Abstract:
Hemodynamic data and imaging data are obtained about a patient, and the data is combined to generate a single report integrating same. While a hemodynamic system obtains the hemodynamic data, an imaging system obtains the imaging data. Preferably, the report confirms the absence or presence (and/or severity) of peripheral arterial disease, including quantitative data. The hemodynamic system and the imaging system can communicate directly, indirectly, and/or wirelessly. They may be contained within a common enclosure and/or integrated into a single apparatus. Either or both of the hemodynamic system and/or the imaging system can also be configured to measure the blood pressure of the patient. Preferably, the imaging system is an ultrasound imaging system, and improved workflows for diagnosing peripheral arterial disease result.

Description:
CROSS-REFERENCE(S) TO RELATED APPLICATION(S) 
       [0001]    Not applicable. 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
       [0002]    Not applicable. 
       REFERENCE(S) TO MICROFICHE APPENDIX AND/OR COPYRIGHT PROTECTION 
       [0003]    Not applicable. 
       BACKGROUND 
       [0004]    1. Field 
         [0005]    In general, the inventive arrangements relate to medical systems, and more specifically, to integrating hemodynamic and imaging systems. 
         [0006]    2. Description of Related Art 
         [0007]    Hemodynamics involve the flow of blood in living animals. Factors influencing hemodynamics include, for example, CO, circulating fluid volumes, respiration, vascular diameter, resistance, and/or blood viscosity. Each of these factors may, in turn, be influenced by physiological factors, such as, for example, a person&#39;s weight, diet, exercise, health, sickness, and/or disease, as well as any medications, drugs, and/or alcohol that a person may be using. Understanding a person&#39;s hemodynamic condition often depends on measuring the person&#39;s blood flow at different points along the person&#39;s blood circulation. 
         [0008]    Ultrasound, on the other hand, is, among other things, a diagnostic medical imaging technique, and it is often used to visualize, for example, muscles, tendons, and/or internal organs of a person. Other imaging techniques can include, for example, medical imaging equipment for general radiology, functional imaging, molecular imaging, vascular imaging, fluoroscopy, mammography, neurology, oncology, radio pharmacology, x-ray, computed tomography (CT), nuclear medicine (NM), positron emission tomography (PET), magnetic resonance imaging (MRI), and/or photoplethysmography. While the present inventive arrangements will be described in particular terms of ultrasound medical imaging, they are not limited in this regard. 
         [0009]    Now then, previous hemodynamic and imaging systems are separate and disparate systems, as will be elaborated upon. 
         [0010]    It is estimated that in North America and Europe, approximately 27 million people suffer from peripheral arterial disease (PAD)—which is also known as peripheral vascular disease (PVD) and/or peripheral artery occlusive disease (PAOD). It is often caused by the obstruction of large arteries in a person&#39;s arms and/or legs. PAD can often result from atherosclerosis, inflammatory processes leading to stenosis, an embolism, and/or thrombus formation. Often, it causes acute and/or chronic ischemia (i.e., lack of blood supply), often in a person&#39;s legs. Moreover, the prevalence of PAD in people aged over 55 years is approximately 10-25%, and it increases with age. Approximately 70-80% of affected individuals are asymptomatic, while others are symptomatic. Typical symptoms of PAD can include any of the following: calf pain in either or both leg(s), particularly while walking or running; painful sensations and/or tingling in the feet; or numbness and/or loss of feeling in a person&#39;s limbs (e.g., arms and/or legs). 
         [0011]    As a result, early detection and monitoring of PAD is of growing importance, particularly in order to be able to provide early treatment to patients, including to general aging populations and older demographics, as is typical in many countries, including the U.S. In general, detecting PAD usually involves evaluating the arteries that supply blood to lower body extremities. 
         [0012]    Upon initial suspicion of symptomatic PAD, a common first examination is used to determine a patient&#39;s ankle brachial pressure index (ABPI or ABI), which measures a fall in blood pressure in the arteries supplying blood to the person&#39;s legs, particularly relative to the person&#39;s arms. Ideally, ABPIs should be at least 1. Reduced ABPIs (e.g., less than 0.9) can be consistent with the on-set of PAD, while values of ABPI less than 0.8 can indicate moderate disease. ABPIs less than 0.5 can indicate severe disease. Such determinations are often referred to as “indirect” assessments, and they are conducted by techniques such as measuring a patient&#39;s blood pressure, segmental limb pressure, toe pressure, pulse volume readings (PVR), exercise stress levels, blood oxygen concentrations (aka oximetry and/or pulse oximetry), and/or cutaneous temperatures. Many of these tests are conducted in special environments, such as a doctor&#39;s office, hospital, and/or other medical facilities. The tests carried out by such hemodynamic systems often require attaching sensors to the patient at various locations on the patient&#39;s body. 
         [0013]    Now then, if a patient&#39;s hemodynamic readings are abnormal and/or otherwise merit additional consideration, a common next step involves conducting a lower limb Doppler ultrasound examination of the patient&#39;s legs, particularly in order to more closely examine a site and extent, if any, of atherosclerosis at the femoral artery. Such determinations are often referred to as “direct” assessments, and they are often conducted by techniques such as duplex imaging, typically through the use of hemodynamic evaluation with Doppler interrogation and ultrasound imaging. Many duplex ultrasound systems include both high and low frequency imaging capabilities, as well as both audible and spectral Doppler evaluation for high and low frequency evaluations. 
         [0014]    One of the difficulties in using two different and independent systems, as described above (e.g., one for hemodynamic assessment, and another for ultrasound and/or other imaging), however, is that both systems are often needed for a single patient. For example, one clinician may use a hemodynamic system to provide an initial diagnosis of PAD, while another may then use an ultrasound imaging system to further the analysis—such that the two systems are used independently and separately, and oftentimes by different caregivers. Moreover, the two different tests may require the patient to have two or more separate appointments, perhaps on different dates. The patient could also be required to move between healthcare rooms and/or facilities for the different tests. The equipment could also need to be moved from one patient&#39;s room to another patient&#39;s room, bringing in the hemodynamic system first, followed by the ultrasound (or other imaging system) next—or vice versa. This can lead to disadvantages of, among other things, wasting space, time, cost, capitol equipment allocations, as well as personnel and/or other inefficiencies. As a result, it is not uncommon for caregivers to chose only one of direct assessment or indirect assessment as a matter of convenience and/or logistics, leading to compromised patient exam quality. Accordingly, at least one or more of patients, healthcare providers, and/or healthcare facilities are thereby inconvenienced. 
         [0015]    Moreover, when both systems are utilized on a single patient, the data generated from the separately utilized systems is received separately, evaluated separately, and provided in separate reports. Accordingly, a single, integrated report combining the findings of the hemodynamic system and the imaging system would be advantageous. Moreover, the amount of time required to carry out and process separate testing systems is considerable. 
         [0016]    As a result of at least the foregoing, it would be advantageous to have an overall integrated system that combines patient workflows and medical evaluations from hemodynamic and imaging systems, such as ultrasound imaging systems, particularly for monitoring PAD. And a single, comprehensive report that combines data from both systems would also be advantageous for patients, healthcare providers, and/or healthcare facilities. 
       SUMMARY  
       [0017]    In one embodiment, an integrated medical system comprises a hemodynamic system, an imaging system, and a processor. The hemodynamic system obtains hemodynamic data about a patient, such as the patient&#39;s blood pressure, while the imaging system obtains imaging data about the patient, such as ultrasound imagery of the patient. The processor then combines the hemodynamic data and the imaging data into a single report integrating same. Either one or both of the hemodynamic system and/or the imaging system can be used to measure the blood pressure of the patient. Preferably, the imaging system is an ultrasound imaging system, and the hemodynamic system and the imaging system can communicate directly, indirectly, and/or wirelessly. In various embodiments, they may be contained within a common enclosure and/or integrated into a single apparatus, and the report preferably reflects a peripheral arterial disease condition of the patient. Thus, wherein the hemodynamic data and the imaging data are obtained about the patient, they are combined into the single report integrating same. When combining the hemodynamic data and the imaging data, the hemodynamic data can be transmitted to the imaging system and/or vice-versa—i.e., the imaging data can be transmitted to the hemodynamic system. They can be transmitted therebetween directly, indirectly, and/or wirelessly. Improved workflows for diagnosing peripheral arterial disease result. 
     
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         [0018]    A clear conception of the advantages and features constituting inventive arrangements, and of various construction and operational aspects of typical mechanisms provided by such arrangements, are readily apparent by referring to the following illustrative, exemplary, representative, and non-limiting figures, which form an integral part of this specification, in which like numerals generally designate the same elements in the several views, and in which: 
           [0019]      FIG. 1  illustrates a prior art schematic view of a common workflow procedure used to diagnose peripheral arterial disease (PAD) in a patient; 
           [0020]      FIG. 2  illustrates a novel schematic view of an improved workflow procedure used to diagnose PAD in a patient, in particular accord with the inventive arrangements; and 
           [0021]      FIGS. 3A-3C  illustrate alternative novel systems used to diagnose PAD in a patient, again in particular accord with the inventive arrangements. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0022]    Referring now to the figures, preferred embodiments of the inventive arrangements will be described in terms of hemodynamic monitoring and ultrasound imaging systems. However, the inventive arrangements are not limited in this regard. For example, while variously described embodiments may provide ultrasound imaging systems in a diagnostic context, other contexts are also hereby contemplated, including various other imaging techniques, and/or the like. 
         [0023]    Now then, referring to  FIG. 1 , there is shown a prior art schematic view of a common workflow procedure  10  used to diagnose peripheral arterial disease (PAD) in a patient (not shown). More specifically, both a hemodynamic system  12  and an imaging system  14 , such as an ultrasound imaging system, are used to diagnose PAD in the patient. As shown, however, both the hemodynamic system  12  and the imaging system  14  are separate systems, with no connections therebetween—physical, electronic, and/or otherwise. 
         [0024]    As can be seen, a healthcare provider (not shown) enters patient data into the hemodynamic system  12  at a first step  16 , after which a hemodynamic examination is performed on the patient at a next step  18 , particularly using hemodynamic equipment, such as the hemodynamic system  12 . At a next step  20 , the hemodynamic system  12  (and/or other) is used to generate a hemodynamic report—after which it is assumed, for the present purposes, that an imaging examination is also desired, and so the hemodynamic equipment is removed from the patient&#39;s presence at a next step  22 . At a next step  24 , imaging equipment, such as the imaging system  14 , is brought into the patient&#39;s presence, particularly for an imaging examination, such as an ultrasound examination. Accordingly, another healthcare provider (not shown), such as an ultrasound sonographer, which may or may not be the same as the initial healthcare provider, again enters (and/or re-enters) patient data into the imaging system  14  at a next step  26 , after which an imaging examination is performed on the patient at a next step  28 , particularly using the imaging equipment, such as the imaging system  14 . At a final step  30 , the imaging system  14  (and/or other) is used to generate an imaging report, after which the hemodynamic report and imaging report are separately used to evaluate the presence and/or condition of PAD in the patient. 
         [0025]    As previously described, common hemodynamic examinations may include blood pressure screenings, ECG monitoring, measuring blood oxygenation, and/or the like. Similarly, common imaging examinations may include ultrasound imaging examinations, commonly used, in this context, for example, to image a portion of the patient&#39;s arterial systems and/or determine the person&#39;s blood flow velocities. Accordingly, the hemodynamic report contains hemodynamic data, as does the separate imaging report contain imaging data, which, when taken together, can be used to diagnose the patient&#39;s PAD condition. 
         [0026]    As described at step  22 , the hemodynamic equipment is moved, for example, out of the patient&#39;s room (not shown), to be stored and/or used at another location (not shown). Alternatively, the patient could, of course, also physically move to another room (not shown), and/or the like, so that the patient is no longer in the presence of (or at least proximate to) the hemodynamic equipment at step  22 . As a result, the imaging equipment is then, for example, brought into the patient&#39;s room (and/or the patient otherwise moves theretowards), as described at step  24 , where it can be set up proximate to the patient for the imaging examination. As described, patient data is entered separately at steps  16  and  26  for the respective hemodynamic system  12  and imaging system  14 . 
         [0027]    As is evident from the workflow procedure  10  of  FIG. 1 , redundant functions are performed by the caregiver(s), and the end result generates two separate reports, both providing data as to the potential incidence of PAD in the patient. It is estimated that the completion of such a workflow procedure  10 , from start to finish, averages approximately 72 minutes per patient. 
         [0028]    As a result of the afore-mentioned cost and time constraints, often only a hemodynamic examination or imaging examination is chosen. However, both direct assessments and indirect assessments have limitations. Accordingly, patient exam quality is compromised. However, when both direct assessments and indirect assessments are deployed, they offer the patient an optimal evaluation and a more accurate overall assessment. 
         [0029]    Referring now to  FIG. 2 , there is shown a novel schematic view of an improved workflow procedure  32  used to diagnose PAD in the patient (not shown). More specifically, the hemodynamic system  12  and the imaging system  14 , such as an ultrasound imaging system, are again used to diagnose PAD in the patient. As shown, however, the hemodynamic system  12  and the imaging system  14  now communicate with one another using, for example, a direct connection  34 , such as a serial cable, parallel cable, fiber optic ink, USB port, LAN line, and/or the like. In another embodiment, the hemodynamic system  12  and the imaging system  14  communicate with one another using, for example, an indirect and/or wireless connection  36 , particularly using, for example, transceivers  38 ,  40  (and/or the like) respectively supported by both systems  12 ,  14 . In either event, the hemodynamic data is made available to the imaging system  14 , and/or vice versa—i.e., the imaging data is made available to the hemodynamic system  12 . 
         [0030]    As can be seen, the healthcare provider (not shown) enters patient data into either the hemodynamic system  12  or the imaging system  14  (or other) at a first step  42 , after which a hemodynamic examination is performed on the patient at a next step  44 , particularly using hemodynamic equipment, such as the hemodynamic system  12 —after which it is assumed, for the present purposes, that an imaging examination is also desired, and so an imaging examination is performed on the patient at a next step  46 , particularly using the imaging equipment, such as the imaging system  14 . Both systems  12 ,  14  were made available to the healthcare provider at a single opportunity during a single evaluation/examination. Then, at a final step  48 , a combined hemodynamic report and imaging report is generated to be used to evaluate the presence and/or condition of PAD in the patient. As can be seen, the patient data only needs to be entered once, at step  42 , and not repeatedly as with the workflow procedure  10  of  FIG. 1 , particularly since the hemodynamic system  12  and the imaging system  14  are now in communication with each other through the direct connection  34  or indirect and/or wireless connection  36 . Thus, once the patient data is entered a single time, such as at step  42 , it is then shared by both the hemodynamic system  12  and the imaging system  14 . 
         [0031]    As such, patient exams can be performed on the patient in any particular order (i.e., either the hemodynamic examination first or the imaging examination first), and the tests for diagnosing PAD can include both those for an indirect evaluation, as well as for a direct evaluation—i.e., tests carried out, respectively, by the hemodynamic system  12  as well as by the imaging system  14 . In addition, at the conclusion of the workflow procedure  32 , a comprehensive report is generated including both the hemodynamic data from the hemodynamic examination and the imaging data from the imaging examination. 
         [0032]    As in  FIG. 1 , common hemodynamic examinations may include blood pressure screenings, ECG monitoring, measuring blood oxygenation, and/or the like. Similarly, common imaging examinations may include ultrasound imaging examinations, commonly used, in this context, for example, to image a portion of the patient&#39;s arterial systems and/or determine the person&#39;s blood flow velocities. Accordingly, the combined report contains hemodynamic data and imaging data, which can be used to diagnose the patient&#39;s PAD condition. 
         [0033]    Since the hemodynamic system  12  and the imaging system  14  now communicate via the direct connection  34  and/or indirect and/or wireless connection  36 , the need to separately enter patient data for each system is thereby eliminated (see, e.g., steps  16  and  26  in  FIG. 1 ). In addition, if the hemodynamic system  12  and the imaging system  14  are brought together under a common platform  50 , the need to remove the hemodynamic equipment from the patient&#39;s presence and separately bring the imaging equipment into the patient&#39;s presence is also thereby eliminated (see, e.g., steps  22  and  24  in  FIG. 1 ). 
         [0034]    As is evident from comparing the workflow procedure  10  of  FIG. 1  and the workflow procedure  32  of  FIG. 2 , performing redundant functions by separate caregivers is eliminated, and the end result generates one report, not two, providing comprehensive data as to the potential incidence of PAD in the patient. It is estimated that the completion of such a workflow procedure  32 , from start to finish, averages approximately 48 minutes per patient—or substantially less than the workflow procedure  10  of  FIG. 1 . Thus, a diagnosis can be completed with more efficiency, cost effectiveness, and greater accuracy. 
         [0035]    In accord with the inventive arrangements, at least one or more of the hemodynamic system  12 , imaging system  14 , and/or common platform  50  includes a processor  52  that receives the hemodynamic data obtained by the hemodynamic system  12 , as well as the imaging data obtained by the imaging system  14 . The processor  52  combines the data into an integrated data set that combines both the hemodynamic data and the imaging data and that can be printed out by a printer  54  to provide a combined, comprehensive report on the patient&#39;s PAD condition, particularly including both sets of data. As a further option, particularly in connection with, or as a supplement to, the printer  54 , the combined data from the hemodynamic system  12  and the imaging system  14  can also be sent to and/or stored at a central data site  56  within the health care facility (not shown) and/or otherwise (not shown). 
         [0036]    Referring now to  FIGS. 3A-3C , there are shown differing exemplary embodiments illustrating additional use of the inventive arrangements. As such, there can be seen in the figures, for example, a patient&#39;s legs  58  having a plurality of blood pressure cuffs  60  displaced along the length of the legs  58 . A pressure manifold  62  is provided to pressurize and depressurize the blood pressure cuffs  60  via one or more conduit(s)  64  connected therebetween the blood pressure cuffs  60  and the pressure manifold  62 . 
         [0037]    In the embodiment depicted in  FIG. 3A , the hemodynamic system  12  controls the pressure in the pressure manifold  62  through a link  66 , and it thus controls inflation and deflation of the blood pressure cuffs  60  via the one or more conduit(s)  64 . The pressures detected by the inflation and deflation of the blood pressure cuffs  60  are detected by the hemodynamic system  12  via a feedback link  68 . Accordingly, in this embodiment, the hemodynamic system  12  controls the pressures in the blood pressure cuffs  60 , and it also detects the pressures therewithin. A link  70  then communicates the hemodynamic pressure data to the imaging system  14 , whereby the hemodynamic data is combined with data obtained by the imaging system  14 , so as to diagnose the PAD condition of the patient (not shown in fall). The link  70  can be either a direct connection  34  or indirect and/or wireless connection  36  (e.g., see  FIG. 2 ). As such, the hemodynamic data is communicated to the imaging system  14  via the link  70 , whereby it is preferably integrated with the image data gathered by the imaging system  14 , and preferably combined together therewith to produce an integrated and/or comprehensive report detailing both the hemodynamic data and the imaging data. 
         [0038]    In the embodiment depicted in  FIG. 3B , the imaging system  14  controls the pressure in the pressure manifold  62  through a link  72 , and it thus controls inflation and deflation of the blood pressure cuffs  60  via the one or more conduit(s)  64 . The pressures detected by the inflation and deflation of the blood pressure cuffs  60  are again detected by the hemodynamic system  12  via the feedback link  68 . Accordingly, in this embodiment, the imaging system  14  controls the pressures in the blood pressure cuffs  60 , but the hemodynamic system  12  detects the pressures therewithin. A link  74  then communicates the hemodynamic pressure data to the imaging system  14 , whereby the hemodynamic data is combined with data obtained by the imaging system  14 , so as to diagnose the PAD condition of the patient (not shown in full). The link  74  can be either a direct connection  34  or indirect and/or wireless connection  36  (e.g., see  FIG. 2 ). As such, the hemodynamic data is communicated to the imaging system  14  via the link  74 , whereby it is preferably integrated with the image data gathered by the imaging system  14 , and preferably combined together therewith to produce an integrated and/or comprehensive report detailing both the hemodynamic data and the imaging data. 
         [0039]    In the embodiment depicted in  FIG. 3C , the hemodynamic system  12  and the imaging system  14  are combined into the common platform  50 . Accordingly, the combined platform  50  contains the full functionality of both the hemodynamic system  12  and the imaging system  14 . As such, it again controls the pressure in the pressure manifold  62  through a link  76 , and it thus controls inflation and deflation of the blood pressure cuffs  60  via the one or more conduit(s)  64 . The pressures detected by the inflation and deflation of the blood pressure cuffs  60  are detected by the common platform  50  via a feedback link  78 . Accordingly, in this embodiment, the common platform  50  controls the pressures in the blood pressure cuffs  60 , and it also detects the pressures therewithin. Since the hemodynamic system  12  and the imaging system  14  are combined into the common platform  50 , a further link (e.g., link  70  in  FIG. 3A  and/or link  74  in  FIG. 3B ) is either unnecessary and/or internal therewithin, whereby the hemodynamic data is combined with data obtained by the imaging system  14 , so as to diagnose the PAD condition of the patient (not shown in fall). As such, the hemodynamic data is preferably integrated with the image data gathered by the imaging system  14 , and preferably combined together therewith to produce an integrated and/or comprehensive report detailing both the hemodynamic data and the imaging data. 
         [0040]    As described in the embodiment depicted in  FIG. 3C , it can be seen that the hemodynamic system  12  and the imaging system  14  have been physically incorporated into the common platform  50 , creating a single integrated system that includes the functions of both the hemodynamic system  12  and the imaging system  14  in a single apparatus within a common enclosure, such that both systems  12 ,  14  are transportable, for example, together as an integrated apparatus via the common platform  50 . They can be contained within a common enclosure and/or integrated into a single apparatus. 
         [0041]    In accordance with the foregoing, one technical effect is to combine a hemodynamic system  12  with an imaging system  14  into a common platform  50  to improve PAD diagnosis workflow  32  for patients, healthcare providers, and/or healthcare facilities. 
         [0042]    Accordingly, it should be readily apparent that this specification describes illustrative, exemplary, representative, and non-limiting embodiments of the inventive arrangements. Accordingly, the scope of the inventive arrangements are not limited to any of these embodiments. Rather, various details and features of the embodiments were disclosed as required. Thus, many changes and modifications—as readily apparent to those skilled in these arts—are within the scope of the inventive arrangements without departing from the spirit hereof, and the inventive arrangements are inclusive thereof Accordingly, to apprise the public of the scope and spirit of the inventive arrangements, the following claims are made: