U.S. patent application number 15/977619 was filed with the patent office on 2018-09-13 for safety features for medical devices requiring assistance and supervision.
This patent application is currently assigned to NxStage Medical, Inc.. The applicant listed for this patent is NxStage Medical, Inc.. Invention is credited to James M. BRUGGER, Jeffrey H. BURBANK, Dennis M. TREU.
Application Number | 20180261323 15/977619 |
Document ID | / |
Family ID | 37968653 |
Filed Date | 2018-09-13 |
United States Patent
Application |
20180261323 |
Kind Code |
A1 |
BURBANK; Jeffrey H. ; et
al. |
September 13, 2018 |
Safety Features for Medical Devices Requiring Assistance and
Supervision
Abstract
An automatic locking system for a medical treatment device helps
to ensure that an assistant is present during treatment of a
patient. Among the features disclosed biometric authentication to
verify that a trained assistant is present, a presence detector to
ensure the assistant is continuously present during treatment, and
warning and recovery processes that allow intermittent lapses in
the continuous presence of the assistant.
Inventors: |
BURBANK; Jeffrey H.;
(Boxford, MA) ; TREU; Dennis M.; (Castle Rock,
CO) ; BRUGGER; James M.; (Newburyport, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NxStage Medical, Inc. |
Lawrence |
MA |
US |
|
|
Assignee: |
NxStage Medical, Inc.
Lawrence
MA
|
Family ID: |
37968653 |
Appl. No.: |
15/977619 |
Filed: |
May 11, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15189532 |
Jun 22, 2016 |
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15977619 |
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14682440 |
Apr 9, 2015 |
9375527 |
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15189532 |
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13618716 |
Sep 14, 2012 |
9024746 |
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14682440 |
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12091728 |
Aug 19, 2008 |
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PCT/US2006/060218 |
Oct 25, 2006 |
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13618716 |
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60596840 |
Oct 25, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 1/14 20130101; G06F
19/328 20130101; G16H 20/00 20180101; G05B 9/02 20130101; G16H
30/40 20180101; G06F 19/00 20130101; G16H 40/63 20180101; A61B
5/117 20130101; A61M 2205/3553 20130101; G08B 21/182 20130101; A61B
5/0077 20130101; G16H 40/67 20180101; A61B 5/746 20130101; A61M
2205/6009 20130101; A61B 5/7475 20130101; A61B 5/0816 20130101;
G05B 1/01 20130101; A61M 2205/18 20130101; A61B 5/015 20130101;
A61M 1/367 20130101; G08B 21/22 20130101; A61M 1/36 20130101 |
International
Class: |
G16H 40/63 20180101
G16H040/63; G08B 21/22 20060101 G08B021/22; G08B 21/18 20060101
G08B021/18; A61B 5/00 20060101 A61B005/00; A61B 5/01 20060101
A61B005/01; A61B 5/08 20060101 A61B005/08; G05B 9/02 20060101
G05B009/02; G05B 1/01 20060101 G05B001/01; A61M 1/36 20060101
A61M001/36; A61M 1/14 20060101 A61M001/14; A61B 5/117 20160101
A61B005/117 |
Claims
1. A medical treatment system, comprising: a medical treatment
device with a controller connected to a network or the Internet and
communicating with information servers and/or remote terminals, the
controller being adapted to obtain instructions from the servers,
to report status, and/or notify of conditions of the medical
treatment device including ones requiring special or immediate
attention and to transmit information and receive commands to/from
the servers and/or remote terminals; the medical treatment device
having a user interface adapted for permitting an operator to
control the medical treatment device treatment functions; the
medical treatment device having storage for storing an internal
representation of a prescription which may be current or
non-current.
2. The system of claim 1, wherein the controller is configured to
report a use of the medical treatment device to a remote supervisor
by means of said Internet or remote terminals.
3. The system of claim 2, wherein the controller is configured to
report to said remote supervisor whether proper or improper,
including whether a prescription has been provided or is
current.
4. The system of claim 1, wherein the controller is configured to
report status of the treatment device including conditions
requiring attention to a remote doctor using said information
servers and/or remote terminals.
5. The system of claim 1, wherein the controller is configured to
report an attempt to authorize a treatment by said medical
treatment device to a remote doctor using said information servers
and/or remote terminals.
6. The system of claim 1, further comprising an authentication
component that authenticates an operator and reports status
information including operations of the medical treatment device to
a remote doctor.
7. The system of claim 1, further comprising a lock that prevents
at least some functions of medical device from being operable
through the controls in response to whether a prescription is
current or non-current.
8. A medical treatment system, comprising: a medical treatment
device with a controller connected to a network or the Internet and
communicating with information servers and/or remote terminals, the
controller being adapted to obtain instructions from the servers,
to report status, and/or notify of conditions of the medical
treatment device including ones requiring special or immediate
attention and to transmit information and receive commands to/from
the servers and/or remote terminals; the medical treatment device
having a user interface adapted for permitting an operator to
control the medical treatment device treatment functions; the
medical treatment device having storage for storing an internal
representation of a prescription.
9. The system of claim 8, wherein the controller is configured to
report a use of the medical treatment device to a remote supervisor
by means of said Internet or remote terminals.
10. The system of claim 9, wherein the controller is configured to
report to said remote supervisor whether proper or improper,
including whether a prescription has been provided or is
current.
11. The system of claim 8, wherein the controller is configured to
report status of the treatment device including conditions
requiring attention to a remote doctor using said information
servers and/or remote terminals.
12. The system of claim 8, wherein the controller is configured to
report an attempt to authorize a treatment by said medical
treatment device to a remote doctor using said information servers
and/or remote terminals.
13. The system of claim 8, further comprising an authentication
component that authenticates an operator and reports status
information including operations of the medical treatment device to
a remote doctor.
14. The system of claim 8, wherein the prescription may be current
or non-current, the system further comprising a lock that prevents
at least some functions of medical device from being operable
through the controls in response to whether a prescription is
current or non-current.
15. The system of claim 1, further comprising a lock that prevents
at least some functions of medical device from being operable
through the controls in response to whether a prescription is
current or non-current.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 15/189,532 filed Jun. 22, 2016, which is a
continuation of U.S. patent application Ser. No. 14/682,440 filed
Apr. 9, 2015, now U.S. Pat. No. 9,375,527 issued Jun. 28, 2016,
which is a continuation of U.S. patent application Ser. No.
13/618,716 filed Sep. 14, 2012, now U.S. Pat. No. 9,024,746 issued
May 5, 2015, which is a continuation of U.S. patent application
Ser. No. 12/091,728 filed Aug. 19, 2008, abandoned, which is a
national stage entry of International Application No.
PCT/US2006/060218 filed Oct. 25, 2006, which claims the benefit of
priority of U.S. Provisional Patent Application No. 60/596,840
filed Oct. 25, 2005, all of which are incorporated herein by
reference in their entireties.
BACKGROUND
[0002] Home treatment can provide tremendous benefits for sufferers
of chronic ailments such as renal failure. But there is potential
for harm in the home setting that is offset in a clinical setting
by the presence of trained staff. If a patient undergoing dialysis,
for example, has a reaction due to unforeseen conditions, the staff
can take immediate action to assist the patient, even if the
patient loses consciousness. In the home, this role may be played
by a trained assistant. The instructions and training associated
with home use may be replete with admonitions against attempting to
perform a treatment without following the requirement that the
assistant be in attendance, but there is always a need for creative
approaches that further help to ensure that such requirements are
fulfilled.
SUMMARY
[0003] A home treatment system includes various devices to limit
the potential for a patient to misuse a home medical treatment
device or its components by limiting access to or use of equipment
while not attended by an assistant or other authorized party.
[0004] According to an embodiment, a method verifies proper use of
a medical device. The method includes authenticating an authorized
person other than a patient to be treated using a device attached
to a treatment device used to treat the patient, generating an
enabling signal to cause the treatment device to become operable in
response to a result of the step of authenticating, verifying at
least one time during a treatment interval that an individual other
than the patient is at a treatment location where the patient and
the treatment device are located, performing a warning procedure
responsively to a result of the step of verifying. The warning
procedure includes generating a signal to indicate an impending
termination of treatment within a specified time. The method
further includes waiting for the individual to verify a presence of
the individual within the specified time and terminating a
treatment of the patient responsively to and after the step of
waiting.
[0005] In a further embodiment, the authenticating includes
machine-recognizing a biometric indicator of identity. The warning
procedure may include displaying requirements for a treatment
procedure, a message requesting the presence of the authorized
person, a message transmission to a remote terminal such as a cell
phone, a remote networked terminal (such as at a medical center),
or a land line telephone. The authenticating may include reading a
magnetic medium storing a data key, a finger, retina, keypad entry,
RFID tag, the receiving of a mechanical key, or any suitable
authentication process.
[0006] In a particular embodiment, the authenticating includes
machine-classification of a video image such as recognizing the
face of an assistant. Video classification is particularly useful
in this context because it allows the treatment scene to be
assessed in a variety of ways. For example, a video scene can be
classified to determine if a person other than the patient remains
with the patient during the treatment. The video system can "watch"
the scene to make sure that if the helper does leave for a period
of time, it is only for a predefined interval. A model of the
treatment scene can be predefined as part of the classification
process. For example, the model may specify that the helper will
prepare a meal at a particular time or that the helper uses the
bathroom with a predefined frequency. Thus, the model may be
identified as storing a "pattern of presences of the helper." The
model can be programmed specifically for this purpose or it can be
acquired passively by observing behavior. By comparing consistency
with the model (or in the case of the passively acquired model,
this amounts to consistency from treatment to treatment) the video
recognition system can determine if the non-presence of a helper is
out of an expected bound. For example, if the model indicates that
the helper should leave approximately at noon for 15 minutes and
the helper leaves for 30 minutes, the system may initiate the
protective features described in this application, such as sounding
an annunciator or displaying a message to try to call back the
helper or, upon failing that, the system may go into a failsafe
mode. A video system even can have the ability to determine if the
helper has fallen asleep by observing posture and movement of the
helper.
[0007] Preferably, the method further includes authenticating an
authorized person at least three times during a treatment interval,
the three times being spaced apart such that the third time is more
than half-way through the treatment interval. Even more preferably,
the system continuously monitors indicia of the presence of the
helper.
[0008] A medical device, comprising: controls for operating the
medical device; a lock that prevents at least some functions of
medical device from being operable through the controls; the lock
granting initial access to the medical when a key is applied to the
lock; a message generator that indicates that the medical device
will go into a failsafe mode unless the lock is applied again at at
least one time during a treatment interval; the lock permitting
continued operation of the in response to the key being applied at
the at least one time; the medical device being configured to go
into the failsafe mode when the key is not applied during the at
least one time.
[0009] The lock may be configured to perform machine-recognition of
a biometric indicator of identity. The device may include a display
and a message generator that displays on the display requirements
for a treatment procedure. The device may also have a communication
device including one of a wireless terminal, a telephone, and a
networked terminal that generates a message indicating the failure
of the key to be applied to the lock at the at least one time. The
key may include a magnetic medium storing a data key. The lock may
include a video camera and a device configured for
machine-classification of a video image from the video camera. The
lock may be a simple structure, for example one that prevent access
by locking an access panel covering the controls.
[0010] Note that here and elsewhere in the specification, the term
"video image" can also refer to a video stream or sequence of
images or a metric derived from it. For example, an activity level
in a scene can be determined from a compression metric such as MPEG
motion compensation vector, or the average total energy in the
motion compensation vector over a period of time. This would also
fall under the meaning of "video image."
[0011] According to another embodiment, a medical device, has a
medical treatment component and a monitoring system configured to
receive data from sensors to confirm the presence of a helper. The
helper is different from a patient receiving treatment by the
medical treatment component. The monitoring system is configured to
confirm a pattern of presences of the helper during a treatment
period in which the medical treatment component is operative to
deliver therapy to a patient. The monitoring system generates a
signal indicative of an abnormal condition when the pattern of
presences of the helper is not confirmed.
[0012] The monitoring system can include a video camera and a video
classification engine that monitors a scene that includes a patient
and a helper. In this embodiment, the monitoring system may
initially authenticate the helper using any of a variety of known
techniques, such as fingerprint identification. This process may
also include machine-classification of a video image such as
recognizing the face of the helper. Video classification is
particularly useful in this context because it allows the treatment
scene to be assessed in a variety of ways and continually
monitored. For example, a video scene can be classified to
determine if a person other than the patient remains with the
patient during the treatment. The video system can "watch"' the
scene to make sure that if the helper does leave for a period of
time, it is only for a predefined interval. A model of the
treatment scene can be predefined as part of the classification
process. For example, the model may specify that the helper will
prepare a meal at a particular time or that the helper uses the
bathroom with a predefined frequency. Thus, the model may be
identified as storing a "pattern of presences of the helper." The
model can be programmed specifically for this purpose or it can be
acquired passively by observing behavior. By comparing consistency
with the model (or in the case of the passively acquired model this
amounts to consistency from treatment to treatment) the video
recognition system can determine if the non-presence of a helper is
out of an expected bound. For example, if the model indicates that
the helper should leave approximately at noon for 15 minutes and
the helper leaves tor 30 minutes, the system may initiate the
protective features described in this application, such as sounding
an annunciator or displaying a message to try to call back the
helper or, upon failing that, the system may go into a failsafe
mode. A video system even can have the ability to determine if the
helper has fallen asleep by observing posture and movement of the
helper.
[0013] The sensors in this embodiment, instead of being a video
camera (or in addition to a video camera and recognition engine)
can also include components that are much simpler such as a
pressure sensor in a chair or a proximity sensor which responds to
the presence of the helper near or on the sensor. The sensor may be
a keypad the prompts the helper to enter a code that indicates that
helper is present and there are no problems with the treatment. The
ability of the keypad entry to be made confirms the helper is
available. Preferably, the helper would know the keycode for entry
into the keypad but the patient would not. In this way the presence
of the helper can be confirmed quite simply.
[0014] The authentication device or the presence indicator or
sensor may include at least one of a key code receiver, an RFID
reader, a mechanical lock, a biometric reader, a mag stripe reader,
a non-volatile memory card reader, a smart card reader, a video
camera, or a bar code reader. The monitoring system may go into a
failsafe mode in response to the abnormal condition signal. The
monitoring system may cause the medical treatment component to go
into a failsafe mode in response to the abnormal condition signal.
The monitoring system can generate an alert signal in response to
the abnormal condition signal. It may wait for the reception of an
alert-cancel command after generating the alert signal in which
case it would reset and continue normal treatment operation of the
medical treatment component. But if the alert-cancel command was
not received, the monitoring system would cause the medical
treatment component to go into a failsafe mode.
[0015] The failsafe mode of the present and other embodiments may
include clamping blood lines and/or sending remote alerts such as a
phone call to an ambulance service or 24 hour medical treatment
facility. It may include the slowing of the blood pumping rate. The
failsafe mode may be any operational mode that reduces the risk to
the patient for any of the problems that can arise in a treatment.
In a preferred embodiment, the features described in the present
patent specification are applied to a renal replacement therapy
system and/or a extracorporeal blood treatment.
BRIEF DESCRIPTION OF THE FIGURES
[0016] FIG. 1A is an illustration of an interface environment that
supports various inventive embodiments.
[0017] FIG. 1B illustrates an embodiment of a locking cabinet used
to store components used for treatment.
[0018] FIG. 2 is a flow chart illustrating a use case including
human behavioral and state machine state changes.
[0019] FIG. 3 is a flow chart illustrating an embodiment for
controlling access or use of equipment or components for home
medical treatment.
[0020] FIG. 4 is a flow chart illustrating a further embodiment for
controlling access or use of equipment or components for home
medical treatment.
[0021] FIG. 5 is a flow chart illustrating a further embodiment for
controlling access or use of equipment or components for home
medical treatment.
[0022] FIG. 6 is a flowchart illustrating a further embodiment for
controlling access or use of equipment or components for home
medical treatment.
DETAILED DESCRIPTION OF THE FIGURES
[0023] Referring to FIG. 1A, a medical device 10 may have a
controller 2 that controls the functions of the medical device 10.
Examples of medical device 10 include renal replacement therapy,
infusion pumps and associated systems; medical monitoring
equipment, medicating systems, exercise equipment, physical therapy
equipment, pulmonary treatment devices such as for chronic
obstructive pulmonary disease, oxygen delivery systems, cardiac
treatment or monitoring devices, and many others that may be
evident to those of ordinary skill based on the current
disclosure.
[0024] The medical device 10 may have a movable or stationary
locking or lockable part 40 that is susceptible to locking or
effects a locked and/or unlocked state. For example, it may be a
part that is locked or a device, such as an actuator, that actually
effects locking. Examples include solenoids, simple mechanical
locks, software state machines with locked states through which
operational flow is blocked, and other equivalent devices.
[0025] The controller 2 may implement a locking function or the
entire medical device 10 may be susceptible to locking. Examples of
a lockable part 30 include an access panel, hatch, door or other
mechanical security component or mechanical interface such as a
slot for receiving consumable components; a component controller,
power supply, or a crucial component such as a pump or other prime
mover; a user interface or component interface. The lockable part
40 may or may not be physically attached to the medical device 10.
Its operative relationship with the medical device 10 and other
elements, however, will become clearer from the greater
disclosure.
[0026] The Medical device 10 may have one or more of a variety of
communications and input and output elements, including:
[0027] A wireless terminal 70 to communicate with remote wireless
terminals 75 such as cell phones, email devices, telemetry systems,
wireless computer terminals, and similar devices. The medical
device 10 may, for example, transmit information and receive
commands via such devices.
[0028] An imaging device 35 such as a charge coupled device (CCD)
video camera, laser scanner such as an industrial photometric
scanner, an infrared camera, terahertz wave (T-wave) shortwave,
acoustic, or other kind of imaging device. The medical device 10
may employ video image processing and recognition techniques to
identify faces, determine the number of individuals present in a
room, patient body surface temperature profile, or myriad other
functions using the one or more imaging devices represented by
imaging device 35.
[0029] A wired terminal 85 such as a plain old telephone (POT),
annunciator such as an audible or visual alarm, intercom, or
similar device. The medical device 10 may employ the wired terminal
85 to notify local or remote personnel of status or change of
status at a treatment site. For example, the device 10 may place an
automatic phone call to emergency medical personnel if predefined
conditions ate detected. The medical device 10 may also report
attempts to authorize a treatment (see further below for discussion
of this) or an attempt to use the medical device 10 to an
authorized party with supervisory obligations.
[0030] The treatment device 10 (or a component thereof) may be
connected to a network or the Internet 54 to communicate with
information servers 55 and/or remote terminals 80. The medical
device may use this capability to obtain instructions from the
server 56, to report status or notify of conditions requiring
special or immediate attention, and similar transactions. The
medical device 10 may also use such communication modes to report
attempts to authorize a treatment (see further below for discussion
of this) or an attempt to use the medical device 10 to an
authorized party with supervisory obligations.
[0031] A direct input/output (I/O) interface 15 such as a keyboard,
keypad, speech interface, digital display, touchscreen, touchpad,
or other I/O device and mechanical interface such as levers,
buttons, knobs, etc. One or more such devices may be used to allow
users or others to command and control the medical device 10 and/or
the controller 2.
[0032] A connector 25 such as a port (e.g., USB port), mechanical
keyhole, smart card reader, bar-code reader, mag-stripe reader,
RFID reader, biometric sensor, handwriting recognition interface,
or other interface device, which may be used for authorizing and/or
authenticating a user and/or assistant.
[0033] A key or identification indicator represented figuratively
at 20. These may include a human finger (fingerprint), retina,
face, or other biometric indicator; an electronic key such as a
magnetic stripe, radio frequency identification device (RFID) unit,
nonvolatile memory (NV memory), bar code or other data carrier;
mechanical key; or any device used in a remote or local
authorization or authentication process. Another example is a key
fob with a password or digital key embedded in a memory and a USB
connector on it.
[0034] The above examples are by no means intended as an exhaustive
list and are considered to encompass their equivalents and
additional examples within the identified categories.
[0035] In an alternative embodiment, shown in FIG. 1B, a locker 55
is provided to contain components that are used with the medical
device 50 such that their inaccessibility reduces the ability of
someone without access to the locker 55 to harm himself or another.
Cloud 70 is intended to represent any or more of the input and
output elements discussed and illustrated with reference to FIG.
1A. An example of the use of the locker would be as a store to hold
consumables such as needle accesses or disposable blood circuits
without which the medical device 50 could not be employed. The
embodiment of FIG. 1B has the additional benefit of mitigating any
risks from harm from the locked-up components themselves with or
without the medical device 50. In the embodiment of FIG. 1B, the
locker 55 may include substantially the same I/O Interface and/or
connector 25 as discussed with reference to FIG. 1A.
[0036] Referring now to FIG. 2. the medical device 10, 50, &/or
associated component(s) such as locker 55, indicated collectively
at M, may be equipped as illustrated in the previous figures to
perform the functions (use cases) indicated in FIG. 2. In
embodiments, there are three individuals who may be involved: a
patient 1; an assistant who is trained to monitor and also,
possibly assist the patient 1 in using the medical device or
associated component(s) M; and a supervisor, such as a medical
doctor who has some responsibility with regard to the use of the
medical device &/or associated component(s) M. The assistant 2
may be trained to provide emergency treatment or help in the set up
of the equipment. In the ease of renal replacement therapy or
chemotherapy, there may be a potential for serious adverse
reactions including loss of consciousness. In embodiments, the
assistant 2 would be present at a site where the medical device 10,
50 is used. The supervisor 3 may be charged with ensuring that a
strict protocol is followed, such as a doctor, or may just be a
second assistant. The supervisor may be at the site or remote from
it.
[0037] A function A may be to prevent access by the patient 1
without the assistant 2 being present. In embodiments, the
assistant 2 carries a key or, inherently, a biometric identifier
such as his/her face. If the assistant 2 is not present, the
medical device &/or associated component(s) M may be equipped,
as discussed above, to deny access to the medical device &/or
associated component(s) M. This prevents the patient 1 from using
the medical device &/or associated component(s) M without
assistance.
[0038] Another function B may be to check external conditions such
as a time of day when use of the medical device &/or associated
component(s) M is permitted or scheduled. This may provide an
additional layer of protection against misuse. The medical device
&/or associated component(s) M may check the external
conditions, such as time of day, whether the assistant's training
is current or expired, whether a prescription has been provided, or
other separate criterion beyond the presence of the assistant. The
presence of the assistance may be verified by another function C
which is an authentication function. In the latter, the assistant
may present his/her key or other indicia of identity and presence
to unlock the medical device &/or associated component(s) M for
use.
[0039] Another function D is to permit access to the medical device
&/or associated component(s) M and, depending on the
embodiment, including receiving and executing commands for control
and setup as well as administering treatment or other service.
Another function E is to provide services by the medical device
&/or associated component(s) M.
[0040] Any improper use or proper attempt, to use the medical
device &/or associated component(s) M may be reported by a
function F to supervisor 3. For example, if the medical device
&/or associated component(s) M detects a failure of
authentication, it may report the event to the supervisor 3. The
medical device &/or associated component(s) M may report every
attempt, whether proper or improper, to the supervisor 3, and may
also report to the assistant 2. In the latter case, if an
authentication function C is executed without the assistant 2 being
present, the assistant 2 may be notified by a communication to a
remote terminal such as a cell phone. The latter situation could
arise if the assistant 2 lost his/her key.
[0041] Note that the above use cases are not comprehensive nor is
each function essential. Some benefits may be provided by a
mechanically-locking cabinet configured to house the medical device
&/or associated component(s) M, where the key is retained by
the assistant. Another simple alternative for the medical device is
for it to have a locking component.
[0042] Referring now to FIG. 3, in a process that may be
implemented by an attached controller (including controller 2)
medical device 10 (50 or locker 55) may be disabled or rendered
inaccessible respectively at step S10. Step 10 may represent a
default condition. The disabling of the medical device may be
provided through locking or lockable part 40. In step S15 an unlock
event is detected, such as the entry of an authorization procedure
implemented through a programmable processor in controller 2 or an
attempt to connect smart card or memory device (embodiments of
key/ID indicator 20). Here a user may be attempting to use the
medical device 10 or 50 or access locker 55. If there is no unlock
event at S15, then control returns to step S10. If there is, then
an authorization process is performed at step S20. The
authorization process may include verifying biometric indicia of
identify, reading a smart card or other device including any of the
devices identified with key/ID indicator 20.
[0043] Physically, what's going on so far in the process of FIG. 3
is that someone is attempting to gain access to the locker 55 or
the medical device 10 or 50 to use it or obtain contents. In a
preferred embodiment, the medical device or locker 10/50/55 is
located at a patient's home and an assistant keeps the key/ID
indicator 20 with him or her such that the patient cannot gain such
access by him or herself. When the assistant or other authorized
party is present, the assistant may complete the authorization
process S20 and generate a valid condition (yes) at step S25.
[0044] In step S25, the validation process may verify that the key
or identification indicia are present. This provide evidence that
the assistant or authorized party is present such that access may
be provided (to medical device 10, 50 or locker 55) in step S30. If
a valid authorization is not completed in step S25, a failure
action may be taken such as the display of a message on the user
interface of the medical device or locker 10/50/55 or an output on
any of the other I/O devices shown in FIGS. 1 and 2, such as a
wireless message to a remote supervising party. The process may
loop through step S35 until a treatment or other medical operation
is performed, as appropriate, permitting the medical device 10/50
to returned to the default state S10. The latter step will loop
through step S15 until an attempt is made to access supplies or
equipment.
[0045] Step S20 may include using any type of key/ID indicator 20
or any action using I/O interface 15. For example, a username
and/or password may be entered using the I/O interface 15 or a
mechanical key may be used to unlock the lockable part 40, Also,
step S30 may include enhancing services that are available through
the medical device &/or associated component(s) M rather than
simply enabling or disabling access. Step S40 may provide for
remote notification such as an automated email or cell phone
message. It may also include permanent logging of failures to
authorize access.
[0046] Referring now to FIG. 4, two steps may be added to the
procedure of FIG. 3 to check for the maintenance of a predefined
status. For example, the predefined status may be that the
assistant must remain, at least between intervals, present at the
use location of the medical device &/or associated component(s)
M. At step S50, it is determined if the status is not being
maintained. If it is being maintained, control loops through step
S50 until it is not. Then a correction procedure may be implemented
at step S55 and if the status is recovered, control returns to step
S50. If not, the medical device &/or associated component(s) M
may be disabled or ameliorative response may be generated or
automatically requested (not shown as a separate step) by the
medical device &/or associated component(s) M.
[0047] Step S50 may correspond to one or more of the following,
which are shown to provide illustrative examples and not to limit
the embodiments in any way:
[0048] Prompting at predefined intervals through I/O interface 15
for confirmation of identity and presence of the assistant 2 by
entering a password or voice command (with voice biometric
identification).
[0049] Prompting at predefined intervals through I/O interface 15
for confirmation of identity and presence of assistant 2 by
connecting a key/ID indicator 20.
[0050] Classifying a scene taken in by imaging device 35 to
determine if the assistant 2 is still present, taking appropriate
actions. Support for known techniques for this and other video
classification concepts are shown in U.S. Pat. No. 6,611,206 for
"Automatic system for monitoring independent person requiring
occasional assistance;" U.S. Pat. No. 7,028,269 for "Multi-modal
video target acquisition and re-direction system and method;" U.S.
Pat. No. 6,931,596 for "Automatic positioning of display depending
upon the viewer's location;" U.S. Pat. No. 6,925,197 for "Method
and system for name-face/voice-role association;" U.S. Pat. No.
6,778,705 for "Classification of objects through model ensembles;"
U.S. Pat. No. 6,714,594 for "Video content detection method and
system leveraging data-compression constructs;" U.S. Pat. No.
5,561,718 for "Classifying faces;" U.S. Pat. No. 7,110,569 for
"Video based detection of fall-down and other events; " U.S. Pat.
No. 7,110,570 for "Application of human facial features recognition
to automobile security and convenience;" US Application Publication
Nos. 20060210112 for "Behavior recognition system;" 20060210958 for
"Gesture training;" 20060204050 for "Face authenticating apparatus
and entrance and exit management apparatus;" 20030128126 for
"Method and apparatus for error warning with multiple alarm levels
and types" and 20030128125 for "Method and apparatus for machine
error detection by combining multiple sensor inputs" all of which
are hereby incorporated by reference as if fully set forth in its
entirety herein. (Note: The latter two applications describe
mechanisms for observing a patient for safety reasons and
illustrate a context in which video is captured of a treatment
scene. This context is similar to what is described presently in
the context of confirming the presence of the patient's helper.
That is, these applications illustrate how a camera may be
positioned to acquire the scene including a patient and a helper.
They also illustrate response mechanism that may be used with the
present embodiments.)
[0051] Classifying a scene taken in by imaging device 35 to
determine the status of the patient, for example, if the patient's
body temperature profile has changed to a predetermined pattern
indicating imminent loss of consciousness, lack of blood flow or a
pathological condition such as rapid or slow breathing. Support for
known techniques for this may also be found in the above
reference.
[0052] Step S55 may correspond to one or more of the following,
which are shown to provide illustrative examples and not to limit
the embodiments in any way:
[0053] Generating a wireless message or automated cell phone call
to the assistant 2.
[0054] Generating a wireless message or automated cell phone call
to the supervisor 3.
[0055] Generating an alarm.
[0056] Changing the operational regime of the medical device 10, 50
to a safe mode.
[0057] Note that step S60 may include returning the medical device
10, 50 to a normal operating mode. If the operating mode is
changed, or performing a function to disable an alarm or respond to
a message.
[0058] Referring now to FIG. 5, a step S120 is added to the flow of
FIG. 3 for verifying some external condition in addition to the
authentication process. This may be for example, checking that the
current time and date are correct for use of the medical device
&/or associated component(s) M. It may include checking an
internally stored prescription for currency. It may include
checking the status of the training or training level of the
assistant. The latter may include checking a database stored on the
server 56 which stores the assistant's identification in relation
to training level and comparing to a predefined protocol also
stored on the server 56.
[0059] Referring to FIG. 6, a step S150 may be added which includes
generating a notification, such as by cell phone, email, instant
message, SMS message, POT call, or other means to notify the
assistant that his or her key is being used to authenticate in step
S20. For example, if the assistant lost his/her key, the
notification would provide the assistant the ability to take some
action if the assistant were not actually present. Step S125 may
include waiting for an additional time for an action to be taken in
response to the step of S150.
[0060] Although the present invention has been described herein
with reference to a specific preferred embodiment, many
modifications and variations therein will be readily occurring to
those skilled in the art. Accordingly, all such variations and
modifications are included within the intended scope of the present
invention as defined by the following claims.
* * * * *