Note: Descriptions are shown in the official language in which they were submitted.
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DISPOSABLE BLOOD COLLECTION DEVICE
BACKGROUND OF THE INVENTION
Field of the Invention,
This invention relates to a disposable blood collection
device employing a double-ended cannula which is attached to the
device preferably immediately prior to use, locked in an extended
position ~or use, and retracted entirely within khe barrel to a
permanently locked position after use to protect against
accidental needle sticks.
Backqround Discussion:
Medical devices using needles which are retained in a
retracted position after the needle is used to yuard against
accidental sticks are well known. Such devices are shown, for
example, in U.S. Patent Nos. 4,650,468; 4,675,005, 4,692,156; and
4,507,117. Devices shown in the aforementioned patents are
generally of the hypodermic syringe type, that is, a single
'needle point normally fixed to the end of a barrel and covered
by a protective guard is utilized to inject fluids into or
extract fluids frum the human body. The needle point is
retracted into the syringe barrel and retained therein by various
means after use.
A somewhat different type of device has come into use
with respect to the collection of blood samples. The device
includes a double-ended cannula or needle, again is fixed to one
end of the barrel and covered by a protective guard prior to use.
The guard is removed and the end of the needle so uncovered is
inserted into the patient's vein. A ~terile evacuated container
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is applied to the other end within the barrel so that the
pressure dif~erential resulting thereby causes blood to be drawn
from the vein into the evacuated container. When the container
is filled, it is removed from the nlsedle, thereby providing a
sealed blood sample in the container. Examples of this type of
device are shown in Figures 4-6 of U.S. Patent No. 4,592,744 and
in Figures 1-3 of U.S. Patent No. 4,643,199. In each o~ these
devices, a double ended cannula is normally fixed to the end o~
the barrel so that one end extends from the barrel and is covered
by a protective guard prior to use. After use, the double ended
cannula is retracted within the barrel so as to be disposable
without the danger of sticking personnel thereafter handling it.
However, both of thess devices require the user to use both hands
in order to retract the needle after use, and thus are relatively
complicated and time consuming in use. In addition, having th~
patient-inserted end of the cannula normally fixed to the end o~
the barrel takes up additional shipping space and requires
removal of the guard prior to use.
A blood collection device having a double-ended cannula
disposed in a barrel, open at one end to permit the insertion of
an evacuated sample collection container therein onto one end of
the double-ended cannula, and an aperture at the other barrel end
to permit the extension and retraction therethrough of the other
end of the double-ended cannula is shown in U.S. Patent No.
4,774,964, entitled Blood Collection Device, issued October 4,
1988, Jean A. Bonaldo, Inventor. This device has a first disc
disposed within the barrel to which the double-ended cannula is
fixed so as to extend to each side thereof and be axially aligned
within the barrel in a shipping position in which the cannula is
completely contained within the barrel prior to use. A second
disc, disposed within the barrel between the first disc and the
barrel open end, has an aperture axially formed therein so as to
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permit one end of the cannula to pass therethrough. The ~irst
disc and the second disc are connected toyeth~r by flexihle
connectors within the barrel to permit preselected r~lative
movemant therebetween. When the second disc is moved toward the
barrel closed end, the ~irst disc is moved against the barrel
closed end, so that the cannula e~xtends out of the barrel
aperture. When the second disk is thereafter moved in the
opposite direction, the first disc is withdrawn by the connectors
from the barrel closed end in a spaced-apart relationship from
the second disc to a position in which both ends of the cannula
are disposed wikhin the barrel. Locking means ~or locking the
first disc and second disc within the barrel in this spaced-apart
relationship and manual operating means operable ~or initiating
the movement of said discs to said spaced-apart relationship in
conjunction with said connectors are provided. However, this
desi~n is comparatively expensive to manufacture and assemble,
by reason of the portions of its structure which use two discs
connected together by the ~lexible connectors.
U.S. Patent No. 4,gOO,310 describes a blood collection
device housing a cylindrical sheath open at one end and partially
-closed at the other end with a closed longitudinal slot ~ormed
in the sheath. A piston, disposed in the sheath so as to be
slidable between a cannula-extended pvsition an a cannula-
retracted position, has a threaded axial bore adapted to receive
a complementary threaded boss on a cannula so the cannula extends
longitudinally through the piston bore with one end of the
cannula in the sheath and the other end of the cannula extending
through the partially c~osed end o~ the sheath when the piston
is in the extended position. A radially extending actuator pin
formed on th2 piston extends through the longitudinal slot so as
to be manipulable with one hand to move the piston from the
extended position to the retracted position to enclose the
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cannula within the sheath. The longitudinal slot may have
suitahle detent means at one or both ends to provide that the
piston be lightly held in the extended position and locked in the
retracted position. However, because the piston is only liyhtly
held in the extended position, when t;he cannula is screwed into
the piston, a possibility exists that excess force will cause the
piston to retract, necessitating holding the piston in place by
the actuator pin.
S~MMARY OF THE INVENTION
A blood collection according to the present invention
is adapted to hold a double ended cannula in a cylindrical
barrel, which is selectively openable at one end to permit
insertion of an evacuated sample collection container
therethrough on to one end of the double-ended cannula, with an
aperture at the other barrel end to permit the extension and
retraction therethrough o~ the other end of the double-ended
cannula, the barrel having a disc disposed therewithin and
adapted to have the double-ended cannula, which, in the preferred
embodiment, is selectively fixed thereto by means of a bore in
the piston threaded in a first direction and adapted to receive
a complementary threaded boss on the cannula so as to have one
end of the cannula extend to each side thereof and be axially
aligned with the barrel in a disposal position in which the
cannula is completely contained with in the barrel after use and
so that when the disc is moved against the barrel closed end, the
disc may be selectively locked by rotation in said first
direction the operating position to receive the cannula in
threaded engagement therewith, and when the disc thereafter
unlocked by rotat:ion in the opposite direction and moved
longitudinally in the direction of the barrel open end to the
disposal position, both ends of the cannula are disposed within
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the barrel, with locking means for locking the disc in the
disposal position within the barrel, and manual operating means
operable for initi~ting the rotary and longitudinal movement o~
the disc from the locked operating position to the locked
disposal position.
:BRIEF DESCRIPTION OF THE DRAWINGS
The blood collection device of the present invention
is illustrated in the accompanying drawing, in which like
numerals indicate like parts, and in which:
Fig. 1 is the isometric view of the blood collection
device of this invention;
Fig. 2 is a side elevational view of the device of Fig.
l;
Fig. 3 is a front elevational view, partially broken
away, of the blood collection device o~ Fig. 1 taken alony lines
3-3 of Fig. 2;
Fig. 4 is a plan view of the blood collection device
in its disposition shown in Fig. 1;
Fig. 5 is a partial isometric view of the blood
collection device in it~ locked operating position; and
Fig. 6 is a partial side elevational view of the blood
collection device in its locked disposal position.
DETAILED DESCRIPTION OF THE INVENTION
Referring to Figures 1 through 4, there is shown a
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blood collection device 10 which has a cylindrical barrel 12 with
an open end 14 and a generally closed end 16, through which an
aperture 18 is formed within a boss 20~ The barrel is
constructed of resilient material, such as molded medical grade
polypropelyne of approximate wall thickness, typically in the
one to two-tenths inch range. A clouble ended cannula 22 is
mounted within the barrel 12 by means of a disc 24 through which
the cannula 22 extends so as to be axially aligned with the
barrel. The disc 24 is mounted on the cannula 22 so that a ~irst
blood collecting needle 26 may be extended through the boss
aperture 18 by movement of the disc 24 toward the closed end 16
to the disposition shown in Figure 5 and may be retracted to the
disposition shown in Figure 6 by movement of the disc 24 away
from the closed end 16.
The double ended cannula 22 has a sample transfer
needle 28 which is enclosed within a latex or similar sheath 30
and is used in conventional fashion to transfer the blood from
the patient through the collecting needle 26 into an evacuated
sample collection container of conventional configuration (not
shown), which is inserted onto the blood collecting needle 26.
Such sample collection containers are well known and are sold,
for example under the trademark VACUTAINER, manufactured by
Becton-Dickinson Company, Rutherford, New Jersey.
The barrel 12 is of circular cross-section with a
longitudinal passage 34 on its periphery tPrminating at the
barrel closed end 16. Opposite the barrel closed end 16, at the
barrel open end 14 a flange 36 is disposed, which surrounds the
open end 14. The longitudinal passage 34 terminates at the
barrel closed end 16 in an offset opening 38. As th~
longitudinal passage 34 extends toward the flange 36 from the
offset opening 38, the longitudinal passage 34 terminates in a
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pair of oppositely disposed camming surfaces 40 which narrow the
first slot portion 34A of the longitudinal passage 34 to a slit
42 formed in the barrel 12. A disposa:L position locking aperture
44 is disposed in the slit 42.
The disc 24 has a stem 46 at the outer periphery
thereof so as to extend into lonyitudinal passage 34. in the
disposition of the device shown in Figure 1, the disc stem 46 is
disposed between the camming surfaces 40 and the offset opening
3~.
Referring now to Figure 5, there is shown an isometric
view, partially broken away, of blood collection device 10 with
the cannula 22 in its extended position. a solid sheath 48,
shown in dotted lines, may be utilized to pxotect the blood
collection needle 26 prior to insertion into the patient's vein,
after the cannula 22 has been fixed to the blood collection
device 10, as is explained hereinafter. In Figure 5, the disc
24 has been moved laterally to abut the barrel closed end 16 so
that the blood collection needle 26 extends through the aperture
18 formed in the bos9 20 SO as to be in its operating position.
As is shown in Figure 5, the disc 24 utilizes a blood collection
needle hub which extends outwardly axially fro~ the disc 24 to
seat in the aperture 18 formed in the boss 20 to provide a rigid
seat for the blood collection needle 26 in the barrel 12.
The disc 24 is moved in to the position shown in Figure
5 by movement applied manually to the disc stem 46 at a finger
engagement portion 52 thereof. The disc stem 46 is disposed and
locked in the offset opening 38 formed in the barrel 12 when the
blood collection device 10 is in the configuration shown in
Figure 5. The disc 24 has been rotated clockwise from the
position shown in F'igure 1, which position is shown if Figure 5
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in dotted lines, so as to have the di.sc stem 46 disposed in the
offset opening 38~ The stem 46 is stabilized against the barrel
12 and held in this rotated position by means of frictional
engagement of a pair of small rails 54, formed on the underside
of the finger engagement portion 52 o~ the lateral extremities
thereof, with the outer sur~ace o~ the barrel 12 at the edge o~
the offset opening 38.
When i~ is desired to retract the blood collection
needle 26 ~rom the operating position shown in Figure 5 ko the
disposal position shown in Figure 6, the d.isc stem A6 is rotated
counter clockwise manually by means of the ~iner engagement
portion 5Z so as to align a stem portion 5S of the stem 46 with
the longitudinal passage slot portion 34A. The disc 24 is then
moved toward the open end 14 of the barrel by manual longitudinal
pressure on the finger engagement portion 52. this longitudinal
movement of the disc 24 away from the closed end 16 of the barrel
12 retracts the blood collection needle 26 into the barrel 12.
As the disc stem 46 reaches the camming surfaces 40,
which are formed on the longitudinal passage 34 so as to kaper
inwardly toward one another, further longitudinal movement of the
stem portion 56 then overrides the camming surfaces 40 to open
the slit 42 and permit the stem portion 56 and so the disc 24 to
approach the disposal position locking aperture 44. When the
stem portion 56 enters the disposal position locking aperture 44,
the camminq action of the stem portion 56 with respect to the
slit 42 ends, permitting the slit 42 to close so as to lock the
stem 56 in the disposal position locking aperture 44~ The disc
24 is thereby locked in its disposal position.
The disc 24 is thereby locked in the disc position
shown in Figure 6, in which the blood collection needle 26 is
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retracted within barrel 12 and the sample transfer needle 28 is
contained within the barrel 12 short of the open end 14 thereof.
The blood collection device 10, having been used, is therefore
in condition for disposal, with both needle points contained with
the barrel 12 so that personnel involved in the disposition are
protected from being stuck by either end of the double-ended
cannula 22. A cap 58 is preferably attached to the barrel open
end 14 by hinges 58A and then i5 in manually pressed onto the
barrel open end 1~ to close the open end so as to avoid any
possibility of sticks from the sample transfer needle 28 by
insertion of a finger into the barrel open end 14~
In the present invention, the cannula 22 may be molded
into the disc 24. However, in the preferred embodiment, it is
desirable, but not e~sential, to secure the double-ended cannula
22 to the disc 24 after shipping storage and similar handling and
immediately prior to actual use, in order to avoid possible
contamination of the needle or accidental sticks. The blood
collection device 10 is configured so that the disc 24, when
disposed adjacent to the barrel closed end 16, may be locked in
such an operating disposition by clockwise rotation of the stem
portion 56 which is attached to the disc 24 into the closed end
locking aperture 18. When so disposed, the disc 24 will be
stopped by the stem portion 56 location in the aperture 18 so as
to prevent the disc 24 from moving longitudinally toward the
barrel open end 14 without the counter-rotation of the disc 24
in a counterclockwise direction to align the stem portion 56 with
the longitudinal passage 34. The cannula 22 can then be screwed
into the disc 24 through the closed end 18 by means of a threaded
aperture 60 axially formed in the disc 24 and a complementary
threaded portion formed on hub 62 of the cannula 22.
As is shown in Figure 2, the threaded apertur 60 has
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clockwise threads, so that when the cannula boss 62 i5 threaded
thereinto, the torque applied in threading forces the stem
portion 56 against the longitudinal wall of the o~set opening
38, to guard against accidental retraction of the disc 24 where
the cannula 22 is being attached thereto.
For ease of assembly of the disc 24 into the barrel 12,
the longitudinal slit 42, between disposal position stop aperture
44 and the flange 36, opens through a second pair of camming
sur~aces 66 into a second longitudinal passage slot 34B, which
passes through the flange 36 at a flange slot 70. The
configuration of the flange slot 70 is complementary to the
configuration of the finger engagement portions 52 of the stem
46, so as to permit passage of the finger engagement portion 52
~5 therethrough. To assemble the device 10, okher than the cannula
22, the disc 24 is inserted into the barrel open end 14 with the
stem 56 aligned with the longitudinal passage slot 34B, so that
the finger engagement portion 5~ passes through the flange slot
70. The finger engagement portion 5~ is manually urged toward
the disposal position stop aperture 44 so that stem portion 56
engages the second camming surfaces 66 to open the slit 42 and
permit the stem 56 to pass into the disposal position locking
aperture 44, at which time the slit 42 closes, locking the stem
56 in the aperture 44. Because the barrel is made of resilient
plastic material, the slit 42 between the camming surfaces 40 and
the aperture 44 can be opened manually by inserting an
appropriate tool of blade type configuration into the
longitudinal passage 34 and rotating the tool up to ninety
degrees so as to open the slit 42 and permit the stem portion 56
to pass ~rom the disposal position locking aperture 44 through
the slit 4~ and through the camming surfaces 40, at which time
any camming action by the stem 56 on camming surfaces 40 ends,
so as to permit the slit 42 to close. The device is then ready
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~or shipment and att~chment of t~e c:annula, as describe~ abov~
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