U.S. patent number 5,108,131 [Application Number 07/252,280] was granted by the patent office on 1992-04-28 for method of controlling transmission of defects.
This patent grant is currently assigned to Mainframe Data Limited. Invention is credited to Labib A. Nassim.
United States Patent |
5,108,131 |
Nassim |
April 28, 1992 |
Method of controlling transmission of defects
Abstract
Apparatus useful in preventing or reducing risks of transmitting
an infectious disease, primarily AIDS, or genetic disorder,
comprises identification means such as a personal card bearing
identity particulars of a first participant and security feature(s)
and a storage medium such as a certificate or data based, bearing
legible or retreivable test result data concerning the particular
defect. A second participant consults the result before permitting
intimate contact or accepting a donation of blood, body tissue or
similar material.
Inventors: |
Nassim; Labib A. (Paris,
FR) |
Assignee: |
Mainframe Data Limited (Paris,
FR)
|
Family
ID: |
26291390 |
Appl.
No.: |
07/252,280 |
Filed: |
September 22, 1988 |
PCT
Filed: |
October 05, 1987 |
PCT No.: |
PCT/GB87/00702 |
371
Date: |
September 22, 1988 |
102(e)
Date: |
September 22, 1988 |
PCT
Pub. No.: |
WO88/02700 |
PCT
Pub. Date: |
April 21, 1988 |
Foreign Application Priority Data
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|
|
|
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Oct 7, 1986 [GB] |
|
|
8624013 |
Nov 27, 1986 [GB] |
|
|
8628345 |
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Current U.S.
Class: |
283/70; 283/116;
283/117 |
Current CPC
Class: |
G06K
19/10 (20130101); B42D 25/305 (20141001); B42D
25/22 (20141001); B42D 25/00 (20141001); B42D
2035/08 (20130101); B42D 25/20 (20141001) |
Current International
Class: |
B42D
15/10 (20060101); G06K 19/10 (20060101); B42D
015/00 () |
Field of
Search: |
;40/640
;283/70,76,904,900,116,117 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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|
|
|
|
|
|
2167252 |
|
Jul 1973 |
|
FR |
|
2229099 |
|
Apr 1974 |
|
FR |
|
2092952A |
|
Aug 1982 |
|
GB |
|
Primary Examiner: Bell; Paul A.
Attorney, Agent or Firm: Lowe, Price, LeBlanc &
Becker
Claims
I claim:
1. A method of enabling a reduction in the transmission of a defect
in the nature of a communicable disease or a disorder from a first
participant to a second participant, the defect being transmittable
by a contemplated transfer of body fluid from the first participant
to the second participant, comprising the steps of:
(a) supplying a first person having control over the first
participant with an identification means,
(b) testing the first participant for the defect and deriving a
first indication of the test result,
(c) storing the first indication resulting from the test of step
(b) with a second indication of the identity of the first
participant, the second indication being stored on the
identification means supplied in step (a),
(d) reading the stored first indication for the test on the first
participant immediately prior to a contemplated transfer of the
body fluid from the first participant to the second
participant,
(e) supplying a second person having control over the second
participant with the identification means supplied in step (a) and
with the stored first indication read during step (d) immediately
prior to the contemplated transfer of the body fluid from the first
participant to the second participant, to enable the second person
to make a decision as to whether the second participant is to
engage in an activity with the first participant which will result
in a transfer of the body fluid from the first participant to the
second participant.
2. The method of claim 1 further including storing the first and
second indications on a portable identification medium for the
results of the test for the first participant and the identity of
the first participant, said portable identification medium having
said identification means; supplying said portable identification
medium with the stored first and second indications to the first
person, said portable medium being carried by the first person, the
first person supplying the portable medium with the first and
second indications thereon to the second person in step (e), step
(d) being performed with the first and second indications on the
medium.
3. The method of claim 2 wherein the portable identification medium
is a personal card including a machine readable storage medium
having the test results of step (b) stored therein during step (c),
step (d) being performed by reading the first and second
indications stored during step (c) with a machine reader.
4. The method of claim 1 further including transferring the body
fluid from the first participant to the second participant as a
result of the decision made by the second person being that the
first participant is free of the defect, as indicated by the test
of step (b) on the first participant.
5. A method of enabling a reduction in the transmission of a defect
in the nature of a communicable disease or a disorder from a first
participant to a second participant, the defect being transmittable
by a contemplated transfer of body fluid from the first participant
to the second participant, comprising the steps of:
(a) supplying a first person having control over the first
participant with an identification means,
(b) testing the first participant for the defect and deriving a
first indication of the test result,
(c) storing the first indication resulting from the test of step
(b) in a data base at a data center and a second indication of the
identity of the first participant on the identification means
supplied in step (a),
(d) reading the stored first indication for the test on the first
participant from the data base at the data center immediately prior
to a contemplated transfer of the body fluid from the first
participant to the second participant,
(e) supplying a second person having control over the second
participant with the identification means supplied in step (a) and
with the stored first indication read during step (d) immediately
prior to the contemplated transfer of the body fluid from the first
participant to the second participant, to enable the second person
to make a decision as to whether the second participant is to
engage in an activity with the first participant which will result
in a transfer of the body fluid from the first participant to the
second participant.
(f) communicating the data read at the data center to the second
person via an electromagnetic communication link.
6. The method of claim 5 wherein plural tests are performed from
time to time for the defect on the first participant, the results
of the most recent test being stored as the first indication in the
data base at the data center.
7. The method of claim 6 further including the steps of providing
the first person with a portable card having thereon a secrete
machine readable code with coded indicia providing a right of
access to the data base, step (d) being performed in response to
the coded indicia on the portable card being read by a machine to
derive a signal, and transmitting the thus derived signal to the
data center via an electromagnetic link, and accessing the data
base at the data center in response to the thus derived signal as
transmitted to the data center.
8. The method of claim 6 further including transferring the body
fluid from the first participant to the second participant as a
result of the decision made by the second person being that the
first participant is free of the defect, as indicated by the test
of step (b) on the first participant.
9. The method of claim 6 wherein plural tests are performed from
time to time for the defect on the first participant, the results
of the most recent test being stored as the first indication in the
data base at the data center.
Description
This invention is concerned with methods of preventing or reducing
the risks of transmission of defects from one participant to
another, e.g. from one human being to another human being or to an
organisation. More particularly it is concerned with such methods
of preventing, or substantially reducing the risk of transmission
of a communicable disease or disorder. By communicable disease or
disorder we include, for example infectious ailments be they viral,
bacterial or the like and genetically transmissible disorders.
The invention may find application amongst humans who are
contemplating intimate contact or contemplating donation of body
fluids or material for reception or use by a second participant.
The invention may also be useful to persons or organisations
responsible for such donations as blood banks, hospitals,
transfusion centers, medical teams and the like. The invention
could even be useful in the field of animal husbandry as a means of
controlling undesirable disease or disorder under human supervised
breeding conditions.
Use of the invention may be a systematic control method to help
stop the spread of communicable disease or disorder in which
medical treatment is not required. As will become apparent, the
invention has a principal application in stemming further spread of
sexually communicable diseases amongst humans, notably Acquired
Immune Deficiency Syndrome (AIDS) for which there is currently no
cure and to a lesser extent, the venereal diseases such as
syphilis, gonorrhea or herpes. The invention may also find
application in preventing, or substantially reducing the risks of
transmission of a genetic disorder from one generation to another
e.g. to an offspring of a participant. In this field of hereditary
defects the invention may be useful in controlling such
communicable defects as, for example, mongolism, cystic fibrosis,
haemophilia, diabetes and sickle cell amaemia.
The following terms and expressions are used throughout the
description and claims to include the following:
"First Participant": an individual contemplating intimate contact
with or donation to a second participant; or a first animal for
breeding or donation purposes.
"Defect": communicable disease or disorder being infectious or
genetic which may adversely affect the health or function of an
individual or animal. The term is used to include any sexually
communicable disease amongst living beings, especially AIDS.
"Second Participant": an individual contemplating intimate contact
with a user, a second animal for breeding or donation-receiving
purposes or an individual, group, team, organisation and the like
which receives or monitors donated body fluid or material, or
contemplates such receipt.
As examples of body fluid or material that may be donated we
include human or animal blood that can be used either immediately
or subsequently for transfusion, for conversion into blood products
such as separation into blood plasma, or concentration and
separation in factor VIII, and e.g. bone marrow for immediate or
subsequent transplantation. We also include organs for
transplantation, for example, one kidney from an individual (first
participant) to a related individual (second participant) when both
such individuals are live or posthumous donation of vital organs
such as kidneys, heart, lungs in the event of an untimely death of
first participant. Individuals wishing to donate any such organs
may carry a donor card expressing a wish or preference for a
donation or, alternatively, the decision to donate may be made by
representatives of the donor, for example, the parents (as second
participants in a monitoring function) of an individual recently
killed. Before a medical team may wish to use any donated organs
they may require up-to-date information in respect of potentially
damaging defects such as contamination by the AIDS virus or subject
to haemophilia genetic disorder and the like.
As a suitable body fluid which may be donated by individuals or
animals we also include semen which may be stored in a sperm bank
and used for artificial insemination. It may be advantageous for
the recipient (second participant) of such semen to have up to date
information in respect of any required defect by having access to a
test result in respect of that defect for such donated
material.
The invention is useful in preventing transmission of disease or
disorder from a potential carrier, which may be anyone or any
animal within a given population, to a potential recipient of that
disease or disorder. The invention may therefore be useful to
people concerned with animal husbandry but principally to
individuals as first and second participants contemplating intimate
contact where there exists a risk of acquiring an infectious
disease. As will become apparent this can be provided by
independent test result for assessment by a second participant.
In many countries there is considerable anxiety over the spread of
the communicable disease known as AIDS. Three possible methods of
controlling the spread include find a cure, find a vaccine or
separate the AIDS infected carriers from intimate or other risky
contact with the rest of the population. The first two solutions
are currently considered to be unobtainable in the immediate
future. The separation proposal has been the only practicable step
at the present time.
The importance of controlling further spread of AIDS into the
non-AIDS infected population is becoming more and more important in
the United Kingdom and is already a problem in countries such as
the United States where many persons are AIDS infected.
The majority of organised attempts to isolate carriers of the AIDS
human immunodeficiency virus HIV from the contact with the
remaining population have been directed at isolating the sick from
the healthy, i.e. those infected from those who are not. The AIDS
virus has a long incubation period and for this reason any control
measures are likely to affect the sensitive issue of personal
liberty. The present invention is based on a surprisingly different
approach to the problem in that it is concerned with isolating the
healthy from the sick rather than the converse. Any attempts by
individuals to isolate themselves from potential or actual carriers
of AIDS have been haphazard. It has been observed that individuals
at risk of contacting AIDS have limited the number of intimate
contacts made with others.
Use of the present invention permits a still further and
significant reduction of risks and therefore may save lives and
reduce anxiety and stress amongst individuals who use the apparatus
and/or method according to the invention.
According to this invention there is provided a method of
controlling transmission of a defect from a first participants to a
second participants comprising:
(a) supplying the first participant with identification means,
(b) performing a test for presence or absence of the defect upon or
in relation to the first participant,
(c1) producing in legible or retrievable form a test result in a
storage medium identifying the first participant or (c2) storing
the test result in a database followed by (c3) retrieval of that
result,
(d) informing the second participant of the test result,
(e) establishing an accept or reject decision by or on behalf of
the second participant, and
(f) permitting contact between first and second participant or
donation from first to second participant if step (e) results in a
decision to accept.
Optionally the first participant may repeat that test or have a
different test for another communicable disease or disorder
performed at any stage after (a). Furthermore, the first
participant may decide to terminate the sequence before step (d) if
the particular test is unfavorable, e.g. after a diagnosis of AIDS
antibody positive.
In step (c1) of the method the result may be stored legibly on an
independently issued certificate and this proof of result may be
presented to or sent to the individual (first participant)
immediately upon completion of the test. The individual will then
be at liberty to disclose this to any second participant of his
choosing. Alternatively, the test result may be stored on or in
electronic, optical or magnetic storage medium such as a database
and subsequently retrieved by the second participant with express
or implicit permission from the first participant. This may be
achieved by the second participant interrogating the appropriate
storage medium to retrieve the result and possibly have a permanent
record of it by certificate, print out or the like. This may be
done in the presence of the first participant or by furnishing
consent to a data center operator who stores a plurality of test
results on a specific database. A second participant may be given a
secret access code from the first participant to retrieve the test
result from the storage medium (e.g. database) without the
intermediary of an operator.
Such interrogation of a database may produce a result by audio
and/or visual means such as, for example, a printed record being
obtained at the request of the recipient.
It may be convenient for the identification means to comprise a
personal identity card similar to plastic credit cards in common
use. The identity information may include a photograph, a name, a
legible code and/or a secret code. Examples of security features
include predetermined patterns and/or holograms. The storage medium
may simply comprise paper such as a certificate bearing a legible
test result giving date, type and result of test, plus information
identifying the first participant. Alternatively the storage medium
may be electronic, optical or magnetic, in which case the test
result would be retrievable and then could be made permanently
legible if desired.
In one embodiment the identification means is a personal card
bearing a magnetic strip having the test result stored on it. The
result can be retrieved subsequently.
One convenient test for a first participant is carried out on a
blood sample, e.g. the test for AIDS antibodies. The present
apparatus and method is especially useful in controlling the
further spread of sexually transmissible disease or disorder.
The present apparatus can be used in conjunction with means for
retrieving a non-legible test result carried on the storage medium.
For example an electronic decoder and display unit optionally with
printing means.
In order that the invention may be illustrated and readily carried
into effect, embodiments thereof will now be described by way of
example only with reference to the accompanying drawings, in
which:
FIG. 1 includes illustrations of a front and reverse sides of an
identification means preferably used with the present
invention,
FIG. 2 is a diagram of a storage medium carrying legible test
result, and
FIGS. 3 and 4 are flow charts of methods that may be carried out
using the apparatus features.
FIGS. 1 and 2 relate to structures to be used immediately prior to
contemplated or to proposed intimate contact between a first
participant and a second individual participant. It may equally
apply with some modifications where intimate contact is proposed
between animals, under human-supervised breeding conditions or for
establishing the suitability of donated body fluid or material for
subsequent transfusion or other use. All participants may subscribe
to a defect screening system in which a data center, controlled by
an operator, stores test results on a database and permits
retrieval of results under authorised terms.
The first participant is provided with a card similar to a credit
card 1. The card has a legible code 4, a secrete code 7
(invisible), a photograph 2 of the holder, and a hologram (not
shown). It should be noted that the name and signature of the user
are unnecessary. The card also has a logo 3, an address 5 and
telephone number 6 of a data center which stores the test
results.
The first participant has his blood tested at least once,
preferably periodically, at a suitable location e.g. one approved
by the above noted screening system operator. The data center would
verify the authenticity of the card and note the legible code. The
result of the test, the type of test, the date of the test and the
code on the card would be sent to the operator if it is to be
stored on a database for subsequent retrieval. This information
could even be applied to a magnetic electronic or optical recording
strip on one side of the card (not shown).
Instead of storage the test result can be compiled as a
certificate, see FIG. 2, which shows a tangible certificate 8
having optional logo 3, photograph 2 of first participant, security
feature 4, date of test 9, type of test 10 and result of test 11.
This certificate can be retained by the first participant.
At any time that the first participant may wish to establish
absence of a defect to a second participant he may interrogate this
database in the presence of that second participant or otherwise
expressly consent to interrogation in his absence. The secrete code
may be used to give right of access to this database. An
alternative way of presenting this data after retrieval would be
for a data center operator to produce on demand, a certificate
explaining the test results of the first participant. At any time
desired the first participant may show this certificate of
independent test to a second participant to establish absence of
defect. At that time a more informed decision to permit intimate
contact or accept donation can be made thus helping control of the
particular disease of disorder tested.
It should be the responsibility of the second participant to
interpret test results to determine whether intimate contact or
receipt/use of donation can be permitted.
Plastic cards are only one of many possible identification means to
establish a link between a first participant, the test result, the
second participant and the storage means, e.g. database.
Operators may wish to communicate anonymous data across regions and
countries in order to improve the method and freedom of first
participants.
Many feasible ways exist for presenting test result data in such a
way as to enhance the ease of use while preventing fraud. For
example, by telephone, by videotex, by certificate and the
like.
Participants using the apparatus and method may therefore make
substantial contributions to controlling the spread of communicable
disease or disorder and consequently enhancing the health and well
being of the human or animal population.
For a general application of the method which illustrates the use
of the apparatus the reader is referred to FIG. 3 whilst for a more
specific example, based on the FIGS. 1 and 2 apparatus the reader
is referred to FIG. 4. The flowcharts themselves are
self-explanatory with an index given relating to each particular
step in the method as defined above.
The invention can be seen to involve testing of living beings or
live organs or useful body fluid/material for certain physical
parameters and a secure system of passing information to
individuals or groups etc. at the choice of the first
participant.
Testing for presence or absence of defects is meant to include all
means and methods for performing such tests, for example by testing
samples of blood, urine, skin, flesh, organs, semen, breath, hair
or nails. In some cases certain tests may not require removal of a
sample but these may be performed in situ.
An important application of the present invention is in the
screening of blood donations by blood banks acting as second
participants. Present arrangements for screening are not altogether
satisfactory and in certain countries blood is donated for
financial reward. In such a situation the donors (first
participants) can be infected by a communicable disease such as
AIDS or hepatitis virus but the blood bank unknowingly accepts
their donation and payment is made. It is only after payment that
such blood is tested and sometimes destroyed because of the
presence of a potentially harmful defect.
By using the present apparatus or method these unnecessary expenses
and risks may be circumvented, particularly if the test results are
securely stored on a database and access thereto is carefully
controlled.
The data center, if used, may pair or twin participants by e.g.
supplying both participants' identity card numbers to the operator.
When such links are present in the data center all such
participants may be notified who could have become infected by e.g.
AIDS virus through contact with other participants. When the
participant interrogates their own data, they may receive a warning
to have medical attention and/or exercise caution in future
intimate contacts or donations.
* * * * *