U.S. patent application number 10/632991 was filed with the patent office on 2004-05-20 for method and system of monitoring a patient.
This patent application is currently assigned to MedOptix. Invention is credited to Berman, Herbert L., Blair, Robert N., Moyer, James W..
Application Number | 20040097796 10/632991 |
Document ID | / |
Family ID | 32298574 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040097796 |
Kind Code |
A1 |
Berman, Herbert L. ; et
al. |
May 20, 2004 |
Method and system of monitoring a patient
Abstract
A patient monitor system implemented by a service provider for
users via recording a patients analytes measurements by an
attenuated total reflection (ATR) infrared total spectroscopy
method. The system comprises an input module that provides a
non-invasive method in measuring analytes in a patient, such as a
measurement of the glucose level and other blood analytes. The
measurement is shared among a plurality of output devices such as
computers, personal digital assistants (PDAs), cellular phones, and
pagers that are stationed or held by various users such as doctors,
patients, researchers, pharmacies, labs, and health insurers. In
addition behavioral attributes are recorded and correlated with the
analytes measurements to generate a profile. The profile is
selectively sent to output devices based on the user profile
corresponding to the output device. Also, access to the profile is
monitored by a security module that encrypts the profile to prevent
access by un-authorized users.
Inventors: |
Berman, Herbert L.; (Los
Altos Hills, CA) ; Blair, Robert N.; (San Jose,
CA) ; Moyer, James W.; (San Francisco, CA) |
Correspondence
Address: |
Fernandez & Associates, LLP
PO Box D
Menlo Park
CA
94026-6402
US
|
Assignee: |
MedOptix
Cupertino
CA
|
Family ID: |
32298574 |
Appl. No.: |
10/632991 |
Filed: |
August 1, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10632991 |
Aug 1, 2003 |
|
|
|
09844687 |
Apr 27, 2001 |
|
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Current U.S.
Class: |
600/310 |
Current CPC
Class: |
G16H 40/67 20180101;
G16Z 99/00 20190201; A61B 5/002 20130101; Y10S 128/903 20130101;
A61B 5/14532 20130101; Y10S 128/92 20130101; A61B 5/0022 20130101;
G01N 21/552 20130101 |
Class at
Publication: |
600/310 |
International
Class: |
A61B 005/00 |
Claims
We claim:
1. A method for implementing a patient monitor program for a user
by a service provider, the method comprising the steps of:
recording a physiological attribute of a patient on a device,
wherein the device utilizes attenuated total reflection (ATP)
infrared spectroscopy to record the attribute; and sending the
attribute to one or more users via at network.
2. The method of claim 1, wherein the attribute is blood glucose
level.
3. The method of claim 1, wherein the attribute is a blood analyte
level.
4. The method of claim 1, further comprising the step of processing
one or more attribute to generate a profile of the patient.
5. The method of claim 1, further comprising the step of recording
one or more behavioral attributes of the patient.
6. The method of claim 5, further comprising the step of
correlating the physiological attributes with the behavioral
attributes in generating the profile of the patient.
7. The method of claim 6, further comprising the step of encrypting
the profile to protect unauthorized access.
8. The method of claim 1, further comprising the step of
transmitting the attribute wirelessly.
9. The method of claim 8, wherein the wireless transmission is
performed via coupling the device to a cellular phone.
10. The method of claim 8, wherein the wireless transmission is
performed via coupling the device to a wireless transmitting
device.
11. The method of claim 1, wherein the attribute is transmitted to
a local processing unit over a short range radio frequency (RF)
link.
12. The method of claim 11, wherein Blue tooth protocol is utilized
in the transmission.
13. A patient monitor system to enable sharing of information among
information recipients comprising: an input device to record an
attribute of an patient, wherein the device utilizes attenuated
total reflection (ATR) infrared spectroscopy to record the
attribute; a data processing unit to process the attributes to
generate and transmit a profile of the patient to a recipient.
14. The system of claim 13, wherein the profile is transmitted via
a network.
15. The system of claim 13, wherein the profile is transmitted
wirelessly.
16. The system of claim 13, wherein the profile is transmitted
based on recipient parameters.
17. The system of claim 13, further comprises a security module to
verify recipient access to profiles.
18. A method of transmitting an analyte measurement from an input
device to a user output device comprising the steps of: contacting
a skill surface of a patient to an ATR plate in said input device;
no recording an analyte level measurement in the skin via ATR
infrared spectroscopy; and transmitting said analyte level
measurement to one or more user.
19. The method of claim 18, wherein said measurement is transmitted
via a network.
20. The method of claim 19, wherein said network is the
Internet.
21. The method of claim 18, wherein said measurement is transmitted
via a wireless protocol.
22. The method of claim 21, wherein said wireless transmission is
performed via coupling the input device to a cellular phone.
23. The method of claim 21, wherein said wireless transmission is
performed via coupling the input device to a pager.
24. The method of claim 21, wherein said input device contains a
wireless transmission module.
25. The method of claim 18, further comprising the step of
restricting user access by a pre-determined rule set.
26. The method of claim 18, further comprising the step of
processing the analyte measurement to generate a profile.
27. The method of claim 26, wherein the processing relates to
correlating said analyte measurement with behavioral attributes of
the patient.
28. The method of claim 18, wherein the analyte measurement is
blood glucose level.
Description
BACKGROUND INFORMATION
[0001] 1. Field of the Invention
[0002] The invention relates in general to devices and methods for
improving the delivery of patient information and care to patients,
particularly to transactions involved in utilizing a non-invasive
monitoring system to deliver physiological information to patients
and patients' service providers.
[0003] 2. Description of Related Art
[0004] Numerous diseases require the monitoring of various
physiological attributes of a patient. These attributes such as
blood glucose level and other blood analytes' level are invaluable
to patients and health service providers such as doctors, medical
professions, pharmacies, researchers insurance companies, and
government agencies.
[0005] Particularly in patients with diabetes, monitoring the level
of blood glucose is extremely important in controlling the
patient's health, and decreasing or delaying the damaging effects
of uncontrolled blood glucose. Diabetes is a disease in which the
body does not produce or properly use insulin, which results in the
increase uptake of glucose from the blood across cell membranes.
About sixteen million people in the United States are diabetics.
The American Diabetes Association reports that diabetes is the
seventh leading cause of death in the United States. The
complications of the disease include blindness, kidney disease,
nerve disease, heart disease, and death.
[0006] Specifically, for diabetes, monitoring various physiological
attributes is essential for diabetic patients. For example, it is
essential that patients practice frequent self-monitoring of blood
glucose (SMBG). Based upon the level of glucose in the blood,
individuals may make insulin dosage decisions before injection.
Monitoring the trends in blood glucose over time provides health
care providers with invaluable information on the adequacy of
therapy, the compliance of the patient and the progression of the
disease. However, the prior systems of glucose monitoring usually
requires obtaining blood from a finger stick (invasive method) or
obtaining body fluids (other than blood) and subcutaneous tissue
(also an invasive method). Now, an optical non-invasive glucose
monitoring system, as illustrated in a related co-pending U.S.
patent application entitled Infrared ATR, Glucose Measurement
System (11), U.S. application Ser. No. 09/547,433, by Herbert L.
Berman and Jeffrey N. Roe, owned by the assignee of this
application and incorporated herein by reference, provides a
solution for non-invasively gathering of blood glucose information
for diabetic patients. Use of a non-invasive technology rather than
an invasive technology permits a significantly better approximation
to continuous monitoring, which in turn may contribute
significantly to improved health care for diabetic patients.
[0007] Therefore, it is advantageous to have a monitoring system
that leverages on the non-invasive glucose-measuring device to
provide a medium for sharing of the monitored information.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a block diagram of a monitor system according to
the present invention.
[0009] FIG. 2 illustrates a more detail illustration of the
internal architecture of a non-invasive monitor device 210 a
processing unit and storage system 510, and information recipients
600.
[0010] FIG. 3 illustrates a flow chart of registering information
into the monitor device.
[0011] FIG. 4 illustrates the step-by-step information flow from
the monitor device to a data processing and storage system.
[0012] FIG. 5 is a flow chart of the information processing in a
data processing unit.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
[0013] Reference is made in detail to embodiments of the invention.
While the invention is described in conjunction with the
embodiments, the invention is not intended to be limited by these
embodiments. On the contrary, the invention is intended to cover
alternatives, modifications and equivalents, which may be included
within the spirit and scope of the invention as defined by the
appended claims. Furthermore, in the following detailed description
of the invention, numerous specific details are set forth in order
to provide a thorough understanding of the invention. However as is
obvious to one ordinarily skilled in the art, the invention may be
practiced without these specific details. In other instances
well-known methods, procedures, and components have not been
described in detail so that aspects of the invention will not be
obscured.
[0014] Referring to FIG. 1, the elements of the patient monitoring
system in accordance with one embodiment of the invention consist
one or more non-invasive analyte monitor devices (110 210 310 410),
a data processing and storage unit 510, and one or more information
recipients 600, such as doctor office 610 researcher 620, pharmacy
630, hospital/labs 640, insurance provider 650, government agency
660, patient 670, family member 680, and health maintenance
organization 690. All elements of the system can communicate with
each other via a network or wireless protocol 50.
[0015] As illustrated in more detail in FIG. 2, the data processing
and storage unit 510 implements for a user a monitoring system that
organizes and processes physiological and behavior attributes of
the user to enable transmission of these attributes to information
recipients 600. The term "information recipients"as defined herein
are person, organization, and corporation that are interested in
the attributes gathered by the non-invasive analyte monitor device
such as doctor office 610, researcher 620, pharmacy 630,
hospital/labs 640, insurance provider 650, government agency 660,
patient 670, family member 680, and health maintenance organization
690. Optionally, the data processing and storage unit can be
programmed to send automated warnings such as by email, phone, or
fax to a patient or information recipients if the patient's
condition falls outside an acceptable limit that can be prescribed
by the patient's caregiver or physician.
[0016] In one embodiment of the system where the user is a diabetic
patient, the user utilizes the non-invasive analyte monitor device
210 based on attenuated total reflection (ATR) technology to
measure blood glucose level. The analyte monitor device comprises
an ATR plate 212 coupled to an analyte measurement generator 213
which calculates the blood glucose level on user's skin that is
placed on the ATR plate 212 for measurement. The measurement is
then stored in a storage module 214, which also can store other
user information. The analyte device 210 requires calibration,
which is accomplished by a calibrator module 215 that correlates
the measurements generated from the analyte measurement generator
213 to measurements taken from standard invasive procedures such as
a finger stick. After calibration, the analyte device 210 can be
used to obtain accurate glucose level measurements without any
other invasive procedures. The input/output module 216 allows the
user to input information and also receive the analyte measurements
from the measurement generator 213 or the storage module 214.
[0017] In an alternative embodiment, the user, via the input/output
module 216, may also input behavior attributes such as time
duration between analyte measurement and last meal, time duration
between analyte measurement and last exercise session, time
duration between analyte measurement and last resting session or
time and dosage of medication taken. These behavior attributes
affect the interpretation of the blood glucose measurement. For
example, blood glucose level tends to be higher for users that have
just eaten a meal. Thus, by adding behavior attributes, the
monitor, system can provide a better profile of the user's health
to information recipients 600 such as the user's doctor 610. Also,
the user utilizes the input/output module 216 to include other
physiological attributes such as heart rate or blood pressure.
Optionally the input/output module 216 can comprise an activity
sensor that determines energy use and/or a metabolic activity
sensor that measures metabolic rates such as oxygen
consumption.
[0018] Additionally, the output module 216 of the analyte device
210 serves as a messaging terminal for the patient. These messages
can be automatic alarms that alert the patient when the analyte
measurements, behavior attributes and physiological attributes are
out of a normal range prescribed by the patient, the patient's
caregiver, and/or the patient's physician. These messages can be
generated by the analyte device itself or from any one of the
information recipients. For example, if the patient's physician
determines that the patient is not responding to a prescribed
medicine dosage, the physician can send a message to the output
module 216 to request the patient to change his dosage or to
request a visit to the physician's office for consultation.
[0019] All the analyte measurements, behavior attributes, and
physiological attributes are communicated to the data processing
and storage unit 510 for processing and storage, which will be
furthered described in detail in FIG. 5. These attributes are sent
to the data processing and storage unit 510 via a network such as
the Internet, local area network (LEN) and/or Slide area network
(WAN), wireless and/or wired or other network infrastructure 50. In
one embodiment or the invention, the monitor device 210 has its own
wireless transmission module. In an alternative embodiment of the
wireless transmission, the monitor device 210 is coupled to a
wireless device such as a cellular phone, a pager or a wireless
modem to enable transmission. Optionally, due to the large amount
of data being collected, the monitor device 210 may send all
information to a local terminal and storage located within a
patient's home, a physician's office, or a hospital. The
information to the local terminal can be transmitted over a
short-range radio frequency (RF) link (e.g. Blue tooth).
Subsequently, the information stored at the local terminal will be
communicated to the processing unit 510.
[0020] After communication is established between the monitor
device 210 and the processing unit 510, an account manager 512 in
the processing unit 510 accesses the user's account and the
security module 511 verifies the user's identity via a password or
any other security means. After verification, the attributes are
transmitted and organized into a physiological database 513, which
stores the user's analyte measurements and other physiological
attributes, and a behavioral database, which stores the user's
behavioral attributes. The account manager 512 also communicates
with an information recipient database 515 that includes the user's
selected information recipients 600 and recipient parameters
associated with each specific information recipient. These
recipient parameters as described herein are requirements that
direct the transmission of the user attributes, which may include
type of information such as report of blood glucose level, all
email to alert if blood glucose level reaches a certain maximum or
minimum, a report of behavioral and blood glucose correlation,
"time of information" such as weekly, monthly, or quarterly,
"format type" such as a graphical representation or text, and
"information recipient" such as sending the information to doctor
and patient personal computer, or sending to family members in case
of emergency.
[0021] The processes of gathering the user's attributes, processing
the attributes, and transmitting the attributes to corresponding
information recipients are furthered described in detail in FIG. 3,
which illustrates the registration of the user, in FIG. 4, which
illustrates the gathering of the user's attributes, and in FIG. 5,
which illustrates the data processing and transmission of the
attributes.
[0022] FIG. 3 illustrates the events that take place in user
registration. The user can register via the monitor device 210 or
any computing machine that enables communication to the processing
unit 510. The user logs-in and account registration is initiated
3000 if user has not registered. The user provides account
information (e.g. name, address, date of birth, prior medical
history, or monitor device serial number). The user then creates
3100 a profile, which is a set of data relating to a specific
service (e.g. monitoring the blood glucose level or monitoring
alcohol level) by selecting 3200 the type of service needed such as
analyte measurement reading, analysis and tracking of physiological
and behavioral attributes, transmitting information among
information recipients, or any combination of the above mentioned
services. After service is selected 3200, the user selects one or
more physiological attributes to track 3300, one or more analytes
to be measured 3400 and one or more behavioral attributes to track
3500. If information transmission among recipients is selected in
step 3200, the user needs to input all recipients' information and
recipient parameters 3600. The profile is stored in the storage
module 214 of the monitor device 210 and in a profile database 516
in the account manger 512 of the processing unit 510. Alternatively
the profile can be stored on either the storage module 214 or the
account manger 512. Profile is completed 3700 and the data
processing unit sends a confirmation with password to the user and
his list of recipients. Alternatively, the user can create numerous
profiles within the same account.
[0023] After user registration, the user can utilize his device to
gather physiological and behavioral attributes, which is
illustrated in FIG. 4. The user logs-in 4000 to the device 210 with
password from the registration and user account is presented by the
input module 4100. Alternatively, user log-in can be accomplished
by voice recognition or by a fingerprint. The user selects the
desired profile 4200. If behavior inputs are required, the user
inputs 4300 the behavior attributes such as time duration between
analyte measurement and last meal, time duration between analyte
measurement and last exercise session, time duration between
analyte measurement and last resting session, or whether other
drugs or alcohol was taken prior to measurement. If no behavioral
attributes are required, the user is presented with opportunity to
select analyte measurement. If selected, the user selects the
desired analyte to be measured 4400 and if calibration is needed,
the calibrator module is initiated to calibrate 4500 the analyte
measurement generator 213. If calibration is complete the user can
place his finger 4600 on the ATR plate and the analyte measurement
generator records 4700 and calculates the analyte level. If only
the analyte measurement is selected and no processing is needed,
the output module 216 of the monitor device 210 will display the
measurement. If further processing is required, the data is sent
4800 to the processing unit and the data is processed, as
illustrated in more detail in FIG. 5.
[0024] In FIG. 5, the data processing unit 510 receives
transmission from the monitor device 5100. The user is verified
5200 via the security module and user account is accessed 5300 by
the account manager. If the transmission pertains to an existing
profile, the data is transferred and the profile database in the
account manager is updated 5700. If the transmission consists of
data pertaining to a new profile, a new profile is created by the
processing unit 5400 and data is transferred 5500. The processing
unit then organizes and correlates the data according to the
behavioral and physiological relationships and recipient parameters
5600 and updates the profile database in the account manager 5700.
After updating the profile database 5700, the account manager is
responsible for sending out the corresponding reports and profiles
at the corresponding time to each recipient based on the recipient
parameters 5800. Alternatively, the reports and profiles are
encrypted and access is only granted to recipients with valid
passwords to prevent unauthorized use.
[0025] Foregoing described embodiments of the invention are
provided as illustrations and descriptions. They are not intended
to limit the invention to precise form described. In particular, it
is contemplated that functional implementation of invention
described herein may be implemented equivalently in hardware,
software, firmware, and/or other available functional components or
building blocks. Other variations and embodiments are possible in
light of above teachings, and it is thus intended that the scope of
invention not be limited by this Detailed Description but rather by
claims following.
* * * * *