Abstract:
A medical device may include a sheath, and an elongate member disposed within a distal portion of the sheath, the elongate member configured to reciprocally move between a sheathed configuration and a deployed configuration. The elongate member may be substantially linear and disposed within the sheath while in the sheathed configuration and extend distally from the sheath in a first direction in the deployed configuration. The elongate member may include a first bend disposed distal to the distal portion of the sheath, the first bend directing the elongate sheath in a second direction that is substantially opposite to the first direction, and a second bend distal to the first bend, the second bend directing the elongate sheath in a third direction substantially transverse to the first and second directions. The elongate member may also include a third bend distal to the second bend, the third bend directing the elongate member in approximately the first direction, and a first elongate portion disposed between the second and third bends. The elongate member may also include a second elongate portion distal to the third bend, and at least one electrode.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This patent application claims the benefits of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 61/860,854, filed Jul. 31, 2013, the entirety of which is incorporated herein by reference. 
     
    
     TECHNICAL FIELD 
       [0002]    Various embodiments of the present disclosure relate generally to systems for assessing a risk of sudden cardiac death and related methods of use. 
       BACKGROUND 
       [0003]    Sudden cardiac death is a natural death due to cardiac causes. In some cases, sudden cardiac death is caused by ventricular fibrillation and/or ventricular tachycardia. Ventricular fibrillation is a condition in which there is uncoordinated contraction of the cardiac muscle of the ventricles in the heart, making them quiver rather than contract properly. Ventricular fibrillation is a commonly identified arrhythmia in cardiac arrest patients that is often only detectable by electrocardiography. Ventricular tachycardia is a tachycardia, or fast heart rhythm, that originates in one of the ventricles of the heart. 
         [0004]    An implantable cardioverter-defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and/or ventricular tachycardia. An ICD is programmed to detect cardiac arrhythmia and correct it by delivering a jolt of electricity. Implanting an ICD is similar to implanting a pacemaker. Similar to pacemakers, ICDs typically include electrode wire(s) that pass through a vein to the right chambers of the heart, usually lodging in the apex of the right ventricle. 
         [0005]    While ICD insertion is a safe and routine procedure, as with any surgical procedure, there is a risk for complications. The range of complications for ICDs is extensive as problems can frequently emerge with the electrode wires. Further, ICDs may be relatively expensive. There are currently no reliable predictors of sudden cardiac death to identify the best candidates for ICD implantation. 
         [0006]    Thus, there remains a need for improved systems for assessing a risk of sudden cardiac death. 
       SUMMARY OF THE DISCLOSURE 
       [0007]    In one aspect of the disclosure, a medical device may include a sheath, and an elongate member disposed within a distal portion of the sheath, the elongate member configured to reciprocally move between a sheathed configuration and a deployed configuration. The elongate member may be substantially linear and disposed within the sheath while in the sheathed configuration and extend distally from the sheath in a first direction in the deployed configuration. The elongate member may include a first bend disposed distal to the distal portion of the sheath, the first bend directing the elongate sheath in a second direction that is substantially opposite to the first direction, and a second bend distal to the first bend, the second bend directing the elongate sheath in a third direction substantially transverse to the first and second directions. The elongate member may also include a third bend distal to the second bend, the third bend directing the elongate member in approximately the first direction, and a first elongate portion disposed between the second and third bends. The elongate member may also include a second elongate portion distal to the third bend, and at least one electrode. 
         [0008]    Various embodiments of the disclosure may also include one or more of the following aspects: wherein each of the first bend, the second bend, and the third bend is a pre-shaped bend in the elongate member, and the elongate member assumes the pre-shaped bends in the absence of an applied force; wherein the at least one electrode includes a first electrode disposed along the first elongate portion, a second electrode disposed at the third bend, a third electrode disposed on the second elongate portion, and a fourth electrode disposed on the second elongate portion downstream of the third electrode; wherein the first bend is configured to extend through the tricuspid valve and into the right ventricle of a patient; wherein the first elongate portion is configured to substantially conform to an inner surface of the right ventricle along an inferior wall to the apex; wherein the third bend is configured to be located at approximately the apex of the heart; wherein the second elongate portion is configured to substantially conform to the septal wall of the heart; and further including a distalmost tip configured to be disposed in the right ventricle outflow tract of the patient. 
         [0009]    In another aspect of the disclosure, a method for determining a risk of sudden cardiac death within a patient may include receiving data including at least one electrogram generated from the patient, and analyzing the data to determine a risk of the patient for sudden cardiac death. The method may also include generating an indicia of the determined risk of sudden cardiac death, and transmitting the indicia to a user. 
         [0010]    Various embodiments of the disclosure may also include one or more of the following aspects: wherein the received data is collected by at least one electrode disposed in the cardiovascular system of the patient; wherein the at least one electrode includes a first electrode contacting an inferior wall of a right ventricle, a second electrode contacting a wall of the right ventricle proximate to the apex, and a third electrode contacting a septal wall of the right ventricle; wherein the at least one electrogram includes a plurality of electrograms generated from a plurality of electrodes within the cardiovascular system of the patient; wherein analyzing the data includes comparing the at least one electrogram to a database of electrograms; wherein a fractionation of the at least one electrogram is compared to a fractionation in the database of electrograms; wherein the fractionation is indicative of discontinuous conduction through the heart muscle of the patient; wherein generating an indicia of the determined risk of sudden cardiac death is based on age, gender, symptoms, drug use, electrocardiograms, status of the coronary arteries, images of coronary arteries, or ejection fraction of the patient; and wherein the indicia includes a score indicating a signal delay. 
         [0011]    In yet another aspect of the disclosure a system for determining a risk of sudden cardiac death within a patient may include a data storage device, and a processor configured to execute instructions to perform a method. The method may include receiving data including at least one electrogram generated from the patient; and analyzing the data to determine a risk of the patient for sudden cardiac death. The method may also include generating an indicia of the determined risk of sudden cardiac death. 
         [0012]    Various embodiments of the disclosure may also include one or more of the following aspects: further including an elongate member having a plurality of electrodes. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0013]    The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments. 
           [0014]      FIG. 1  is a schematic view illustration of a system in accordance with an embodiment of the present disclosure. 
           [0015]      FIG. 2  is an in vivo illustration of a catheter in accordance with an embodiment of the present disclosure. 
           [0016]      FIG. 3  is a schematic view illustration of a hardware device in accordance with an embodiment of the present disclosure. 
           [0017]      FIG. 4  is a flowchart of an exemplary method in accordance with an embodiment of the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0018]    Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. 
         [0019]    Referring now to the enclosed figures,  FIG. 1  is a schematic diagram of a system and environment for collecting, processing, and displaying sudden cardiac death risk data, according to an exemplary embodiment of the present disclosure. As shown in  FIG. 1 , the system and environment may include a plurality of catheters  102 , hardware devices  104 , and interface devices  105  disposed in communication with an electronic network  100 .  FIG. 1  depicts one of each of catheter  102 , hardware device  104 , and interface device  105 . It is understood, however, that any number of catheters  102  and associated hardware devices  104  and interface devices  105  may be used in the system. The catheters  102 , hardware devices  104 , and interface devices  105  comprise the portions of the system that the physician or other health care provider interacts with. This disclosure first describes these aspects of the system, followed by disclosure of the remainder of the system, including the servers, and exemplary methods of use. 
         [0020]    Catheter  102   
         [0021]    Catheter  102  and hardware device  104  are configured to gather the data that will be used to predict the risk of sudden cardiac death and/or the need for an ICD. As shown in  FIG. 2 , catheter  102  may configured to be inserted into the cardiovascular system, e.g., the heart, of a patient. In some embodiments, catheter  102  may be inserted into the patient by a physician, e.g., a cardiologist, or another suitable person. In some embodiments, the cardiologist may utilize catheter  102  during a patient visit where a coronary angiogram is being performed. In some embodiments, the patient may only need to be sedated for approximately an additional 15 minutes, although other sedation times are also contemplated. Thus, the patient may experience minimal discomfort. Catheter  102  may be disposed within a sheath  202  or other like overtube. Sheath  202  may be any conventional sheath that can be inserted at least partially into a body lumen. Sheath  202  may be flexible, or include a portion that is flexible, to allow sheath  202  to be maneuvered within the body lumen, such as, e.g., portions of the cardiovascular system. In one embodiment, sheath  202  may be inserted through a vein in the groin or leg and directed into the heart of a patient. In addition, other conventional techniques of guiding and positioning sheath  202 , including guidewires and/or imaging techniques, can be used to guide sheath  202  and catheter  102  into position. 
         [0022]    Catheter  102  may be configured to have a geometry that assists in navigating the tortuous pathways of the cardiovascular system leading to the right atrium RA and the right ventricle RV. In one embodiment, catheter  102  may be formed of a shape memory material, such as, e.g., Nitinol, or any other suitable material. Once the distal end of sheath  202  reaches the entrance of the right atrium RA just proximal to the inferior vena cava, catheter  102  may extend distally from the distal end of sheath  202  and have a pre-shaped set of bends to follow a path within the right ventricle RV, such as the path shown in  FIG. 2 . Prior to catheter  102  exiting sheath  202 , sheath  202  restrains the shape of catheter  102  to a substantially linear shape. Upon exiting sheath  202 , however, catheter  102  has a set of discrete bends and curves to extend from the right atrium RA, through the tricuspid valve TV, into the right ventricle RV, conform to surfaces of the right ventricle RV, and exit the right ventricle RV at the pulmonary valve PV. More particularly, a bend  206  of catheter  102  may be U-shaped and extend from just distal sheath  202 , through the tricuspid valve TV, and into the right ventricle RV. U-shaped bend  206  may direct catheter  102  approximately 180° from the inferior vena cava, through the right atrium RA and tricuspid valve TV to the right ventricle RV. Catheter  102  may extend from U-shaped bend  206  to another bend/curve  207  that directs catheter  102  toward the inner surface of the right ventricle RV near the tricuspid valve TV. Bend  207  may direct catheter  102  toward a catheter portion  208  that substantially conforms to the inner surface of the right ventricle RV along the inferior wall to the apex. Catheter portion  208  may terminate at a bend  209  located approximately at the apex, which directs catheter  102  toward the pulmonary valve PV via a catheter portion  210 . Catheter portion  210  may substantially conform to the septal wall and extend toward a distal tip  211  of catheter  102 . Distal tip  211  of catheter  102  may terminate in or around the right ventricle outflow tract at the pulmonary valve PV or within the pulmonary artery. This overall catheter configuration, including the correspondence between various bends/catheter positions, and right ventricle geometry may provide stability to catheter  102  and to minimize movement. They may also provide reference locations for clinicians so that locations of the various electrodes (described below) are standardized and facilitate data collection that is robust and comparable between different patients and different patient groups. 
         [0023]    Catheter  102  may include a plurality of electrodes, for example three to ten, or another suitable number of electrodes. The electrodes may provide stimulation pulses to the heart tissue, measure the tissue response, and send the response along the catheter  102  back to a hardware device  104 . Each electrode may be a pair of electrodes and may be bipolar electrodes, although other configurations, such as, e.g., monopolar electrodes are also contemplated. In some embodiments, electrodes may be irregularly spaced about catheter  102 , although other configurations, including regular spacing, are also contemplated. In one exemplary embodiment, catheter  102  may include eight bipolar sets of electrodes, although other numbers of electrodes are also contemplated. 
         [0024]    In another embodiment, catheter  102  may include a first electrode  212  that is configured to be deployed along the inferior wall of right ventricle RV between the tricuspid valve TV and the apex (e.g., along catheter portion  208 ), and a second electrode  214  configured to be deployed along the inner surface of right ventricle RV proximate the apex (e.g., at bend  209 ). A third electrode  216  may be deployed along the septal wall of right ventricle RV between the apex and the pulmonary valve PV (e.g., along catheter portion  210 ), and a fourth electrode  218  may be deployed along the outflow tract of right ventricle RV proximate (just proximal to) the pulmonary valve PV (e.g., distal to third electrode  216  along a part of catheter portion  210 ). Each electrode may be a cylindrical electrode that extends around the circumference of the catheter  102 , although other electrode configurations are also contemplated. In some embodiments, electrode placement may be configured to subtend as much of the ventricular myocardium as possible. The septal placement of electrodes may allow access to the left ventricle that is otherwise difficult to access for electrophysiological recording. In some embodiments, the arrangement of electrodes may provide data from the septum. Electrodes may be disposed in the outflow tract as this is some distance from other parts and has particular and interesting electrical properties. For similar reason, an electrode may be placed on the inferior wall  212  and at the apex  214 . Electrode placement may be configured to obtain maximum coverage of muscle. 
         [0025]    In some embodiments, catheter  102  may be configured for single (e.g., one-time, disposable, etc.) use, while in other embodiments, catheter  102  may be configured to be used multiple times. Catheter  102  may have any suitable size and may include a central lumen for a guidewire. In one exemplary embodiment, catheter  102  may have a 7 French diameter, although other suitable diameters and configurations are also contemplated. 
         [0026]    Hardware Device  104   
         [0027]    In one embodiment, a hardware device  104  may be coupled to a proximal end of a catheter  102  to control the stimulation pulsing and data acquisition by the electrodes. In some embodiments, hardware device  104  may deliver stimuli to a patient&#39;s heart and obtain data. Hardware device  104  may include a memory, a battery (or other suitable element for powering device  104 ), and/or a transceiver. Each of hardware devices  104  may be connected to electronic network  100  through a cellular network and/or a Wi-Fi network. Thus, each of hardware devices  104  may be configured to collect physiological data from a patient via catheter  102 , and transmit collected physiological data over electronic network  100 . Each of hardware devices  104  may also have a web browser or mobile browser installed for receiving and displaying content from web servers, in addition to other components to facilitate with operation, such as, e.g., start and stop buttons, keyboards, touch screens, and the like. Electronic network  100  may be the Internet, or any other combination of wired and/or wireless electronic networks. 
         [0028]    As seen in  FIG. 3 , hardware device  104  may include a port  302  for coupling a proximal end of catheter  102  (referring to  FIG. 2 ) to hardware device  104 . Hardware device  104  may include a controller  306 . Controller  306  may include one or more processors coupled to one or more non-transitory computer readable storage devices  308  that may perform any of the actions described herein for operating catheter  102 , storing collected data, and transmitting data to server system  106  (to be described herein) via electronic network  100 . Hardware device  104  may be configured to allow a user to log into a doctor or hospital account and create patient profiles. Hardware device  104  may be configured to perform patient testing while offline or online, if desired. Hardware device  104  may include or be coupled to a visual display to assist a user during operation of hardware device  104 . In some embodiments, hardware device  104  may be configured to show a progress of the data collection, indicate that data collection is complete, and/or indicate that transmission to server system(s)  106  is complete. In some embodiments, hardware device  104  may include error logs and solutions. In some embodiments, hardware device  104  may use error logs to alert the physician and other members of the clinical team to a problem. An error may indicate that a relocation of catheter  102  positioning is desired to obtain optimal data. An error may also indicate that, during the course of the study, the clinical condition of the patient has changed and the device may provide further alerts to the medical team of this occurrence for, e.g., remedial action by the medical team. In addition, a failsafe position may be adopted if the patient&#39;s condition changes so that the test procedure is automatically terminated. After such a termination, the already collected data may be safely stored for appropriate analysis, including, e.g., its relationship to the patient&#39;s condition. In some embodiments, hardware device  104  may be in a 120 volt, 60 Hz configuration, while in other embodiments, hardware device  104  may be in a 240 volt 50 Hz configuration, although other suitable configurations are also contemplated. 
         [0029]    Controller  306  may be configured to run a plurality of algorithms to prepare and control catheter  102  for data collection. In one embodiment, controller  106  may cause one of the plurality of electrodes to pulse at a given time (for example, via square wave pulses), and cause the remaining plurality of electrodes to record data, such as, e.g., the electric heart wall response at the various locations of the remaining plurality of electrodes. The electrograms thereby recorded may vary by location within the ventricle related to the specific nature of the heart tissue in that location, but also related to the contact with the tissue that is made. The amplitude, duration, morphology and number of components of the individual electrograms may be analyzed through the systems described. These may vary in response to the timing of the pulses, and the relationships between the characteristics of the electrograms recorded at different times will be measured and compared. For example, in the embodiment described in  FIG. 2 , first electrode  212  may pulse, while second, third, and fourth electrodes  214 ,  216 , and  218  may record data. Controller  306  may select the first electrode to pulse based on which electrode initially provides the strongest signal or based on another suitable method. Each of first, second, third, and fourth electrodes  212 ,  214 ,  216 , and  218  may rotate between a pulsing or recording mode, where no more than one of electrodes  212 ,  214 ,  216 , and  218  act as a pulsing electrode at a given time. 
         [0030]    During data collection, controller  306  may send pulses in a delayed fashion. For example, pulses may be first sent with a delay of 450 milliseconds between pulses or in relation to the recording and inscription of previous intrinsically generated electrograms. Controller  306  may be further configured to send pulses with a decremental or even an incremental delay. For example, subsequent pulse delays may be, e.g., two milliseconds shorter or two milliseconds longer than a previous delay. Thus, if a first delay between pulses is 450 milliseconds, a subsequent delay may be 448 milliseconds. The purpose of the decremental/incremental delays is to fully and dynamically interrogate the heart muscle and observe the response of the tissue to the conditions that may trigger an arrhythmia and potentially trigger an episode of sudden cardiac death. The particular pulsing sequence may be optimized based upon clinical trials, and may be subject to modification based upon future clinical trials, if desired. A goal of the pulsing sequence is to extract data as quickly as possible. The data collected by hardware device  104  may be filtered by conventional mechanisms to prepare the extracted data for sending through the electronic network  100 . 
         [0031]    In some embodiments, hardware device  104  may be compatible with standardized equipment at cardiology centers, hospitals, or the like. Hardware device  104  may be fitted with ports and connections to allow compatibility with a variety of currently used standard electrophysiological, cardiological, radiological and other medical and non-medical devices. In some embodiments, hardware device  104  may be customized to a specific country or environment in which hardware device  104  will be used, as well as being compatible with the equipment that a given cardiology center currently uses. 
         [0032]    In some embodiments, hardware device  104  may implement appropriate security protocols, such as requiring the physician to enter logon credentials, so as to appropriately limit access to patient data and comply with regulations, such as the Health Insurance Portability and Accountability Act (HIPAA). 
         [0033]    Interface Device  105   
         [0034]    In one embodiment, each of the interface devices  105  may include a server, personal computer, tablet computer, mobile device, smartphone, and/or personal digital assistant (“PDA”) disposed in communication with electronic network  100 . For example, in one embodiment, each of interface devices  105  may be a touchscreen enabled device, such as an Apple iPad, Samsung Galaxy, Amazon Kindle, Microsoft Surface, or any other equivalent or similar device. Each of interface devices  105  may have a web browser or mobile browser installed for receiving and displaying content from web servers. Thus, each of the interface devices  105  may be configured to receive and display data that is received and processed from hardware devices  104 , over electronic network  100 . For example, interface device  105  may receive output from the electronic network and display it to the user. The output may include a prediction of a risk of death due to a sudden cardiac event. The output may be a low, medium, or high prediction. 
         [0035]    In some embodiments, interface device  104  may implement appropriate security protocols, such as requiring the physician to enter logon credentials, so as to appropriately limit access to patient data and comply with regulations, such as the Health Insurance Portability and Accountability Act (HIPAA). 
         [0036]    Server Systems 
         [0037]    As shown in  FIG. 1 , a plurality of server systems  106 , a browser web server  114 , and/or a mobile web server  116  may also be disposed in communication with electronic network  100 . In one embodiment, server systems  106  may be configured to receive physiological data from hardware devices  104  over electronic network  100 . Any of the devices or functionality of server systems  106 , browser web server  114 , and/or a mobile web server  116  may be combined together or separated, and may be operated by a single administrative entity, or outsourced to one or more other entities, such as a web hosting entity, web storage entity, and/or cloud computing service. 
         [0038]    As shown in the embodiment of  FIG. 1 , server systems  106  may include a data analyzer  110 , which may analyze the received physiological data. Specifically, data analyzer  110  may be configured to analyze received physiological data for assessing a patient&#39;s risk for sudden cardiac death, and/or perform any other analysis, classification, and/or sorting of detected sudden cardiac death risk factors and/or patients having sudden cardiac death risk factors, as will be described in more detail below. 
         [0039]    Server systems  106  may also include one or more databases  108 , where data analyzer  110  may be configured to store the received physiological data and/or the computed data. Any received data may be stored in the databases  108  in an encrypted form to increase security of the data against unauthorized access. 
         [0040]    Server systems  106  may also include a health-care provider application program  112  that allows a physician or other health care provider to control parameters of the system, such as values used by the data analyzer  110  in the analysis. The application program  112  also displays data to the physician and allows the physician to select types of data to display, time periods of the data to display, levels of data detail to display and other operating parameters of the system. In response to a query by the physician, the application program  112  may fetch and display data from the databases  108 . The application program  112  may implement appropriate security protocols, such as requiring the physician to enter logon credentials, so as to appropriately limit access to patient data and comply with regulations, such as the Health Insurance Portability and Accountability Act (HIPAA). In some embodiments, server system  106  may track and bill procedures and/or diagnosis to accounts associated with the physician, patient, hospital, or other entity. Server system  106  may also be configured to generate reports based upon numerous criteria, such as, e.g., patient account, region, zip code, territory, country, continent or the like. 
         [0041]    As shown in  FIG. 1 , server systems  106  may be disposed in communication with a browser web server  114  and/or a mobile web server  116 . Each of browser web server  114  and/or mobile web server  116  may be configured to interact with interface devices  105 , such as to generate appropriate displays to facilitate user interaction with the application program  112 . For example, browser web server  114  and/or mobile web server  116  may be configured to generate a window-metaphor based computer user interface on a screen of interface devices  105  or screen (not shown) coupled to the remote server systems  106 , or the browser web server  114  and/or mobile web server  116  may generate web pages that are rendered by a browser or application of the interface devices  105 . The interface devices  105  and the browser web server  114  and/or mobile web server  116  may communicate with each other using an appropriate encrypted protocol, such as Hypertext Transfer Protocol Secure (HTTPS). 
         [0042]    Exemplary Method 
         [0043]      FIG. 4  is a flow diagram of a method  400  for collecting, processing, and displaying sudden cardiac death data, e.g., using the exemplary system and devices of  FIGS. 1-3 , according to an exemplary embodiment of the present disclosure. As shown in  FIG. 4 , method  400  may initially include collecting sudden cardiac death data from one or more patients (step  402 ). For example, a physician may locate a catheter  102  within a patient and run a test algorithm on the electrodes via hardware device  104 . After hardware device  104  sends the required stimulation pulses and collects the required data, server system(s)  106  may receive sudden cardiac death data from hardware device  104 , which may then be stored in database(s)  108  (step  404 ). The data may be collected in response to a preset protocol of decremental/incremental stimulation. The exact protocol may vary and be simplified with fewer pulses, or made more complex with more pulses based on the results of further clinical experience and clinical trials. The complete dataset of electrograms and other recorded information may be sent to the cloud for subsequent analysis. 
         [0044]    Method  400  then may include checking that the transmitted data is of sufficient quality (step  405 ). A human analyst or a computer program may analyze data received from hardware device  104  to ensure that the data is of sufficient quality to analyze. The main limiting factor in the quality of the data would be if insufficient electrodes had been able to record data. In some embodiments, at least two electrodes may be required to collect sufficient data. A complete data set may include an electrogram from all electrodes at numerous pulsing intervals. The analyst or computer may also reject data if the noise level within the data is too high. If the data is rejected, a signal may be sent to, e.g., hardware device  104  or interface device  105 , indicating that the sample quality is poor and that data must be recollected at step  402  before any analysis may be conducted. It is contemplated that step  405  may be fully automated and performed without a human analyst. 
         [0045]    If at step  405 , the transmitted data is determined to be of sufficient quality, the sudden cardiac death data may be processed by data analyzer  110  to assess a risk for sudden cardiac death. The analyst may, after conducting a quality check of the data checking for completeness and noise, direct the signals to be entered into the next stage of analysis. The analysis may include an automatic assessment of the components of the individual electrograms, including, e.g., the number of components, the timing of each of these components in regard to the timing of the pulse (which is the extent to which they are delayed). In some embodiments, the collected data may be compared to animal models and/or patient models showing the characteristics of the delay and fractionation (the breakup of the electrogram into multiple components) that has been associated with possession of damaging underlying muscle on the background of the possession of an adverse genetic variant or some acquired condition or indeed a combination of genetic and acquired heart conditions. In other words, collected data may be processed before a patient&#39;s risk for sudden cardiac death is calculated. 
         [0046]    Data analyzer  110  may analyze electrograms generated based on data collected by catheter  102  and hardware device  104 . For example, the electrograms produced by diseased muscle in a patient deemed to be at risk will take a different shape than the electrograms produced by muscle observed in a low risk cardiac patient. In some embodiments, data analyzer  110  may search for fractionation within the received electrograms. The fractionation patterns may have been associated in both animal models of arrhythmias with the characteristics of sudden death conditions and patients already seen to be at high risk as being associated with risk and a predisposition to sudden death. 
         [0047]    In some embodiments, electrograms taken from patients deemed to be at high risk may have more components with delays, and this is described as having a fractionated pattern. Fractionation has been associated with diseased tissue and may represent discontinuous conduction through the muscle that may have arisen either through the presence of structural change, e.g., due to scar, or alternatively through some functional change due to the presence of genetic variants in proteins involved in the normal transmission of the cardiac impulse. These proteins may often be ion channels but could be other proteins. The pattern of delay may also be modified with other changes in the electrical properties of the heart, and the pattern of the electrograms may additionally reflect all these changes. The characteristics observed and measured in the electrograms may include size (amplitude), numbers of components, and delay in each of the components. The data may be converted to a format that is quantitative and summarizes the conduction through the ventricular muscle. 
         [0048]    Analyzer  104  may interrogate each individual electrogram. In some embodiments, several thousand electrograms may be recorded during the course of study of a single patient, or another suitable number of electrograms may be recorded, if desired. The electrogram may be categorized by the timing of its collection in the decremental/incremental protocol and all characteristics of the electrogram may be related to that timing. Specific measurements may be made automatically that describe the numbers of components of the electrogram, their amplitude and their timing related to the delivered pulse. These measurements may be open to manual and visual checking by an expert human analyst. The final output may be a description of the composite of timing and degree of breakup of the signal and this may use an averaging method and/or may be adapted based on prospective clinical experience. In some embodiments, the output of the signals that have been observed in animal models and human patients may be compared to the individual patient under study. Those patients at higher risk deviate incrementally from the results obtained in a gold standard normal population that will be newly acquired. In some embodiments, a score may be reported in milliseconds representing a delay. A higher delay may correspond to a higher risk of sudden cardiac death. The results may be presented to the physician as a continuous rather than a categorical variable, and the physician may use the information in conjunction with other data they have available from the patient to make a diagnosis and/or treatment recommendation. In some embodiments, categorical recommendations may be made with the caveat that other data would also be needed by the physician as would be usual practice with any single items of clinical data obtained from patients. 
         [0049]    In some embodiments, a database of collected data may be generated. The predictive capability of the database may increase as the database grows. That is, as the diseases that various patients have may be divergent, their responses to disease may be heterogeneous, and the procedure results that are accumulated may reflect that and have the individual signature of that patient with that disease with past histories and outcomes. This may allow prospective prediction in new patients as they then present. Data analyzer  110  may also process any number of additional characteristics relevant to assessing a patient&#39;s risk of sudden cardiac death, including, but not limited to age, gender, symptoms, drug use, electrocardiograms, status of coronary arteries, images of coronary arteries, ejection fraction, among others. Additional data may be input to data analyzer  110  via hardware device  104 , interface device  106 , or via another input mechanism, such as, e.g., a hospital input terminal or a patient database entry website that communicates with data analyzer  110  via electronic network  100 . 
         [0050]    The prediction of sudden death may reflect general heart function and most specifically the function of the left ventricle chamber may be used. In some embodiments, data analyzer  110  may weigh such factors according to a given factor&#39;s relative significance in determining a risk of sudden cardiac death. In some embodiments, data analyzer  110  may ignore data if it is deemed to be anomalous but the physician skilled in the art is likely to be aware that on occasion such anomalies may occur. In some embodiments, the risk assessment may be performed after the data collection procedure at step  402 . In some embodiments, the risk assessment may be generated while hardware device  104  and catheter  102  are offline, e.g., in approximately  48  hours, although other suitable time frames are also contemplated. In some embodiments, data analyzer  110  may analyze data from catheter  102  and hardware device  104  in real-time. That is, at the conclusion of a data collection procedure at step  402 , the physician may utilize interface device  105  or hardware device  104  to visualize a risk assessment determined by data analyzer  110 . In some embodiments, the physician may be directed to recollect data at step  402 , e.g., if the data was determined by the analyst or data analyzer  110  to be anomalous. In other embodiments, the physician may view the risk assessment and choose to recollect data at step  402  even if the analyst or data analyzer  110  does not transmit specific instructions to recollect data. 
         [0051]    From step  406 , method  400  may proceed to step  408 , where data analyzer  110  may transmit an assessment of a patient&#39;s risk of sudden cardiac death to interface device  105 , where the assessment may be accessed by a user, such as, e.g., the patient&#39;s cardiologist. In one embodiment, data analyzer  110  may transmit a risk level of sudden cardiac death, such as, e.g., low, medium, or high, if desired. Each risk level may be associated with a value range calculated at step  406 . 
         [0052]    It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed systems and processes without departing from the scope of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only. The following disclosure identifies some other exemplary embodiments.