Note: Descriptions are shown in the official language in which they were submitted.
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1 COLLECTION DEVICE AND MATERIAL
2
3
4
Technical Field
6 The present disclosure describes a swab, and collection material for
use
7 therein, for collecting biological specimens.
8 Background
9 Devices, such as swabs, for collecting biological specimens of
organic
material are known in the field of clinical and diagnostic analyses, which
11 generally include a cylindrical rod or stick containing on a collection
end or tip a
12 wad of fiber material, such as rayon or a natural fiber such as cotton,
with
13 hydrophilic properties to allow rapid absorption of the quantity of
specimen to be
14 collected and tested. Stable adherence of the fiber wrapped around the
end or tip
of the rod or stick is generally achieved by gluing.
16 Collection swabs containing the collected material are often
immersed in a
17 culture media, such as in a test tube, vial, culture dish, or culture
bottle, soon or
18 immediately after collection to preserve and conserve the collected
specimen
19 during storage and/or transport to, for example, an analytical
laboratory.
Collection swabs and devices of the prior art are described, for example, in
21 EP0643131 and W02004/086979.
22 Summary
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Devices, such as swabs, and materials of the present disclosure, and
methods of making same, Include randomly arranged sea-island bicomponent
fibers.
The present disclosure provides a swab for collecting and releasing a
biological sample containing an applicator and sea-island bicomponent fibers.
The swab of present disclosure contains fibers attached to an end portion
of the applicator, such as by adhesive.
The present disclosure provides a method of forming the swab of the
disclosure which includes adhering the bicomponent fibers to the applicator.
The present disclosure provides a method of collecting a biological sample
which includes contacting the swab of the disclosure with a source of
biological
material such that a sample of the material is retained by the swab.
According to further aspects, the invention provides for the following (1) to
(25):
(1) A swab for collecting and releasing a biological sample, comprising a
flock
fiber tipped applicator, wherein the flocked fibers are sea-island bicomponent
composite fibers, and said composite fibers are not split.
(2) The swab of (1), wherein said sea component of the composite fibers is
not removed from the composite fibers.
(3) The swab of (1) or (2), wherein said bicomponent fibers comprise a
first
polyester sea material and a second polyester island material,
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(4) The swab of (3), wherein said first polyester has a lower melting point
than
said second polyester.
(5) The swab of (3), wherein said first polyester has a greater solubility
in
alkaline solution than said second polyester.
(6) The swab of (5), wherein the first polyester has a greater solubility
in
alkaline solution of sodium hydroxide, as compared to the second polyester,
(7) The swab of (6), wherein the first polyester has greater solubility in
an
alkaline solution of sodium hydroxide solution containing about 5% to about
50%
by weight sodium hydroxide in water, as compared to the second polyester.
(8) The swab of (7), wherein the first polyester has greater solubility in
an
alkaline solution of about 10% by weight sodium hydroxide in water, as
compared
to the second polyester.
(9) The swab of (5), wherein the first polyester has greater solubility in
a
heated alkaline solution as compared to the second polyester.
(10) The swab of (9), wherein the first polyester has greater solubility in
an
alkaline solution heated to a temperature of about 170 F to about 190 F, as
compared to the second polyester.
(11) The swab of any one of (1) to (10), wherein said fibers are adhered to
the
applicator with an adhesive.
(12) The swab of (11), wherein said adhesive is a photocurable acrylic
adhesive or a polyurethane adhesive,
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(13) The swab of (1) or (2), wherein said bicomponent fibers comprise a
polyethylene terephthalate sea material and a polyamide island material.
(14) The swab of (1) or (2), wherein said bicomponent fibers comprise a
polyethylene terephthalate island material and a poiyamide sea material.
(15) The swab of (13) or (14), wherein said fibers are adhered to the
applicator
with an adhesive.
(16) The swab of (15), wherein said adhesive is a photocurable acrylic
adhesive or a polyurethane adhesive.
(17) The swab of any one of (1) to (16), wherein said bicomponent fibers
comprise 10-3000 island parts per fiber.
(18) The swab of (17), wherein said fibers comprise 10-240 island parts per
fiber.
(19) The swab of (17), wherein said fibers comprise 10-64 island parts per
fiber.
(20) The swab of (17), wherein said fibers comprise 10-37 island parts per
fiber.
(21) The swab of (17), wherein said fibers comprise 10-36 island parts per
fiber.
(22) The swab of (17), wherein said fibers comprise 10-24 island parts per
fiber.
(23) The swab of (17), wherein said fibers comprise 24-36 island parts per
fiber.
(24) A method of forming the swab as defined in any one of (1) to (23),
comprising adhering the bicomponent flocked fibers to said applicator.
(25) A method of collecting a biological sample, comprising contacting the
swab
as defined in any one of (1) to (23) with a source of biological material such
that a
sample of the material is retained by the swab.
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Brief Description of Drawings
Figure 1 provides an end view of a bicomponent fiber of PET/PET.
Figure 2 is a photograph of an experimental swab stick head.
Detailed Description
Devices, such as swabs, and materials of the present disclosure, and
methods of making same, include randomly arranged sea-island bicomponent
fibers.
Materials of the present disclosure may be included as a high absorbency
member of medical swab devices. The "splitable" flock fiber materials of the
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present disclosure attached to the end of a thin "stick-like" polymeric shaft
are
2 described and contemplated herein as swabs of the present disclosure.
3 The materials of the disclosure may include micro- and nano-fibers,
such
4 as bicomponent sea-island materials. Segmented pie materials may also be
used. Bicomponent sea-island materials and segmented pie materials are
6 known and described, for example in Ndaro et al Journal of Engineered
Fibers
7 and Fabrics, volume 2, Issue 4, 2007 "Splitting of Islands-in-the-Sea
Fibers
8 (PA6/COPET) During Hydroentanging of Nonwovens"; and Fedorova, Nataliya
9 "investigation of the Utility of Islands-in-the-sea Bicomponent Fiber
Technology in
the SpunBond Process" Ph.D. Dissertation, North Carolina State University,
11 Raleigh, NC (2006); as well as in U.S. Patent Application Publication
Nos.:
12 20100075143 (FIBER STRUCTURE AND METHOD FOR PRODUCTION
13 THEREOF), 20100068516 (THERMOPLASTIC FIBER WITH EXCELLENT
14 DURABILITY AND FABRIC COMPRISING THE SAME), and 20100029158
(ISLANDS-IN-SEA TYPE COMPOSITE FIBER AND PROCESS FOR
16 PRODUCING SAME), And W02002042528 (A SEA-1SLAND TYPED
17 COMPOSITE FIBER USED IN WARP KNITTING, AND A PROCESS OF
18 PREPARING FOR THE SAME), W02002042529 A SEA-ISLAND TYPE
19 COMPOSITE FIBER FOR RAISED WARP KNIT FABRIC, AND A PROCESS OF
PREPARING FOR THE SAME), W02002088438 (A SEA-ISLAND TYPED
21 CONJUGATE MULTI FILAMENT COMPRISING DOPE DYEING COMPONENT,
22 AND A PROCESS OF PREPARING FOR THE SAME), and as are commercially
23 available from, for example, Kolon Industry, Kumi City, Kyungbuk, Korea
and
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I generally described as ROJEL - polyester/polyester conjugated fiber yarn
2 (sea/island) or SPECIAL TYPE OF ROJEL - polyester/nylon conjugated fiber
3 yarn (sea/island); or Hyosung Corporation, Ulsan City, Kyungbuk, Korea
and
4 generally described as MIPAN XF - Nylon/polyester conjugated yarn (pie-
wedge
cross-section).
6 In the islands-in-sea type composite fiber of the presently
described
7 material, an easily soluble polymer is incorporated for the sea portion
and
8 preferably contains at least one polymer easily soluble in aqueous alkali
9 solutions, such as polylactic acid, super high molecular weight
polyalkyleneoxide-
condensate polymers, polyethyleneglycol compound-copolymerized polyesters,
11 and copolymerized polyesters of polyethylene glycol (PAG) compounds with
5-
12 sodium sulfoisophthalic acid or dimethy1-5-sulfoisophthalate sodium salt
(DM1S).
13 Polyester sea materials may include alkali soluble copolymer polyester
materials
14 with polyester mainly containing polyethylene terephthalate of more than
90 mole
percept as island component (such as is described, for example, in
16 W02002042528.
17
18 The islands-in-sea type bicomponent composite fiber of the present
19 disclosure contains a sea part containing or composed of polymer of
greater
solubility than a plurality of island parts containing or composed of a less
soluble
21 polymer, in the cross-sectional profile of which the number of the
island parts is
22 about 10, 24, 36, 37, 64 or 240 islands per fiber, or ranges of islands
per fiber
23 between any of 10, 24, 36, 37, 64, 240 or 3000 islands per fiber.
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1 The island component of the bicomponent composite fiber of the
present
2 disciosure may be a polyamide, such as nylon, or a polyester. Examples of
the
3 polyamide include polymers having an amide bond, such as nylon 6, nylon
66,
4 nylon 610, and nylon 12. The polyester is not particularly limited as
long as it is a
polymer synthesized from dicarboxylic acid or an ester-forming derivative and
6 diol or an ester-forming derivative thereof and can be used as the fiber.
Specific
7 examples thereof include polyethylene terephthalate, polytrimethylene
8 terephthalate, polytetramethylene terephthalate,
polycyclohexylenedimethylene
9 terephthalate, polyethylene-2,6-naphthalene dicarboxylate, polyethylene-
1,2-
bis(2-chlorophenoxy)ethane-4,4'-dicarboxylate and the like. In an embodiment
of
11 the present invention, a polyethylene terephthalate or a polyester
copolymer
12 containing mainly an ethylene terephthalate unit, may be used.
13 The islands-in-sea type bicomponent composite fiber of the present
14 disclosure have a linear mass density in the range of about 1-7 deniers,
alternatively in the range of about 2 to 6 deniers or the range of 2 to 5.8
deniers
16 (or 2.22 to 6.49 dtex) wherein a denier is the mass in grams per 9000
meters of
17 fiber and dtex is the mass in grams per 10,000 meters. The diameter (0,
in
18 centimeters) of a bicomponent composite fiber may be estimated from the
19 following formula, wherein p represents a materials density in grams per
cubic
centimeter:
14 x 10-6 = dtex
0
77-p
21
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1 Estimating the fiber specific gravity as being equal to 1 (specific
gravity
2 values of common fiber polymers according to Gafe et al ("Polymeric
Nanofibers
3 and Nanofiber Webs: A New Class of Nonwovens" INTO 2002: International
4 Nonwovens Technical Conference (Joint INDA TARP! Conference), Atlanta,
Georgia, September 24-26, 2002) are as follows: 0.92 (polypropylene or PP),
6 1.14 (polyamide 66 or nylon or PA66) and 1.38 (polyethylene terephthalate
or
7 PET)), the diameter of bicomponent composite fiber of the present
disclosure
8 having a linear mass density in the range of 2 to 5.8 deniers would be
about
9 16.7pm to 28.6pm.
The islands of the bicomponent composite fibers of the present disclosure
11 have a mass linear density of about 0.01 to about 0.3 deniers, or about
0.05 to
12 about 0.2 deniers, or about 0.06 to about 0.16 deniers, depending on the
linear
13 mass density of the bicomponent composite fibers of the present
disclosure.
14 The islands-in-sea type bicomponent composite fibers of the material
of
the present disclosure have a length, or cut length, of about 10 to about 100
16 thousandths of an inch (about 254 pm to about 2,540 pm), or about 20 to
about
17 90 thousandths of an inch, or about 20 to about 80 thousandths of an
inch, or
18 about 20 to about 70 thousandths of an inch, or about 20 to about 60
19 thousandths of an inch.
The islands-in-sea type bicomponent composite fibers of the material of
21 the swabs of the present disclosure are not split. The seas of the
islands-in-sea
22 type bicomponent composite fibers of the material of the swabs of the
present
23 disclosure are not dissolved or removed from the islands of the
composite fibers.
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=
1 Figure 1 is a scanning photograph of an example of a fiber of the
present
2 disclosure wherein ends of the bicomponent composite fibers is
illustrated and
3 the islands of the fiber is intact and not dissolved or removed.
4 The bicomponent composite fibers of the material of the present
diSclosure are preferably randomly arranged.
6 The number of fibers on a swab of the present disclosure may be
7 evaluated by light microscope (Amscope) at 180X power with a 1 mm
calibration
8 scale (NIST) in conjunction with a video camera (Amscope 3.0 megapixel)
and
9 suitable video analysis software, such as for example, Version
3Ø12.498
Amscope video software calibrated to 180X.
11 A swab of the present disclosure, which includes material of the
present
12 disclosure, may be any shape adapted for collection, and optional
retention, of
13 biological samples from a host directly or already collected biological
fluid or
14 sample. Shapes and sizes of such devices are known in the art. The swab
of
the present disclosure is constructed of materials known in the art, such as
16 acrylonitrile-butadiene-styrene (ABS). The swab of the present
disclosure is
17 such that the material of the present disclosure may be attached to the
applicator
18 of the swab through an adhesive during a flocking technique known in
the art.
19 An applicator of the swab of the present disclosure may be a rod
or rod-
like thermoplastic substrate wherein one end is coated, partially,
substantially or
21 completely, with an adhesive to anchor or hold fibers of the present
disclosure to
22 the substrate in an initial arrangement generally perpendicular to the
substrate
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1 and generally parallel to adjacent fibers to thereby create, for example,
a bristle
2 or bristly end on the substrate.
3 in a method of making devices according to the present disclosure,
4 individual, loose or connected substrate, such as applicator shafts,
sticks or rods
have adhesive applied by at least one adhesive applicator container, block,
head,
6 nozzle, or roller by, for example, spraying, dipping, rolling, printing
or a
7 combination thereof, optionally in a metered fashion, under pressure or
by
8 gravity, and in a manner which may or may not include any combination of
linear
9 and/or rotational, such as by axial rotation or spinning, of the adhesive
applicator
relative to the applicator.
11 In the flocking technique of the present disclosure, an electric
field of
12 alternating or direct current is applied to the fibers in a manner know
in the art to
13 organize and transport charged fibers to opposite charged adhesive-
covered
14 substrate such that the fibers are held in place by the tackiness or
adhesive
strength of the adhesive, only in areas where the adhesive has been applied to
16 produce flock fiber tipped applicators, or swabs of the disclosure. The
technique
17 may include movement of the substrate, linearly and/or rotationally,
such as by
18 axial rotation or spinning, at any time or throughout the process of
applying fibers
19 to the adhesive. Where further curing of the adhesive, such as by light
or heat, is
required, the flock fiber tipped applicator swab may be treated with light
and/or
21 heat so as to cure the adhesive.
22 Swabs of the disclosure may contain approximately 104 to
approximately
23 1010, or approximately 104 to approximately 109, or approximately 104 to
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1 approximately 108, or approximately 104 to approximately 107, or
approximately
2 104 to approximately 106, or approximately 104 to approximately 105,
flock fibers
3 per substrate.
4 The adhesive of the present disclosure is not particularly limited
and
general and photo or heat cured acrylic-based, polyurethane-based, polyamide-
6 based, polyester-based, vinyl-based and/or two-part epoxy adhesives may
be
7 used. Silicones, cyanoacrylates, polyurethanes and/or latex adhesives may
be
8 used. Polyurethane adhesive are generally known and available, such as
from
9 K&VV Adhesive Products.
The swabs of the present disclosure are adapted or designed for
11 collection of, for example, biological samples from oral, nasal, ocular,
rectal,
12 urethral, or vaginal orifices of a mammal, such as a human, or patient.
13 The swabs may be used and is designed for collection of a biological
14 specimen by contact with the fibers of the device such that the device
may
collect, for example, about 35 to about 200 pl, such as 40, 50, 60, 70, 80,
90,
16 100, 120, 130, 140, 150, 160, 170, 180 or 190 pl, without causing damage
or
17 substantial discomfort to the patient during specimen collection.
18 The swabs of the present disclosure is useful for and in a method of
19 collecting biological specimens. A swab of the present disclosure is of
the type
containing a rod terminating with a tip covered in the fibers described herein
to
21 allow absorption of said specimens, wherein the fibers cover or
substantially
22 cover the tip in the form of a layer applied by means of flocking.
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1 The present disclosure further provides a method of collecting a
biological
2 sample which includes contacting a swab as described herein with a source
of
3 biological material such that a sample of the material is retained by the
swab.
4 The swabs of the disclosure may be provided, for example, as a
component part of a collection, transport, culture and/or transport kit or
device
6 wherein additional specimen handling containers and/or devices are
included
7 and the swab of the present disclosure is specially adapted to be
integrated with
8 such other container and/or devices to assure, for example, specimen
retention,
9 integrity and/or sterility.
The present disclosure provides a swab for collecting and releasing a
11 biological sample containing sea-island bicomponent fibers. The swabs
may
12 further contain bicomponent fibers which are composed of a first
polyester sea
13 material and a second polyester island material; the first polyester may
have a
14 lower melting point than the second polyester and/or the first polyester
may have
a greater solubility in alkaline solution than the second polyester. The
alkaline
16 solution may more specifically be a sodium hydroxide solution - the
sodium
17 hydroxide solution may contain about 5% to about 50% by weight sodium
18 hydroxide in water, or alternatively about 10% by weight sodium
hydroxide in
19 water. The alkaline solution wherein the first polyester sea material is
more
soluble than the second polyester sea material may be a heated alkaline
solution
21 - the heated alkaline solution alternatively having a temperature of
about 170 F
22 to about 190 F, such as about 180 F.
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1 The present disclosure provides a swab, wherein material described
2 herein is attached to an end portion of an applicator stick or rod. The
material
3 may be adhered to the end of the applicator with an adhesive, and the
adhesive
4 may be a photocurable acrylic adhesive or a polyurethane adhesive.
The bicomponent fibers of the present disclosure may be composed of a
6 polyethylene terephthalate sea material and a polyamide island material.
7 The bicomponent fibers of the present disclosure may be composed of
or
8 contain 10-3000 island parts per fiber, 10-240 island parts per fiber, 10-
64 island
9 parts per fiber, 10-37 island parts per fiber, 10-36 island parts per
fiber, 10-24
island parts per fiber, and/or 24-36 island parts per fiber.
11 The present disclosure provides the fibrous material of the swab
described
12 herein. The fibrous material may be incorporated separately as a part of
a
13 device other than a swab, such as a filter or cleaning pad or brush.
14 The present disclosure provides a method of forming a swab of the
disclosure involving adhering the bicomponent fibers to an applicator, such as
a
16 rod or stick, wherein the sea component of the fiber is not removed.
17
18
19 The following examples further illustrate the materials and methods
of the
disclosure without limiting same.
21 EXAMPLE 1-SWABS
22 A quantity of (about 30 or so) experimental medical swabs were
prepared
23 from ABS plastic "sticks' of Puritan Medical Products (Guilford, ME)
with 0.5 mm
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1 long (0.020, nominal length, as determined by a Flock-ln-Spect flock
fiber length
2 optical measurement instrument) Nylon/PET sea/island type flock fiber.
Two
3 adhesive systems were employed in these experimental fabrications; the
4 polyurethane rubber (K&W polyurethane adhesive - MECFLOCK L876/1,
MEDCODUR H5530 two part polyurethane adhesive, mixed 85 grams L876/1
6 resin and 15 grams H5530 hardener - product of Kissel and Wolf; cured 3
hours
7 at 110 C or else cured 16 hours at 80 C ) and a UV photo-curable adhesive
from
8 Puritan Medical Products.
9 The following materials and instruments were used in fabrication:
ABS
(plastic) swab sticks (supplied by Puritan): Maag Flockmaschinen Motion (flock
11 activity) Tester SPG 1000; K & W adhesive in a shallow aluminum dish
(adhesive
12 depth about 1 cm); photo-curable adhesive in light-blocked packet; flock
screen
13 sifter; and a supply of Nylon/PET 0.5 mm long Flock fibers
14 The experimental swabs were fabricated as follows. The flock
activity
tester's 4" diameter aluminum base plate is covered (by sifting) with about 2
16 grams of loose flock. This sample of loose flock was mounted on to the
bottom
17 electrode pedestal of the Flock Activity Tester. The end of the swab
sticks were
18 perpendicularly dipped into the fluid K & W adhesive to a depth of about
1 cm
19 and slowly removed to produce end-coated swab-sticks. Some swab samples
were made using photo-curable adhesive. Water-based acrylic (F1059B Lubrizol
21 Corp.) flock adhesive and other water based adhesives could be used. A
3.5
22 KV/cm strength was applied to the DC electrodes of the Flock Activity
Tester
23 (upflocking machine). This causes the flock fibers to align themselves
and
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1 actively move to the top electrode. As this flock is being propelled from
the
2 bottom to the top electrode, the adhesive coated tip plastic swab-stick
is then
3 placed in the "flock fiber cloud" about 1 cm from the bottom electrode
(source of
4 the activated flock fibers). While in the "flock fiber cloud", the swab-
stick was
slowly rotated by rolling the stick held in gripping fingers.
6 Flock fibers fully adhered to the saturate at the (adhesive wet) end
of the
7 swab-stick after about a 2 to 5 second flock field immersion time. The
swab
8 adhesive was subsequently cured.
9 The average amount of adhesive and the average amount of flock
applied
to the ABS base (sticks) were determined by weight with the following results:
11 average weight of "Bare" ABS sticks: 0.5644 .0-0.00426 grams; average
weight
12 of K & W Adhesive on "Sticks" before flocking: 0.0046 grams; and average
13 weight of PET/Nylon Flock on "Sticks": 0.0135 grams. With an average of
0.0135
14 grams of sea/island flock fiber on each "stick" this translates to
approximately 1.2
X 105 flock fibers per "stick".
16 The water "pick-up" capabilities of the flocked medical swabs was
17 determined by a procedure whereby a number of swab and "stick" materials
were
18 first weighed (dry). Then this same series of flocked swabs and "sticks"
were
19 immersed in room temperature (23 C) water (tips only) for 5 seconds and
then
reweighed.
21 The per cent water pick-ups of the various swab configurations were
then
22 compared. The results demonstrate that the "bare" ABS swab sticks pick-
up or
23 capture little or no water. The polyurethane adhesive coated (tip only)
swabs
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1 picked up or captures a little water indicating that the adhesive is a
more wettable
2 surface that the "bare" ABS. The flocked fiber swab picked up or captured
a
3 measurable amount of water (8.95%).
4 Several fiber material types (of sea/island fiber) have been evaluated.
The
nylon/PET (Kolon) and PET/PET (Kolon-Rojel) fibers appear useful in the fiber
6 flocked medical swab application of the present disclosure. While 0.5 mm
long
7 nylon/PET flock fiber were initially investigated, fibers of various
sizes may be
8 used and are contemplated.
9 The following two flock adhesives have been investigated: the two-
package polyurethane (clear rubbery) and the photo-curable (clear film
plastic)
11 systems. Other adhesives are contemplated.
12
13
14
14
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