FIELD OF THE INVENTION
The present invention relates to fluid collection system including 5 a sampling port
to obtain a fluid sample for laboratory analysis. More particularly, the present
invention relates to a fluid sampling port. The fluid sampling port has improved
means for obtaining a fresh sample of fluid from the system without contaminating
the fluid within the system or risking injury to medical personnel or attendants to
10 the patients.
BACKGROUND OF THE INVENTION
Urine collection systems for collecting urine from a patient to obtain a sample for
15 laboratory analysis are well known in the art. A urine collection system may
include a urine collection bag, a drain tube and a sampling port. Typically, the
drain tube has a first end connected to a urinary catheter of a catheterized patient
and a second end connected to a urine collection bag. The urine collection bag
includes an outlet port for draining fluid from the bag. The sampling port is
20 supported in fluid communication with the drain tube upstream of the fluid inlet of
the urine collection bag.
Sometimes syringes or hypodermic needles are used inserting them through walls
of the drain tubing in order to obtain a sample for laboratory analysis. In other
25 cases, sometimes samples are obtained by piercing a port on the collection bag
itself or by draining fluid from the collection bag through an outlet port. Such
sampling techniques bear great risk in that they expose medical personnel to
potential needlestick injury and to urine contact. Moreover, such sampling
techniques run the risk of contamination of fluid within the collection system, thus
30 exposing a patient to potential infections.
Sometimes, it is desirable to take the most recent urine sample from the collection
system without having above-discussed risks. Old or stale samples can become
3
contaminated rendering the urine sample unfit for analysis and subjecting medical
personnel to contamination.
Urine collection systems including collection bags having a vent or vents formed
therein are also well known. Such vents allow air to enter or exit 5 the collection bag
during emptying or filling of the collection bag. Although vents in the collection bag
are somewhat effective, emptying of the collection bag can still effect siphoning of
fluid from a patients bladder.
10 Various needleless sampling ports are also known. However, these needleless
sampling ports include many parts, which can fail and are more complicated and
expensive to manufacture.
It is desired to provide a fluid collection system which facilitates the collection of
15 fresh fluid samples from a collection system minimizing the risk of contamination
or injury of medical personnel and/or contamination of fluid within the collection
system. It is also desired to provide a fluid collection system having more effective
venting to prevent siphoning of fluid from a patient's bladder.
20 Accordingly, it is desired to provide a fluid sampling port in particular, a needless
sampling port having improved means for obtaining a fresh sample of fluid from
the system which overcomes the above-discussed disadvantages and is
inexpensive to manufacture, efficient, effective and simple in its construction and
use.
25
SUMMARY AND OBJECTS OF THE INVENTION
A primary object and advantage of the present invention is to provide a fluid
30 sampling port in particular, a needleless sampling port having improved means for
obtaining a fresh sample of fluid from the system.
4
Another object and advantage of the present invention is to provide an improved
fluid sampling port which is inexpensive to manufacture, efficient, effective and
simple in its construction and use.
Accordingly, the present invention relates to a fluid sampling port 5 for use in a fluid
collection system for obtaining a fresh sample of fluid from the system, the fluid
sampling port comprising: a housing defining a longitudinal channel along axis
L having an inlet end, an outlet end and a transverse opening, wherein the
transverse opening defines a fluid passage therethrough in communication with
10 said longitudinal channel and is configured to receive a valve assembly, and
wherein said valve assembly is provided with a flexible sealing member which can
be pierced with a fluid sample extractor to access fluid running/available within
said longitudinal channel and is configured to seal upon itself when said fluid
sample extractor is removed from said sealing member. The fluid sample extractor
15 is a needleless syringe or a needle of a syringe used to collect a fluid sample.
In an embodiment, the said transverse opening forms a tubular projection
extending in a direction transverse, in particular, perpendicular to the axis ‘L’. The
inlet and outlet ends are connected to flexible tubing which is part of the fluid
20 collection system. The inlet and outlet ends include ridged surfaces or stepped to
enhance frictional engagement with the flexible tubing.
In an embodiment the valve assembly defines a transverse throughbore which is
aligned with transverse opening.
25
In an embodiment, the sealing member is configured to achieve a first position in
which a fluid path is established through the valve assembly and with the fluid
passage in communication with the longitudinal channel of the housing when a
fluid sample extractor is pierced therethrough thereby permitting collection of the
30 fluid sample through the port. The sealing member is also configured to achieve a
second position in which it provides a sealed environment preventing fluid flow
through the port. The sealing member includes at least one opening dimensioned
to permit passage of fluid when the sealing member is in the first position.
5
In one embodiment, the fluid sampling port includes a flexible pierceable member
which is self-sealable after use once a sample is taken out.
In another embodiment, the fluid sampling port is adapted to engage a luer-lock.
5
In another embodiment, the sampling port is adapted to engage an in-line vent
located upstream from the fluid collection bag. The in-line vent limits siphoning of
a patient's bladder during emptying of the urine collection bag.
BRIEF DESCRIPTION OF THE ACCOMPANYING 10 DRAWINGS:
The foregoing and other objects, features, and advantages of the invention will be
apparent from the following detailed description taken in conjunction with the
accompanying drawings, wherein:
15
Fig. 1 is a perspective view of a fluid sampling port according to the present
invention.
Fig. 2 is a cross-sectional view of a fluid sampling port according to the
present invention.
20
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the presently disclosed fluid collection system including a fluid
sampling port will now be described in detail with reference to the drawings
25 wherein like reference numerals designate identical or corresponding elements. In
the drawings and in the description, the term “proximal” refers to a region of the
device or parts thereof or a location on the device which is closest to, for example,
a user using the device. In contrast to this, the term “distal” refers to a region of
the device which is farthest from the user, for example, the distal region of a
30 needle will be the region of a needle containing the needle tip which is to be
inserted e.g. into a patient's vein.
6
A fluid collection system is used to collect fluid from a catheterized patient to
obtain a fluid sample for laboratory analysis. The fluid collection system includes a
fluid collection bag, a drain tube, a sampling port and a discharge valve. One end
of the fluid sampling port is thus connected to a drain tube and other end is
connected to a transfer tube which is connected to a urinary 5 catheter of a
catheterized patient. The fluid flows via the transfer tube connected to a urinary
catheter of a catheterized patient, through fluid sampling port and into drain
tube which is connected to a fluid collection bag.
10 The fluid collection bag is also provided with one vent opening for allowing air into
and out of the fluid collection bag. An anti-reflux valve is also positioned at a
second end of drain tube. Anti-reflux valve allows fluid to flow from drain tube into
collection bag but restricts flow from collection bag back into drain tube. Anti-reflux
valve can be secured directly to collection bag using any known fastening
15 technique, e.g., welding, adhesives, etc. The discharge valve is operable in a
known manner to selectively drain the fluid from collection bag.
Referring to FIGS. 1 and 2, one of the preferred embodiments of the fluid
sampling port 10 is illustrated. The fluid sampling port 10 includes a housing 12
20 defining a longitudinal channel along axis L having an inlet end 14, an outlet end
16 and a transverse opening 18. The transverse opening 18 defines a fluid
passage 20 therethrough in communication with said longitudinal channel and is
configured to receive a valve assembly 22. The transverse opening 18 forms a
tubular projection which extends in a direction transverse, in particular,
25 perpendicular to the axis ‘L’. The direction of tubular projection is not limited to
perpendicular arrangement only and may also include a slanted arrangement or
being in an arrangement of an angle of 45°, 30° etc. or the like.
The inlet 14 and outlet 16 ends are connected to flexible tubing (not shown) which
30 is part of the fluid collection system. The valve assembly 22 defines a transverse
throughbore 24 which is aligned with transverse opening 18.
7
The valve assembly 22 is provided with a pierceable flexible sealing member 26 to
seal throughbore 24. Sealing member 26 is formed from a material which can be
pierced with a fluid sample extractor (not shown) to access fluid running/available
within said longitudinal channel of the sampling port 10 and will seal upon itself
when said fluid sample extractor is removed from sealing 5 member 26. The fluid
sample extractor is a needleless syringe or a needle of a syringe used to collect a
fluid sample.
The sealing member 26 is configured to achieve a first position in which a fluid
10 path is established through the valve assembly 22 and with the fluid passage 20 in
communication with the longitudinal channel of the housing 12 when a fluid
sample extractor such as, a needless syringe or a needle of the syringe is pierced
therethrough thereby permitting collection of the fluid sample through the port 10.
In the second position the sealing member 26 is configured to achieve a sealed
15 environment preventing fluid flow through the port 10. The sealing member
includes at least one opening dimensioned to permit passage of fluid when the
sealing member 26 is in the first position.
The transverse opening 18 and the valve assembly 22 is illustrated as being
20 circular. However, other configurations are envisioned for transverse opening 18
and the valve assembly 22, e.g., square, rectangular, etc.
Inlet and outlet ends 14, 16 may include ridged surfaces or be stepped to enhance
frictional engagement with the flexible tubing. When in use, inlet end 14 of fluid
25 sampling port 10 is connected to a transfer tube (not shown) which is connected
to a urinary catheter of a catheterized patient. The outlet end 16 of the sampling
port 10 is connected to one end of drain tube or to in-line vent (not shown), such
that urine from the patient flows through the sampling port 10 and the drain tube to
fluid collection bag.
30
In operation, the fluid sampling port 10 in a fluid collection system is used in
accordance with methods known by those skilled in the art. In order to take a fluid
sample, a clinician or medical personnel pierces sealing member 26 with a
8
needless syringe or a needle of a syringe (not shown) and fluid is withdrawn from
sampling port 10 upstream of fluid collection bag. Once, the needleless syringe or
the needle of the syringe is withdrawn from sealing member 26 it seals the
piercing preventing fluid from longitudinal channel flowing out therefrom. The fluid
collected in syringe can be used as a sample for laboratory 5 examination and
analysis.
The housing 12 and valve assembly 22 may be made of a rigid material, such as,
plastic, or metal or combination thereof. The housing 12 and valve assembly 22 if
10 made of the same material, such as plastic, the housing 12 and valve assembly
22 may be ultrasonically welded together. Alternatively, the housing 12 and valve
assembly 22 may be connected by any suitable means, such as by chemical
welding or adhesives or the like material.
15 The construction and shape of the fluid sampling port 10 of the present disclosure
provides a simple configuration. This simple design is advantageous in a clinical
setting because it is less likely to get caught onto other objects during use.
Moreover, it is less likely to interfere with the patient, and thereby reducing injury
or discomfort to patient. Furthermore, it is less likely to create an obstacle to a
20 clinician during a medical procedure. In addition, the fluid sampling port 10 also
offers the benefit of requiring fewer parts than other known fluid sampling ports.
Such design greatly reduces manufacturing costs and is efficient, effective and
simple in its construction and use.
25 Although this invention has been disclosed in the context of certain preferred
embodiments and examples, it will be understood by those skilled in the art that
the present invention extends beyond the specifically disclosed embodiments to
other alternative embodiments and/or uses of the invention and obvious
modifications and equivalents thereof. Thus, from the foregoing description, it will
30 be apparent to one of ordinary skill in the art that many changes and modifications
can be made thereto without departing from the spirit or scope of the invention as
set forth in the claims.
9
Accordingly, it is not intended that the scope of the foregoing description be
limited to the exact description set forth above, but rather that such description be
construed as encompassing such features that reside in the present invention,
including all the features and embodiments that would be treated as equivalents
thereof by those skilled in 5 the relevant art.
Thus, it is intended that the scope of the present invention herein disclosed should
not be limited by the particular disclosed embodiments described above but
should be determined only by a fair reading of the appended claims.
10
10
List of Reference numerals:
10 Fluid sampling port
5 12 housing
14 inlet end
16 outlet end
18 transverse opening
20 fluid passage
10 22 valve assembly
24 transverse through bore
L Longitudinal axis

WE CLAIM:
1. A fluid sampling port (10) for use in a fluid collection system for obtaining a
fresh sample of fluid from the system, said fluid sampling port (10) comprising:
a housing (12) defining a longitudinal channel along 5 axis L having an inlet
end (14), an outlet end (16) and a transverse opening (18), wherein the transverse
opening (18) defines a fluid passage (20) therethrough in communication with said
longitudinal channel and is configured to receive a valve assembly (22), and
wherein said valve assembly (22) is provided with a flexible sealing member (26)
10 which can be pierced with a fluid sample extractor to access fluid
running/available within said longitudinal channel and is configured to seal upon
itself when said fluid sample extractor is removed from said sealing member (26).
2. The fluid sampling port (10) as claimed in claim 1, wherein said transverse
15 opening (18) forms a tubular projection extending in a direction transverse, in
particular, perpendicular to the axis ‘L’.
3. The fluid sampling port as claimed in claim 1, wherein the inlet (14) and
outlet (16) ends are connected to flexible tubing which is part of the fluid collection
20 system.
4. The fluid sampling port as claimed in claim 1, wherein the valve assembly
(22) defines a transverse through bore (24) which is aligned with transverse
opening (18).
25
5. The fluid sampling port as claimed in claim 1, wherein the inlet and outlet
ends (14), (16) include ridged surfaces or stepped to enhance frictional
engagement with the flexible tubing.
30 6. The fluid sampling port as claimed in claim 1, wherein the sealing member
(26) is configured to achieve a first position in which a fluid path is established
through the valve assembly (22) and with the fluid passage (20) in communication
with the longitudinal channel of the housing (12) when a fluid sample extractor is
12
pierced therethrough thereby permitting collection of the fluid sample through the
port (10).
7. The fluid sampling port as claimed in claim 1, wherein the sealing member
(26) is configured to achieve a second position in which 5 it provides a sealed
environment preventing fluid flow through the port (10).
8. The fluid sample port (10) as claimed in any preceding claims, wherein the
sealing member includes at least one opening dimensioned to permit passage of
10 fluid when the sealing member (26) is in the first position.
9. The fluid sample port (10) as claimed in claim 1, wherein said fluid sample
extractor is a needleless syringe or a needle of a syringe used to collect a fluid
sample.
15
10. The fluid sample port (10) as claimed in claim 1, wherein the housing (12)
and valve assembly (22) may be made of a rigid material, such as, plastic, or
metal or combination thereof.