U.S. patent application number 13/558404 was filed with the patent office on 2012-11-15 for device for drug distribution and method of using thereof.
This patent application is currently assigned to 2P2D Solutions Ltd.. Invention is credited to Ofer BARAM, Ran FRENKEL, Mordechai PEER.
Application Number | 20120285858 13/558404 |
Document ID | / |
Family ID | 41319559 |
Filed Date | 2012-11-15 |
United States Patent
Application |
20120285858 |
Kind Code |
A1 |
PEER; Mordechai ; et
al. |
November 15, 2012 |
DEVICE FOR DRUG DISTRIBUTION AND METHOD OF USING THEREOF
Abstract
A medicament dispensing device comprises (a) at least one
container adapted for accommodating and dispensing at least one
elongate packagible elongate blister pack carrying a plurality of
blisters containing the medicament; (b) transporting means adapted
for transporting the blister pack toward opening of the container;
(c) dispensing means adapted for releasing a fragment of the
blister pack bearing a predetermined number of the blisters from
the container through the opening to a patient; and (d) controlling
means adapted for identifying the patient before dispensing the
blister to the patient, activating the dispensing means, recording
actions of dispensing. The substrate is foldable and configured to
be folded within the container. In the folded configuration,
non-foldable portions bearing the blisters face each other.
Inventors: |
PEER; Mordechai;
(Tzur-Yigal, IL) ; BARAM; Ofer; (Tel-Aviv, IL)
; FRENKEL; Ran; (Yahud-Monosson, IL) |
Assignee: |
2P2D Solutions Ltd.
Kiryat-Arba
IL
|
Family ID: |
41319559 |
Appl. No.: |
13/558404 |
Filed: |
July 26, 2012 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
13003394 |
Jan 10, 2011 |
|
|
|
PCT/IL2009/000689 |
Jul 9, 2009 |
|
|
|
13558404 |
|
|
|
|
61079462 |
Jul 10, 2008 |
|
|
|
Current U.S.
Class: |
206/531 ;
53/452 |
Current CPC
Class: |
G16H 20/13 20180101;
G07F 11/68 20130101; G16H 10/20 20180101; A61J 2205/70 20130101;
A61J 7/0481 20130101; G07F 17/0092 20130101; A61J 1/035 20130101;
A61J 2200/30 20130101; G06F 19/00 20130101; A61J 7/0084
20130101 |
Class at
Publication: |
206/531 ;
53/452 |
International
Class: |
B65D 83/04 20060101
B65D083/04; B65B 5/02 20060101 B65B005/02 |
Claims
1. An elongate continuous blister pack comprising: a plurality of
blisters, each blister accommodating a medicament dose; at least
three non-folded portions containing said blisters, said non-folded
portions packaged for distribution as layers in a stack in a
multiply folded configuration.
2. The blister pack of claim 1, wherein said non-folded portions
include a plurality of blister-occupied positions in which a
blister is disposed; and at least one blister-empty position;
wherein, in said multiply folded configuration a blister-empty
position in a non folded portion is a blister-occupied position in
facing non-folded portion so that a distance between facing
non-folding portions is substantially the height of a blister.
3. The blister pack according to claim 1, adapted for cutting off a
fragment of said blister pack carrying a predetermined number of
said medicament doses within intact blisters of said blisters.
4. The blister pack of claim 1, wherein said blister pack is
manufactured for said multiply folded configuration having a
predetermined shape.
5. The blister pack of claim 1, wherein said multiply folded
configuration is distributed in a container.
6. The blister pack according to claim 1, adapted for transporting
thereof by means a cogwheel along a guide member; said blister pack
having at least one line of perforations; said line is directed in
parallel to said blister pack; said perforations are adapted for
engaging with cogs of said cogwheel so that said blister pack is
linearly transported along said guide member.
7. The blister pack according to claim 1, wherein said blister pack
includes at least four non-folded portions containing said blisters
and said stack includes at least three layers.
8. The blister pack according to claim 1, wherein said blister pack
includes at least twelve non-folded portions containing said
blisters and said stack includes at least six layers.
9. The blister pack according to claim 2, wherein each of said
non-folded portions contain at least one of said blisters and at
least one of said blister occupied positions and at least one of
said blister empty positions.
10. The blister pack according to claim 3, wherein said
predetermined number is one.
11. A method of dispensing a medication; said method comprising:
manufacturing at least one elongate continuous blister pack having
a plurality of blisters in a plurality of non-folded portions of
the blister pack, each blister accommodating a medicament dose;
folding said blister pack into a multiply folded configuration of
at least three of the non-folded portions stacked in at least two
layers, and loading said blister pack in said multiply folded
configuration into a container.
12. The method of claim 11, further comprising: releasing a
fragment of said blister pack, said fragment bearing a
predetermined number of said doses.
13. The method according to claim 12, wherein said releasing is
performed in intact blisters.
14. The method of claim 12, wherein said releasing is to a patient
via a dispenser, said dispenser including a processor and a memory
and the method further comprising: said processor performing at
least one action selected from the group consisting of identifying
said patient, controlling said releasing according to a treatment
protocol recorded in a memory, informing said patient about a
clinical trial protocol, monitoring patient compliance with a
clinical trial protocol, monitoring patient compliance with a
treatment program, recording actions of dispensing, and
transmitting obtained records to a clearing house.
15. The method according to claim 11, wherein said at least one
blister pack includes a plurality of blister packs, each said
blister pack including a different medicament and further
comprising: dispensing said different medicaments concurrently
and/or consecutively according to a treatment protocol.
16. The method according to claim 14, further comprising at least
one action selected form the group consisting of said processor
broadcasting a notification message to take a corresponding dose of
said medicament according to said protocol; receiving said message
by a mobile device carried by said patient; receiving said message
by a bracelet carried by said patient; or any combination
thereof.
17. The method according to claim 14, wherein said identifying said
patient is performed using a RFID technology.
18. The method according to claim 12, wherein said predetermined
number is one.
19. The method according to claim 11, further comprising:
transporting said blister pack toward a slot is said container.
20. The method of claim 19, wherein said transporting includes
transporting said blister pack linearly along a guide member via
cogs of a cogwheel, said cogs fitting into perforations located on
said blister pack.
21. The method according to claim 14, wherein said container
includes a knife controlled by said processor and further
comprising: cutting off with said knife said fragment of said
blister pack carrying said predetermined number of said medicine
doses and said blisters in an intact state.
22. The method of claim 11, wherein said folding is into said stack
of least four of the non-folded portions in at least three
layers.
23. The method of claim 11, wherein said folding is into said stack
of least twelve of the non-folded portions in at least six layers.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 13/003,394 filed on Jan. 10, 2011, which is a
National Phase of PCT Patent Application No. PCT/IL2009/000689
filed on Jul. 9, 2009, which claims the benefit of priority of U.S.
Provisional Patent Application No. 61/079,462 filed on Jul. 10,
2008. The contents of the above applications are all incorporated
herein by reference.
FIELD OF THE INVENTION
[0002] The field of the invention relates to a device for pill
medication dispensing to patients, more specifically, a pill
dispensing device adapted for procuring medication compliance by
patients in the clinical trials.
BACKGROUND OF THE INVENTION
[0003] Drug regimen compliance is defined as: the degree of
correspondence between actual dosing history and the prescribed
regimen. This means that the administration/intake of a correct
dose of the drug must take place at a defined time of intake, and
the patient will continue in doing so for the whole period of
treatment. Perhaps the most critical point for measuring patient
compliance is during the clinical research trials used to determine
the efficacy of new pharmaceuticals. On the basis of the results of
such trials, new medications are either licensed for general
medical use or abandoned. Clinical trials data also determine the
recommended dosing strategies for specific clinical indications.
Consequently, inaccurate data during clinical trials can result in
decisions that will affect everyone who uses the drug during its
lifetime--tens of millions of patients in the case of widely used
drugs. It can also result in a potentially therapeutic drug being
unnecessarily abandoned.
[0004] Best practice guidelines in clinical pharmacotherapy are
designed to maximize the therapeutic effect of medications while
minimizing side effects and cost. The dose, dosing interval, and
duration of pharmacotherapy are based on the best estimate of the
time during which a therapeutic plasma level will achieve the
desired therapeutic effect. New medications are tested clinically
on patients having the disease of interest, and the outcome
contributes significantly to the best practice guidelines. Patient
compliance with the dosing regimen during clinical trials is
critical to establishing accurate dosing guidelines.
[0005] In a clinical trial, poorly compliant patients may require
an average of 10 days to cure; perfectly compliant patients only
five days. However, due to individual differences, some poorly
compliant patients may need 12 days of therapy and some perfectly
compliant patients may require only three days. The ensuing best
practice guidelines must ensure that all patients being treated
will be cured. Thus, physicians prescribing the drug for the rest
of its life will prescribe it for 10 days for everyone although for
compliant patients only five days are necessary. If the physician
knew a patient was perfectly compliant, he or she could prescribe a
five-day course of the antibiotic with confidence.
[0006] Conversely, if a non compliant patient did not respond to
the antibiotic the prescribing physician might educate the patient
and continue the same antibiotic rather than assuming the drug is
resistant and changing to another antibiotic. In both scenarios,
knowledge of the patient's compliance would have positive
implications for health care at the macro level.
[0007] Patient diary is one tool often used. The patient has to
state time of administration immediately as it occurs. However,
data from a diary is at least questionable. There is a very high
discrepancy between patient-reported events (as intake) and the
actual access to the diary, which was monitored by means of a timer
hidden in a cover for a paper diary. The term "car park compliance"
and "white coat compliance" (poor or partial compliers improving
their compliance around the time of scheduled following visits) are
important notions, which must be taken seriously, because
investigators might reach incorrect conclusion with respect to
effects caused by noncompliance or by the test drug itself. Also,
"white coat compliance" pattern makes therapeutic drug monitoring a
potential unreliable tool for long-term drug exposure. The most
widely used techniques for monitoring compliance with medication
are pill counts and medication diaries. These are used in most
clinical pharmaceutical trials, and rarely in clinical settings.
The former technique involves counting the number of pills returned
to the study monitor at the end of an interval and checking to see
if this is congruent with compliance. In the latter, patients keep
a diary of their medication-taking and may also record side
effects, clinical response, and other events of interest.
[0008] The data can then be used to assess compliance and, if
desired, target education to non-compliant patients. Unfortunately,
both have been demonstrated to be ineffective. Patients are prone
to filling out diaries retrospectively just before meeting with the
study monitor or "adjusting" their medication to compensate for
missed doses. Neither pill counts nor medication diaries address
the issue of patients not taking their medication on schedule. Yet,
despite their limitations, these techniques remain the industry
standard.
[0009] The electronic monitoring methods, i.e. time and date
stamping micro circuitry incorporated into drug packages, provide a
continuous record of timing of presumptive doses throughout periods
of many months, but do not prove dose ingestion. The electronic
record has been judged robust enough to detect certain types of
investigator fraud, and to support modeling projections of the
complete time course of the plasma drug concentration during a
trial. Both marker and electronic methods show that the predominant
errors are those of omission, i.e. delays or omissions of scheduled
doses. Patient interviews, diaries, and counts of returned, untaken
doses have been shown by both marker and electronic monitoring
methods to consistently and substantially to overestimate
compliance. Monitoring of plasma drug concentrations also
overestimates compliance; because white-coat compliance is
prevalent, and the pharmacokinetic turnover of most drugs is rapid
enough that measured concentrations of drug in plasma reflect only
drug administration during the period of white-coat compliance.
Thus, compliance is a great deal poorer in clinical trials than has
been revealed by the older methods. The long-standing
underestimation of poor compliance in drug trials has many
implications for the interpretation of drug trials, for optimal
dose estimation, for the interpretation of failed drug therapy, and
for accurate labeling of prescription drugs.
[0010] The introduction of radiofrequency identification device,
RFID tags-enabled computer chip technology has introduced the
possibility of monitoring that a patient has taken medication, and
when the medication was taken. It is evident that pharmaceutical
products-even within identical indication-differ widely in the
degree of compliance needed in their dosing schedules.
[0011] Focusing on the financial and human costs associated with
medication non-compliance, Information Mediary Corporation has
developed the Med-ic.TM. ECM.TM. Package, an electronic device that
provides precise inventory monitoring in clinical settings for
blister-packaged medication. The use of electronic compliance
packaging continues to grow, with two recently launched products
joining the fray. MeadWestvaco Healthcare Packaging (Mebane, N.C.)
has begun initial testing of Cerepak, an electronic update Dosepak
package. Information Mediary Corp. (IMC; Ottawa, ON, Canada),
meanwhile, is currently testing the Med-ic ECM blister package.
Cerepak employs smart technology to measure and improve patient
compliance. It reminds patients when to take medication, records
when they do, and reports that data back to their doctor or
pharmacist. The package's built-in `brain` also provides real-time
compliance measurement that can expedite drug development through
clinical trials, enhance patient persistence, and improve the
bottom line. The technology allows the removal of each pill from a
blister package. When a pill is removed, the package emits a slight
beeping noise, recording the time and date of removal of
medication. It also records which pill has been taken. In addition,
a patient questionnaire is integrated into the package, featuring a
log for patient side effects and time to onset. The questionnaire
also measures pain and nausea. IMC's Medic is also currently being
tested in clinical settings. The package uses an electronic device
that is integrated into a blister package. It tracks medication
usage without active patient input and contains an RFID smart tag
that records the time at which the tablet or capsule is expelled,
logging the patient's medication use. Following completion of a
clinical trial, the patient can return the blister package to a
clinician, who uses the RFID scanner to download the information
into a database. The data are downloaded through a 13.56-MHz RF
wireless reader to a researcher's computer.
[0012] The Med-ic ECM is designed to streamline clinical data
collection. It also integrates IMC's CertiScan peripheral hardware
and software with IT and packaging engineering support. The
Med-ic.TM. ECM.TM. Package can be tailored for specific clinical
requirements including monitoring temperature, vibration, humidity,
light, radiation or shock to which the blister package has been
exposed and recording the time of the exposure. Visual and auditory
reminders, including LCDs, can also be integrated with the device
as required. The Med-ic.TM. ECM.TM. Package uses a proprietary,
disposable, nontoxic power cell and is environmentally safe. eCAP,
a smart RFID closure for medication bottles and vials. It consists
of the Med-ic RFID smart tag embedded in a Remind Cap bottle
closure. Similar to the other packages, it reminds the patient when
the next dose is due and records the time the patient opens the
bottle to remove the tablet or capsule, logging compliance at that
moment.
[0013] The recorded data are then retrieved with IMC's CertiScan
reader for a physician or pharmacist to review.
[0014] Medication Event Monitoring System (MEMS.RTM.)
[0015] The most successful microelectronic device primarily used in
clinical trials is Aardex's MEMS device, a pill bottle with a cap
that transmits data to a server, and reminds the patient to take
his medicine.
[0016] The MEMS.RTM. measures and analyses the compliance of
patients to prescribed drug regimens by: (a) collecting real time
data on the patients monitor; (b) transferring the data from the
monitor to a personal computer by means of a communicator; (c)
storing the data in database; (d) displaying and printing reports
of the results (tables and plots).
[0017] Principal components of MEMS.RTM. system are (a) MEMS.RTM.
monitor that collects real time data and store; (b) the data in a
non-volatile internal storage unit; (c) a communicator that
transfers the data from the monitor to a personal computer; (d) a
computer program such as PowerView.RTM. that stores the data in a
database calculates the results and displays or prints reports of
these results.
[0018] In Intelligent Drug Administration System (IDAS), there are
other devices primarily designed to regulate dosing that could be
used to ensure patient's compliance. Some of these systems are
disposable card-boxes, which can be up-loaded through a computer at
the investigator site. Other strategies include reusable
intelligent drug administration systems that accommodate blister
strips. B&O Medicom has developed two such devices. Internally,
they are referred as IDAS I and IDAS II respectively. The IDAS I is
an electronic device with a multicolored diode display that serves
as a reminder and even as a compliance indicator. The device
registers every time the blister strip is taken out, signifying
that a tablet/capsule has been swallowed. IDAS II device works with
blister strips that have conductive lines printed on thin foil
covering the plastic wells containing an active drug as tablet or
capsule.
[0019] The blister strips are held in a monitor that is equipped
with contact points for the conductive lines. A microprocessor
sends electric current through the conductive lines at regular
intervals and, when the patient takes a tablet/capsule from the
pack, the foil and conductive lines are broken. This is registered
in the microprocessor as a tablet has been taken. The information
is stored in the blister monitor's memory. The dosing data are then
loaded onto a PC or a server, enabling physicians and investigators
to perform detailed analysis of each and every patient's dosing
history, therapeutic coverage, and drug holiday and so on. IDAS II
also has audible and visual indicators to remind the patient to
take their medication. Its LCD screen shows the time since last
dose, actual time and a battery indicator.
[0020] An electronic "pill" dispenser (Medtime XL automatic
medication dispenser/pill organizer/pill box, Med-Time XL) and
reminder system helps to ensure that medications and vitamins are
taken properly (pill identification) and on time. Med-Time XL is a
device for dispensing medicine, reminding the user when medicine
shall be taken, and making the correct dose available.
[0021] US Patent Application 2006/0079996 ('996) discloses a unit
dose medication compliance monitoring and reporting apparatus and
system that includes a dispenser shell formed with dose
compartments. A retainer sheet affixed to the shell seals each
compartment and partially bursts upon dispensing. A sensor network
and monitoring and reporting circuitry records dispensing times and
determines an average time interval, which can be reported with
other data on an integral data display. The system can thereby
monitor and report patient compliance with prescription regimens.
Additional data can be recorded and displayed for augmented patient
compliance assistance and analysis, which data can include
customized informational messages, telephone and other patient
support contact information, unit doses dispensed and remaining,
reminder alarms, identification data, prescription regimens, among
other data.
[0022] It should be understood that the apparatus disclosed in '996
is provides a limited number of medicament doses. The aforesaid
number is defined by configuration of the dispenser shell and
amounts to 10-20 medicament doses. The medicament doses for
clinical trials should be prewrapped into the disclosed dispenser
shells. It is worthy of note that the disclosed technical solution
is sufficiently expensive. Thus, there is an unmet and long-felt
need to provide a universal apparatus which is adapted for
dispensing a predetermined number of medicaments to a predetermined
plurality of patients with minimal expenses.
SUMMARY OF THE INVENTION
[0023] It is hence one object of the invention to disclose a
medicament dispensing device comprising (a) at least one container
adapted for accommodating and dispensing at least one elongate
packagible elongate blister pack carrying a plurality of blisters
containing the medicament; (b) transporting means adapted for
transporting the blister pack toward opening of the container; (c)
dispensing means adapted for releasing a fragment of the blister
pack bearing a predetermined number of the blisters from the
container through the opening to a patient; and (d) controlling
means adapted for identifying the patient before dispensing the
blister to the patient, activating the dispensing means, recording
actions of dispensing.
[0024] It is a core purpose of the invention to provide the
substrate foldable and configured to be folded within the
container. The dispensing means is adapted to cut off the blister
bearing fragment.
[0025] Another object of the invention is to disclose the
dispensing means adapted to cut off the blister bearing fragment
such that the blisters remain intact.
[0026] A further object of the invention is to disclose the blister
pack configured for folding in a manner selected from the group
consisting of a concertina-like substrate, a serpentine-like
substrate, a zig-zag-like substrate and any combination
thereof.
[0027] A further object of the invention is to disclose the device
adapted for monitoring patient compliance with a clinical trial
protocol and a treatment program.
[0028] A further object of the invention is to disclose the
controlling means adapted for performing at least one function
selected from the group consisting of informing the patient about
the clinical trial protocol, identifying the patient when arrived
for taking the medication, recording actions of dispensing,
transmitting obtained records to a clearing house and any
combination thereof.
[0029] A further object of the invention is to disclose the device
adapted for dispensing a number of medications concurrently and/or
consecutively according to a treatment protocol.
[0030] A further object of the invention is to disclose the
controlling means pre-programmable such that the controlling means
broadcasts a message alerting the patient to take a predetermined
dose of medicament accommodated in the blister according to the
treatment protocol.
[0031] A further object of the invention is to disclose the device
further comprising a mobile device configured to be carried by the
patient. The mobile device is adapted for receiving the
message.
[0032] A further object of the invention is to disclose the mobile
device which is a bracelet carried by the patient.
[0033] A further object of the invention is to disclose the
controlling means adapted for identifying patient by means of an
RFID technology.
[0034] A further object of the invention is to disclose the
transporting means comprising a guide member and a cogwheel. Cogs
of the wheel are adapted for engaging with perforations located on
the blister pack and linearly transporting the blister pack along
the guide member.
[0035] A further object of the invention is to disclose the
transporting means comprising a guide member and a wheel. The wheel
adapted for tractably engaging with the blister pack and linearly
transporting the blister pack along the guide member.
[0036] A further object of the invention is to disclose the
dispensing means comprising a cutting knife. The knife is adapted
for reciprocatively moving such that the knife cuts off the
fragment of the blister pack carrying the predetermined number of
the medicine doses.
[0037] A further object of the invention is to disclose a
packagible elongate blister pack adapted for bearing blisters
accommodating medicament doses. The blister pack is configured for
converting into a packaged configuration by means of multiply
folding in a predetermined shape. The blister pack comprises a
plurality of non-foldable portions bearing the at least one blister
mechanically connected in series by means of foldable portions. The
blisters are disposed on the foldable portions in a staggered
arrangement so that when the blister pack is multiply folded. The
blisters do not contact each other.
[0038] A further object of the invention is to disclose the
predetermined shape of the foldable blister pack selected from the
group consisting of a concertina-like shape, a serpentine-like
shape, a zig-zag-like shape and any combination thereof.
[0039] A further object of the invention is to disclose the blister
pack adapted for transporting thereof by means a cogwheel along a
guide member. The blister pack has at least one line of
perforations. The aforesaid line is directed in parallel to the
blister pack. The perforations are adapted for engaging with cogs
of the rotating cogwheel so that the blister pack is linearly
transported along the guide member.
[0040] A further object of the invention is to disclose the
foldable portion adapted to be cut off such that the fragment of
the blister pack carrying the predetermined number of the medicine
doses within the blisters borne by non-foldable portion are in a
intact state.
[0041] A further object of the invention is to disclose a method of
dispensing a medication. The aforesaid method comprises the steps
of: (a) providing a medication dispensing device comprising: (i) at
least one container adapted for accommodating and dispensing at
least one elongate blister pack carrying a plurality of blisters
containing the medicament; (ii) transporting means adapted for
transporting the blister pack toward opening of the container;
(iii) dispensing means adapted for releasing a fragment of the
blister pack bearing a predetermined number of the blisters from
the container through the opening to a patient; (iv) controlling
means adapted for identifying the patient before dispensing the
blister to the patient, activating the dispensing means, recording
actions of dispensing; (b) providing at least one blister pack
carrying a plurality of blisters accommodating medicament doses;
(c) packaging the substrate; (d) loading the at least one substrate
into the container; (e) identifying the patient when arrived; (f)
dispensing the fragment of the blister pack.
[0042] It is a core purpose of the invention to provide the step of
packaging comprising multiply folding the blister pack. The step of
dispensing comprises cutting off the blister pack fragment carrying
a predetermined number of the blisters.
[0043] A further object of the invention is to disclose the step of
dispensing medication doses performed in intact blisters.
[0044] A further object of the invention is to disclose the method
further comprising a step of monitoring patient compliance with
clinical trial protocol and a treatment program.
[0045] A further object of the invention is to disclose the method
further comprising steps of informing the patient about the
clinical trial protocol, recording actions of dispensing and any
combination thereof and transmitting obtained records to a clearing
house.
[0046] A further object of the invention is to disclose the method
further comprising a step of dispensing a number of medications
performed concurrently and/or consecutively according to a
treatment protocol.
[0047] A further object of the invention is to disclose the method
further comprising a step of broadcasting a message enacting to
take a corresponding dose of medicament according to the treatment
protocol.
[0048] A further object of the invention is to disclose the method
further comprising a step of receiving the message by a mobile
device carried by the patient.
[0049] A further object of the invention is to disclose the step of
receiving the message performed by bracelet carried by the
patient.
[0050] A further object of the invention is to disclose the step of
identifying the patient performed by means of an RFID
technology.
[0051] A further object of the invention is to disclose the step of
transporting the blister pack further comprising a sub-step of
coming cogs of a cogwheel into perforations located on the blister
pack and linearly transporting the substrate along the guide
member.
[0052] A further object of the invention is to disclose the step of
transporting dispensing medication comprising a sub-step of
reciprocatively moving a cutting knife such that the knife cuts off
the fragment of the blister pack carrying the predetermined number
of the medicine doses and the blisters borne by non-foldable
portion are in an intact state.
BRIEF DESCRIPTION OF THE DRAWINGS
[0053] FIG. 1A is an upper view of the blister pack;
[0054] FIG. 1B is a side view of Option a blister pack;
[0055] FIG. 1C-F are schematic views of steps in folding a blister
pack;
[0056] FIG. 2 is an upper view of the first alternative embodiment
of the blister pack;
[0057] FIG. 3A is an upper view of the second alternative
embodiment of the blister pack;
[0058] FIG. 3B is a side view of the second alternative embodiment
of the blister pack;
[0059] FIG. 4 is an upper view of the third alternative embodiment
of the blister pack;
[0060] FIG. 5 is a kinematic scheme of the medicament dispensing
device;
[0061] FIG. 6A is a front view of the medicament container;
[0062] FIG. 6B is a back view of the medicament container;
[0063] FIG. 7 is a schematic view of the medicament dispensing
device;
[0064] FIG. 8 is a front view of the medicament dispensing device;
and
[0065] FIG. 9 is an electric block scheme of the medicament
dispensing device.
DETAILED DESCRIPTION OF THE INVENTION
[0066] The following description is provided, alongside all
chapters of the present invention, so as to enable any person
skilled in the art to make use of the invention and sets forth the
best modes contemplated by the inventor of carrying out this
invention. Various modifications, however, are adapted to remain
apparent to those skilled in the art, since the generic principles
of the present invention have been defined specifically to provide
a device for drug distribution and a method of using thereof.
[0067] Clinical trials which constitute one of the essential and
expensive stages in the continuous process of the medicines
development are the critical stage in developing new medications.
The clinical process phase is defined by the laws of different
states and especially the FDA. The process includes a number of
phases, in which the advance from one stage to another is possible
only if the drug was proven efficacious in an earlier stage. The
clinical trial management must execute the experiment according to
protocols and the current standards (Good Clinical Practice--GCP).
Every year thousand of clinical trials are conduced around the
world, with the participation of hundreds in each trial. It is
crucial to the pharmaceutical companies (sponsors) to reduce the
time and costs of the trial to minimum possible, mainly by (a)
obtaining a full and real knowledge of the participant's compliance
& adherence to the trials protocols; (b) increasing
participant's compliance & adherence to the given medicament;
(c) minimizing the duration of the clinical trial period to a
minimum; and (d) minimizing medication packaging and distribution
costs.
[0068] In accordance with the current invention, a portable
personal computerized device, designated for controlling, timing
and supervision the dispensing of medicament to participants in
clinical trials is disclosed.
[0069] The system is adapted to dispense a number of different
medicines together or separately according to treatment program
(timetable/protocol) and in doses determined by a manager of the
clinical trial. Additionally, the system is adapted for providing
the patient with instructions about a manner of using the
medicaments. Reference is now made to FIGS. 1a and 1b, showing an
elongate blister pack 100.
[0070] The aforesaid pack comprises non-foldable portions 110
bearing blisters 120 accommodating medicament doses 125 and
foldable portions 130 having openings 140. The blisters 120 are
disposed asymmetrically relative to a pack axis 105 so that so that
when the blister pack 100 is multiply folded, the blisters 120 do
not contact each other. The blister pack 100 is provide with
indents 160 adapted for fixing thereof in a moment of cutting off a
predetermined fragment in a dispensing device (not shown).
Perforations 150 punctured along lateral edges are designed for
transporting the blister pack from a container (not shown).
[0071] Reference is now made to FIGS. 1c-1f, presenting stages of
folding the blister pack 100 in a serpentine manner. It should be
emphasized that proposed folding procedure provides space saving
because sides of the non-foldable portions 110 bearing the blisters
120 are faced each other at a distance equal to a blister height,
while opposite sides are adjacent with each other.
[0072] Reference is now made to FIG. 2, showing an embodiment 100b.
The blister pack 100b is adapted for packaging medicament doses
configured as a ball, a drop or any similar shape.
[0073] Reference is now made to FIGS. 3a and 3b, presenting an
alternative embodiment of the current invention 100a. The blister
pack 100a is characterized by laterally disposing the blister 120
with a constant longitudinal shift relative to a geometrical center
115. When the blister pack 100 is multiply folded, the blisters 120
do not contact each other.
[0074] Reference is now made to FIG. 4, showing an embodiment 100c
characterized by both lateral and longitudinal shift from the pack
axis and geometrical center, respectively. It should be appreciated
that the disclosed configuration provides space saving due to
folding the blister pack 100c so that the blisters 120 do not
contact each other.
[0075] Reference is now made to FIG. 5, schematically presenting a
mechanical scheme of the disclosed medicament dispensing device.
The device is powered by an electric motor 310 provided with a gear
wheel 320 mechanically connected to a motor shaft (not shown). The
wheel 320 is engaged with a wheel 340 which is a part of a wheel
pair 330. A pulley 350 transmits a torque from to a pulley 380
which is mechanically connected to a wheel pair 360. Further, the
torque is transmitted from wheel 370 to a pulley 230. As shown in
FIG. 5, the wheel pairs are interconnected by a notched belt 390
engaged with a gear wheel 410. The gear assembly 400 includes the
driving wheels 420 and a driven wheel 410. The aforesaid driven
wheel 210 is engaged with a knife 430 adapted for cutting of a
predetermined fragment of the blister pack 100 due to reciprocative
motion along tracks (not shown). It should be emphasized that the
driving wheel 420 is in a reversible engagement with a notched belt
390 so that the rotational torque is transmitted from the electric
motor 310 discretely.
[0076] A wheel pair 200 driven by the pulley 230 is adapted for
dragging the blister pack 100 along tracks (not shown). Wheels 210
are provided with cogs 220 which adapted for engaging with
perforations 140. The rotating wheels 210 provide dragging the
blister pack according to an arrow downward.
[0077] The mechanical part of the medicament dispensing device
operated as follows. The wheel pair 200 drags out a predetermined
fragment of the blister pack 100 from the container 500 where the
aforesaid blister pack 100 is in a multiply folded state. Further
the knife 430 cuts out the predetermined fragment which is released
to the patient.
[0078] Reference is now made to FIGS. 6a and 6b, presenting an
outside appearance of the container 500. An access into the
container is provided by a top cover 510. On a front face of the
container there are an identification mark 520 and electronic
circuit 530. A dispensing slot 550 provided with tracks 540 and
knife tracks 570 are on the underside of the container 500. Anchor
slots are on the back side.
[0079] Reference is now made to FIG. 7, showing a further
embodiment of the current invention. The medicament dispensing
device 600 comprises a number of containers 500 (two containers are
shown in FIG. 7 in a non-limiting manner), a lever cutting
mechanism 630, central electrical unit 650 and cellular
communication unit (GSM) containing a SIM 640.
[0080] Reference is now made to FIG. 8, showing a further
embodiment of the current invention. The medicament dispensing
device 600 has on the outer surface following elements: a slot for
changing the containers 620, an electrical unit slot 610, USB
connectors 680 for transferring data between the system and an
external computer, an electrical outlet 690 for an external power
unit, slots for Sound System 670, 3 control indicators for the
following states: Working, Failure, Standby 660. Reference is now
made for FIG. 9, presenting an electrical circuit of medicament
dispensing device which the following components: CPU 700, a memory
chip 720, MP3 for broadcasting warnings 810, a control unit
responsible for releasing the pills 770, an RFID identification
system 760, a cellular communication unit (GSM) containing a SIM
820, a backup system 740, a central clock 750. The CPU 700 receives
the time from the central clock 750 and the treatment schedule
recorded on the pill container's chip (not shown). When the time
for dispensing the pills arrives, the system sends an audible
signal using the MP3 810 and/or the special bracelet on the
patient's hand.
[0081] The system identifies the patient with the help of the RFID
760; after the identification, the system activates the pill
dispenser and the appropriate pills are released into the
container. After the patient takes the pills, the system sends an
SMS to the central management facility of the Clinical Trial using
the communication unit 820. If the patient did not take the
medication, the system activates a warning process as explained
below.
[0082] The patient can select from among a number of ring tones;
when the time for taking the medication arrives, the system
activates the tone a number of times and/or activates a special
system that sends a signal to the bracelet on the patient's hand
causing it to vibrate.
[0083] When a signal corresponding to a time of medicament
releasing is received, the RFID system is activated, sends a search
signal and waits for the patient to answer. The patient brings the
RFID tag that he is wearing close to the system and when
identification is made, the system sends a signal to the main
processor 700 to start the process of releasing a pill from the
container. If the patient is not identified within a certain time
period, the system activates a "late process" and patient
reminder.
[0084] If the patient does not identify himself after receiving the
signal and does not remove the medication from the container, the
system sends an audible signal (ring tone) after 30 minutes. If the
patient does not take the medication, the system sends an SMS to
the patient's telephone to remind him. If after 120 minutes the
identification activity has still not been executed, or a pill
taken out, the system sends an SMS to the central management of the
clinical trials.
[0085] The controller 770 receives the command from the CPU 700 to
release the pill from a certain container. The controller activates
the electric motor 780 that causes the container's dispenser to
move.
[0086] When the pill is in place, the cutting mechanism is
activated at the designated cutting line. If the pill gets stuck
for any reason, the system sends an SMS to the central clinical
supply.
[0087] When it is necessary to send an SMS, the system receives the
number of the message that it must send. The CPU 700 finds the
message and phone number that is needed to send the message, from
the system memory 720.
[0088] The system activates the communication system 820 that dials
and sends the message.
[0089] The system calculates the number of pills that remain in the
container. When the number reaches 5 or less, the system sends
messages to the user and to the clinical trial center, warning that
the container will be finished. After the container is emptied, a
similar message is sent. Simultaneously, the date and time when the
container becomes empty is written to the container's memory. When
the container is replaced the system writes the required
information (day, hour, number of patient, number of container,
etc.) to the CHIP on the container.
[0090] In accordance with one embodiment of the current invention,
a medicament dispensing device comprises (a) at least one container
adapted for accommodating and dispensing at least one elongate
packagible elongate blister pack carrying a plurality of blisters
containing the medicament; (b) transporting means adapted for
transporting the blister pack toward opening of the container; (c)
dispensing means adapted for releasing a fragment of the blister
pack bearing a predetermined number of the blisters from the
container through the opening to a patient; and (d) controlling
means adapted for identifying the patient before dispensing the
blister to the patient, activating the dispensing means, recording
actions of dispensing.
[0091] It is a core feature of the current invention to provide the
substrate foldable and configured to be folded within the
container. The dispensing means is adapted to cut off the blister
bearing fragment.
[0092] In accordance with another embodiment of the current
invention, the dispensing means is adapted to cut off the blister
bearing fragment such that the blisters remain intact.
[0093] In accordance with a further embodiment of the current
invention, the blister pack is configured for folding in a manner
selected from the group consisting of a concertina-like substrate,
a serpentine-like substrate, a zig-zag-like substrate and any
combination thereof.
[0094] In accordance with a further embodiment of the current
invention, the device is adapted for monitoring patient compliance
with a clinical trial protocol and a treatment program.
[0095] In accordance with a further embodiment of the current
invention, the controlling means is adapted for performing at least
one function selected from the group consisting of informing the
patient about the clinical trial protocol, identifying the patient
when arrived for taking the medication, recording actions of
dispensing, transmitting obtained records to a clearing house and
any combination thereof.
[0096] In accordance with a further embodiment of the current
invention, the device is adapted for dispensing a number of
medications concurrently and/or consecutively according to a
treatment protocol.
[0097] In accordance with a further embodiment of the current
invention, the controlling means is pre-programmable such that the
controlling means broadcasts a message alerting the patient to take
a predetermined dose of medicament accommodated in the blister
according to the treatment protocol.
[0098] In accordance with a further embodiment of the current
invention, the device further comprises a mobile device configured
to be carried by the patient. The mobile device is adapted for
receiving the message.
[0099] In accordance with a further embodiment of the current
invention, the mobile device is a bracelet carried by the
patient.
[0100] In accordance with a further embodiment of the current
invention, the controlling means is adapted for identifying patient
by means of an RFID technology.
[0101] In accordance with a further embodiment of the current
invention, the transporting means comprises a guide member and a
cogwheel. Cogs of the wheel are adapted for engaging with
perforations located on the blister pack and linearly transporting
the blister pack along the guide member.
[0102] In accordance with a further embodiment of the current
invention, the transporting means comprises a guide member and a
wheel. The wheel adapted for tractably engaging with the blister
pack and linearly transporting the blister pack along the guide
member.
[0103] In accordance with a further embodiment of the current
invention, the dispensing means comprises a cutting knife. The
knife is adapted for reciprocatively moving such that the knife
cuts off the fragment of the blister pack carrying the
predetermined number of the medicine doses.
[0104] In accordance with a further embodiment of the current
invention, a packagible elongate blister pack is adapted for
bearing blisters accommodating medicament doses. The blister pack
is configured for converting into a packaged configuration by means
of multiply folding in a predetermined shape. The blister pack
comprises a plurality of non-foldable portions bearing the at least
one blister mechanically connected in series by means of foldable
portions. The blisters are disposed on the foldable portions in a
staggered arrangement so that when the blister pack is multiply
folded. The blisters do not contact each other.
[0105] In accordance with a further embodiment of the current
invention, the predetermined shape of the foldable blister pack is
selected from the group consisting of a concertina-like shape, a
serpentine-like shape, a zig-zag-like shape and any combination
thereof.
[0106] In accordance with a further embodiment of the current
invention, the blister pack is adapted for transporting thereof by
means a cogwheel along a guide member. The blister pack has at
least one line of perforations. The aforesaid line is directed in
parallel to the blister pack. The perforations are adapted for
engaging with cogs of the rotating cogwheel so that the blister
pack is linearly transported along the guide member.
[0107] In accordance with a further embodiment of the current
invention, the foldable portion is adapted to be cut off such that
the fragment of the blister pack carrying the predetermined number
of the medicine doses within the blisters borne by non-foldable
portion are in a intact state.
[0108] In accordance with a further embodiment of the current
invention, a method of dispensing a medication is disclosed. The
aforesaid method comprises the steps of: (a) providing a medication
dispensing device comprising: (i) at least one container adapted
for accommodating and dispensing at least one elongate blister pack
carrying a plurality of blisters containing the medicament; (ii)
transporting means adapted for transporting the blister pack toward
opening of the container; (iii) dispensing means adapted for
releasing a fragment of the blister pack bearing a predetermined
number of the blisters from the container through the opening to a
patient; (iv) controlling means adapted for identifying the patient
before dispensing the blister to the patient, activating the
dispensing means, recording actions of dispensing; (b) providing at
least one blister pack carrying a plurality of blisters
accommodating medicament doses; (c) packaging the substrate; (d)
loading the at least one substrate into the container; (e)
identifying the patient when arrived; (f) dispensing the fragment
of the blister pack.
[0109] It is a core feature of the invention to provide the step of
packaging comprising multiply folding the blister pack. The step of
dispensing comprises cutting off the blister pack fragment carrying
a predetermined number of the blisters.
[0110] In accordance with a further embodiment of the current
invention, the step of dispensing medication doses is performed in
intact blisters.
[0111] In accordance with a further embodiment of the current
invention, the method further comprises a step of monitoring
patient compliance with clinical trial protocol and a treatment
program.
[0112] In accordance with a further embodiment of the current
invention, the method further comprises steps of informing the
patient about the clinical trial protocol, recording actions of
dispensing and any combination thereof and transmitting obtained
records to a clearing house.
[0113] In accordance with a further embodiment of the current
invention, the method further comprises a step of dispensing a
number of medications performed concurrently and/or consecutively
according to a treatment protocol.
[0114] In accordance with a further embodiment of the current
invention, the method further comprises a step of broadcasting a
message enacting to take a corresponding dose of medicament
according to the treatment protocol.
[0115] In accordance with a further embodiment of the current
invention, the method further comprises a step of receiving the
message by a mobile device carried by the patient.
[0116] In accordance with a further embodiment of the current
invention, the step of receiving the message is performed by
bracelet carried by the patient.
[0117] In accordance with a further embodiment of the current
invention, the step of identifying the patient is performed by
means of an RFID technology.
[0118] In accordance with a further embodiment of the current
invention, the step of transporting the blister pack further
comprises a sub-step of coming cogs of a cogwheel into perforations
located on the blister pack and linearly transporting the substrate
along the guide member.
[0119] In accordance with a further embodiment of the current
invention, the step of transporting dispensing medication comprises
a sub-step of reciprocatively moving a cutting knife such that the
knife cuts off the fragment of the blister pack carrying the
predetermined number of the medicine doses and the blisters borne
by non-foldable portion are in an intact state.
* * * * *