U.S. patent application number 14/828983 was filed with the patent office on 2016-09-15 for specimen observation, collection, storage and preservation device and method of use.
The applicant listed for this patent is My EcoHealth, LLC. Invention is credited to Rachell A Ekroos, Erik J Ernst, Diana Faugno, John M Hawkins, Glenda Beth Horn Herring, Stacey A. Mitchell, Jonathan M. Speck, Ronald L. Speck.
Application Number | 20160262730 14/828983 |
Document ID | / |
Family ID | 51841801 |
Filed Date | 2016-09-15 |
United States Patent
Application |
20160262730 |
Kind Code |
A1 |
Speck; Jonathan M. ; et
al. |
September 15, 2016 |
SPECIMEN OBSERVATION, COLLECTION, STORAGE AND PRESERVATION DEVICE
AND METHOD OF USE
Abstract
The devices and methods taught in this disclosure are directed
to facilitate the observation, collection, transportation, storage,
and preservation of specimens possibly containing DNA, said
specimens potentially constituting evidence of sexual assault. The
devices and methods described further allow for a means of
minimizing the possibility of specimen contamination, dilution, or
degradation during the collection and storage processes. The
disclosed devices may contain electrical components that provide
for the generation and recordation of information (specifically,
times, dates, and locations) related to circumstances surrounding
the collection of such specimens. This information may serve as
evidence corroborating the circumstance of specimen collection, it
may help to maintain a known and identifiable Chain of Custody
(CoC), and it may additionally be used for unique device
identification (UDI), inventory control, and current procedural
terminology (CPT) coding purposes.
Inventors: |
Speck; Jonathan M.;
(Memphis, TN) ; Speck; Ronald L.; (Memphis,
TN) ; Horn Herring; Glenda Beth; (Gulf Breeze,
FL) ; Faugno; Diana; (Palm Desert, CA) ;
Ekroos; Rachell A; (Henderson, NV) ; Mitchell; Stacey
A.; (Magnolia, TX) ; Ernst; Erik J; (San
Diego, CA) ; Hawkins; John M; (Covington,
GA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
My EcoHealth, LLC |
Memphis |
TN |
US |
|
|
Family ID: |
51841801 |
Appl. No.: |
14/828983 |
Filed: |
August 18, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14267818 |
May 1, 2014 |
9265580 |
|
|
14828983 |
|
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61818070 |
May 1, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2010/0003 20130101;
A61B 2010/0006 20130101; G06Q 10/1095 20130101; A61B 50/30
20160201; A61B 2010/009 20130101; A61B 10/0058 20130101; A61B
2010/0074 20130101; A61B 10/0291 20130101; A61B 2010/0216 20130101;
A61B 10/0096 20130101; A61B 1/06 20130101 |
International
Class: |
A61B 10/00 20060101
A61B010/00; G06Q 10/10 20060101 G06Q010/10; A61B 1/06 20060101
A61B001/06 |
Claims
1. A specimen-collection device for observing, collecting,
securing, and preserving DNA-containing material potentially
constituting evidence of a sexual assault, said device comprising:
an outer sheath for insertion into a human body cavity, said an
outer sheath having an oblong shape, an interior volume, and a
longitudinal axis; an inner sheath for retaining a specimen
collector and specimen in a sealed environment, disposed within
said inner volume of said outer sheath, said inner sheath having an
interior volume, wherein said inner sheath is movable along said
longitudinal axis into and from said interior volume of said outer
sheath; a specimen collector for collecting specimens comprising
DNA-containing material, said specimen collector disposed within
said interior volume of said inner sheath, wherein said specimen
collector is movable along said longitudinal axis into and from
said interior volume of said inner sheath; a cap for preventing
exposure of said interior volume of said inner sheath to a volume
exterior to said specimen-collection device when said cap is in a
closed configuration, said cap coupled to an end of said inner
sheath, wherein said cap is openable to accommodate passage of said
specimen collector to said volume exterior to said
specimen-collection device when said specimen collector is in an
extended position, and wherein said cap is closeable to prevent
exposure of said specimen collector to the volume exterior to said
specimen-collection device when said specimen collector is in a
retracted position; an actuation mechanism for moving said inner
sheath into and from said interior volume of said outer sheath, for
moving said specimen collector into and from said interior volume
of said inner sheath, and for opening and closing said cap to
accommodate movement of said specimen collector, said actuation
mechanism being arranged relative to said actuator, said cap, said
specimen collector, said inner sheath, and said outer sheath; an
actuator for operating said actuation mechanism, wherein said
actuator is coupled to said actuation mechanism, whereby actuation
of the actuator engages said actuation mechanism moves said
specimen collector along said longitudinal axis, between a
retracted position and an extended position relative to said inner
and outer sheaths; a circuit for identifying information related to
use of said specimen-collection device, said information comprising
one or more parameters selected from the group consisting of: a
time for establishing the time when said specimen-collection device
is used to collect a specimen; a location for establishing the
location of said specimen-collection device when said
specimen-collection device is used to collect a specimen; a date
value for establishing a year, month, and day when said
specimen-collection device is used to collect a specimen; and
security information for determining whether a specimen collected
by said specimen-collection device has been accessed, or otherwise
tampered with, after its collection; a memory for recording said
information related to use of said specimen-collection device
identified by said circuit; a processor for transferring said
information related to use of said specimen-collection device from
said circuit to said memory; a switch for triggering said circuit
to identify said information related to use of said
specimen-collection device, and for triggering said information
related to use of said specimen-collection device to be recorded in
said memory; and a power source for supplying electrical power to
said circuit, said processor, and said memory, said power source
being electrically connected to said circuit, said processor, and
said memory.
2. A specimen-collection device for the collection organic,
inorganic, and non-organic material, said device comprising: an
outer sheath having an oblong shape, an interior volume, and a
longitudinal axis; an inner sheath having an interior volume,
disposed within said inner volume of said outer sheath, wherein
said inner sheath is movable along said longitudinal axis into and
from said interior volume of said outer sheath; a specimen
collector disposed within said interior volume of said inner
sheath, wherein said specimen collector is movable along said
longitudinal axis into and from said interior volume of said inner
sheath; a cap coupled to an end of said inner sheath, wherein said
cap is openable to accommodate passage of said specimen collector
to a volume exterior to said interior volume of said inner sheath
when said specimen collector is in said extended position, and
wherein said cap is closeable to prevent exposure of said specimen
collector to the volume exterior to said specimen-collection device
when said specimen collector is in said retracted position; an
actuation mechanism for moving said inner sheath into and from said
interior volume of said outer sheath, for moving said specimen
collector into and from said interior volume of said inner sheath,
and for opening and closing said cap to accommodate movement of
said specimen collector; and an actuator for engaging and operating
said actuation mechanism, wherein said actuator is coupled to said
actuation mechanism, whereby actuation of the actuator engages said
actuation mechanism and moves said specimen collector along said
longitudinal axis between a retracted position and an extended
position relative to said inner and outer sheaths.
3. The specimen-collection device of claim 2, further comprising: a
circuit for identifying information related to use of said
specimen-collection device, said information related to use of said
specimen-collection device comprising one or more parameter
selected from the group consisting of: a time; a location; a date;
and security information; a memory in communication with said
circuit, wherein said memory is configured to record said
information identified by said circuits; a processor in
communication with said circuit and said memory, said processor
configured to transfer said information from said circuit to said
memory; a switch coupled to said circuit, wherein activation of
said switch causes said information related to use of said
specimen-collection device to be identified by said circuit and
recorded in said memory; and a power source in electrical
communication with said circuit, said processor, and said memory,
wherein said power source is configured to supply electrical power
to said circuit, processor, and memory.
4. The specimen-collection device of claim 3, further comprising a
transmitter in communication with said processor, wherein said
transmitter is configured to transmit said information related to
use of said specimen-collection device identified by said circuit
through a network to a remote computing device.
5. The specimen-collection device of claim 3, wherein said circuit,
memory, processor, and power source are contained within the
structure of said specimen-collection device.
6. The specimen-collection device of claim 3, wherein said security
information enables said specimen-collection device to be uniquely
identifiable.
7. The specimen-collection device of claim 2, wherein said outer
sheath has a diameter ranging between approximately a fraction of
an inch and approximately three inches.
8. The specimen-collection device of claim 2, further comprising
one or more additional inner sheaths, said one or more additional
inner sheaths having progressively decreasing dimensions, and
wherein said more than one inner sheaths having progressively
decreasing dimensions are disposed of inside of and extendable from
one another in a telescoping fashion.
9. The specimen-collection device of claim 2, wherein said inner
sheath, said specimen collector, said cap, said actuation
mechanism, and said actuator are removable from and insertable into
said outer sheath.
10. The specimen-collection device of claim 2, wherein said
specimen collector has a length ranging between fractions of an
inch and approximately four inches.
11. The specimen-collection device of claim 2, wherein said
actuator has a length between approximately two and approximately
eight inches.
12. The specimen-collection device of claim 2, wherein said device
is configured for self-collection.
13. The specimen-collection device of claim 2, further comprising a
lock coupled to said cap, wherein said lock is configured to secure
said device in said retracted position.
14. The specimen-collection device of claim 2, wherein said
actuator is actuated electrically.
15. The specimen-collection device of claim 2, further comprising a
seal arranged between said inner sheath and said cap, whereby said
seal prevents said specimen collector from being in contact with a
volume external to said interior volume of said inner sheath when
said cap is in a closed position.
16. The specimen-collection device of claim 2, wherein said
actuator comprises a rod having a handle, and wherein said rod is
fixedly attached to said specimen collector.
17. The specimen-collection device of claim 2, further comprising a
light.
18. The specimen-collection device of claim 15, wherein said light
is detachable from said specimen-collection device.
19. The specimen-collection device of claim 2, wherein said
specimen-collection device is disposable after a single use.
20. The specimen-collection device of claim 2, wherein said
specimen-collection device is sterilizable and reusable.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of and claims priority to
U.S. Non-Provisional patent application Ser. No. 14/267,818, filed
May 1, 2014 which is hereby incorporated by reference in its
entirety. This application claims priority to U.S. Provisional
Patent Application Ser. No. 61/818,070, filed May 1, 2013, which is
also hereby incorporated by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present disclosure relates to devices for the
observation, collection, storage, and preservation of specimens and
the methods of their use. More precisely, the present disclosure
relates to devices and the methods of their use for the
observation, collection, storage, and preservation of specimens
that may constitute evidence, including, but not limited to,
biologic specimens that may contain deoxyribonucleic acid (DNA),
and/or non-biological materials that may include chemical elements,
including minerals and yet unknown particles. The disclosed devices
and methods further provide for the incorporation of electrical
circuits that may identify, record, and transmit information
related to the device's use, for the purposes of corroborating
specimen collection, and means for device identification and
tracking for facilitating chain of custody (CoC) creation and
maintenance, current procedural terminology (CPT) coding, inventory
control, and for complying with unique device identification (UDI)
regulations as set forth by the United States Food and Drug
Administration (FDA). The specimens collected may be part of
evidence related to crimes specifically including, but not limited
to, sexual assault. Additionally, the specimens collected may
provide diagnostic testing as part of a woman's well woman exam or
in order to diagnose a sexually transmitted infection related to a
gynecological complaint.
BACKGROUND OF THE INVENTION
[0003] For the purposes of clarity, when interpreting the
disclosure contained in this document, several terms will be
defined before their use. When used herein "sexual assault" is to
be interpreted broadly in order to encompass rape and sexual
assault as defined by the Bureau of Justice Statistics whose
definitions are to follow. According to the Bureau of Justice
Statistics, "rape" is defined as "[f]orced sexual intercourse
including both psychological coercion as well as physical force.
Forced sexual intercourse means penetration by the offender(s).
Includes attempted rapes, male as well as female victims, and both
heterosexual and homosexual rape"; and "sexual assault" is defined
as "[a] wide range of victimizations, separate from rape or
attempted rape. These crimes include attacks or attempted attacks
generally involving unwanted sexual contact between victim and
offender". This definition of sexual assault as it is used in the
disclosure made herein should be considered to further include any
of the aforementioned events perpetrated against gay, bisexual,
lesbian, transgendered, and questioning (GBLTQ) individuals. The
term "evidence", when used herein, should be interpreted so as to
include any material that may provide for specimens that may
potentially contain either DNA or other information that may be
pertinent to a controversy. The term "degradation", as used in this
disclosure, should be interpreted as any loss of integrity or
quality. Additionally, for the purposes of interpreting the
disclosure made herein, the terms "component" and "module", or
derivations thereof, as well as "sample" and "specimen", or
derivations thereof, are used interchangeably and should be
considered synonymous.
[0004] Unless otherwise defined, all terms (including technical and
scientific terms) used herein have the same meaning as commonly
understood by one of ordinary skill in the art to which this
disclosure belongs. It will be further understood that terms, such
as those defined in commonly used dictionaries, should be
interpreted as having a meaning that is consistent with their
meaning in the context of the relevant art and the present
disclosure, and will not be interpreted in an idealized or overly
formal sense unless expressly so defined herein.
[0005] Specimens, including those that may include DNA, may be
retrieved from one or more of any number of areas including, but
not limited to, body cavities for some time following their
deposition or exchange, and from environments with non-biological
chemical elements, including but not limited to areas outside the
body. Specimens containing DNA obtained immediately after, or
proximate to, an incident stand the highest chances of producing
meaningful results; however, despite this, specimens obtained up to
one week after their deposition still may have up to approximately
an 80% chance of producing a positive result for present DNA using
state of the art analysis technology (e.g. enhanced Y-chromosome
short tandem repeat (Y-STR) analysis, etc.). The chances of
successful collection of viable DNA from these specimens decline at
a rate of approximately 20% for each week that passes between
specimen deposition and collection. As a result of continuing
improvements in DNA analysis, it is possible that specimens
obtained even 4 weeks following an incident still have a 20% chance
of yielding viable DNA that could be analyzed in order to yield a
DNA profile.
[0006] Locard's principle holds that the perpetrator of a crime
will bring something into the crime scene and leave with something
from it, and that any materials exchanged in such a manner may be
used as forensic evidence. Should bodily fluids containing DNA of
the perpetrator be deposited in, on, and/or near a victim, to
increase the likelihood that authorities may identify a
perpetrator, evidence should be collected in a timely fashion
without dilution or contamination. Furthermore, the collected
specimen must remain non-diluted and contaminant-free, while
maintained and handled within a regimented, identifiable, and
documented chain of custody (CoC) until analysis, in accordance
with standard operating procedure (SOP), may be completed. The
device(s) used to collect all relevant specimen(s) may additionally
comport with current and forthcoming Unique Device Identification
(UDI) regulations as defined by the United States Food and Drug
Administration (FDA).
[0007] Few people who are victims of sexual assault possess the
training to successfully collect a specimen from their own body
that could potentially contain a sexual assault perpetrator's DNA.
Additionally, even if a victim of a sexual assault knows how to
collect a specimen that may contain DNA, it is unlikely that they
will have immediate access to tools for specimen collection and
preservation at, or immediately following, the time of the assault.
Furthermore, devices currently employed in the art are not
constructed for self-collection by the victim, but rather for use
by a qualified, trained medical professional in a setting that has
specialized exam tables and other apparatus. This, combined with
the awkward ergonomics of these devices in the self-collection
context, make self-collection of such specimens difficult, if not
impossible.
[0008] Frequently, a specimen becomes contaminated through the
collection process itself, rendering that evidence of little to no
use. Contamination may obscure or obliterate a perpetrator's
potential identification. Specimens may become contaminated,
diluted, or suffer degradation despite being collected in a timely
and skillful manner if the specimen is not transported, handled,
stored, and analyzed effectively.
[0009] Packaging, handling, transportation, and/or storage of
collected specimens are usually necessary before the collected
specimen can be tested, examined, and otherwise analyzed in
accordance with SOPs. During packaging, handling, transportation,
handling, and/or storage, collected specimens may suffer
contamination, dilution, or degradation, even if the collected
specimens had been properly collected. In court cases where DNA
evidence is being introduced, improper or procedurally proper but
ineffective methods of storing the DNA evidence may be introduced
to challenge the validity of the evidence and/or the associated
test results. There are several ways that these can be challenged:
a) the methods not being properly followed, b) the results not
being properly applied, or c) the current method itself being
ineffective. Therefore, it is important to have collected specimens
retained in such a manner consistent with standardized policies and
procedures for analysis so as to best preserve specimens until such
time as described in analysis and storage policies and
procedures.
BRIEF SUMMARY OF THE INVENTION
[0010] The purpose of this summary is to present integral concepts
in a simplified form as a prelude to the more detailed disclosure
that is presented herein.
[0011] Disclosed herein is an explanation of how to make and use a
specimen-collection device for observing, collecting, securing,
transporting, and preserving material potentially containing DNA or
other information related to a controversy that could potentially
constitute evidence of a sexual assault. Embodiments of the
specimen-collection device may comprise an outer sheath, an inner
sheath, a specimen collector, an actuator, a cap, an actuation
mechanism, a circuit, a memory, a processor, a switch, and a power
source. The outer sheath may have a generally oblong shape for
insertion into a human body cavity and an interior volume inside of
which other parts of the specimen-collection device may be
retained. The inner sheath may be disposed of inside of the
interior volume of the outer sheath, and may be movable such that
it may extend partially outside of the inner volume of the outer
sheath in a telescoping fashion. The interior volume of the inner
sheath may be configured to retain the specimen collector and any
specimens it has collected in a sealed environment, while the inner
sheath is closed. The specimen collector may be disposed inside of
the interior volume of the inner sheath, and may be movable such
that it may extend partially outside of the interior volume of the
inner sheath in a telescoping fashion. The actuator is a portion of
the specimen-collection device that may be operated by the device's
user. Actuation of the actuator may cause the actuation mechanism
to extend the inner sheath from the interior volume of the outer
sheath, with further (or an alternate method of) actuation of the
actuator causing the actuation mechanism to open the cap and extend
the specimen collector from the interior volume of the inner
sheath. The actuation mechanism may also cause the closing of the
cap and retraction of the specimen collector and inner sheath, when
the actuator is actuated in reverse. The cap may be positioned at
the end of the inner sheath. The cap may be openable to allow for
the specimen collector to extend from the interior volume of the
inner sheath, and it may be closeable to allow for the specimen
collector and any collected specimen to be sealed inside of the
interior volume of the inner sheath, thereby protecting the
collected specimen from contamination, dilution, and/or
degradation. The circuit may identify information related to the
operation of the specimen-collection device; including information
related to the time and date of the specimen-collection device's
use, the location where the specimen-collection device was used,
and security information. The circuit may identify such information
in response to the activation of the switch. Activation of the
switch may be triggered by actuation of the actuator, opening
and/or closing of the cap, or any number of other actions
associated with operation of the specimen-collection device. The
processor may take the information identified by the circuit in
response to activation of the switch and transfer it to the memory.
The memory may record the information identified by the circuit.
The power source may provide electrical power, including
low-voltage electrical power, to the electronic components of the
specimen-collection device.
[0012] This disclosure further provides details related to such
specimen-collection devices and methods for observing, collecting,
handling, transporting, storing, and preserving evidentiary
specimens, including those that contain DNA, cellular, or other
material, while protecting them from contamination, dilution, or
degradation. This disclosure additionally delineates a means for
generating, recording, and/or transmitting corroborating evidence
related to specimen collection, as well as a means for device
identification and tracking to comport with FDA UDI regulation and
to assist with CoC validation, current procedural terminology (CPT)
coding, and inventory control.
[0013] Collected specimens refer specifically to specimens,
including but not limited to, specimens of bodily fluids or
surfaces potentially having DNA-containing material that may be
collected from body cavities, body surfaces, and/or surfaces in the
environment. Such specimens may constitute evidence of a sexual
assault.
[0014] The disclosed devices allow for storage of collected
specimens in a manner that protects them from contamination,
dilution, and/or degradation. Specimen integrity would thereby be
best-maintained by crime scene analysts and/or laboratory personnel
using proper packaging, handling, and storage methods in accordance
with specimen collection and laboratory SOPs. These specimens could
then potentially be available for later forensic or medical
analysis, evidentiary use, etc.
[0015] Embodiments of this disclosure may be used in conjunction
with bona fide scientific methods to collect specimens that may
have been deposited in sexual assault victims 6 weeks, or longer
prior to its collection, or specimens that may have been deposited
on surfaces months prior to their identification and
collection.
[0016] Some embodiments provide specimen-collection devices
comprising a specimen collector, two or more sheaths, and an
actuator. The specimen collector defining a longitudinal axis while
the inner sheath is disposed about and spaced apart from the
specimen collector, and the outer sheath is disposed about the
inner sheath. The complete specimen-collection device may be
specifically shaped and dimensioned for insertion into a particular
body cavity.
[0017] The specimen-collection device may be configured as a
roughly cylindrical sheath, inside of which one or more additional
inner sheaths may be retained. Upon the actuation of an actuator, a
portion or more of one or more of the inner sheaths may extend past
the terminal end of the outer sheath in a telescoping fashion. An
alternate method of actuating the actuator, or other further
actuation of the actuator, may cause a specimen collector that is
as of yet unexposed to the volume exterior to the most inner sheath
to become exposed at the terminal end of the telescoped sheaths.
The specimen collector should only be exposed when the terminal end
of the telescoped most inner sheath is in proximity (proximity
being considered a distance ranging from approximately fractions of
an inch to approximately twelve inches) to the specimen collection
site. After the specimen has been collected, but while the specimen
collector is still in proximity to the specimen collection site,
the actuator may be actuated in a reverse manner, causing the
retraction of the specimen collector into the interior volume of
the most inner sheath. By exposing the specimen collector only
while in proximity to the specimen collection site, the user of the
device may avoid possible contamination or dilution of the
collected specimen during the placement of the device in proximity
to the specimen collection site, or removal of the device from the
specimen collection site. Once the specimen collector is retracted
into the most inner sheath, the actuator may be further actuated in
a reverse manner, causing the telescoping inner sheaths to be
retracted into one another, and into the interior volume of the
outer sheath. Once retracted, the device may be removed from the
sample collection site without contaminating or diluting, the
collected specimen during the device's withdrawal.
[0018] Specimen-collection devices disclosed herein need not be of
a single defined shape or dimension; rather, the specific shape
and/or dimensions of embodiments of such devices may vary in
accordance with the specimen to be collected and/or the environment
of the specimen to be collected.
[0019] Having embodiments of the disclosed specimen-collection
device available in a variety of sizes allows for increased
comfort. Multiple sizes allow for an individual or their physician
or health care provider to use the device with the most appropriate
dimensions depending on the body cavity from which the specimen is
to be collected and/or the individual's height, weight, number of
vaginal deliveries, sexual experience, and/or other factors
affecting comfort. An individual would be more likely to use a
specimen-collection device configured for self-collection when
empowered with multiple size choices for comfort and to avoid
injury. Furthermore, a properly-sized specimen-collection device
would reduce the likelihood of contamination of the specimen.
[0020] Embodiments of the present disclosure may include additional
structures for identifying, recording, and transmitting information
related to the specimen-collection device's use. These structures
may include, but are not limited to, circuits, including timing
circuit(s), location sensing circuit(s), and/or security
circuit(s). Additionally, embodiments may provide for a processor
and memory in communication with the aforementioned circuit(s),
which may be configured to record information related to the
specimen-collection device.
[0021] A security circuit may be configured to monitor and/or
regulate access to, or modification of, any information stored in
the memory (e.g. a dielet).
[0022] The security circuit may enable each specimen-collection
device to be uniquely identifiable, and more specifically uniquely
identifiable in a manner that comports to FDA UDI regulations. By
enabling each individual specimen-collection device to be uniquely
identified and monitored the security circuit may allow for CoC
initiation and corroboration, while additionally facilitating
inventory control, and CPT coding.
[0023] Inventory control may be achieved by having a database
monitor the uniquely identified specimen-collection devices and
notify appropriate personnel or an inventory management system,
when the number of such devices in inventory falls below a
predetermined number. Alternatively, the database may be configured
to automatically order additional devices when it detects that the
number of devices in inventory has fallen below a predetermined
threshold.
[0024] The security circuit may facilitate the specimen-collection
devices' conformity with FDA UDI regulations. These regulations
imposed by the FDA mandate that medical devices have a means for
UDI. FDA UDI regulations are set forth in Unique Device
Identification System, 78 Fed. Reg. 58785 (Sep. 24, 2013) which is
hereby incorporated by reference in its entirety. The same security
circuit that may enable identification and tracking of each of
these specimen-collection devices may be configured to enable the
device to conform to FDA medical device UDI regulations.
[0025] Descriptions of certain illustrative aspects are described
herein in connection with the annexed FIGURES. These aspects are
indicative of various non-limiting ways in which the disclosed
subject matter may be utilized, all of which are intended to be
within the scope of the disclosed subject matter. Other advantages,
emerging properties, and features will become apparent from the
following detailed disclosure when considered in conjunction with
the associated FIGURES that are also within the scope of the
disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The disclosed subject matter itself, as well as a preferred
mode of use, further objectives, and advantages thereof, will best
be illustrated by reference to the following detailed description
of embodiments of the device read in conjunction with the
accompanying FIGURES, wherein:
[0027] FIG. 1 depicts a cross-sectional view of a
specimen-collection device in a closed configuration.
[0028] FIG. 2 depicts a cross-sectional view of a
specimen-collection device in a partially open configuration,
wherein a portion of an inner sheath has extended outside of the
outer sheath in a telescoping fashion, but remains closed.
[0029] FIG. 3 depicts a cross-sectional view of a
specimen-collection device in a fully open configuration wherein a
portion of an inner sheath has extended outside of the outer sheath
and is open and unsealed, and where the specimen collector is
extended, exposed, and ready to receive a specimen.
[0030] FIG. 4 depicts an exterior view of a specimen-collection
device when in a closed configuration.
[0031] FIG. 5 depicts an exemplary circuit diagram of a circuit
capable of identifying, recording, and transmitting information,
including but not limited to a date, time, and location (DTL) in a
date, time, and location stamp (DTLS), which may be incorporated
into embodiments of the specimen-collection device, and/or its
packaging.
[0032] FIG. 6 depicts a flowchart exemplifying a manner in which
the circuit provided for in embodiments of specimen-collection
device may identify, record, and transmit information related to
the specimen-collection device, and how that information may be
used for CoC, CPT coding, and inventory control purposes.
[0033] FIGS. 7A-F depict exemplary specimen collection sites,
specifically cross-sectional views of various human body
cavities.
[0034] FIG. 8 depicts an exemplary specimen collection site,
specifically body having a cross-sectional view of a female
reproductive system.
[0035] FIG. 9 depicts a cross-sectional view of a
specimen-collection device inside of a vaginal body cavity while
the specimen-collection device is in its initial closed and sealed
configuration.
[0036] FIG. 10 depicts a cross-sectional view of a
specimen-collection device inside of a vaginal body cavity wherein
the specimen-collection device has been partially actuated and is
in its partially open configuration.
[0037] FIG. 11 depicts a cross-sectional view of a
specimen-collection device inside of a vaginal body cavity wherein
the specimen-collection device is in its fully open configuration
having an exposed specimen collector in proximity to the specimen
collection site.
[0038] FIG. 12 depicts a cross-sectional view of a
specimen-collection device inside of a vaginal body cavity wherein
the specimen-collection device has been partially actuated in
reverse from its fully open configuration and has returned to its
partially open configuration, wherein the specimen collector has
been retracted into, and sealed inside of, the inner sheath.
[0039] FIG. 13 depicts a cross-sectional view of a
specimen-collection device inside of a vaginal body cavity wherein
the specimen-collection device has been fully actuated in reverse
and has returned to its fully closed and sealed configuration.
[0040] FIG. 14 depicts a flowchart detailing an exemplary process
to establish an identifiable and verifiable CoC related to
specimens collected using embodiments of the specimen-collection
device.
[0041] FIG. 15 depicts an example of a number of options for CPT
coding a selection of different potential uses for different
embodiments of the specimen-collection device.
[0042] FIG. 16 depicts a flowchart detailing an exemplary method of
creating a CoC for a specimen collected by a specimen-collection
device and maintaining said CoC throughout the course of the
evidence processing procedure.
[0043] FIG. 17 depicts an exemplary specimen collection site,
specifically the skin on the surface of an arm and/or hand.
[0044] FIG. 18 depicts the use of a specimen-collection device for
collecting a specimen from an exemplary specimen collection site,
specifically from the surface of the skin.
[0045] FIGS. 19A-B depict an exemplary specimen collection site,
specifically the space underneath a fingernail or toenail.
[0046] FIG. 20 depicts the use of a specimen-collection device,
wherein the outer sheath has been removed, to collect a specimen
from a specimen collection site underneath a fingernail or
toenail.
[0047] FIG. 21 depicts an exemplary embodiment of a
specimen-collection device wherein there are more than one inner
sheaths that may extend and retract from one another and from the
outer sheath in response to actuation of the actuator.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0048] Reference now should be made to the FIGURES in which the
same reference numbers are used throughout the multiple FIGURES to
designate the same components.
[0049] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting. As
used herein, the singular forms "a", "an", and "the" are intended
to include the plural forms as well, unless the context clearly
indicates otherwise. It will be further understood that the terms
"comprises" and/or "comprising" or "includes" and/or "including"
when used in this specification, specify the presence of stated
features, regions, integers, steps, operations, elements, and/or
components, but do not preclude the presence or addition of one or
more other features, regions, integers, steps, operations,
elements, components, and/or groups thereof.
[0050] While the examples discussed in this disclosure relate
mainly to the observation, collection, storage, handling,
transportation, analysis, and preservation of biologic specimens,
this is in no way intended to limit the teachings of this
disclosure to such applications. It will be apparent to those
skilled in the art that the embodiments of the device and the
methods of its use as taught herein may be applied to any number of
different scenarios related to specimen collection and
preservation.
[0051] FIG. 1 illustrates a specimen-collection device. The
specimen-collection device 100 of the embodiment depicted in FIG. 1
is in a closed configuration. Specimen-collection device 100
includes an actuator 102, an outer sheath 104, an inner sheath 105,
a specimen collector 106, a cap 108, an actuation mechanism 114,
and a seal 110. The actuator 102 is coupled to the specimen
collector 106 and moves it between an extended position in which it
is positioned outside of and extending from the inner 104 and outer
105 sheaths and a retracted position in which it is positioned
within the sheaths 104 and 105. This movement of the inner sheath
105 through the motion of the actuator 102 is facilitated by
actuation mechanism 114. Inner sheath 105 comprises a hollow
cylinder of a length sufficient to contain the specimen collector
106 therein. Specimen collector 106 is coupled to the distal end of
actuator 102. As actuator 102 is actuated, actuation mechanism 114
engages inner sheath 105 and urges it to extend from inside of
outer sheath 104. As actuator 102 is actuated further (or actuated
in an alternate manner), after inner sheath 105 reaches its
extended configuration, actuation mechanism 114 engages cap 108 and
causes cap 108 to open, allowing for specimen collector 106 to
extend, unhindered, out from inner sheath 105. Once specimen
collector 106 is in its fully extended configuration, actuation
mechanism 114 engages with, and may prevent further positive
actuation of, actuator 102 (actuator 102 may still be actuated in a
reverse manner so as to retract both specimen collector 106 and
inner sheath 105).
[0052] FIG. 2 depicts a cross-sectional view of a
specimen-collection device 100 in a partially open configuration.
The actuator 102 has been partially actuated (or partially actuated
in the reverse direction from being fully actuated) causing a
portion of inner sheath 105 to extend outside of outer sheath 104
in a telescoping fashion, while the specimen collector 106 is
retained inside of the sealed inner sheath 105.
[0053] FIG. 3 depicts a specimen-collection device 100 in a fully
open configuration. The actuator 102 has been fully actuated,
causing a portion of the inner sheath 105 to extend outside of the
outer sheath 104 in a telescoping fashion, and further causing
actuation mechanism 114 to open cap 108 and allow for the specimen
collector 106 to extend outside of the inner sheath 105 in a
telescoping fashion and to become exposed to the volume exterior to
the specimen-collection device 100.
[0054] FIG. 4 depicts an exterior view of a specimen-collection
device 100 in a closed configuration. In this depiction, the
actuator 102 is in a fully un-actuated (or fully actuated in
reverse) position causing all other parts of the
specimen-collection device 100 to be retained coaxially within the
exterior sheath 104.
[0055] In none embodiment, outer sheath 104 may be about 1 inch in
external diameter and about 4 inches in length. Outer sheath 104 of
this size should allow for comfortable insertion into a body cavity
(e.g. vagina, anus, or mouth) of interest of most users. Devices
provided by alternate embodiments of the disclosed subject matter
could be adopted for insertion into other environments, including,
but not limited to, alternate bodily cavities such as those exposed
during surgery, requiring adjustments in diameter and length to
accommodate the use and function of the procedure. In certain
embodiments the specimen collector 106 may be approximately 4 to
about 5 inches in length while the actuator 102 may be
approximately 4 inches in length. As previously noted, the various
dimensions of the device may vary in proportion to one another and
may differ depending on the specimen being collected and the
environment in which it is located.
[0056] Embodiments of the devices disclosed herein may include, but
are not limited to, having an actuator ranging between
approximately 2 and 8 inches in length and a specimen collector of
approximately 4 inches in length. Other embodiments may provide for
specimen-collection devices, wherein the diameter of the exterior
sheath may be as small as mere fractions of an inch to
approximately 3-4 inches.
[0057] Embodiments of the specimen-collection device of various
shapes and dimensions may be used in lieu of, or in addition to,
vaginoscope(s), anoscope(s), oral scope(s), otoscope(s),
nasoscope(s), laproscope(s), speculum(s), obturator(s), or other
instruments.
[0058] FIG. 2 illustrates a specimen-collection device 100 in a
partially open configuration. In the partially open configuration
depicted the actuator 102 has been partially actuated causing a
portion of the inner sheath 105 to extend from the outer sheath 104
in a telescoping fashion. However, the actuator 102 has not been
actuated to the point where actuation mechanism 114 has caused cap
108 to open (which in turn would breach seal 110), thereby
maintaining specimen collector 106 inside of the sealed inner
sheath 105.
[0059] The configuration of the specimen-collection device 100
depicted in FIG. 2 allows for the specimen collector 106 to be
inserted deeply into a body cavity (or other environment) before
being removed from the sealed interior of the inner sheath 105.
This facilitates contaminant-free, non-diluted collection of
specimens from such environments by allowing the specimen collector
106 to only become exposed to an environment exterior to the sealed
interior of inner sheath 105 when it is in proximity with the
specimen collection site.
[0060] FIG. 3 depicts a specimen-collection device 100 in a fully
open configuration. In this fully open configuration the actuator
102 has been fully actuated, causing actuation mechanism 114 to
cause a portion of inner sheath 105 to extend outside of outer
sheath 104 in a telescoping fashion and causing actuation mechanism
114 to cause specimen collector 106 to traverse the cap 108 and
seal 110 and extend from the inner sheath 105 in a telescoping
fashion, becoming exposed to the volume exterior to
specimen-collection device 100. The fully open configuration of the
specimen-collection device 100 illustrated in FIG. 3 allows for
specimen collector 106 to become exposed in order to facilitate the
collection of a specimen.
[0061] FIG. 4 depicts an exterior view of specimen-collection
device 100 in its closed configuration, wherein actuator 102 is in
its fully un-actuated (or full actuated in the reverse) state and
all parts of specimen-collection device 100 except for said
actuator 102 are retained inside of outer sheath 104.
[0062] FIG. 5 illustrates a schematic diagram of an exemplary
circuit which may be provided for in embodiments of the
specimen-collection device. More specifically, FIG. 5 illustrates a
circuit 200 including an antenna 202, a subscriber interface module
(SIM) component 204, a processor 206, a memory 208, a security
component 210, a location component 212, a time (and/or date)
component 214, a power component 215, and a switch 216. Most of the
components of the circuit 200 communicate electronically with the
processor 206 either directly or indirectly, while the various
components 210, 212, and/or 214 reside on, execute on, etc. the
processor component 206. More specifically, the switch 216
communicates with the processor component 206 for determining
actions associated with the specimen-collection device's use.
[0063] Embodiments of the processor 206 may include any type of
processor capable of executing various applications such as the
time and/or date module 214, the location module 212, the security
module 210, etc. An alternate embodiment may allow the processor
modules to be implemented in the included hardware. The time and/or
date module 214 may maintain a clock to record the time of day and
a day, time, and year feature that may communicate via the SIM
circuit 204 to send/receive information related to the time and/or
date. For instance, the time and/or date module 214 may comprise a
timer that relies on some external service/source for date
information, time change information, etc. Additionally, the time
and/or date module 214 may be configured to send to the memory 208
the current time and/or date whenever the switch 216 opens and/or
closes. In this way, the present disclosure time/date stamps the
action of the switch 216. The switch 216 may be activated by one or
more of any number of actions, including but not limited to, the
opening/closing of cap 108, the actuation of actuator 102, the
opening the packing in which the specimen-collection device 100 is
originally sealed, etc. The memory 208 may store a multi-entry
table of such time stamped operations of the specimen-collection
device 100.
[0064] In addition to or alternatively, FIG. 5 illustrates that the
processor may execute the location module 212. More specifically,
the location module 212 may be configured to determine the location
of the specimen-collection device 100. Various location techniques
may be employed by the location module 212 working in conjunction
with the SIM card 204 and/or antenna 202. The location module 212
can determine its location via time-delayed receipt of signals from
various in-range cellular base stations (i.e., antennas), Global
Positioning System (GPS) based signals, etc. and derive the
location or best approximation of the device's location therefrom.
In some embodiments, the location module 212 may query external
services/systems (such as cellular telephony systems) in order to
determine its location or the nearest location that such services
are available to provide. Additionally, the location module 212 may
be configured to store its location information in the memory 208
when the switch 216 activates. Accordingly, the embodiment enables
the location at which the specimen-collection device was operated
to be stored in and recalled from the memory 208.
[0065] The time circuit(s) and location sensing circuit(s) may be
configured to allow the memory of the device to record and store
date, time, and location information related to the use of the
device in a date/time/location stamp (DTLS). The DTLS comprises
information related to the time, date, and location when/where the
device was used. The DTLS may be used as evidence that may
corroborate the validity of, and circumstances related to, or an
account of the collection of a specimen. This generation of
corroborating evidence is of particular importance in the event
that a specimen is collected outside of the legal system's control
(e.g. self collection or collection in a remote location).
[0066] In different embodiments the triggering of the time and
location circuits in order to create a DTLS may be tied to the
actuation of the device's actuator, to the opening of the device's
cap, to the unsealing and/or sealing of the device's seal, or to
the opening of the packaging in which the specimen-collection
device is distributed to users, etc. The result of such a
triggering of said circuits being an information burst in which the
information associated with the specimen-collection device's use is
identified and recorded.
[0067] FIG. 5 also depicts an exemplary circuit comprising a
security module 210. The security module 210 may be configured to
protect the information (the DTLS(s) for example) stored in the
memory 208. The security module 210 may also provide security for
the processor 206, so that malware and/or other attempts to fake,
spoof, destroy, tamper with, etc. the information being generated
by the processor 206 (or the modules executing thereon) or stored
in the memory 208 may be prevented or alternatively readily
detected. For example, access to the memory 208 and/or modules
executing on the processor 206 may be password protected,
encrypted, etc. by the security module 210. Some embodiments of the
specimen-collection devices 100 may include some form of physical
security (e.g. a dielet, or lock, etc.) for the circuit 200 by one
or more techniques. For example, the circuit may be sealed inside a
closed container or even embedded in protective material such that
an attempt to physically alter, access, etc. the circuit 100
(and/or its components) may be prevented or alternatively, readily
detected. Alternatively, or in addition, security module 210 may be
configured to enable the specimen-collection device 100 to be
uniquely identifiable.
[0068] The memory 208 may be any type of computer readable medium
capable of storing the information obtained by the device
including, but not limited to, DTLS(s) generated by various
embodiments of circuits 200. For example, the memory 208 could be
any type of non-volatile memory such as flash memory.
[0069] The SIM card 204 and the antenna 202 may be configured to
function with particular types of telecommunications systems. For
example, some embodiments may use Code Division Multiple Access
(CDMA), SIM cards 204, and antennas 202 with associated protocols.
Other embodiments may use Global System for Mobile communications
(GSM), or radio frequency identification (RFID) compatible hardware
with their respective associated protocols. Further embodiments may
use other communication standards not listed in conjunction with
the circuits integrated into the specimen-collection device in
order to facilitate transmission of the collected information.
[0070] In one embodiment the means for uniquely identifying and/or
DTL stamping a specimen-collection device may be through the use of
RFID. In such an embodiment, the RFID component of the
specimen-collection device may begin in a non-active state and then
become active upon the triggering of the time and location circuits
or the resultant generation of the information burst.
[0071] In some embodiments, the specimen-collection device may
further comprise a transmitter, antenna, and/or other structures
connected to the device's memory such that the memory may be
configured to communicate with a network, including wireless and
secure networks, in order to facilitate the transmission of
information stored in the specimen-collection device's memory to
remote devices. Such remote devices may include, but are not
limited to, computers, mobile computing devices (e.g. smart phones,
tablets, etc), databases (including secure databases), etc. These
remote devices may be capable of generating and transmitting
responses upon receipt of information, or upon being queried by an
outside source (e.g. law enforcement agencies, laboratory
facilities, etc.), in order to confirm the receipt of said
information, or to confirm transfer of the specimen-collection
device. The remote device may additionally record the identity of
outside sources requesting or verifying said information for CoC
purposes.
[0072] In some embodiments, the security or location circuit(s)
that may allow for tracking the location of, and access to, the
specimen-collection device in order to identify, establish, or
corroborate, a CoC that may be independently verified. Such a
security/location circuit configured to track the location of the
device may additionally be used for inventory control purposes.
[0073] FIG. 14 depicts a flowchart 500, exemplifying a set of steps
that may be used to create, identify, and support a CoC for a
specimen collected with a specimen-collection device, including the
manner in which DTL stamping may be used to interact with and
augment the CoC identification procedure. Flowchart 500 begins with
step 501, in which the victim of sexual assault is presented. The
victim of a sexual assault, or other assisting individual(s), then
may use a specimen-collection device to collect a specimen to be
used as evidence of the sexual assault, and in-so-doing triggers
the circuit(s) to capture information associated with the
collection in an information burst, as shown in step 502. The DTLS
generated in the information burst may then be transmitted to, or
read by, a remote device as in step 503. Step 504 shows that the
remote device may then generate and return a confirmatory response
indicating that it has received the information, thus beginning the
CoC. The collected specimen may then be retracted into and, sealed
inside of, the specimen-collection device in step 505. Then, in
step 506, the specimen-collection device containing the collected
specimen may then be transferred to the authorities. The
authorities may then register the DTLS associated with the
collection of the specimen through use of a remote device in
accordance with step 507. The remote device may then send a further
confirmatory response, and log the change in the CoC as indicated
in step 508. This logging of the DTLS associated with the
collection of the specimen, and the remote devices' sending of a
confirmatory response and logging of the change in the CoC is then
repeated each time possession of the specimen-collection device,
and the collected specimen retained inside of the
specimen-collection device, is transferred (steps 509-515).
[0074] FIG. 15 depicts an exemplary method in which embodiments of
the specimen-collection device may be configured so that the
electrical circuits integrated into the device may identify and/or
indicate the CPT coding related to the devices use. This integrated
CPT coding identification and association with the device may
provide a simpler and less error-prone means of CPT coding the
device's use (for medical documentation and billing purposes) than
what is currently known in the art.
[0075] FIG. 8 depicts an exemplary specimen collection environment,
in this case a body 300 having a body cavity (and more specifically
a vaginal cavity). Here, body 300 has a vaginal opening 301, which
provides access from the outside of the body 300 to the vagina 303,
and a specimen collection site 302 located inside of the uterus
305, which is beyond the cervix 304.
[0076] FIG. 9 depicts a specimen-collection device 100 in an
initial closed configuration retained within the vagina 303 having
been inserted through the vaginal opening 301.
[0077] FIG. 10 depicts a specimen-collection device 100 in an
intermediary, partially open, configuration within the body 300.
The actuator 102 has been partially actuated causing a portion of
inner sheath 105 to extend outside of outer sheath 104 in a
telescoping fashion, wherein inner sheath 105 has extended past the
cervix 304, nearing specimen collection site 302, while the outer
sheath 104 remains in the vagina 303.
[0078] FIG. 11 a specimen-collection device 100 in a fully open
configuration while inside of a body 300. The actuator 102 has been
fully actuated causing a portion of the inner sheath 105 to extend
outside of the outer sheath 104 in a telescoping fashion, and
further causing the specimen collector 106 to traverse the cap 108
and extend outside of the inner sheath 105 in a telescoping
fashion. In this configuration the specimen collector 106 is in an
exposed position proximate to the specimen collection site 302,
while the inner sheath 105 remains mostly inside of the cervix 304
and the outer sheath 104 remains inside of the vagina 303. The
complete actuation of the actuator 102 and the resultant exposure
of the specimen collector 106 while in proximity to the specimen
collection site 302 allows the specimen collector 106 to collect a
specimen from specimen collection site 302.
[0079] FIG. 12 depicts a specimen-collection device 100 in a
partially retracted, partially open, configuration while inside of
a body 300. Here, the specimen has already been collected by the
specimen collector 106 from the specimen collection site 302. After
having collected the specimen, the actuator 102 has been actuated
partially in the reverse direction, causing the specimen collector
106 to disengage from its interaction with the specimen collection
site 302 and return to the interior of inner sheath 105. Once the
specimen collector 106 has entered into the interior volume of the
inner sheath 105 the actuation mechanism 114 causes the cap 108 to
close and the seal 110 to seal the interior of inner sheath 105
from the volume exterior to specimen-collection device 100. This
allows for further retraction of the specimen-collection device 100
from inside of the body 300 while preventing the specimen collector
106 from becoming exposed to any sites other than the specimen
collection site 302, thereby preventing the possibility of specimen
contamination or dilution from other areas of the body 300 during
its retraction and removal.
[0080] FIG. 13 depicts a specimen-collection device 100 in a fully
retracted, closed, configuration while inside of a body 300. Here,
the specimen has already been collected by the specimen collector
106 from the specimen collection site 302. After having collected
the specimen, the actuator 102 has been fully actuated in the
reverse direction, causing the specimen collector 106 to disengage
from its interaction with the specimen collection site 302 and
return to the interior of inner sheath 105, further causing the
inner sheath 105 to return to the interior of the outer sheath 104.
The specimen-collection device 100 is now in a closed and sealed
configuration and is ready for removal from the body 300 through
the vaginal opening 301.
[0081] Some embodiments of the specimen-collection device may be
configured to allow a user to collect specimens from their own body
without assistance (self-collection). Alternatively, the user of
the specimen-collection device 100 may be an individual (e.g. a
trained health care professional or an untrained individual) other
than the victim of a sexual assault. Additionally, the
specimen-collection device 100 may be used for purposes other than
DNA evidence collection (e.g. pap spear sampling, human
papillomavirus (HPV) sampling, and medicine delivery). For
instance, the device may be used to obtain other forms of evidence
from a crime scene or specimens not constituting DNA evidence from
any location of interest.
[0082] In some embodiments, the actuator portion of the
specimen-collection device may be a rod with a handle located at
the proximal end of the device with the specimen collector being
located at the distal end of the specimen-collection device. Other
embodiments may have alternate devices, attachments, tool, and/or
accessories at the distal end of the actuator, in place of the
specimen collector.
[0083] In one embodiment, the actuator operably couples with the
specimen collector and the inner sheath through the use of one or
more actuation mechanisms, and may be adapted to move the specimen
collector longitudinally relative to the sheaths. Accordingly, as
the actuator is operated, the specimen collector may move between a
retracted position and an extended position relative to the
sheaths.
[0084] In an embodiment, the specimen collector portion of the
specimen-collection device may be exposed by actuating the actuator
portion of the device completely. In other embodiments, the
specimen collector portion of the device may only be exposed by an
alternate method of actuating the actuator, whereby the primary
method of actuation causes the extension and retraction of the
devices' inner sheath(s) and the alternate method of actuation
(e.g. rotation of the actuator) cause the extension and retraction
of the specimen collector.
[0085] The specimen collector 106 may be a cotton swab or any other
type of specimen collector suitable for insertion into the
appropriate body cavity or other specimen collection site. Specimen
collectors other than cotton swabs may also be used with the
specimen-collection device 100. Any material, device, etc. that can
collect a specimen may be used as the specimen collector 106. For
example, a brush or appropriately sized roller (similar to an
appropriately sized lint roller) may be used as the specimen
collector 106. In some embodiments, adhesive tape may cover the
specimen collector 106 so that anything that comes into contact
with the specimen collector 106 will adhere to it. Additionally,
the specimen collector 106 need not be limited to just
configurations that solely retrieve the sought-after material. For
example, the specimen collector 106 may include indicator
chemicals, reagents, or other materials, such as dyes used to
detect human blood, animal blood, chemicals, certain other
conditions (e.g. environmental pH levels, etc.) etc.
[0086] Alternatively, other devices, tools, attachments, and/or
accessories may be coupled to the specimen-collection device 100 in
the place of the specimen collector 106 so as to facilitate a
multitude of functions. Examples of such devices, tools,
attachments, and/or accessories include, but are not limited to,
tweezers, brushes, silk, Dacron on paper, plastic sticks, scissors,
spoons, punches, bores, needles, etc.
[0087] Some embodiments may provide quick attachment features to
allow one end attachment (perhaps a specimen collector) to be
replaced with another end attachment, such as a specimen collector
of a different size, type, and/or configuration. Alternatively the
quick attachment feature may facilitate the attachment of an
applicator or some other type of end attachment device in the place
of the specimen collector 106.
[0088] In an exemplary method of the disclosed device's use, the
user starts with the specimen collector 106 in its retracted
position within the inner and outer sheaths 104 and 105. The user
may then insert the distal end of the outer sheath 104 into the
body cavity of interest, such as the body cavities shown in FIGS.
7A-F, (or other specimen collection location) to a depth of
approximately 4 inches such that the rim of the sheath 104 comes to
rest proximal to the body cavity or the surface of the user's body.
The rim (and/or end) of the outer sheath 104 may present a slightly
raised surface relative to the rest of the outer sheath 104 such
that the raised surface of the rim provides the user an indication
of how far to insert the specimen-collection device 100 into the
body cavity. Once the specimen-collection device 100 has been
inserted into the body cavity to a desired depth, the user may then
actuate the actuator 102 thereby causing the specimen collector 106
to move further into the body cavity and to expose the specimen
collector 106. The user may then operate the actuator 102 in
reverse in order to retract the specimen collector 106 into the
inner sheath 105, which then may be retracted into the outer sheath
104 before removing the collector device 100 from the specimen
collection location 302.
[0089] Once the specimen collection device 100 is inserted to
appropriate depth, the actuator 102 is used to deploy the specimen
collector 106. Once the specimen collector 106 and inner sheath 105
exits the outer sheath 104, the actuation mechanism 114 releases
the inner sheath 105, thereby freeing the specimen collector 106 to
move independently from the inner sheath 105. As the user moves the
actuator 102 the specimen collector 106 moves relative to the inner
sheath 105 and begins approaching the cap 108. The cap 108 is
positioned at the terminal end of the inner sheath 105 and is
articulated to enable the specimen collector 106 to move from the
interior volume of the inner sheath 105 to a volume exterior to the
specimen-collection device 100. The cap 108 also prevents the
interior of the inner sheath 105 from being in communication with
the volume exterior to the device 100, when the specimen collector
106 is not in its extended position. At some point (preferably
before the specimen collector 106 contacts the cap 108), the
actuation mechanism 114 opens the cap 108, thereby breaking seal
110, while allowing the specimen collector 106 to continue moving
forward toward the specimen collection site 302 by the actuator
102. Thus, the specimen collector 106 moves through the aperture
created by the opening of the cap 108 and out of the inner sheath
105.
[0090] While the specimen collector 106 is retained inside of the
inner sheath 105, it is protected from contamination by seal 110.
By the act of fully deploying the actuator 102, the user may move
the specimen collector 106 from the protection of the inner sheath
105 to an exposed configuration. This facilitates contact with
specific specimens to be collected. The specimen collector 106,
configured in its extended position in the body cavity, may contact
materials therein that might be present without contamination or
dilution from surfaces outside of the specimen collection location
302. Further, or alternate actuation of the actuator 102 (e.g.
rotation of the actuator 102 about its longitudinal axis), may
allow for movement of the operational, distal, end of the specimen
collector 106 so that it collects material from its immediate
environment (e.g. from the walls of a body cavity, and/or other
surfaces). The user may then use the actuator 102 to release the
lock, and/or retract the specimen collector 106 back into the inner
and outer sheaths 105 and 104 into its retracted position. The cap
108 and seal 110 seals the interior volume of the inner sheath 105
so that while the cap 108 is closed, the specimen collector 106
remains inside of the inner sheath 105 and protected from
contamination and dilution.
[0091] Embodiments of the specimen-collection device and the method
of its use may enable all portions of the specimen-collection
device, save for the outer sheath, to be completely withdrawn from
the interior volume of the outer sheath, while the outer sheath
remains inside of the body cavity (or other specimen collection
site). Furthermore, in some such embodiments, additional and/or
different configurations of the specimen-collection device (lacking
the outer sheath) may then be inserted into and removed from the
specimen collection site through the outer sheath, which remains
inside of the body cavity (or other specimen collection site).
These embodiments allow for multiple, separate, specimen
collections and/or alternate functions provided for by embodiments
of the specimen-collection device described herein, to take place
without the need for more than a single penetration. This allows
for increased comfort for the subject being penetrated.
[0092] Other embodiments of the specimen-collection device and the
method of its use may provide for use of specimen-collection
devices lacking their outer sheaths to be used for the collection
of specimens, as exemplified in FIG. 20.
[0093] Specimens collected in devices with seals, such as seal 110,
are less likely to dry out after collection since residual moisture
will be retained in the sealed environment of the interior volume
of the inner sheath 105. Embodiments of the specimen-collection
device 100 may omit the seal 110 or be otherwise configured to
allow the collected specimen to dry out for long-term specimen
preservation, which may be important to the viability of DNA
analysis. In one such embodiment, the interior volume of the inner
sheath 105 may contain a desiccant located in a position that does
not interfere with or otherwise influence specimen collection
activities while still being able to draw moisture from the
specimen to best insure its integrity.
[0094] FIG. 1 illustrates one arrangement of the cap 108 as being
hinged. Further embodiments provide for a cap 108 that may be
arranged in any number of other configurations. For example, in an
alternate embodiment, the cap 108 could slide relative to the
longitudinal axis of the specimen-collection device 100 so that the
linear movement of the actuator 102 causes the cap 108 to open or
close.
[0095] Some embodiments of the specimen-collection device may
additionally comprise a lock to ensure that the specimen collector
106 remains in its retracted position, after collection of a
specimen, until such time that the collected specimen is analyzed.
In one embodiment, the lock may be configured to allow the actuator
102 to only actuate the device once, and then latch or lock the
device in its closed configuration following the actuator's 102
retraction of the specimen collector 106 into the inner sheath 105.
In this way, the present disclosure provides a means for attempting
prevention or identification of attempts to tamper with the
collected material. The present disclosure and the inherent
security features may be used to corroborate the CoC of the
specimen in the event that the specimen is to be used as evidence.
In addition to, or alternatively, embodiments may provide for a
lock configured to releasably lock the specimen collector 106 in
its extended position. If so, the device could be manipulated while
extended and locked to facilitate the deposition, manipulation,
application, collection, etc. of material in situ.
[0096] In some embodiments, the specimen-collection device may be
configured for self-collection. Self-collection allows for a
multitude of benefits. Having the specimen-collection device
configured for self-collection may allow for collection of
specimens, likely containing DNA evidence, immediately after a
sexual assault. Accordingly, this increases the probability of
successful collection of a specimen potentially containing viable
DNA that may allow for the determination of a perpetrator's DNA
profile. The ability of the device to be configured for
self-collection may additionally allow for collection of specimens
when access to an appropriate medical, legal, or forensic facility
is difficult or unavailable. For the victim of a sexual assault a
specimen-collection device configured for self-collection would
enable them to collect a specimen in a timely manner no matter
where they may be. Due to the limited funding and geographic
constraints for many individuals, there is a present lack of
availability of professionals trained to collect specimens. A
specimen-collection device configured for self-collection would
allow individuals in any setting (i.e. rural, suburban, in theater)
to collect and secure bodily fluids and/or other DNA-containing
material(s) without the intervention of additional individuals.
Furthermore, by facilitating self-collection, embodiments of the
specimen-collection device may allow for specimen collection in an
environment that is more comfortable for the individual collecting
the specimen than would otherwise be available. This is of
particular importance given the inherently traumatic nature of
sexual assault, as well as the potentially traumatic specimen
collection procedure.
[0097] The size and shape of the specimen-collection device 100 may
be configured such that it can facilitate self-collection of
specimens. For example, the distal end of the device may be rounded
(as can all edges of such devices) to allow for easier, more
comfortable insertion into various body cavities. Additionally, the
position of the handle or actuator 102 positioned at the proximal
end of the device (as in many embodiments), may enable
self-collecting users to grasp the handle with relative ease. The
simple linear action of actuator 102 of various embodiments also
facilitates self-collection of specimens. The inner 104 and outer
105 sheaths protect the specimen collector 106 (and/or the
collected specimen) from contamination even if the user experiences
some difficulty in using the specimen-collection device 100.
[0098] The validity of evidence secured by self-collection of
specimens constituting evidence using the specimen-collection
device may benefit from additional structures incorporated into the
specimen-collection device that may allow for the identification,
recordation, and transmission of information related to the devices
use. This information may serve as evidence corroborating the
specimen collection and track the device for CoC, CPT, UDI, and
inventory control purposes.
[0099] All of the electronics (e.g. power supply, battery, etc.)
may be housed within the specimen-collection device 100 or
otherwise incorporated into the device's construction. These
electronic components may operate on low voltage power.
Additionally, the electronics may be housed within a portion of the
specimen-collection device 100 that may be closed, sealed, and/or
locked by the lock provided for in some embodiments. As a result,
the electronics may be protected from tampering, damage, etc. In
some embodiments the packaging for the device may include the
electronics that may trigger the identification and recordation of
a DTLS related to use of the specimen-collection device 100.
[0100] All portions of specimen-collection devices 100 and aspects
of the embodiments that might come into contact with the body,
internal organs, tissues, structures, fluids, etc. of the user may
be cleaned to (or beyond) an appropriate industry practice
standard. Additionally, any portion of the specimen-collection
device 106 of embodiments that comes into contact with the
subject's body may be made from biocompatible materials (e.g.
stainless steel, titanium, etc.). Some embodiments provide for
devices in which all of the corners, edges, etc. that might contact
a user's body are rounded and de-burred resulting in surfaces
polished to a smoothness sufficient to ensure safety and to avoid
irritating or injuring sensitive tissue.
[0101] In addition, embodiments of the specimen-collection device
may be designed to be disposable, wherein the device is disposed of
after a specimen has been collected and/or subsequently
analyzed.
[0102] Embodiments of the specimen-collection device may enable a
portion of the collected specimen to remain in a protected state,
free from contamination, dilution, and/or degradation, and within a
CoC even after the specimen has been analyzed per medical and/or
laboratory SOPs.
[0103] Embodiments of the disclosed specimen-collection device may
include a means to prevent, or reduce, the likelihood of successful
tampering with, or violation of, the specimen-collection device, or
any specimen retained inside the device, after collection.
Tamper-proofing measures may be enhanced by the integration of
dielets, and/or a lock coupled to the specimen collector and/or the
inner sheath of the specimen-collection device. Such a dielet
and/or lock may be adapted to lock the inner sheath(s) of the
specimen-collection device, or the specimen collector in their
retracted, closed, and secured position. In contrast, when the lock
is in its unlocked position, the specimen collector may move to its
extended position, and be fixed in said extended position to ensure
accurate specimen collection.
[0104] Embodiments of the specimen-collection device may include a
seal arranged relative to the specimen collector and inner sheath
in order to seal the specimen collector within the inner sheath
when the specimen collector is in its retracted position; thereby
sealing the collected specimen inside of the inner sheath's
protected interior volume. This process of securing the collected
specimen within the closed, sealed interior volume of the inner
sheath protects the specimen from contamination, dilution, and/or
degradation during its collection, transportation, and storage.
[0105] Embodiments of the specimen-collection device may include a
light, which may either be detachable or otherwise affixed on
embodiments of the specimen-collection device. Such a light may be
used to facilitate the observation and/or recording of the specimen
to be collected.
[0106] In one embodiment, a portion (or portions) of the
specimen-collection device may be made of a transparent material in
order to facilitate observation and/or recording of the specimen
being collected during the collection process.
[0107] In accordance with disclosed embodiments,
specimen-collection devices may be used to preserve evidence
resulting from various types of incidents and make use of specimens
obtained therewith. More specifically, many victims of sexual
assault are (or become) too scared or embarrassed to report the
incident. The victim may sometimes wait to report the incident
thereby allowing contamination, dilution, or degradation of the
specimens that might still be available. Furthermore, some
authorities may discredit or discount minorities or discredit
victim's accounts based on documented societal realities, thereby
heightening these victims' reluctance. Despite their reluctance to
report an incident, embodiments of the specimen-collection devices
described herein would enable these individuals to collect the
specimens themselves shortly after the incident. Once an individual
is able to overcome their reluctance, they may then provide the
specimen in the closed, sealed and locked device to law enforcement
(or other authorities, e.g. Sexual Assault Response Team (SART)
Center, or military officials) for analysis. The specimen stored in
and protected by the inner sheath 105 could still allow for
analysis of fluids, samples from skin surfaces, or other specimens
collected to be analyzed for DNA, potentially leading to the
successful identification of the perpetrator. Additionally, the DTL
stamping of the specimen provided for by embodiments of the
specimen-collection device may provide corroborating evidence of a
victim's account of events (e.g. the collection of a specimen, or
the sexual assault itself). As a result, independent third parties
such as law enforcement, judges, military officials, insurance
companies, and/or juries, etc. may have improved chances of
resolving so-called he-said, she-said controversies.
[0108] Embodiments of the devices provided herein, furthermore, may
be used as a base platform onto which other devices, attachments,
tools, and/or accessories may be coupled.
[0109] In summary, the disclosure herein provides an explanation of
how to make and use a specimen-collection device for observing,
collecting, securing, and preserving DNA-containing material, which
could potentially constitute evidence of a sexual assault.
Embodiments of the specimen-collection device may comprise an outer
sheath, an inner sheath, a specimen collector, an actuator, a cap,
an actuation mechanism, a circuit, a memory, a processor, a switch,
and a power source. The outer sheath may have a generally oblong
shape for insertion into a human body cavity and an interior volume
inside of which other parts of the specimen-collection device may
be retained. The inner sheath may be disposed of inside of the
interior volume of the outer sheath, and may be movable such that
it may extend partially outside of the inner volume of the outer
sheath in a telescoping fashion. The interior volume of the inner
sheath may be configured to retain the specimen collector and any
specimens it has collected, in a sealed environment while the inner
sheath is closed. The specimen collector may be disposed inside of
the interior volume of the inner sheath, and may be movable such
that it may extend partially outside of the interior volume of the
inner sheath in a telescoping fashion. The actuator is a portion of
the specimen-collection device that may be operated by the user of
the device. Actuation of the actuator may cause the actuation
mechanism to extend the inner sheath from the interior volume of
the outer sheath, and further (or an alternate method of) actuation
of the actuator may cause the actuation mechanism to open the cap
and extend the specimen collector from the interior volume of the
inner sheath. The actuation mechanism may also cause the closing of
the cap, and retraction of the specimen collector and inner sheath,
when the actuator is actuated in reverse. The cap may be positioned
at the end of the inner sheath. The cap may be openable to allow
for the specimen collector to extend from the interior volume of
the inner sheath, and it may be closeable to allow for the specimen
collector and any collected specimen to be sealed inside of the
interior volume of the inner sheath, thereby protecting the
collected specimen from contamination, dilution, and degradation.
The circuit may identify information related to the operation of
the specimen-collection device; including information related to
the time and date of the specimen-collection device's use, the
location where the specimen-collection device was used, and
security information. The circuit may identify such information in
response to the activation of the switch. Activation of the switch
may be triggered by actuation of the actuator, opening and/or
closing of the cap, or any number of other actions associated with
operation of the specimen-collection device. The processor may take
the information identified by the circuit in response to activation
of the switch and transfer it to the memory. The memory may record
the information identified by the circuit. The power source may
provide electrical power to the electronic components of the
specimen-collection device.
[0110] It is important to note that while the device and methods
detailed above are discussed with specific reference to the
collection of biologic specimens potentially constituting evidence
related to sexual assault, persons having ordinary skill in the art
will understand that such devices and methods can be applied to any
number of scenarios (e.g. other forensic evidence collection,
medical procedures including surgical procedures, environmental
sampling, food sampling, etc.).
[0111] All methods described herein can be performed in a suitable
order unless otherwise indicated herein or otherwise clearly
contradicted by context. The use of any and all examples, or
exemplary language (e.g., "such as"), is intended merely to better
illustrate the disclosure and does not pose a limitation on the
scope of the disclosure unless otherwise claimed. No language in
the specification should be construed as indicating any non-claimed
element as essential to the practice of the disclosure as used
herein.
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