The subject matter disclosed herein relates to the use of acoustic sensing in the context of vascular assessment.
In many instances it may be desirable to acquire vascular information about a patient either based on prior events or treatments or as a way to monitor or predict cardiovascular and heart health, or the hemodynamic significance of a vascular anomaly. In general, however, techniques providing the most detailed or comprehensive information are the most time intensive or involved, potentially involving a lengthy scan or procedure and/or subjecting the patient to an imaging protocol that may also involve the use of sedation, exogeneous contrast agents, or other techniques which add to the complexity and invasiveness of the procedure. Moreover, in some instances, such as early onset of disease, techniques may also increase the overall cost for managing the patient.
Conversely, those techniques that are less involved may, correspondingly, provide less useful or comprehensive information. For example, techniques that do not image the heart or vasculature in some manner may fail to provide useful structural detail or information that is needed to obtain an accurate assessment of a patient's current vascular health or is inadequate for use in predicting future vascular health. Alternatively, less-complex imaging methods that provide quantitative information about the hemodynamic significance of vascular anomalies, such as doppler ultrasound, may be used but all imaging techniques require a greater degree of complexity and training on the part of the operator, or require more sophisticated medical equipment. This makes continuous monitoring not feasible as the imaging methods require separate equipment and may not be necessarily available in any setting, especially outside a medical treatment facility.
Certain embodiments commensurate in scope with the originally-claimed subject matter are summarized below. These embodiments are not intended to limit the scope of the claimed subject matter, but rather these embodiments are intended only to provide a brief summary of possible embodiments. Indeed, the invention may encompass a variety of forms that may be similar to or different from the embodiments set forth below.
The present disclosure relates to the use of acquired acoustic signals in a vascular monitoring or assessment context. In various described implementations, the acquired acoustic signals (e.g., acoustic spectral signals—frequency-dependent energy content in the acoustic signal—or acoustic temporal signals) for a patient may be used to assess a current vascular state of the patient or assess or predict future vascular characteristics of the patient. In certain implementations, the current acoustic signals are used in conjunction with a model or other data construct that relates image or other structural and/or functional vascular data to corresponding acoustic signals. In this manner, the current acoustic signal may be related to a structural and/or functional assessment of the vasculature, which may be used to assess a current patient state or to assess the risk for future cardiovascular events.
The present disclosure also teaches that for a specific patient, the changes in acoustic spectral signals can be better predicted if coupled with prior imaging data that characterize the vascular region and associated collateral vascular structures relevant to the site of the vascular anomaly, and a baseline acoustic spectral measurement. Subsequent to this, changes in the vascular anomaly, i.e., changes in vessel cross-sectional area or regurgitant volume in the case of valvular anomalies, can be modeled and the resulting changes in the acoustic spectral signal can be predicted and matched with the physical change in the vascular anomaly, and the associated hemodynamic significance. As such, any measured acoustic spectral signal can be matched to the modeled acoustic spectral signature to provide an accurate assessment of the change in hemodynamic significance of the progression or regression of vascular disease without enduring multiple diagnostic imaging sessions. Furthermore, this approach, after acquiring a baseline examination to provide the prior imaging data for information on the vascular structure and hemodynamic vascular data, generates a patient-specific library of possible changes as a function of vascular anomalies. This allows at any point in time, comparison of the present acoustic spectral signature with that of the patient-specific library to determine the severity of the vascular anomaly in a rapid and simple manner without requiring additional complex imaging
These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein:
One or more specific embodiments will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.
When introducing elements of various embodiments of the present invention, the articles “a,” “an,” “the,” and “said” are intended to mean that there are one or more of the elements. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Furthermore, any numerical examples in the following discussion are intended to be non-limiting, and thus additional numerical values, ranges, and percentages are within the scope of the disclosed embodiments.
As discussed herein, assessment of current or predicted vascular conditions using acoustic signals is described. In accordance with the techniques discussed herein the acoustic signals may be used in conjunction with models or constructs generated based on prior acoustic, structural, and hemodynamic data (e.g., from X-ray-based angiography data, computed tomography data, magnetic resonance data, ultrasound data, population models, and so forth, and combinations thereof) to predict the acoustic spectral signature corresponding to a current or future vascular prognosis for a patient. With this in mind, certain specific use cases may be described herein to provide real-world contexts and to simplify explanation. It should be understood, however, that the examples discussed herein are provided merely to illustrate and provide context for the present techniques, and should not be construed as limiting. Specifically, although the techniques are described in the context of assessing patency of coronary arteries, the techniques are applicable to vascular disease in other contexts, e.g., peripheral cardiovascular disease, valvular disease, cardiovascular disease of non-cardiac organ systems, and so forth.
With the preceding in mind, and by way of providing useful context,
In the depicted example, the sensor 12 is in communication with an acoustic monitoring system 20. The depicted example depicts a physical or wired connection, though it should be understood that the sensor 12 and acoustic monitoring system may also communicate wirelessly. A processing component 24 (e.g., a microprocessor) may be used to execute stored routines (such as routines stored in a memory 26, to process data acquired using the sensor 12 and to output an acoustic signal 30 (e.g., an acoustic spectral signature or sound spectrum) representative of the acquired acoustic data. Acoustic signal 30 may be analyzed directly or compared to longitudinal data and/or data generated using one or more models of vasculature and surrounding environment.
With the preceding system level discussion in mind as useful context, the present techniques may utilize such an acoustic sensing system 10 to acquire acoustic or sound data that may be used in the evaluation of vasculature of a patient. As noted above, though the present discussion may utilize a specific example to provide context, the present techniques should be understood to be generally applicable to detecting or predicting a range of (if not all) vascular defects or irregularities based on acoustic signature data.
One implementation of the current technique, unlike prior techniques, uses images previously acquired of the patient and an acoustic signature (e.g., an acoustic signature acquired contemporaneously or close to contemporaneously with imaging data in the example below) to create a patient-specific model of sound propagation from vasculature of interest (e.g., the coronary arteries). This model may then be subsequently used to monitor the progression of a vascular disease, such as to determine the degree of stenosis or re-stenosis, using subsequently acquired acoustic signals. In a further aspect, population-based images may be used to generate predictive data when prior, patient-specific imaging information is not available. Such an approach may be useful for risk stratification of asymptomatic patients at risk for coronary artery disease, but without prior history of cardiovascular disease or cardiac events for which image data may be obtained.
To provide one example, the present technique may be useful in evaluating a patient for occurrence of re-stenosis. By way of background, stents are small wire meshes used to invasively treat arterial blockages. To deploy a stent, a catheter is inserted into a blocked artery during an interventional procedure, typically under X-ray guidance. Angioplasty is used to reestablish blood flow and the stent is then deployed within the location of the previous blockage, thereby allowing blood to pass more freely.
However, over time, the artery may become blocked again due to excessive tissue growth and/or plaque deposition around the stent. This is referred to as a re-stenosis. In the case of the coronary arteries, re-stenosis can lead to recurrence of previously alleviated symptoms, such as angina, indicating that the blood flow to the heart is not sufficient to supply the patient's needs. The patient then may need to undergo another interventional procedure to assess vessel patency and/or again open the blocked artery.
Current clinical guidelines recommend invasive coronary angiography for symptomatic patients to check for the presence of re-stenosis. Approximately, 900,000 coronary interventions involving stent placement are performed yearly in the US and re-stenosis rates of 12% to 30% have been reported. The average cost of a coronary angiogram to check for the presence of re-stenosis is around $3000, not to mention the risks associated with this invasive procedure, and the additional contrast and radiation dose to the patient. Thus, a low-cost method to non-invasively evaluate a stented patient, without subjecting the patient to additional radiation and contrast burden, may be of economic and clinical value.
With this in mind, one implementation of the present technique uses previously-acquired X-ray images acquired in the guided procedure for stent deployment, in conjunction with acoustic data, to assess the health of the patient's vasculature, such as the likelihood or extent of re-stenosis. In some cases, X-ray images (or additional X-ray images) may be obtained after the stent placement and such images can also be utilized. In addition to X-ray images obtained during an interventional procedure, suitable images for the present technique may also be obtained using Computed Tomography Angiography (CTA) (such as prior to stent placement), Magnetic Resonance Angiography (MRA), phase-contrast Magnetic Resonance Imaging (MRI), Ultrasound, or other suitable imaging technique. The X-ray, CTA, MRA, phase-contrast MRI, or ultrasound images may be uploaded to or maintained on a storage platform, such as a cloud- or network-based storage platform, for further access and use.
This process is shown diagrammatically in
In addition, a sensor 12 of an acoustic sensing system 10 is used to collect acoustic data or signals 30, here depicted as a sound spectrum 30A contemporaneous or close to contemporaneously with the stenting procedure, such that the sound spectrum 30A corresponds to the structural and functional characteristics of the vasculature in question at the time of the procedure. By way of example, in the present stenting context, one or more sensors 12 are placed on the patient's chest wall after stenting and a baseline sound spectrum 30A is recorded. Signal processing techniques may be employed to isolate the sound generated from the coronary arteries from the other larger heart sounds. At a follow-up monitoring (bottom frame of
Using the uploaded or stored images 40, any other available imaging data of the anatomy, e.g. CTA and MRA images, a patient-specific computational model of sound propagation from the vasculature of interest at the time of stenting is generated and tuned to match the sound spectra at baseline (sound spectrum 30A). It is to be understood that in constructing this model not only are the stored images used to extract the vessel anatomy but also the blood flow in the vessels of interest. The flow in the vessel of interest could be obtained based on contrast dynamics information in stored X-ray/CTA images. It could also be obtained from stored phase-contrast MRI images, Doppler Ultrasound, or other suitable imaging techniques. The stored images could be two-, three-, or four-dimensional, the fourth dimension being time. Flow information extracted could be the volume flow rate or the velocity field in the vessel of interest as a function of time. In addition, the sensor measurements at baseline can be calibrated against the flow obtained from the baseline patient images and the calibrated sensor can be then used to predict the flow at subsequent time points in addition to the acoustic signature. To generate the computational model, the stored images are segmented to extract the vasculature of interest as well as the surrounding structures. Using the segmented vessel, transient hemodynamics calculations are conducted. Flow in the vessels of interest, obtained from the stored images, are used as boundary conditions. Pressure fluctuations, obtained on the vessel walls from the hemodynamics calculations, are then used as input for a linearized structural wave equation for the propagation of vibrations through the surrounding tissue. This describes a one-way coupled computational model. A two-way coupled approach can also be used, where the hemodynamics and the propagation of vibrations through the surrounding structures are solved at the same time. The generated computational model is then used to estimate the change in stenosis size needed to generate the observed differences in sound spectra between the baseline scan (sound spectrum 30A) and the one recorded at follow-up (sound spectrum 30B). These steps are illustrated in
In a further aspect, the present techniques may also be employed to provide a low-cost process for stratifying patients at risk of their first cardiac event (i.e., patients for whom prior screening data may not exist). By way of example, an implementation of this technique may be useful for detection (and subsequent therapy monitoring) of the presence of vulnerable plaques in high-risk individuals suspected of coronary artery disease. Approximately, 550,000 individuals in the United States have their first ischemic cardiac event each year without any a priori knowledge of heart disease. However, their risk factors (such as body habitus, sedentary lifestyle, smoking history, in vitro diagnostics, etc.) may indicate that they may be at risk for the disease. Of these, approximately 350,000 of the patients will not survive this first cardiac event. In practice, it may not be cost-effective to screen this patient cohort with medical imaging due to the time and expense involved. As such, a readily-available, low-cost, non-invasive method to first identify at-risk individuals, and then to monitor disease regression/progression in these individual longitudinally or during treatment would be of high value.
With this in mind, in one implementation, for a population where X-ray or CTA images may not be available (such as individuals previously untreated for heart disease), a population-derived model of a typical heart and coronary vasculature may instead be derived. One can then assume blockages in the population-derived coronary vessel models to characterize sound spectra signatures for classes of one or more stenosis (or other vascular structural features/anomalies), either in single-vessel or multi-vessel disease presentation. Population data can then be used to estimate prognostics or diagnostics (e.g., stenosis percentages) by correlating these sound spectra signatures to patient-specific measurements using sensors positioned on the patient's chest wall. In some embodiments, the population data could be augmented by low-cost, non-invasive ultrasound data acquired concurrently during the procedure to improve the relevance of the population data.
This process is shown diagrammatically in
At a screening examination (bottom frame of
At step 70, the measured screening sound spectrum 30C may be compared to or correlated with the representative acoustic spectral signatures 66 which correspond to or incorporate various structural irregularities or defects. Based on this comparison, the patient 18 may be risk stratified (step 72) (e.g., extremely high risk, high risk, moderate risk, low risk, etc.) for future cardiac events from cardiovascular anomalies, e.g., vascular defects in one or more coronary arteries or valvular defects. In this manner, a patient may be non-noninvasively characterized or categorized with respect to various vascular risks. Though the present example relates generally to cardiac events, the present approach may be more generally applied to detecting or predicting a range of (if not all) vascular defects or irregularities based on acoustic signature data.
Technical effects of the invention include, but are not limited to, the use of prior images acquired of the patient and stenosis acoustic signature to create a patient-specific model of sound propagation from the coronary arteries. This model is then used to detect the presence of disease and determine the degree of stenosis, using subsequently-acquired acoustic signals. In an alternate embodiment, population-based images are used to generate predictive data when a priori imaging information is not available and this data is used to characterize or categorize at-risk patients suspected of coronary artery disease, but without prior cardiac events.
In another embodiment, illustrated in
Subsequent to this, different estimated acoustic spectral signal signatures 82 can be generated by the vascular model 80 with different degrees of vascular changes or severity of the vascular anomaly 83, with each different vascular state having a unique acoustic spectral signature specific to this patient. These vascular signatures and the modeling of changes would have been previously validated using the population-based data 60. The patient can then have continuous or close-to-continuous monitoring with the measured acoustic spectral signal matched against the library of acoustic spectral signatures 81 specific to that patient. In this manner, the physician can be alerted as to any significant change in the hemodynamic significance of the vascular anomaly of the patient and intervene accordingly.
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims. For example, in the descriptions above, the acoustic signals have been characterized by spectral content. The acoustic signals also can be characterized by their time-domain representations or signatures. The relationship between time-domain and spectral-domain representations is known in the art, and the methods described herein equally apply to time-domain representations or signatures. Furthermore, in the description above, acoustic signals are used to explain the multiple embodiments. However, the use of the term “acoustic signal” is not meant to be limiting, and signals with spectral or temporal components outside of the audible range are also contemplated.
This application claims priority to and the benefit of Provisional Patent Application No. 62/793,278, entitled “VASCULAR ASSESSMENT USING ACOUSTIC SENSING”, filed Jan. 16, 2019, which is herein incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US2020/013935 | 1/16/2020 | WO | 00 |