U.S. patent application number 10/501571 was filed with the patent office on 2005-09-29 for irreversibly closable flow control clamp.
Invention is credited to Di Stefani, Gianni, Mathias, Jean-Marie.
Application Number | 20050215975 10/501571 |
Document ID | / |
Family ID | 27663267 |
Filed Date | 2005-09-29 |
United States Patent
Application |
20050215975 |
Kind Code |
A1 |
Mathias, Jean-Marie ; et
al. |
September 29, 2005 |
Irreversibly closable flow control clamp
Abstract
A flow control clamp (30) having first and second legs (36, 38)
disposed in a generally facing relationahip. The clamp includes
apertures (40, 44) for receiving a flexible tube therethrough. The
first and second legs include surfaces disposed to irreversibly
secure the legs together in the closed position.
Inventors: |
Mathias, Jean-Marie;
(Lillois, BE) ; Di Stefani, Gianni; (Ath,
BE) |
Correspondence
Address: |
Bradford R L Price
Baxter International Inc
DF2-2E
One Baxter Parkway
Deerfield
IL
60015
US
|
Family ID: |
27663267 |
Appl. No.: |
10/501571 |
Filed: |
April 27, 2005 |
PCT Filed: |
January 21, 2003 |
PCT NO: |
PCT/US03/01758 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60353938 |
Jan 30, 2002 |
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Current U.S.
Class: |
604/403 |
Current CPC
Class: |
A61M 39/08 20130101;
A61J 1/10 20130101; A61M 39/284 20130101; A61M 2202/0413 20130101;
F16K 7/063 20130101 |
Class at
Publication: |
604/403 |
International
Class: |
A61B 019/00 |
Claims
What is claimed:
1. A flow control clamp comprising: a flexible body having a first
leg and a second leg disposed in a general facing relationship and
movable between a first spaced apart position and a second closed
position; a pair of apertures in said body for receiving a flexible
tube therethrough and between said legs; at least one tube
contacting member carried by one of said legs for clamping a tube
when said legs are in the closed position; said first and second
legs including surfaces disposed to irreversibly secure said legs
together in said closed position.
2. The flow control clamp of claim 1 wherein said first leg
includes a pair of spaced apart walls defining a slot, and said
second leg includes an extension, whereby movement of said legs
from said spaced apart position to said closed position introduces
said extension into said slot.
3. The flow control clamp of claim 2 wherein said first leg
comprises a pair of inwardly projecting, spaced apart walls
defining said slot, and said second leg comprises an inwardly
projecting extension.
4. The flow control clamp of claim 1 wherein said first and second
legs include surfaces disposed to irreversibly interlock said legs
together.
5. The flow control clamp of claim 4 wherein one of said legs
comprises a lip and said other leg comprises a hook for engaging
said lip in said closed position.
6. The flow control clamp of claim 1 wherein one of said legs
comprises a socket and the other of said legs comprises a ball for
engaging said socket in said closed position.
7. The flow control clamp of claim 4 wherein one of said legs
comprises a notch and the other of said legs comprises a peg for
engaging said notch in said closed position.
8. The flow control clamp of claim 1 wherein said body is made of a
polymeric material selected from the group consisting of
polyoxymethylene and polypropylene.
9. The flow control clamp of claim 1 further comprising a tube
contacting member carried by said other of said legs for clamping
said tube between said contacting members when said legs are in the
closed position.
10. The flow control clamp of claim 1 wherein the outer surface of
said body is substantially free of sharp ends and corners.
11. The flow control clamp of claim 1 wherein; said, apertures are
adapted to completely surround a tube at the point where the tube
extends through said aperture.
12. The flow control clamp of claim 2 wherein one of said
spaced-apart walls is more rigid than said other of said
spaced-apart walls.
Description
[0001] The present relates to clamps for controlling the flow of
liquid through a flexible tube. More particularly, the present
invention relates to flow control clamps that can be substantially
irreversibly secured in a closed position, thereby discouraging
reopening of the flow path of the tube.
BACKGROUND OF THE INVENTION
[0002] A disposable plastic container and tubing set or fluid
circuit is typically used for collecting blood from a donor. The
disposable blood collection set includes a venipuncture needle for
insertion into the arm of the donor. The needle is attached to one
end of a flexible plastic tube which provides a flow path for the
blood. The other end of the plastic tube is attached to one or more
plastic bags or containers for collecting the withdrawn blood.
[0003] The blood collection set may also include a sampling
sub-unit. The sampling sub-unit allows for collection of a sample
of blood, which sample can be used for testing of the blood.
Preferably, the sample is obtained prior to the "main" collection
of blood. Collecting the sample prior to the main collection
reduces the risk that bacteria residing on the donor's skin where
the needle is inserted (i.e., in particular, the small section of
detached skin commonly referred to as the "skin plug") will not
enter the collection container and contaminate the blood collected
for transfusion. Thus, it is preferred that the blood sample, which
may include the skin plug, be diverted from the main collection
container.
[0004] An example of a blood collection set with such a
"pre-donation" sampling sub-unit is described in U.S. patent
application Ser. No. 09/364,628 filed Jul. 29, 1999 and U.S. patent
application Ser. No. 09/492,060 filed Jan. 27, 2000, which are
incorporated by reference herein. The collection sets described
therein include a needle and a length of tubing, one end of which
is attached to the needle and the other end of which is attached to
one or more collection containers. The tubing set also includes an
additional line which is branched from the main line at a
Y-connection site in the tubing set. The branched line is attached
to a sampling pouch for collecting a smaller volume of blood from
which samples may be obtained.
[0005] The sampling sub-unit may further include a pre-attached
holder for receiving blood sample vials or tubes. The holder is
connected to the outlet port of the sampling pouch and includes a
needle in the holder interior. When the blood sample vial is
inserted into the holder, the needle pierces the rubber cap
(septum) of the vial and blood from the sampling pouch is drawn
into the vial. The blood-filled vial is removed from the holder and
the procedure may be repeated with as many vials as required.
[0006] The blood collection set described above also includes flow
control clamps for controlling the flow of biological fluid (e.g.,
blood) through the set and to the sampling pouch and/or collection
container. Flow control clamps commonly used are the Roberts-type
clamps, which are well known in the art. The Roberts-type clamps
are placed on the tubing line leading to the blood collection
container and on the tubing line leading to the sampling pouch. A
Roberts-type clamp is typically made from a strip of plastic. The
ends of the strip are curved toward each other to provide two
"legs" which are adapted to engage each other in a snap-fit, spring
relation. The body of the clamp includes a pair of apertures
through which the tubing passes.
[0007] The clamp further includes a pair of projections or tube
contacting members which compress the tubing when the body of the
clamp is depressed, thereby restricting flow through the tube.
Clamps of this type are generally described in U.S. Pat. Nos.
3,942,228, 6,089,527 and 6,113,062, all of which are incorporated
herein by reference.
[0008] The clamps described in these patents also typically include
means for locking the legs together and release means which, when
actuated by the technician, disengages the locked legs of the flow
control clamp. Disengagement of the ends decompresses the tube and
permits fluid flow through the flow path. Thus, by selectively
opening and closing the different flow paths (by depressing or
releasing the clamps), the technician can control the flow of blood
from the donor, diverting the blood to the desired container or
sampling pouch, as necessary.
[0009] In certain instances, however, it may not be desirable to
reopen a closed flow path. This may particularly be the case when
drawing blood samples from the sampling pouch into sample vials.
For example, when the sampling pouch is filled with the required or
desired volume of blood(for sampling), the line from the donor to
the pouch is typically closed by the Roberts-type clamp, and
remains closed as the sampling vials are filled. After clamping the
sampling line closed, technicians are further instructed to more
permanently seal the line using metal clips or by heat-sealing the
line in ways that will be known to those in the field. Sealing the
sampling line substantially ensures that airborne bacteria or other
contaminants that may enter the set through the sampling sub-unit
do not contaminate the remainder of the set, including the needle
and tube leading to the collection container. In short, the clips
or heat seal provide a sterile barrier to the remainder of the
set.
[0010] Unfortunately, on occasion, prior to permanently sealing the
sampling line, some technicians have been known to unclamp the
sampling line in order to draw additional blood into the pouch so
that additional sample vials may be filled. However, by doing so,
the system becomes "open" and contaminants introduced from the
outside environment may enter the system. Current flow control
clamps are readily and easily openable, and do not provide a
disincentive to drawing additional blood into the sampling pouch.
If the clamp could not be so readily released from the closed
position, the technician would not have the option of reopening the
line but would, hopefully, proceed with permanently sealing the
line to form the sterile barrier. Accordingly, it would be
desirable to provide a clamp that discourages and substantially
prevents the reopening of the sampling or other blood tube
line.
SUMMARY OF THE INVENTION
[0011] In one aspect, the present invention is directed to a flow
control clamp that includes a flexible body. The body has a first
leg and a second leg disposed in a generally facing relationship.
The legs are moveable between a first spaced apart position and
closed position. The clamp includes two apertures in the body for
receiving a flexible tube therethrough and between the legs. The
clamp further includes at least one tube contacting member carried
by one of the legs for clamping the tube when the legs are in the
closed position. The first and second legs include surfaces
disposed to irreversibly secure the legs together in the closed
position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a perspective view of a blood tubing set including
a flow control clamp embodying the present invention;
[0013] FIG. 2 is a perspective view of a flow control clamp
embodying the present invention;
[0014] FIG. 3 is a plan view of the flow control clamp of FIG. 2
taken from lines 3-3 of FIG. 2;
[0015] FIG. 4 is a plan view of the flow control clamp of FIG. 2
taken from lines 4-4 of FIG. 2;
[0016] FIG. 5 is a plan view of the flow control clamp of FIG. 2
from lines 5-5;
[0017] FIG. 6 is a plan view of the flow control clamp of FIG. 2
taken from lines 6-6;
[0018] FIG. 7 is a cross-sectional, side view of the flow control
clamp embodying the present invention in the open position;
[0019] FIG. 8 is a cross-sectional, side view of the flow control
clamp embodying the present invention in the irreversibly locked
position.
[0020] FIG. 9 is a side view of an alternative embodiment of the
flow control clamp of the present invention;
[0021] FIG. 10 is a side view of another alternative embodiment of
the flow control clamp of the present invention;
[0022] FIG. 11 is a side view of another alternative embodiment of
the flow control clamp of the present invention; and
[0023] FIG. 12 is a side view of another alternative embodiment of
the flow control clamp of the present invention;
DETAILED DESCRIPTION OF THE DRAWINGS
[0024] Turning now to the drawings, FIG. 1 depicts a blood
collection set 10 of known type that is used in the collection of
blood from a donor. Tubing set 10 includes a venipuncture needle 12
and a length of tubing 14. Tubing 14 branches at Y-connector 16
into tubing segment 14a and tubing segment 14b. Tubing segment 14a
provides a flowpath to a collection container 18 and tubing segment
14b provides a flow path to a sampling pouch 20. The sampling pouch
may also include a holder 21 for receiving a blood sampling vial or
tube. (Also shown is a needle protector 15 for storing the needle
after use.)
[0025] In the blood tubing sets of the type shown in FIG. 1, tubing
segments 14a and 14b are passed through flow control clamps 22 and
30 which may be a standard Roberts-type clamp and an irreversibly
closable flow control clamp embodying the present invention. As
used herein, the terms "irreversibly" closed or closable means that
the flow control clamp, once in the closed position, is not readily
releasable from the closed position in the normal and intended mode
of operation. An "irreversibly" closed or closable flow control
clamp can only be released from the closed and locked position by
extraordinary and unintended manipulation of the clamp, including
breakage of the clamp. A flow control clamp that is "irreversibly"
closed or closable includes no release members such as, but not
limited to, those described in U.S. Pat. Nos. 3,942,228, 6,089,527,
6,113,062.
[0026] Thus, whereas flow control clamp 22 can be selectively
opened and closed, as desired, clamp 30, made in accordance with
the present invention, once closed, remains irreversibly
closed.
[0027] Turning now to FIG. 2, flow control clamp 30 of the present
invention includes a generally curved, bent or otherwise non-linear
body 34 (described in more detail below). Preferably, flow control
clamp 30 may be made of any flexible, moldable, plastic material
that can be steam sterilized. In addition, flow control clamp 30
and body 34 should be made of a material that is strong, yet
sufficiently flexible so that the clamp can be flexed and squeezed
by the technician without breaking. Examples of suitable materials
are many of the known plastic materials typically used in the
medical field, including, but not limited to polyoxymethylene and
polypropylene. Most preferred of the above-identified materials is
polyoxymethylene, such as the polyoxymethylene known as
Hostaform.TM. available from Ticona of Frankfurt, Germany. In
addition, other materials that can be sterilized by other forms of
sterilization, such as gamma sterilization, may also be used. One
such material is a terpolymer of acrylonitrile, butadiene and
styrene (ABS).
[0028] As further shown in FIG. 2, flow control clamp 30 includes
body 34 that has two legs 36 and 38. Legs 36 and 38 are disposed in
a generally facing relationship relative to each other. Legs 36 and
38 are initially in a spaced apart position as shown in FIG. 7, and
are movable from the spaced apart position toward each other and to
a closed position.
[0029] Body 34 further includes apertures 40 and 44 for receiving a
length of plastic tubing therethrough. As shown in FIG. 2,
apertures 40 and 44 are preferably circular or oval-like and are
entirely contained within body 34 of flow control clamp 30. Thus,
when a length of tubing 43 is inserted through apertures 40 and 44,
the apertures completely enclose and surround the tubing at the
point where the tubing extends through the apertures. Also, it may
be preferable that apertures 40 and 44 be generally aligned with
each other and not substantially offset relative to one another.
This provides, among other things, for easier threading of the
length of tubing 43. Alternatively, apertures need not completely
surround the tube, but instead may include lateral slots, as
described, for example, in U.S. Pat. No. 6,113,062. The lateral
slots extend to the outer edge of the body so that during insertion
of the tube, the clamp can be laterally slipped on the tube (as
opposed to threading).
[0030] Flow control clamp 30 includes one or more tube contacting
members 48 and 50. Tube contacting members 48 and 50 are carried by
legs 36 and 38, respectively. As shown in FIG. 2, tube contacting
members 48 and 50 may be teeth-like projections which compress the
tubing when the clamp is closed. Alternatively, tube contacting
members 48 and 50 may simply be blunt, oppositely facing surfaces.
Although two oppositely facing contacting members are shown in FIG.
2 and are preferred, it will be understood that flow control clamp
30 of the present invention may include only one tube contacting
member carried by one of the legs 36 or 38.
[0031] The outer surface 52 of flow control clamp 30 is generally
flat and smooth. However, outer surface 52 may include portions
that are roughened or textured to provide some friction when
contacted by the fingertips of the technician during operation. As
shown in FIGS. 3 and 4, outer surface 52 of body 34 includes ribbed
portions 54 and 56, which provide such a frictional surface for
contacting by the fingers of the technician during closure and
compression of flow control clamp 30.
[0032] As best shown in FIGS. 7 and 8, flow control clamp 30 is
substantially free of any sharp corners or edges. For example,
bends 58, 60 and 62 in body 34 are not abrupt, sharp corners, but
are gradually curved and rounded. In addition, edges 63 of body 34
are preferably rounded or beveled. A flow control clamp 30 that is
substantially free of sharp corners and edges and is more rounded
or beveled, like the flow control clamp shown in FIGS. 7 and 8,
ensures that the flow control clamp will not puncture the packaging
of blood processing sets, thereby maintaining sterility of the
packaged set.
[0033] As discussed generally above, where the blood processing set
includes a sampling pouch of the type shown in FIG. 1, it may be
desirable to provide a flow control clamp 30 that provides an
additional level of sterility maintenance by discouraging and
perhaps even preventing the technician from reopening a previously
closed clamp. This way, the sterility of the remainder of the blood
processing set will be maintained and will not be compromised by
bacteria from the outside environment.
[0034] Accordingly, flow control clamp 30, and more particularly,
legs 36 and 38 include surfaces that are disposed for irreversibly
securing together legs 36 and 38 when the legs of flow control
clamp 30 are moved from a spaced-apart position to the closed
position, as shown in FIGS. 7 and 8.
[0035] Many different means for securing legs 36 and 38 together in
a way that prevents easy reopening by the technician are
contemplated by the present invention. For example, flow control
clamp 30 may include means on the leg surfaces for interlocking
legs 36 and 38. Specifically, as shown in FIGS. 7 and 8, leg 36 of
flow control clamp 30 may include a pair of spaced-apart walls 66
and 68. Spaced-apart walls 66 and 68 define a slot 70 for receiving
an extension 72 carried by leg 38. One of the spaced-apart walls 66
or 68 may further include a lip 74 that projects into slot 72,
while the extension 72 includes a hook 76 that projects toward the
wall 66.
[0036] As the legs 36 and 38 are moved from the spaced-apart
position, as generally depicted in FIG. 7, to the closed position,
tube contacting members 48 and 50 compress the tube 43, thereby
restricting flow therethrough. As flow control clamp 30 is
compressed further, extension 72 is outwardly displaced by wall 66
and enters slot 70. As hook 76 contacts lip 74, extension 72 is
again outwardly displaced until it clears lip 74. Once clear of lip
74, extension 72 snaps forward toward wall 66, and hook 76 engages
lip 74 to effectively close and lock flow control clamp 30.
[0037] Wall 68 prevents release or further outward displacement of
extension 72 from the closed position, thereby resulting in an
"irreversibly closed" flow control clamp 30. As shown in FIG. 8,
wall 68 is a thicker and a less flexible wall than, for example,
wall 66, thereby providing more strength to wall 68 and making it
even more difficult to release extension 72. As will be appreciated
by those in the field, flow control clamp 30 does not include any
tabs or other means for readily releasing extension 72. Thus, flow
control clamp 30 remains in the closed position.
[0038] FIGS. 9-12 include additional means for securing legs 36 and
38 in an "irreversibly closed" position. For example, as shown in
FIG. 9, extension 72 may include a peg, and wall 66 includes a
mating notch 84 for receiving peg 86 of extension 72. Extension 72
enters slot 70 in the manner generally described above, until peg
86 snaps into notch 84. Wall 68 again prevents outward movement of
extension 72, thereby retaining flow control clamp 30 in an
"irreversibly closed" position.
[0039] FIG. 10 is an alternative embodiment where extension 72
includes a notch for receiving lip 74 of wall 66. In FIG. 11, lip
74 is located on wall 68 and is engaged by hook 76, as previously
described.
[0040] FIG. 12 shows yet another alternative embodiment of the flow
control clamp 30 of the present invention wherein leg 36 includes a
single wall 85 projecting toward the interior (i.e., toward leg 38)
of the flow control clamp 30. Leg 38 includes an extension,
likewise projecting toward the interior (i.e., and toward leg 36)
of the flow control clamp 30. In order to secure legs 36 and 38 in
the "irreversibly closed" position, one of the legs may include a
socket 86, and the other of the legs may include a ball 88 for
insertion into socket 86. This way, as in the previous embodiments,
flow control clamp 30 may be closed or locked in the "irreversibly
closed" position.
[0041] It will be appreciated that the description set forth above
has been offered for illustrative purposes only. Other embodiments
and other modifications to the flow control clamp shown and
described above may also be included within the scope of the
present invention. The above description is not intended to limit
the scope of the invention of this application, which is as defined
in the claims below.
* * * * *