U.S. patent application number 13/920115 was filed with the patent office on 2013-10-24 for controlled protocol timer.
The applicant listed for this patent is National Biological Corporation. Invention is credited to Steven Hendrix, Michael Kaufman, Kenneth Oif.
Application Number | 20130282080 13/920115 |
Document ID | / |
Family ID | 39402484 |
Filed Date | 2013-10-24 |
United States Patent
Application |
20130282080 |
Kind Code |
A1 |
Hendrix; Steven ; et
al. |
October 24, 2013 |
CONTROLLED PROTOCOL TIMER
Abstract
A phototherapy treatment dispensing device provides therapeutic
light emissions treatments. The device provides additional means
for controlling a patient's exposure to those treatments through a
controlled protocol timer. The controlled protocol timer can
provide for incremental exposure increases; monitors patient
compliance with a treatment regimen; and reminds the patient when a
treatment will soon be overdue.
Inventors: |
Hendrix; Steven; (Sagamore
Hills, OH) ; Oif; Kenneth; (Beachwood, OH) ;
Kaufman; Michael; (Beachwood, OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
National Biological Corporation |
Beachwood |
OH |
US |
|
|
Family ID: |
39402484 |
Appl. No.: |
13/920115 |
Filed: |
June 18, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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11940852 |
Nov 15, 2007 |
8486124 |
|
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13920115 |
|
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|
60859363 |
Nov 15, 2006 |
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Current U.S.
Class: |
607/88 |
Current CPC
Class: |
A61N 5/0616 20130101;
A61N 2005/0661 20130101; A61N 2005/064 20130101 |
Class at
Publication: |
607/88 |
International
Class: |
A61N 5/06 20060101
A61N005/06 |
Claims
1. A light treatment dispensing device, comprising: a therapeutic
treatment dispenser configured to emit therapeutic treatments; an
input device; and a controller in electrical communication with the
therapeutic treatment dispenser and the input device, the
controller configured to determine a prescribed therapeutic
treatment protocol based on a coded input received via the input
device, wherein the prescribed treatment protocol comprises a
plurality of treatment control parameters.
2. The light treatment dispensing device of claim 1, wherein the
plurality of treatment control parameters comprise: a prescribed
number of sessions, and one or more of a prescribed session
frequency and a prescribed duration for each session.
3. The light treatment dispensing device of claim 2, wherein the
plurality of treatment control parameters further comprise a
prescribed number of therapeutic treatments per session.
4. The light treatment dispensing device of claim 2, wherein the
prescribed session frequency identifies a number of the prescribed
number of sessions dispensable per a designated time period.
5. The light treatment dispensing device of claim 2, wherein the
prescribed session frequency identifies a designated time period
between consecutive sessions.
6. The light treatment dispensing device of claim 2, wherein the
controller is configured to determine a permitted adjustment to one
of more of the plurality of treatment control parameters.
7. The light treatment dispensing device of claim 6, wherein the
permitted adjustment is a percentage of the prescribed duration
that can be added to the determined prescribed duration.
8. The light treatment dispensing device of claim 6, wherein the
permitted adjustment is an amount of time that can be added to the
prescribed duration.
9. The light treatment dispensing device of claim 1, wherein the
controller is configured to operate the therapeutic treatment
dispenser in accordance with the prescribed therapeutic treatment
protocol.
10. The light treatment dispensing device of claim 9, wherein the
controller is configured to store operational information.
11. The light treatment dispensing device of claim 10, comprising a
removable memory medium for storing the operational
information.
12. The light treatment dispensing device of claim 1, wherein the
input device comprises one of more of a keyboard and a
touchscreen.
13. The light treatment dispensing device of claim 1, wherein the
therapeutic treatment dispenser comprises one or more ultraviolet
ray-emitting tubes.
14. A method for controlling the exposure of a patient using a
phototherapy treatment dispensing device, comprising: receiving a
coded input via an input device; determining, by a controller, a
prescribed treatment protocol based on the coded input, the
prescribed treatment protocol comprising a plurality of treatment
control parameters, wherein the plurality of treatment control
parameters comprises a prescribed number of phototherapy sessions,
and one or more of a prescribed session frequency and a prescribed
duration for each session; and dispensing a phototherapy session in
accordance with the plurality of treatment control parameters.
15. The method of claim 14, comprising: adjusting at least one of
the plurality of treatment control parameters.
16. The method of claim 15, wherein the adjustment is an increment
of the prescribed duration for each session.
17. The method of claim 16, comprising: limiting, by the
controller, the increment based on a duration of one or more
previous phototherapy sessions.
18. A light treatment dispensing device, comprising: a therapeutic
treatment dispenser configured to emit therapeutic treatments; and
a controller in electrical communication with the therapeutic
treatment dispenser, the controller configured to receive a coded
input and, based on the coded input, determine a plurality of
treatment control parameters.
19. The light treatment dispensing device of claim 18, wherein the
plurality of treatment control parameters comprises a prescribed
number of sessions, and one or more of a prescribed session
frequency and a prescribed duration for each session.
20. The light treatment dispensing device of claim 19, wherein the
controller is configured to determine a permitted adjustment to one
of more of the plurality of treatment control parameters.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation patent application of
U.S. application Ser. No. 11/940,852, filed on Nov. 15, 2007,
entitled "Controlled Protocol Timer", which claims the benefit of
U.S. provisional patent application Ser. No. 60/859,363, filed on
Nov. 15, 2006, entitled "Controlled Protocol Timer," the
disclosures of which are both hereby incorporated by reference
herein in their entirety.
BACKGROUND
[0002] The present disclosure relates generally to controls for
phototherapeutic devices useful for ultraviolet light phototherapy.
Methods of making and using such controls and/or devices are also
disclosed.
[0003] Phototherapy relates to the treatment of disease, such as
skin conditions including psoriasis, acne, eczema, vitiligo, and
mycosis fungoides, by exposure to light, especially by various
concentrated light rays such as long-wave or short-wave ultraviolet
light. The treatment may be alone or in combination with a
sensitizer which sensitizes the skin to light.
[0004] In particular, ultraviolet light ("UV light," radiation in
the region of the electromagnetic spectrum including wavelengths
from 100 to 4000 angstroms) has been used for over 30 years in a
clinical setting for treating severe skin diseases, such as
psoriasis and vitiligo. The treatment regimen is called
phototherapy.
[0005] In a clinical setting, a physician, nurse or phototherapy
technician is responsible for ensuring that a patient receives the
correct treatment protocol. The protocol comprises a series of
light exposure sessions including the duration of exposure for each
session and the frequency of sessions (i.e, the interval between
sessions).
[0006] In the 1990s, National Biological Corporation of Twinsburg,
Ohio began offering a home-based phototherapy medical device that
was approved by the Food and Drug Administration for sale in the
United States. One concern of such a device was that unsupervised
usage of the device by patients to administer ultraviolet light
sessions could result in patients burning themselves. This concern
was ameliorated by the provision of a prescription-controlled
timing device, known as a controlled prescription timer, in
phototherapy medical devices offered under the brand name PANOSOL
II.
[0007] In the PANOSOL II, the controlled prescription timer was
preprogrammed with a fixed number of sessions for the patient. When
the fixed number of sessions was exhausted, the patient could
obtain additional sessions by contacting their physician. The
physician would authorize the additional sessions by providing a
code number that the patient would enter into the keypad of their
home phototherapy device. For additional information, see U.S. Pat.
Nos. 5,604,619 and 6,345,215, the entire contents of both patents
being fully incorporated herein by reference. National Biological
Corporation has sold over 15,000 home phototherapy devices in the
10-year period up to 2006.
[0008] However, more people could benefit from home-based
ultraviolet light phototherapy. For example, an estimated 2-3% of
the population has a severe version of the skin disease psoriasis.
Psoriasis is a common skin disease characterized by thickened
patches of inflamed, red skin, often covered by silvery scales. The
exact cause of psoriasis is not known. It affects men and women
relatively equally. The underlying abnormality in psoriasis is that
new skin cells are produced much faster than normal, but the rate
at which cells are shed remains unchanged. Consequently, the live
cells build up and form thickened patches covered with dead, flaky
skin.
[0009] Phototherapy is generally considered the safest, most
effective, and least expensive option for sufferers of severe
psoriasis. With the US population approaching 300 million, 9
million potential patients could benefit from a home phototherapy
device.
[0010] Some prescribing dermatologists have embraced the control
offered by the controlled prescription timer and prescribed home
phototherapy. However, a controller that provides additional
control over patients' usage of the phototherapy device is
beneficial.
[0011] Accordingly, there is a need for devices that provide
additional control over patients' usage of a home-based
phototherapy device.
BRIEF DESCRIPTION
[0012] Disclosed herein, in various exemplary embodiments, are
treatment dispensing devices that include additional means for
controlling usage of the device. The device provides a controlled
protocol timer that embodies the instructions for using the device.
The controlled protocol timer can provide for incremental exposure
increases; monitors patient compliance with a treatment regimen;
and reminds the patient when a treatment will soon be overdue.
Methods and processes of making and using such devices are also
disclosed. The controlled protocol timer is especially useful in
medical devices.
[0013] In embodiments, a light treatment dispensing device
comprises: a generator including a light emission device for
emitting a therapeutic light emissions treatment; and a controller
configured to control the generator, the controller including: (A)
an engine that contains a prescribed protocol, each protocol
comprising (i) a prescribed number of sessions, (ii) a prescribed
session frequency, (iii) a prescribed number of treatments per
session, and (iv) a prescribed duration for each treatment; (B) a
treatment limiter configured to limit a number of therapeutic light
emissions treatments according to the prescribed number of sessions
and the prescribed number of treatments per session of the
protocol; (C) a frequency limiter configured to limit a frequency
at which therapeutic light emissions treatments are dispensed
according to the prescribed session frequency of the protocol; (D)
a duration limiter configured to limit a duration of a particular
treatment to the prescribed duration for the particular treatment
according to the protocol; (E) a timer configured to time a total
actual duration of therapeutic light emissions treatments in a
first period of time; and (F) a calculator for calculating a
permitted increase in a total duration of therapeutic light
emissions treatments in a second period of time based on the total
actual duration of therapeutic light emissions treatments in the
first period of time.
[0014] The controller may further include an input means for
entering a passcode corresponding to a desired prescription,
wherein the engine is configured to convert the passcode to the
prescribed protocol.
[0015] The permitted increase may be based on a percentage of the
total actual duration of therapeutic light emissions treatments in
the first period of time.
[0016] The first and second periods of time may bother be from 2
hours to 96 hours.
[0017] The timer may further time an actual duration and a
beginning time of a therapeutic light emissions treatment; and the
device may further comprise a recorder for recording the beginning
time and the actual duration of the therapeutic light emissions
treatment. The device can also include a transmitter for
transmitting the recorded beginning time and actual duration of the
therapeutic light emissions treatment to a third party.
[0018] The device may further comprise: a comparator for comparing
(i) an elapsed time beginning after the end of a particular session
and (ii) the prescribed session frequency; and an alarm for
generating an alert when the elapsed time differs from the
prescribed session frequency by a specified amount.
[0019] In other embodiments, a light treatment dispensing device
comprises: a generator including a light emission device for
emitting a therapeutic light emissions treatment; and a controller
configured to control the generator, the controller including: (A)
an engine that contains a prescribed protocol, each protocol
comprising (i) a prescribed number of sessions, (ii) a prescribed
session frequency, (iii) a prescribed number of treatments per
session, and (iv) a prescribed duration for each treatment; (B) a
limiter configured to limit (i) a number of therapeutic light
emissions treatments according to the prescribed number of sessions
and the prescribed number of treatments per session of the
protocol, (ii) a frequency at which therapeutic light emissions
treatments are dispensed according to the prescribed session
frequency of the protocol, and (iii) a duration of a particular
treatment to the prescribed duration for the particular treatment
according to the protocol; (C) a timer configured to time a total
actual duration of therapeutic light emissions treatments in a
first period of time; and (D) a calculator for calculating a
permitted decrease in a session frequency based on the total actual
duration of therapeutic light emissions treatments in the first
period of time.
[0020] The controller may further include an input means for
entering a passcode corresponding to a desired treatment schedule,
wherein the engine is configured to convert the passcode to the
prescribed protocol.
[0021] In still other embodiments, a phototherapy treatment
dispensing device comprises: a generator for generating a
therapeutic light emissions treatment; a controller configured to
control the generator, the controller including: (A) an engine that
contains a prescribed protocol, each protocol comprising (i) a
prescribed number of sessions, (ii) a prescribed session frequency,
(iii) a prescribed number of treatments per session, and (iv) a
prescribed duration for each treatment; (B) a treatment limiter
configured to limit a number of therapeutic light emissions
treatments according to the prescribed number of sessions and the
prescribed number of treatments per session of the protocol; (C) a
frequency limiter configured to limit a frequency at which
therapeutic light emissions treatments are dispensed according to
the prescribed session frequency of the protocol; (D) a duration
limiter configured to limit a duration of a particular treatment to
the prescribed duration for the particular treatment according to
the protocol; and (E) a timer for timing an actual duration of the
therapeutic light emissions treatment and a beginning time of the
therapeutic light emissions treatment; a recorder for recording the
beginning time and the actual duration of the therapeutic light
emissions treatment; and a transmitter for transmitting the
recorded beginning time and actual duration of the therapeutic
light emissions treatment to a third party.
[0022] The controller may further include an input means for
entering a passcode corresponding to a desired treatment schedule,
wherein the engine is configured to convert the passcode to the
prescribed protocol.
[0023] The transmitter may be selected from the group consisting of
a removable medium, a wired connection, a wireless connection
utilizing a sound, ultrasound, radio, microwave, infrared, or
optical transmission medium, or a human-readable display that
requires an authentication code.
[0024] The timer may further time a total actual duration of
therapeutic light emissions treatments in a first period of time;
and the device may further comprise a calculator for calculating a
permitted increase in the total duration of therapeutic light
emissions treatments in a second period of time based on the total
actual duration of therapeutic light emissions treatments in the
first period of time.
[0025] The device may further comprise: a comparator for comparing
(i) an elapsed time beginning after the end of a particular session
and (ii) the prescribed session frequency; and an alarm for
generating an alert when the elapsed time differs from the
prescribed session frequency by a specified amount.
[0026] In yet other embodiments, a phototherapy treatment
dispensing device for providing a therapeutic radiation treatment
is disclosed, the device including a controller configured to
perform a method comprising: providing a prescribed protocol, the
protocol comprising (i) a prescribed number of sessions, (ii) a
prescribed session frequency, (iii) a prescribed number of
treatments per session, and (iv) a prescribed duration for each
treatment; timing an elapsed time beginning after the end of a
particular session; comparing the elapsed time to the prescribed
session frequency; and generating an alert when the elapsed time
differs from the prescribed session frequency by a specified
amount.
[0027] The specified amount may be a percentage of the prescribed
session frequency.
[0028] In other embodiments, a treatment dispensing device
comprises a treatment dispenser and a controller, the controller
including: (A) an engine that contains a prescribed protocol, each
protocol comprising (i) a prescribed number of sessions, (ii) a
prescribed session frequency, (iii) a prescribed number of
treatments per session, and (iv) a prescribed duration for each
treatment; (B) a treatment limiter configured to limit a number of
dispensed treatments according to the prescribed number of sessions
and the prescribed number of treatments per session of the
protocol; (C) a frequency limiter configured to limit a frequency
at which treatments are dispensed according to the prescribed
session frequency of the protocol; and (D) a duration limiter
configured to limit a duration of a particular treatment to the
prescribed duration for the particular treatment according to the
protocol.
[0029] The controller may further include an input means for
entering a passcode corresponding to a desired treatment schedule,
wherein the engine is configured to convert the passcode to the
prescribed protocol.
[0030] A method for controlling the exposure of a patient using a
light treatment dispensing device is also disclosed, comprising:
providing a light treatment device capable of producing a
therapeutic light emissions treatment and containing a prescribed
protocol, each protocol comprising (i) a prescribed number of
sessions, (ii) a prescribed session frequency, (iii) a prescribed
number of treatments per session, and (iv) a prescribed duration
for each treatment; producing a therapeutic light emissions
treatment; recording a beginning time and an actual duration of the
therapeutic light emissions treatment; and transmitting the
recorded beginning time and actual duration of the therapeutic
light emissions treatment to a third party.
[0031] In some embodiments, multiple therapeutic light emissions
treatments are produced; the beginning time and actual duration of
each treatment is recorded, and the recorded beginning time and
actual duration of the multiple treatments are simultaneously
transmitted to the third party.
[0032] Another method for controlling the exposure of a patient
using a phototherapy treatment dispensing device comprises:
providing a phototherapy treatment device capable of (A) producing
a therapeutic light emissions treatment and (B) containing a
prescribed protocol, each protocol comprising a first session, a
second session, and a session interval; comparing (i) an elapsed
time beginning after the end of the first session and (ii) the
session interval; and generating an alarm when the elapsed time
differs from the session interval by a specified amount.
[0033] Other methods for controlling the usage of a treatment
dispensing device, comprise: entering a passcode corresponding to a
particular profile; providing a treatment device capable of
dispensing a treatment and generating a prescribed protocol from
the passcode, each protocol comprising (i) a prescribed number of
sessions, (ii) a prescribed session frequency, and (iii) a
prescribed duration for each session; limiting the number of
sessions to the prescribed number of sessions of the protocol;
limiting the frequency between successive sessions to the
prescribed session frequency of the protocol; and limiting the
duration of a particular session to the prescribed duration for the
particular session according to the protocol.
[0034] The method may further comprise: measuring a total actual
duration of treatments dispensed in a first period of time; and
determining a permitted increase in a total duration of treatments
allowed in a second period of time based on the total actual
duration of treatments dispensed in the first period of time.
[0035] Alternatively, the method may further comprise: recording a
beginning time and an actual duration of each treatment; and
transmitting the recorded beginning time and actual duration of
each treatment to a third party.
[0036] Other methods may further comprise: recording the ending
time of a treatment and an elapsed time since the ending time; and
generating an alarm when the elapsed time differs from the
prescribed session frequency of the protocol.
[0037] These and other non-limiting aspects and/or objects of the
development are more particularly disclosed below.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] The following is a brief description of the drawings, which
are presented for the purposes of illustrating the development
disclosed herein and not for the purposes of limiting the same.
[0039] FIG. 1 is a perspective view of one embodiments of a
phototherapy treatment dispensing device of the present
disclosure.
[0040] FIG. 2 is a block diagram of one embodiment of a treatment
dispensing device of the resent disclosure that dispenses
treatments according to a prescribed protocol.
[0041] FIG. 3 is a block diagram of one embodiment of a
phototherapy treatment dispensing device of the present disclosure
that controls incremental exposure increases.
[0042] FIG. 4 is a block diagram of another embodiment of a
phototherapy treatment dispensing device of the present disclosure
that records patient usage of the device.
[0043] FIG. 5 is a block diagram of another embodiment of a
phototherapy treatment dispensing device of the present disclosure
that reminds the patient of an overdue treatment.
[0044] FIG. 6 is a block diagram of another embodiment of a
phototherapy treatment dispensing device of the present disclosure
that has multiple control features.
[0045] FIG. 7 is a perspective view of an exemplary booth form of
the phototherapy treatment dispensing device of the present
disclosure.
[0046] FIG. 8 is a perspective view of an exemplary handheld wand
form of the phototherapy treatment dispensing device of the present
disclosure.
[0047] FIG. 9 is a perspective view of an exemplary desk-type
device form of the phototherapy treatment dispensing device of the
present disclosure.
DETAILED DESCRIPTION
[0048] A more complete understanding of the processes and
apparatuses disclosed herein can be obtained by reference to the
accompanying drawings. These Figures are merely schematic
representations based on convenience and the ease of demonstrating
the present development, and are, therefore, not intended to
indicate relative size and dimensions of the phototherapeutic
devices or components thereof.
[0049] Although specific terms are used in the following
description for the sake of clarity, these terms are intended to
refer only to the particular structure of the embodiments selected
for illustration in the drawings, and are not intended to define or
limit the scope of the disclosure. In the drawings and the
following description below, it is to be understood that like
numeric designations refer to component of like function.
[0050] The present disclosure relates to treatment dispensing
devices that have imbedded in them a controlled protocol timer. The
controlled protocol timer imbeds in the treatment dispensing device
a full profile for the usage of that device. Controlled protocol
timers may be useful in any sort of device. In particular, the
disclosure relates to medical devices, light treatment dispensing
devices, and phototherapy treatment dispensing devices where the
controlled protocol timer contains a physician's full prescription
for the usage of that device. As a result, the patient has
practically no opportunity to use the device in any fashion other
than in the manner prescribed by their physician.
[0051] The controlled protocol timer can include a refill
mechanism. When less than a defined number of sessions remain, the
medical device can inform the user via auditory, visual, or tactile
signals. The device can provide instructions to contact the third
party maintaining the device, optionally including a phone number.
The device may also provide a unique code number to be provided to
the third party. The third party inputs this unique code number
into a software application along with the details of any desired
changes to the profile. The software application then provides a
new unique code number corresponding to the new profile. That new
unique code number is then entered into the controlled protocol
timer by the user, which decodes the new profile and allows for
continued use of the device pursuant to the new profile.
[0052] The phototherapy device can also adjust its dosimetry. For
example, it can measure the output of the ultraviolet lamp and
adjust dosages to compensate for lamp aging, line voltage, and
other variables known in the art
[0053] The construction of the medical device is useful and
provides user convenience and safety. For example, the device can
monitor line voltage, current, frequency, phase, and power factor
to provide for fault detection and diagnostics. It can accept input
power from 90 VAC to 250 VAC, and 45 Hz to 65 Hz, providing
efficient conversion with no need for user intervention. Line power
can be magnetically coupled into the device via a transformer,
reduced to low voltage within the power supply, and insulated from
the user by having no conductive materials exposed. Devices having
an access door have a door safety switch that detects the door
opening, suspends treatment, and alerts the operator. A
rechargeable energy source, a charger, and monitoring software may
be included for use as backup power to ensure timekeeping and data
retention functions. Triple-redundant safety protection can be
provided by three independent shutoff mechanisms which guarantee
that no exposure will be provided except as authorized by the
prescription, even in the event of two credible simultaneous
failures. Each shutoff mechanism can be independently verified
before each treatment begins or on any other desired schedule.
[0054] Several user controls can be included for the patient to
interact with the medical device. Audio controls may allow the
volume of any audible alerts to be adjusted to suit the user and
the ambient noise environment. Visual controls may be provided. For
example, in some embodiments, the device can include six separate
lights on a front panel. Two lights are hard-wired (power, lamp on)
and four are controlled by firmware/software within the device to
indicate various fault or alert conditions. The operator can adjust
display brightness and contrast to suit his preferences. The device
may use variable font sizes to indicate different information. For
example, small fonts can be used for detailed diagnostic
information and instructions, while larger fonts are used for
visibility from greater distances for items such as the
time-remaining countdown. Operator input can be accepted via sealed
capacitive sensing "pushbuttons" located in such proximity to the
display as to allow software-defined changes to the functionality
of any given button by displaying appropriate nomenclature adjacent
to the button. Other mechanical or other pushbutton technology may
also be used. Low-noise capacitive touch detection may also be
incorporated, where each keypad button serves as the timing
capacitor for a simple and efficient relaxation oscillator.
Multiple periods of this relaxation oscillator are timed, providing
strong noise immunity. A baseline reference is maintained by the
firmware to detect changes in capacitance when a key is touched,
and debouncing is provided in firmware to prevent false touch
detection.
[0055] As previously mentioned, the controlled protocol timer
provides controls such that the user can only use the device in the
manner prescribed by their physician. The medical device also
provides controlled access to certain settings, such as through
requiring authentication to view or adjust certain internal
settings. This authentication can be provided using a simple
passcode or using more sophisticated rolling-code or
challenge-response type authentication mechanisms. The initial
session time can also be preprogrammed at the factory prior to the
medical device being delivered to the patient's home. This initial
session time can then serve as the starting baseline point for all
of the remaining sessions from that device. If desired, other
external sensors can also be connected to the device, for example
via the 1-Wire.RTM. bus promulgated by Dallas Semiconductor.
[0056] As previously discussed, the controlled prescription timer
limited only the number of sessions allowed by the home
phototherapy device. The controlled protocol timers of the present
disclosure, on the other hand, include multiple control features.
First, it counts and/or limits the number of allowed sessions to
the number prescribed by the physician. Second it also limits the
patient's usage to the frequency prescribed by the physician. For
example, the controlled protocol timer can prevent the phototherapy
device from operating any more frequently than a once-a-day or
once-every-other-day regimen prescribed by the physician. Other
intervals can be used as prescribed. Allowance can be made for
slight variations in the patient's daily schedule by allowing a
tolerance (such as 4%) in the minimum interval between sessions.
Allowances can also be made for a weekly rotation for patient
convenience, such as sessions on Monday, Wednesday, and Friday,
rather than a fixed every-two-days interval. The controlled
protocol timer can also limit the duration of each treatment to
that prescribed by the physician.
[0057] The controlled protocol timers of the present disclosure are
used to control a device, particularly a treatment dispensing
device such as a phototherapy treatment dispensing device. The
controlled protocol timer does this by containing the full
prescription for the usage of the device. A first type of
prescription might comprise a prescribed number of sessions, a
prescribed session frequency, and a prescribed duration for each
session. For example, a prescription might be for 10 sessions, one
session per day, ten minutes per session. In some cases though, the
prescription might call for a prescribed number of treatments per
session. As one example, the prescribing physician may wish to
treat the patient's front differently from the patient's back by
exposing them to light for different periods of time. Then, this
second type of prescription might comprise a prescribed number of
sessions, a prescribed session frequency, a prescribed number of
treatments per session, and a prescribed duration for each
treatment. For example, such a prescription might be for 10
sessions, one session per day, two treatments per session, 10
minutes for the first treatment, 5 minutes for the second
treatment. Of course, if the prescribed number of treatments per
session is one, then the second type of prescription is the same as
the first type of prescription
[0058] The prescribed session frequency may vary between sessions.
For example, a prescription for sessions on a
Monday-Wednesday-Friday (M-W-F) schedule could be described as one
day between M-W and W-F, then two days from Friday to Monday. The
session frequency may also be described by multiple means. For
example, the session frequency could be described as "one session
per day," "at least 12 hours between sessions," or "only 10 minutes
of light per 24 hour period." In other words, there is no one
specific way to describe the session frequency.
[0059] In some embodiments, the controlled protocol timer takes the
form of a controller configured to control the device, the
controller including (A) an engine that contains a prescribed
protocol, each protocol comprising (i) a prescribed number of
sessions, (ii) a prescribed session frequency, (iii) a prescribed
number of treatments per session, and (iv) a prescribed duration
for each treatment.
[0060] The controller may further comprise (B) an input means for
entering a passcode corresponding to a desired treatment schedule,
wherein the engine further converts the passcode into a prescribed
protocol. Exemplary input means include a display panel or control
panel, a keyboard, a graphical display screen, and/or a
touchscreen. These input means can use LED lights, graphical
displays, keys or buttons, speakers, and other components to
communicate information to the user. The input means can also allow
for a prescription refill mechanism, as described further
herein.
[0061] In particular embodiments, the treatment schedule is a
prescription from a prescribing physician. The prescription can be
converted as a prescribed protocol for the device to follow. The
prescribed protocol may be expressed in different ways. For
example, a protocol may comprise (i) a prescribed number of
sessions, (ii) a prescribed session frequency, and (iii) a
prescribed duration for each session. A protocol may also comprise
(i) a prescribed number of sessions, (ii) a prescribed session
frequency, (iii) a prescribed number of treatments per session, and
(iv) a prescribed duration for each treatment. A protocol may also
comprise a first session, a second session, and a session interval.
In this last protocol, each session would have a duration and the
session interval corresponds to a session frequency.
[0062] Besides the input means and the engine, the controlled
protocol timer may further comprise (C) a treatment limiter
configured to limit a number of treatments according to the
prescribed number of sessions and the prescribed number of
treatments per session of the protocol; (D) a frequency limiter
configured to limit a frequency of sessions according to the
prescribed session frequency of the protocol; and (E) a duration
limiter configured to limit a duration of a particular treatment to
the prescribed duration for that treatment according to the
protocol. Depending on the protocol, the treatment limiter may
essentially function as a session limiter as well. The treatment
limiter, frequency limiter, and duration limiter can be three
separate limiters or a single limiter that limits all three aspects
(treatment number, frequency, and duration).
[0063] The controlled protocol timer of the present disclosure
further includes at least one of the following three features: (1)
the ability to control incremental exposure increases by the
patient; (2) the ability to record patient usage of the device and
form a treatment history; and (3) the ability to remind the patient
of an overdue treatment. These features encourage compliance with
the physician's prescription by controlling the usage of the
phototherapy device, monitoring patient usage, and providing
information that encourages patient compliance.
[0064] Referring first to FIG. 1, an exemplary phototherapy
treatment dispensing device 10 comprises an ultraviolet radiation
reflecting panel 12 containing a bank of ultraviolet ray-emitting
tubes 14. This device 10, by FDA regulations, can be sold only by
the manufacturer to a patient upon presentation of a prescription
from a duly accredited physician. The physician prescribes an
initial treatment regimen comprising (i) a prescribed number of
therapeutic light emissions treatments and (ii) a maximum duration
of each treatment. The treatment regimen is converted by the
controlled protocol timer into a prescribed protocol. A
programmable controller 16 is mounted on the front face 18 of panel
12.
[0065] Referring to FIG. 2, a treatment dispensing device 12
comprises a therapeutic treatment dispenser 22 and a controller 16.
The therapeutic treatment dispenser 22 dispenses a therapeutic
treatment. An exemplary dispenser 22 is a generator 20, such as an
ultraviolet radiation reflecting panel 12 containing a bank of
ultraviolet ray-emitting tubes 14, as shown in FIG. 1. Other
exemplary generators include those that can provide UVA light (320
nm to 400 nm), UVB light (280 nm to 320 nm), and blue light (400 nm
to 495 nm).
[0066] The controller 16 includes an input means 30, an engine 40,
a treatment limiter 50, a frequency limiter 60, and a duration
limiter 70. The input means 30 allows a patient to enter a passcode
corresponding to a particular prescription. The passcode may be
formed from alphanumeric characters and be of any length necessary
to fully describe the prescription, including from 4 to 16
characters. The engine 40 converts the passcode to a prescribed
protocol, each protocol comprising (i) a prescribed number of
sessions, (ii) a prescribed session frequency, (iii) a prescribed
number of treatments per session, and (iv) a prescribed duration
for each treatment. The treatment limiter 50 limits a number of
therapeutic treatments according to the prescribed number of
sessions and the prescribed number of treatments per session of the
protocol. In other words, it counts the number of prescribed
sessions or treatments and prevents the dispenser from activating
once the protocol is complete. The frequency limiter 60 limits the
frequency at which therapeutic treatments are dispensed according
to the prescribed session frequency of the protocol. For example,
if the protocol is for one session a day, then the frequency
limiter prevents the dispenser for activating for the rest of the
day after the patient has completed her session. The duration
limiter 70 limits the duration of a particular treatment to the
prescribed duration for the particular treatment according to the
protocol. The three limiters 50, 60, 70 can be separate limiters or
the same limiter can limit all three aspects (treatment number,
frequency, and duration).
[0067] In a phototherapy device, the maximum duration of each
therapeutic light emissions treatment is generally preset. The
patient may generally adjust the duration downwards, i.e. to have a
shorter duration. However, previous controlled prescription timers
also permitted the patient to adjust the duration of the next
treatment upwards. In some embodiments, the phototherapy treatment
dispensing device provides a controlled protocol timer which
controls incremental exposure increases by the patient.
[0068] Referring to FIG. 3, the device 10 comprises a generator 20
and a controller 16. This controller, however contains combination
limiter 55, which performs the same functions as treatment limiter
50, frequency limiter 60, and duration limiter 70. The controller
16 further comprises a timer 80 and a calculator 90. The timer 40
is used for timing at least (i) the actual duration of each
therapeutic light emissions treatment and (ii) the total actual
duration of therapeutic light emissions treatments in a first
period of time.
[0069] The calculator 50 calculates the amount of incremental
exposure increase which can be permitted. This incremental exposure
increase can be done in one of two ways. First, the duration of
treatments can be increased. In other words, the total duration of
therapeutic light emissions treatments in a second period of time
can be increased based on the total actual duration of therapeutic
light emissions treatments in the first period of time. For
example, a treatment of 1 hour in the first day might allow a
treatment of 1.02 hours on the second day. Second, the session
frequency can be decreased. In other words, the session frequency
can be decreased based on the total actual duration of therapeutic
light emissions treatments in the first period of time. For
example, where the prescription is 1 hour of treatment, wait 12
hours, then another 1 hours of treatment, the session frequency
could be decreased to only waiting 11 hours.
[0070] The permitted increase in duration may be calculated in
several ways. A first method of calculating the permitted increase
may be based on a given percentage of the total duration of
therapeutic light emissions treatments in the first period of time.
The percentage may range, for example, from 2% to 4%. Thus, for
example, a patient who had received light exposure for 1 hour on
the first day would be allowed by the controlled protocol timer to
self-adjust her light exposure to 1.02 hours on the second day.
However, if the patient attempted to self-adjust her light exposure
to 2 hours on the second day, the controlled protocol timer would
either reject the patient's light exposure or automatically reduce
it to 1.02 hours. This method can encourage patient compliance
because the actual duration of a session or treatment is used to
calculate the permitted increase, not the prescribed duration of
the session or treatment. The percentage on which the permitted
increase is based does not need to remain constant between sessions
or treatments.
[0071] A second method of calculating the permitted increase may be
based on the difference between the total actual duration of
treatments in the first period of time and the prescribed duration
of treatments for that first period of time. This method would
allow a patient to "catch up" on the missing dosage. For example, a
patient who had a prescription for 1 hour of light exposure a day,
but who had only received 0.75 hours of light exposure on the first
day, would be permitted by the controlled protocol timer to receive
1.25 hours of light exposure on the second day (0.25 hours catch-up
time plus the prescribed 1.0 hour for the second day) or to receive
the next scheduled session 0.25 hours earlier.
[0072] A third method of calculating the permitted increase may be
based on a stepwise function determined by the total actual
duration of treatments in the first period of time. This method
would allow the physician to prevent incremental increases that may
be inappropriate or unsafe at higher dosages. For example, a
patient who had received light exposure of 1 to 2 hours in a day
might be permitted to increase the duration of the next session by
up to 15 minutes, but a patient who had received light exposure of
2 to 3 hours in a day might only be permitted to increase the
duration of the next session by up to 5 minutes. Alternatively, the
session frequency could be decreased so that a patient could
receive the next session 15 minutes or 5 minutes earlier,
respectively.
[0073] The first period of time and second period of time used by
the calculator to calculate permitted increases do not need to be
equal, though they generally are for purposes of convenience to the
physician and patient. The length of each period of time may also
vary. For example, the physician may wish to allow a patient to
"catch up" on missing dosages, but only by a certain amount a day.
Then, the first period of time might be longer than the second
period of time. In particular embodiments, though, both periods of
time are from about a day to about a week. They may also be from
about a day to about three days. In other embodiments, the periods
of time are both from 2 hours to 96 hours, from 12 hours to 48
hours, or about 24 hours. These periods are generally determined by
how strictly the physician desires to control the patient's
usage.
[0074] The engine 40, limiters 50, 60, 70, timer 80, and calculator
90 may generally be implemented as special firmware within the
device or as software routines run by a controller 16 within the
device. The input means 30 may be a separate physical component or
be integrated with the controller 16.
[0075] Other embodiments of the phototherapy treatment dispensing
device provide the ability to record patient usage of the device
and form a treatment history. Referring to FIG. 4, the device 10
comprises a generator 20 and a controller 16. Again, the controller
comprises an input means 30, an engine 40, a treatment limiter 50,
a frequency limiter 60, and a duration limiter 70 that function as
described above. The controller also comprises a timer 80 that
times at least (i) the actual duration of each therapeutic light
emissions treatment and (iii) the time at which each therapeutic
light emissions treatment begins. This information allows the
patient's treatment history to be formed.
[0076] The device 10 further comprises a recorder 100 and a
transmitter 110. The recorder 100 records the beginning time and
the actual duration of each therapeutic light emissions treatment.
The transmitter 110 can transmit the recorded beginning time and
actual duration of each therapeutic light emissions treatment to a
third party. Depending on the desires of the physician, the
transmitter can be set to transmit (i) on a periodic basis (such as
every week), (ii) after each treatment, (iii) after a set period of
time, or (iv) after the entire protocol has been completed.
Similarly, the recorder can record (i) only the last treatment,
(ii) all treatments since last transmissions, or (iii) all
treatments for the entire protocol. In other words, the recorder
and transmitter can transmit the information for each treatment
separately or record the information for multiple treatments and
then transmit that accumulated information at one time. This can
allow the physician to monitor the patient's compliance with the
prescription or allow the patient to substantiate usage compliance
of the phototherapy device to their medical insurance company.
[0077] The recorder can be implemented as a mechanical device, such
as a paper printer or a tape cassette. However, the recorder is
usually implemented as computer memory (flash, RAM, EPROM, etc.).
The transmitter can be any item that successfully transmits
information. Exemplary transmitters include a removable medium
(such as a memory card), a wired connection (such as a serial
connection or a modem connection), a wireless connection utilizing
a sound, ultrasound, radio, microwave, infrared, or optical
transmission medium, or a human-readable display that requires an
authentication code. The connections generally allow the
information to be transmitted over the Internet (or other
proprietary networks); the provider of the connection (e.g. cable,
DSL, satellite) is immaterial. The recorder and transmitter may
also be embodied in the same device. For example, a removable
memory card may simultaneously serve as the recorder and the
transmitter. The recorder and transmitter may either be independent
components of the device or be integrated with the controller
16.
[0078] Other embodiments of the phototherapy treatment dispensing
device provide the ability to remind the patient of an overdue
treatment. Referring to FIG. 5, the device 10 comprises a generator
20 and a controller 16. The controller includes an input means 30,
an engine 40, a treatment limiter 50, a frequency limiter 60, and a
duration limiter 70 that function as described above. In these
embodiments, the session frequency of the prescription is easier
visualized as a session interval, or an interval between
sessions.
[0079] The device 10 further comprises a comparator 120 and an
alarm 130. The comparator compares (iv) an elapsed time beginning
after the end of a session. The comparator 90 compares the elapsed
time to the prescribed session frequency (or session interval).
When the elapsed time differs from the prescribed session frequency
by a specified amount, the alarm 100 generates an alert.
[0080] The specified amount may be considered as a percentage of
the prescribed session frequency, a fixed amount, a stepwise
function, or inversely related to the prescribed session frequency.
In other words, the specified amount may vary between sessions and
does not need to be fixed. It may vary, for instance, depending on
how the patient uses the machine. For example, the protocol calls
for a one session of 10 minutes each day. Here, the prescribed
session frequency is expressed as one session a day. If the patient
takes the first session at 10:00 pm on day 1, then the device might
wait until 11:30 pm on day 2, or an interval of 25 hours 30
minutes, before alerting the patient, who can then meet the
protocol (and their prescription) by beginning her 10 minute
session for day 2 within the next 20 minutes. Then the device might
wait again until 11:30 pm on day 3, or an interval of 23 hours 30
minutes, before alerting the patient again. In these embodiments,
the alarm generally generates an alert prior to the patient missing
a session. If the alarm is generated prior to the patient missing a
session, the specified amount should be considered as a positive
value. If the alarm is generated after the session frequency has
elapsed, the specified amount should be considered as a negative
value. As an example of a fixed specified amount, the device might
always alert the patient one hour before the session frequency will
elapse.
[0081] The comparator 120 may be special firmware within the device
or a software routine run by a microprocessor within the device.
The comparator may also contain its own clock that allows it to
measure the elapsed time, rather than needing a separate timer
(though one can be provided). The alarm 130 may be auditory (such
as a siren), visual (via graphical display screen, light, LED), or
tactile. The alarm may also be a separate physical component or be
integrated with the controller 16.
[0082] The phototherapy devices of the present disclosure can also
include the components necessary to achieve any combination of the
three features. For example, referring to FIG. 6, the device 10 can
comprise a generator 20, an input means 30, an engine 40, a
treatment limiter 50, a frequency limiter 60, a duration limiter
70, multiple timers 82, 84, 86, 88, a calculator 90, a recorder
100, a transmitter 110, a comparator 120, an alarm 130 for
providing all three features in the same device. More than one
timer may be present. For example, there may be four timers, one
each for timing (i) the actual duration of a therapeutic light
emissions treatment 82; (ii) the total duration of therapeutic
light emissions treatments in a period of time 84; (iii) the
beginning time of a therapeutic light emissions treatment 86; and
(iv) the elapsed time since the end of a therapeutic light
emissions treatment 88. These devices allow the patient's exposure
to be controlled.
[0083] It should be understood that in the preceding description,
the term "device" refers to a phototherapy device that includes the
controlled protocol timer for controlling the on/off function of
the generator. In other words, the term "controlled protocol timer"
can refer to the logical components of the phototherapy device or a
single physical component of the phototherapy device. For example,
the controlled protocol timer can, if desired, be implemented as a
microprocessor 22 which runs functions corresponding to the engine
40, a treatment limiter 50, a frequency limiter 60, a duration
limiter 70, timer 80, calculator 90, recorder 100, transmitter 110,
and comparator 120. The phototherapy device may also include an
input means 30, recorder 100, a transmitter 110, and/or an alarm
130 as physical components separate from the microprocessor.
[0084] The phototherapy treatment dispensing device 10 depicted
herein is a 6-foot tall panel. However, the device is not
restricted only to such panels. For example, the device could be in
the form of a tanning bed or a booth that surrounds the patient.
The device could also be a 2-foot panel, a handheld wand, or a
desk-type device for the treatment of hands and/or feet. An
exemplary booth is shown in FIG. 7; an exemplary handheld wand is
shown in FIG. 8; and an exemplary desk-type device is shown in FIG.
9 for both hands and feet. The panels making up the booth of FIG. 7
can also be foldable for a smaller footprint during storage if
desired.
[0085] Persons having ordinary skill in the art will be able to
make the embodiments described above or combinations of the
embodiments described above using methods known in the art.
[0086] Various methods for controlling the usage of a treatment
dispensing device and controlling the exposure of a patient using a
light treatment dispensing device are also provided. The methods
all require that the device be capable of producing a treatment and
providing a prescribed protocol using the controlled protocol
timer. In some methods, the production of treatments is limited
based on the prescribed protocol. In other methods, the beginning
time and duration of the light treatments are recorded and
transmitted to a third party. Such information for multiple
treatments can be recorded and then transmitted simultaneously. In
still other methods, an alarm is generated if an elapsed time
between sessions exceeds the session interval by a specified
amount.
[0087] The present disclosure has been described with reference to
exemplary embodiments. Obviously, modifications and alterations
will occur to others upon reading and understanding the preceding
detailed description. It is intended that the present disclosure be
construed as including all such modifications and alterations
insofar as they come within the scope of the appended claims or the
equivalents thereof.
* * * * *