WO1998050873A1 - Cyber medicine disease management - Google Patents

Abstract

The subject health monitoring system is designed to supplement in an embodiment of the invention the health care efforts in caring for patients confined to their homes. The system may also be utilized within a facility such as a nursing home for monitoring patients within the home. The system integrates components distributed between a hospital and/or a central monitoring office to provide improved monitoring of these patients. The system provides for the translation of initiating orders into a computerized format. The system further provides for the programming of a patient monitoring unit at the remote site with the specific protocols consistent with the diagnoses of the doctor, as indicated on the initiating order. The system further provides for computerized training and prompting of the patient to assure their compliance with the initiating orders. Additionally, the system provides for intelligent communication between the remote site and the central office when appropriate. The system provides for the transmission of relevant data from the remote site to the central office when a critical event occurs. The system also provides for notification and graphical presentment to the doctor of trending of the patients biometric parameters. The trending parameters computed and presented to the doctor are disease specific, thus making for a more timely response. Finally, the system provides for the accumulation of a statistically normalized database correlating various medications as to their efficacy, duration, and side effects.

Description

CYBER MEDICINE DISEASE MANAGEMENT

BACKGROUND

Field of the Invention

This invention relates to a method and apparatus for monitoring a subject.

More particularly this invention relates to monitoring a patient at a remote site -from

a central station.

Prior Art

Modern society with its improvement in living conditions and advanced

health care has brought about a marked prolongation of life expectancy. This

change has resulted in a dramatic and progressive increase in the geriatric

population. A large percentage of the geriatric population needs continuous general,

as well as medical, supervision and care. For example, supervision of daily

activities such as dressing, personal hygiene, eating and safety as well as supervision

of their health status is necessary. Furthermore, the relief of loneliness and anxiety

is a major, yet unsolved, problem that has to be dealt with. These and other facets of

the management of the ever increasing geriatric population have yet to be

successfully

addressed and solved.

The creation of retirement facilities and senior housing, as well as other

geriatric facilities, provide only a partial solution to the problems facing the geriatric

population. The geriatric population, a constantly increasing fraction of society, has become increasingly dependent upon the delivery of home health and general care,

which has its own set of challenges and drawbacks.

The notion of ambulatory (home environment) patient care is gaining

increased popularity and importance. According to some recently published reports,

the number of senior persons receiving home care services under Medicare has

shown a 13% annual growth rate and has tripled in 10 years (1978-1988) from

769,000 to 2.59 million. This dramatic shift in patient care from the "sheltered"

institutional milieu to the patient's home, work place, or recreational environment is

due primarily to a radical change in concepts. That is, specialists in geriatric care

recommend keeping the aging in their own natural environment for as long as

possible. Moreover, the marked increase in the cost of institutional patient care, the

important technological advances and the development of medical equipment, and

the explosive development in the field of telecommunication are some of the

additional factors that may help in creating proper home care for the aged.

Presently, geriatric home care is still in its first stages of development.

However, according to some recently published market research reports, the market

for home care services and products is booming. Annual spending on home care

services is estimated to have increased from $8.8 billion in 1988 to $16 billion in

1995, while annual spending on home care products is estimated to have increased

from $1.15 billion to $1.86 billion during the same period. Changes in healthcare

also extend to the locale for the provision of care to non-geriatric populations. Home care for these persons with acute or chronic illnesses has gained in popularity as

institutions sited care has receded.

Except for limited supervised housing arrangements, non-medical home care

is carried out either by the patient's family or by nonprofessional help. The

monitoring equipment at home care facilities is usually minimal or nonexistent. The

patient has to be transported to the doctor's office or other diagnostic facility to allow

proper evaluation and treatment. Patient follow-up is done by means of home visits

by nurses which are periodic in nature, time consuming, and generally very

expensive. A visiting nurse can visit 5-6 homes per day. The visits are limited in

time and can usually not be carried out on a daily basis to an individual patient.

Moreover, a visiting nurse program provides no facilities for continuous monitoring

of the patient and thus, no interventional care, except in fortuitous circumstances in

times of emergency. The remainder of day after the visiting nurse has left is often a

period of medical isolation and loneliness for the elderly patient.

The existing home care nursing organizations divert skilled nurses, a scarce

commodity, from the hospital environment and use them in a highly inefficient

manner due to travel time to widely dispersed patients and the lack of sophisticated

diagnostic capabilities in the patients' home. Clearly, the practice of visiting nurses

is constrained.

These above considerations, which apply to the general population, as well

as the spiraling cost of hospital care have led to a dramatic increase in the use of

outpatient care as a treatment modality. One of the areas in which ambulatory patient monitoring is most widely used

is out-of-the-hospital surveillance of the cardiac patient. Patients with

cardiovascular problems (diseases of the heart and blood vessels) constitute the

largest and most important diagnostic and therapeutic challenge facing the

authorities responsible for the deployment of health care to the adult and specifically

aging population in the U.S. About 15% of the adult population of the industrialized

world suffers from hypertension, a major risk factor for atherosclerosis, heart

disease, and stroke. Other commonly accepted risk factors such as: elevated blood

lipid levels, obesity, diabetes, smoking, mental stress and others are abundant.

Every year more than 1.5 million people in the U.S. suffer a heart attack.

This together with a stroke constitutes the number one cause of death in our adult

population. More importantly, the majority of cardiac related deaths occur outside

of the sophisticated and sheltered hospital environment. Therefore, the need for

means for ambulatory monitoring of these patients is obvious.

To date the electrocardiogram (ECG) and blood pressure are two main

parameters most commonly monitored in the out-of-the-hospital environment.

Holter monitoring (continuous 24 hour tape recording of the electrocardiogram) and

continuous recording of blood pressure are useful modalities for the evaluation of

changes in the cardiovascular system. These, however, are short term monitoring

systems that provide only off line information that becomes available at best hours

after their recording. Moreover, the hook up should be done by a nurse or

technician. Lately, transtelephonic ECG surveillance has been gaining in importance.

This system uses small ECG transmitters which allow the transmission of the

patients ECG over any telephone line to a diagnostic center. This on-line

information system is operative 24 hours a day, 365 days a year. The patient is in

direct contact with a highly trained team that can intervene at any time and make real

time decisions. The drawback of this system is its communication system, which

does not lend itself to prolonged

monitoring sessions and does not allow for visual observation of the subject.

A home medical surveillance system is described in U.S. Pat. No. 4,838,275,

issued to Lee. This system involves the generation and transmission of health-

parameter signals from a patient's home to a central station. However, the described

system envisions only two way voice communication between the patient and the

observer at the central station. This system does not provide for interactive visual

communications between the patient and health care provider, and thus lacks a

principal feature and advantage of the present invention.

U.S. Pat. No. 4,524,243, issued to Shapiro discloses a personal alarm system

in which a warning signal is sent to a central monitoring station if the patient's

activity level becomes inactive, such as in the case of a medical emergency. This

technology is limited in its diagnostic and therapeutic value, and does not, in and of

itself, provide for interactive voice or visual communication between the patient and

the physician. Other patents disclose techniques for the transmission of still medical images

over a communications line to a remote site. For example, U.S. Pat. No. 4,860,112,

issued to Nichols et al., discloses methods and apparatus for scanning medical

images such as x-ray images and transmitting the scanned image to a remote

location. U.S. Pat. No. 5,005,126, issued to Haskin, discloses a system for picking

off an internal analog video signal from imaging diagnostic equipment such as a

CAT scanner and transmitting the image to a remotely located physician's station.

U.S. Pat. No. 4,945,410, issued to Walling, discloses a satellite communications

system for transmission of still medical images from a remote satellite transmission

station to a central headquarters. These patents have their own inherent limitations

and lack the interactive audio and visual capabilities provided by the present

invention.

There exists, at present, home health care and monitoring products that

perform various functions. The simplest include, amongst others, instruments such

as self-operated blood pressure devices (sphygmomanometers), blood glucose

measuring instruments, automated medication dispensers and others. While these

products are designed to be useable by a patient without any assistance, they have no

inherent capability of remote monitoring. Moreover, they are often difficult to use

by elderly or infirm patients.

The other end of the spectrum includes the development of computer

controlled robots that provide an integrated, highly sophisticated, home based

monitoring unit. An example of such a device is the HANC (Home Automated Nursing Center) system described in U.S. Pat. No. 5,084,828, issued to Kaufman et

al. This patent includes a robot capable of monitoring the patient's vital signs,

reminding the patient of his or her medications, dispensing them in due time, and

contacting a control center for routine follow-up as well as in emergency situations.

This device is generally an unsatisfactory solution to the problem of at-home patient

monitoring because it is extremely expensive, cumbersome, and lacks interactive

communication capabilities between the patient and their physician.

The complex robotic units and home computer are impressive in their

capacity, they but lack the human contact which is so important in effective geriatric

care. The patient's interaction with a machine, as sophisticated as it may be, will

always be inferior to the direct human contact. Moreover, these systems are very

expensive and will in the foreseeable future be available to only a very small number

of patients who can afford them. Moreover, the older population does not adjust

easily to computers

and robots, and mistakes in their use are frequent. Maintenance and problems and

the difficulty in programs in the computerized system make the upkeep more

complex. Thus, the currently available techniques for providing home patient

monitoring, particularly of the elderly, leave much to be desired.

Additional facts support development of an improved home health care

system especially for a geriatric population. For example, falls are a major health

problem among the elderly, causing injury, disability and death. One third (some

studies suggest half) of those over the age of 65 suffer at least one fall each year. The rate of falling increases to 40% among those who exceed the age of 80.

According to the National Safety Council, falls accounted for one-third of the death

total for the elderly. Those who survive falls may have restricted activity, soft-tissue

injuries, or fractures. It is estimated that up to 5% of falls by elderly persons result

in fractures. A similar percent result in soft-tissue injury requiring hospitalization or

immobilization for an extended period. It is estimated that hip fractures resulting

from falls cost approximately $2 billion in the United States during 1980. Falls are

mentioned as a contributing factor to admissions to nursing homes.

The factors leading to falls can be divided into two main groups:

environmental factors and medical factors. In spite of the difficulty in the

surveillance of patient condition before a fall, almost all researchers share the

conclusion that environmental hazards are decreasingly important in causing falls as

age increases. A clear correlation between clinical or medical problems and the

incident of falls by the elderly has been established. Many of these medical

problems of the elderly or infirm can be detected by simple clinical observation. For

example gait, and balance abnormality may indicate difficulty with neurologic and

musculoskeletal functions that may contribute to physical instability. Changes in

gait can be identified by the following: slow speed, short step length, narrow stride

width, wide range of stepping frequency, a large variability of step length, and

increasing variability with increasing frequency.

Thus, there are relatively straight forward techniques which enable diagnosis

of a predisposition or likelihood of falls among elderly. However, there is no inexpensive procedure for undertaking such diagnosis or investigating such

predisposition in a large patient population, wherein the kinematic condition of the

patient can be investigated or where the appearance, and reflex activity of the patient

can be investigated with ease.

Accordingly, there is a need for improved methods and devices for (remote

monitoring patients.

SUMMARY OF INVENTION

The invention has the benefit of allowing multiple remote sites to

continuously monitor patient data. Each of the remote cites is equipped with a user

configurable decision making process to determine when to transmit patient data.

When the programmable processor that is detecting patient data determines that one

or more of the vital signs being monitored exceeds a threshold determined by a

position then the data for that vital biometric parameter as well as the data

concurrently obtained from the monitoring of other biometric parameters is retrieved

from the respective storage buffers and transferred to the monitoring site. This

selective broadcasting only under unstable or alarming conditions from plurality of

patients to receiving cite assures that only those patients requiring attention are

broadcasting data to the receiving cite. When an alarm condition occurs the physician has the opportunity to review relevant history for better determining the

severity and immediacy of the condition.

In an embodiment of the invention a computer implemented method for

managing the care of a patient on the basis of a discharge order containing a

diagnosis of at least one disease of the patient is disclosed. The method for

managing comprising the acts of:

determining a protocol for monitoring the patient, the protocol including at

least one biometric parameter to be monitored and at least one response associated

therewith;

monitoring the at least one biometric parameter; and

executing the at least one response associated with the biometric parameter

when the biometric parameter is beyond a selected threshold.

BRIEF DESCRIPTION OF THE DRAWING

In the detailed description of presently preferred embodiments of the present

invention which follows, reference will be made to the drawings comprised of the

following figures, wherein like reference numerals refer to like elements in the

various views and wherein:

FIG. 1 is an overall functional block diagram of a first embodiment of the

patient monitoring system of the present invention;

FIG. 2 is a hardware block diagram of the portable patient monitor shown in

FIG. 1 for monitoring and training a patient at a remote site and for transmitting

data directly from the remote site to a central office when appropriate.

FIG. 3 is a hardware block diagram of the portable patient monitor shown in

FIG. 1 for monitoring a patient at a remote site and for transmitting patient biometric

parameters to a patient monitoring computer at the remote site.

FIG. 4 is a hardware block diagram of the patient monitoring computer

shown in FIG. 1 at the remote site.

FIG. 5 shows the software modules associated with the central office and

remote site.

FIG. 6 shows an embodiment of the data structure associated with discharge

orders for a patient.

FIG. 7A-C show the data structures associated with the disease specific

protocol records of the current invention. FIG. 8 is a graph showing representative signals obtained from monitoring

biometric parameters.

FIG. 9 is a process flow diagram of the processes associated with the

monitoring a patient at the central office shown in FIG. 1.

FIGS. 10A-B are process flow diagrams of an embodiment of the invention

which show the processes associated with monitoring a patient at respectively the

remote site and the central office.

FIGS. 11-17 are process flow diagrams of the processes at the remote site for

monitoring specific disease states according to an embodiment of the invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

The patient health monitoring system is designed to supplement the health

care efforts in caring for patients confined to their homes. The system may also be

utilized within a facility such as a nursing home for monitoring patients within the

home. The system integrates components distributed between a hospital and/or a

central monitoring office to provide improved monitoring of these patients. The

system provides for the translation of physician orders: including traditional

discharge, or patient transfer orders, into a computerized format. In a healthcare

setting an initiating order may be generated by a physician for a patient in a health

care facility such as a hospital or nursing home, or for a patient leaving such

facilities, or for a patient in an ambulatory setting. As will be obvious to those

skilled in the art other settings exist for initiating orders, including non-medical

settings such as biologic monitoring of normal subjects both human and animal.

The system further provides for the programming of a patient monitoring unit at the

remote site with the specific protocols consistent with the diagnoses of the doctor, as

indicated on the initiating order. The system further provides for computerized

training and prompting of the patient to assure their compliance with the initiating

orders. Additionally, the system provides for intelligent communication between the

remote site and the central office when appropriate. This latter capability reduces the

time required at the central office to monitor patients, yet assures that critical events

occurring during patient monitoring will not be overlooked. The system provides

for the transmission of relevant data from the remote site to the central office when a critical event occurs. The system also provides for notification and graphical

presentment to the doctor of trending of the patients biometric parameters. The

trending parameters computed and presented to the doctor are disease specific, thus

making for a more timely response. Finally, the system provides for the

accumulation of a statistically normalized database correlating various medications

as to their efficacy, duration, and side effects.

FIG. 1 is an overall system diagram of an embodiment of the patient health

monitoring system of the current invention. Shown in FIG. 1 are Hospital/Central

Monitoring Office 100, a first embodiment of the patient monitor is shown at site

102, and a second embodiment of the patient monitor is shown at site 104. The

Hospital/Central Monitoring Office includes a computer 114 with access to a storage

device 116. A "one-piece" version of the remote monitoring system 102 includes

portable patient monitor 140 also known as patient monitoring device, which may

include a display, microphone, camera, speaker and biometric sensors, and is

constructed to be attached to patient 148. This version features a portable patient

monitor that includes monitoring, training and transmitting functions in one device,

which is attached to the patient. A "two-piece" version of the remote monitoring

system may include a portable patient monitor 160 also known as patient

monitoring device, with a display, speaker and sensors and is constructed to be

attached to patient 164. This version of the remote monitoring system also includes

patient monitoring computer 170, which may include camera 172,

microphone/speaker 174, keyboard 176, and display 178. The two-piece version of the remote monitoring system facilitates a reduction in the size of the portable

patient monitoring unit by packaging several functions in the patient monitoring

computer.

Computer 114 may access a plurality of databases in storage device 116. Six

databases are shown specifically: patient history database 118, initiating order

database 120, training database 122, protocol database 124, drug study database 126,

and question & answer ("Q&A") database 128. The patient history database

contains records pertaining to the medical history of various patients treated at the

Hospital/Central Monitoring Office 100. Such records may be created by health care

workers during their care of the patient. The initiating orders database contains

records with information corresponding to the initiating orders 112. The discharge

order may be used by the patient monitoring system in generating a protocol record

that may be used in the monitoring of the patient according to the invention. The

initiating order also serves as a starting point for further treatment plans by health

care workers. The training database contains records such as audio clips, short

visual displays or films, and text-based messages. These records contain

information that instructs patients how to use the various sensors which are part of or

connected to the portable patient monitor at the remote site. The drug study database

contains records that relate to use of data generated through operation of the patient

health monitoring system for developing new or improved drugs. The Q&A

database includes records with predetermined questions appropriate for a specific

disease state or for response to a particular event detected by the monitoring system. These questions may be used, for example, to interrogate the patient about the

patient's condition or about the relevance of the information received through

sensors in the portable patient monitors, etc. The records may be audio files which

can be played to the patient by the remote monitoring system in order for that system

to record the patients answers and transmit them to the doctor.

In the one-piece design for monitoring equipment shown at site 102 (See

FIG. 1) the portable patient monitor 140 contains a file 146, which contains the code

associated with performing the training, monitoring, and transmitting functions

corresponding to the particular disease state with which the doctor characterized the

patient in the initiating order. In contrast, the two-piece design for monitoring

equipment at site 104 (See FIG. 1) the portable patient monitor 160 contains within

it a file 190, which contains code associated with monitoring the patient. The

remaining code is contained in the patient monitoring computer 170 in file 180,

which contains code and associated Q&A and training files for training a patient and

for transmitting patient data to the central office when appropriate.

In operation, physician or other permitted health care professional 110 enters

initiating orders 112 into computer 114, which stores them in initiating order

database 120. The initiating orders include information regarding personal

information, insurance, diagnoses, and prescribed medications. Initiating orders are

described in more detail below. From the initiating order database, patient history

database 118, training database 122, protocol database 124, and Q&A database 128,

the processes 114P generate a management record. The management record is then transmitted to a remote monitoring system. Typical management records include

information such as types and frequency of medication to be administered, types of

sensors to be used, training files and Q&A files that might be appropriately

associated with carrying out the protocol.

The management records are downloaded to remote monitoring systems,

such as the one-piece and two-piece systems. In the case of patient monitoring

system 140, processes 140P are implemented by portable monitoring device 140 for

monitoring the patient, for training the patient in the use of monitoring devices, or

sensors for selecting the time of day to monitor, and for deciding when to transmit

data from the remote site to the central office. All of these processes may be

implemented on a disease specific basis, each with its own different monitoring

protocol. Results from the monitoring carried out by the portable patient monitor are

transmitted 144 back to the Hospital/Central Monitoring Office 100 by processes

140P. The portable patient monitor may buffer the results until it is appropriate to

transmit them. Likewise, at site 104, portable patient monitor 160 implements

processes 160P to monitor the patient's condition, and to transmit the monitoring

results to the patient monitoring computer (PMC) 170, as suggested by element 162.

File 190 contains code to direct these activities. The patient monitoring computer

implements processes 170P to display training information and to transmit 182 back

to the Hospital/Central Monitoring Office 100 the results of the monitoring. The

patient monitoring computer may buffer the results until it is appropriate to transmit them. File 180 contains the information and code necessary for the training and

transmitting functions carried out by the patient monitoring computer.

FIG. 2 is a detailed hardware block diagram of the one-piece version of the

portable patient monitor 140, shown in FIG. 1 attached to patient 148. The

one-piece portable patient monitor serves to monitor various sensors, to transmit

data, and to train the patient in various functions. The one-piece patient monitor

includes microprocessor 202, buffer memory 210, limit memory 212, screen or

audio driver 206, key interface 208, cellular transceiver 204, storage device 224,

display or audio output device 240, sensors 242 and 244 and confirmation switch

246 also called enabling switch. Buffer 210 comprises individual buffers 216 and

218 for respectively the last hour of data received from sensors 242 and 244. Limit

memory 212 comprises limit memory 220 and 222 to store, respectively, established

values for triggering events.

In operation this system performs as follows. Storage device 224 contains

within it a management record file 146 received from a central monitoring station

(not shown). The management record includes instructions concerning which

sensors to read, when to take readings of those sensors, information as to what levels

of sensor readings or times, etc., might serve as triggering events, and also training

and Q&A files for display by the display or audio output device 240. The file

containing the management record may be updated as desired by transmitting

information from the central monitoring station, which is received by cellular

transceiver 204. Signal unit 214 is in continuous receipt of signal corresponding to the biometric parameters being monitored by sensors 242 and 244. These sensors

may be selected according to the patient's situation, but often will include such

baseline parameters as blood pressure, pulse, temperature, and respiratory rate. This

data is continuously stored in buffers 216 and 218. The data in these buffers is

continuously monitored according to reprogramable signal limits stored in memory

units 220 and 222. When microprocessor 202 detects that any single limit or

combination of limits in any arrangement according to the management record is

triggered, then the data in all buffers is passed to cellular transceiver 204 for wireless

transmission to the central monitoring office.

When this packet of data is received by the central monitoring office,

additional data may be requested from the remote site. The user may be requested to

confirm the severity of the bodily dysfunction. Patient confirmation may be sent by

the patient, in this case by enabling switch 246 to key input 208, and wirelessly

transmitted via transceiver 204 to the central monitoring office. This data along with

the biometric parameter data is included in a packet available for the health care

worker who is made aware of this packet. At appropriate times, such as upon the

occunence of a triggering event, training information may be displayed for the

patient using display 240. Such training information is contained in the training

record which forms part of the management record. The training information may

show the patient how to use the device. The training information may show the

patient how to hook up additional sensors to the portable patient monitoring device, or how to properly position the existing sensors 242-244 to attain a proper biometric

parameter reading.

FIG. 3 is a hardware block diagram of the portable patient monitor portion of

the two-piece version of remote patient monitoring system shown in FIG. 1. The

two-piece monitor serves to monitor various sensors and transmit them to a patient

monitoring computer (not shown). The portable patient monitor 160 includes

sensors 320 and 318, handshake confirmation switch 302, A/D converter 316, timer

308, display 306, encoder 310, decoder 312, and transceiver unit 304. Decoder 312

contains a modified version of the management record in file 190 that may contain

only the information needed to monitor patient data. The patient data is received

from sensors 320 and 318 and is converted to digital form in A/D unit 316. The

separate signals are then passed to encoder 310 where they are tagged within

identifier indicating which biometric parameter, i.e., to which sensor the digital

signal corresponds. These signals are sent via receiver 304 to the patient monitoring

computer, for further processing, upon the occwrence of a triggering event, as is

defined in the modified management record.

FIG. 4 is a hardware block diagram of the patient monitoring computer

portion of the two-piece version of the remote patient monitoring system shown in

FIG. 1. The patient monitoring computer serves to transmit and receive data to the

central monitoring office (note shown) and to provide training and Q&A information

to the patient, when appropriate. The two-piece patient monitor includes

microprocessor 402, buffer memory 410, limit memory 412, audio driver 406, key interface 408, cellular transceiver 404, storage device 424, video/audio output 440,

video input 442, signal unit 430, short range transmitter 432, and short range

receiver 434. Buffer 416 comprises individual buffers 416 and 418 for data received

from sensors contained in the portable patient monitor, shown in FIG 3. Limit

memory 412 comprises limit memories 420-422 to store established values for

triggering events.

In operation this system performs as follows. Storage device 424 contains

within it a management record file 180 received from the central monitoring station

shown in FIG. 1. The management record includes program codes for: sensors to

read, when to take readings of those sensors, information as to what levels of sensor

readings or times, etc., might serve as triggering events, and also training and Q&A

files for display by audio output device 440, or video output 440 under appropriate

circumstances. The management record file may be updated as desired by

transmitting information from the central monitoring station, which is received by

cellular transceiver 404. Portions of the management record relating to monitoring

are sent to the portable patient monitor 160 via short range transmitter 432. These

instructions serve to guide the operation of the portable patient monitor, as discussed

above in FIG. 3. In return, the portable patient monitor sends signals that are

received by short range receiver 434 and are processed by signal unit 430. These

signals are from devices in the portable patient monitor, and may be selected

according to the patient's situation, but often will include such baseline parameters

as blood pressure, pulse, temperature, and respiratory rate. This data is continuously stored in buffers 416-418. The data in these buffers is continuously monitored

according to reprogramable signal limits stored in limit memories 420-422. When

microprocessor 402 detects that any single limit or combination of limits in any

arrangement according to the management record is triggered, then the data in all

buffers is passed to cellular transceiver 404 for wireless transmission to the central

monitoring office. Additionally, video input 442 may be used to receive video data

as needed to evaluate the patient's condition. At appropriate times, such as upon the

occurrence of a triggering event, training information may be displayed for the

patient via video output 440. Such training information is contained in the training

record which forms part of the management record.

FIG. 5 shows a software block diagram that illustrates software operations in

one embodiment of the patient health monitoring system according to the invention.

Shown are the software modules associated with hospital/central monitoring office

100 and with portable patient monitor (See FIG. 1). The software modules

associated with hospital/central monitoring office 100 includes translation module

500, notification module 502, and graphical user interface module 504. The

software modules associated with portable patient monitor includes control module

554, event module 550, training module 552, timer module 556, recording module

558, and sensing module 560.

Translation module 500 receives initiating order 112 as an input. The

translation module additionally interfaces with the databases contained in storage

device 116, which has been discussed above in more detail. The translation module also outputs and downloads a management record 582 based on the information

contained in the various databases and initiating orders. The translation module may

receive an uploaded event record as an input from portable patient monitor . The

translation module then outputs information from the uploaded event record to

notification module 502. The notification module then may output this information

to graphical user interface module 504, which displays the information on display

506 for a health care worker to see.

Control module 554 receives a downloaded management record 582 as an

input. The control module then outputs the triggering event portion of the record to

the event module 550, and the training portion of the record to training module 552.

The training module outputs the training portion of the record upon instructions to

do so from the control module. The control module additionally interfaces with

timer module 556 to track time. The control module interfaces with the sensing

module to switch it to the appropriate ones of the sensors 590-594. The control

module also receives input from sensing module 560 and from recording module

558, regarding input from the selected ones of sensors 590-594. Sensing module

560 receives input from sensors 1-3, (elements 590, 592, and 594, respectively) and

then outputs the information to both the control module and the recording module.

The recording module stores the information from the sensing module and transmits

it to the control module at an appropriate time.

In operation, translation module 500 receives initiating order 112, stores it in

the initiating order database 120, and then assembles a management record based on the initiating order, and the patient history, training, protocol, drug study (if

applicable), and Q&A databases. This management record is downloaded as

program code and data files to portable patient monitoring device . Additionally,

upon receipt of an uploaded event record 580, the translation module functions to

activate notification module 502, which notifies a health care worker. The

notification module can then drive graphical user interface 504, which uses display

506 to display the contents of the uploaded event record for the health care worker at

hospital/central monitoring station 100.

In portable patient monitor , the control module functions to coordinate the

flow of information to and from the hospital/central monitoring station. Upon

receiving the downloaded management record, the control module divides up the

record and distributes the relevant information to the various functional modules,

such as the event, training, sensing, and recording modules. The control module

also serves to coordinate the flow of information upon the occunence of a triggering

event. Such an event, detected by the event module based upon information

delivered to it by the sensing module or the timing module, results in the control

module assembling the event record to be uploaded, if necessary, from information

provided to it by the recording and sensing module. A triggering event may also

result in the activation of the training module by the control module, with the

attendant displaying of training information to the patient. Such information may be

used to train the patient in the proper attachment of external sensors to the portable

patient monitors 140, 160 or to the patient monitoring computer 170 (See FIG. 1). FIG. 6 shows a plurality of records, labeled 600, 602, and 604, that

conespond to initiating orders. Physician orders, e.g. initiating orders may be

generated by a patient's physician or assistant and may be generated at the time a

patient is released from a hospital or other care setting. Each initiating record may

contain patient information in fields 610, diagnosis in field 612, and medication

information in fields 614. As will be obvious to those skilled in the art the diagnosis

field may include more than one diagnosis.

As shown in initiating record 600 patient information field 610A includes

name (John Smith), age (66), sex (male), residence (11 Oak Street), Insurance

(Everlast), and physician name (Dr. Fine). Diagnosis field 612A contains the

diagnosis (diabetes) for the patient who has been described in patient information

field 610A. Medication fields 614A contains the prescription from the patient's

physician to describe a medication and its dosing regimen for the patient. In the

medication fields, inputs are accepted for type of medication (insulin), route of

administration (subcutaneous), the name of the medication (NPH), the frequency of

administration (2x/daily), and the dose per administration (20 Units). Additional

medications may be included in the initiating orders in similar formats.

Initiating records 602-604 contain similar information to initiating record

600, but for Lucile Jones, and Donna Hengst, respectively. In record 602, the patient

information for Lucille Jones is contained in patient information field 610B. The

diagnosis for Lucile Jones (congestive heart failure) is contained in diagnosis field

612B. The appropriate medication for the patient (ACE inhibitor) is contained in medication field 614B. Similarly in initiating record 604, the patient information for

patient Donna Hengst is contained in patient information field 6 IOC, the diagnosis

(hypertension) is contained in diagnosis field 612C, and the medication (calcium

channel blocker) is contained in field 614C.

FIGS. 7A-C show examples of three initiating protocol records. These

example records illustrate the prefened monitoring protocols for diabetes,

congestive heart failure, and high blood pressure, respectively. These records are

part of the protocol database as shown in element 124 in FIG. 1. Each protocol

record generally contains detailed instructions to be transmitted to the remote

monitoring equipment, along with corresponding Q&A and training files.

In FIG. 7 A, diabetes protocol record 700 includes primary biometric field

710A, frequency/time field 712A, sensor field 714A, additional sensor field 716 A,

baseline biometric field 718A, display type field 720A, Q&A file field 730A,

training file field 732A. Also included is random field 734A, which may be used as

part of a drug study.

Primary biometric field 710A contains information about the primary

biometric to be monitored, in this case, glucose. The frequency and time field,

712A, contains information about both the frequency and the time period in the day

in which to monitor for the primary biometric. In this case, glucose is to be

monitored twice daily, once at 9:00 a.m. and once at 4:00 p.m. Sensor A field 714A

describes a first sensor to be used, and also includes information about what received

values of sensor A may be considered to be triggering events. Field 716A describes sensor B, which is in this case a finger prick blood glucose test. Also contained in

field 716A, in a similar fashion to field 714A, are various values of results from the

sensor which will trigger different responses from the portable patient monitoring

system. Baseline biometric field 718 A contains information about whether the

patient is to be monitored for baseline biometric parameters such as: blood pressure,

pulse, temperature and respiration rate. Display fields 720A contain information

about how to display information accumulated during the monitoring operation of

the patient health system so as to allow for focused rapid physician response to an

event detected by the remote patient monitoring system. Q&A field 730A contains a

file that has various questions that could be accessed in the course of obtaining

subjective information from the patient during the monitoring process. Training

field 732A contains training files that can be used to train the patient in the use of

monitoring equipment, or the attachment of existing or additional biometric sensors.

Random field 734A contains information about when to randomly include an

additional monitoring of the patients biometric parameters. By requiring for

example, each patient in the remote population to perform an additional test, e.g.

finger prick and blood sample, information on the efficacy and durability of a

specific drug can be obtained. This information is obtained through the aggregation

of information from each member of the patient population under the control of the

central monitoring station.

Elements 714 A- 716 A contain information instructing the remote monitoring

equipment how to respond to particular ranges of the biometric parameters being sensed. For example, if sensor A is employed for testing the patient's urine and the

result is 1+, the regime is maintained. However, if the response is 2+, then the

patient is instructed to employ sensor B. Fields 716A correlate glucose levels

obtained by blood samples obtained by finger prick with appropriate responses. At a

level of glucose less than 150 mg/dl the existing regimen is maintained. At a level

between 150 and 250 mg/dl an additional 5 units of insulin should be administered.

At a level between 250 and 350 mg/dl an additional 10 units of insulin should be

administered. At levels above 350 mg/dl the patient should be asked the questions in

the Q&A file and the answers to those questions should be recorded. The

information including biometric parameters, patient responses to questions, etc.,

should then be sent to the central office. When the information is received by the

central office the event may be brought to the attention of a doctor.

In FIG. 7B, congestive heart failure protocol 702 includes primary biometric

field 710B, frequency field 712B, sensor field 714B, additional sensor field 716B,

baseline biometric field 718B, display type field 720B, question and answer file field

730B, training file field 732B. Also included is random field 734B, which may be

used to normalize drug studies by inserting an additional monitoring time for each

drug so that collectively from various other sites at which the drug is being used as

well as this site, time sampled information on the performance of each drug can be

obtained.

Primary biometric field 710B contains information about the primary

biometric to be monitored, in this case, congestive heart failure. The frequency and time field, 712B, contains information about both the frequency and the time period

in the day in which to monitor for the primary biometric. In this case, fluid retention

is to be monitored once daily, at 9:00 a.m. Sensor field 714B describes a sensor A

and a sensor B to be used, and also includes information about what received values

of sensor A-B may be considered to be triggering events. Field 716B describes

sensor C, which is in this case a blood oxygen test. Also contained in fields

714B-716B are various values of results from the sensors that will trigger different

responses from the portable patient monitoring system. Baseline biometric field

718B contains information about whether the particular biometric is actually enabled

or not enabled, instructing the remote monitoring equipment as to whether or not to

monitor this particular biometric. Display fields 720B contain information about

how to display information accumulated during the monitoring operation of the

patient health system. Question and answer field 730B contains a file that has

various questions that could be accessed in the course of obtaining subjective

information from the patient during the monitoring process. Training field 732B

contains training files that can be used to train the patient in the use of monitoring

equipment. Random field 734B contains information about when to randomly

include an additional test, for drug study purposes.

Elements 714B and 716B contain information instructing the remote

monitoring equipment how to respond based on the particular condition. For

example, sensor A is employed for testing the patient's weight and sensor B is

employed for measuring the patient's edema. In the setting of congestive heart failure fluid congestion in the lungs may be indicated by a fall in SAO₂ and fluid

retention in the body will be indicated by a rise in body weight. If the result is a

weight gain of two or more pounds and there is an increase in edema reading of

more than 15%, then the patient is instructed to take 20 mg. of furosemide. If the

patient gains more than five pounds, then regardless of the edema reading, the

patient is instructed to take 20 mg. of furosemide. However, if the result is a weight

gain of five or more pounds and there is an increase in edema reading of more than

20%), then the patient is instructed to employ sensor C. In sensor C, element 716B,

the results of a blood oxygen test are used to determine whether it is appropriate to

maintain the regimen (SaO₂ >92%) ; recheck the blood oxygen (SaO₂ is 90-92%) in

twelve hours; or play a question and answer file contained in field 730B, and notify

the central monitoring station (SaO₂<90%) with an appropriate event record,

including the Q&A results.

In FIG. 7C, high blood pressure protocol 704 includes primary biometric

field 710C, frequency field 712C, sensor field 714C, baseline biometric field 718C,

display type field 720C, question and answer file field 730C, training file field

732C. Also included is random field 734C, which may be used as part of a drug

study.

Primary biometric field 710C contains information about the primary

biometric to be monitored, in this case, blood pressure. The frequency and time

field 712C, contains information about both the frequency and the time period in the

day in which to monitor the primary biometric. In this case, blood pressure is to be monitored four times daily, once at 8:00 a.m., 12:00 noon, 6:00 p.m, and 10 p.m.

Sensor A field 714C describes a sensor to be used, and also includes information

about what received values of sensor A may be considered to be triggering events.

Also contained in field 714C are various values of results from the sensor which will

trigger different responses from the portable patient monitoring system. Baseline

biometric field 718C contains information about whether the particular biometric is

actually enabled or not enabled, instructing the remote monitoring equipment as to

whether or not to monitor this particular biometric. Display fields 720C contain

information about how to display information accumulated during the monitoring

operation of the patient health system. Question and answer field 730C contains a

file that has various questions that could be accessed in the course of obtaining

subjective information from the patient during the monitoring process. Training

field 732C contains training files that can be used to train the patient in the use of

monitoring equipment. Random field 734C contains information about when to

randomly include an additional blood pressure test, for drug study purposes.

Element 714C contains information instructing the remote monitoring

equipment how to respond based on the particular condition. For example, if sensor

A is employed for testing the patient's blood pressure and the result is a systolic

blood pressure less than 90 mm Hg then the patient is instructed to recheck her

blood pressure in one hour. However, if the result is either systolic greater than 200

or less than 80, then the monitoring system plays a question and answer file

contained in field 730C, and notifies the central monitoring station with an appropriate event record, including the Q&A results. As will be obvious to those

skilled in the art additional biometric parameters may be monitored including

diastolic pressure. Also other responses may be substituted without departing from

the teachings of this invention.

FIG. 8 is a graph showing two hypothetical signals 850 and 856 which might

be generated by sensors present in the portable patient monitoring devices 140,160

(See FIG. 1). These signals in digital form would be stored in first in first out

fashion (FIFO) as above discussed in separate buffers in buffer memories 210 or 410

(See FIGS. 2,4). An upper and lower limit also called thresholds 852 and 854 is

shown in connection with signal 850 and an upper and lower limit 858 and 860 also

called thresholds respectively is shown in connection with signal 856. These limits

conespond to the above discussed limits which would be stored in limit memories

212 and 412 (See FIGS. 2,4). The graphical snapshot is shown commencing at time

Tl . At time T2 signal 850 has passed beyond upper threshold 852. If the physician

has programmed limit memory in such a way as to require that the passage of this

one biometric parameter beyond its upper limit is sufficient to trigger an alarm

condition then in this instance, the data contained in both the buffer for signal 850

and the buffer for signal 856 will be uploaded and transferred via wirelessly to

remote receiver 46. Thus, at the time the alarm condition is triggered, not only the

immediate physiological data for the patient is transferred but also that data which

occuned during the buildup to this alarm condition, i.e. the historical data. Data is

continuously transmitted during the interval between time 2 and time 3. T3 conesponds to the point at which the biometric parameter e.g. the signal 850 has

returned to an amplitude below upper threshold 852. Of course it is possible that the

biometric parameter indicated by signal 850 would not return below the upper limit

852 in which case data would be locked in a continuous transmit condition until

such time as the patient received attention or the biometric parameter being

monitored returned below the upper threshold, indicated by T3. For an appropriate

amount of time in this case indicated as the interval between T3 and T4 after a given

biometric parameter triggering an alarm condition returns below the threshold

condition which caused the alarm condition, data will continue to be transmitted in

real time to the central office. At time T4 data may cease to be transmitted, having

normalized for a sufficient interval. Alternately, data may continue to be transmitted

until a physician indicates otherwise. As will be obvious to those skilled in the art,

the reprogramable feature of the current invention and the programming feature

itself allows any combination of upper and lower limits at any number of biometric

parameters in any combination or grouping to be the condition upon which an alarm

condition should be generated. For example, a rise in heart rate to a certain level

unaccompanied by a corresponding fall n some other biometric parameter such as

blood pressure may not, according to the physician, be a cause for triggering an

alarm condition. This more complex thresholding condition is stored in limit

memory. As will also be obvious to one skilled in the art, an alarm condition need

not merely correspond to the amplitude of a biometric parameter but might correspond to the frequency or increase in frequency of the biometric parameters,

e.g., heart rate.

One who is skilled in the art will recognize that the alarm limits 852, 854,

858, and 860 may correlate to the integral of the biometric signal or to its derivative

or to the ratio of two signals or to another mathematical operator.

Fig. 9 is a process flow diagram showing an embodiment of the processes

114P implemented at the central office 100 (see FIG. 1). Processing begins as

decision process 902 in which a determination is made as to whether a new initiating

order needs to be processed. The initiating order 112 (see Fig. 1) may be entered

manually or electronically into the computer. When a new initiating order needs to

be processed control is passed to process 904. In process 904 the disease listed in

the diagnosis field 612 (see FIG. 6) is determined. Control is then passed to process

906. In process 906 the protocol record conesponding to the disease listed in the

diagnosis field 612 is retrieved from the protocol database 124 (see FIG. 1). The

protocol database contains as described and discussed above in connection with

Figs. 7A-C contains protocol records for monitoring specific diseases. Control is

then passed to process 908. In process 908 a comparison is made between the

initiating record and the selected protocol record. Control is then passed to decision

process 910. In decision process 910 a determination is made as to whether the

physician or initiating order conflicts in any way with the selected protocol record.

If for example the physician's medication or dosage amounts differ from those listed

in the protocol record then control is passed to process 912. In process 912 the conflict is brought to the attention of a physician so that they may resolve it before

programming the remote monitoring system.

In the event there is no conflict between the physician initiating and the

protocol record, or in the event that a physician has modified an existing protocol

record to harmonize it with his/her initiating orders, then control is passed to process

914. In process 914 any files such as Q&A and/or training files associated with the

protocol record are retrieved from respectively databases 122 and 128 (see FIG. 1).

Control is then passed to process 916. In process 916 statistical information

gathering processes are implemented for retrieving from this patient additional

information useful for the aggregate characterization of the drug being utilized to

treat this patient. This may take the form of an additional time of day at which to

monitor the patient. This time may correspond to 1/2 hour after prescription dosage.

If another patient treated with the same drug is monitored at 1 hour after prescription

dosage, and so forth, a complete time weighted study of the drug efficacy and

duration can be created from the aggregation of a plurality of patients. This time will

be placed in field 734 (see FIG.7A-C). Control is then passed to process 918. In

process 918 the management record including the Q&A and training records and the

code associated with implementing the protocol record retrieved in process 906 are

downloaded to the remote site. Control is then passed to decision process 920.

In decision process 920 a determination is made as to whether an event

record has been received from a remote site. In the event that determination is in the

negative, control is returned to decision process 902 for the processing of the next initiating record. Alternately, if a decision is made that an event record has been

received then control is passed to process 922. In process 922 a determination is

made on the basis of the initiating record and specifically field 720 thereof as to

what format of display and what combination of biometric parameters and/or

question and answer sequences allows for the most targeted response on the part of

the physician from the voluminous available patient data. This data is formatted

according to the format indicated in field 720 (see Figs. 7A-C). The correct

presentment of data can be crucial in a timely reaction to a possibly critical event

which the patient has experienced and which the remote monitoring equipment has

transmitted to the central office.

Control is then passed to process 924. In process 924 the data is gathered in

the appropriate format for display to the physician. Control is then passed to process

926. In process 926 the patient history record for the patient with respect to which

an event has been recorded is fetched from the patient history database 118 (see

FIG.1). Control is then passed to process 928. In process 928 the doctor is notified

that an event has been recorded that needs his/her attention. Control is then passed

to process 930. In process 930 the targeted information discussed above in

connection with processes 922-924 is displayed to the doctor to allow them to make

a timely decision for managing the patient. Control then returns to decision process

902 for the detection of the input of the next initiating record.

FIG. 10A is a process flow diagram showing the steps connected with the

operation of a first embodiment of the portable patient monitoring device shown in FIG. 1. The process commences at 1000 where data is being obtained from the

sensors processed and put into FIFO buffers conesponding to the respective sensors.

The data in these buffers is continuously compared with the limits and limit

conditions stored in limit memory in process 1002. Control is then passed a decision

step 1004 in which a determination is made on the basis of the comparison as to

whether an alarm condition corresponding to a limit, or a set of limits programmed

by the physician has been exceeded. In the event this determination is in the

affirmative then control is passed to decision process 1006. In process 1006, the

transceiver begins transmitting not only the historical data contained in the buffers,

but also a real time transmission of all sensor data to the central office. Control is

then passed to process 1008 in which an on-going monitoring of limits is made.

These may be the limits as discussed in connection with FIGS. 7A-C, or may be

different set of physician programmable limits set by a physician by a transmission

from the central office. These not need be the same limits. Control is then passed to

decision step 1010 in which a determination is made as to whether the cease alarm

condition has been reached. This process is optional as in certain embodiments it

may not be appropriate to cease transmitting at all even after biometric parameters

have returned to normal. The cease alarm condition could be input by a physician

from the central office, or from an visiting nurse present at the remote site, or could

be automatically generated through a return of the patient's biometric parameters to a

prolonged period of normalcy. If a determination is made in the negative that a cease alarm condition has not been reached then control is passed to decision step

1012.

In decision process 1012 a determination is made as to whether a

confirmation sequence has been initiated by the central office. If it has then control

is passed to process 1014 for implementation of the confirmation sequence. A

confirmation sequence provides additional data on the patient's condition to be used

in assessing the severity of the patients condition. The confirmation sequence can

include a request by the central office in video or audio form to the user to indicate

whether in their subjective opinion the alarm condition warrants a physician's

attention. The confirmation sequence can include a question and answer sequence

generated from the Q&A file downloaded from the central office. The confirmation

sequence can also include a snapshot or live camera feed of the patient obtained by

the portable patient monitoring device or the patient monitoring computer which is

sent to the central office. Control is then passed from process 1014 back to process

1006 for a continuation of the transmission of real time data to the central office.

Alternately, if in decision step 1012 a negative determination is made, i.e., that no

confirmation is requested by the central office, then control is passed directly to

process 1006.

If in process 1010 a determination is made that a cease alarm condition has

been reached, e.g. that biometric parameters have returned to normal then control is

passed to process 1016 for the imposition of a delay period during which biometric

parameters continue to be transmitted to the central office. This interval is shown in FIG. 8 between times T3-T4. When the interval has elapsed data transmission to the

central office may be terminated. Control is then passed to decision 1018 in which a

determination is made as to whether a reset of limit request has been sent from the

central office to the remote site portable patient monitor. These new limits may be

automatically generated at the central office or may be input by a doctor at the

central office. They may be appropriate when the patient needs to be more closely

monitored. If this determination is in the affirmative then control is passed to

process 1020 in which the limit memory is reset. Control is then returned to process

1000 discussed above. Alternately if in decision step 1018 a determination is made

that no physician reset of the reprogammable limits is requested, then control is

directly returned to process 1000. The methods outlined above in processes 1000-

1018 have the benefit of minimizing the communications between the central office

and the remote site while assuring that critical detailed patient data is transmitted to

the central office in a timely manner. Because the data transmitted to the central

office is time stamped, a full record of the patient's biometric parameters including

normal and abnormal readings can be reconstructed from the received information.

FIG. 10B shows the processing connected with the central office in an

embodiment of the invention. The process begins at decision step 1054 in which a

determination is made as whether an alarm event has been detected and data is being

received from the remote site. If that determination is in the affirmative then control

is passed to process 1056 in which all the buffer data from the remote site plus a real

time feed from that site is prepared for viewing by the health care professional. Control is then passed to process 1058 in which the medical care provider is notified

by pager, monitor, telephone or any other a number of means and the data is made

available to the medical care provider (MCP) in real time. The historical data from

the buffer is included in the information provided to the MCP. Control is then

passed to decision process 1060 in which a determination is made as whether a

confirmation of the alarm condition has been programmed into the protocol for the

remote site. If confirmation is appropriate control is passed to process 1064. In

process 1064 a Q&A sequence, a video feed or a still image of the patient may be

obtained to help confirm the patient's condition. Control is then passed to process

1066. Alternately, if in decision process 1060 a determination is made that no

confirmation protocol is called for in the event of an alarm condition then control is

passed directly to process 1066. In process 1066 the biometric data on the patient

as well as any confirmation data, e.g. images or Q&A results are made available to

the MCP. Control is then passed to decision process 1068. In decision process

1068 a determination is made as to whether the MCP desires to reset threshold

conditions and/or the combination of biometric parameter value(s) required to

trigger an alarm condition. If that determination is in the negative then control

returns to decision step 1054 discussed above. Alternately if that determination is in

the affirmative then control is passed directly to process 1070 in which the MCP is

queried as to what new limits and limit combinations are required for the biometric

parameters. These new limits are transmitted from the central office to the portable

patient monitoring device and the limit memory is updated with the new limits. Control is then returned to process 1054 for the processing of the next event or alarm

condition received from a remote site.

FIGS. 11-17 are process flow diagrams of the processes at the remote site for

monitoring specific disease states according to an embodiment of the invention.

These processes can be downloaded from the central office as part of a management

record or can be contained in the portable patient monitor and selected from a menu

of options displayed on that monitor. Each of the following processes may be

accompanied by additional processes to enhance the functionality of the patient

monitoring system at the remote site. These additional processes include:

authentication of patient identity, visual or still images of the patient, buffering of

patient data, etc..

FIG. 11. Management of fluid balance:

Edema is an abnormal accumulation of fluid in the tissue spaces, cavities or

joint capsules of the body that may cause swelling and pain in the affected area. A

physician whose patient presents with a history of recurrent edema may wish to have

the patient continuously monitored for early signs of fluid retention. A system for

performing this monitoring is described in the process flow diagram of FIG. 11.

In process 1102 the patient is monitored by a device strapped to his or her

ankle that can detect presence of, and relative change in the circumference of the

ankle indicating edema. The signal from the monitoring device is then transmitted to the portable patient monitoring device or the PMC for processing using short

range half duplex RF transmission, or some other means of transmission. In process

1104, the signal from the monitoring device is compared against a specified range of

values. Control is then passed to decision process 1106. In decision process 1106 a

determination is made as to whether the biometric parameters in this case ankle

swelling is within the specified range of values. If a determination in the negative is

reached, i.e. that ankle swelling exceeds the specified range of values then control is

passed to process 1108. In process 1108 a central monitoring station (e.g. a remote

monitoring nurse) is automatically notified of the patient's condition. Alternately, if

in decision process 1106 a determination is made that swelling is within range then

control is returned to process 1104.

FIG. 12 Sleep disorders

A patient may have a history of night-time hypoxia or sleep apnea. These

conditions involve low blood oxygen levels due to a variety of conditions, such as

difficulty in breathing, etc. Low blood oxygen may lead to consequences such as

fatigue, loss of alertness, and possibly some tissue damage. Additionally, low blood

oxygen due to hypoxia or sleep apnea may be surrogate markers for some other,

more serious, disease condition. Accordingly, the patient's physician may well be

interested in monitoring these conditions while the patient is sleeping. A system for

monitoring these conditions is described in the process flow diagram of FIG. 12. The patient at risk for hypoxia during sleep and/or sleep apnea wears a

device to monitor oximetry and/or to detect respiratory airflow and/or chest wall

excursions, as shown in process 1202. The signal from the device is then

transmitted to the portable patient monitoring device or the PMC for processing. If

necessary, the signal may be sent to a patient monitoring computer for processing

using short range half duplex RF transmission, or some other means of transmission.

Control then passes to process 1204. In process 1204 the signal from the monitoring

device is compared against a specified range of values for the biometric parameters

being monitored. Control is then passed to decision process 1206. In decision

process 1206 a determination is made as to whether the signal from the monitor is

within the specified range of values. If that determination is in the affirmative

control returns to process 1204 for continued monitoring of the patient. If the

determination is in the negative, e.g. that values exceed the specified range(s) then

control is passed to process 1208. In process 1208 the patient is then awakened.

Next, in step 1210, a central monitoring station (e.g. a remote monitoring nurse) is

automatically notified of the patient's condition.

FIG. 13 Arrhythmia management:

Arrhythmia is any disturbance in the electrical rhythm of the heart. An

anhythmia is an unstable series of disturbances in heartbeats, and may be associated

with serious medical conditions, such as congestive heart failure or myocardial infarction. As such, a patient prone to development of an anhythmia may be at high

risk for serious cardiovascular consequences. That patient's physician would

understandably wish to monitor the patient to determine the occunence, extent and

nature of an arrhythmia using electrocardiography (ECG) each day. A system for

monitoring for arrhythmias is described in the process flow diagram of FIG. 13.

In operation, the patient is prompted, once per day, to use an ECG device, as

shown in process 1302. Subsequently control is passed to process 1304. In process

1304 instructions for using the device are displayed on an appropriate display panel,

of the portable patient monitor or the PMC, for example. Control is then passed to

process 1306. In process 1306 the signals generated by the ECG sensor are

monitored. Monitoring may take place at the portable monitoring device or the

PMC. If necessary, the signal may be sent to the PMC from the ECG sensor using

short range half duplex RF transmission, or some other means of wireless

transmission. Control is then passed to decision process 1308. In decision process

1308 a determination is made as to whether the ECG values are within a specified

range of acceptable values. If the values are within an acceptable range control is

passed to process 1310. In process 1310 if the signal from the monitor is within the

specified range of values, then the system displays the results and also displays

management techniques for the patient. Alternately, if in decision process 1308 a

determination is made that the patients ECG values are outside the specified range

then control is passed to process 1312. In process 1312 a central monitoring station

(e.g. a remote monitoring nurse) is automatically notified in an appropriate way, and data values are transmitted to the central monitoring station. As will be obvious to

those skilled in the art ECG monitoring may also be used for detecting other

conditions of the heart such as ischemia.

FIG. 14 Monitoring for exacerbations of airway disease.

Peak expiratory flow rate in a patient can be used as an indicator of serious

respiratory problems. For example, decreased peak expiratory flow rate can be

indicative of lung collapse, pneumonia, or pulmonary edema, as well as airway

disease such as asthma. Understandably, if the patient has airway disease, or is at

risk for airway disease, then the patient's physician would want to monitor the

patient's peak expiratory air flow. A system for monitoring peak air flow is

described in the process flow diagram of FIG. 14.

In step 1402, the patient is beckoned and prompted to use the peak

expiratory flow meter, once per day. Next, in step 1404, instructions are displayed

for the patient to use the spirometer or other peak flow sensor device. The peak flow

test is then performed, as indicated in step 1406. The signal from the device is then

transmitted to the portable patient monitoring system for processing. If necessary,

the signal may be sent to a patient monitoring computer for processing using short

range half duplex RF transmission, or some other wireless means of transmission.

The test value is thereby recorded, as shown in step 1408. Until the test has been

repeated three times, the patient will be directed to repeat the test, as indicated by steps 1412 and 1410. After the third test such test control will be passed to process

1414. In process 1414 the system will then query the patient for a self-assessment of

the patient's condition. This may be accomplished by using a display menu

containing a variety of choices, as shown in step 1414, for example: "symptom-

free", "mild shortness-of-breath", "moderate shortness-of-breath", etc., from which

the patient selects the appropriate response. Another menu alternative is a linear

scale, with "best" and "worst" marked at opposing ends, whereupon the patient

selects a point along the scale conesponding to their symptom state. Alternatively,

the patient may enter the self-assessment in other ways, such as entering general

notes about their self-assessed condition. After the query process control is passed to

decision process 1416.

In decision process 1416 the signal from the monitoring device is compared

against a specified range of values. If the values are not within the acceptable range

control is passed to process 1418. In process 1418 the central monitoring station

(e.g. a remote monitoring nurse) is automatically notified in an appropriate way, and

graphs of recent peak flows and pulmonary symptom scores are transmitted to the

central monitoring station. The portable patient monitor may in addition instruct the

patient to undertake certain therapeutic steps and to repeat the peak flow

measurements at a specified time. Alternately, if in decision process the values are

determined to lie within an acceptable range control is passed to process 1420. In

process 1420 the signal from the monitoring device the system compares the signal

with the highest patient value that has been previously stored. Next, the system generates a pulmonary symptom score and a pulmonary management plan based on

the NTH Asthma Guidelines (NILTPublication 97-4053, October 1997).

FIG. 15 Wound Assessment:

Patients with healing wounds need to be checked on a regular basis. This is

for obvious reasons: improperly healing wounds can lead to serious infection,

gangrene, and possibly even death. Especially in the context of post-operative care,

wound assessments need to be performed on a periodic basis. Understandably, the

patient's physician would want to monitor the patient's wound. A system for

monitoring wound healing is described in the process flow diagram of FIG. 15.

In operation, the patient is prompted, at an appropriate frequency, to assess

their wound through an appropriate video system, in process 1502. Such a video

system is preferably a digital video system, to facilitate transmission and processing

of the video images. The patient exposes their wound to the video system, and the

image or images is recorded, as shown in step 1504. Next, in step 1506, the patient

is prompted to assess the wound through measurements and symptoms. The

measurements of the wound may be made in a variety of ways. In one embodiment,

the diameter or circumference of the wound is measured with electronic calipers or a

transparent template with circles arranged in "bull's eye" pattern laid over the

wound. The evaluation of the wound may also be accomplished by pattern matching

processes implemented on an electronic image of the wound obtained by a video or still camera on the portable patient monitor. The patient can register symptoms

through a series of self-assessment questions. In one embodiment, these questions

may be "Has the size of the wound changed?", "Has the color of the wound

changed?", "Is there an odor to the wound?", "Is the wound more painful?" The

answers to these questions is stored in the portable patient monitor or PMC for

transmission to the central office. The data may be sent to a patient monitoring

computer for processing using short range half duplex RF transmission, or some

other means of transmission. The data from these assessments is then recorded, as

shown in step 1508. Control is then passed to decision process 1510. In decision

process 1510 a determination is made as to whether the data, e.g. answers and

measurements are within a specified range. If they are control is passed to process

1518. In process 1518 the data is stored in a patient file at the central monitoring

facility. Alternately, if the data is not within a specified value for either the

assessment results or for the image processing of the wound video, then in step

1512, appropriate information on wound management is displayed for the patient.

Next, in step 1514, the recorded data is transmitted to the patient's physician or other

healthcare worker, in a central monitoring facility.

FIG. 16 Monitoring for exacerbations of respiratory disorders.

Patients with a history of cardiorespiratory disease may experience difficulty

in absorbing oxygen from the air and delivering it, through the blood system, to various body tissues. These difficulties can lead to fatigue, muscle atrophy, death of

the affected tissue, and other life-threatening conditions. Understandably, the

patient's physician will want to monitor the state of the patient's disease. A system

for monitoring the patient is described in the process flow diagram of FIG. 16.

In process 1604, the patient is prompted twice a day (or at a different

frequency) to use a pulse oximeter to monitor his/her oxygen saturation (SaO₂).

Next, in process 1606, instructions for using the pulse oximeter are displayed. The

patient then performs the SaO₂ test, as shown in process 1608. The signal from the

pulse oximeter may be transmitted to the portable patient monitor or the PMC for

processing. The data may be sent to a patient monitoring computer for processing

using short range half duplex RF transmission, or some other wireless means of

transmission. The signal is then recorded, as shown in step 1610. Control is then

passed to decision process 1612. In decision process 1612 a determination is made

as to whether the SaO₂ value is within an acceptable range. If it is control is passed

to process 1624. If it is not control is passed to decision process 1614. In decision

process 1614 a determination is made as to whether this is the second test. If it is not

control is passed to process 1616 for a repeat of the test. Subsequently control

returns to process 1610. If alternately in decision process 1614 a determination is

made that the test has already been repeated, then the patient will be prompted to use

a different finger in process 1618 and the test will be repeated in process 1620. If

the signal value in the new finger is within an acceptable range as determined in

decision process 1622, then the results are stored in process 1624 for later transmission and the patient is notified in process 1626 that the signal value results

are acceptable.

If the signal value for the different finger is not within an acceptable range as

determined in decision process 1622 , then control is passed to process 1630 in

which the patient is directed to perform a peak expiratory flow maneuver and to

capture the results using a spirometer, for example. Additionally, the patient is

instructed to place a stethoscope on the patient's chest in appropriate positions to

record heart sounds. Then in process 1632 the patient may be asked to provide

additional information such as a self-assessment by answering questions ("Do you

feel short of breath?"), or using other diagnostic instruments, or by prompting the

patient to describe how the patient feels in the patient's own words. The patient is

then prompted to standby for instructions from the central monitoring station.

Finally, all information is recorded, in process 1634 and the recorded information,

including trend charts stored from previous pulse oximetry, for example, is

transmitted to the central monitoring station, as shown in process 1634.

FIG. 17 Diabetes Management: Insulin adjustment

Management of diabetes can be very complex, and yet such management is

crucial to maintaining the health of a diabetic patient. The central measurement for

monitoring and managing diabetes is blood glucose. Understandably, a diabetic

patient's physician would want to monitor the patient's blood glucose levels, and provide feedback to the patient regarding disease management. FIG. 17 shows a

process flow diagram of a system for managing a diabetic patient's disease.

In operation, the patient is prompted to perform a glucoscan using a blood

glucose monitoring device, as shown in step 1702. Instructions on how the patient

should use the device are displayed on the display of the portable patient monitor or

PMC in process 1704. The device is then used by the patient to perform the test, and

determine the blood glucose level in process 1706. The signal from the glucose

monitoring device may be transmitted to a patient monitoring computer for

processing using short range half duplex RF transmission, or some other means of

transmission. The signal is then recorded in process 1708. Control is then passed to

decision process 1710. In decision process 1710 a determination is made as to

whether the signal value is within an acceptable range. If it is not then control is

passed to process 1712 in which the system informs the patient what dose of insulin

to take.

If, however, the blood glucose level is abnormally high or low, then control

is passed to process 1714 in which the patient is prompted to make a self-

assessment. This may be accomplished by using a display menu or an audio

question sequence followed by recording of responses. For example: "are you

dizzy?", "are you febrile?", "are you thirsty?", etc., are questions the patients may be

asked. In an alternate embodiment a menu lists alternatives in a linear scale, with

"best" and "worst" marked at opposing ends, whereupon the patient selects a point

along the scale corresponding to their symptom state or states. Alternatively, the patient may enter the self-assessment in other ways, such as entering general notes

about their self-assessed condition. Next, in step 1716, the patient is prompted to

take vital sign measurements using devices, such as stethoscopes or blood pressure

cuffs, etc., that have been either discussed above or are known to one of skill in the

art. Then in process 1718 the results of these measurements are recorded and then

transmitted to a central monitoring station, with graphs, for analysis by a clinician or

other health care worker.

The foregoing description of embodiments of the present invention has been

presented for purposes of illustration and description only. It is not intended to be

exhaustive or to limit the invention to be forms disclosed. Obviously, many

modifications and variations will be apparent to practitioners skilled in the art.

Claims

What is Claimed is:

1. A computer implemented method for managing the care of a subject with at

least one condition, and the method for managing comprising the acts of:

determining a protocol for monitoring the subject, the protocol including at

least one biometric parameter to be monitored and at least one response associated

therewith;

monitoring the at least one biometric parameter; and

executing the at least one response associated with the biometric parameter

when the biometric parameter is beyond a selected threshold.

2. The method of claim 1, wherein the selected threshold comprises at least one

of: a value, range of values, and a rate of change in a value.

3. The method of claim 1 , wherein the determining act further comprises the

act of:

retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored and at least one response associated therewith.

4. The method of claim 1 , wherein the determining act further comprises the

acts of: retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored and at least one response associated therewith,

and the at least one response including a dosage of a medication.

5. The method of claim 1, wherein the determining act further comprises the act

of:

retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored and at least one response associated therewith,

and the at least one response including training data associated with a sensor for

monitoring the at least one biometric parameter.

6. The method of claim 1, wherein the determining act further comprises the act

of:

retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored and at least one response associated therewith,

and the at least one response including questions for the subject.

7. The method of claim 1, wherein the determining act further comprises the act

of: retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored, at least one time at which to monitor the

biometric parameter, and at least one response associated therewith.

8. The method of claim 1, wherein the determining act further comprises the

acts of:

retrieving from among a plurality of disease protocol records a protocol

record for the at least one condition, and the protocol record containing at least one

biometric parameter to be monitored, at least one time at which to monitor the

biometric parameter and at least one response associated therewith, and the at least

one response including a dosage of a medication; and

calculating an additional time at which to monitor the at least one biometric

parameter to obtain information about the medication.

9. The method of claim 1, wherein the subject is located at a first site and

wherein the determining act further comprises the acts of:

retrieving from among a plurality of disease protocol records at a

central office a protocol record for the at least one condition, and the protocol record

containing at least one biometric parameter to be monitored and at least one response

associated therewith; translating the protocol record to a management record, and the

management record including computer code for monitoring the biometric

parameter;

downloading the management record to a portable subject monitor at

the first site; and

wherein further the monitoring and executing acts are performed by the

portable subject monitor at the first site.

10. The method of claim 1, wherein the subject is located at a first site; and

wherein the determining act further comprises the acts of:

retrieving from among a plurality of disease protocol records a

protocol record for the at least one condition, and the protocol record containing at

least one biometric parameter to be monitored and at least one response associated

therewith, and the at least one response including a dosage of a medication;

translating the protocol record to a management record, and the

management record including computer code for monitoring the biometric

parameter;

downloading the management record to a portable subject monitor at

the first site; and

wherein further the monitoring and executing acts are performed by the

portable subject monitor at the first site.

11. The method of claim 1, wherein the subject is located at a first site; and

wherein the determining act further comprises the acts of:

retrieving from among a plurality of disease protocol records a

protocol record for the at least one condition, and the protocol record containing at

least one biometric parameter to be monitored and at least one response associated

therewith, and the at least one response including training data associated with a

sensor for monitoring the at least one biometric parameter;

translating the protocol record to a management record, and the

management record including computer code for monitoring the biometric

parameter;

downloading the management record to a portable subject monitor at

the first site; and

wherein further the monitoring and executing acts are performed by the

portable subject monitor at the first site.

12. The method of claim 1, wherein the subject is located at a first site; and

wherein the determining act further comprises the acts of:

retrieving from among a plurality of disease protocol records a

protocol record for the at least one condition, and the protocol record containing at

least one biometric parameter to be monitored and at least one response associated

therewith, and the at least one response including questions for the subject; translating the protocol record to a management record, and the

management record including computer code for monitoring the biometric

parameter;

downloading the management record to a portable subject monitor at

the first site; and

wherein further the monitoring and executing acts are performed by the

portable subject monitor at the first site.

13. The method of claim 1, wherein the subject is located at a first site; and

wherein the determining act further comprises the acts of:

retrieving from among a plurality of disease protocol records a

protocol record for the at least one condition, and the protocol record containing at

least one biometric parameter to be monitored, at least one time at which to monitor

the biometric parameter, and at least one response associated therewith;

translating the protocol record to a management record, and the

management record including computer code for monitoring the biometric

parameter;

downloading the management record to a portable subject monitor at

the first site; and

wherein further the monitoring and executing acts are performed by the

portable subject monitor at the first site.

14. The method of claim 1, wherein the subject is located at a first site, and

wherein the executing act further comprises the acts of:

detecting at the first site that the biometric parameter is beyond a selected

threshold;

sending from the first site to a second site, data on the biometric paremeter

accumulated during the monitoring act.

15. The method of claim 14, further comprising the acts of:

receiving at the second site the data;

retrieving from among a plurality of disease protocol records at the second

site a protocol record for the at least one condition, and the protocol record

containing a display protocol for displaying the data; and

displaying the data in accordance with the protocol.