| Method and algorithm for defining the pathologic state from a plurality of intrinsically and extrinsically derived signals -> Monitor Keywords |
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Method and algorithm for defining the pathologic state from a plurality of intrinsically and extrinsically derived signalsRelated Patent Categories: Surgery: Light, Thermal, And Electrical Application, Light, Thermal, And Electrical Application, Electrical Therapeutic Systems, Control Signal Storage (e.g., Programming)Method and algorithm for defining the pathologic state from a plurality of intrinsically and extrinsically derived signals description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060167529, Method and algorithm for defining the pathologic state from a plurality of intrinsically and extrinsically derived signals. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] This patent application claims priority to provisional patent applications No. 60/647,102 filed Jan. 26, 2005; and 60/660,101 filed Mar. 9, 2005, incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This application pertains to a system and apparatus for determining the status of a patient and more particularly to a system and apparatus wherein measurements from the patient are combined with external information such as statistical information collected from other patients and results of diagnostic testing to obtain a diagnosis, treatment options and prognostic information for the patient quickly and accurately using evidence based medicine. [0004] 2. Description of the Prior Art [0005] Major advances are occurring in the development of imaging modalities and implantable technologies capable of diagnosing and treating a variety of pathophysiology. Thus, the clinician has numerous diagnostic tests at his or her disposal and an option of therapeutic regimens. Coupled with the wealth information from these tests, there is a need to expeditiously evaluate the results of a plethora of diagnostic tests, and compare the data to historical data sets. Treatment algorithms designed to assess such informational data sets provide better direct therapy (evidence-based medicine). [0006] To a large extent, practice decisions based on anecdotal data and individual studies have dictated medical practice to date. However, large scale population studies and the development of registries along with digitization of acquired diagnostic data obtained from these studies provide more powerful statistical analyses of patient outcome by comparing differing therapeutic modalities. The availability of such data will depend on a means for device-device communication and the evolution of wide range digitization of medical records and of data derived from different diagnostic equipment. Though the majority of the algorithms and examples described herein are in reference to advances in cardiovascular medicine and genetics, the inventions described have broad range application to any medical field. [0007] The advent of digital signal processing (DSP) in evolving technologies (e.g. implantable pacemaker/defibrillators) will allow for informational data sets to be available in discrete numeric format, processed by high-speed microprocessors, and incorporated into device-based software algorithms. Such processing will allow a user to relate, in a complementary fashion, clinically relevant data obtained from both an imaging apparatus and implanted device as to derive a composite of information for diagnostic purposes and for optimizing patient management. The application of DSP will enable calculation algorithms to perform several processing operations simultaneously. [0008] By way of example, software algorithms for readily evaluating a number of variables descriptive of cardiac performance and electromechanical dysynchrony (physiological properties) are assimilated within an implanted device or downloaded between an implanted device and a separate apparatus/extrinsic diagnostic equipment (e.g. echocardiography machine, cardiac MRI). A composite of physiological properties obtained from the implanted device is digitized (if necessary) and compared to normal and pathologic values as to generate physiological descriptors that have a numerical score. Models constructed to predict probability of outcome from the data obtained are implemented for such comparisons (Selker et al. Patient specific predictions of outcomes in myocardial infarction for real-time emergency use: a thrombolytic predictive instrument. Ann Intern med 1997; 127: 538-56). These physiologic descriptors are then input into software algorithms as to produce an informational data set of clinical and technical relevance. This informational data set (IDS) is output in form of an easily interpretable set of recommendations or prognostic data for the clinician. In one embodiment, such IDS can be downloaded into removable digital storage media or other media compatible with implanted device software and incorporated into an electronic medical record (EMR). In a preferred embodiment, the IDS is available to closed loop control systems that direct device based therapies (e.g. Cardiac Resynchronization Therapy, CRT). [0009] The following references provide background information for the present application and illustrate the state of the art. All these references are incorporated by reference. U.S. Pat. Nos. 6,804,559, 6,795,732, 6,792,308, 6,816,301, 6,572,560, 6,070,100, 6,725,091, 6,628,988, 6,740,033, 5,971,931, 5,833,623, 6,826,509, 6,805,667, 6,574,511, 6,418,346, 5,549,650 Published US patent applications: 20040176810, 20030083702, 20020026103, 20040111127, 20020072784, 20030216620, 20040167587, 20050182447, 20050043895 REFERENCES IN PEER-REVIEWED JOURNALS [0010] Meluzin Jaroslav, Novak Miroslav, Mullerova Jolana, Krejci Jan, Hude Petr, Eisenberger Martin, Dusek Ladislav, Dvorak, Ivo, Spinarova Lenka, A fast and simple echocardiographic method of determination of the optimal atrioventricular delay in patients after biventricular stimulation. PACE, 2004. 27: p. 58-64. [0011] Perego Giovanni B, Chianca Roberto, Facchini Mario, Frattola Alessandra, Balla Eva, Zucchi Stefania, Cavaglia Sergio, Vicini Ilaria, Negretto Marco, Osculati Giuseppe, Simultaneous vs. sequential biventricular pacing in dilated cardiomyopathy: an acute hemodynamic study. The European Journal of Heart Failure, 2003. 5: p. 305-313. [0012] Ritter P, Padeletti L, Gillio-Meina L, Gaggini G., Determination of the optimal atrioventricular delay in DDD pacing. Europace, 1999. 1: p. 126-130. [0013] Van Gelder Berry M, Bracke Frank A, Meijer Albert, Lakerveld Lex J M, Pijis Nico H J, Effect of optimizing the VV interval on left ventricular contractility in cardiac resynchronization therapy. Am J Cardiol, 2004. 93: p. 1500-1503. [0014] Yu C M, Lin H, Zhang Q., High prevalence of left ventricular systolic and diastolic asynchrony in patients with congestive heart failure and normal QRS duration. Heart, 2003. 89: p. 54-60. [0015] Pappone C, Augello G, Rosanio S, et al. First Human Chronic Experience with Cardiac Contractility Modulation by Nonexcitatory Electrical Currents for Treating Systolic Heart Failure: Mid-Term Safety and Efficacy Results from a Multicenter Study. J Cardiovasc Electrophysiol, 2004; 15, 418-422. [0016] Dipla K, Mattiello J A, Margulies K B et al. The sarcoplasmic reticulum and the sodium/calcium exchanger both contribute to the calcium transient of failing human ventricular myocytes. Circ Res 1999; 84: 435-444. [0017] Burkoff D, Shemer I, Feizen B, et al. Electric currents applied during the refractory period can modulate cardiac contractility in vitro and in vivo. Heart Fail Rev 2001; 6: 27-34. [0018] Pappone C, Rosanio S, Burkoff D, et al. Cardiac Contractility Modulation by Electric Currents Applied During the Refractory Period in Patients with Heart Failure Secondary to Ischemic or Idiopathic Dilated Cardiomyopathy. Am J Cardiol 2002; 90: 1307-1313. [0019] Willems R, Sipido K R. Nonexcitatory Stimulation as a novel treatment for heart failure: cause for excitement? European Heart Journal 2004. 25: 626-628. [0020] Padeletti L, Barold S S. Digital Technology for Cardiac Pacing. Am J Cardiolo 2005; 95: 479-482. [0021] Thomas J D, Greenberg N L, Garcia M J. Digital echocardiography 2002: now is the time. J Am Soc Echocardiograpy 2002; 15: 831-8. [0022] Feignebaum H. Digital echocardiography [review]. Am J Cardiology 2000; 86: 2G-3G. SUMMARY OF THE INVENTION [0023] The present invention relates to acquiring a plurality of diagnostic information based on intrinsic properties of a given patient and extrinsic information derived from diagnostic testing performed on the patient, and combining the available data to derive prognostic information about a specific pathologic state using evidence based medicine. Recommendations for therapy delivered intrinsically via an implanted device or extrinsically via various therapeutic modalities are made with such analysis algorithms. Some of the examples used herein are focused mainly on implantable cardiac rhythm management (CRM) devices and other similar devices for diagnosing or treating heart failure. These types of devices generate a multitude of measurements diagnostic of a specific pathologic state, based on software algorithms incorporated into device-based platforms to obtain a composite of relevant physiological data from implanted sensors/transducers. The algorithms generate informational data sets for diagnostic/monitoring purposes with the object of guiding physician management and/or programming of an implanted device via a closed loop control system. Such informational data sets may be used, for example, to guide titration of pharmaceutical therapies, diagnose myocardial ischemia or determine a patient's candidacy for coronary revascularization or valve replacement surgery. This technology is also capable of incorporating downloadable indices/data from extrinsic diagnostic equipment into implanted devices/programmers and vice versa at periodic intervals via removable digital media (e.g. removable hard drive, magnetic-optical disc) or wireless telemetry (e.g. Bluetooth). Bi-directional communication of this data is used to confirm adequate functioning of an implanted device and verify diagnoses made with extrinsic equipment (cross-verification). This data can be examined to confirm response to specific therapeutic modalities such as cardiac resynchronization therapy (CRT), cardiac contractility modulation (CCM) or alternate Non-Pharmacologic Inotropic Therapy (NPIT). [0024] In an alternate application, these algorithms are used in the field of genetic medicine through a similar means, combining data reflective of properties intrinsic to an individual in conjunction with environmentally based or extrinsic characteristics of that individual in context of known predictors of a given disease state derived from large population studies. [0025] Diagnostic imaging modalities are moving toward digitization with standardization of storage format adherent to standard models (Digital Imaging and Communication in Medicine). Thus, there is a need to formulate composite indices which can be digitally processed and input into fast software algorithms for processing. Extrinsically derived composite indices can be evaluated from time to time and compared to similar indices generated from an implanted device (intrinsic), assimilated into an implanted device's existing diagnostic data. Translation of mathematical indices derived from signals acquired by implanted device sensors into conventional indices commonly used with external imaging modalities will facilitate device-device communication. [0026] Through the utilization of this invention, a means of translation between analogous intrinsic/extrinsic indices is developed from the acquired pooled data after significant numbers of patients gain access to these technologies. The concepts underlying this invention are extended to imaging technologies including, but not limited to, echocardiography, magnetic resonance imaging, PET scans, nuclear imaging or computed tomography, and other diagnostic/laboratory tests. The extrinsically derived composite data can be downloaded into an implanted device for storage (e.g. medical record keeping) and available to the clinician in combination with similarly derived device based indices. The combined informational data set (intrinsic and extrinsic) can then more accurately provide prognostic information and generate recommendations for various therapies (e.g. using neural networks). Comparisons between extrinsic and intrinsic diagnostic data can be used to confirm diagnoses (e.g. presence of myocardial ischemia). A method and means for correlating intrinsically and extrinsically derived data with a translation function is developed once large numbers of patients have access to these technologies and patient outcome under varying clinical circumstances is determined. Digitization and standardization of storage formats will facilitate the application of such a translation function for derivation of analogous intrinsic and extrinsic indices using a universal mathematical language that will provide the clinician with prognostic information and treatment suggestions. [0027] By way of example, this technology is generally described in relation to its application to implanted devices in patients with congestive heart failure as this particular field is in a state of rapid technologic evolution. Such implanted devices can be expected to have lead based and non-lead based sensors and transducers capable of acquiring data that is analogous to the diagnostic information obtained from extrinsic imaging modalities. A brief review and examples of such technologies are included herein along with related references. This review serves to familiarize the reader with the mechanical and physiological principles helpful for understanding this invention by correlating device based sensor data to analogous data acquired with echocardiography. [0028] Patients referred for consideration of CRT implantation undergo echocardiographic or other imaging analysis. Current ultrasound technologies allow for a means of evaluating changes in regional volume, differential myocardial motion and contractility. Temporal frame rates for evaluating such subtle differences in timing are currently under 10 milliseconds. Available equipment manufactured by a number of companies such as General Electric, Philips, TomTec and Siemens are capable of measuring changes in both global and regional volumes within the cardiac chambers during the cardiac cycle. Analysis of tissue Doppler data allows for calculation of tissue velocities, myocardial strain and strain rate derived from the spatial gradient of tissue velocity (strain rate equation). This can also be performed by defining relative locations of ultrasound reflectors in two or three dimensional space over time using a technique referred to as speckle tracking (GE). Such data is currently processed at fast enough rates as to generate real time parametric imaging. As improvements in processing and microprocessor robustness occur (Moore's law), one can expect a number of analyses (unique and redundant) will be performed simultaneously in digital format and be able to be compiled into informational data sets that can be used for diagnostic purposes. This also holds true for implantable CRM and heart failure devices. [0029] Recent advances in cardiac MRI have allowed temporal frame rates that approach the level of ultrasound imaging. These frame rates are adequate enough to allow for regional strain analyses that define degree and location of electromechanical dysynchrony during two cardiac cycles. Magnetic resonance tagging, phase contrast MRI, and stimulated MRI (DENSE techniques) are MR methodologies capable of characterizing myocardial motion and strain. Newer techniques such as use of harmonic phase analysis (HARP) vastly improve upon imaging and processing time and allow for more rapid strain analysis. In the Fourier domain, spatial modulation of magnetization (SPAMM) tagged MR data will have multiple spectral peaks. Any off-origin spectral peak will relate to tissue motion. Spatial derivatives of harmonic phase can be computed for any pixels as to derive strain measurements. Such techniques allow for acquisition of a number of cardiac performance parameters and measurements of electromechanical timing (dysynchrony). The details of such innovations are described in the cardiac MRI literature. [0030] An index of dysynchrony or dysynchrony index, DI, and cardiac performance parameters, CP, may be derived by any and all of these imaging modalities as well as within an implanted device. The DIs and CPs allow for a means of quantifying and localizing electromechanical dysynchrony and quantifying systolic and diastolic cardiac performance. A number of DIs and CPs have been defined in the literature and these, as well as, several novel DIs and CPs developed by the inventor (see below and cited references) may be used for such analysis. The user can implement fast software algorithms using DSP to compile informational data sets (IDS) descriptive of cardiac performance (CP) and electromechanical dysynchrony. 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