Abstract:
A method for acquiring, externally or internally, for utility purposes a subject&#39;s anatomical heart-sound information including (a) for a selected time period, applying continuous, near-sensor-mechanical-resonance, vibratory stimulation to an acoustic sensor placed on or within the subject&#39;s anatomy, and (b) during that time period, detecting, as direct indications of heart sounds, changes in the sensor&#39;s physical resonance properties produced by heart sounds arriving at the sensor.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]    This Application claims priority to U.S. Provisional Patent Application Ser. No. 61/068,353, filed Mar. 6, 2008, for “Heart Activity Sound Monitoring”, the contents of which are incorporated hereinto by reference. 
     
    
     BACKGROUND AND SUMMARY OF THE INVENTION  
       [0002]    This invention relates to methodology enabling, selectively, external, or implantable, active detection of anatomical acoustic heart-sound information. Specifically it pertains to an active method based upon: (a) utilizing a wave-generator-driven stimulator, or actuator, to stimulate mechanically, and thereby vibrate, an acoustic sensor (designed especially for capturing heart sounds, and placed externally on, or within, the anatomy) at a frequency close to the sensor&#39;s nominal, characteristic, mechanical resonance frequency; (b) observing variations in this characteristic mechanical frequency that occur over time in the sensor as a consequence of the mechanical impinging of acoustic waves, and particularly heart-sound waves; and then (c) effectively recognizing that these time-based variations may accurately and thoughtfully be interpreted as being representative of occurring anatomical acoustical activity, and in particular, heart sounds. 
         [0003]    With this unique approach, acoustic sensitivity is very high, and so also is signal-to-noise ratio. For primary illustration purposes herein, one preferred and best-mode manner of practicing the methodology of the invention is described chiefly in the “external” placement and operational setting, wherein it has been found to offer exemplary performance. 
         [0004]    Regarding the prior-art setting of the present invention, external electronic and acoustic transducers have been used, and are well known, to detect chest wall vibrations caused by heart sounds. Generally, passive transducer systems have been employed to detect such vibrations. These transducers typically employ any of microphones embedded in a generally bell-shaped (or other) housing, accelerometer techniques using piezoelectric and/or resistive transducers, or fully integrated medical event-monitoring systems (MEMS) devices. The techniques used in conjunction with such known devices and techniques are often limited because of less than satisfactory sensitivity and signal-to-noise-ratio behaviors associated with the transducers. 
         [0005]    In general terms, overall prior art data-collection practice for evaluating, and even for “driving” real-time therapy and treatment of, cardio-function conditions of a subject&#39;s heart involves principally the gathering of two, different categories of data—electrical, and acoustical. For example, ECG-electrical information for diagnostic purposes, such as for providing “synchronizing” fiducial markers to understand when certain heart-activity events are occurring, as well as for other important reasons, is very well known. Known also is the fact that collected, heart-activity-produced sound (acoustical) information, i.e., heart sounds, provides extremely useful diagnostic data. With respect to the matter of heart-sound collection, since the early days of phonocardiography, the importance of gathering the so-called S 1 , S 2 , S 3  and S 4  heart sounds has been clearly recognized. Information-gathering practice over the years has demonstrated how electrical ECG signals and the important, heart-produced S 1 , S 2 , S 3  and S 4  heart-sound signals may be correlated in different ways to produce accurate, useful diagnostic information. 
         [0006]    In all of this background, heart-related, signal-collection practice, a continuing challenge remains. It relates to achieving the clear, accurate and plainly identifiable gathering of heart sounds. The present invention focuses its attention on this issue, and does so with a featured, special and unique, “active”, rather than purely passive, methodology which may be practiced either externally, or implantably, as, for example, in association with an implanted pacemaker. 
         [0007]    In accordance with a preferred, and best-mode, implementation of the invention, what is proposed is a method for acquiring, for various utility purposes, such as the display-presentation of accurate heart-sound data, or the establishment of a patient-treatment protocol, among others, a subject&#39;s anatomical heart-sound information involving the following basic steps: 
         [0008]    (a) utilizing a wave-generator-driven stimulator, or actuator, to stimulate mechanically, and vibrate, an acoustic sensor (placed on or within the anatomy) at a frequency close to the sensor&#39;s nominal, characteristic, mechanical resonance frequency; 
         [0009]    (b) observing variations in this characteristic mechanical frequency that occur over time in the sensor as a consequence of the mechanical impinging of acoustic heart-sound waves; and then 
         [0010]    (c) effectively recognizing that these time-based variations may accurately be interpreted as being representative of occurring heart sounds. 
         [0011]    In a more specific sense, the invention furnishes a unique, active method for acquiring a subject&#39;s anatomical heart-sound information which is useful in performing a cardio investigation, and in producing a related utility output, such as the ones briefly mentioned above, involving that subject. This method more specifically includes the steps of: 
         [0012]    (a) placing on or within the subject&#39;s anatomy at a selected anatomical site an acoustic sensor having the form of an acoustical-to-electrical-output transducer possessing a known, characteristic mechanical resonance frequency; 
         [0013]    (b) using a wave generator having an electrical output, stimulating (actuating) the transducer via an actuator to vibrate the transducer mechanically at a frequency which is close to its characteristic resonance frequency; 
         [0014]    (c) coupling to a frequency and phase comparator the electrical outputs of the transducer and of the wave generator; 
         [0015]    (d) observing over time any time-based differences which exist between the two, thus-compared outputs; 
         [0016]    (e) interpreting such observed differences as being representations of the subject&#39;s heart sounds; and 
         [0017]    (f) from such interpreted differences, producing a utility output associated with the subject. 
         [0018]    The transducer and the actuator/stimulator may either be directly mechanically integrated in a unified structure, or alternatively, may be non-integrated, but used during practice of the method of the invention in what might be referred to as being in close “mechanical communication”, i.e., in close proximity to one another, as through closely adjacent contact with a subject&#39;s anatomy. While certain modest structural suggestions are made herein, it should be understood that the present invention is not concerned with the particular structural configuration(s) chosen for the transducer/actuator component, or components, and thus no special details of either are elaborated herein. Those generally skilled in the relevant art will know how to configure and implement such structures in conventional manners, both for external and internal (implanted) applications. 
         [0019]    Preferably, the transducer is selected to possess a natural mechanical resonance frequency which lies within the known range of heart-sound frequencies (about 5-Hz to about 110-Hz). We have found that a good range to consider for this resonance frequency is about 10-Hz to about 110-Hz, and we illustrate the invention herein with an excellent choice of about 30-Hz. With this natural mechanical resonance frequency chosen for the transducer, a good, and very practical stimulation/vibration frequency has been found to be about 15-Hz. This turns out to be a frequency which resides naturally toward one side of the peak natural resonance frequency response curve, or graph, of the transducer, and “lies” on that curve at a point which is approximately centered on, and between the opposite ends of, one of the two, well-recognized, substantially linear portions of the response-amplitude curve that are disposed on laterally opposite sides of the “central” natural resonance frequency. 
         [0020]    These and other important features and advantages offered by the methodology of the present invention will become more fully apparent as the description now follows below is read in conjunction with the accompanying drawings. 
     
    
     
       DESCRIPTION OF THE DRAWINGS  
         [0021]      FIG. 1  is a block/schematic diagram of the methodology of the present invention, and also of a system organization which is useful for practicing this methodology. As will be seen,  FIG. 1  is organized and presented in a manner which permits illustrated discussion of several preferred practice versions or modifications of the invention, including both external and implanted (in a pacemaker) applications. 
           [0022]      FIG. 2  is a graph depicting the characteristic relationship (the above-mentioned curve) between frequency and mechanical resonance response amplitude associated with a sensor/transducer which is employed preferably in the practice of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0023]    Turning now to the drawings, and referring first of all to  FIG. 1 , indicated generally at  10 , in block/schematic form, are both the preferred and best-mode versions, or embodiments, of the methodology of the present invention, and a relevant system organization of electrical circuit components which may be assembled as illustrated to carry out and perform the methodology of the invention. Indicated generally at  12  is a fragmentary portion of a subject&#39;s anatomy, such as a portion of the chest, with respect to which the methodology of the invention is to be practiced in accordance with what is shown in  FIG. 1 . Description of the invention will proceed principally and initially in the context of an external application wherein the various circuitry elements/components shown in  FIG. 1  are all disposed outside anatomy  12 . A bracket  13  which appears at the right side of the figure represents aspects of an internal/implanted modified-invention-form application wherein, for example, this bracket specifically represents an implanted pacemaker wherein the same, just-mentioned circuitry elements are present within anatomy  12  in the pacemaker structure, per se. 
         [0024]    Continuing, then, with a representative, external-application description, included further in what is shown in  FIG. 1  are several, solid-outline blocks  14 ,  16 ,  18 ,  20 ,  22 ,  24  and  26 . Different, operative, signal-flow and communication connections, represented by arrow-headed connection, or communication, lines, variously interconnect these blocks, as shown at  28 ,  30 ,  32 ,  34 ,  36 ,  38 , and  40 . Also appearing in  FIG. 1 , within block  14 , is a dash-dot-outline block  16   a,  the nature of which involves another modified form of the invention. Block  16   a  will be explained shortly. 
         [0025]    As can be seen, each of the several blocks which is pictured in solid outline in  FIG. 1  is word-labeled to indicate both its function, and to some extent its structure. 
         [0026]    Block  14  represents an acoustic sensor in the form of what is referred to herein as an acoustic-to-electrical transducer which may take any one of a different number of suitable conventional forms, such as the form of a generally bell-shaped structure (not specifically shown) having a generally circular footprint which seats appropriately against the illustrated, selected site in the anatomy portion of the chest wall shown at  12 . This transducer is equipped with an appropriate device of any nature, such as a microphone like device, a piezoelectric device, etc. which is designed nominally to respond well to anatomical acoustic sounds, and most preferably to each of the four, above-mentioned, recognized, important heart sounds, S 1 , S 2 , S 3  and S 4 , and to produce, on and over communication line in  32 , an electrical signal output which has a waveform that is characteristic of whatever sounds are collected and noted by the transducer. Transducer  14  herein has a known, natural, characteristic resonance frequency of about 30-Hz which, as was mentioned earlier, lies within the known frequency range of the four, above-identified, important heart sounds. 
         [0027]    Block  16  herein represents an energizable actuator or stimulator which may be energized, via signal line  28 , from block  18 —a conventional electrical wave generator. Actuator  16 , as illustrated in solid-outline block form herein, is represented in a condition wherein it is not integrated with transducer  14 , but is being used, in the particular practice of the invention so far described and illustrated in  FIG. 1 , in what is referred to herein as being an operatively mechanically communicative relationship with the transducer, preferably in very close proximity on anatomy  12  to the transducer. Where, as an illustration, transducer  14  is a bell-shaped, circular-footprint device, actuator  16  might usefully be a generally circular, transducer-circumsurrounding, piezoelectric, ceramic ring-like structure. We will assume for the purposes of further, present discussion herein, that these respective configurations and natures of the transducer and actuator are fact. 
         [0028]    It is intended that operation of wave generator  18 , in accordance with practice of the invention, will stimulate actuator  16  by energizing it, which action will thereby stimulate and vibrate the transducer at whatever is the stimulation frequency employed by wave generator  18  to energize the actuator. Generator  18  herein is nominally “referenced”, effectively by block  24 , through block  22  and line  36  (as will be explained), to “operate” at a frequency of about 15-Hz. More will be spoken of this shortly. 
         [0029]    Signal line  40  is electrically the same as line  36 , and functions to send to block  26  exactly the same signal voltage, whatever it is at the moment. Block  26  functions to create what is referred to herein as a utility output which may take one or more of various useful forms, such as a display (as will be explained shortly) of heart-sound waves, a control signal for initiating/performing some form of cardio-function therapy, such as adjusting the operation of a pacemaker, and other things which will readily come to the minds of those skilled in the relevant art. 
         [0030]    Turning attention for a moment to  FIG. 2 , here there is illustrated, generally at  44 , a curve, or a graph, which represents the mechanical natural frequency response characteristic of transducer  14 . Response amplitude A is represented by the vertical axis in  FIG. 2 , and frequency f is represented on the horizontal axis in this figure. 
         [0031]    The central natural resonance frequency of transducer  14  is represented in  FIG. 2  on the horizontal axis therein at f 0 . The illustrated resonance amplitude response characteristic, which is very typical in form, and well understood by those generally skilled in the art, has a somewhat bell-shaped curvature, with opposite lateral sides distributed on the opposite side of the central resonance frequency, and with each side including a generally linear region, such as the linear region shown by a darkened portion  44   a  of curve  44  located toward the left side in  FIG. 2 . In general terms, the nominal frequency at which wave generator  18  stimulates and excites actuator  16 , thereby similarly stimulating and vibrating transducer  14  is represented by a vertical, dashed line  46  in  FIG. 2 , and is labeled on the horizontal axis in this figure with the designator f op . One can see in  FIG. 2  that this stimulation frequency intersects linear portion  44   a  approximately centrally between that portion&#39;s opposite ends. 
         [0032]    As was indicated earlier herein, transducer  14  has been selected to have a central natural resonance frequency of about 30-Hz, and that the stimulation operating frequency of wave generator  18 , under this circumstance, has been chosen to be about 15-Hz. Accordingly, axis mark f 0  in  FIG. 2  indicates the frequency 30-Hz, and axis mark f op  in this figure indicates the frequency 15-Hz. 
         [0033]    Blocks  20  and  22  in  FIG. 1  respectively represent the structures and functionalities of a Lock-in Amplifier Comparator, and a PID (proportional integral derivative) Amplifier Comparator, which are conventional structures that perform conventional functions, and which are well understood by those generally skilled in the art. Nominally, i.e., in the absence of any anatomical acoustic sounds detected by transducer  14 , in-phase electrical output signals from wave generator  18  are supplied at the frequency of 15-Hz via communication line  28  to actuator  16 , and via communication line  30  to one of two, provided comparator inputs in block  20 , the lock-in amplifier comparator. Electrical output signals, of whatever nature, from transducer  14  are supplied to the other comparator input in block  20  via communication line  32 . The electrical “comparison” output of block  20  (shortly to be explained) is coupled to one of two, provided comparator inputs in PID Amplifier Comparator block  22  by communication line  34 , and what will be referred to herein as a wave-generator frequency-control signal (which will also shortly be explained) is supplied by block  22  via communication line  36  to the wave generator. This very same signal, as was mentioned above, is furnished by signal line  40  to utility output block  26 . 
         [0034]    Nominally, block  24  functions as a DC Reference voltage block which supplies a DC reference voltage via signal line  38  to the other comparator input in comparator block  22 . This arrangement results in Reference block  24  effectively, nominally, through block  22 , and signal line  36 , establishing the mentioned 15-Hz operating frequency for output from wave generator  18  via signal line  28  to actuator  16 , and via signal line  30 , to the lock-in amplifier comparator represented by block  20 . These so-called nominal conditions are the conditions existing in the absence of any anatomical acoustic activity (waves) detected by transducer  14 . 
         [0035]    By way of an operation which will shortly be described, signal line  40  couples an appropriate output control signal from block  22  to block  26 . Block  26  represents the generation and or production by the methodology of the present invention of what is referred to as a utility output. This utility output may take the form of an appropriate output readout provided on a display screen to inform an operator of the methodology of information acquired from a subject, may be utilized to perform certain tasks that are related to managing the hemodynamic condition of the subject whose data is being collected, and otherwise may be employed for the production of an appropriate therapy or treatment protocol for a particular subject. 
         [0036]    One aspect to note in relation to what has just been described in relation to  FIG. 1  is that transducer  14 , actuator  16 , wave generator  18 , lock-in amplifier comparator  20 , and referenced PID amplifier comparator  22  are organized in a closed, negative feedback circuit or loop which plays an important role, as will become apparent, in the practice of the methodology of the invention. 
         [0037]    Explaining now the operation of what is shown and has just been described in relation to  FIG. 1 , and starting this description under circumstances where no anatomical acoustic waves, such as heart sounds, are being detected by transducer  14 , wave generator  18 , through adapter  16 , stimulates and vibrates the transducer at the frequency of 15-Hz. Transducer  14  responds to this vibratory stimulation to produce an electrical output signal having an amplitude which is related to the amplitude of its mechanical frequency response curve at the location pictured in  FIG. 2  where dashed line  46  intersects linear portion  44   a  in the curve  44 . This signal is in-phase with the vibratory stimulation signal then being sent by wave generator  18 . 
         [0038]    The transducers&#39; electrical output signal is supplied to amplifier comparator  20  via signal line  32 , is compared in comparator  20  with the same-frequency, and in-phase, signal supplied by wave generator  18  to the amplifier comparator  20  via signal line  30 , and the result is that comparator  20  produces, on signal line  34 , some level of a DC voltage. This line- 34  DC voltage, when compared in PID amplifier comparator  22  with the DC reference voltage supplied from reference block  24  over line  38 , produces some predetermined DC voltage on line  36  which, when applied as shown to wave generator  18 , functions to maintain the operating frequency of the wave generator substantially constant at 15-Hz. 
         [0039]    Those skilled in the art will recognize that there are many levels of appropriate DC voltages, of the characters and functionalities just mentioned, which may be established in the “nominal” operating pattern that has just been described. Under these “nominal” conditions, there exists in the arrangement shown at  10  in  FIG. 1 , a steady-state condition having the features just described. This condition, of course, is largely a fiction, disappearing just as soon as transducer  14  is positioned to react to anatomical acoustic behavior, but the description of the “nominal” condition sets an informative stage for understanding what takes place when such a reaction begins occurring. 
         [0040]    This “nominal” situation thus changes immediately upon receipt by transducer  14  of impacting mechanical sound waves, such as heart-sound waves, coming from anatomy  12 . When this occurs, these impacting sound waves effectively change and alter the characteristic resonance frequency of the transducer, causing the transducer&#39;s resonance-frequency response curve which is pictured in  FIG. 2  to shift to the left or to the right, and in fact continuously laterally back and forth in that figure relative to dashed line  46  in accordance with the amplitude and phase of the impacting sound waves. 
         [0041]    This responsive change in the behavior of transducer  14  produces a time-based voltage variation in the transducer&#39;s electrical output signal which appears on signal line  32 , and thus at one of the two, earlier-mentioned comparator inputs present in amplifier comparator  20 . In amplifier comparator  20 , this situation produces an immediate comparison with the signal being provided thereto from the wave generator over signal line  30 , and what then results is a time-based voltage shift in the voltage level present on signal line  34  which is supplied to one of the earlier-mentioned comparator inputs provided in PID amplifier comparator  22 . 
         [0042]    A consequence of this operation, of course, is that the time-based voltage changes, or variations, arriving from transducer  14 , which variations then become distinguished by comparison in block  20  with the voltage waveform arriving from the wave generator, produce on signal line  34  a time-varying voltage whose variations directly follow the waveform(s) of the acoustic information arriving at the transducer. In other words, what now appears on line  34  is a signal which directly follows, and thereby directly indicates, transducer-received anatomical acoustic sounds—the S 1 , S 2 , S 3  and S 4  sounds 
         [0043]    Supplied, then, by block  20  to amplifier comparator block  22 , over signal line  34 , to become compared in block  22  with the fixed DC reference voltage supplied over line  38  by block  24  to block  22 , is this time-varying voltage signal just described on line  34 . The comparison which then takes place in block  22  produces, on each of signal lines  36 ,  40 , a common, time-based varying voltage signal which also, and very clearly, directly follows the waveform(s) of the acoustic S 1 , S 2 , S 3  and S 4  waves impacting the transducer. This “common” signal now has two functionalities. 
         [0044]    The first of these functionalities involves the delivery of this varying voltage signal to the wave generator over signal line  36 . The effect of this delivery is to perform, in a negative feedback manner, real-time, voltage-variation-following adjustments, up and down, in the operating frequency f op  of the wave generator in an attempt to maintain the relative point of intersection between line segment  44   a  and dashed line  46  exactly as shown in  FIG. 2 , no matter in what lateral direction resonance curve  44  shifts as a consequence of changes occurring in the natural resonance frequency of transducer  14  as determined by the now time-varying, transducer-impacting, anatomical, acoustical wave information (i.e., the “impacting” heart-sound information). 
         [0045]    The second functionality involves the effect(s) of what is commonly delivered via signal line  40  to utility output block  26 . More specifically, line  40  supplies to block  26  the same time-varying voltage signal which is directly reflective of acoustic information impacting transducer  14 . Block  26 , as determined freely by the user of this invention, provides a desired utility output which might take the form of a direct display of heart-sound wave forms, a display of numeric and/or text data relating to these waveforms, a control signal, or signals, employable to establish or implement a heart-treatment protocol, such as adjusting/controlling the operation of a pacemaker, and so forth. 
         [0046]    The system, the methodology, and their interrelated operations which have just been described will clearly be understood by those skilled in the art to furnish a performance which is distinguished by an extremely high signal-to-noise ratio with respect to gathered acoustical anatomical signals, such as heart-sound signals, accompanied by a large, “effective” sensitivity of transducer  14  regarding such acoustic information. 
         [0047]    Turning attention now back briefly to previously mentioned dash-dot-outline block  16   a  which appears inside the perimeter of transducer block  14  in  FIG. 1 , block  16   a  represents a version—a variation—of the invention wherein transducer  14  has been prepared with a fully integrated, i.e., fully mechanically integrated, actuator. 
         [0048]    Also as was mentioned earlier, bracket  13  in  FIG. 1  represents yet another variation in the implementation of the methodology of the present invention. Specifically, this bracket represents a modified practice wherein what is shown in  FIG. 1  is fully embedded within the structure of an anatomically implanted, or implantable, device, such as a pacemaker. In such a modified application, except for the facts that heart-sound signal-gathering activities in terms of transducer vibrating, and of “negative-feedback” adjusting of the stimulating frequency of an actuator, take place entirely within the anatomy, in all other respects, this modification of the invention performs in substantially exactly the same manner which has just been described in conjunction with the described, external methodology application. 
         [0049]    The practice of the present invention thus features and involves producing a mechanical disturbance in the natural resonance characteristics of an acoustic transducer—a disturbance which, through the unique application of negative feedback, effectively increases both the signal-to-noise functioning capability, and the effective signal-gathering sensitivity, of that transducer in the practice of gathering heart-sound signals. The fundamental steps of the invention, and relevant, more detailed facets thereof, are expressed in the below-following claims to invention 
         [0050]    Accordingly, while preferred and best-mode methodology practices, along with certain illustrated and/or suggested variations, have been described herein for improving greatly the signal-to-noise and sensitivity behaviors of an acoustic transducer designed to gather the important, earlier mentioned heart-sounds, we appreciate that other variations and modifications than those specifically mentioned herein may be made without departing from the spirit of the invention.