10A includes an IMD 14A, wherein leads 16A are inserted through the scalpel 26 into and implanted within the brain 24 of a patient 12A to deliver deep brain stimulation (DBS). One or more electrodes 20A or 20B at the distal ends of one or more leads 16A provide stress pulses to surrounding anatomical regions of the brain 24 in a therapy that can alleviate symptoms in the patient 12A. In some examples, more than one lead 16A may be implanted within the brain 24 of the patient 12A to stimulate multiple anatomical regions of the brain.

[0027] DBS can be used to treat dysfunctional neuronal activity in the brain, manifesting as diseases or disorders such as Huntington's disease, Parkinson's disease, or movement disorders. The exact reason why electrical stimulation therapy can treat such brain conditions is unclear, but the symptoms of these diseases can be reduced or eliminated through electrical stimulation. Certain anatomical areas of the brain (24) are responsible for producing the symptoms of such brain disorders. As an example, stimulating anatomical areas in the brain (24), such as the substantia nigra, can reduce the number and magnitude of tremors experienced by the patient (12A). Other anatomical areas may include the hypothalamic nucleus, medial globus pallidus, ventral media, and area of ​​indeterminacy. During lead 16A implantation, clinicians target anatomical areas such as these. In other words, clinicians may attempt to position the distal portion of lead 16A (including one or more electrodes) as close as possible to these areas.

[0028] exist Figure 1B In the example, system 10B may be similar to system 10A and includes an implantable medical device (IMD) 14 configured to deliver therapy to and / or sense physiological signals from the target tissue. The target tissue may include or be located near the spinal cord 28 and / or pelvic nerves 6 (e.g., the pudendal nerve or sacral nerve), or any other nerve or muscle tissue that can be stimulated or from which physiological signals of the patient 12B can be sensed via lead 16B. More specifically, IMD 14B may be located via sensors (e.g., at one or more locations (or one or more lengths) along lead 16B. Figure 2 One or more sensors 220A and 220B are used to track mechanical exposure. Stimuli and signals can be conducted between the sensor and the IMD 14B via a conductor within lead 16B, which is electrically connected to the IMD 14B via a contact at the proximal end 18B of lead 16B. The IMD 14B can provide neural stimulation to treat symptoms of patient 12B, such as pain, fecal or urinary incontinence, erectile dysfunction, or other sexual dysfunctions.

[0029] exist Figure 1C In the example, system 10C may be similar to system 10A or 10B. However, IMD 14C is configured to deliver drug therapy to target tissue and / or sense physiological signals from target tissue. Target tissue may include or be located near the spinal cord 28 and / or pelvic nerve 6 (e.g., pudendal nerve or sacral nerve), or any other nerve or muscle tissue that may benefit from drug delivery or from which physiological signals of patient 12C may be sensed via catheter 16C. More specifically, IMD 14C may be located via sensors (e.g., at one or more locations (or one or more lengths) along catheter 16B. Figure 2One or more sensors 220A and 220B may be used to track mechanical exposure. The IMD 14C may include a drug pump that forces fluid from a fluid reservoir of the IMD 14C through a catheter 16C and out of an outlet 20C in the distal end of the catheter 16C. The IMD 14C may provide neurostimulation to treat symptoms of the patient 12C, such as pain, fecal or urinary incontinence, erectile dysfunction, or other sexual dysfunctions.

[0030] IMDs 14A, 14B, and 14C (collectively, “IMD 14”) may include electronics and other internal components necessary or desired to provide the functionality described herein as associated with the device. In one example, IMD 14 includes processing circuitry, memory, signal generation circuitry, sensing circuitry, telemetry circuitry, and a power source. Generally, the memory of IMD 14 may include computer-readable instructions that, when executed by the processing circuitry of the IMD, cause the processing circuitry to perform various functions attributable to the device herein. For example, the processing circuitry of IMD 14 may control the signal generation circuitry, pump control circuitry, and sensing circuitry according to instructions and / or data stored in the memory to deliver therapy to patient 12, sense the patient’s physiological signals, and perform other functions related to treating one or more conditions of the patient with IMD 14.

[0031] In any of systems 10A, 10B, and 10C, one or more leads 16A or 16B or catheters 16C may include one or more sensors for monitoring mechanical exposure of the leads or catheters to deformation, strain, or other mechanical stresses that may reduce the expected operational life of the leads or catheters. Thus, the system can use this sensed information from the leads or catheters to predict the remaining operational life of the leads or catheters due to mechanical exposure, such as deformation. In one example, the system includes an elongated member (e.g., lead 16A, 16B, or catheter 16C or its housing or body) configured for implantation in a patient, wherein the elongated member is configured to be coupled to an IMD (such as one of IMDs 14), wherein the IMD is configured to deliver therapy to the patient via the elongated member. The system may also include sensors (such as... Figure 2 The sensor (either of 220A or 220B) is carried by an elongated member and configured to provide a signal indicating deformation experienced by the elongated member. The elongated member may be or includes a medical lead comprising a plurality of electrodes configured to deliver electrical stimulation generated by the IMD. In other examples, the elongated member may be or includes a catheter configured to deliver fluid supplied from the IMD.

[0032] In some examples, the sensor includes a conductive element configured to break after a predetermined number of bending cycles associated with deformation experienced by the elongated member. The predetermined number of bending cycles can be selected to be less than the number of bending cycles expected to cause breakage or other failure of operational parts of the elongated member, such as conductors in medical leads or structural walls of catheters. In this way, the breakage of the sensor's conductive element can predict impending failure of one or more other components of the elongated member.

[0033] In other examples, the sensor may be configured to change the electrical properties of the electrical signal applied to the sensor during deformation experienced by the elongated member. For example, a voltage may be applied to the strain-sensing component, such as a Wheatstone bridge or other strain gauge, a force sensor, a deformation sensor that detects changes in distance along the sensor, or any other sensor. In some examples, the sensor may include a carbon film, carbon nanotubes in silicone to generate a voltage, or even just a metal wire. The IMD or other device may monitor this change in the electrical sensor to determine the cumulative and / or magnitude of the deformation predicted by the IMD for the end of the elongated member's service life.

[0034] In some examples, sensors for detecting mechanical exposure are carried on the outer surface of the lead body of the elongated member. In other examples, the sensors are embedded within a flexible polymer defining the lead body of the elongated member. In either case, the sensors may be configured to experience the deformation and / or strain that the elongated member also experiences.

[0035] An IMD coupled to an elongated member can provide operating power, such as current and / or voltage, enabling the sensor to operate. In other examples, the sensor may use its own power. For example, a capacitor or other battery storage device may be carried on the elongated body and coupled to a component of the sensor. In some examples, the sensor includes sensing circuitry and an energy harvesting device configured to generate and store electrical power from movement of the elongated member to supply power to the sensor, and to use the electrical power to supply power to the sensor's sensing circuitry. The energy harvesting device may generate current in response to bending of the elongated member, acceleration associated with a patient's body movement, or any other mechanism for generating current for storing energy.

[0036] An IMD or other computing device can receive signals from sensors and, based on those signals, determine the functional lifespan status of a slender component implanted in a patient. As discussed above, the functional lifespan status can be, for example, a predicted remaining functional lifespan of a lead or catheter, or an indication of a percentage of its total lifespan, or other indication of how long or how much the device may be usable before it should become inoperable. In some examples, the IMD can monitor signals from sensors over time to determine cumulative mechanical exposure that reduces the expected lifespan. In other examples, received signals from sensors can indicate planned sensor component failure due to mechanical exposure, and the IMD can apply a predicted amount of time remaining from that point of mechanical exposure or the amount of device usage.

[0037] As discussed above, the conductive element of the sensor can be configured to break after a predetermined number of bending cycles associated with the experienced deformation or after some known mechanical exposure. Therefore, the signal received from the sensor can be configured to change in response to the breakage of the conductive element. The IMD or other device can then determine the functional lifespan status of the implanted device by determining that the signal has changed to indicate that the conductive element has broken.

[0038] In other examples, the electrical properties of the signal are configured to change during deformation experienced by the slender member. For example, a strain gauge or other circuitry can provide a changing electrical signal in response to deformation or strain. In this case, the IMD can apply the signal to a sensor and sense the return signal from the sensor to detect any changes caused by mechanical exposure, such as deformation. The IMD or other device can then determine the functional lifetime state of the leads or conduits including the sensor by determining the change of the signal over time and determining the functional lifetime state based on the change of the signal over time.

[0039] In some examples, the IMD can take various actions based on signals from sensors. For instance, the IMD can be configured to compare a functional lifetime state with a threshold and determine whether the functional lifetime state exceeds or does not exceed the threshold. In response to a functional lifetime state exceeding the threshold, the processing circuitry can control the IMD to perform at least one of the following: perform an integrity check on the elongated component or stop the delivery of the therapy via the elongated component. These example actions can be triggered by signals where sensor signals can indicate a problem with the implanted device.

[0040] The IMD 14, external programmer 22, or other devices may be configured to output functional lifespan status for display to the user. Functional lifespan status may be presented via information such as how long the implanted device can be used before replacement, prompts for adjustment or termination of therapy, requests to schedule a clinician visit to replace the implanted device, or any other such information. In some examples, functional lifespan status may be presented as a numerical percentage, a graphical portion, or some other indication of the proportion of time used or remaining for operation of the implanted device.

[0041] Figure 2 This is a block diagram illustrating an example configuration of the components of IMD 200. IMD 200 can be any of the IMDs in IMD 14. Figure 2 In the example shown, IMD 200 includes processing circuitry 210, storage device 212, stimulus generation circuitry 202, sensing circuitry 206, communication circuitry 308, sensor controller 222, and power source 224. Sensors 220A and 220B on corresponding leads 230A and 230B can detect deformation or other mechanical exposure of one or more portions of the corresponding leads. Storage device 212 can store computer-readable instructions that, when executed by processing circuitry 210, cause IMD 200 to perform the various functions described herein.

[0042] exist Figure 2 In the example shown, storage device 212 stores therapeutic stimulation program 214 and deformation sensor data 216. Each stored therapeutic stimulation program defines a specific therapeutic procedure with respect to corresponding values ​​of electrical stimulation parameters, such as the combination of stimulating electrodes, electrode polarity, current or voltage amplitude, and the therapeutic program may define the values ​​of pulse width and pulse rate of the stimulation signal if the stimulation generation circuit 202 generates and delivers stimulation pulses. In the example, when the IMD 200 delivers electrical stimulation therapy on a cyclic basis (as opposed to on-demand), storage device 212 stores, for example, cyclic parameter information, such as the duration within and outside the cycle, as part of the therapeutic stimulation program 214. In some examples, therapeutic programs may be stored as therapy groups, which define a set of therapeutic programs that can be used to generate stimulation. Stimulation signals defined by the therapeutic programs of the therapy group may be delivered together on an overlapping or non-overlapping (e.g., time-staggered) basis.

[0043] An accelerometer 225, controlled by sensor controller 222, can measure and detect changes in acceleration. The accelerometer 225 can monitor and estimate patient movement or motion-related parameters. The collected acceleration data can provide insights into patient mobility, fall detection, rehabilitation progress, or other parameters. The output of the accelerometer 225 is processed within the IMD 200 processing circuitry 210, which may include algorithms for activity recognition, event detection, or trend analysis. The processed data can be stored, wirelessly transmitted, or used to trigger specific responses or interventions within the IMD 200.

[0044] The deformation sensor data 216 stored by storage device 212 may include information collected during mechanical exposure such as buckling or bending. For example, deformation sensor data 216 may include information indicating fracture or other changes in a component of one of the sensors in sensor 220. In some examples, deformation sensor data 216 may include information indicating changes in the sensor 220 signal over time, which may track cumulative deformation and / or deformation magnitude values ​​that may affect the determination of the functional lifespan state of lead 230. Larger deformation in a buckling cycle may extend the device lifespan more than smaller deformation magnitude values ​​during a single cycle.

[0045] The stimulation generation circuit 202 located below the processing circuit 210 can be a single-channel stimulation generator circuit or a multi-channel stimulation generator circuit. Specifically, the stimulation generation circuit 202 can be capable of delivering a single stimulation pulse, multiple stimulation pulses, or a continuous signal at a given time via a single electrode combination, or multiple stimulation pulses at a given time via multiple electrode combinations. However, in some examples, the stimulation generator 202 can be configured to deliver multiple channels on a time-staggered basis. For example, thus, in some examples, the stimulation generation circuit 202 generates an electrical stimulation signal according to the described electrical stimulation parameters. Other ranges of stimulation parameter values ​​can also be useful and can depend on the target stimulation site within the patient 12A. Although stimulation pulses have been described, the stimulation signal can have any form, such as a continuous-time signal (e.g., a sine wave). Switching circuit 204 may include one or more switch arrays, one or more multiplexers, one or more switches (e.g., a switch matrix or other set of switches), or other circuitry configured to direct stimulation signals from stimulation generation circuit 202 to one or more of electrodes 232, 234, or to direct sensed signals from one or more of electrodes 232, 234 to sensing circuit 206. In other examples, stimulation generation circuit 202 and / or sensing circuit 206 may include sensing circuitry to direct signals to and / or from one or more of electrodes 232, 234, which may or may not include switching circuitry 204.

[0046] Sensor controller 222 can be configured to monitor signals from sensor 220. In some examples, sensor controller 222 can receive signals via sensing circuitry 206 to sense mechanical exposure of the IMD implanted in patient 12A. In other examples, sensor controller 222 can receive electrical signals directly from sensor 220.

[0047] Sensing circuit 206 monitors signals from any combination of electrodes 232, 234. In some examples, sensing circuit 206 includes one or more amplifiers, filters, and analog-to-digital converters. Sensing circuit 206 can be used to sense physiological signals, such as ECAP. Additionally or alternatively, sensing circuit 206 can sense one or more stimulation pulses delivered to patient 105 via electrodes 232, 234. In some examples, sensing circuit 206 detects electrical signals, such as stimulation signals and / or ECAP from a specific combination of electrodes 232, 234. In some cases, the specific combination of electrodes used to sense ECAP includes electrodes different from the set of electrodes 232, 234 used to deliver stimulation pulses. Alternatively, in other cases, the specific combination of electrodes used to sense ECAP includes at least one electrode from the same set of electrodes used to deliver stimulation pulses to patient 105. Sensing circuit 206 can provide signals to analog-to-digital converters for conversion into digital signals for processing, analysis, storage, or output by processing circuit 210.

[0048] Communication circuit 208, under the control of processing circuit 210, supports wireless communication between IMD 200 and external programmer 22 or another computing device. As an update to the program, processing circuit 206 of IMD 200 can receive values ​​of various stimulation parameters, such as amplitude and electrode combinations, from programmer 14 via communication circuit 208. Updates to the therapy program can be stored within the therapy stimulation program 214 portion of storage device 212. Communication circuit 208 in IMD 200, as well as communication circuits in other devices and systems described herein (such as programmer 14), can communicate via RF communication technology. Furthermore, communication circuit 208 can communicate with external medical device programmer 14 via proximal sensor interaction between IMD 200 and programmer 14. Therefore, communication circuit 208 can send information to external programmer 14 on a continuous basis, at periodic intervals, or upon request from IMD 200 or programmer 14. For example, processing circuit 210 can transmit deformation sensor data 216 to programmer 14 via communication circuit 208.

[0049] Power source 224 is configured to deliver operating power to various components of IMD 16. Power source 224 may include, for example, a small rechargeable or non-rechargeable battery and power generation circuitry to generate operating power. Recharging can be achieved via proximal inductive interaction between an external charger and an inductive charging coil within IMD 200. In some examples, the power requirement may be small enough to allow IMD 200 to utilize patient movement and implement kinetic energy clearance mechanisms to trickle charge the rechargeable battery. In other examples, conventional batteries may be used for a limited time.

[0050] Figure 3 This is a block diagram illustrating an example configuration of components of an external programmer 22 according to one or more technologies of this disclosure. The external programmer 22 includes a storage device 354, processing circuitry 352, communication circuitry 358, a user interface 356, and a power source 350. An IMD may include sensors that capture physiological data or signals from a patient's body.

[0051] Storage device 354 stores data and parameters required for IMD operation, including patient-specific information, firmware, and configuration settings. Storage device 354 may include instructions for operating user interface 356 and processing circuitry 352, communication circuitry 358, and for managing power source 350. Storage device 354 may also store any therapeutic data retrieved from IMD 200, such as, but not limited to, brain activity information. Clinicians can use this therapeutic data to determine the progression of the patient's condition in order to plan future treatment for the patient's impairment (or symptoms). Storage device 354 may include any volatile or non-volatile memory, such as RAM, ROM, EEPROM, or flash memory. Storage device 354 may also include a removable memory portion that can be used to provide memory updates or increase storage capacity. The removable memory may also allow sensitive patient data to be removed before the programmer 14A is used on different patients.

[0052] Processing circuitry 352 analyzes and interprets signals acquired from sensors, while performing calculations and controlling the operation of the device. Processing circuitry 352 may include any or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed herein to processing circuitry 210, which may be embodied herein as firmware, hardware, software, or any combination thereof. Processing circuitry 210 controls stimulation generation circuitry 202 to generate stimulation signals based on therapeutic stimulation program 214 and deformable sensor data 216 stored in storage device 212, to apply stimulation parameter values ​​specified by one or more programs, such as the amplitude, pulse width, pulse rate, and pulse shape of each stimulation signal in the stimulation signal. Processing circuitry 352 may be configured to present information in digital, textual, or graphical form, representing deformable sensor data or functional lifetime status of one or more implanted devices.

[0053] Communication circuitry 358 is coupled to processing circuitry 352. Communication circuitry 358 enables bidirectional communication between the IMD and external devices (such as programmers or monitoring systems), facilitating data exchange, programming updates, and remote monitoring. Under the control of processing circuitry 352, communication circuitry 358 supports wireless communication between the IMD 200 and external programmer 22 or another computing device. As a program update, the processing circuitry 352 of programmer 22 can receive values ​​of various stimulation parameters (such as amplitude and electrode combinations) from the external programmer via communication circuitry 208. Updates to the therapeutic stimulation program 214 and deformation sensor data 216 can be stored in storage device 354. Communication circuitry 358 in programmer 22, as well as communication circuitry in other devices and systems described herein (such as external programmers), can communicate via radio frequency (RF) communication technology. Furthermore, communication circuitry 358 can communicate with the IMD 200 via proximal induction interaction. The communication circuit 208 of the IMD 200 can continuously, periodically, or according to a request from the IMD 200 or an external programmer to send information to an external programmer.

[0054] Users such as clinicians or patients 12A can interact with programmer 22 through user interface 356. User interface 356 includes a display (not shown), such as an LCD or LED display or other type of screen, to present therapy-related information, such as information related to bioelectrical signals. User interface 356 is coupled to processing circuitry 352. User interface 356 can provide components for interaction between the patient and IMD 200, thereby allowing access to information or control of certain functions. Furthermore, user interface 356 may include input mechanisms for receiving input from the user. Input mechanisms may include, for example, buttons, a keypad (e.g., an alphanumeric keypad), peripheral pointing devices, or another input mechanism that allows the user to navigate and provide input within the user interface presented by the processor 352 of programmer 22.

[0055] As discussed above, if programmer 22 includes buttons and a keypad, these buttons may be dedicated to performing a specific function, or they may be soft keys that change function depending on the portion of the user interface currently viewed by the user. Alternatively, the screen (not shown) of programmer 22 may be a touchscreen that allows the user to provide input directly to the user interface displayed on the monitor. The user may use a stylus or their fingers to provide input to the monitor. In other examples, user interface 86 may also include audio circuitry for providing audible instructions or sounds to patient 12A and / or receiving voice commands from patient 12A—this may be useful if patient 12A has limited motor function. Patient 12, a clinician, or another user may also interact with programmer 22 to manually select therapy programs, generate new therapy programs, modify therapy programs through individual or global adjustments, and transfer new programs to IMD 200.

[0056] In some examples, dedicated keys within the user interface 356 can be associated with specific symptoms. The patient 12A can easily initiate the delivery of stimulation to relieve symptoms by pressing the key associated with the specific symptom. In some examples, the processing circuitry 352 can limit the number of times stimulation can be delivered within a specific timeframe in response to patient input.

[0057] Power source 350 is configured to deliver operating power to components of programmer 22. Power source 350 may include a battery and power generation circuitry for generating operating power. In some examples, the battery may be rechargeable to allow for extended operation. Recharging can be achieved by electrically coupling power source 350 to a bracket or plug connected to an alternating current (AC) outlet. Alternatively, recharging can be achieved via near-side inductive interaction between an external charger and an inductive charging coil within programmer 22. In other examples, conventional batteries (e.g., nickel-cadmium or lithium-ion batteries) may be used. Furthermore, programmer 22 may be directly coupled to an AC outlet for operation. Power source 350 may include circuitry for monitoring remaining power within the battery. Thus, user interface 356 can provide a current battery level indicator or a low battery level indicator when the battery needs replacement or recharging. In some cases, power source 350 may be able to estimate the remaining operating time using the current battery.

[0058] Figure 4A and Figure 4B These are conceptual diagrams of example sensors 406 and 422 configured to detect deformation via component fracture. Figure 4A As shown in the example, lead 400 is an example implanted device and can be similar to any lead (e.g., lead 16A, 16B, or 230), but in other examples it can be a catheter. Lead 400 includes an elongated member 402 (e.g., the body or housing of lead 400) that carries an electrode 404 disposed at the distal end of lead 400.

[0059] Sensor 406 can be configured to detect deformation of lead 400 via a planned component fracture of conductive element 410 housed within sensor 406. Conductive element 410 can be electrically coupled to a proximal contact via conductor 408. Thus, an IMD (such as IMD 200) can transmit an electrical signal through conductor 408 and conductive element 410. Conductive element 410 can be constructed with selected materials and dimensions (e.g., cross-sectional area, width, thickness, length, etc.), the material being configured to fracture after a predetermined amount of mechanical exposure (such as a predetermined amount of deformation, pressure, strain, etc.). This predetermined amount inducing fracture can be selected to occur prior to failure of any other component of lead 400 and is used as a predictive indicator of the functional lifespan of lead 400.

[0060] Figure 4BExamples include lead 420, which can be substantially similar to lead 400. However, sensor 422 can utilize a single loop of conductor 422, which is itself or includes a conductive element constructed with selected materials and dimensions (e.g., cross-sectional area, width, thickness, length, etc.), which can be configured to break after a predetermined amount of mechanical exposure (such as a predetermined amount of deformation, pressure, strain, etc.). Thus, the breakage of any portion of conductor 422 can indicate that the functional life state of lead 420 is nearing its end.

[0061] In some examples, leads 400 or 420 may include multiple different sensors located at different axial positions along the length of elongated member 402 and / or at different circumferential positions around the periphery of elongated member 402. These individual sensors may be connected in series to supply power, or individually and separately connected to IMD 200. Different sensors 406 or 422 may be used to monitor deformation that may occur at different locations on the respective leads 400 or 420. In other examples, different sensors 406 or 422 may be configured to break over time after different amounts of deformation, as a progressive indicator of functional life status. For example, different sensors may use conductive elements of different materials and / or different sizes to break after different amounts of mechanical exposure. IMD 200 can then update the functional life status after each sensor indicates breakage. Sensors 406 and 422 may be disposed on the outer surface of elongated member 402 and / or within elongated member 402.

[0062] Figure 5 This is a conceptual diagram of an example sensor 510 configured to generate a change in electrical signal in response to deformation. (See diagram for example.) Figure 5 As shown in the example, lead 500 is an example implanted device and can be similar to any lead (e.g., lead 16A, 16B, or 230), but in other examples it can be a catheter. Lead 500 includes an elongated member 402 (e.g., the body or housing of lead 400) that carries an electrode 404 disposed at the distal end of lead 400.

[0063] Sensor 510 can be configured to detect deformation of lead 500 via changes in an electrical signal output by sensor 510 in response to mechanical exposures such as deformation, bending, strain, pressure, etc. For example, sensor 510 may include one or more Wheatstone bridges or other strain gauges, a flexible conductor whose resistance changes with elastic deformation, an optical sensor that measures changes in distance, or any other type of sensing device connected to IMD 200 via conductor 508. Other example sensors may include force sensors, carbon films, carbon nanotubes in silicone to generate voltage, or even simply a metallic wire whose electrical properties can change in response to mechanical changes such as bending, buckling, or strain. IMD 200 can then determine the functional lifetime state of lead 500 by monitoring deformation over other times (such as the number of bending cycles, the magnitude of bending, stretching, and / or strain). These measures from the deformation data can be compared to one or more thresholds to generate a functional lifetime state that can represent the time-dependent or other uses of lead 500.

[0064] In some examples, lead 500 may include multiple different sensors 510 located at different axial positions along the length of elongated member 402 and / or at different circumferential positions around the periphery of elongated member 402. These individual sensors may be connected in series to supply power, or individually and separately connected to IMD 200. The different sensors 510 can be used to monitor deformations that may occur at different locations on lead 500. Sensors 510 may be disposed on the outer surface of elongated member 402 and / or within elongated member 402.

[0065] Figure 6A , Figure 6B and Figure 6C This is a cross-sectional view of exemplary leads at different locations for the deformation sensor 608. Lead 600 may represent a cross-sectional view of any of leads 16A, 16B, 230, 400, 420, or 500. The placement of sensor 608 (e.g., sensor 406 or 422) can also be applied to catheters configured to deliver medication from a drug pump to a patient. Figure 6A As shown, lead 600 includes lead body 602 (or elongated member), electrode 604, coil conductor 606, and sensor 608. Electrode 604 is an annular electrode disposed on the outer surface of lead body 110 and electrically connected to coil conductor 606. Specifically, each electrode 604 is electrically connected to a wire of coil conductor 606, and each wire can be screwed out from coil conductor at any location around the circumference of lead 600 to allow conduit and / or core needle to be passed to a distal portion of lead body 602. In some embodiments, coil conductor 606 may not be in a coil configuration.

[0066] Sensor 608 can be disposed within lead body 602, such as Figure 6B As shown in the figure, this diagram shows lead 600 in... Figure 6A The cross-section is located at plane A in the lead body 602. The longitudinal axis 612 may extend through the center of the lead body 602. The coil conductor 606 is coiled around the longitudinal axis 612, but radially inward from the placement position of the conductor 610 of the sensor 608. The conductor 610 can thus be embedded within the polymer or other material used for the lead body 602. The conductor 610 may extend generally parallel to the longitudinal axis 612, but may deviate in certain directions as needed to accommodate other features of the lead 600.

[0067] Figure 6C An example lead 630 is shown, which is essentially similar to lead 600. Figure 6C The cross-sectional view is from Figure 6A The plane A is cut off. However, the sensor 630, including conductor 640, may be disposed on the outer surface of the lead body 602. Conductor 640 may include an insulating sheath or other elements that electrically isolate the conductor from the patient. In some examples, the conductor on the outer surface of the lead body 602 may include nanotubes that can be attached to or coated onto the surface of the lead body. In some examples, these conductors on the surface of the lead body may be in electrical contact with passive retaining screws or other electrical contacts on the IMD that can be coupled to the conductor.

[0068] Figure 7 This is a conceptual diagram of an example sensor 706 configured to detect deformation of a medical lead and the included energy source. Figure 7 As shown in the example, lead 700 is an example implanted device and can be similar to any lead (e.g., lead 16A, 16B, or 230), but in other examples it can be a catheter. Lead 700 includes an elongated member 702 (e.g., the body or housing of lead 700) that carries an electrode 704 disposed at the distal end of lead 700.

[0069] Sensor 706 can be configured to detect deformation of lead 700 via a change in the electrical signal output due to deformation. Sensor 706 includes conductor 714, which can be broken after a predetermined number of bending cycles or other mechanical exposures similar to sensor 422. However, sensor 706 can optionally operate to generate a changing signal, such as sensor 510. Sensor 706 can be operated from a separate power source, such as energy harvesting power source 708. Energy harvesting power source 708 can generate a current caused by bending or other deformation of lead body 702 and store energy in a battery or capacitor. The energy stored in energy harvesting power source 708 can be applied to operate processing circuitry 710, which processes the signal from conductor 714 indicating deformation. Processing circuitry 710 can also control antenna 712 to wirelessly transmit deformation data to IMD 200, since sensor 706 is not wired to IMD 200. In some examples, processing circuitry 710 may monitor signals from conductor 714 and generate deformation data and / or generate a functional lifetime state of lead 700 based on the deformation data. In other examples, IMD 200 or other devices may receive deformation data and determine the functional lifetime state of lead 700 by monitoring for breakage or other events in conductor 714, such as deformation at other times, such as the number of bending cycles, the magnitude of bending, stretching, and / or strain. These measures from the deformation data may be compared to one or more thresholds to generate a functional lifetime state that can represent the time-related or other uses of lead 700.

[0070] In some examples, lead 700 may include multiple different sensors 706 located at different axial positions along the length of elongated member 702 and / or at different circumferential positions around the periphery of elongated member 702. These individual sensors may be connected to each other for power supply (e.g., utilizing a single energy harvesting power source for multiple different deformation sensors) or operated individually. The different sensors 706 can be used to monitor deformations that may occur at different locations on lead 700. Sensors 706 may be disposed on the outer surface of elongated member 702 and / or within elongated member 702. Since sensors 706 may be self-contained and have included energy sources, sensors 706 can be attached to the outer surface of lead 700 as needed to obtain deformation data for generating the functional lifetime state of lead 700.

[0071] Figure 8 This is a flowchart illustrating an example technique for sensing the breakage of an IMD and generating an alarm according to one or more techniques of this disclosure. Figure 8In the example, IMD 200 and processing circuit 210 will be described as performing functions, but in other examples, other processing circuits from other devices may perform functions partially or completely.

[0072] Processing circuitry 210 can control IMD 200 to deliver therapy to patient 12A using IMD 200 (800). Processing circuitry 210 can receive sensor signals from deformation sensors such as sensor 220 (802). These sensor signals can provide binary information associated with the deformation sensor (e.g., a complete or broken conductor). If the sensor signal does not indicate a break (the "No" branch of block 804), processing circuitry 210 can continue delivering therapy and receive additional signals from sensor 220 (800).

[0073] However, if processing circuit 210 determines that the sensor signal does indeed indicate a break within the sensor (the "Yes" branch of block 804), processing circuit 210 can generate and send an alarm (806) to the user indicating that the functional lifespan status has changed and that a certain amount of lifespan has been used or that lead 230 has a certain amount of remaining operational lifespan. Processing circuit 210 can control communication circuit 208 to transmit the functional lifespan status to programmer 22. Additionally or alternatively, processing circuit 210 can adjust one or more parameters limiting the therapy and / or completely terminating the therapy in response to a functional lifespan status indicating that lead 230 is no longer suitable for providing therapy.

[0074] Figure 9 This is a flowchart illustrating an example technique for generating an alarm in response to determining that cumulative deformation exceeds a deformation threshold, according to one or more techniques of this disclosure. Figure 9 In the example, IMD 200, processing circuit 210, and lead 500 will be described as performing functions, but in other examples, other processing circuits from other devices may perform functions partially or completely.

[0075] Processing circuitry 210 can control IMD 200 to deliver therapy to patient 12A using IMD 200. Processing circuitry 210 can receive and monitor sensor signals from deformation sensors such as sensor 510 (900). These sensor signals can indicate changes in electrical signals output by sensor 510 in response to mechanical exposures such as deformation, bending, strain, pressure, etc. For example, sensor 510 may include one or more Wheatstone bridges or other strain gauges, a flexible conductor whose resistance changes with elastic deformation, an optical sensor that measures changes in distance, or any other type of sensing device connected to IMD 200 via a conductor. Processing circuitry 210 can determine a cumulative deformation metric indicating the amount of deformation that lead 500 has undergone during implantation (902).

[0076] Processing circuit 210 can then compare the accumulated deformation with a deformation threshold (904). If the accumulated deformation does not exceed the deformation threshold (the "No" branch of block 906), processing circuit 210 can continue to monitor the signal from deformation sensor 510 (900). However, if processing circuit 210 determines that the accumulated deformation does exceed the deformation threshold (the "Yes" branch of block 906), processing circuit 210 can generate and send an alarm to the user indicating that the functional lifespan status has changed and that a certain amount of lifespan has been used or that lead 500 has a certain amount of remaining operational lifespan (908). Processing circuit 210 can control communication circuit 208 to transmit the functional lifespan status to programmer 22. Additionally or alternatively, processing circuit 210 can adjust one or more parameters limiting the therapy and / or completely terminating the therapy in response to a functional lifespan status indicating that lead 230 is no longer suitable for providing therapy.

[0077] In some examples, processing circuitry 210 may compare cumulative deformation to multiple different thresholds or input the cumulative deformation into a formula to generate a more accurate functional lifetime state of lead 500. For example, cumulative deformation may be divided by the expected maximum lifetime deformation of lead 500 to generate a percentage of the lifetime used by lead 500. The reciprocal of this percentage can provide the remaining percentage of the lifetime of lead 500. Processing circuitry 210 may monitor multiple sensors 510 from the same implanted device (e.g., a single lead or catheter), and in some examples, the maximum deformation experienced by the sensors can control the functional lifetime state of lead 500.

[0078] The deformation sensors described herein are generally described as providing data related to the remaining lifespan of the lead. However, in some examples, the system may also, or alternatively, monitor one or more physiological or anatomical parameters based on the deformation of the identified implanted device (e.g., a lead or catheter). For example, the IMD 200 can be configured to monitor respiratory cardiac metrics based on deformation caused by pulsatile flow, patient activity, bladder filling circulation, patient falls, or any other patient function. The IMD 200 can adjust therapeutic parameters based on this deformation data even before any device failure is predicted.

[0079] The following embodiments are described in this article.

[0080] Example 1. A system comprising: an elongated member configured for implantation in a patient, wherein the elongated member is configured to be coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member; and a sensor carried by the elongated member and configured to provide a signal indicative of deformation experienced by the elongated member.

[0081] Example 2. The system according to Example 1, wherein the elongated member is a medical lead, the medical lead comprising a plurality of electrodes configured to deliver electrical stimulation generated by the IMD.

[0082] Example 3. The system according to any one of Examples 1 and 2, wherein the elongated member is a conduit configured to deliver fluid supplied from the IMD.

[0083] Example 4. A system according to any one of Examples 1 to 3, wherein the sensor includes a conductive element configured to break after a predetermined number of bending cycles associated with the deformation experienced by the elongated member.

[0084] Example 5. A system according to any one of Examples 1 to 4, wherein the sensor is configured to change the electrical characteristics of the electrical signal applied to the sensor during the deformation experienced by the elongated member.

[0085] Example 6. The system according to any one of Examples 1 to 5, wherein the sensor is carried on the outer surface of the lead body of the elongated member.

[0086] Example 7. A system according to any one of Examples 1 to 6, wherein the sensor is embedded in a flexible polymer that defines the lead body of the elongated member.

[0087] Example 8. A system according to any one of Examples 1 to 7, wherein the sensor includes a sensing circuit and an energy harvesting device, the energy harvesting device being configured as follows:

[0088] Electrical power is generated and stored from the movement of the elongated member to supply power to the sensor; and the electrical power is used to supply power to the sensing circuit of the sensor.

[0089] Example 9. The system according to any one of Examples 1 to 8, the system further comprising the IMD, wherein the IMD includes processing circuitry configured to: receive the signal from the sensor; and determine the functional lifespan state of the elongated member implanted in the patient based on the signal.

[0090] Example 10. The system according to Example 9, wherein the IMD includes a stimulation generation circuit configured to generate an electrical stimulation therapy that can be delivered by an electrode carried by the elongated member, and wherein the sensor is different from the electrode.

[0091] Example 11. A method comprising: receiving a signal from a sensor carried by an elongated member by a processing circuit, wherein the elongated member is configured to be implanted in a patient and coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member, and wherein the signal indicates deformation experienced by the elongated member; and determining, by the processing circuit and based on the signal, a functional lifetime state of the elongated member implanted in the patient.

[0092] Example 12. The method according to Example 11, wherein the signal is configured to change in response to a conductive element configured to break after a predetermined number of bending cycles associated with deformation experienced by the elongated member, and wherein determining the functional lifetime state includes determining that the signal has changed, thereby indicating that the conductive element has broken.

[0093] Example 13. The method according to any one of Examples 11 and 12, wherein the electrical characteristics of the signal are configured to change during the deformation experienced by the elongated member, and wherein determining the functional lifetime state includes determining the change of the signal over time, and determining the functional lifetime state based on the change of the signal over time.

[0094] Example 14. The method according to any one of Examples 11 to 13, the method further comprising applying an electrical signal to the sensor, wherein the signal indicates a change in the electrical signal, the change in the electrical signal indicating the deformation.

[0095] Example 15. The method according to any one of Examples 11 to 14, the method further includes outputting the functional lifetime status through the processing circuit for display to the user.

[0096] Example 16. The method according to any one of Examples 11 to 15, the method further comprising: comparing the functional lifetime state with a threshold; determining that the functional lifetime state exceeds the threshold; and in response to the functional lifetime state exceeding the threshold, controlling the IMD to perform at least one of the following: performing an integrity check on the elongated member or stopping the delivery of the therapy via the elongated member.

[0097] Example 17. The method according to any one of Examples 11 to 16, the method further comprising controlling the delivery of the therapy to the patient via the elongated member.

[0098] Example 18. The method according to Example 17, wherein the elongated member is a medical lead comprising a plurality of electrodes, and wherein controlling the delivery of therapy comprises controlling the delivery of electrical stimulation therapy via a subset of the plurality of electrodes to the IMD.

[0099] Example 19. The method according to Example 17, wherein the elongated member is a catheter configured to deliver fluid from the IMD, and wherein controlling the delivery of the therapy includes controlling the IMD to deliver fluid to the patient via the catheter.

[0100] Example 20. A computer-readable storage medium comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to: receive a signal from a sensor carried by an elongated member, wherein the elongated member is configured to be implanted in a patient and coupled to an implantable medical device (IMD), the IMD being configured to deliver a therapy to the patient via the elongated member, and wherein the signal indicates deformation experienced by the elongated member; and determine, based on the signal, a functional lifetime state of the elongated member implanted in the patient.

[0101] The techniques described in this disclosure can be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of the described techniques can be implemented within one or more processors, such as fixed-function processing circuitry and / or programmable processing circuitry, including one or more microprocessors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, and any combination of such components. The terms "processor" or "processing circuitry" can generally refer to any of the aforementioned logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit, including hardware, can also perform one or more of the techniques disclosed herein.

[0102] Such hardware, software, and firmware can be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described units, modules, or components can be implemented together or separately as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units can be performed by separate hardware or software components, or integrated within common or separate hardware or software components.

[0103] The techniques described in this disclosure can also be embedded or encoded in a computer-readable medium (such as a computer-readable storage medium) containing instructions. Instructions embedded or encoded in a computer-readable storage medium can cause a programmable processor or other processor to perform the method, for example, when executing those instructions. Computer-readable storage media may include random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, hard disk, CD-ROM, floppy disk, magnetic tape cassette, magnetic media, optical media, or other computer-readable media.

[0104] Various embodiments have been described. These and other embodiments are within the scope of the appended claims.

Claims

1. A system comprising: An elongated member configured to be implanted in a patient, wherein the elongated member is configured to be coupled to an implantable medical device (IMD) configured to deliver a therapy to the patient via the elongated member; and A sensor carried by the elongated member and configured to provide a signal indicating the deformation experienced by the elongated member.

2. The system of claim 1, wherein the elongated member is a medical lead comprising a plurality of electrodes configured to deliver electrical stimulation generated by the IMD.

3. The system according to any one of claims 1 and 2, wherein the elongated member is a conduit configured to deliver fluid supplied from the IMD.

4. The system according to any one of claims 1 to 3, wherein the sensor includes a conductive element configured to break after a predetermined number of bending cycles associated with the deformation experienced by the elongated member.

5. The system according to any one of claims 1 to 4, wherein the sensor is configured to change the electrical characteristics of the electrical signal applied to the sensor during the deformation experienced by the elongated member.

6. The system according to any one of claims 1 to 5, wherein the sensor is carried on the outer surface of the lead body of the elongated member.

7. The system according to any one of claims 1 to 6, wherein the sensor is embedded within a flexible polymer of a lead body defining the elongated member.

8. The system according to any one of claims 1 to 7, wherein the sensor comprises a sensing circuit and an energy harvesting device, the energy harvesting device being configured to: Electrical power is generated and stored from the movement of the elongated member to supply power to the sensor; and The electrical power is used to supply power to the sensing circuit of the sensor.

9. The system according to any one of claims 1 to 8, the system further comprising the IMD, wherein the IMD includes processing circuitry configured to: Receive the signal from the sensor; and The functional lifespan status of the elongated component implanted in the patient is determined based on the signal.

10. The system of claim 9, wherein the IMD includes a stimulation generation circuit configured to generate an electrical stimulation therapy that can be delivered by an electrode carried by the elongated member, and wherein the sensor is different from the electrode.

11. A computer-readable storage medium comprising instructions that, when executed by a processing circuit, cause the processing circuit to perform the function according to any one of claims 1 to 10.

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