Software Technology for “Methods and systems for improving the vascular system in humans by using biofeedback, network data communication, and network data communication.”

Digital Healthcare – Alexander F. Castellanos

Abstract for “Methods and systems for improving the vascular system in humans by using biofeedback, network data communication, and network data communication.”

Methods for treating vascular diseases in humans and creating data to support treatment plans are described. The first set of clinical data pertaining to vascular health from a healthcare provider, representing the vascular condition of a patient, is received at a server in a data center that is communicatively connected to a public network. To create and store an initial treatment plan for the patient, one or more vascular disease analytics algorithms are applied to the first vascular health data. A second set is obtained from a patient-associated monitoring device, which is communicatively connected to the data network. The second set includes Doppler monitor data from the patient’s peripheral vascular system. A variety of vascular analysis algorithms can be applied to create one or more supplementary treatment plan for the patient. A minimum of one treatment plan includes a biofeedback interaction. The patient receives the treatment plans via the data network. As determined by the doctor and the patient, the above steps can be repeated iteratively one or more times. This results in better vascular health.

Background for “Methods and systems for improving the vascular system in humans by using biofeedback, network data communication, and network data communication.”

“The approaches described herein could be used, but they are not necessarily approaches that were previously thought of or pursued.” The approaches described in this section, except as otherwise stated, are not prior art for the claims in the application. They are therefore not admissible to be prior art by being included in this section.

Vascular disease is common in humans, and it’s a major cause of premature deaths in many people. Vascular disease is generally characterized by the buildup of fat deposits on the walls and walls of the blood vessels. This causes the arterial walls to become more rigid and thicken. This causes a decrease in blood flow to all tissues and cells. One example of vascular diseases is heart disease. Coronary artery disease is the leading cause for death in the American adult population.

The medical community is aware that vascular disease can be significantly reduced in many people. The best way to lower the risk of developing vascular disease is by identifying individuals at high risk for hypertension, elevated cholesterol and obesity. These conditions are strongly linked to vascular disease. One commentator observed that? One commentator observed that???? would be a welcome and more powerful tool than the current additive technique. S. Sheps, “Treating Hypertension”,? Hippocrates, v. 13 no. 11 (Dec. 1999).”

“Currently, medical evaluation and treatment for vascular diseases involves using vascular exams to determine if a person’s symptoms are caused by vascular disease. These studies can involve the use of expensive machines and procedures such as angiograms and magnetic resonance imaging. They are not recommended for patients with other signs or symptoms of vascular disease. The American Heart Association recently issued a Scientific Declaration (see Circulation 2000;101:e3 & Circulation 2000;101 El 63), suggesting that there may be interventions to evaluate ankle brachial blood pressure, ultrasound, volume studies, and scans. These methods aren’t widely used in clinical settings for the evaluation of vascular diseases.

Doppler vascular studies can be used to assess peripheral artery disease in the legs or arms. The AHA Scientific Statement referred to prior work that used duplex vascular studies of carotid vessels to correlate anatomical changes in the coronary arteries. Doppler vascular studies of the peripheral circulatory systems (functional studies) are not currently used to assess risk for cardiovascular disease. They are also not used to assess risk in patients who are not yet symptomatic.

The current standard of care is not always the best for patients with vascular disease. Beta blockers, a class of drugs, are often prescribed. However, these can cause serious complications such as depression of the heart and emotional depression, exercise-related effects, and effects on diabetes control.

Biofeedback is a method that trains people to recognize signals from their bodies and can be used to treat certain health conditions. B. Runck explains Biofeedback. National Institute of Mental Health, Dept. Pub. No. (ADM) 83?1273. Biofeedback is currently not used to treat vascular disease.

“Another problem with the treatment of vascular diseases is that health care professionals lack the ability to evaluate and receive data about the current vascular health of an individual. There are certain techniques that can be used to capture snapshots of data. A Holter monitor could be used to collect an electrocardiogram of an individual while they are not in a clinic setting. The individual is attached to an EKG electrode at a clinic. The electrodes are connected to a portable data collector device that records and stores EKG data for a set period of time. This is usually 24 hours. The individual is then allowed to return to the clinic after the data collection period. There, the data are downloaded into a computer and the monitor is removed. Holter monitors may not be reliable and can only detect severe cardiac disease. These same issues are also known for treadmill stress tests.

Online businesses are the best way to address similar problems. For example, ?Healtheheart.com? Online monitoring of cardiovascular disease and online storage of medical records is available, but it is only for physicians. It does not monitor any other diseases. ?Stayhealthy.com? Provides certain tools online for health evaluation but acts only as an information service. ?Wellmed.com? Online services to personal health, including customized records and files from clinics. ?Lifemasters.com? Provides online monitoring for patients with chronic illnesses. ?Dynapulse.com? Provides blood pressure monitoring devices that measure cardiac function using blood pressure readings uploaded over the Internet. A data analysis center interprets the data and generates reports. However, none of these methods use biofeedback interactions and none use Doppler vascular data from the peripheral vein system as a global measurement instrument for evaluating vascular diseases.

“Based on what has been said, we believe there is a need to improve systems and treatment methods for vascular disease.”

“A healthcare provider must also be able to collect vascular information from an individual engaging in daily activities that are not restricted by a clinic over a prolonged period of time such as months or even years.”

“Another need is for patients and healthcare providers to simultaneously have access to these vascular data.”

“Further it would be helpful to have means for patients to self-direct follow-up treatment for vascular disease using biofeedback techniques after an initial physician evaluation.”

“The present invention addresses the above needs and other objects as described in detail. It also includes, in one aspect of the invention, a method to improve the vascular system in humans through biofeedback and network data communications.

“In one aspect, this invention provides a method to improve diagnosis, prevention, reduction, and prognosis for vascular disease through evaluating an individual’s vascular system. Embodiments can include measuring the risk of developing vascular disease by using blood pressure, pulse measurements and Doppler-vascular monitoring from the peripheral vein system. These measurements are combined with biofeedback mechanisms, data communication over a network, and data communication. Embodiments provide methods and means to prevent, reduce, diagnose, and determine a prognosis of vascular disease.

“In other embodiments, methods of treating vascular disease in people and generating treatment plans are disclosed. The first set of clinical data pertaining to vascular health from a healthcare provider is received at a server in a data center that is communicatively connected to a public network. The first set of vascular data is subject to one or more vascular disease analytics algorithms. This results in the creation and storage of an initial treatment plan.

After initial physician evaluation, a second set of vascular data is obtained from a monitor that is connected to the data network and is associated with the patient. Data obtained from a Doppler-vascular monitor attached to an external site proximate the patient’s peripheral vascular system are the second set of vascular data. A variety of vascular analysis algorithms can be applied to create one or more supplementary treatment plans. A minimum of one treatment plan includes a biofeedback interaction. The patient receives the treatment plans via the data network. As determined by the doctor and the patient, the above steps can be repeated iteratively one or more times. This results in better vascular health.

“Embodiments can be used to treat individuals who are asymptomatic, or symptomatic, with respect to vascular diseases, hypertensions, high cholesterol, and diabetes. They are also useful in stress reduction, weight loss, quitting, and improving lifestyle choices and habits.

“In another aspect, the invention includes a computer apparatus as well as a computer-readable medium that can be used to perform the above steps.”

“A method and apparatus to improve the treatment of vascular diseases in humans by using biofeedback, network data communication and network data communication is presented. The following description provides a detailed explanation of the invention. However, it will be obvious to those skilled in the art that this invention can be used without these details. Other instances of well-known devices and structures are shown in block diagrams to avoid obscure the invention.

“Embodiments” are described in the following outline:

“In one aspect, an invention provides a method to improve diagnosis, prevention, reduction, and prognosis for vascular disease through evaluating the individual’s vascular system. Embodiments can include measuring the risk of vascular diseases using blood pressure, pulse measurements and Doppler-vascular testing. These measurements are combined with biofeedback mechanisms, data communication over a network, and data communication. Embodiments provide methods and means to prevent, reduce, diagnose, and determine a prognosis of vascular disease.

“FIG. “FIG. 1” is a block diagram of an exemplary system to improve the vascular systems of humans. A patient 10, or user, has a monitoring device 12, which is communicatively connected to a first client 14A. A client system 14A could be, for instance, a personal computer or personal digital assistant (PDA), a wireless computing device, workstation, or other device that can be interfaced to the monitoring device 12 via a suitable hardware interface and /or software interface. The terms “patient” and “user” are used throughout this description. The terms?patient? and?user are interchangeable to refer to any individual who uses the systems and methods described herein. These terms are interchangeable to refer to anyone who uses the methods and systems described herein.

“The monitoring device 12 can be used to monitor and generate data related to one or more patient physiological characteristics. One embodiment of a monitoring device comprises a pulse monitor and blood pressure monitor as well as vascular Doppler monitor. Each of these monitors can be contained in a single device that is either handheld or securely attached to the body. Alternately, several conventional monitoring devices, including a Doppler monitor, may be used. These are represented collectively by element 12 in these drawings. Other embodiments may use different monitoring devices. For example, monitoring device 12 could include a glucose monitor for monitoring blood glucose or diabetes using the same techniques as those for vascular disease. One embodiment of monitoring device 12 includes a vascular Doppler scanner that can collect pulse waveform data. Server 18 contains analysis software to generate waveforms from the sensor.

“Client System 14A is communicatively connected, directly or indirectly, through one or more routers switches, gateways or other network equipment to a public information network 16. Network 16 in one embodiment is the network of interconnected global internetworks that are known as the Internet.

“A second client system 14B is also communicatively connected to the network 16 and is associated with a healthcare provider 30. A healthcare provider 30 is a doctor or other healthcare professional who is involved in patient treatment. Healthcare provider 30 could be the personal physician for patient 10. The client system 14B might be found in the clinic or office of this physician. You can also locate the client system 14B in an area other than the clinical setting. This includes mobile locations, informal evaluations and treatment locations. No specific treatment location is necessary.

“Healthcare provider 30” also refers to an institution, such as a hospital, or any other facility, and the personnel involved in treating patients 10. Client system 14B executes all the software elements relating to client system 1 4A. Client system 14A can execute a physician’s version of client application 15 in certain embodiments. This client version offers functions that are appropriate or of interest to physicians.

“In this description, we use the terms?physician?” “Physician” and “Healthcare provider?” They are interchangeable and can be used to refer to doctors, nurses, nutritionists and psychologists as well as psychiatrists and alternative health providers.

FIG. One client system 14A and one patient are shown together in FIG. In a practical embodiment however, any number of patient systems, client systems and healthcare providers can be connected simultaneously to network 16. It is possible to use thousands or even millions of these clients.

“A server 18 is communicatively connected to network 16. Below is a detailed description of server 18. Server 18 is an enterprise-server computer system that runs a vascular analysis program 20, Web server 24, operating system 22, and other functions. Server 18 is a central point that stores patient data, treatment plans, user information, as well as performs administrative functions like user registration, report generation, and so forth. Server 18 can also be communicatively connected to database 26 for the storage of patient data and treatment plans, user information, as well as system support information. Database 26 could be a traditional relational database system like Oracle 8i, Microsoft SQL Server or Microsoft Access.

“Network 16 can be communicatively connected to client system 14A and client system 14B and server 18 via network links 13b, 13c, and 13d, respectively. Any type of communication link can be used to connect each link 13 b., 13c., or 13 d to network 16.

“Similarly, client system 14A is connected to monitoring device 12 via a link 13a. This link can be wired or wireless. Another embodiment of monitoring device 12 includes a processor, cellular radio modem, and the appropriate software to enable wireless communication between monitoring device 12, and server 18 or client 14A over a network. Wireless embodiments allow signals to pass through one or several wireless gateways. They can also traverse network 16 or other wireless networks.

“The server 18 as well as client systems 14A and 14B are equipped with security measures and privacy protections to protect patient information. Hardware elements, such as firewalls, may be used. Software mechanisms, such as passwords, user authentication and encrypted data communications, may also be used.

“FIG. “FIG. 1. According to one embodiment. FIG. FIG. 2. and all other flow charts provided herein, the order in which steps are presented is optional, unless stated otherwise. Additional steps can be added or omitted without affecting the spirit and scope.

“In block 200, a patient arrives in a medical office to receive treatment. Alternate embodiments are described herein. A patient can interact with elements in the system of FIG. 1. at any location. Therefore, interaction at a healthcare office is not necessary. Block 204 is where the patient gives and the healthcare provider receives the patient’s medical history and any pre-existing laboratory results. The patient and/or healthcare provider may complete a medical record that includes information about the patient’s family history and any laboratory results.

“In block206, the medical staff receives more physiological data measurements related to the patient. The healthcare provider may collect data for the patient, conduct one or more laboratory tests, or perform data collection. Data collection may include, for instance, a physical exam of the patient and measurement of one or more physiological data value of the patient such as their age, height, weight blood pressure, body mass, and index. Doppler vascular studies, blood cholesterol testing, and pulse oximetry may all be part of physiological testing.

“As indicated in arrow 208 at block 206, a first biofeedback interactions may be performed. The biofeedback interaction described in arrow 208 could include communication between patient and physician. This may involve the use of 3D models, reminders of patient’s goals, affirmations from the patient, and/or the illustration of goals.

“In block210, data from blocks 204 and 206 are transmitted over a public network such as the Internet to a data centre that can store and analyze the data. Referring to FIG. 1. The data is sent by the client system 14B to the server 18. The data communication between client system 14B of healthcare provider 30 and server 18 can use standard techniques like HTTP messaging, calls at Java Server Pages (JSPs), submission to HTML forms, etc. One specific embodiment sends data from a vascular exam at the medical office through network 16 with or without assistance from one or more wireless networks to server 18. A software program will analyze and interpret the data and recommend treatment programs for hypertension or elevated cholesterol, diabetes or nutrition.

“In block212, data is analysed using one or more vascular analysis algorithms. Example: vascular analysis app 20 (FIG. 1) receives the data values and executes one of the algorithms to analyze them. It then generates one or several treatment plans and/or recommendations messages.

Block 216 contains the treatment plans, recommendation messages and any other data generated at the data center (e.g. server 18 in FIG. 1) are sent over the public network to the healthcare provider. Data from server 18 can be sent over network 16 to client 14B. Block 218 is where the data provided by the data centre is received by the medical staff and patient. Block 220 is where the medical staff and patient review the data from the data center in order to decide on a course of actions. A healthcare provider may interpret data from the data center and modify treatment plans or explain options to patients. A second biofeedback event can be performed as part of block 220 (arrow 222). Further sections provide examples of biofeedback events that are suitable.

“In block 224, the healthcare provider and patient initiate one or several medical programs that include using one or multiple treatments, taking one or more medication, watching videos, or interfacing with computer-displayed 3D models. A third biofeedback event can be performed as part of block 226, as indicated by the arrow 226. One embodiment of this third biofeedback event is where the patient views a computer screen that shows a 3D model of their vascular system. The patient is also connected to a pulse monitor and a blood pressure monitor. The patient can view the 3D graphical model and perform relaxation exercises. They also have the ability to observe the effects of therapy on the patient’s vascular function. Another example is that the patient is connected with equipment that measures blood pressure and changes Doppler vascular waveforms. The patient then hears a signal that corresponds to pulse action in his vascular system and is shown an animated graphical display that shows vascular wall movement proportional to the data being collected in real-time.

“In block 228, the patient communicates remotely with the medical program via computer access to the public network. Referring to FIG. Referring to FIG. 1, the patient connects client 14A to network 16 while at home, work, or anywhere else. The patient interacts with the vascular data client app 15 locally, and remotely with server 18 or 20 remotely. A fourth biofeedback event, as indicated by Arrow 230, is performed in block 228, which is part of block 228, At home, for example, the patient connects the monitoring device 12 to him, while the client system 14A is connected via network 16 to server 18. The patient then engages in an athletic activity such as using a treadmill at home or exercising on a bicycle. The client system 14A displays data values that are associated with the patient’s cardiovascular functions. To improve the patient’s vascular system, the patient can adjust the pace of the patient’s athletic activity. The patient may also choose to relax, watch educational videos, or do other activities. It is not necessary to use the device during athletic activity. The monitoring device 12 can be used, and data may be viewed before or after the activity.

Block 232 contains data generated by the medical programs as part of blocks 228 or block 230. It is transmitted over the public network to the data centre. Server 18 receives, for example, real-time data on vascular health or user inputs to the vascular client application 15. This is non-real time. Block 234, the data centre stores data values that represent patient interaction with the system. Block 234 could also include the modification of one or more treatment plans, or recommendations, that were previously generated from the data center.

“Thereafter control flows optionally to block 204 or block 212. FIG. 2. may repeat as the patient or healthcare provider do additional activities, such as biofeedback events and data gathering and analysis functions, treatment plan modifications, and so on.

The above-mentioned vascular risk evaluation achieves many useful objectives. Asymptomatic and symptomatic patients can be assessed for vascular disease risk. Vascular medicine has improved the clinical skills of doctors. The outcomes of patient treatment are recorded and analyzed. Patients take part in their own treatment for a longer time.

“2.0 Structural Details for One Embodiment”

“2.1 Vascular Data Measuring Device”

“FIG. “FIG.

“Monitoring device 12, which consists of a processor 210 and a battery208, serves as a power supply. A clock 212 provides synchronization signals. The processor 210 can be used as a microprocessor or micro controller. Instructions and data to control processor 210’s operation are stored in a read only memory (ROM) 214 or random-access memory 216. In certain embodiments, ROM 214 or RAM 216 can be integrated with processor 210 as on-chip storage. An Universal Serial Bus interface (USB), 218 connects the monitoring device with a personal computer, peripherals or other suitable system via a USB port 221.

“Monitoring Device 12 also includes a pulse data interface 200, an oxymetry interface 204, and a blood pressure interface205, which are connected to probes 206A and 206B, respectively, and a blood pressure bracelet 207. One embodiment incorporates probes 206A and 206B into a housing that protects and conceals the other elements of FIG. 3 to form a portable, easily-accessible monitor that can be used for a wide range of physical activities. Probe 206A is designed to receive pulse data and can be attached to a finger or wrist, ankle, or any other anatomical structure with a superficial pulse point. Probe 206B is designed to receive oxygen saturation information. It can be attached to a fingernail, or toenail. Cuff 207 can be attached to a finger or wrist, arm, ankle or ankle. In one embodiment probe 206A can be used as an acoustic Doppler sensor to collect acoustic pulse data. Analysis software is available in server 18. This embodiment attaches probe 206A to a pulse point on one extremity of the vascular system such as the ankle. Alternately, a separate probe, wand or sensor can be used to collect acoustic Doppler data for analysis in server 18. This server software can create and store data representing one, or more, vascular data waveforms. These data can be stored in either graphical format or as raw data values. It is based on the acoustic signals from probe 206A. Monitoring device 12 acts as a data collection mechanism, while server 18 analyses and generates graphics images and other interpretations from the acoustic data.

“Further in this arrangement, pulse, blood pressure and pulse oxymetry measurements are received by processor210 when the monitoring unit 12 is held by a patient, or another user. In cooperation with interfaces 200, 204 and 205, processor 210 determines data values and provides them to RAM 216 and external systems through the USB interface 218. Client system 14A, for example, can send appropriate messages through USB interface 218 to processor 210 and receive the data values.

“Optional, monitoring device 12 includes an RF interface 218, antenna, and the appropriate software to enable wireless communication between monitoring device 12, and server 18 and client system 14A over a network. Wireless communication allows the user to easily transport monitoring device 12 for use in an exercise, biofeedback, or any other activity.

“2.2 Vsdvilst Client Application”

“FIG. “FIG.

“Presentation Layer 404 is responsible to receive data from subordinate levels and present the data to a person. Presentation layer 404 may call functions of a browser dynamic library (DLL), which is associated with the operating system 412 of client system 14A to create output that can be viewed using browser 17. Presentation layer 404 can also call the windowing and display functions from the operating system 412; or, in another alternative, it generates a bitmapped graphic display.

“Treatment planning engine 406 is responsible to generate one or several treatment plans for a patient, present one or two treatment plans to the patient, manage patient interaction with them, and modify one or more of the treatment plans received from the server 18. The local data store 414 contains one or several patient data values 414A, and one or two treatment plans 414B. Treatment plan engine 406 interacts with the local data store 414. A local data store 414 could contain a database that is stored on the client’s local disk storage 14A. Microsoft Access, for example, may be used to store data locally. Or, a proprietary format of data may be used. The treatment plans 414B may also include audio streams, video streams, or graphical models of anatomical or physiological elements.

“Data transfer engine 408 manages data communication from vascular client application 15 to other systems or software. Data transfer engine 408 can interact with device interface 416 to retrieve physiological data from the monitoring device 12. Data transfer engine 408 can also interface with the TCP/IP stack 412 of operating system 412 in order to transmit data via HTTP over a public network.

“2.3 Data Center Server Architecture”

“FIG. “FIG.

“In FIG. “In FIG. 5, data center server 18 and network 16 are coupled through firewall 502 which allows only authorized data traffic into the data center server. Server 18 may be coupled to a wireless gateway 502 that in turn is connected to one or more wireless networks. Server 18 can transmit and receive data via traditional landline methods such as the Internet, or wireless networks.

In one embodiment, the server 18 is a server-class computer which executes an app server 504 or 20. A Java 2, Enterprise Edition (J2EE), application server, such as those available commercially from WebLogic, is an example of suitable software. But, embodiments do not have to be limited to a J2EE server. Any other suitable server can also be used.

“Server app 20 includes control functions, treatment plan engine function functions, invoicing, payment functions and data transfer functions. In one embodiment, server app 20 can interact with multiple software services that perform support functions. FIG. FIG. 5 shows such services as a presentation service512, registration service 516 and administration service 518.

“Presentation Service 512” is responsible for receiving HTTP requests and rendering content. One embodiment of content rendering uses a combination Java servlets (JSPs) and Java Server Pages. The presentation service 512 can include an image server, panel and servlet control. The image server renders images requested by clients browsers, as well as images that are part of a treatment plan or medial program. The panel is responsible to receive user interface elements from a medical program, treatment plan, and render them by ordering and laying them out. This panel can also render device-specific elements. The servlet controller receives and processes servlet request and sends them to the appropriate subsystem. A servlet controller can contain a number of different servlets and is responsible for retrieving the data used in JSP pages.

The “Registration Service 516” is responsible for the registration of patient users and healthcare users within the system. This includes recording identification information, passwords, as well as other data. Administration service 518 allows editing and configuration of application server 504, such as the creation, update, deletion, and modification of users and groups, and data communication settings. The authentication service 520 handles requests from users to log in to the system or use it, to verify passwords and to authenticate them before they can be offered services. Wireless data service 514 handles data transmissions to and receptions from wireless data services (e.g. wireless gateway 501).

“Database service510 manages interaction to a database 508. A database 508 can be a traditional relational database system that stores patient data, healthcare provider data tables, treatment plan tables, and other data. Any of the above tables can be stored in a separate database server for privacy or security reasons.

“System service 511 in one embodiment includes auditing, caching and logging, offline persistence, and time-service components. The auditing component allows the creation of an audit trail within database 508 which identifies other system elements. The caching component allows caching of objects, including user data, treatment plan data, images and text. The logging component allows you to access an operational log in the database 508 for error evaluation and debugging purposes. Clients can receive notifications of information changes that occur when clients are disconnected from network 16. In one embodiment, the offline components interact with each client’s offline client plug-in 14A, 14B. This is omitted to simplify. The persistence component stores stored procedures that are used for reading and storing data. The time service component allows for recurring, persistent actions to be created and schedule.

“In some embodiments, server 18 or server application 20 offer a hosted service for one or more patients 10, and healthcare providers 30, in certain cases. An entity that owns server 18 or operates it may be an application service provider, making services of server 20 available to patients 10, and healthcare providers 30, on a fee basis. You can choose to pay per-service or monthly fees. A healthcare provider may have to pay a fee for every clinical study that is done on a patient. Access to the data could also be charged separately or included in the fee.

“3.0 Functional Details for One Embodiment”

“The descriptions of some functions below could refer to actions that can be taken by a client, user, or system. For simplicity, the description could refer to only a user. However, in this case, the term “user” is used. It can refer to any individual who acts through a computer user interface or client computer that interacts programmatically using an appropriate machine interfacing or an external server, program application or other computer system that interacts programmatically via an appropriate machine interfacing. All references to user action are meant to be broad and not limited to human action.

“3.1 Network Biofeedback Vascular Disease Treatment Method.”

“FIG. “FIG. FIG. FIG. 6A shows how a patient undergoing treatment for vascular diseases interacts with a medical software program. Another approach, described below, allows the patient to interact with a medical software program hosted on a server and accessible by him over a data network such as the Internet. A third option is for the patient to interact with the program while under physician care at a hospital or medical office.

“In an alternative embodiment, institutions such a managed care organization, community centers and hospitals, as well as employers offering employee assistance programs, may interact with the client application or server application. Researchers such as university researchers may also interact with the client application or server application in order to conduct research using data stored on the server and correlated with other investigation procedures in the area vascular disease evaluation, treatment and follow-up.

“Each of these approaches provides an educational component. The medical program includes video, audio, and/or 3D graphic models that show normal and abnormal structures and physiology related to the heart and circulatory system. These audiovisual information can be interacted with by the patient to help them understand the effects of medications and activities on their physiology. The audiovisual interactions illustrate the dramatic changes that may occur in vascular disease.

“One or more such audiovisual interactions could include a biofeedback component. A patient can view and hear the audiovisual information to evaluate their own circulation and other vascular characteristics. The client system can display the patient’s blood pressure and Doppler waveform data by using a monitoring device. The client system can simultaneously play audio from the Doppler-vascular monitor data of the patient, allowing the patient to hear their pulse rate and circulatory characteristics. The patient can see and hear changes in their physiology over time by following one or more treatment programs. This may lead to a positive improvement in vascular health.

These interactions can vary in frequency. A physician might recommend one or more periodic examinations, such as three times per year or monthly depending on the patient’s risk factors and their physical condition.

The server or client system may collect data that can be used to study long-term populations of patients or for the long-term improvement of the patient. Data gathered by the server or client system may be used to track lifestyle changes such as diet and exercise changes. Data gathered by the system can be used to determine the effects of medication or dietary supplements. Researchers can use aggregated or anonymized data to correlate with other data and other treatment methods. Researchers may use the data to compare biofeedback and lifestyle changes to surgical or invasive imaging methods.

Clinical studies are becoming more affordable and available. Patients and physicians have continuous, online access to patient information. Physicians can monitor and remotely assess patients over the long-term without having to visit a lot of offices or clinics.

“In one embodiment, the above-mentioned approaches can be combined with other medical treatment. The above-mentioned approaches can be used in combination with prescriptions of drugs such as calcium channel blockers or ACE inhibitors, ACE blocking medications, vitamin B12, niacin therapy, ACE blockers, ACE blockers, ACE blockers, ACE blockers, ACE blockers, ACE inhibitors and ACE blockers. These drugs have been shown to reduce side effects associated beta-blockers and promote circulation in all tissues. These approaches may provide significant benefits for treatment. These benefits include improved circulation in the extremities and heart, brain and muscles; migraine headache control; early Alzheimer’s disease prevention and treatment; increased cardiovascular circulation; greater exercise capacity; increased blood flow to the sexual organs which results in better sexual function and many other benefits.

“The methods described herein could include biofeedback principles and meditation in conjunction with physiological measurements taken from Doppler vessels monitors and other devices. These treatments are typically given and instructed by paramedical and medical providers. The present approaches, however, are self-administered and managed by the patient and physician.

These methods can be used to save time and money, as well as increase the effectiveness and skills of the user in addressing certain physiological goals such reverse or prevention of cardiovascular disease and complications like strokes and heart attacks. After having reviewed the results of the treatment, the primary healthcare provider or doctor can make further recommendations to the patient.

“In a similar way, both the client and server applications can help the user address other treatment recommendations such as lifestyle changes. Embodiments can also recommend one or more exercise programs. This approach involves attaching a monitoring device 12 to collect data for blood pressure, heart rate, and oxygen saturation while on a stationary bicycle or treadmill at home. Client application 15 analyzes and stores the data values during exercise and after it has ended. Client application 15 provides safety parameters which suggest a protocol for exercise based on physiological data previously collected and stored at the server.

“Another embodiment provides a nutrition evaluation function and recommendation function using vascular server application 20 and vascular client application 15. The patient fills out a questionnaire online or software-driven that collects information about recent food consumption, quantity, preparation methods, and other relevant data. The completed questionnaire is submitted to server 18 via server application 20. Alternatively, the user can save the questionnaire locally using client app 15. Applications 15, 20 respond to the questionnaire and provide a nutritional analysis of the foods. The report includes information about the food’s nutritional content such as the amount of carbohydrates, proteins, fat, cholesterol and poly- and unsaturated fats, as well as salt, minerals, vitamins, fiber, and other characteristics.

“The nutrition function generates suggested meal plans and dietary plans. Based on data values from database 26, the nutrition plan function generates dietary plans. These include weight, blood pressure, and cholesterol. You may be asked to input additional data values by the nutrition plan function, such as preferences or weight.

“Another embodiment receives input from a digital still camera or digital video camera at client system 14A, and then communicates over network 16 to the server 18. Client application 15 asks the user periodically to position the camera for recording an image. The client then records one or more digital images. The digital images are sent over network 16 to server 18. The images are transmitted over network 16 to server 18. Client application 15 or 20 can use the images to document body weight, evaluate facial expressions to measure anxiety and tension, and to record skin torpor to aid in evaluating circulation. A healthcare provider may also use the digital image information to track the user’s biofeedback functions.

“3.2 User interaction alone (after initial physician evaluation)”

FIG. 6A shows a specific approach that involves interaction between a patient or user with server application 20 and client application 15. 6A. Block 602: The patient arrives at a computer desk, or other similar location where client system 14A can be found. A block 602 could also include activating a PDA/wireless device at any location. These embodiments are not restricted to home use.

“In block 604, the patient completes a data form to provide basic physiological data, including medical history, as per prompts from vascular client application 15 (FIG. 1). Block 604 is usually performed following a physician’s initial evaluation. Block 604 can also include receiving data about the medications that the patient is currently taking to aid in risk analysis. Block 606 is where the patient uses a monitoring device for blood pressure, blood oxygen saturation, and Doppler vascular data. Block 606 could involve the user attaching a monitoring device 12 to their body and activating client application 15, which retrieves data from the monitoring device. The data values are saved locally to client system 14A.

“As block 606 collects data, a biofeedback mechanism takes place as per block 608. One embodiment of the biofeedback mechanism in block 608 is client application 15, which generates and displays a real-time graphic representation of data values that the monitoring devices 12 are collecting. Client application 15 could generate a display showing an artery in cross section and animated it in coordination with the Doppler blood pressure monitor data pulses. The patient can see the patient’s physiological state and can alter certain characteristics such as breathing rate to effect other internal modifications.

Block 610: Data collected by the patient are sent to a data centre for analysis. Data from the monitoring device 12 is sent to a data center for analysis. Block 612 is where one or more algorithms are applied to data obtained by the monitoring device 12 and stored by client system 14A. This results in one or more reports, plans or other output data that could be of use to the patient.

Block 612 may also include performing a risk assessment for the patient. The results may be reported to them in the later steps of block 616. FIG. 6A describes the operation of FIG. 6A can vary depending on the outcome of the risk analysis. If block 612 concludes that the patient is low risk, then this could be an example. The patient would then be allowed to use the remaining steps of the method at their own discretion. Block 612 could also include a recommendation to the patient that they give copies of the reports and other recommendations to their treating physician.

Block 612 can request that the patient take another action if the user is on treatment with a healthcare provider. This may prohibit the patient from performing other steps in FIG. 6A may be used to perform biofeedback interactions, as discussed below in relation to blocks 624, 626 and 628. Client application 15 and server application 20 may enforce such control. Client application 15 or 20 can be used to instruct users to consult their physician if they are taking blood pressure medication, diabetic or have other symptoms.

“If the patient is classified as high risk,? Client application 15 might recommend that the patient not engage in certain biofeedback interaction, such as the one described herein with regard to FIG. 9 without consulting a physician. A client application 15 can control if a patient 10 is considered high risk. The program may still be used for other purposes. The ‘high risk? category is an example. The patient can perform biofeedback interactions related to stress reduction, weight loss, and nutritional modifications.”

“In block 614 the reports, treatment plans or other results data are communicated with the patient. These result data are sent over network 16 from server 18 to client system 14A, for client application 15.

“In block 616 the patient uses the received information in one or more local patient interactions. Client application 15 shows a graphical model which allows the patient to see pathological changes in relation to the arterial walls. A biofeedback mechanism is activated, as indicated by the arrow 618.

“In block620, the patient and physician review the results data. The physician may interpret the data and make recommendations to improve vascular health. The physician may also confirm the results and ask the patient to start a program according to the data. As indicated by the arrow 622, this is how biofeedback interactions occur.

“In block 624 the patient selects and executes one or more of the biofeedback processes. FIG. 7 shows specific biofeedback procedures. 7, FIG. 8, FIG. 8, FIG. 10A?10B. Client application 15 in one embodiment displays a list of biofeedback interactions. This can be done using the client application or a graphical user interface. Client system 14A receives input from patient 10, which selects one of the available biofeedback interactions. You can choose from a progressive relaxation interaction or a nutrition interaction. Or, you could do an exercise interaction. Client application 15 responds by generating graphical displays, images, audio files or video information that guide the patient through the biofeedback interaction. Biofeedback occurs to the patient as shown by arrow 626.

“Patients may be asked to participate in biofeedback interactions. These response data are communicated to the server in block 628 for processing and analysis. The server then analyzes and evaluates this response data using one or more medical calculators. The patient is then presented with the results of such analysis and evaluation. This will result in further biofeedback, as indicated by Arrow 630.

“In block 632 the patient is informed about the results via the data network. The patient can then return to block 632, where they may continue providing additional physiological or historical data or repeat the previous steps. A patient can repeat the steps of FIG. 6A may be repeated as many times as the patient wishes, or in consultation with a physician. This will result in improved vascular health.

Summary for “Methods and systems for improving the vascular system in humans by using biofeedback, network data communication, and network data communication.”

“The approaches described herein could be used, but they are not necessarily approaches that were previously thought of or pursued.” The approaches described in this section, except as otherwise stated, are not prior art for the claims in the application. They are therefore not admissible to be prior art by being included in this section.

Vascular disease is common in humans, and it’s a major cause of premature deaths in many people. Vascular disease is generally characterized by the buildup of fat deposits on the walls and walls of the blood vessels. This causes the arterial walls to become more rigid and thicken. This causes a decrease in blood flow to all tissues and cells. One example of vascular diseases is heart disease. Coronary artery disease is the leading cause for death in the American adult population.

The medical community is aware that vascular disease can be significantly reduced in many people. The best way to lower the risk of developing vascular disease is by identifying individuals at high risk for hypertension, elevated cholesterol and obesity. These conditions are strongly linked to vascular disease. One commentator observed that? One commentator observed that???? would be a welcome and more powerful tool than the current additive technique. S. Sheps, “Treating Hypertension”,? Hippocrates, v. 13 no. 11 (Dec. 1999).”

“Currently, medical evaluation and treatment for vascular diseases involves using vascular exams to determine if a person’s symptoms are caused by vascular disease. These studies can involve the use of expensive machines and procedures such as angiograms and magnetic resonance imaging. They are not recommended for patients with other signs or symptoms of vascular disease. The American Heart Association recently issued a Scientific Declaration (see Circulation 2000;101:e3 & Circulation 2000;101 El 63), suggesting that there may be interventions to evaluate ankle brachial blood pressure, ultrasound, volume studies, and scans. These methods aren’t widely used in clinical settings for the evaluation of vascular diseases.

Doppler vascular studies can be used to assess peripheral artery disease in the legs or arms. The AHA Scientific Statement referred to prior work that used duplex vascular studies of carotid vessels to correlate anatomical changes in the coronary arteries. Doppler vascular studies of the peripheral circulatory systems (functional studies) are not currently used to assess risk for cardiovascular disease. They are also not used to assess risk in patients who are not yet symptomatic.

The current standard of care is not always the best for patients with vascular disease. Beta blockers, a class of drugs, are often prescribed. However, these can cause serious complications such as depression of the heart and emotional depression, exercise-related effects, and effects on diabetes control.

Biofeedback is a method that trains people to recognize signals from their bodies and can be used to treat certain health conditions. B. Runck explains Biofeedback. National Institute of Mental Health, Dept. Pub. No. (ADM) 83?1273. Biofeedback is currently not used to treat vascular disease.

“Another problem with the treatment of vascular diseases is that health care professionals lack the ability to evaluate and receive data about the current vascular health of an individual. There are certain techniques that can be used to capture snapshots of data. A Holter monitor could be used to collect an electrocardiogram of an individual while they are not in a clinic setting. The individual is attached to an EKG electrode at a clinic. The electrodes are connected to a portable data collector device that records and stores EKG data for a set period of time. This is usually 24 hours. The individual is then allowed to return to the clinic after the data collection period. There, the data are downloaded into a computer and the monitor is removed. Holter monitors may not be reliable and can only detect severe cardiac disease. These same issues are also known for treadmill stress tests.

Online businesses are the best way to address similar problems. For example, ?Healtheheart.com? Online monitoring of cardiovascular disease and online storage of medical records is available, but it is only for physicians. It does not monitor any other diseases. ?Stayhealthy.com? Provides certain tools online for health evaluation but acts only as an information service. ?Wellmed.com? Online services to personal health, including customized records and files from clinics. ?Lifemasters.com? Provides online monitoring for patients with chronic illnesses. ?Dynapulse.com? Provides blood pressure monitoring devices that measure cardiac function using blood pressure readings uploaded over the Internet. A data analysis center interprets the data and generates reports. However, none of these methods use biofeedback interactions and none use Doppler vascular data from the peripheral vein system as a global measurement instrument for evaluating vascular diseases.

“Based on what has been said, we believe there is a need to improve systems and treatment methods for vascular disease.”

“A healthcare provider must also be able to collect vascular information from an individual engaging in daily activities that are not restricted by a clinic over a prolonged period of time such as months or even years.”

“Another need is for patients and healthcare providers to simultaneously have access to these vascular data.”

“Further it would be helpful to have means for patients to self-direct follow-up treatment for vascular disease using biofeedback techniques after an initial physician evaluation.”

“The present invention addresses the above needs and other objects as described in detail. It also includes, in one aspect of the invention, a method to improve the vascular system in humans through biofeedback and network data communications.

“In one aspect, this invention provides a method to improve diagnosis, prevention, reduction, and prognosis for vascular disease through evaluating an individual’s vascular system. Embodiments can include measuring the risk of developing vascular disease by using blood pressure, pulse measurements and Doppler-vascular monitoring from the peripheral vein system. These measurements are combined with biofeedback mechanisms, data communication over a network, and data communication. Embodiments provide methods and means to prevent, reduce, diagnose, and determine a prognosis of vascular disease.

“In other embodiments, methods of treating vascular disease in people and generating treatment plans are disclosed. The first set of clinical data pertaining to vascular health from a healthcare provider is received at a server in a data center that is communicatively connected to a public network. The first set of vascular data is subject to one or more vascular disease analytics algorithms. This results in the creation and storage of an initial treatment plan.

After initial physician evaluation, a second set of vascular data is obtained from a monitor that is connected to the data network and is associated with the patient. Data obtained from a Doppler-vascular monitor attached to an external site proximate the patient’s peripheral vascular system are the second set of vascular data. A variety of vascular analysis algorithms can be applied to create one or more supplementary treatment plans. A minimum of one treatment plan includes a biofeedback interaction. The patient receives the treatment plans via the data network. As determined by the doctor and the patient, the above steps can be repeated iteratively one or more times. This results in better vascular health.

“Embodiments can be used to treat individuals who are asymptomatic, or symptomatic, with respect to vascular diseases, hypertensions, high cholesterol, and diabetes. They are also useful in stress reduction, weight loss, quitting, and improving lifestyle choices and habits.

“In another aspect, the invention includes a computer apparatus as well as a computer-readable medium that can be used to perform the above steps.”

“A method and apparatus to improve the treatment of vascular diseases in humans by using biofeedback, network data communication and network data communication is presented. The following description provides a detailed explanation of the invention. However, it will be obvious to those skilled in the art that this invention can be used without these details. Other instances of well-known devices and structures are shown in block diagrams to avoid obscure the invention.

“Embodiments” are described in the following outline:

“In one aspect, an invention provides a method to improve diagnosis, prevention, reduction, and prognosis for vascular disease through evaluating the individual’s vascular system. Embodiments can include measuring the risk of vascular diseases using blood pressure, pulse measurements and Doppler-vascular testing. These measurements are combined with biofeedback mechanisms, data communication over a network, and data communication. Embodiments provide methods and means to prevent, reduce, diagnose, and determine a prognosis of vascular disease.

“FIG. “FIG. 1” is a block diagram of an exemplary system to improve the vascular systems of humans. A patient 10, or user, has a monitoring device 12, which is communicatively connected to a first client 14A. A client system 14A could be, for instance, a personal computer or personal digital assistant (PDA), a wireless computing device, workstation, or other device that can be interfaced to the monitoring device 12 via a suitable hardware interface and /or software interface. The terms “patient” and “user” are used throughout this description. The terms?patient? and?user are interchangeable to refer to any individual who uses the systems and methods described herein. These terms are interchangeable to refer to anyone who uses the methods and systems described herein.

“The monitoring device 12 can be used to monitor and generate data related to one or more patient physiological characteristics. One embodiment of a monitoring device comprises a pulse monitor and blood pressure monitor as well as vascular Doppler monitor. Each of these monitors can be contained in a single device that is either handheld or securely attached to the body. Alternately, several conventional monitoring devices, including a Doppler monitor, may be used. These are represented collectively by element 12 in these drawings. Other embodiments may use different monitoring devices. For example, monitoring device 12 could include a glucose monitor for monitoring blood glucose or diabetes using the same techniques as those for vascular disease. One embodiment of monitoring device 12 includes a vascular Doppler scanner that can collect pulse waveform data. Server 18 contains analysis software to generate waveforms from the sensor.

“Client System 14A is communicatively connected, directly or indirectly, through one or more routers switches, gateways or other network equipment to a public information network 16. Network 16 in one embodiment is the network of interconnected global internetworks that are known as the Internet.

“A second client system 14B is also communicatively connected to the network 16 and is associated with a healthcare provider 30. A healthcare provider 30 is a doctor or other healthcare professional who is involved in patient treatment. Healthcare provider 30 could be the personal physician for patient 10. The client system 14B might be found in the clinic or office of this physician. You can also locate the client system 14B in an area other than the clinical setting. This includes mobile locations, informal evaluations and treatment locations. No specific treatment location is necessary.

“Healthcare provider 30” also refers to an institution, such as a hospital, or any other facility, and the personnel involved in treating patients 10. Client system 14B executes all the software elements relating to client system 1 4A. Client system 14A can execute a physician’s version of client application 15 in certain embodiments. This client version offers functions that are appropriate or of interest to physicians.

“In this description, we use the terms?physician?” “Physician” and “Healthcare provider?” They are interchangeable and can be used to refer to doctors, nurses, nutritionists and psychologists as well as psychiatrists and alternative health providers.

FIG. One client system 14A and one patient are shown together in FIG. In a practical embodiment however, any number of patient systems, client systems and healthcare providers can be connected simultaneously to network 16. It is possible to use thousands or even millions of these clients.

“A server 18 is communicatively connected to network 16. Below is a detailed description of server 18. Server 18 is an enterprise-server computer system that runs a vascular analysis program 20, Web server 24, operating system 22, and other functions. Server 18 is a central point that stores patient data, treatment plans, user information, as well as performs administrative functions like user registration, report generation, and so forth. Server 18 can also be communicatively connected to database 26 for the storage of patient data and treatment plans, user information, as well as system support information. Database 26 could be a traditional relational database system like Oracle 8i, Microsoft SQL Server or Microsoft Access.

“Network 16 can be communicatively connected to client system 14A and client system 14B and server 18 via network links 13b, 13c, and 13d, respectively. Any type of communication link can be used to connect each link 13 b., 13c., or 13 d to network 16.

“Similarly, client system 14A is connected to monitoring device 12 via a link 13a. This link can be wired or wireless. Another embodiment of monitoring device 12 includes a processor, cellular radio modem, and the appropriate software to enable wireless communication between monitoring device 12, and server 18 or client 14A over a network. Wireless embodiments allow signals to pass through one or several wireless gateways. They can also traverse network 16 or other wireless networks.

“The server 18 as well as client systems 14A and 14B are equipped with security measures and privacy protections to protect patient information. Hardware elements, such as firewalls, may be used. Software mechanisms, such as passwords, user authentication and encrypted data communications, may also be used.

“FIG. “FIG. 1. According to one embodiment. FIG. FIG. 2. and all other flow charts provided herein, the order in which steps are presented is optional, unless stated otherwise. Additional steps can be added or omitted without affecting the spirit and scope.

“In block 200, a patient arrives in a medical office to receive treatment. Alternate embodiments are described herein. A patient can interact with elements in the system of FIG. 1. at any location. Therefore, interaction at a healthcare office is not necessary. Block 204 is where the patient gives and the healthcare provider receives the patient’s medical history and any pre-existing laboratory results. The patient and/or healthcare provider may complete a medical record that includes information about the patient’s family history and any laboratory results.

“In block206, the medical staff receives more physiological data measurements related to the patient. The healthcare provider may collect data for the patient, conduct one or more laboratory tests, or perform data collection. Data collection may include, for instance, a physical exam of the patient and measurement of one or more physiological data value of the patient such as their age, height, weight blood pressure, body mass, and index. Doppler vascular studies, blood cholesterol testing, and pulse oximetry may all be part of physiological testing.

“As indicated in arrow 208 at block 206, a first biofeedback interactions may be performed. The biofeedback interaction described in arrow 208 could include communication between patient and physician. This may involve the use of 3D models, reminders of patient’s goals, affirmations from the patient, and/or the illustration of goals.

“In block210, data from blocks 204 and 206 are transmitted over a public network such as the Internet to a data centre that can store and analyze the data. Referring to FIG. 1. The data is sent by the client system 14B to the server 18. The data communication between client system 14B of healthcare provider 30 and server 18 can use standard techniques like HTTP messaging, calls at Java Server Pages (JSPs), submission to HTML forms, etc. One specific embodiment sends data from a vascular exam at the medical office through network 16 with or without assistance from one or more wireless networks to server 18. A software program will analyze and interpret the data and recommend treatment programs for hypertension or elevated cholesterol, diabetes or nutrition.

“In block212, data is analysed using one or more vascular analysis algorithms. Example: vascular analysis app 20 (FIG. 1) receives the data values and executes one of the algorithms to analyze them. It then generates one or several treatment plans and/or recommendations messages.

Block 216 contains the treatment plans, recommendation messages and any other data generated at the data center (e.g. server 18 in FIG. 1) are sent over the public network to the healthcare provider. Data from server 18 can be sent over network 16 to client 14B. Block 218 is where the data provided by the data centre is received by the medical staff and patient. Block 220 is where the medical staff and patient review the data from the data center in order to decide on a course of actions. A healthcare provider may interpret data from the data center and modify treatment plans or explain options to patients. A second biofeedback event can be performed as part of block 220 (arrow 222). Further sections provide examples of biofeedback events that are suitable.

“In block 224, the healthcare provider and patient initiate one or several medical programs that include using one or multiple treatments, taking one or more medication, watching videos, or interfacing with computer-displayed 3D models. A third biofeedback event can be performed as part of block 226, as indicated by the arrow 226. One embodiment of this third biofeedback event is where the patient views a computer screen that shows a 3D model of their vascular system. The patient is also connected to a pulse monitor and a blood pressure monitor. The patient can view the 3D graphical model and perform relaxation exercises. They also have the ability to observe the effects of therapy on the patient’s vascular function. Another example is that the patient is connected with equipment that measures blood pressure and changes Doppler vascular waveforms. The patient then hears a signal that corresponds to pulse action in his vascular system and is shown an animated graphical display that shows vascular wall movement proportional to the data being collected in real-time.

“In block 228, the patient communicates remotely with the medical program via computer access to the public network. Referring to FIG. Referring to FIG. 1, the patient connects client 14A to network 16 while at home, work, or anywhere else. The patient interacts with the vascular data client app 15 locally, and remotely with server 18 or 20 remotely. A fourth biofeedback event, as indicated by Arrow 230, is performed in block 228, which is part of block 228, At home, for example, the patient connects the monitoring device 12 to him, while the client system 14A is connected via network 16 to server 18. The patient then engages in an athletic activity such as using a treadmill at home or exercising on a bicycle. The client system 14A displays data values that are associated with the patient’s cardiovascular functions. To improve the patient’s vascular system, the patient can adjust the pace of the patient’s athletic activity. The patient may also choose to relax, watch educational videos, or do other activities. It is not necessary to use the device during athletic activity. The monitoring device 12 can be used, and data may be viewed before or after the activity.

Block 232 contains data generated by the medical programs as part of blocks 228 or block 230. It is transmitted over the public network to the data centre. Server 18 receives, for example, real-time data on vascular health or user inputs to the vascular client application 15. This is non-real time. Block 234, the data centre stores data values that represent patient interaction with the system. Block 234 could also include the modification of one or more treatment plans, or recommendations, that were previously generated from the data center.

“Thereafter control flows optionally to block 204 or block 212. FIG. 2. may repeat as the patient or healthcare provider do additional activities, such as biofeedback events and data gathering and analysis functions, treatment plan modifications, and so on.

The above-mentioned vascular risk evaluation achieves many useful objectives. Asymptomatic and symptomatic patients can be assessed for vascular disease risk. Vascular medicine has improved the clinical skills of doctors. The outcomes of patient treatment are recorded and analyzed. Patients take part in their own treatment for a longer time.

“2.0 Structural Details for One Embodiment”

“2.1 Vascular Data Measuring Device”

“FIG. “FIG.

“Monitoring device 12, which consists of a processor 210 and a battery208, serves as a power supply. A clock 212 provides synchronization signals. The processor 210 can be used as a microprocessor or micro controller. Instructions and data to control processor 210’s operation are stored in a read only memory (ROM) 214 or random-access memory 216. In certain embodiments, ROM 214 or RAM 216 can be integrated with processor 210 as on-chip storage. An Universal Serial Bus interface (USB), 218 connects the monitoring device with a personal computer, peripherals or other suitable system via a USB port 221.

“Monitoring Device 12 also includes a pulse data interface 200, an oxymetry interface 204, and a blood pressure interface205, which are connected to probes 206A and 206B, respectively, and a blood pressure bracelet 207. One embodiment incorporates probes 206A and 206B into a housing that protects and conceals the other elements of FIG. 3 to form a portable, easily-accessible monitor that can be used for a wide range of physical activities. Probe 206A is designed to receive pulse data and can be attached to a finger or wrist, ankle, or any other anatomical structure with a superficial pulse point. Probe 206B is designed to receive oxygen saturation information. It can be attached to a fingernail, or toenail. Cuff 207 can be attached to a finger or wrist, arm, ankle or ankle. In one embodiment probe 206A can be used as an acoustic Doppler sensor to collect acoustic pulse data. Analysis software is available in server 18. This embodiment attaches probe 206A to a pulse point on one extremity of the vascular system such as the ankle. Alternately, a separate probe, wand or sensor can be used to collect acoustic Doppler data for analysis in server 18. This server software can create and store data representing one, or more, vascular data waveforms. These data can be stored in either graphical format or as raw data values. It is based on the acoustic signals from probe 206A. Monitoring device 12 acts as a data collection mechanism, while server 18 analyses and generates graphics images and other interpretations from the acoustic data.

“Further in this arrangement, pulse, blood pressure and pulse oxymetry measurements are received by processor210 when the monitoring unit 12 is held by a patient, or another user. In cooperation with interfaces 200, 204 and 205, processor 210 determines data values and provides them to RAM 216 and external systems through the USB interface 218. Client system 14A, for example, can send appropriate messages through USB interface 218 to processor 210 and receive the data values.

“Optional, monitoring device 12 includes an RF interface 218, antenna, and the appropriate software to enable wireless communication between monitoring device 12, and server 18 and client system 14A over a network. Wireless communication allows the user to easily transport monitoring device 12 for use in an exercise, biofeedback, or any other activity.

“2.2 Vsdvilst Client Application”

“FIG. “FIG.

“Presentation Layer 404 is responsible to receive data from subordinate levels and present the data to a person. Presentation layer 404 may call functions of a browser dynamic library (DLL), which is associated with the operating system 412 of client system 14A to create output that can be viewed using browser 17. Presentation layer 404 can also call the windowing and display functions from the operating system 412; or, in another alternative, it generates a bitmapped graphic display.

“Treatment planning engine 406 is responsible to generate one or several treatment plans for a patient, present one or two treatment plans to the patient, manage patient interaction with them, and modify one or more of the treatment plans received from the server 18. The local data store 414 contains one or several patient data values 414A, and one or two treatment plans 414B. Treatment plan engine 406 interacts with the local data store 414. A local data store 414 could contain a database that is stored on the client’s local disk storage 14A. Microsoft Access, for example, may be used to store data locally. Or, a proprietary format of data may be used. The treatment plans 414B may also include audio streams, video streams, or graphical models of anatomical or physiological elements.

“Data transfer engine 408 manages data communication from vascular client application 15 to other systems or software. Data transfer engine 408 can interact with device interface 416 to retrieve physiological data from the monitoring device 12. Data transfer engine 408 can also interface with the TCP/IP stack 412 of operating system 412 in order to transmit data via HTTP over a public network.

“2.3 Data Center Server Architecture”

“FIG. “FIG.

“In FIG. “In FIG. 5, data center server 18 and network 16 are coupled through firewall 502 which allows only authorized data traffic into the data center server. Server 18 may be coupled to a wireless gateway 502 that in turn is connected to one or more wireless networks. Server 18 can transmit and receive data via traditional landline methods such as the Internet, or wireless networks.

In one embodiment, the server 18 is a server-class computer which executes an app server 504 or 20. A Java 2, Enterprise Edition (J2EE), application server, such as those available commercially from WebLogic, is an example of suitable software. But, embodiments do not have to be limited to a J2EE server. Any other suitable server can also be used.

“Server app 20 includes control functions, treatment plan engine function functions, invoicing, payment functions and data transfer functions. In one embodiment, server app 20 can interact with multiple software services that perform support functions. FIG. FIG. 5 shows such services as a presentation service512, registration service 516 and administration service 518.

“Presentation Service 512” is responsible for receiving HTTP requests and rendering content. One embodiment of content rendering uses a combination Java servlets (JSPs) and Java Server Pages. The presentation service 512 can include an image server, panel and servlet control. The image server renders images requested by clients browsers, as well as images that are part of a treatment plan or medial program. The panel is responsible to receive user interface elements from a medical program, treatment plan, and render them by ordering and laying them out. This panel can also render device-specific elements. The servlet controller receives and processes servlet request and sends them to the appropriate subsystem. A servlet controller can contain a number of different servlets and is responsible for retrieving the data used in JSP pages.

The “Registration Service 516” is responsible for the registration of patient users and healthcare users within the system. This includes recording identification information, passwords, as well as other data. Administration service 518 allows editing and configuration of application server 504, such as the creation, update, deletion, and modification of users and groups, and data communication settings. The authentication service 520 handles requests from users to log in to the system or use it, to verify passwords and to authenticate them before they can be offered services. Wireless data service 514 handles data transmissions to and receptions from wireless data services (e.g. wireless gateway 501).

“Database service510 manages interaction to a database 508. A database 508 can be a traditional relational database system that stores patient data, healthcare provider data tables, treatment plan tables, and other data. Any of the above tables can be stored in a separate database server for privacy or security reasons.

“System service 511 in one embodiment includes auditing, caching and logging, offline persistence, and time-service components. The auditing component allows the creation of an audit trail within database 508 which identifies other system elements. The caching component allows caching of objects, including user data, treatment plan data, images and text. The logging component allows you to access an operational log in the database 508 for error evaluation and debugging purposes. Clients can receive notifications of information changes that occur when clients are disconnected from network 16. In one embodiment, the offline components interact with each client’s offline client plug-in 14A, 14B. This is omitted to simplify. The persistence component stores stored procedures that are used for reading and storing data. The time service component allows for recurring, persistent actions to be created and schedule.

“In some embodiments, server 18 or server application 20 offer a hosted service for one or more patients 10, and healthcare providers 30, in certain cases. An entity that owns server 18 or operates it may be an application service provider, making services of server 20 available to patients 10, and healthcare providers 30, on a fee basis. You can choose to pay per-service or monthly fees. A healthcare provider may have to pay a fee for every clinical study that is done on a patient. Access to the data could also be charged separately or included in the fee.

“3.0 Functional Details for One Embodiment”

“The descriptions of some functions below could refer to actions that can be taken by a client, user, or system. For simplicity, the description could refer to only a user. However, in this case, the term “user” is used. It can refer to any individual who acts through a computer user interface or client computer that interacts programmatically using an appropriate machine interfacing or an external server, program application or other computer system that interacts programmatically via an appropriate machine interfacing. All references to user action are meant to be broad and not limited to human action.

“3.1 Network Biofeedback Vascular Disease Treatment Method.”

“FIG. “FIG. FIG. FIG. 6A shows how a patient undergoing treatment for vascular diseases interacts with a medical software program. Another approach, described below, allows the patient to interact with a medical software program hosted on a server and accessible by him over a data network such as the Internet. A third option is for the patient to interact with the program while under physician care at a hospital or medical office.

“In an alternative embodiment, institutions such a managed care organization, community centers and hospitals, as well as employers offering employee assistance programs, may interact with the client application or server application. Researchers such as university researchers may also interact with the client application or server application in order to conduct research using data stored on the server and correlated with other investigation procedures in the area vascular disease evaluation, treatment and follow-up.

“Each of these approaches provides an educational component. The medical program includes video, audio, and/or 3D graphic models that show normal and abnormal structures and physiology related to the heart and circulatory system. These audiovisual information can be interacted with by the patient to help them understand the effects of medications and activities on their physiology. The audiovisual interactions illustrate the dramatic changes that may occur in vascular disease.

“One or more such audiovisual interactions could include a biofeedback component. A patient can view and hear the audiovisual information to evaluate their own circulation and other vascular characteristics. The client system can display the patient’s blood pressure and Doppler waveform data by using a monitoring device. The client system can simultaneously play audio from the Doppler-vascular monitor data of the patient, allowing the patient to hear their pulse rate and circulatory characteristics. The patient can see and hear changes in their physiology over time by following one or more treatment programs. This may lead to a positive improvement in vascular health.

These interactions can vary in frequency. A physician might recommend one or more periodic examinations, such as three times per year or monthly depending on the patient’s risk factors and their physical condition.

The server or client system may collect data that can be used to study long-term populations of patients or for the long-term improvement of the patient. Data gathered by the server or client system may be used to track lifestyle changes such as diet and exercise changes. Data gathered by the system can be used to determine the effects of medication or dietary supplements. Researchers can use aggregated or anonymized data to correlate with other data and other treatment methods. Researchers may use the data to compare biofeedback and lifestyle changes to surgical or invasive imaging methods.

Clinical studies are becoming more affordable and available. Patients and physicians have continuous, online access to patient information. Physicians can monitor and remotely assess patients over the long-term without having to visit a lot of offices or clinics.

“In one embodiment, the above-mentioned approaches can be combined with other medical treatment. The above-mentioned approaches can be used in combination with prescriptions of drugs such as calcium channel blockers or ACE inhibitors, ACE blocking medications, vitamin B12, niacin therapy, ACE blockers, ACE blockers, ACE blockers, ACE blockers, ACE blockers, ACE inhibitors and ACE blockers. These drugs have been shown to reduce side effects associated beta-blockers and promote circulation in all tissues. These approaches may provide significant benefits for treatment. These benefits include improved circulation in the extremities and heart, brain and muscles; migraine headache control; early Alzheimer’s disease prevention and treatment; increased cardiovascular circulation; greater exercise capacity; increased blood flow to the sexual organs which results in better sexual function and many other benefits.

“The methods described herein could include biofeedback principles and meditation in conjunction with physiological measurements taken from Doppler vessels monitors and other devices. These treatments are typically given and instructed by paramedical and medical providers. The present approaches, however, are self-administered and managed by the patient and physician.

These methods can be used to save time and money, as well as increase the effectiveness and skills of the user in addressing certain physiological goals such reverse or prevention of cardiovascular disease and complications like strokes and heart attacks. After having reviewed the results of the treatment, the primary healthcare provider or doctor can make further recommendations to the patient.

“In a similar way, both the client and server applications can help the user address other treatment recommendations such as lifestyle changes. Embodiments can also recommend one or more exercise programs. This approach involves attaching a monitoring device 12 to collect data for blood pressure, heart rate, and oxygen saturation while on a stationary bicycle or treadmill at home. Client application 15 analyzes and stores the data values during exercise and after it has ended. Client application 15 provides safety parameters which suggest a protocol for exercise based on physiological data previously collected and stored at the server.

“Another embodiment provides a nutrition evaluation function and recommendation function using vascular server application 20 and vascular client application 15. The patient fills out a questionnaire online or software-driven that collects information about recent food consumption, quantity, preparation methods, and other relevant data. The completed questionnaire is submitted to server 18 via server application 20. Alternatively, the user can save the questionnaire locally using client app 15. Applications 15, 20 respond to the questionnaire and provide a nutritional analysis of the foods. The report includes information about the food’s nutritional content such as the amount of carbohydrates, proteins, fat, cholesterol and poly- and unsaturated fats, as well as salt, minerals, vitamins, fiber, and other characteristics.

“The nutrition function generates suggested meal plans and dietary plans. Based on data values from database 26, the nutrition plan function generates dietary plans. These include weight, blood pressure, and cholesterol. You may be asked to input additional data values by the nutrition plan function, such as preferences or weight.

“Another embodiment receives input from a digital still camera or digital video camera at client system 14A, and then communicates over network 16 to the server 18. Client application 15 asks the user periodically to position the camera for recording an image. The client then records one or more digital images. The digital images are sent over network 16 to server 18. The images are transmitted over network 16 to server 18. Client application 15 or 20 can use the images to document body weight, evaluate facial expressions to measure anxiety and tension, and to record skin torpor to aid in evaluating circulation. A healthcare provider may also use the digital image information to track the user’s biofeedback functions.

“3.2 User interaction alone (after initial physician evaluation)”

FIG. 6A shows a specific approach that involves interaction between a patient or user with server application 20 and client application 15. 6A. Block 602: The patient arrives at a computer desk, or other similar location where client system 14A can be found. A block 602 could also include activating a PDA/wireless device at any location. These embodiments are not restricted to home use.

“In block 604, the patient completes a data form to provide basic physiological data, including medical history, as per prompts from vascular client application 15 (FIG. 1). Block 604 is usually performed following a physician’s initial evaluation. Block 604 can also include receiving data about the medications that the patient is currently taking to aid in risk analysis. Block 606 is where the patient uses a monitoring device for blood pressure, blood oxygen saturation, and Doppler vascular data. Block 606 could involve the user attaching a monitoring device 12 to their body and activating client application 15, which retrieves data from the monitoring device. The data values are saved locally to client system 14A.

“As block 606 collects data, a biofeedback mechanism takes place as per block 608. One embodiment of the biofeedback mechanism in block 608 is client application 15, which generates and displays a real-time graphic representation of data values that the monitoring devices 12 are collecting. Client application 15 could generate a display showing an artery in cross section and animated it in coordination with the Doppler blood pressure monitor data pulses. The patient can see the patient’s physiological state and can alter certain characteristics such as breathing rate to effect other internal modifications.

Block 610: Data collected by the patient are sent to a data centre for analysis. Data from the monitoring device 12 is sent to a data center for analysis. Block 612 is where one or more algorithms are applied to data obtained by the monitoring device 12 and stored by client system 14A. This results in one or more reports, plans or other output data that could be of use to the patient.

Block 612 may also include performing a risk assessment for the patient. The results may be reported to them in the later steps of block 616. FIG. 6A describes the operation of FIG. 6A can vary depending on the outcome of the risk analysis. If block 612 concludes that the patient is low risk, then this could be an example. The patient would then be allowed to use the remaining steps of the method at their own discretion. Block 612 could also include a recommendation to the patient that they give copies of the reports and other recommendations to their treating physician.

Block 612 can request that the patient take another action if the user is on treatment with a healthcare provider. This may prohibit the patient from performing other steps in FIG. 6A may be used to perform biofeedback interactions, as discussed below in relation to blocks 624, 626 and 628. Client application 15 and server application 20 may enforce such control. Client application 15 or 20 can be used to instruct users to consult their physician if they are taking blood pressure medication, diabetic or have other symptoms.

“If the patient is classified as high risk,? Client application 15 might recommend that the patient not engage in certain biofeedback interaction, such as the one described herein with regard to FIG. 9 without consulting a physician. A client application 15 can control if a patient 10 is considered high risk. The program may still be used for other purposes. The ‘high risk? category is an example. The patient can perform biofeedback interactions related to stress reduction, weight loss, and nutritional modifications.”

“In block 614 the reports, treatment plans or other results data are communicated with the patient. These result data are sent over network 16 from server 18 to client system 14A, for client application 15.

“In block 616 the patient uses the received information in one or more local patient interactions. Client application 15 shows a graphical model which allows the patient to see pathological changes in relation to the arterial walls. A biofeedback mechanism is activated, as indicated by the arrow 618.

“In block620, the patient and physician review the results data. The physician may interpret the data and make recommendations to improve vascular health. The physician may also confirm the results and ask the patient to start a program according to the data. As indicated by the arrow 622, this is how biofeedback interactions occur.

“In block 624 the patient selects and executes one or more of the biofeedback processes. FIG. 7 shows specific biofeedback procedures. 7, FIG. 8, FIG. 8, FIG. 10A?10B. Client application 15 in one embodiment displays a list of biofeedback interactions. This can be done using the client application or a graphical user interface. Client system 14A receives input from patient 10, which selects one of the available biofeedback interactions. You can choose from a progressive relaxation interaction or a nutrition interaction. Or, you could do an exercise interaction. Client application 15 responds by generating graphical displays, images, audio files or video information that guide the patient through the biofeedback interaction. Biofeedback occurs to the patient as shown by arrow 626.

“Patients may be asked to participate in biofeedback interactions. These response data are communicated to the server in block 628 for processing and analysis. The server then analyzes and evaluates this response data using one or more medical calculators. The patient is then presented with the results of such analysis and evaluation. This will result in further biofeedback, as indicated by Arrow 630.

“In block 632 the patient is informed about the results via the data network. The patient can then return to block 632, where they may continue providing additional physiological or historical data or repeat the previous steps. A patient can repeat the steps of FIG. 6A may be repeated as many times as the patient wishes, or in consultation with a physician. This will result in improved vascular health.

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