U.S. patent number 3,877,465 [Application Number 05/404,659] was granted by the patent office on 1975-04-15 for fluid collection device.
This patent grant is currently assigned to Jintan Terumo Co., Ltd.. Invention is credited to Sanae Miyake.
United States Patent |
3,877,465 |
Miyake |
April 15, 1975 |
FLUID COLLECTION DEVICE
Abstract
A fluid collection device provided with a plurality of fluid
sample containers to permit continuous fluid collection which
comprises a cannula having a slantwise cut opening formed at both
ends, a hub disposed at the middle part of the cannula so as to be
connected to a holder used in the insertion of a sample container
and a blind, cylindrical, self-sealing elastic sheath provided on
one side of the hub so as to loosely envelop part of the cannula,
whereby, when connected to the sample container, the sheath is
pressed by the plug member of the sample container to have its top
portion punctured by the pointed end of the needle member and in
consequence collapses toward the hub and, when the sample container
is drawn out of the subject device, is brought back to its original
position, thereby preventing the efflux of a fluid outside of the
sheath.
Inventors: |
Miyake; Sanae (Tokyo,
JA) |
Assignee: |
Jintan Terumo Co., Ltd. (Tokyo,
JA)
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Family
ID: |
27308714 |
Appl.
No.: |
05/404,659 |
Filed: |
October 9, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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208246 |
Dec 15, 1971 |
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56283 |
Jul 20, 1970 |
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Foreign Application Priority Data
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Oct 17, 1969 [JA] |
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44-98595 |
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Current U.S.
Class: |
600/577 |
Current CPC
Class: |
A61B
5/150221 (20130101); A61B 5/150351 (20130101); A61B
5/150732 (20130101); A61B 5/150389 (20130101); A61B
5/154 (20130101); A61B 5/150572 (20130101); A61B
5/155 (20130101); A61B 5/15003 (20130101); A61B
5/150496 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61b 005/14 () |
Field of
Search: |
;128/2F,2R,DIG.5,DIG.21,276,214R,214B,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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1,019,500 |
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Feb 1966 |
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GB |
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1,239,808 |
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May 1967 |
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DT |
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Primary Examiner: Howell; Kyle L.
Attorney, Agent or Firm: Kemon, Palmer & Estabrook
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application is a continuation of Ser. No. 208,246, filed Dec.
15, 1971, now abandoned, which was in turn a continuation-in-part
of Ser. No. 56,283, filed July 20, 1970, now abandoned.
Claims
What we claim is:
1. A blood transfer device comprising a tubular container holder
having an open end and a closed end, a double-ended, hollow needle
fitted to the closed end of the holder through a hub parallel to
the longitudinal axis of said holder and having its rear end within
the interior of the holder and its front end outside the holder, a
needle puncturable, self-sealing, rubber elastic sheath sealingly
enveloping said rear end of the needle, a cylindrical container
having a closed end and an open end in which a stopper is sealingly
attached, said container extending at said open end at least part
way into said holder, said needle being 0.7 to 0.9 mm in outer
diameter, said elastic sheath being 0.7 to 0.8 mm in wall thickness
and having a closed hemispherical end portion, the clearance
between the inner surface of said hemispherical end portion of the
sheath and the rear end of the needle being 1 to 3 mm, and the
clearance between the inner side wall of the sheath and the opposed
side wall of the needle being 0.1 to 0.5 mm and, when upon further
movement of said container into the holder said rear end of the
needle pierces the container stopper, the sheath is pressed by the
container stopper to have said hemispherical top portion punctured
by said rear end of the needle and collapsed toward said hub and to
allow said rear end of the needle member to communicate with the
fluid sample container, thus assuming a position at which the fluid
is permitted to be conducted through the needle to the fluid sample
container, and upon removal of the needle member from the fluid
sample container, the sheath spontaneously regains its original
position enveloping the rear end of the needle.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a fluid collection device capable
of repeatedly collecting a fluid, for example, blood sample with a
venipuncture needle inserted into the vein.
In recent years, there has come into use a vacuum blood collection
device in collecting blood samples for various blood examinations.
A prior art fluid collection device of such type consists of a
vacuum fluid collection container, a holder used for its insertion
and a venipuncture needle member fitted to the holder. Said needle
member has a pointed blade formed at both ends, one of which
penetrates the plug member of the vacuum fluid collection container
to effect blood collection. With the conventional fluid collection
apparatus, the end opening of the needle member penetrating the
plug member of the vacuum fluid collection container is always left
open. Accordingly, when the needle member is inserted into the vein
for blood collection, the blood tends to flow into the holder under
its own pressure and soil a blood collection cylindrical member
before the needle member pierces the plug member of the blood
collection container, leading to not only blood loss but also
discomfort to patients. There occurs the further drawback that
blood still remaining in the needle member after blood collection
most likely drips into the holder.
While various blood examinations naturally require large amounts of
blood to be collected, the aforesaid prior art fluid collection
apparatus fails to collect a plurality of blood samples with the
venipuncture needle inserted into the vein.
In addition to the fluid collection apparatuses described above,
there are other types wherein there is fitted an elastic rubber
sheath on to a needle member to eliminate the aforementioned
drawbacks. Among said other types, there is one wherein the rubber
sheath is tightly attached to the needle member. Such apparatus is
likely to present difficulties in allowing the sheath to be brought
back to its original position and also in steam sterilizing the
tightly contacted portion of the needle member and sheath. There
are still other types wherein the end of the needle member is
fitted with a cylindrical rubber sheath whose bottom end is cut at
right angles to its lengthwise direction. If, in such case, the
needle member should slantwise pierce the sheath, it will penetrate
the side wall of the sheath deeply, preventing the sheath from
being quickly returned to its original position due to a great
resistance presented by the needle.
SUMMARY OF THE INVENTION
The present invention has been accomplished in view of the
aforementioned situation and is intended to provide a fluid
collection apparatus which is capable of continuously collecting
many fluid samples with a needle member inserted into the human
body, for example, the vein and also preventing blood and other
types of liquid from soiling the interior of the holder as is the
case with the conventional fluid collection apparatus.
Another object of this invention is to provide a fluid collection
device which enables a rubber sheath to make a substantially full
return, thereby permitting quick fluid collection. Still another
object of the invention is to provide a fluid collection device
which facilitates the fitting of the rubber sheath to a cannula
and, once fitted, prevents it from being readily loosened
therefrom.
The fluid collection device of the present invention comprises a
fluid collection device which comprises a holder for inserting a
fluid sample container into the device, a needle member fitted to
one end of the holder through a hub parallel to the longitudinal
axis of the holder and having a slantwise cut opening formed at
both ends, one of which projects outside of the holder to
constitute the front part of the needle member for piercing the
skin and the other end of which projects into the holder for
connection with a fluid sample container to form the rear part of
the needle member and a self-sealing elastic sheath 0.7 to 0.8 mm
in thickness overall and having hemispherical top portion, said
sheath being fixed to a projection comprising neck portion and
frustoconically chamfered larger head portion and enveloping the
whole rear part of the needle member, whereby, before the rear part
of the needle member is connected to the fluid sample container,
the sheath assumes a first position where it loosely envelops all
the rear part of the needle member, the clearance between inner top
portion of the sheath and pointed portion of the rear part of the
needle member being 1 to 3 mm, and the clearance between the inner
side wall of the sheath and side wall of the needle member being
0.1 to 0.5 mm and, when said rear part is connected to the fluid
sample container, the sheath is pressed by the container to have
its top portion punctured by the pointed end of the rear part of
the needle member and collapses toward the hub to allow the end of
the rear part of the needle member to communicate with the fluid
sample container, thus assuming a second position at which the
fluid is permitted to be conducted from the human body to the fluid
sample container, and upon removal of the needle member from the
fluid sample container, the sheath spontaneously regains said first
position.
BRIEF EXPLANATION OF THE DRAWING
FIG. 1 is an enlarged view, partly in section, of a needle member
to which a sheath is fitted;
FIG. 2 is an enlarged partial view, partly in section, of another
embodiment to which a sheath is fitted; and
FIGS. 3 to 5 are sectional views showing the sequential steps of
fitting a fluid sample container.
DETAILED DESCRIPTION OF THE INVENTION
There will now be described the present invention by reference to
the appended drawings. FIG. 1 denotes a needle member to which
there is fitted a sheath. The needle member comprises a metal
cannula 11 having a slantwise cut opening formed at both ends which
constitute the front and rear parts 11a and 11b respectively, and a
hub 14 fixed substantially at the middle part of the cannula 11 by
means of a through hole bored along the central axis of said hub
and provided with a male screw 13 for engagement with the later
described holder 16. The hub 14 is made of, for example, a plastics
material, and to that side of the hub 14 which faces the rear part
11b of the cannula 11 is fitted through the projection 14a of the
hub 14 a blind, cylindrical sheath 15 so as to envelop the whole
rear part 11b of the cannula 11. As shown in FIG. 2, the projection
14a comprises a neck portion 14b and larger head portion 14c having
a frustoconically chamfered end 14d. Since the head portion 14c is
sufficiently tapered, for example, at an angle of about 45.degree.
to effect the easy engagement of a rubber sheath 15 and has a
proper outer diameter, the rubber sheath 15 will be prevented from
coming off simply by being fitted on to the needle member, thereby
withstanding a pulling load of, for example, 150 to over 400 g. The
sheath 15 consists of, for example, an elastic rubber member which
is puncturable and self-sealing and envelops the rear part 11b of
cannula 11 loosely or with a slight gap allowed. The top 15a of the
sheath 15 is hemispherical, with a clearance A of about 1 to 3 mm,
preferably 1.5 to 2.5 mm allowed between the inner wall of said top
15a and the end of the rear part 11b of the cannula 11. Where the
clearance A is reduced to below 1 mm, the sheath will be obstructed
in its return due to an insufficient resilient force. Conversely
where the clearance exceeds 3 mm, the needle will probably pierce
the side of the sheath, preventing it from making a full return.
Further, the clearance between the inner wall of the sheath 15 and
the outer wall of the cannula 11b should be 0.1 to 0.5 mm. If the
clearance falls to below 0.1 mm, the contact of the sheath with the
cannula 11b will present so great a resistance as to obstruct the
return of the sheath 15. If, otherwise, the clearance is larger
than 0.5 mm, the sheath 15 will loosely engage the projection 14a,
preventing the sheath from being pricked by the needle exactly at
the center of the end and in consequence obstructing the return of
the sheath due to its side being possibly pierced by the needle.
The wall of the sheath 15 need not be made particularly thick, but
should preferably be 0.7 to 0.8 mm thick. If the wall thickness is
smaller than 0.7 mm, the sheath will be decreased to below 250 g in
resilience, resulting in its insufficient return. Conversely, if
the thickness is larger than 0.8 mm, the sheath will have a
resilient force of more than 400 g, giving rise to the drawback
that such great recoiling force will push back the sample container
12 pierced by the needle for fluid collection to the outside of the
holder 16. A sheath of the aforementioned size is particularly
adapted for use with a cannula 0.7 to 0.9 mm in diameter.
The needle member thus constructed is engaged with a cylindrical
holder 16 as shown in FIG. 3. At one end of the holder 16 is
projectingly formed a fitting part 17 provided with female screws.
The hub 14 of the needle member registers with said female screws
in such a manner that the rear part 11b of the needle member
projects into the holder 16, thereby connecting the needle member
to the holder 16.
Where there is used a fluid collection device arranged as described
above, for example, in blood collection, there is first inserted,
as shown in FIG. 3, the fluid sample container 12 into the holder
16, or alternatively, prior to the fitting of the needle member to
the holder 16, the fluid sample container 12 is inserted into the
holder 16 so as to allow it to approach the needle member, and then
the needle member is connected to the holder 16. Under such
condition, the front part 11a of the needle member is inserted into
the vein of a person from whom there is to be collected blood.
Though, at this time, blood comes into the rear part 11b of the
needle member, said rear part 11b is enveloped by the sheath 15, so
that blood is prevented from flowing outside of the sheath 15, and
in consequence soiling the interior of the holder 16. Further
insertion of the fluid sample container 12 into the holder 16
causes, as shown in FIG. 4, the projecting end of the sheath to
contact a depression 18a formed in the plug member 18 of the fluid
sample container 12. When the fluid sample container is further
pushed in, the top portion of the sheath 15 is punctured, as shown
in FIG. 5, by the pointed end of the rear part 11b, and then, the
sheath 15 collapses toward the hub 14, allowing the rear part 11b
to penetrate a self-sealing plug member 18. At this moment, the
interior of the fluid sample container 12 is in an evacuated state,
exerting a suction force, so that blood flows into the fluid sample
container 12 through the needle member. When the fluid sample
container 12 is drawn out after required amounts of blood are
collected, then the sheath 15 will regain its original position,
namely, so as to fully envelop the rear part 11b of the needle
member as shown in FIG. 3, preventing the holder 16 from being
soiled with blood after its collection is completed. Accordingly,
blood collection can be repeated by connecting a fresh fluid sample
container 12 to the needle member which is kept inserted into the
vein throughout this period. The surface of the rear part 11b may
preferably be coated with silicone oil. In this case, instant
restoration of the sheath 15 will be promoted by the lubricating
action of the silicone oil.
With a fluid collection device according to the present invention,
the rear part of the needle member is enveloped, as mentioned
above, with a puncturable, self-sealing elastic sheath, so that the
rear part is not exposed during operation or at the time fluid
sample containers are replaced, but is saved from contamination.
Further, the fluid collection device of this invention has an
elastic sheath having its end formed into a hemisphere and prepared
in substantially uniform thickness with an adequate space allowed
between the inner wall of the sheath and the outer wall of the
cannula, thereby enabling the sheath to return quickly and reliably
when released from contraction. Further, the sheath can be tightly
fitted to the hub simply by engaging it with the projection formed
at the end of the hub, offering very great practical advantage in
fabricating and manipulating the device. According to the present
invention, blood collection can be easily effected without the
possiblity of the interior of the holder being soiled with blood
spilled. Blood thus spilled not only goes to waste, but also sticks
to an operator collecting the blood and gives psychological
discomfort to the operator as well as to the patient. Further, the
open section of the rear part of the needle member assumes the form
cut slantwise with respect to the longitudinal axis of the cannula
so that the needle member as a whole is easy to manufacture due to
its simple construction, and enables streams of blood to run
smoothly therethrough. It should also be noted that since the
structure of the rear part of the cannula is the same as that of an
ordinary type of needle, it is possible to employ a relatively fine
needle, e.g. 0.7 to 0.9 mm in diameter as the cannula.
In the foregoing embodiment, there has been described blood
collection for illustration of the needle member according to the
present invention. It will be apparent, however, that the invention
is not limited to such application but will be applicable in
collecting samples of other types of fluid.
* * * * *