Endoluminal bioelectronic monitoring apparatus, systems and methods

Abstract

An intravascular prosthesis comprises an at least partially tubular scaffolding, integrated circuit(s), transducer(s), and transmitter(s) to provide monitoring and effecting functions to the vascular tissue. The prosthesis can be powered externally, or harvest energy from the body, and deliver therapeutic regimens to mitigate in-stent restenosis. The apparatus also monitors and characterizes surrounding tissues, optionally characterizes its own structural integrity, and reports this information to an external system over an encrypted channel.

Description

[0001] ENDOLUMINAL BIOELECTRONIC MONITORING APPARATUS, SYSTEMS AND METHODS

[0002] CROSS-REFERENCE TO RELATED APPLICATION

[0003] This patent application claims priority of U.S. Patent Application No. 63 / 696,835, filed on September 19, 2024, the entire disclosure of which is hereby incorporated by reference herein for all purposes.

[0004] FIELD

[0005] The application generally relates to the field of stents for medical applications. More specifically, the present application relates to a stent with integrated electronics for imaging and measuring various physiological parameters, optionally to prevent restenosis, and optionally to monitor an operational integrity of the stent.

[0006] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0007] This invention was made with Government support under 75N91024C00033 awarded by Advanced Research Projects Agency for Health (ARPA-H). The government has certain rights in the invention.

[0008] BACKGROUND

[0009] Percutaneous-coronary intervention (PCI) has become a common treatment for addressing stenosed arteries in lieu of more invasive bypass surgeries. This procedure originally involved accessing a major artery, introducing a catheter, navigating the vascular system under fluoroscopic guidance to the site of the blockage, penetrating the blockage, and inflating a balloon to open the vessel (balloon angioplasty). Restenosis (closure of the vessel after it had been opened with the balloon angioplasty procedure) was common, so bare metal stents were developed to maintain the patency of the vessel lumen. Nevertheless, the pathological processes of neointimal hyperplasia and neoatherosclerosis gradually result in the accumulation of tissue inside the circumference of the stent. Drug-eluting stents have reduced the rate of in-stent restenosis (ISR) in the weeks and months following PCI, however, occlusions requiring reintervention or causing myocardial infarction (Ml) or cardiac death (“target lesion failures”) continue to accumulate at a rate comparable to that of bare metal stents in the years status post implantation. Moreover, even though the risk factors for target lesion failure are known (e.g. stent breakage, multiple stents, malposition, diabetes mellitus) and ISR-related target lesion failure accounts for a significant percentage of PCI procedures, surveillance angiography is typically not recommended. In fact, PCI follows presentation for acute coronary syndrome in the vast majority of these cases.

[0010] Fraction flow reserve (FFR) is the standard functional measure of vascular occlusion, calculated as the ratio of pressures distal and proximal to the stenosis at hyperemia. FFR is used to determine the need for intervention in stenosed vessels, whether the etiology of the stenosis is ISR or conventional stable coronary artery disease. Other techniques, like instantaneous wave-free ratio (iFR), which use pressure ratios during specific phases of the cardiac cycle, have demonstrated similar diagnostic accuracy to FFR, but do not require (typically pharmacologically induced) hyperemia. Despite the risk of target lesion failure status post stent implantation, about 40% of patients undergoing angiography and FFR evaluation for ISR across studies do not require further intervention despite initially concerning presentation.

[0011] Thus, it may be advantageous to provide systems, devices, and methods to address the twin challenges of the danger of ISR-related target lesion failure and the rate at which patients status post PCI present with concerning anginal symptoms, but do not ultimately require intervention. Continuous monitoring, characterization, treatment, reducing, and prevention of ISR would also provide substantial advantages over the existing state-of-the-art.

[0012] Moreover, patients status post PCI are at greater risk of Ml than the general population. The diagnosis of Ml typically requires elevation in serum cardiac biomarkers, the most specific of which are cardiac troponins I and T (cTnl and cTnT, respectively). Women, individuals with diabetes mellitus, older adults and other sub-populations are more likely to experience atypical presentations of Ml. These presentations pose both a diagnostic challenge for the clinician and a barrier to early recognition and presentation by the patient. Systems, devices, and methods that can monitor and warn patients about risks of Ml would represent a significant advantage of the current state of the art.

[0013] Angioplasty with stent implantation has been adapted to vascular beds outside of the heart. In the peripheral vasculature, commonly in the legs (iliac, femoral, and popliteal arteries), stents can be implanted in cases of limb-threatening ischemia and lifestyle-limiting claudication. In contrast to status post PCI, patients with peripheral stents are typically monitored for signs and symptoms of ISR in the months and years after their procedures. Follow-up often includes Doppler ultrasonography, which, in addition to the binary presence or absence of flow, can be used to assess the velocity of blood flow through the vessel, which corresponds to the degree of stenosis.

[0014] Patients who have undergone stent implantation, whether in the coronary vasculature or elsewhere in the body, are at risk for stent thrombosis, which typically leads to acute occlusion of the vessel and, in cases of limited collateral flow, ischemia of the distal tissues. Though the rate of stent thrombosis has been declining due to improved stent technologies, it remains a persistent problem.

[0015] Systems, devices, and methods that provide early warning of stent thrombosis and I SR, and reduce the onerous follow-up regimen typically recommended for peripheral stent implants would represent a significant advantage over the state of the art.

[0016] BRIEF SUMMARY

[0017] The following is intended to be a brief summary of various aspects of the disclosed implementation and is not intended to limit the scope of the invention(s).

[0018] In at least one implementation, scaffolding (e.g., a metallic, polymeric, resorbable, or hybrid scaffolding) is expandable into a body lumen, such that when expanded the scaffolding is braced against an inner wall of the body lumen. The scaffolding includes at least a tubular portion, to provide a fluidly communicative passageway through the scaffolding. The scaffolding may be comprised in part or entirely of, for example, a bare metal stent, drug eluting stent, peripheral bare metal stent, bioresorbable stent, inferior vena cava filter, though other common endoluminal structures may comprise the majority of or all of the scaffolding.

[0019] At least one transducer is physically coupled to the scaffolding, such that the transducer is mechanically coupled to a tissue of the body, or a fluid of the body adjacent to the scaffolding when the scaffolding is in a body lumen and in an expanded configuration. In some implementations, the transducer is any one of: an acoustic transducer, piezoelectric micromachined ultrasound transducer (PMUT), piezoelectric material, cavity pressure sensor, capacitively micromachined ultrasound transducer (CMUT), or the like. In further implementations, the transducer is at least one electrode, comprised of at least one of gold, silver / silver chloride, tantalum, titanium nitride, iridium oxide, platinum, glassy carbon, PEDOT:PSS, or other metallics, alloys, dielectrics, or conductive polymers. The at least one transducer may be positioned on the adluminal or abluminal side of the apparatus.

[0020] At least one integrated circuit (I C) chip is physically coupled to the scaffolding, and that is communicatively coupled to the at least one transducer. In some implementations, the IC is selected or designed to match the volumetric dimensions of one or more struts in the scaffolding. In further implementations, the IC is a structurally thinned IC to provide for mechanical flexibility, and the integrated circuit will comprise a relatively thin portion to allow for a region of enhanced flexibility. In some implementations, the IC comprise a driver, such that one or more transducers is operable to deliver at least a mechanical or electrical pulse or wave to at least the tissue adjacent to the scaffolding. The IC is also communicatively coupled to one or more transducers to receive a signal from a returned pulse or wave detected by one or more transducers, where the returned pulse or wave contains information about a structural or functional characteristic of a tissue of a human or animal body. In some implementations, a frequency of an outgoing mechanical or electrical wave or pulse initiated by one or more transducers is modulated, such that the returned pulse or wave detected by one or more transducers includes further frequency-dependent information about the body tissue. Such can also allow the IC to associate a returned pulse or wave with an outgoing mechanical or electrical pulse or wave and the transducer that initiated the outgoing pulse or wave. In some implementations, the signal from the returned pulse or wave is received at the interface of the same transducer that initiated (e.g., delivered) the outgoing mechanical or electrical pulse or wave. In another implementation, the signal from the returned pulse or wave is received at an interface of a different transducer than the transducer that initiated or delivered the outgoing mechanical or electrical pulse or wave. The IC is operable to at least one of process, store, or transmit the information about a tissue of the body. In some implementations, this information includes information about a patency of the body lumen.

[0021] The IC is communicatively coupled to at least one transmitter and optionally a receiver, which transmitter is physically coupled to the scaffolding. The at least one transmitter is operable to transmit information from the apparatus when the apparatus is implanted in the body lumen of the body. In some implementations, the transmitter is a part of the integrated circuit. In some implementations, a PMLIT, electromagnetic radiator, strut of the scaffolding, coil, or antenna system are communicatively coupled to the at least one transmitter. In some implementations, the IC may be communicatively coupled to an external system, outside the apparatus and, or outside of the body. A communication link between the apparatus and the external system may occur over an instrumentation scientific medical (ISM) band, 13.56 MHz, 433 MHz, 866 MHz, 915 MHz, medical instrumentation communication service band, 402-405MHz, an IEEE communication standard band, an IEEE 802.15.1 protocol, an IEEE 802.15.4 protocol, or an IEEE 802.11 protocol, or any communication protocol or adhering to any standard.

[0022] In some implementations, the IC is further communicatively coupled to one or more coils, inductors, antenna, electromagnetic receivers, piezoelectric transducers, operable to receive energy from an external system or device, and the IC is further comprised of a power receiver, power recoverer, power converter, or power harvester operable to receive at least one of information or power from an external system. In a further implementation, at least one of the transducers is a piezoelectric transducer (e.g., piezoelectric transduction element), which converts a time-changing pressure into an electrical charge based on a piezoelectric effect.

[0023] The transducers may be affixed to the scaffolding, patterned into the scaffolding, and electrically coupled to the IC via a polymeric interconnect board designed to route conductors from one or more integrated circuits to the one or more piezoelectric element(s). In at least some implementations, at least one piezoelectric transducer can be used to harvest energy from organs or tissues creating hydrodynamic power the scaffolding is subject to while implanted in the body lumen of the body. The piezoelectric transducer may harvest energy from a body or fluid movement, including at least one of articular motion, pulsatile motion, or skeletal motion.

[0024] In some implementations, the IC can further comprise at least one of: a power-on reset (POR) circuit to place the digital control systems into a known initial state, a low- drop-out (LDO) voltage regulator to provide a stable and regulated supply for logic elements, a voltage reference, a current reference, a bias circuit, a charge pump, a high voltage regulator, an analog to digital converter, a low-noise-amplifier, a digital to analog converter, an operational amplifier (op-amp), a transconductance amplifier, a comparator, an oscillator, a phase-locked-loop, a memory, a controller, a state machine, a modulator, a mixer, a filter, an encoder.

[0025] In some implementations, the IC further comprises a driver operational coupled to drive one or more transducers (e.g., piezoelectric transducers) to generate a mechanical wave or pulse ( / .e., outgoing mechanical wave or pulse) from the transducer, which outgoing mechanical wave or pulse can be directed into the tissue or fluid adjacent to the scaffolding. This mechanical wave or pulse will interact with tissue surrounding the scaffolding, and return pulse-echo-responses at regions of mechanical impedance mismatch, implying structural changes in the tissue or fluid of the body. The interface to the IC can receive a signal from one or more of the transducers (e.g., piezoelectric transducers), and the IC can receive, process, digitize, and, or store information recoverable from the signal by the IC. This information may be used to procedurally construct an image of the structure or a graphical representation of the function of the at least one tissue of the human body or the animal body from the converted signal according to A mode, B mode, M mode, Doppler ultrasonography, duplex ultrasonography, compressive sensing, harmonic imaging, echocardiography, or another imaging procedure. In at least some implementations, this information can provide a characterization of the scaffolding itself. In at least some implementations, this information can be used to infer a structural or functional patency of the vessel lumen. This information can be used to calculate fluid flow based on a Doppler effect. In some implementations, at least one transducer (e.g., piezoelectric transducer, resistive electrode) may be driven to agitate the tissue adjacent to the scaffolding, providing heat or ultrasonic treatment (sonotherapy) to at least one of disrupt or prevent in-stent restenosis (ISR), neointimal hyperplasia, neoatherosclerosis, stent thrombosis, atherosclerosis, restenosis, by disrupting fibrin and other structural formation and modify vulnerable plaques. In some implementations, at least one transducer (e.g., piezoelectric transducer) can receive power, communicate with an external system or device, and acoustic imaging to assess the buildup of material on the scaffolding, the mechanical integrity of the prosthesis (e.g., instrumented stent), and / or characteristics of the fluid flowing through the body lumen in which the prosthesis is deployed. In some implementations, a plurality of transducers (e.g., piezoelectric transducers) can line the abluminal and / or the adluminal side of the scaffolding, extending along all or a portion (e.g., more than half) of a length thereof, depending on whether the goal is evaluation / treatment of ISR (inside) or existing plaques (outside).

[0026] In at least one implementation, the one or more transducers are electrochemical transducers that measure a concentration of circulating proteins and / or biomolecules in the fluid communicative passage, the circulating proteins and / or biomolecules which may be biomarkers for pathological conditions, or whose levels may be of clinical interest. These electrochemical transducers may be comprised of a metallic structure, such as gold, platinum, or carbon-based substrate, with conjugated aptamers bonded to the surface, either directly or through a linkage molecule. The electrochemical transducer is communicatively coupled to the I C, which can comprise a potentiostat, such that a signal can be generated from the interface through cyclic voltametric sweeps, those cyclic voltammetry sweeps ultimately containing information about the tissue or fluid in the body. Aptamers bound to the surface of the electrochemical transducer may be sensitive to at least one of cTnl, cTnT, CK-MB, myoglobin and glucose, serotonin, cytokines, inflammatory biomarkers, cortisol, or any other biomarker of clinical interest.

[0027] In at least some implementations, the at least one transducer element is a piezoelectric transducer and is incorporated into one or more struts in the scaffolding, taking advantage of the flexural stain on the scaffolding to transmit vibratory energy throughout the structure for evenly-distributed sonotherapy.

[0028] In at least some implementations, the electrical or communicative interconnection between the IC(s) and transducers, includes conductive wiring, or a conductive metallic patterned on a flexible polymer that can be wrapped around the metallic scaffolding, and have a same physical footprint as the metallic structure, or be patterned in such a way to facilitate expansion / retraction. In a further implementation, interconnection between the transducer(s), IC(s), and transmitter includes wiring or interconnect internal to the scaffolding (e.g., between exterior or exposed surface layers of a multi-layered scaffolding structure).

[0029] In at least some implementations, the transducer(s) can include at least one of: a cavity pressure sensor, capacitive pressure sensor, MEMS pressure sensor, or the like. The pressure sensor is commonly comprised of two metallic thin films separated by a compressible dielectric or a compressible cavity. Environmental pressure modulates the capacitance of this sensor in a reproducible fashion. The pressure sensor is communicatively coupled to the integrated circuit, which receives a signal from the interface containing information about the localized pressure adjacent to the pressure sensor. In some implementations, the IC(s) will autonomously take periodic measurements (e.g., periodically sample) from the pressure sensor(s). In other implementations, the IC(s) will take measurements on-demand, for example in response to receiving a command from a system or a device located outside of the body and communicatively coupled to the IC(s). This information can be aggregated and stored on a memory at least one of inside the IC or in a second I C, and transmitted by the transmitter to the external system or external device located outside of the body.

[0030] In some implementations, the transducer(s) comprise pressure sensors located respectively at a distal end and a proximal end of the scaffolding or stent (or distal and proximal to an occlusion of interest). The signals received from the interface to these transducers can represent and estimate of various physiological parameters. In some implementations, the system or apparatus is operable to receive such information from the proximal and distal transducers, and at least one process, store, or transmit while or just after a pharmacologic agent is administered to the body to induce hyperemia, the resulting information at least includes the FFR. In some implementations, the information received from the proximal and distal transducers is synchronized to a mechanical or electrical activity of the body, such that the signal from the transducer(s) is received or sampled at the appropriate phase of diastole, the resulting information at least includes the iFR. Other physiological metrics can be calculated from proximal and distal transducers (e.g., pressure sensors) in this way, with or without the use of data from other sensors, like the electrocardiography, described here. This description should not be interpreted as a comprehensive list, or limit or restrict the scope of physiological parameters inferred from sensor interrogation.

[0031] In some implementations, the IC can be configured (e.g., wired, programmed, structured) to process the information about the body and to generate and, or transmit an alert, for example to an external system or device that is located outside the body. Such can occur for significant deviations from defined thresholds or ranges (e.g., prior received information), for instance an arithmetic mean, statistically-derived thresholds, raw setpoints, or any other specification to bound the response. The IC can cause the transmitter to transmit a warning or state-specific information if the processed information about the body extends beyond the thresholds or ranges. The IC is also operable to transmit an error or warning state depending on the operational state of the IC (e.g., detection of an electrical discontinuity).

[0032] In some implementations, a mechanical integrity of the implanted prosthesis is assessed through electrical coupling with at least one of the struts that comprise the mechanical scaffolding, forming a portion of at least one transmission lines that can be electrically characterized to assess the mechanical integrity of the scaffolding. In some implementations, a thin flexible interconnect with a patterned conductor designed to follow the mechanical construction of the prosthesis comprises one or more transmission lines. During scaffolding mechanical breakage, the interconnect is disrupted, which can be measured by the IC(s) by characterizing an electrical response of the transmission line. Biological growths on the stent, and mechanical conformation may be assessed through the deconvolution of the equivalent LCR circuit model determined by characterizing the transmission line electrical response.

[0033] In some implementations, the stent may be outfitted with contact sensors on the exterior surface that alert an clinician if the stent is under-expanded during PCI. In some implementations, the stent may be outfitted with position sensors that detect and report a degree of its expansion and report these data to the interventionalist during PCI.

[0034] In at least some implementations, the transducer(s) comprises piezoelectric transducer(s), and which is physically coupled to the scaffolding such that driving the piezoelectric transducer, by the IC, causes the scaffolding to vibrate. Vibration of at least one of the transducers, or a CMLIT transducer, or any mechanical to electrical transducer is then a signal is received by the IC. The IC may repeatedly drive the transducers at different frequencies to assess a broad frequency response of the scaffolding. Tracking this response across an arbitrary time course could be used for assessing biological growth on the scaffolding, the mechanical integrity of the scaffolding, or otherwise assessing the scaffolding and its surroundings.

[0035] In some implementations, the IC(s) is communicatively coupled with an external system or external device located outside the apparatus and, or outside the body. The external system or external device can provide at least one of: wireless power to the IC(s) through at least one of an RF, near-field, mid-field, or inductive link, communication with the integrated circuit over at least one of an electromagnetic radiator or electromagnetic receiver, antenna, coil, or the like, or a means of communicating with the integrated circuit encoded by modulation of the powering downlink, or a means of communicating with the IC(s) over a discrete frequency band (including ultra-wide band implementations). In some implementations, the communication with the IC(s) may further control the IC(s) with a command / response interface, either over the same frequency band or over multiple bands, and / or the ability to request information from the memory. This information may come from the one or more transducers taken on demand or previous information autonomously captured by the integrated circuit over one or more time points.

[0036] The external system or external device can comprise one or more processors that can at least one execute processor-executable logic and, or command instructions or serve as a digital signal processor (DSP). In some implementations, the external system or external device comprises at least one of an FPGA, a memory storage, and can be communicatively coupled with a data hub, mobile phone, tablet device, computer, web interface, cloud-based infrastructure, electronic medical record, custom human- interface-system, or any other modality providing access, storage, and manipulation of the information and interaction model between the external system or external device and the IC(s) implanted in the human or animal body. The external system or external device can be used to calculate statistics or derived values based on the information from the IC(s) implanted in the human or animal body, and may be configured (e.g., wired, programmed, structured) to provide statistically derived or arbitrarily established warning thresholds that may be indicative of elevated risk of the patient experiencing an adverse event. The external system or external device can be configured (e.g., wired, programmed, structured) to upon the apparatus detecting a biomarker exceeding one or more thresholds or outside one or more ranges, cause an alert to be issued to the patient, to a healthcare provider, to healthcare infrastructure, or other selected individuals / entities. The external system or external device can be configured (e.g., wired, programmed, structured) to send the risk thresholds or risk ranges to the IC(s) of the apparatus, and the apparatus can transmit an emergency communication immediately upon detection of a biomarker level indicative of elevated risk to patient health.

[0037] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0038] In the drawings, identical reference numbers identify similar elements or acts. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements and angles are not drawn to scale, and some of these elements are arbitrarily enlarged and positioned to improve drawing legibility. Further, the particular shapes of the elements as drawn, are not intended to convey any information regarding the actual shape of the particular elements, and have been solely selected for ease of recognition in the drawings. FIG. 1A is a schematic diagram of an apparatus comprising a scaffolding with one or more integrated circuits, transducers and transmitters, implantable in a body lumen, the electronics mounted to (e.g., on a surface or embedded in) the scaffolding and facing outwardly from the scaffolding, according to at least one implementation.

[0039] FIG. 1B is a cross-sectional view of the apparatus of FIG. 1A, according to at least one implementation.

[0040] FIG. 10 is a cross-sectional view of the apparatus of FIG. 1A, according to at least another implementation.

[0041] FIG. 1D is a cross-sectional view of the apparatus of FIG. 1A, according to at least another implementation.

[0042] FIG. 2A is a schematic diagram of an apparatus comprising a scaffolding with one or more integrated circuits, transducers and transmitters, implantable in a body lumen, the electronics mounted to (e.g., on a surface or embedded in) the scaffolding and facing inwardly from the scaffolding, according to at least one implementation.

[0043] FIG. 2B is a cross-sectional view of the apparatus of FIG. 2A, according to at least one implementation.

[0044] FIG. 20 is a cross-sectional view of the apparatus of FIG. 2A, according to at least another implementation.

[0045] FIG. 2D is a cross-sectional view of the apparatus of FIG. 2A, according to at least another implementation.

[0046] FIG. 3A is a schematic diagram of an apparatus comprising a scaffolding with one or more integrated circuits, transducers and transmitters, implantable in a body lumen, the electronics mounted to (e.g., on a surface or embedded in) the scaffolding and including electronics to harvest power to power the other electronics, according to at least one implementation.

[0047] FIG. 3B is a cross-sectional view of the apparatus of FIG. 3A, according to at least one implementation.

[0048] FIG. 30 is a cross-sectional view of the apparatus of FIG. 3A, according to at least another implementation.

[0049] FIG. 3D is a schematic diagram of the apparatus of FIG. 3A, implanted in an artery of a heart in a body, according to at least one implementation.

[0050] FIG. 3E is a partial cross-sectional view of the artery of the heart of Figure 3D, showing the apparatus of FIG. 3A implanted therein, according to at least one implementation.

[0051] FIG. 3F is a schematic diagram of the apparatus of FIG. 3A, implanted in an artery of a heart in a body, according to at least another implementation. FIG. 3G is a partial cross-sectional view of the artery of the heart of Figure 3F, showing the apparatus of FIG. 3A implanted therein, according to at least another implementation.

[0052] FIG. 4A is a schematic diagram of the apparatus of patient or user holding an interface proximate a chest, positioned to at least one of supply power to and communications (e.g., a telemetry link) with the apparatus implanted in the artery of the heart, according to at least one implementation.

[0053] FIG. 4B is a schematic diagram of the interface of FIG. 4A illustrating a supplying of power to and communications with the apparatus implanted in the artery of the heart, according to at least one implementation.

[0054] FIG. 40 is a schematic diagram of a heart with the apparatus of any of the previous Figures implanted in an artery of the heart, according to at least another implementation.

[0055] FIG. 4D is a partial cross-sectional view of the artery of the heart of FIG. 40, showing the apparatus of any of the previous Figures implanted therein, according to at least one implementation.

[0056] FIG. 5A Is a cross-sectional view of a portion of an apparatus including a number of effectors operable to treat vulnerable plaques and in-stent restenosis, illustrating transducers interacting with anatomical structure, according to at least one implementation.

[0057] FIG. 5B Is a cross-sectional view of a portion of an apparatus including a number of effectors operable to treat vulnerable plaques and in-stent restenosis, illustrating transducers interacting with bodily fluid, according to at least another implementation.

[0058] FIG. 6. Is a flow diagram showing a method of operating a system including an apparatus to monitor, detect and report an operational condition of the apparatus, for instance due to structural damage, according to at least one implementation.

[0059] FIG. 7A is a schematic diagram of an external system or device, according to at least one implementation.

[0060] FIG. 7B is a schematic diagram of an external system or device, according to at least another implementation.

[0061] FIG. 8A is a flow diagram showing a method of operation of a system including an instrumented implantable apparatus to alert patients and, or clinicians based on data collected from the device, according to at least one implementation.

[0062] FIG. 8B is a graph showing a monitoring of a parameter versus a threshold, useful in performing the method illustrated in FIG. 8A, according to at least one implementation. FIG. 9A is a block diagram of electronic systems in nominal implementation of an instrumented implantable apparatus, according to at least one implementation.

[0063] FIG. 9B is a block diagram of an integrated circuit of the electronic systems of FIG. 9A, according to at least one implementation.

[0064] FIG. 90 is a block diagram of an interface for a transducer of the electronic systems of FIG. 9A, according to at least one implementation.

[0065] FIG. 9D is a block diagram of an interface for an ultrasonic transducer of the electronic systems of FIG. 9A to drive the transducer and receive responses detected by the transducer, according to at least one implementation.

[0066] FIG. 9E is a block diagram of a piezoelectric transducer of the electronic systems of FIG. 9A operable to harvest energy, and to optionally transmit outgoing signals and, or receive responses or returned energy or returned signals, according to at least one implementation.

[0067] FIG. 10. is a flow diagram showing a method of operating a system including an instrumented implantable apparatus, according to at least one implementation.

[0068] FIG. 11 A is a schematic diagram of an apparatus showing a scaffolding with struts replaced by integrated circuits and piezoelectric transducers, according to at least one implementation.

[0069] FIG. 11 B is a cross-sectional diagram of the apparatus of FIG. 11 A, according to at least one illustrated implementation.

[0070] FIG. 110 is a cross-sectional diagram of the apparatus of FIG. 11 A, according to at least another illustrated implementation.

[0071] FIG. 12 Is a flow chart showing a method of operation of a system including an instrumented implantable apparatus, according to at least one implementation.

[0072] FIG. 13A is a schematic diagram of a portion of an instrumented implantable apparatus that illustrates a mounting of and connectivity between an integrated circuit and a transducer carried by a scaffolding, according to at least one implementation.

[0073] FIG. 13B is a cross-sectional view of a portion of the instrumented implantable apparatus of FIG. 13A, according to at least one implementation.

[0074] FIG. 13C is a cross-sectional view of a portion of the instrumented implantable apparatus of FIG. 13A, according to at least one implementation.

[0075] FIG. 13D is a cross-sectional view of a portion of the instrumented implantable apparatus of FIG. 13A, according to at least one implementation.

[0076] FIG. 14A is a schematic diagram of a human individual with a plurality of instrumented implantable apparatus implanted in body lumens of the human individual, illustrating a subset of potential target implantation sites for the apparatus in the human body, according to at least one implementation. FIG. 14B is a schematic diagram of a plurality of instrumented implantable apparatus implanted in selected body lumens of the human individual, according to at least one implementation.

[0077] FIG. 15A is a cross-sectional view showing a portion of an instrumented implantable apparatus implanted in a body lumen, illustrating a transducer that transmits an outgoing signal and the same transducer receiving a return or response signal (e.g., a returned mechanical pulse or wave reflected from and passing through the tissue) with information characterizing a bodily tissue (e.g., anatomical structure, bodily fluid), according to at least one implementation.

[0078] FIG. 15B is a cross-sectional view showing a portion of an instrumented implantable apparatus implanted in a body lumen, illustrating a first transducer that transmits an outgoing signal and second transducer receiving a return or response signal (e.g., a returned mechanical pulse or wave reflected from and passing through the tissue) with information characterizing a bodily tissue (e.g., anatomical structure, bodily fluid), according to at least one implementation.

[0079] DETAILED DESCRIPTION

[0080] In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with processor-based systems, computers, processors, memory and other storage media; telecommunications equipment including wired and wireless communication equipment, firewalls, servers, wireless radios ( / .e., transmitters, receivers or transceivers); transducers and sensors, and artificial intelligence, machine-learning and / or artificial neural networks have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments.

[0081] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.”

[0082] Reference throughout this specification to “one implementation” or “an implementation” or to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the implementation or embodiment is included in at least one implementation or embodiment. Thus, the appearances of the phrases “in one implementation” or “in an implementation” or “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same implementation or embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more implementations or embodiments.

[0083] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and / or” unless the content clearly dictates otherwise.

[0084] As used in this specification and the appended claims, the term module means a set of hardware ( / .e., a set of circuitry) and, or, a set of processor-executable instructions or processor-executable logic stored in nontransitory processor-readable media (also known as computer-readable media) as software and / or firmware or as embodied in a set of circuits (Application Specific Integrated Circuit, programmed Field Programmable Gate Array), and can include or be implemented in artificial intelligence systems, machine-learning systems, machine-learning models, and, or, trained artificial neural networks (e.g., autoencoders, variational autoencoders).

[0085] As used herein and in the claims, the term tissue and various thereof (e.g., tissues) mean bodily tissue including anatomical bodily tissue (e.g., vasculature, organs, muscle, tendon, ligament, bone, skin, cartilage) and bodily fluids (e.g., blood) unless expressly limited to one or the other type of bodily tissues.

[0086] The headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0087] The apparatus described in this disclosure is comprised of a metallic, polymeric, resorbable, or hybrid scaffolding that is expandable into a body lumen, such that when expanded it is braced against an inner wall of a body lumen. The scaffolding is comprised of at least a plurality of struts and includes at least a tubular portion, such that a fluidly communicative passageway through the scaffolding is formed when the scaffolding is expanded within a body lumen and braced against the inside wall of the body lumen. The scaffolding may be comprised in part or entirely of, for example, a bare metal stent, drug eluting stent, peripheral bare metal stent, bioresorbable stent, inferior vena cava filter, or flow diverter, though other common endoluminal structures may comprise the majority of or all of the scaffolding. The scaffolding may be braced in one of a coronary vasculature, a cerebral vasculature, a pulmonary vasculature or a peripheral vasculature, any great vessel, a carotid artery, a popliteal artery, a femoral artery, a posterior tibial artery or a renal artery, a gastrointestinal tract, an esophagus, a colon or a rectum, a biliary duct or a pancreas, a urethra or a ureter or any body lumen inside the human or animal body. The scaffolding is physically coupled to at least one transducer, such that the transducer is mechanically coupled to a tissue of the body, or a fluid of the body adjacent to the mechanical scaffolding. In some implementations the transducer is an acoustic transducer, piezoelectric micromachined ultrasound transducer (PMLIT), piezoelectric material, cavity pressure sensor, capacitively micromachined ultrasound transducer (CMLIT), or the like. In further implementations, at least two of the at least one transducer are electrodes, comprised of at least one of gold, silver / silver chloride, tantalum, titanium nitride, iridium oxide, platinum, glassy carbon, PEDOT:PSS, or other metallics, alloys, dielectrics, or conductive polymers. In some implementations, the electrodes may be used to measure a biological voltage differential across the length of the body lumen traversed by the scaffolding. In some implementations, the at least one electrode may be used to deliver a therapeutic electrical current to the tissue. In some implementations the at least one electrode is used to characterize the impedance of at least one of the body lumen, the tissue adjacent to the scaffolding at at least one frequency. The at least one transducer may be positioned on any combination of the adluminal, abluminal, or side aspect of the scaffolding.

[0088] In some implementations, the one or more transducers are at least one of an LED, VCSEL, photodiode, single-photon-avalanche diode (SPAD), or other electro- optical transducer. The one or more integrated circuits physically coupled to the scaffolding is further comprised of a driver to energize an optical emission (e.g. lightemitting diode). In further implementations, the at least one interface is communicatively coupled to one or more of these electro-optical transducers. These elements may be operable in the visible, infrared or ultraviolet range. They may be used to evaluate vascular health (for example, monitoring of atheromatous plaques with near infrared spectroscopy), or radiate light into the vessel wall ( / .e. photobiomodulation). Optical transducers may line the abluminal and adluminal aspects of the scaffolding, depending on if the implementation is designed to treat ISR (adluminal) or existing plaques (abluminal).

[0089] The scaffolding is also physically coupled to at least one integrated circuit (IC) chip, that is communicatively coupled to the at least one transducer. In some implementations, the IC is structurally thinned to the point of mechanical flexibility. The IC is operable to at least one of process, store, or transmit the information about a tissue of the body. In some implementations, this information includes information about the patency of the body lumen. The at least one IC may be positioned on the adluminal or abluminal aspect of the scaffolding.

[0090] FIG. 1A shows an example implementation of the apparatus in which the IC (102) is on the abluminal aspect of the scaffolding (101). The abluminal aspect (109) is the surface facing the inner wall of the body lumen when the scaffolding is implanted, the adluminal surface (110) forms a fluidly communicative passageway (112) when the scaffolding is expanded, and ICs, transducers, transmitters, and other components may also be attached to the side surface (111) in some implementations. The transducers in this implementation are physically coupled to the ICs, but they may optionally be physically coupled to the scaffolding directly, or to any other component that is physically coupled to the scaffolding. The transducers illustrated in this implementation are: a pair of electrodes (105), acoustic transducers (106), a photodetector (107), and a lightemitting diode (108). The electrode present in this implementation is electrically coupled to an anatomical structure or bodily fluid, which is itself coupled to electrically-active tissues of the human body or animal body, and is operable to sense an electrophysiological, electrocardiogram, electroencephalogram, or an electromyogram signal.

[0091] The IC is communicatively coupled to at least one transmitter, which is physically coupled to the scaffolding. The at least one transmitter is operable to transmit information from the apparatus when it is implanted in the body lumen of the body. In some implementations, the transmitter is a part of the integrated circuit. In some implementations, an acoustic transducer, electromagnetic radiator, strut of the scaffolding, coil, antenna, or antenna system are communicatively coupled to the at least one transmitter. Consequently, the transmitter may transmit information about the tissue or the apparatus in the form of electromagnetic or mechanical pulses or waves.

[0092] In some implementations, the IC may be communicatively coupled, via the transmitter, to an external system, outside of the body. In some implementations, the IC may be communicatively coupled, via the transmitter, to another device implanted within the body, but external to the apparatus. The communication link between the apparatus and the external system may occur over an instrumentation scientific medical (ISM) band, 13.56 MHz, 433 MHz, 866 MHz, 915 MHz, medical instrumentation communication service band, 402-405MHz, an IEEE communication standard band, an IEEE 802.15.1 protocol, an IEEE 802.15.4 protocol, or an IEEE 802.11 protocol, ultrawideband link, or any communication protocol or adhering to any standard. In some implementations, the integrated circuit is further comprised of a cryptographic element, which makes the integrated circuit operable to further process the data by at least one of encrypting, encoding, processing, decrypting, decoding, hashing, obfuscating, or otherwise generating derived information or metadata to be sent. The transmitter may transmit data, metadata, or a value derived from data collected from the at least one transducer, information about a state of the apparatus or software running on the at least one integrated circuit, or a notification, by the transmitter of the apparatus to an external device at such time that an amount of collected data, a value derived from the data or an integrity of the apparatus takes certain defined values, or at a defined time or defined set of times that is specified by a manufacturer, a clinician, a patient, or a third party. In some implementations, the transmitter may be operable to respond to at least one of: receipt of a query from the external system; or a wireless technology activated by an electronic medical record software.

[0093] In some implementations, the IC is further communicatively coupled to at least one of a conductive coil, inductor, antenna, electromagnetic receiver, or at least one strut of the scaffolding, operable to receive energy from an external system or device in the form of electromagnetic radiation incident on the apparatus. In a further implementation, the scaffolding is physically coupled to at least one piezoelectric transducer, which converts a time-changing pressure into electrical charge based on the piezoelectric effect, so that the apparatus may receive power in the form of mechanical, ultrasonic or acoustic energy from an external system or device. This allows the implant to be energized by ultrasonic signal originating from outside of the apparatus. The transducers may be affixed to the scaffolding, patterned into the scaffolding, and electrically coupled to the IC via a polymeric interconnect board designed to route conductors from one or more integrated circuits to the one or more piezoelectric element(s). The at least one piezoelectric transducer can be used to harvest energy from the motion of organs or tissues while implanted in the body lumen. The at least one piezoelectric transducer element may generate a charge in response to a stimulus applied to the at least one transducer, from a body or fluid movement, including at least one of articular motion, pulsatile motion, or skeletal motion. In implementations receiving power from an external device or system, at least one of the ICs is further comprised of a power receiver, power recoverer, or power converter, operable to supply power to the IC and other components. Any of the power receiver, power recoverer, or power converter may also be a transmitter or receiver of information about the tissue of the body or about the apparatus using its respective modality: electromagnetic or mechanical.

[0094] The transmitter in the implementation shown in FIG. 1A is on the IC (104), and makes contact with the scaffolding (101), which functions as an antenna, and improves the effectiveness of the transmitter in transmitting information about the tissue or apparatus to the external device in the form of an electromagnetic signal. Moreover, in this implementation, (104) also functions as a receiver of information from the external device, the scaffolding (101) functioning as an antenna to improve the effectiveness of the receiver. Receiving, by the receiver, can be used to upload now alert criteria, software updates, firmware, or effector commands to the apparatus. It can also be used to enter modes in which data are collected and transmitted in real-time. FIG. 1B shows a cross-sectional view of a strut of the scaffolding of FIG. 1A. In this implementation, the IC (102) is on the abluminal aspect of the scaffolding (101), which is a bare metal stent. FIG. 1C shows the corresponding cross-section of an alternative implementation, in which the scaffolding as a drug-eluting stent. In this implementation, the IC (102) and the scaffolding (101) are surrounded by a resorbable material (103), which releases a drug such as sirolimus, everolimus, zotarolimus, or paclitaxel into the anatomical structure adjacent to the scaffolding, typically an artery. The exterior position of the resorbable material in this implementation facilitates elution of drug into the tissue. Other implementations may comprise hybrid scaffoldings with resorbable and non-resorbable parts wherein the resorbable parts are load-bearing struts of the scaffolding. FIG. 1D shows a cross-section of an alternative implementation wherein the scaffolding (101) fully surrounds the IC (102) in the plane of the section. Such a construction is achievable through, for example, sputter coating of scaffolding material onto the IC or 3-D printing techniques familiar to those skilled in the art, allowing for the integrated circuit to be encased in metallic or polymeric packaging. In some implementations the IC (102) comprises a relatively thin portion to allow for a region of enhanced mechanical flexibility.

[0095] In some implementations, the one or more transducer elements are electrochemical transducers that measure the concentration of circulating proteins and / or biomolecules in the fluid communicative passage that may be biomarkers for pathological conditions, or whose levels may be of clinical interest. These electrochemical transducers may be comprised of a metallic structure, such as gold, platinum, or carbon-based substrate, with conjugated aptamers bonded to the surface, either directly or through a linkage molecule. The electrochemical transducer is communicatively coupled to the integrated circuit, which is further comprised of a potentiostat, such that a signal can be generated from the interface through cyclic voltametric sweeps, those cyclic voltammetry sweeps ultimately containing information about the tissue or fluid in the body. The bound aptamers to the surface of the electrochemical transducer may be sensitive to at least one of cTnl, cTnT, CK-MB, myoglobin and glucose, serotonin, cytokines, inflammatory biomarkers, cortisol, or any other biomarker of clinical interest. The optical signal received by electro-optical transducers may also be used to infer concentrations of one or more compounds within the body through spectroscopy.

[0096] In some implementations, the at least one transducer is at least one a cavity pressure sensor, capacitive pressure sensor, MEMS pressure sensor, or the like. The pressure sensor is commonly comprised of two metallic thin films separated by a compressible dielectric or a compressible cavity. Environmental pressure modulates the capacitance of this sensor in a reproducible fashion. The pressure sensor is communicatively coupled to the integrated circuit, which receives a signal from the interface containing information about the localized pressure adjacent to the pressure sensor. In some implementations the IC will autonomously take periodic measurements from the at least one pressure sensor adjacent to the scaffolding. In some implementations, the measurement is taken on-demand by receiving a command from the system outside of the body communicatively coupled to the integrated circuit. This information can be aggregated and stored on a memory at least one of inside the integrated circuit or in a second integrated circuit, and transmitted by the transmitter to the external system outside of the body. In some implementations, at least one of the at least one pressure sensor is comprised of a piezoelectric transducer.

[0097] In some implementations, the at least one transducer is further comprised of pressure sensors at the distal and proximal ends of the scaffolding (or distal and proximal to an occlusion of interest) when expanded within the body lumen. The signal received from the interface to these transducers contains information that can be used to estimate physiological parameters, for example, the value of the hydrodynamic pressure drop between the two ends of the scaffolding, and, consequently, an inferred functional patency of the body lumen. In some implementations, the apparatus is implanted in an artery and is operable to receive such information from the proximal and distal transducers, while a pharmacologic agent which induces hyperemia, for example adenosine, is administered. The ratio of the pressures at the ends of the scaffolding represent FFR across the segment of the artery traversed by the scaffolding. It may be advantageous for the clinician to have access to real-time information while measuring FFR or other parameters. Some implementations include a function in IC state space, firmware, or software that allows an operator to enter an “FFR mode” in which information is transmitted in real time, with low latency (e.g. less than 60 seconds), from the apparatus to an external device, and displayed to the operator. Such a mode may have utility in other clinical scenarios, such as apparatus implantation, deployment, or expansion, in routine postoperative care, or in yet other scenarios.

[0098] In some implementations, the proximal and distal information received from the at least two pressure transducers is synchronized to a mechanical or electrical activity of the body, such that the signal from the transducer interface is received at the appropriate phase of diastole, the resulting information may be used to calculate the iFR. In some implementations, the at least one transducer is further comprised of an electrode to sense an electrophysiological, electrocardiogram, electroencephalogram, or an electromyogram signal. In some implementations, the at least one of electrocardiogram, electroencephalogram or electromyogram recorded by the electrode transducers is used to synchronize the cardiac cycle to diastole. The phase of the cardiac cycle can also be inferred from the acoustic imaging data, or data collected by other transducers about the mechanical or electrical activity of the body.

[0099] Other physiological metrics can be calculated from proximal and distal pressure sensors (with or without the use of signal from at least an interface, like the electrocardiography from the at least one electrode, described here), and this description should not be interpreted as a comprehensive list, or limit or restrict the scope of physiological parameters inferred from received transducer signals. In some implementations, the derivation, calculation, processing, or evaluation of the physiological metric is performed by the IC, which is further operable to at least one store the information, or transmit this information via the at least one transmitter. In other implementations, the transmitter transmits raw information received by the integrated circuit from the transducer interfaces, and an external system outside of the body performs the derivation, calculation, processing, or evaluation of the physiological metric. The received electrical or mechanical information from the body may be periodic or aperiodic. An example of an aperiodic signal to which synchronization may be advantageous is the activity of skeletal muscle in an implementation wherein the apparatus consists of a peripheral stent deployed in the artery of a leg: in such an implementation, collection of data, such as acoustic imaging data, at times when the body is not moving may be advantageous, and such times when the body is not moving may be identified by the use of electromyography or information gathered by other transducers.

[0100] FIG. 2A shows an example implementation of the apparatus in which the IC (202) is on the adluminal aspect of the scaffolding (201). The transducers illustrated in this implementation are: a pair of pressure sensors (204), and a pair of electrodes (205), acoustic transducers (206), a photodetector (207), a light-emitting diode (208), a set of electrochemical transducers (209). The pressure sensors are located near the ends of the scaffolding to better measure hydrodynamic pressure drop across the length of the body lumen traversed by the scaffolding. The transmitter is within the IC (202).

[0101] FIG. 2B shows a cross-sectional view of a strut of the scaffolding of FIG. 2A. In this implementation, the IC (202) is on the abluminal aspect of the scaffolding (201), which is a bare metal stent. FIG. 2C shows the corresponding cross-section of an alternative implementation, in which the scaffolding as a drug-eluting stent. In this implementation, the IC (202) and the scaffolding (201) are surrounded by a resorbable material (203), which releases a drug such as sirolimus, everolimus, zotarolimus, or paclitaxel into the anatomical structure adjacent to the scaffolding, typically an artery. FIG. 2D shows a cross-section of an alternative implementation wherein there are ICs (202) on both the adluminal and abluminal aspects of the scaffolding (201). Additionally, ICs may be physically coupled to the side aspects of the scaffolding, which may be especially advantageous in implementations utilizing interference fits. ICs, transducers, transmitters, receivers, drivers and interfaces may be physically coupled to any combination of adluminal, abluminal and side aspects of the scaffolding.

[0102] In some implementations, the at least one transducer element is an acoustic transducer and is incorporated into one or more struts in the scaffolding, taking advantage of the acoustic conductivity of the scaffolding to transmit vibratory energy throughout the structure for evenly-distributed sonotherapy. It may also be advantageous for the flexural strain on the scaffolding to actuate one or more piezoelectric transducers, which may, in turn, harvest power for the apparatus. In some implementations, piezoelectric transducers are incorporated into one or more struts of the scaffolding, and are subject to loading forces from the articular motion of the body lumen.

[0103] FIG. 3A shows an implementation of the apparatus in which piezoelectric transducers (306) are incorporated into several of the struts in the scaffolding (301) and comprise loadbearing components of the scaffolding. ICs (302) are electrically coupled to the piezoelectric transducers. FIG. 3B shows a cross-sectional view of a stent strut in this implementation, comprising a layered structure in which metallic conductive materials (301) are separated by a dielectric material (303), which allow for power and data to be shared among the electronic elements through a two-terminal system. FIG. 3C shows a cross-sectional view of a piezoelectric transducer (306) incorporated into the strut of the scaffolding. It may be advantageous to reinforce the tensile strength of such struts into which piezoelectric transducers are incorporated. In this implementation, a spring (305) runs through a hole (304) in the transducer. This allows for some degree of elastic deformation in the piezoelectric component while also limiting mobility to prevent breakage and plastic deformation

[0104] FIGS. 3D though 3G show how power from the flexural motion of the scaffolding within the body lumen may be harvested by the piezoelectric elements that are integrated into the struts of the scaffolding. FIG. 3D represents the heart at end-diastole. 307 is the left anterior descending (LAD) artery. FIG. 3E is a detail view of FIG. 3D showing an exposed section (308) the LAD (307) with a stent (309) implanted therein.

[0105] 309 demonstrates the position of the stent at end-diastole. Dotted outline 310 represents the position of the stent at end-systole. The difference between the positions of 309 and

[0106] 310 demonstrates the flexural motion of the stent within the artery during a normal cardiac cycle. Piezoelectric elements integrated into the stent scaffolding can transduce this time-varying mechanical strain into electrical power for use by the apparatus. Correspondingly, FIG. 3F represents the heart at end-systole. The structure labeled 307 is the LAD. FIG. 3G is a detail view of FIG. 3F showing an exposed section (308) the LAD (307) with the stent (311) implanted therein. 311 demonstrates the position of the stent at end-systole. Dotted outline 312 represents the position of the stent at enddiastole. The difference between the positions of 311 and 312, equal in magnitude to that between 309 and 310, demonstrates the flexural motion of the stent within the artery during a normal cardiac cycle.

[0107] The IC is communicatively coupled with an external system or device, which may either be external to the body of the human or animal in which the apparatus is implanted, or external to the apparatus but implanted within the same body. The external system or device may provide at least one of: wireless power to the integrated circuit through at least one of an radiofrequency (RF), nearfield, midfield, capacitive, or inductive link, communication with the integrated circuit over at least one of an electromagnetic radiator or electromagnetic receiver, antenna, coil, or the like, or a means of communicating with the integrated circuit encoded by modulation of the powering downlink, or a means of communicating with the integrated circuit over a discrete frequency band (including ultra-wideband implementations). In some implementations, the communication with the integrated circuit may further control the integrated circuit with a command / response interface, either over the same frequency band or over multiple bands, and / or the ability to request information from memory. This information may come from the one or more transducers taken on demand or previous information autonomously captured by the integrated circuit over one or more time points.

[0108] The external system may further be comprised of a processing unit that can at least one execute command instructions or serve as a digital signal processing unit. In some implementations the external system is further comprised of at least one of an FPGA, memory storage element, and can be communicatively coupled with a data hub, smart cellular phone, tablet device, personal computer, web interface, cloud-connected device, cloud-based infrastructure, switch, router, a server hosting an electronic medical record system, an electronic medical record, custom human-interface-system, or any other modality providing access, storage, and manipulation of the information and interaction model between the external system and the integrated circuit implanted in the human or animal body. The external system may is operable to display at least one of structural or functional information about the body tissue, raw data, a ratio of flow rates of fluid through the body lumen, a difference of flow rates of fluid within the body lumen or a difference of pressures of fluid within the body lumen, a graphical presentation in which a relative position of each fluid flow rate datum from within the body lumen or fluid pressure datum from within the body lumen on a screen or printed page corresponds its respective relative position within the human body or the animal body from which the flow rates or pressures are assessed, a duplex ultrasonography image in which flow rate data are additionally superimposed on structural ultrasound imaging data assessed from the human body or the animal body, or an inferred fraction or percentage of stenosis of the body lumen.

[0109] In some implementations, the external system may be used to calculate statistics or derived values based on the information from the integrated circuit implanted in the human or animal body, and may be configured to provide statistically derived or arbitrarily established warning thresholds that may be indicative of elevated risk of the patient experiencing an adverse event. The external system may be configured in such a way that upon implant detecting a biomarker exceeding one or more thresholds an alert is issued to the patient, to a healthcare provider, to healthcare infrastructure, or other selected individuals / entities. The external system may be configured such that it can send the risk thresholds to the implant, and the implant can provide an emergency alert communication immediately upon detection of a biomarker level indicative of elevated risk to patient health.

[0110] FIGS. 4A through 4D illustrate an example of the wireless exchange of energy and information between the apparatus implanted within the body and an external system or device, external to the body. FIG. 4A shows a patient holding the external device (401) to his chest. FIG. 4B is an expanded view of the external device (401). Arrows schematically illustrate the bidirectional exchange of information (402) and the transmission of power (403) by the external device to the apparatus deployed within the LAD of the patient. FIG. 4C is an exposed view of the heart of the patient. The LAD (404) of the heart is shown. FIG. 4D shows an exposed section (405) of the LAD (404) with the apparatus (406) comprised of a stent implanted within the lumen of the LAD, the apparatus receiving power and exchanging information with the external apparatus illustrated in FIG. 4B.

[0111] In some implementations, the at least one acoustic transducer may also be driven to agitate the tissue adjacent to the scaffolding, providing heat or ultrasonic treatment (sonotherapy) to at least one of disrupt or prevent in-stent restenosis (ISR), neointimal hyperplasia, neoatherosclerosis, stent thrombosis, atherosclerosis, restenosis, by disrupting fibrin and other structural formation and modify vulnerable plaques. In some implementations, the at least one acoustic transducer is a piezoelectric transducer that can receive power, communicate with an external system or device, and perform acoustic imaging to assess the buildup of material on the scaffolding, the mechanical integrity of the prosthesis, and / or characteristics of the fluid flowing through the body lumen. In some implementations, piezoelectric transducers may line the abluminal aspect of the scaffolding, the adluminal aspect of the scaffolding, or both, depending on whether the goal is evaluation / treatment of ISR (inside) or existing plaques (outside).

[0112] FIGS. 5A and 5B are cross-sectional views of implementations of the apparatus in which effectors act on the tissue of the artery into which the apparatus is deployed. FIG. 5A shows the action of the effectors on native atheromatous plaque. In the implementation of the apparatus shown in this figure, energy, represented by the arrows (501), is radiated from transducers placed on the struts of the scaffolding (502) into an atheromatous plaque (503) in the wall (505) of the vessel into which the scaffolding (504) is implanted. This energy may be in the form of ultrasound, electromagnetic waves of any frequency (including, but not limited to: infrared, visible and radiofrequency), heat from a resistive element, etc., or any combination of these, and it is generated by one or more transducers physically coupled to the scaffolding. Energy is used to treat and stabilize the plaque in situ. Positioning of transducers on the struts of the scaffolding for such an implementation can be seen in FIG. 1A. FIG. 5B shows the action of the effectors on restenotic tissue. In the implementation of the apparatus shown in this figure, energy, represented by the arrows (506), is radiated from transducers placed on the struts of the scaffolding (502) into neointimal or neoatherosclerotic restenotic tissue (507) in the vessel (505) into which the scaffolding (504) is implanted. This energy may be in the form of ultrasound, electromagnetic waves of any frequency (including, but not limited to: infrared, visible and radiofrequency), heat from a resistive element, etc., or any combination of these, and it is generated by one or more transducers physically coupled to the scaffolding. Energy is used to at least one of prevent, or disrupt, neointimal hyperplasia, neoatherosclerosis and thrombus formation. Positioning of transducers on the struts of the scaffolding for such an implementation can be seen in FIG. 1B. Some implementations may contain both of the effector aimed inward toward the fluidly communicative passageway and the effectors aimed outward toward the surrounding tissue.

[0113] In some implementations, a mechanical or electrical or electromagnetic perturbation is generated by the at least one transducer, and the response of the scaffolding, the tissue, or the scaffolding-tissue interface to the perturbation is used to characterize the scaffolding or tissue. For example, in one implementation, an acoustic transducer is mechanically coupled to the scaffolding such that driving the acoustic transducer, by the IC, causes the scaffolding to vibrate at the driven frequency (and harmonics). The mechanical response of the scaffolding to vibration at the frequency driven carries information about the scaffolding and the tissue, which is received by the same or a different acoustic transducer, and is transmitted to the IC via an interface. The IC may repeatedly drive the transducer at different frequencies to assess a broad frequency response of the scaffolding. Tracking this response across an arbitrary time course may be used for assessing biological growth on the scaffolding, detecting thrombosis, assessing the mechanical integrity of the scaffolding, confirming apposition of the scaffolding to the inner wall of the lumen, estimating expansion of the scaffolding within the lumen, or otherwise assessing the scaffolding and its surroundings.

[0114] In some implementations, at least one of the transducers may function as a contact sensor, confirming apposition with the inner wall of the body lumen during deployment. For example, pulse-echo latency in an acoustic transducer, pressure in a pressure sensor, impedance in an electrode, or a change in a mechanical or electrical or electromagnetic response of the scaffolding-tissue interface to a mechanical or electrical or electromagnetic perturbation generated by a transducer may be used to characterize the apposition of the scaffolding with the inner wall of the body lumen. In some implementations, at least one of the transducers may function as a configuration sensor, allowing for assessment of full expansion of the scaffolding within the body lumen during deployment. For example, pulse-echo latency in an acoustic transducer, a change in the output properties of a transducer placed at an articulation point in the scaffolding (such as transducer 205 in FIG. 2A) which is subject to strain during the expansion of the scaffolding, or a change in a mechanical or electrical or electromagnetic response of the scaffolding to a mechanical or electrical or electromagnetic perturbation generated by a transducer may be used to estimate the degree of expansion of the scaffolding within the lumen.

[0115] In some implementations, the IC processes the information about the body received from the one or more transducer through the use of at least one algorithm, which is communicatively coupled to at least one signal received from the at least one transducer. This algorithm may include an artificial neural network, a support vector machine, a linear discriminant classifier, a relevance vector machine, a lookup table, a statistical inference algorithm, an image reconstruction algorithm, a feature extraction algorithm, or other algebraic numerical operations on the information familiar to those skilled in the art. In some implementations, the algorithm may perform at least one of processing, aligning, reconstructing, storing, or loading information that the implant has in its memory or has received. The algorithm may be implemented in a state-machine, hardware unit, firmware, or software, and in some implementations the integrated circuit is operable to update the algorithm, from a data received from the external system, while it is implanted in the lumen of the body. The result of this processing by the at least one integrated circuit may be transmitted, via the at least one transmitter, to the external system. The at least one integrated circuit may also use the output of the at least one algorithm to generate an alert to the external system of deviations from prior received information, through deviation from a moving average, exceeding of a statistically derived threshold, exceeding of a user-defined value, or any other means of event detection. The IC can transmit a warning, alert or state-specific information if the measured or derived information about the body exceeds the threshold. The IC is also operable to transmit an error or warning indication upon detecting an occurrence of an error, warning, or alert-state condition within software, hardware, or in hard-programmed state space logic during operation. The integrated circuit is operable to alert, via the transmitter, the external system of the occurrence of myocardial infarction, stroke, stent thrombosis, arterial dissection, fall and the like.

[0116] FIG. 6 is a flowchart showing one implementation of the method for detection of stent breakage. A response of the scaffolding to mechanical perturbation (here, an impulse) introduced into the scaffolding by a mechanical transducer is measured by the same or a different mechanical transducer, and the data are collected by the IC via a transducer interface. The measured signal is shown (601), with the impulse (602), the response of the scaffolding when the scaffolding is intact (603) and the response of the scaffolding when the scaffolding is damaged (604). The measured data may optionally undergo a nonlinear transformation, such as processing by a deep neural network, projection onto nonlinear basis functions, or another nonlinear transformation familiar to those in the art (605). The results are then processed by a classifier (606) which separates the responses associated with stent damage from those associated with stent integrity according to a hyperplane (607) of one or more dimensions. If a break is detected (608), then at least one of the clinician, the patient, or a third-party is alerted according to the settings of the device and any modifications to the effector regime are initiated (609). These may include shutting down functions which may be harmful to the patient if performed by a malfunctioning apparatus, such as ultrasonic agitation, or any other preset action determined by the clinician. If no break is detected, then the integrity of the stent will re-interrogated after some preset or variable time. In another implementation wherein the response to an at least one mechanical, or electrical, or electromagnetic perturbation is used to detect the presence or absence of stent thrombosis, an acoustic transducer effector is activated to mitigate the harms of stent thrombosis by applying lytic acoustic energy to the thrombus.

[0117] FIGS. 7A and 7B show alternative implementations of the external device with which the apparatus exchanges information and from which it may, in some implementations, receive energy. The external device may be integrated into a wearable accessory, such as a watch, or a piece of furniture or upholstery to which the patient may be in close proximity on a regular or recurring basis. FIG. 7A illustrates one implementation of the external device in which the external device is incorporated into a bedsheet or blanket (701). An antenna (702) is integrated into the fabric. Electronic components (703) are connected to the antenna. For convenience, the external device may also be affixed to or integrated into an object with which the patient frequently interacts. FIG. 7B illustrates an external device incorporated into a cellular phone case (704). Electronics and an antenna are indicated by 705. In other implementations, the external device may be incorporated into any of: a keychain, a purse, a rucksack, an article of clothing, a blanket, a duvet cover, a mattress, a mattress cover, a pillow, a pillowcase, a chair, an upholstery cover, a piece of furniture, or a furniture-covering. A cellular phone, a tablet device, a personal computer, a data hub, a cloud connected device, a switch or a router may be programmed to interact with the apparatus in some implementations.

[0118] FIG. 8A is a flowchart showing an implementation that autonomously tracks a biomarker, physiological parameter, or statistically derived metric, such as a weighted moving average, over time, and notifies a patient, clinician, or third party when a detected or derived value exceeds an alert threshold. These data are optionally stored to track values over time. An initial measured or derived value and an initial bounding threshold are established (801). The at least one integrated circuit waits for a specified period of time (802), during which energy is harvested from the human or animal body to provide sufficient power to take the measurement from the at least one transducer. When the implant wakes up, new samples are taken and statistically derived parameters are updated with new values (803). The values are compared against a fixed threshold, range, or a statistically derived threshold, or range, such as a multiple of an adaptive noise floor (804). If the value exceeds the thresholds, an alert condition is raised to the external system, ultimately alerting a patient or physician (805). In some implementations, the integrated circuit drives one of the transducers to effect an intervention in the tissue at least adjacent to the at least one transducer. After the alerts are issued the implant goes back to its low-power state to harvest power (802). If the recorded datum is within the normal range at 804, the implant goes back to its low-power state (802). FIG. 8B shows a time series representation of the information and the relevant statistically derived thresholds (806). The data trace (807), is displayed with its calculated mean (808) and a normal range (809). When a datum (810) exceeds the threshold range (809) an error condition, alert, or warning is delivered to the external system or device.

[0119] In some implementations, the IC is further comprised of a driver for the at least one piezoelectric transducers, creating a mechanical wave or pulse from the transducer directed into at least one anatomical structure or bodily fluid adjacent to the scaffolding when the integrated circuit is energized to drive the at least one transducer. In some implementations this mechanical wave or pulse is an acoustic or ultrasonic wave or pulse, and interacts with tissue near the scaffolding, and with the scaffolding itself, and returns pulse-echo responses at regions of mechanical impedance mismatch, conveying information about structural changes in the tissue or fluid of the body as the wave propagates through the tissue. The one or more transducers convert the returned mechanical pulse or wave into an electrical signal, and this information is communicated to and, processed, digitized, and stored by the IC via an interface. This information may be used to procedurally construct an image of the structure or a graphical representation of the function of the at least one tissue of the human body or the animal body from the converted signal according to A mode, B mode, M mode, Doppler, or duplex ultrasonography, compressive sensing, harmonic imaging, echocardiography, or another imaging procedure familiar to those skilled in the art. This information may provide characterization of the scaffolding itself, including the structural integrity, functional integrity, mechanical continuity, and configuration (such as the degree of expansion) of the scaffolding, or the interaction between the scaffolding and the inner wall of the body lumen of the body against which the scaffolding is braced. This information may be used to infer a structural or functional patency of the vessel lumen. This information may serve as a means of calculating fluid flow with the Doppler effect. This information may be enriched with respect to statistical noise through the use of mathematical techniques familiar to those skilled in the art. In some implementations, a numerical transformation is computed by at least one of the integrated circuit or the external system, based on the pulse-echo-response information from the tissue adjacent to the scaffolding to account for a distortion to the received signal resulting from the at least one tissue that could affect the representational accuracy of the information. This numerical transform may be subsequently applied by at least one of the integrated circuit, or the external system, to compensate for the distortion.

[0120] The scaffolding is physically coupled to at least one integrated circuit (IC) chip. FIG. 9A is a block diagram for the electronic systems for the preferred implementations. The IC (901) is communicatively coupled to at least one transducer (902 and 903), and is further communicatively coupled to at least one transmitter (904). In some implementations, an electromagnetic receiver, antenna, coil, inductor, or conductive component of the scaffolding for receiving wireless power from an external system (905) is further communicatively coupled to the at least one integrated circuit. FIG. 9B denotes a block diagram for the IC (901). Energy transmitted by the external system to the implanted apparatus is received by least one of an electromagnetic radiator or electromagnetic receiver, antenna, coil, inductor, conductive component of the scaffolding, mechanical transducer, or other transducer, that is electrically coupled to the integrated circuit and converted into a useable supply voltage by a power recoverer circuit (906), allowing for energizing of the integrated circuit (901). In some implementations, the modulation of this delivered power signal may comprise the transmission of data from the external system to the implant. In some implementations, the energy recovered by the power recoverer (906) generates one or more DC supply voltages, from which one or more of biases or references (912) are developed by means of one or more circuit familiar to those skilled in the art. The IC is further comprised of at least one interface (911) to the one or more transducers (902, 903). The interface uses the biases and references to condition the signals received from the one or more transducers (902, 903). In this implementation, the specifications of the interfaces (911) vary according to the type of transducer with which they are paired, however all interact with the control system (908) that is responsible for properly tuning the transducer interfaces, implementing software algorithms, scheduling events, ensuring stable voltage sources and references, handling commands from the external system, and packaging data to transmit via the transmitter via the transmitter controller (910). In some implementations, the at least one transmitter controller (910) is comprised of a tx / rx switch, making the IC operable to both transmit information to and receive information from the external system or device. In such implementations wherein the IC is operable to both transmit and receive information, the IC implements a transmitter driver for data transmit and a baseband amplifier for data reception. The transmitter controller is further comprised of an oscillator frequency source (913), which generates the RF carrier frequency that is modulated for wireless communication. In some implementations, this is the MICS band, 402-405 MHz, though other electromagnetic wave frequencies may also be used. The control system is operable to directly send, via the at least one transmitter controller (910), information about the body contained within the signal from the at least one transducer (902, 903) in real time to the external system or device, and to send information stored in a memory (909), to the external system or device. The control system is operable to drive the at least one transducer (902, 903), via the interface (911), which, in this implementation, also functions as a driver, to deliver an effector function at the command of the external system or device, or should a condition requiring effector activation otherwise be reached. The control system (908) may be operable to implement a software algorithm, classifier, statistical inference algorithm, or the like. The control system (908) further monitors and compares information received from the transducers (902, 903) against a statistically derived threshold or predefined constant threshold. When the external system is removed, the control system (908) places the integrated circuit (901) into an ultra-low-power state, and the ultra-low-power timer circuit (907) is activated to count a discrete periodic interval during which power is harvested by the at least one transducers (902, 903). When the timer (907) reaches a predefined value, the control system (908) checks to ensure the power supplies, and references and biases (912) are stable. If these systems are not stabilized the controller puts the integrated circuit (901) back into its low-power state mode, for a shorter time period, and this process repeats until the power supplies are stable. Then the control system (908) takes a series of measurements about the tissue through the reception of signals from the at least one transducer, via the at least one interface (911), and stores this information in the memory (909). The control system (908) transmits this information to the external system the next time that the external system is brought in communicative contact with the apparatus.

[0121] FIG. 9C denotes the interface (914) for receiving a signal from a transducer (915) that converts a mechanical, electrochemical, or electrical energy into a signal, such as from an electrode transducer or a capacitive pressure transducer. The interface is comprised of a low noise amplifier (916) with a feedback circuit (917), which may be comprised of at least one passive circuit element, active circuit element, or switch. The low noise amplifier may be operable to amplify a voltage signal in a way the minimally contributes electronic noise to the output, or converts a current signal into a voltage signal in a way that minimally contributes to the electrical noise of the output. Those skilled in the art will be familiar with circuit topologies suitable to provide this amplification. The interface then includes transducer-specific filtering and further gain in (918), leading to anti-alias filtering and to an analog to digital converter (919). The analog to digital converter makes the circuit operable to convert electrical perturbations into digital information that can be processed, stored, or transmitted.

[0122] FIG. 9D denotes the interface (920) for an acoustic or ultrasonic transducer (927). The acoustic or ultrasonic transducer (927) interface (920) has a switch (925), which allows the control system (908) to select between a driven mode (TX) and a receive mode (RX). In the driven mode, the control system generates and delivers a signal or pulse (921), which is amplified by amplifier (922) and driver (923) to achieve a strong enough pulse (924) to drive the acoustic or ultrasonic transducer (927) to generate a mechanical wave or pulse directed into the tissue at least adjacent to the scaffolding. The control system (908) switches the interface into a receive mode, by way of a control signal (926), such that the interface can be responsive to variations in a signal generated by the transducer in response to a mechanical pulse or wave. This signal is conditioned and digitized, as described in FIG. 9C.

[0123] FIG. 9E illustrates an example interface (928) for a piezoelectric transducer (930). The interface (928) for the piezoelectric transducer (930) is similar to the acoustic transducer denoted in FIG. 9D. The control system (908) generates a pulse or wave (921) that is amplified by a amplifier (922) and driver (923) to a pulse strong enough to drive the piezoelectric transducer (930) through the switch (929) to generate a mechanical pulse or wave when the control system (908) has configured the switch (929) to the driven mode, using control signals (932). After driving the piezoelectric transducer, the interface is also operable to receive a signal generated by the piezoelectric transducer (930) when exposed to a returned mechanical pulse or wave. The control system (908) configures the switch (929) to a receive mode through the control signals (932), which communicatively couples the reception system (914) to the transducer

[0124] (930). The architecture of the reception system is shown in FIG. 9C (914). When not driving or receiving a signal from the piezoelectric transducer (930), the control system (908) communicatively couples the piezoelectric transducer (930) to a rectifier circuit

[0125] (931) through the switch (929), via the control signals (932). The rectifier circuit (931) takes the signal received from converting the mechanical pulsatility or body movement of a fluid or tissue of the body as an input, and converts that charge into a usable direct- current voltage source (933). This allows the integrated circuit (901) to harvest energy from the body, while still supporting acoustic imaging, as well as driving acoustic energy into the scaffolding itself, or to be used as a means of disrupting a formation of at least one of a neointimal hyperplasia, neoatherosclerosis, stent thrombosis, atherosclerosis, restenosis. The rectifier circuit (931) may be an active rectifier, passive rectifier, voltage doubler, or any suitable circuit topology for converting a periodic or aperiodic oscillation and producing a direct-current voltage. Those skilled in the art will be familiar with a variety of potential applicable topologies.

[0126] In some implementations, the IC may be further comprised of at least one of: a power-on reset (POR) circuit to place the digital control systems into a known initial state, a low-drop-out (LDO) voltage regulator to provide a stable and regulated supply for logic elements, a voltage reference, a current reference, a bias circuit, a charge pump, a high voltage regulator, an analog to digital converter, a low-noise-amplifier, a digital to analog converter, an op-amp, a transconductance amplifier, a comparator, an oscillator, a phase-locked-loop, a memory, a controller, a state machine, a modulator, a mixer, a filter, or an encoder. In some implementations the IC is electronically coupled to at least one passive circuit element that is physically coupled to the scaffolding. In some implementations the integrated circuit (901) may further contain a cryptographic element to provide for encryption, decryption, hashing, obfuscation, or otherwise protecting information to be transmitted. In further implementations, the integrated circuit (901) may further be comprised of a driver to deliver electrical signals into tissue adjacent to electrodes. The driver may be an H-Bridge circuit, a cascode output stage, gm-boosted output stage, amplifier, or the like. Those skilled in the art will be familiar with suitable topologies to provide for the delivery of electrical signals to tissue. In some implementations, the at least one transducer is comprised of two or more acoustic transducers communicatively coupled to the at least one integrated circuit wherein the driving of the two or more transducers occur at computed relative time delays, such that the mechanical wavefront generated from the at least one transducer is a mechanical wave that converges to a higher pressure amplitude at a focal point at some distance from the tissue adjacent to the scaffolding. In some implementations, the focal point of the pressure wave is used to at least one improve imaging resolution, modulate nervous system tissue, ablate tissue, stimulate mechano-sensitive tissue, or achieve a mechanically-mediated physiological effect.

[0127] FIG. 10 is a flow chart that outlines the typical usage model for the preferred implementation. The implant ( / .e. apparatus) starts up (1001) during the deployment into the lumen of the body, after which it begins to harvest energy from its environment, (1002). The apparatus will continue to harvest energy continuously, however, when an operational command (1019) is to be issued to the apparatus, and an external system is brought proximal to the apparatus (1020). The at least one transmitter of the apparatus becomes communicatively linked to the external system, and the external system provides supplemental power to the apparatus. The apparatus will detect this external system as it becomes communicatively coupled with the apparatus in (1003), and be operational to accept the wireless power, further energizing the integrated circuit (1010), which is converted to at least a usable direct-current system voltage through a power converter, power receiver, or power recoverer. It is possible that the external system, device, or method configured to provide wireless power will also transmit, via a communicative link or through modulation of the power link itself, a command to the apparatus (1019). The decision tree is thus elucidated in (1011): if a command has not been received, the system will return to harvesting power from its environment, and will continue accepting external power if still available. However, if a command sequence is detected, the command is validated and decoded (1012), and the apparatus will implement an action to follow the command. The command sequence may require the apparatus to transmit data that is stored on the apparatus in memory, in which case the data are read, packaged into a packet, and transmitted via the one or more transmitter (1014). Alternatively, the command may request that the apparatus take a measurement. In some cases, the external system may request readings of the supplies, bias points, and status of the electronic systems of the apparatus, in which case this information is the data transmitted by the at least one transmitter back to the external system in (1016). In other cases, the external system may request a reading from the at least one transducer. The apparatus becomes operable to receive a signal from at least one of the transducers (1015). The information received is packaged and transmitted to the external system by the at least one transmitter (1016). Alternatively, the command may be to provide some effect on the apparatus or the tissue surrounding the scaffolding. In this case, the appropriate transducers are selected and driven to elicit the desired effect (1017), after which a confirmation or result is sent to the external system by the at least one transmitter (1018). In most implementations, the apparatus responds with acknowledgement and result of the command, (1014), (1016), and (1018). The apparatus then returns to harvesting energy, (1002), and may continue to receive wireless energy (1010), and further commands (1011) as dictated by the external system, device, or method. If no external system, device, or method is providing power or interacting with the apparatus, the apparatus will periodically check whether the supplies are stabilized and check for a scheduled action, (1004). For instance, in the preferred implementation the apparatus wakes up at a regular intervals to take at receive information from the at least one transducer, assess the stability of the system voltage and biases in the electronic system of the apparatus, or provide some effect, (1004). The apparatus performs a function if doing so will not brown-out or otherwise deplete the charge powering the apparatus, and the apparatus will perform a function if the integrated circuit determines that sufficient charge is available to complete the function in its entirety. If these stipulations are not met, in the best implementation, the apparatus will return to continuously harvesting energy (1002) until these conditions are satisfied. When sufficient charge is available to complete the function in its entirety, the device will either receive information from the one or more transducers, (1006), and store the result of in memory (1007), or provide some effect (1008), and record the effect and any data surrounding the effect that are germane to the operation (1009). Upon completion of the action, the integrated circuit will schedule the next action (1018). The apparatus then goes back to harvesting energy, (1002), until an external interaction occurs (1003), or until the conditions for a scheduled measurement or effect are met (1004).

[0128] In some implementations, the electrical interconnection between the integrated circuit, transducers, and transmitters may be facilitated through the usage of conductive wiring, or a conductive metal patterned on a flexible polymer that can be wrapped around the scaffolding, or be patterned in such a way to facilitate expansion / retraction. In a further implementation, interconnection between the transducer, integrated circuit, and transmitter is facilitated by wiring or interconnect internal to the scaffolding. In a further implementation, an electrically-conductive circuit is embedded within or attached upon the scaffolding in a helical configuration and which forms an inductor, one or more capacitors are electrically coupled to the scaffolding or any electrically conductive circuit attached upon or embedded within the scaffolding, and one or more digital switches with inputs from the at least one integrated circuit are placed in series with the inductor and the one or more capacitors, forming an electromagnetic radiator element as well as a transmission line through which a mechanical, structural, or functional integrity of the scaffolding can be assessed.

[0129] In some implementations, the mechanical integrity of the scaffolding is assessed through electrical coupling with at least one of the struts that comprise the scaffolding, forming a portion of at least one transmission lines that can be electrically characterized to assess the mechanical integrity of the scaffolding. In some implementations, a thin flexible interconnect with a patterned conductor designed to follow the mechanical construction of at least one part of the scaffolding comprises one or more transmission lines. During scaffolding mechanical breakage, the interconnect is disrupted, which can be measured by the integrated circuit electrically coupled to the transmission line, by characterizing the electrical response of the transmission line. Biological growths on the stent, and mechanical conformation may be assessed through the deconvolution of an equivalent circuit model determined by characterizing the transmission line electrical response

[0130] FIG. 11 A, FIG. 11 B, and FIG. 11C illustrate an implementation in which struts (1105) of the scaffolding (1101), are replaced at least in part by at least one of an integrated circuit (1102), or a transducer (1106). These struts (1105) can be removed from a fully fabricated scaffold (1101). Alternatively in an additive manufacturing process, as the scaffolding is forming the regions that will be comprised of the functional element will not be deposited, and instead a connecting interface to the rest of the scaffolding is created to which a functional element can be affixed. In one implementation, the strut (1105) is a load bearing member of the scaffolding (1101). One such physical element is denoted in FIG. 11 B, in which an IC (1102) is encased in a biocompatible passivation (1108), replacing the structural material that comprises the rest of the physical structure in (1101). The functional element encased in the biocompatible passivation (1108) is affixed to the rest of the scaffolding using an interfacial material, (1103), such as a biocompatible epoxy designed to have similar mechanical and structural properties as the rest of the scaffolding (1101). The integrated circuit may be operable to provide electrical connectivity to a wire harness, interconnect, or flexible circuit board (1109), which may provide interconnectivity via a low-resistance pathway (1104) to other functional elements, such as a piezoelectric transducer (1106). In FIG. 11C, a piezoelectric transducer (1106), is encased in a biocompatible passivation material (1107). The terminals of the piezoelectric transducer are connected to flexible interconnect (1109). In some implementations, an acoustic lens, acoustic coupling material (1110), or other biocompatible interfacial material are applied around the terminals of the piezoelectric transducer, which provides advantages for optimally delivering acoustic or mechanical energy from the transducer (1106) to the tissue adjacent to the scaffolding at the boundary of the tissue and the coupling material (1110). In other implementations these regions are instead comprised of the same passivating material (1108), as surrounds the rest of the functional unit in FIG. 11B. In another implementation, the integrated circuit (1102) is circumferentially encased in the same material that comprises the scaffolding (1101).

[0131] FIG. 12 is a flowchart illustrating an example implementation of the processes for measuring acute and chronic changes in flow in the vessel in which the apparatus is deployed; detecting damage to the structural integrity of the scaffolding; alerting clinicians, caregivers, patients and, if required, emergency medical services, to urgent or important structural and functional changes detected by the apparatus; storing direct or derived measurements in memory; accessing device memory; displaying measured and derived data; uploading measured and derived data to electronic medical records (EMRs); programming effector activity as a function of measured or derived data; and changing effector activity in response to acute events. Transducers (1201) physically coupled to the apparatus include a combination of pressure sensors, electrodes, and, optionally, other optical and electromagnetic transducers such as light-emitting diodes (1205). Signals containing information about the tissue converted by acoustic and ultrasonic transducers (1206) are received by interfaces (1207) that are specific to acoustic and ultrasonic transducer types. In some implementations, the data are collected synchronously (1204) with a periodic or aperiodic signal from the body, and that signal may be measured by the electrode or another transducer. For example, data from the electrodes measuring electrophysiology and pressure sensors can be used to infer the time-position within the cardiac cycle, and this, in turn, can be used to collect data to calculate iFR. In the illustrated implementation, collection of synchronous data takes the form of gating of data such that data only at specific times is utilized; gating data may be an advantageous approach for collection of data from transducers that do not require much energy to convert into a signal. However, this collecting synchronous data can also be achieved in some implementations by driving the transducers at times that are synchronous to the periodic or aperiodic signal from the body.

[0132] If any alert conditions are met by the processed or directly-measured data, as shown in FIG. 8A, or the breakage detection procedure (FIG. 6) identifies a compromise to the structural integrity or continuity of the scaffolding, an alert process from the alert stack (1202) is activated. The alert is transmitted via the internet or a local network, from the external device, a mobile device connected to the external device, or another external system, to the server network hosting the EMR system used by the clinician treating the patient; the clinician receives the alert on the EMR (1216). In the best implementation, it is also transmitted through a cellular or local network to the patient’s mobile device in the form of a text or voice message, or a notification within a software application on the mobile device (1217). The patient’s caregiver or caregivers may also elect to receive notifications in this manner (1218). In some implementations, the alert may be sent to an off-site monitoring center server (1219). Other alert options may be selected, including e-mail sent from the external system through the internet (1220). Some individuals, including the patient, or the at least one caregiver, clinician or monitoring center employee may be privileged in the software (1228) to evaluate the urgency of the alert and activate emergency medical services (1230) or to defer action (1229). In the latter case, in the preferred implementation, the alert would still be noted in the EMR and the monitoring center would still be notified, if applicable. In the former case, in some implementations, the alert would be transmitted back to the implanted component of the device through the IC (1231) and this would trigger a procedure that changes the action of the transducers acting as effectors (light-emitting diodes, mechanical transducers, etc.) to mitigate injury resulting from the physiological conditions which triggered the alert. In some conditions, e.g. stent thrombosis, it may be advantageous to drive the acoustic transducers (1208) to provide sonotherapy, thrombus disruption or another intervention. This is facilitated through drivers on the IC. In other implementations, emergency medical services may be summoned directly by the external system though the internet or a telephone line. In some implementations, an alert can be sent for detection of acute coronary syndrome by the integrated circuit or external system based on information collected by electrodes or by electrochemical troponin or myoglobin sensors, stent breakage (FIG. 6), patient falls, electronics malfunctions, variations in blood glucose, etc. The process for these alerts may be the same as that described for acute occlusion, however, specific changes (e.g. a different set of devices receiving notifications) could be specified. A clinician interface (1203) is a piece of software that, among other functions listed herein, allows for the selection of these presets on an external personal computer or mobile device, or, in some implementations, a dedicated external device for clinician use (1221). The clinician interface may or may not be integrated with the EMR software on the device on which it is being utilized. In addition to programming the presets heretofore described, the clinician interface can also be used to set conditions for effector activation (1234). Effectors include, in some implementations, heating elements, light-emitting elements, mechanical transducers, etc. on the apparatus. If conditions detected by the transducers (1201) match those specified in the clinician interface, then the effectors are activated in the manner specified in the clinician interface. Though the clinician interface is hosted on a personal computer, mobile device or external device belonging to the clinician, the presets are housed in memory on the at least one IC on the apparatus in the body lumen, and the comparison between the sensor measurements and the conditions specified for effector intervention (1234) does not require the persistent presence of the device hosting the clinician interface in the preferred implementation. Via the clinician interface (1203), the treating clinician may activate a state on the apparatus wherein the intraluminal pressures measured by the transducers, and especially the ratio of the sensor readings in the proximal and distal portions of the prosthesis are measured, and these values, and / or filtered derivatives thereof (e.g. moving averages), are calculated and transmitted back to the device hosting the clinician interface (1203) for display in real time (1222), described here as “FFR mode” (1224). One advantage to this feature is that it allows for a method of administering a pharmacologic agent (e.g. adenosine) to estimate the fractional flow reserve in the vessel into which the apparatus is implanted, and the real-time reporting of this value. Another mode accessible through the clinician interface in the preferred implementation is “clinical-implant mode” (1225), which, when activated, causes data from the transducers about contact with the inner wall of the lumen and the configuration of the scaffolding, and derivatives thereof, to be transmitted to the device hosting the clinician interface (1203) and displayed in real time (1222). This is advantageous in the initial deployment of the device to ensure full expansion of the scaffolding within the lumen and bracing of the scaffolding against the inner wall of the lumen. In “FFR mode” and “clinical-implant mode,” measurements are taken by the transducers, passed to the IC, transmitted wirelessly to the external device, and then to the device hosting the clinician interface, if applicable. Calculation of derivative values (e.g. moving averages), may be performed on any of these devices. Two- or 3- dimensional images that are interpretable by clinicians may be generated from data recorded by electro-optical and acoustic transducers on any of these devices and displayed (1222). Finally, some or all measured values and derivatives thereof are stored in memory (1226), either on the apparatus, the external system, a server hosting the EMR, a mobile device connected to the external device or another device connected via network protocols known to those experienced in the art to any of the previously- mentioned devices. The values to be stored are specified by the clinician. In the preferred implementation, the clinician interface can query the memory (1223) and display historical measured and derived values (1222) as well as real-time values from all the transducers (1201). Derived values may be recalculated from stored measured values. Values uploaded to the servers hosting the EMR (1227) may also be viewed by clinicians who do not have access to the clinician interface. The at least one transducer may also comprise a load-bearing member of a strut of the scaffolding, or be physically coupled to an at least partial-thickness hole within the scaffolding, such that a centripetal force is exerted on the transducer by virtue of the size differential compared to the hole. The at least one IC may also comprise a load-bearing member of a strut of the scaffolding, or be physically coupled to an at least partialthickness hole within the scaffolding, such that a centripetal force is exerted on the IC by virtue of the size differential compared to the hole.

[0133] FIG. 13A illustrates an implementation wherein the transducers (1306) comprise load-bearing members of the struts of the scaffolding (1301) and wherein the centripetal force exerted on the transducer due to its larger size, relative to the hole in the scaffolding produces as interference fit which holds the transducers in place. A low- resistance pathway (1305) connects at least one transducer to an IC (1302). Any damage or discontinuity in the low-resistance pathway that wraps around the scaffolding changes the impedance of the pathway and provide a mode of interrogation for the IC in evaluating scaffolding mechanical integrity. FIGS. 13B and 13C show section views of two different potential implementation of the scaffolding, FIG. 13B with a full-thickness hole, FIG. 13C with a partial-thickness hole. FIG. 13D shows an alternative implementation, wherein a casing (1303) is welded to the scaffolding (1301), and holds down and protects the transducer (1306). A pinhole in the case (1304) forms a fluidly communicative channel between the anatomical structure or bodily fluid adjacent to the scaffolding and the transducer.

[0134] FIG. 14A and 14B are schematics illustrating some of the body lumens in the body (1401) in which the apparatus may be implanted, including the great vessels of the heart, like the aorta (1406) and in the pulmonary arteries (1405). These figures are intended to summarize various potential indications and locations for implantation of the apparatus, and are not intended to limit the scope of the invention. The scaffolding may be a vascular stent, and the apparatus may be implanted in the coronary arteries (1403) of the heart (1402). The apparatus may also be implanted in the pulmonary arteries (1405) leading to the lung (1404). The apparatus may also be implanted in the aorta (1406), renal artery (1407), and other peripheral vessels, including the iliac artery (1408), femoral artery (1409), and popliteal artery (1410). The scaffolding may be an inferior vena cava filter (1412) and the apparatus may be implanted in the inferior vena cava (1411). The scaffolding may also be a urinary or ureteral stent and the apparatus may be implanted in the ureter (1414) of the kidney (1413) and in the urethra (1416) of the urinary bladder (1415). The scaffolding may also be a colorectal stent, and the apparatus may be implanted in the colon (1417) and in the rectum (1418). The scaffolding may also be an esophageal stent and the apparatus may be implanted in the esophagus (1419). The scaffolding may also be a carotid stent and the apparatus may be implanted in the carotid artery (1423). The scaffolding may also be a cerebral stent or cerebral flow diverter, and the apparatus may be implanted in the cerebral vasculature (1420), such as in cases of cerebral aneurysm (1421). The scaffolding may also be a biliary stent (1425), and it may be implanted in the biliary system including in the common bile duct (1426) leading from the gallbladder (1424) and the liver, or in the pancreatic duct of the pancreas (1427) or in the Ampulla of Vater (1428).

[0135] FIGS. 15A and 15B schematically illustrate the characterization of a tissue by the apparatus by means of a mechanical pulse or wave, such as an acoustic or ultrasonic pulse. FIG. 15A shows one implementation of the apparatus with the scaffolding, a stent (1504), expanded within an artery (1505) with annular in-stent restenosis (1503). Mechanical transducers are affixed to the struts (1502) of the scaffolding. A mechanical pulse or wave is emitted by the transducers on the strut (1501) and is directed toward an anatomical structure or the bodily fluid that is adjacent to the strut, i.e. the closest restenotic tissue (1503). The mechanical pulse or wave passes through several layers of tissue, interacts with the restenotic tissue, and reflects back toward the transducer that emitted the pulse as a returned mechanical pulse or wave (1506). The transducer that emitted the mechanical pulse or wave then receives the returned pulse or wave, containing information about the restenotic tissue, and converts the returned pulse into a signal, which is passed to the IC. In FIG. 15B, the stent is placed and the mechanical pulse or wave (1501) is emitted from the strut, much the same as in FIG. 15A. However, in FIG. 15B, the after interacting with the restenotic tissue (1503), the returned pulse or wave (1507) passes through the restenotic tissue, and is received by a transducer other than the one that emitted the pulse or wave that caused the returned pulse or wave. Reception of the returned mechanical pulse or wave by a transducer other than the one that emitted the pulse or wave that caused the returned pulse or wave allows both for structural characterization and functional (Doppler) characterization, and may optionally be used together with reception of the returned pulse or wave by the transducer that emitted the pulse or wave that caused the returned pulse or wave, however, each technique may be used individually.

[0136] Example Method of Manufacturing

[0137] Example 1 : A method of manufacturing a bioelectronic stent, comprising: i. providing an expandable scaffolding that is at least in-part tubular, ii. physically coupling at least one integrated circuit (IC) to the scaffolding, iii. physically coupling at least one transmitter to the scaffolding, iv. physically coupling to the scaffolding any combination of: at least one acoustic or ultrasonic transducer element; at least one pressure sensor and one piezoelectric transducer element that is capable of harvesting power from a motion of the body of the human or animal into which the scaffolding is implanted; or at least two pressure sensors whose measurements are gated by, or sorted by data from, at least one other pair of electrode transducers, acoustic or ultrasonic sensor, or other sensor, that collects data about a periodic motion or an aperiodic motion or electrical activity of the body of the human or animal into which the scaffolding is implanted, wherein the integrated circuit is affixed to the scaffolding, either directly or by means of an interposed flexible substrate, or held in place by a packaging element that in turn is affixed to the scaffolding by any combination of: point welding, biocompatible epoxy, selective encapsulation through sputter-deposited thin film, one or more snap fits, one or more interference fits, or intercalation of the integrated circuit between subelements of the scaffolding.

[0138] Example 2: The method of example 1 , wherein the scaffolding is a bare metal or drug eluting stent, or flow diverter.

[0139] Example 3: The method of example 1 , wherein the scaffolding is stent that is in whole or part, any combination of: bioresorbable, or constructed from including poly- / - lactide.

[0140] Example 4: The method of example 1 , further comprising encasing the manufactured apparatus in a bioresorbable drug-eluting polymer.

[0141] Example 5: The method of example 1 , wherein an interconnect substrate material is comprised of polyimide, parylene, PDMS, HDPE, or any other biocompatible flexiblepolymeric substrate.

[0142] Example 6: The method of example 1 , wherein one or more of the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements is mechanically thinned all or in part by means of a mechanical grinding and polishing process, in which a bulk substrate material is gradually removed until the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements is thinned to 100 pm or less.

[0143] Example 7: The method of example 1 , wherein one or more of the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements is mechanically thinned all or in part via a reactive ion etching process, in which a plasma removes a bulk substrate material until the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements is thinned to 100 pm or less.

[0144] Example 8: The method of example 1 , wherein the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements is affixed to the flexible interconnect through a metallic reflow process, in which any combination of: tin, silver, or copper, alloy balls are deposited on to a number of contact pads and reflowing at a temperature of 235-245 C.

[0145] Example 9: The method of example 1 , wherein a biocompatible insulating epoxy is used as an underflow material to strengthen a bond between a surface of the one or more integrated circuits, acoustic or ultrasonic transducers or sensors elements and a flexible interconnect sheet or the mechanical scaffolding.

[0146] Example 10: The method of example 1, wherein one or more strut elements belonging to the mechanical scaffolding are electrically isolated through an introduction of any combination of: biocompatible insulating epoxy, biocompatible polymer, or HDPE; so as to operate as an antenna element through electrical contact to one or more of: the flexible substrate material, integrated circuit, acoustic or ultrasonic transducer element, or sensor.

[0147] Example 11: The method of example 1, wherein the one or more of: acoustic or ultrasonic transducer elements, sensors, or telemetry elements; is affixed to the one or more integrated circuits through any combination of: an interposed anisotropic conducting film, thermosonic bonding to gold pad bumps, low temperature conductive epoxy, or wire-bonding; through which electrical connectivity is established.

[0148] Example 12: The method of example 1, wherein the one or more acoustic or ultrasonic transducer elements, sensors, or telemetry elements is affixed to one or more tethered conductive interfaces, such that one end of the tethered interface is connected to the one or more integrated circuit and the other end of the interface is connected to the one or more acoustic or ultrasonic transducer elements, sensors, or telemetry element through any combination of: a low-temperature conductive epoxy, anisotropic conducting film, or other conductive media.

[0149] Example 13: The method of example 1, wherein the one or more acoustic or ultrasonic transducer elements, integrated circuits, sensors, or telemetry elements is mechanically integrated into a cross section of the scaffolding through any combination of: interference fit, snap fit, or biocompatible epoxy.

[0150] Example 14: The method of example 1, wherein an acoustic matching material covers a biological-media-facing-side of one or more of the acoustic or ultrasonic transducers.

[0151] Example 15: The method of example 1, wherein the one or more acoustic or ultrasonic transducer elements are backed by depositing a first substrate, a spacer material, and bonding a third substrate to the spacer material such that an air pocket forms, and an acoustic- or ultrasonic-transduction material is placed over the air pocket such that acoustic energy reflects off of the air pocket and is directed into a biological media.

[0152] Example 16: The method of example 1, wherein any combination of the one or more integrated circuit, acoustic or ultrasonic transducer, sensor or telemetry element is held in place by a packaging element that in turn is affixed to the scaffolding through a biocompatible epoxy, point weld, snap fit, interference fit or intercalation between struts belonging to the mechanical scaffolding.

[0153] Example 17: The method of example 1, wherein the scaffolding; one or more integrated circuits; telemetry elements; and any combination of: acoustic or ultrasonic transducer elements, pressure sensors, electrode transducers, and other electronic elements; are collectively placed in a pressure-controlled deposition chamber, and uniformly subjected to physical vapor deposition of substrate material through the direction of an electronically-mediated argon plasma at any subset of material targets of a mechanical scaffolding material sputter-targets, including cobalt, chromium, nickel, titanium, platinum, tantalum, or any metallic alloy targets therein.

[0154] Example 18: The method of example 1 , wherein the scaffolding; one or more integrated circuits; telemetry elements; and any combination of: acoustic or ultrasonic transducer elements, pressure sensors, electrode transducers, and other electronic elements; are placed in a pressure-controlled deposition chamber, and selectively masked through a lithographic process, or mechanical shadow mask, such that all or part of any combination of: the one or more integrated circuit, acoustic or ultrasonic transducer elements, pressure sensors and other sensors, electrode transducers, or other electronic elements; are subjected to physical vapor deposition of scaffolding material through the direction of an electronically-mediated argon plasma at any subset of material sputter-targets, including cobalt, chromium, nickel, titanium, platinum, tantalum, or any metallic alloy targets therein.

[0155] The various implementations described above can be combined to provide further implementations. Aspects of the implementations can be modified, if necessary, to employ systems, circuits and concepts of the various patents, applications and publications to provide yet further implementations.

[0156] The foregoing detailed description has set forth various implementations of the devices and / or processes via the use of block diagrams, schematics, and examples. Insofar as such block diagrams, schematics, and examples contain one or more functions and / or operations, it will be understood by those skilled in the art that each function and / or operation within such block diagrams, flowcharts, or examples can be implemented, individually and / or collectively, by a wide range of hardware, software, firmware, or virtually any combination thereof. In one implementation, the present subject matter may be implemented via Application Specific Integrated Circuits (ASICs). However, those skilled in the art will recognize that the implementations disclosed herein, in whole or in part, can be equivalently implemented in standard integrated circuits, as one or more computer programs running on one or more computers (e.g., as one or more programs running on one or more computer systems), as one or more programs running on one or more controllers (e.g., microcontrollers) as one or more programs running on one or more processors (e.g., microprocessors), as firmware, or as virtually any combination thereof, and that designing the circuitry and / or writing the code for the software and or firmware would be well within the skill of one of ordinary skill in the art in light of this disclosure.

[0157] The above described method(s), process(es), or technique(s) may include various acts, though those of skill in the art will appreciate that in alternative examples certain acts may be omitted and / or additional acts may be added. Those of skill in the art will appreciate that the illustrated order of the acts is shown for exemplary purposes only and may change in alternative examples. Some of the exemplary acts or operations of the above described method(s), process(es), or technique(s) are performed iteratively. Some acts of the above described method(s), process(es), or technique(s) can be performed during each iteration, after a plurality of iterations, or at the end of all the iterations.

[0158] The above description of illustrated implementations, including what is described in the Abstract, is not intended to be exhaustive or to limit the implementations to the precise forms disclosed. Although specific implementations of and examples are described herein for illustrative purposes, various equivalent modifications can be made without departing from the spirit and scope of the disclosure, as will be recognized by those skilled in the relevant art.

[0159] These and other changes can be made to the implementations in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the claims to the specific implementations disclosed in the specification and the claims, but should be construed to include all possible implementations along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.

Claims

1. CLAIMSI / We claim:

1. An apparatus implantable in a body lumen of a body, the apparatus comprising: a scaffolding that is expandable and that includes at least a tubular portion, wherein the scaffolding is insertable into the body lumen of the body and expandable such that the scaffolding when expanded is mechanically braced against an inner wall of the body lumen and when expanded the tubular portion of the scaffolding forms a fluidly communicative passageway through the scaffolding; at least one transducer, the at least one transducer physically coupled to the scaffolding and when the scaffolding is expanded, the at least one transducer is mechanically coupled to at least one of an anatomical structure or a bodily fluid at least adjacent to the expandable tubular scaffolding; at least one integrated circuit physically coupled to the scaffolding, the at least one integrated circuit comprises at least: a driver to energize at least one of the at least one transducer to generate a mechanical pulse or wave, and at least one interface that is communicatively coupled to at least one of the at least one transducer and that is responsive to variations in a signal generated by the at least one transducer when the at least one transducer is exposed to a mechanical pulse or wave; and at least one transmitter physically coupled to the scaffolding and operable to transmit information from the apparatus while the apparatus is implanted in the body lumen of the body.

2. An apparatus implantable in a body lumen of a body, the apparatus comprising: a scaffolding that is expandable and that includes at least a tubular portion, wherein the scaffolding is insertable into the body lumen of the body and expandable such that the scaffolding when expanded is mechanically braced against an inner wall of the body lumen and when expanded the tubular portion of scaffolding forms a fluidly communicative passageway through the scaffolding; at least one integrated circuit physically coupled to the scaffolding; at least one transducer physically coupled to the scaffolding, the at least one transducer electrically coupled to the at least one integrated circuit to partly or wholly energize the at least one integrated circuit in response to stimulus applied to the at least one transducer from a body movement or fluid movement; andat least one transmitter physically coupled to the scaffolding and operable to transmit information from the apparatus while the apparatus is implanted in the body lumen of the body, wherein the at least one integrated circuit is operable to at least one of process, store or transmit information represented by signals generated by at least one of the at least one transducer responsive to at least one of a mechanical or an electrical stimulus.

3. An apparatus implantable in a body lumen of a body, the apparatus comprising: a scaffolding that is expandable and that includes at least a tubular portion, wherein the scaffolding is insertable into the body lumen of the body and expandable such that the scaffolding when expanded is mechanically braced against an inner wall of the body lumen and when expanded the tubular portion of scaffolding forms a fluidly communicative passageway through the scaffolding; at least one transducer, the at least one transducer physically coupled to the scaffolding; at least one integrated circuit physically coupled to the scaffolding, the at least one integrated circuit operable to at least one of process, store or transmit data from the at least one transducer at a set of times that is synchronized to electrical or mechanical activity of the body; and at least one transmitter physically coupled to the scaffolding and operable to transmit information from the apparatus while the apparatus is implanted in the body lumen of the body.

4. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one transducer comprises at least one acoustic or ultrasonic transducer and the mechanical pulse or wave is an acoustic or ultrasonic pulse or wave.

5. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one interface is communicatively coupled to at least one of the at least one transducer that generates the mechanical pulse or wave or wherein the at least one interface is communicatively coupled to at least one of the at least one transducer that does not generate the mechanical pulse or wave.

6. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one transducer comprises at least one piezoelectric transducer.

7. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one transmitter is operable to transmit information from the body while the apparatus is implanted in the body lumen of the body.

8. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one transmitter is communicatively coupled to the at least one integrated circuit or is a part of the at least one integrated circuit.

9. The apparatus according to any one of claims 1 , 2, and 3, wherein an at least one receiver is physically coupled to the scaffolding and is operable to receive information from outside of the apparatus while the apparatus is implanted in the body lumen of the body.

10. The apparatus according to any one of claims 1, 2, and 3, wherein the at least one scaffolding is one of a coronary bare metal stent, peripheral bare metal stent, drug eluting stent, inferior vena cava filter, resorbable scaffold, or cerebral flow diverter.

11. The apparatus according to any one of claims 1 , 2, and 3, wherein the at least one transmitter is communicatively coupled to at least one strut of the scaffolding.

12. The apparatus according to any one of claims 1, 2, and 3, wherein the apparatus further comprises at least one of an antenna, an electromagnetic radiator, a piezoelectric transducer, physically coupled to the scaffolding and communicatively coupled to the at least one integrated circuit.

13. The apparatus according to any one of claims 1, 2, and 3, wherein the apparatus further comprises at least one of an antenna, electromagnetic receiver, a piezoelectric transducer, physically coupled to the scaffolding and electrically coupled to the at least one integrated circuit, the at least one integrated circuit further comprised of at least one of a power recoverer, power converter, or a power harvester.

14. The apparatus according to any one of claims 1, 2, and 3, wherein the at least one integrated circuit is electronically coupled to at least one of a passive circuit element that is physically coupled to the scaffolding.

15. The apparatus according to any one of claims 1, 2, and 3, wherein the at least one integrated circuit is electronically coupled to at least one strut of the scaffolding.

16. The apparatus according to any one of claim 1, 2, and 3, wherein the scaffolding is further physically coupled to at least one of passive electronic elements forming a transmission line, that transmission line communicatively coupled to the at least one integrated circuit, and electrically characterizable to infer at least one of a structural integrity, functional integrity, or structural expansion of the scaffolding.

17. The apparatus according to any one of claim 1, 2, and 3, wherein at least one of the at least one transducers are at least one of mechanically, electrically coupled to the scaffolding and generate a pulse or wave directed towards the scaffolding, and the at least one interface communicatively coupled to the at least one transducer is responsive to variations in a signal generated by the at least one transducer wherein the signals contain information about at least one of structural integrity, functional integrity, structural expansion of the scaffolding.

18. The apparatus according to any one of claims 1, 2, and 3, wherein at least one of the at least one transducer is at least one of a capacitively micromachined ultrasonic transducer, capacitive pressure transducer, cavity pressure transducer, MEMS pressure transducer.

19. The apparatus according to any one of claim 1, 2, and 3, wherein the at least one integrated circuit are operable to implement at least one of a software algorithm, a firmware algorithm, a digitally-controlled algorithm, the at least one of the software algorithm, the firmware algorithm, or the digitally-controlled algorithm including one or more of: an artificial neural network, a support vector machine, a linear discriminant classifier, a relevance vector machine, a lookup table, a statistical inference algorithm, an image reconstruction algorithm, or a feature extraction algorithm.

20. The apparatus according to claim 19, wherein the at least one integrated circuit is operable to modify at least one of the software algorithm, the firmware algorithm, after the apparatus has been implanted in the body lumen of the body.

21. The apparatus according to claim 19, wherein the signal generated by the at least one transducer is communicatively coupled to the at least one algorithms.

22. The apparatus according to claim 19, wherein an output from the one or more algorithms triggers an activation signal to one or more of the at least one transducer.

23. The apparatus according to claim 19 in which the information is transmitted contains functional or structural information about a fluid flow in the body lumen of the body.

24. The apparatus according to any one of claims 1, 2, and 3, wherein the at least one integrated circuit is further comprised of at least one cryptographic element operable to at least one encrypt, decrypt hash, obfuscate, the information.

25. The apparatus according to any one of claims 1, 2 and 3, wherein at least one of the at least one transducer comprise an electrode and at least one of the at least one transducer comprise an acoustic transducer, and the at least one integrated circuit is further comprised of an interface responsive to electrophysiological data from the at least one electrode and the at least one integrated circuit is further comprised of an interface responsive to acoustic data from the acoustic transducer.

26. The apparatus of claim 25, wherein the information recorded is further processed by the at least one integrated circuit and represents a fractional flow rate in the body lumen of the body.

27. The apparatus according to any one of claim 1, 2, and 3 in which the at least one transmitter is communicatively linked to an external system operable to at least one of power the apparatus, receive information from the apparatus, transmit information to the apparatus, or control the apparatus.

28. The apparatus according to claim 27, wherein at least one external system is further communicatively coupled to a at least one of a smart cellular phone, a tablet device, a personal computer, a data hub, a cloud connected device, a switch or router, a server hosting an electronic medical record system.

29. The apparatus according to any one of claims 1, 2, and 3, wherein the at least one transmitter is communicatively coupled to at least one of the at least one transducers.

30. The apparatus according to any one of claims 1, 2, and 3 in which the at least one transducer is electrically coupled to the at least one integrated circuit and that circuit is operable to convert at least one electrical perturbation into digital information that is processed, stored, or transmitted.

31. The apparatus according to any one of claims 1 , 2 and 3, wherein when the scaffolding is expanded, the at least one transducer is at least one mechanically or electrically coupled to at least one of an anatomical structure or a bodily fluid at least adjacent to the expandable tubular scaffolding.

32. The apparatus according to claim 31, wherein the at least one integrated circuit comprises at least: a driver coupled to energize at least one of the at least one transducer to generate an at least one mechanical pulse or wave, electrical pulse or wave, and at least one interface that is communicatively coupled to at least one of the at least one transducer and that is responsive to variations in a signal generated by the at least one transducer when the at least one transducer is exposed to at least one a mechanical pulse or wave, an electrical pulse or wave.

33. The apparatus according to any one of claims 1, 2 and 3, wherein the at least one transducer comprises at least two transducers indicative of a respective pressure at each of two or more locations along an axis of fluid flow within the body lumen.

34. The apparatus according to any one of claims 1, 2 and 3, wherein at least one of the at least one transducer is an electrode transducer.

35. The apparatus according to any one of claims 1, 2 and 3, wherein the at least one integrated circuit is physically coupled to a strut of the scaffolding on at least one of an adluminal aspect, an abluminal aspect, or a side aspect of the strut of the scaffolding.

36. The apparatus according to claim 35, wherein at least one of the scaffolding, the at least one integrated circuit, the at least one transducer, or the at least one transmitter, is covered with a resorbable drug-eluting material.

37. The apparatus according to any one of claims 1, 2 and 3, wherein the at least one integrated circuit is encased in a metallic or polymeric packaging that is physically coupled to a surface of the scaffolding.

38. The apparatus according to any one of claims 1, 2 and 3, wherein the at least one integrated circuit is circumferentially encased within a material of a strut of the scaffolding in at least one cross section.

39. The apparatus according to any one of claims 1, 2 and 3, wherein the at least one transducer is a load-bearing member of a strut of the scaffolding.

40. The apparatus according to any one of claims 1, 2 and 3 , wherein at least one of the at least one integrated circuit, the at least one transducer, or the at least one transmitter, is physically coupled to a full-thickness hole or a partial-thickness hole within the scaffolding, and the scaffolding exerts a centripetal force on the at least one integrated circuit, the at least one transducer, or the at least one transmitter by virtue of a greater size of the at least one integrated circuit, the at least one transducer, or the at least one transmitter as compared with the hole.

41. The apparatus according to any one of claims 1 , 2 and 3, wherein an electrically-conductive circuit is embedded within or attached upon the scaffolding in a helical configuration and which forms an inductor, one or more capacitors are electrically coupled to the scaffolding or any electrically conductive circuit attached upon or embedded within the scaffolding, and one or more digital switches with inputs from the at least one integrated circuit are placed in series with the inductor and the one or more capacitors.

42. A method of operation of a system comprising an apparatus to gather structural or functional information about a human body or an animal body using an expandable tubular scaffolding that carries at least one integrated circuit, at least one transducer, and at least one transmitter, the scaffolding when expanded is mechanically braced against an inner wall of a body lumen of the human body or the animal body, the method comprising: energizing the at least one integrated circuit to drive the at least one transducer; generating a mechanical pulse or wave by at least one of the at least one transducer, the mechanical pulse or wave directed toward at least one of an anatomical structure or a bodily fluid at least adjacent to the expandable tubular scaffolding; receiving, by at least one of the at least one transducer, a returned mechanical pulse or wave returned from at least one tissue, the returned mechanical pulse or wave representing structural or functional information about the at least one tissue; converting, by the at least one transducer, the returned mechanical pulse or wave into a signal; communicating the signal from the at least one transducer to the at least one integrated circuit, the signal containing structural or functional information about the at least one tissue; andtransmitting, by the transmitter, the information about the at least one tissue of the human body or the animal body to an external device that is external to the apparatus.

43. A method of operation of a system comprising an apparatus to gather structural or functional information about a human body or an animal body, the apparatus which comprises an expandable tubular scaffolding that carries at least one integrated circuit, at least one transducer, and at least one transmitter, the scaffolding when expanded is mechanically braced against an inner wall of a body lumen of the human body or the animal body, the method comprising: energizing the at least one integrated circuit; converting into a signal, by at least one of the at least one transducer, electrical or mechanical information from least one of an anatomical structure or a bodily fluid at least adjacent to the expandable tubular scaffolding, at least at a set of times that are synchronized to an electrical activity or a mechanical activity of the human body or the animal body; communicating the signal from the at least one transducer to the integrated circuit, the signal which characterizes at least one of a function or a structure of at least one tissue of the human body or the animal body; and transmitting, by the transmitter, the information about the at least one tissue of the human body or the animal body to an external device that is external to the apparatus.

44. The method according to claim 43, further comprising: computing the set of times that are synchronized to an electrical activity or a mechanical activity of the human body or the animal body by converting into a signal, by at least one of the at least one transducer, electrical or mechanical information from the least one tissue and processing the electrical or mechanical information, by a processor that is part of the at least one integrated circuit or that is outside of the apparatus, to identify a periodic or an aperiodic electrical activity or mechanical activity of the human body or animal body.

45. The method according to claim 43, further comprising: generating a mechanical pulse or wave by at least one of the at least one transducer directed toward at least one of the anatomical structure or the bodily fluid that is at least adjacent to the expandable tubular scaffolding; and receiving, by at least one of the at least one transducer, a returned mechanicalpulse or wave returned from the at least one tissue, the returned mechanical pulse or wave representing structural or functional information about the at least one tissue, and wherein converting into a signal, by at least one of the at least one transducer, includes converting the returned mechanical pulse or wave, by the at least one transducer, into a signal that characterizes at least one of a structure or a function of the at least one tissue of the human body or the animal body.

46. The method according to any one of claims 42 and 45, wherein generating the mechanical pulse or wave includes generating an acoustic or ultrasonic pulse or wave.

47. The method according to any one of claims 42 and 45, wherein the receiving the returned mechanical pulse or wave includes receiving, by at least one of the at least one transducer that emitted the pulse or wave, or the at least one transducer that is different from the at least one transducer that emitted the pulse or wave, the returned pulse or wave that is returned from the at least one tissue.

48. The method according to any one of claims 42 and 45, wherein the receiving the returned mechanical pulse or wave includes receiving the returned pulse or wave is returned after any combination of reflecting from or passing through the tissue.

49. The method according to any of claim 42 and 45, further comprising: receiving, by at least one of the at least one transducer, a returned mechanical pulse or wave returned from all or a part of the scaffolding, the returned mechanical pulse or wave representing information about at least one of a position, a continuity, a configuration, or a structural integrity of the scaffolding, and wherein converting into a signal, by at least one of the at least one transducer, includes converting the returned mechanical pulse or wave, by the at least one transducer, into a signal that characterizes the scaffolding; and wherein transmitting comprises transmitting, by the transmitter, the information about the scaffolding.

50. The method according to any one of claims 42 and 45, further comprising: generating a charge, by at least one of the at least transducer, in response to a stimulus applied to the at least one transducer by movement in the human body or the animal body, wherein energizing the at least one integrated circuit includes supplying the charge to the at least one integrated circuit.

51. The method according to claim 50, wherein generating a charge includes generating the charge by at least one piezoelectric transducer.

52. The method according to claim 50, wherein the converting into a signal includes converting into the signal by at least one of the at least one transducer that generates the charge, or the at least one transducer that does not generate the charge.

53. The method according to any of claims 42 and 43, further comprising: generating a charge, by the at least one of the at least one transducer, in response to a stimulus applied to the at least one transducer by movement in the human body or the animal body.

54. The method according to any one of claims 42 and 43, wherein the at least one transducer includes a first transducer and at least a second transducer, the first transducer and the second transducer located at respective positions spaced along a major axis of the scaffolding and along an axis of fluid flow within the body lumen.

55. The method according to any one of claims 42 and 43, further comprising: detecting, by the at least one integrated circuit, at least one of an error condition, warning condition, or alert-state condition; and transmitting, by the transmitter, an indication of an occurrence of the at least one error condition, warning condition, or alertstate condition.

56. The method according to any one of claims 42 and 43, wherein the communicating the signal from the at least one transducer to the integrated circuit includes communicating the signal which includes information about a functional patency of the body lumen.

57. The method according to any one of claims 42 and 43, wherein the at least one transducer is comprised of at least two transducers that are located at respective positions spaced along an axis of fluid flow within the body lumen, and communicating the signal from the at least one transducer to the integrated circuit includes communicating the signal which includes pressure information from the body lumen.

58. The method according to any one of claims 42 and 43, wherein the method of operation of the apparatus in the body lumen in which the bracing of the scaffolding occurs is one of: a coronary vasculature, a cerebral vasculature, a pulmonary vasculature or a peripheral vasculature; any great vessel; a carotid artery, a poplitealartery, a femoral artery, a posterior tibial artery or a renal artery; a gastrointestinal tract, an esophagus, a colon or a rectum; a biliary duct or a pancreas; or a urethra or a ureter.

59. The method according to any one of claims 42 and 43, further comprising: receiving electromagnetic radiation by at least one antenna through: an inductive, capacitive, or other nearfield or midfield link; and providing all or part of an amount of energy to operate at least one of the at least one integrated circuit, the at least one transducer, or the at least one transmitter of the apparatus from the electromagnetic radiation received by the at least one antenna.

60. The method according to any one of claims 42 and 43, further comprising: introducing an electrical, electromagnetic, ultrasonic, or acoustic pulse, wave, or perturbation, into the scaffolding by at least one of the at least one transducers; and wherein converting into a signal comprises converting into the signal a mechanical or electrical response of the scaffolding to the electrical, electromagnetic, ultrasonic, or acoustic pulse, wave or perturbation that contains information about at least one of a structural integrity of the scaffolding, a mechanical continuity of the scaffolding, a degree of expansion of the scaffolding, an interaction between the scaffolding and the inner wall of the body lumen against which the scaffolding is braced, and subjecting the signal to a linear or nonlinear transformation such that the information about the structural integrity of the scaffolding, the mechanical continuity of the scaffolding, the degree of expansion of the scaffolding, or the interaction between the scaffolding and the inner wall of the body lumen against which the scaffolding is braced, is enriched with respect to statistical noise.61 . The method according to claim 60, wherein introducing an electrical or electromagnetic, ultrasonic, or acoustic pulse, wave, or perturbation, into the scaffolding comprises introducing an electrical or electromagnetic pulse, wave, or perturbation into a transmission line that is part of the scaffolding, embedded in the scaffolding, or affixed to the scaffolding.

62. The method according to claim 60, further comprising: selecting, for display or processing, at least one of electrical or mechanical information that is converted into the signal by the at least one transducer at a set of times synchronized to an electrical activity or a mechanical activity of the human body or the animal body.

63. The method according to any one of claims 42 and 43, further comprising: procedurally constructing an image of the structure or a graphical representation of the function of the at least one tissue of the human body or the animal body from the converted signal according to A mode, B mode, M mode, Doppler, duplex, compressive sensing, harmonic imaging, echocardiography, or another imaging procedure.

64. The method according to any one of claims 42 and 43, further comprising: combining information that is converted into the signal by the at least one transducer from at least two mechanical pulses or waves to achieve at least one of: higher spatial image resolution, greater image signal-to-noise ratio, combination of components of an image obtained through generation of the pulses by different subsets of the at least one transducer, or combination of components of an image obtained by converting each pulse into a signal by a varying subset of transducers.

65. The method according to claim 42 and 43, wherein transmitting information includes transmitting information from the body while the apparatus is implanted in the body lumen of the body.

66. The method according to any one of claims 42 and 43, wherein transmitting, by the at least one transmitter, includes transmitting an electromagnetic signal for which the all or a part of the scaffolding acts as part or all of an electromagnetic radiator.

67. The method according to any one of claims 42 and 43, further comprising: receiving, by at least one receiver, at least one of a command or a data stream sent to the receiver from a device outside of the apparatus, and communicating the command or data stream to the at least one integrated circuit.

68. The method according to claim 66, wherein receiving, by the at least one receiver, includes receiving an electromagnetic signal for which the scaffolding acts as part or all of the receiver.

69. The method according to claim 66, wherein receiving, by the receiver, constitutes reception of an acoustic or ultrasonic signal originating from outside of the apparatus by at least one of the at least one transducer.

70. The method according to any one of claims 42, and 43, further comprising: encrypting, encoding, processing, decrypting, decoding, hashing, obfuscating, or otherwise generating derived information or metadata by at least one of the at least oneintegrated circuit; and herein the transmitting includes transmitting, by the transmitter, the encrypted, encoded, processed, decrypted, decoded, hashed, obfuscated, or otherwise generated information or metadata.

71. The method according to any one of claims 42, and 43, further comprising: computing at least one numerical transform, the numerical transform computed based on a subset of the information about the at least one tissue of the human body or the animal body, by a processor that is part of the at least one integrated circuit or that is outside of the apparatus; and applying the at least one numerical transform to the information about the at least one tissue of the human body or the animal body to compensate for a distortion to the signal resulting from the at least one tissue, the distortion that affects a representational accuracy of the information.

72. The method according to any one of claims 42 and 43, further comprising converting into a signal, by at least one of the at least one transducers, at least one of an electrocardiogram, an electroencephalogram, or an electromyogram.

73. The method according to any one of claims 42 and 43, further comprising: implementing, by the at least one integrated circuit, at least one of a firmware, software, or state-machine algorithm for at least one of processing, aligning, reconstructing, storing, or loading the information from the body and at least one of storing, by the at least one integrated circuit, information output of the algorithm in a memory; or transmitting, by the transmitter, the information output of the algorithm.

74. The method according to claim 73, further comprising: receiving, by the at least one receiver, a data stream comprising at least one of a set of parameters, a firmware or software algorithm; and updating the firmware or software algorithm, based on the received data stream.

75. The method according to any one of claims 42 and 43, further comprising: directing, by at least one of the at least one transducers, a mechanical or electrical pulse, into the anatomical structure or the bodily fluid adjacent to the scaffolding, and disrupting, by the mechanical or electrical pulse, a formation of at least one of a neointimal hyperplasia, neoatherosclerosis, stent thrombosis, atherosclerosis, restenosis.

76. The method according to any one of claims 42 and 43, further comprising: classifying, by at least one of the at least one integrated circuit, the external system, the signal relative to a statistical baseline, updateable thresholding algorithm; and alerting, by at least one of the at least one integrated circuit, the external system, when the signal represents myocardial infarction, stroke, vascular trauma.

77. The method according to any one of claims 42 and 43, further comprising: introducing an electrical or electromagnetic pulse, wave of any frequency, or perturbation, into the tissue by at least one of the at least one transducers; and wherein converting into a signal comprises converting into a signal an electrical response or impedance measurement of the tissue to the electrical or electromagnetic pulse, wave of any frequency, or perturbation that contains structural or function information about the at least one tissue.

78. The method according to any one of claims 42 and 43, further comprising: displaying the structural or functional information about the human body or the animal body as at least one of: raw data, a ratio of flow rates of fluid through the body lumen, a difference of flow rates of fluid within the body lumen or a difference of pressures of fluid within the body lumen, a graphical presentation in which a relative position of each fluid flow rate datum from within the body lumen or fluid pressure datum from within the body lumen on a screen or printed page corresponds its respective relative position within the human body or the animal body from which the flow rates or pressures are assessed, a duplex ultrasonography image in which flow rate data are additionally superimposed on structural ultrasound imaging data assessed from the human body or the animal body, an inferred fraction or percentage of stenosis of the body lumen.

79. The method according to any one of claims 42 and 43, wherein a same one of the at least one transducer performs at least two of: energizing the at least one of the at least one integrated circuit; converting into a signal; generating a mechanical pulse or wave; or receiving an acoustic or ultrasonic signal originating from outside of the apparatus.

80. The method according to any one of claims 42 and 43, wherein converting into a signal comprises converting into a signal pressure measured from the human body or the animal body by at least one of the at least one transducer operable to change at least one of capacitance, inductance, resistance or resonant frequency in response to changing pressure.

81. The method of according to any one of claims 42 and 43, further comprising: sensing, by at least one of the at least one transducer, contact between the scaffolding and the inner wall of the body lumen, where sensing constitutes a change of at least one electrical property of the transducer in accordance with at least one of proximity of the at least one transducer to the inner wall of the body lumen, or pressure applied to the at least one transducer by the inner wall of the body lumen; and interrogating the change of the at least one electrical property of the transducer by the integrated circuit, whereby the change in the electrical property is converted into a signal; and communicating the signal from the at least one transducer to the integrated circuit, the signal containing structural or functional information about the at least one tissue.

82. The method according to any one of claims 42 and 43, further comprising: storing, on an at least one memory element that is accessible by the at least one integrated circuit or that is on the at least one integrated circuit, the information about the at least one tissue of the human body or the animal body.

83. The method according to any one of claims 42 and 43, further comprising: transmitting at least one of: data, metadata, a value derived from data collected from the at least one transducer, information about a state of the apparatus or software running on the at least one integrated circuit, or a notification, by the transmitter of the apparatus to an external system that is external from the human body or the animal body, wherein the transmitting occurs in response to at least one of: an amount of collected data, a value derived from the data or an integrity of the apparatus takes certain defined values, or a defined time or defined set of times that is specified by a manufacturer, a clinician, a patient, or a third party.

84. The method according to any one of claims 42 and 43, further comprising: transmitting at least one of: data, metadata, a value derived from data collectedby the at least one transducer, information about a state of the apparatus or software running on the at least one integrated circuit, or a notification, by the transmitter of the apparatus to an external system that is external from the human body or the animal body, in response to at least one of: receipt of a query from the external system; or a wireless technology activated by an electronic medical record software.

85. A system including an apparatus implantable in a body lumen of a body, the system comprising: a scaffolding that is expandable and that includes at least a tubular portion, wherein the scaffolding is insertable into the body lumen of the body and expandable such that the scaffolding when expanded is mechanically braced against an inner wall of the body lumen and when expanded the tubular portion of the scaffolding forms a fluidly communicative passageway through the scaffolding; at least one transducer, the at least one transducer physically coupled to the scaffolding and when the scaffolding is expanded, the at least one transducer is mechanically coupled to at least one of an anatomical structure or a bodily fluid at least adjacent to the expandable tubular scaffolding; at least one integrated circuit physically coupled to the scaffolding, the at least one integrated circuit comprises at least: a driver to energize at least one of the at least one transducer to generate a mechanical pulse or wave, and at least one interface that is communicatively coupled to at least one of the at least one transducer and that is responsive to variations in a signal generated by the at least one transducer when the at least one transducer is exposed to a mechanical pulse or wave; and at least one transmitter physically coupled to the scaffolding and operable to transmit information from the apparatus while the apparatus is implanted in the body lumen of the body, wherein the apparatus is operable to perform any one of the methods of claims 42 through 84.

Images