U.S. patent number RE37,908 [Application Number 09/579,315] was granted by the patent office on 2002-11-19 for needle holder for fluid collection and/or injection system.
This patent grant is currently assigned to Bio-Plexus, Inc.. Invention is credited to Phillip Spencer Kinsey.
United States Patent |
RE37,908 |
Kinsey |
November 19, 2002 |
Needle holder for fluid collection and/or injection system
Abstract
A needle holder for use with a fluid transfer system of the type
having a standard threaded cannula and a fluid container. The
needle holder includes an actuation mechanism for detachably
mounting a cannula to the holder, the actuation mechanism including
pivotable threaded halves and an actuator operably associated
therewith. In a cannula-mounting position, facing surfaces on the
threaded halves cooperate to define a threaded passageway for
engaging the cannula. Upon operation of the actuator, the threaded
halves pivot to a retracted position to disengage from the
cannula.
Inventors: |
Kinsey; Phillip Spencer
(Newington, CT) |
Assignee: |
Bio-Plexus, Inc. (Vernon,
CT)
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Family
ID: |
24320629 |
Appl.
No.: |
09/579,315 |
Filed: |
May 25, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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580322 |
Dec 28, 1995 |
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Reissue of: |
904811 |
Aug 1, 1997 |
05755673 |
May 26, 1998 |
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Current U.S.
Class: |
600/577 |
Current CPC
Class: |
A61M
5/344 (20130101); A61B 5/15003 (20130101); A61B
5/150496 (20130101); A61B 5/150732 (20130101); A61B
5/154 (20130101); A61M 2005/3206 (20130101); A61B
5/150389 (20130101); A61B 5/150572 (20130101) |
Current International
Class: |
A61B
5/15 (20060101); A61M 5/34 (20060101); A61M
5/32 (20060101); A61B 005/00 () |
Field of
Search: |
;600/573,576-578
;604/187,192 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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883053 |
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Jul 1953 |
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DE |
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2147183 |
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Jul 1975 |
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DE |
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3049503 |
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Apr 1983 |
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DE |
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2564726 |
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Nov 1985 |
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FR |
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802351 |
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Oct 1958 |
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GB |
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801838 |
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Feb 1981 |
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RU |
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WO 89/05118 |
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Jun 1989 |
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WO |
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Primary Examiner: Hindenburg; Max
Attorney, Agent or Firm: Libert & Associates Libert;
Victor E.
Parent Case Text
This application is a continuation of application Ser. No.
08/580,322 filed on Dec. 28, 1995, now abandoned.
Claims
What is claimed is:
1. A needle holder for use with a fluid collection and/or injection
system of the type having a double-ended cannula and a fluid
container, the cannula including a fluid passage bore extending
therethrough and a generally cylindrical, externally threaded hub
with a hub disk at one end thereof, the fluid container including a
sealed open end and an opposing closed end, said needle holder
comprising: a hollow body having an end wall at a closed first end
thereof, said end wall having an aperture therethrough, said hollow
body also having an open second end disposed opposite to said first
end for receiving a fluid container within said hollow body such
that, upon reception of the fluid container, the open end of the
fluid container is adjacent to said end wall; housing means
abutting said first end of said hollow body for maintaining at
least a portion of an actuation mechanism within said holder, said
housing means including means defining an aperture therethrough
which is generally coaxial with said aperture of said end wall; and
an actuation mechanism for threadably mounting a threaded cannula
hub therein with one end of the cannula extending forwardly of said
actuation mechanism for venipuncture and the other end extending
rearwardly into said hollow body for engagement with the fluid
container, said actuation mechanism including: first and second
threaded halves mounted within said housing means for removably
mounting the cannula hub upon threading the cannula hub into said
actuation mechanism, each of said threaded halves including a
threaded surface, at least one of said first and second threaded
halves being movable between a cannula-mounting position wherein
said threaded surfaces cooperate to define a threaded passageway
complementary in cross-sectional shape to the cross-sectional shape
of the threaded cannula hub, and a retracted position wherein said
threaded surfaces cooperate to define an opening having a
cross-sectional size which is greater than the cross-sectional size
of the threaded cannula hub; means for movably mounting at least
one of said first and second threaded halves within said housing
means; and actuation means for urging at least one of said first
and second threaded halves between said cannula-mounting and
retracted positions, said actuation means being slidably mounted to
said housing means for movement between an initial position wherein
at least one of said first and second threaded halves is urged into
said cannula-mounting position, and a secondary position wherein at
least one of said first and second threaded halves is urged into
said retracted position.
2. The needle holder of claim 1 wherein said at least one of said
first and second threaded halves is pivotable between the
cannula-mounting position and the retracted position, and said
means for movably mounting at least one of said first and second
threaded halves within said housing means comprises means for
pivotably mounting said at least one of said first and second
threaded halves.
3. The needle holder of claim 2, wherein at least one of said first
and second threaded halves further comprises a torque member; and
wherein said actuation means includes: a user-operable external
element; and at least one drive arm extending from said actuation
means, said drive arms engaging said torque members to urge at
least one of said first and second threaded halves into said
retracted position in response to the application of linear force
to said user-operable external element.
4. The needle holder of claim 1 or claim 3, wherein said actuation
means further comprises: resilient means for biasing said actuation
means to said initial position wherein at least one of said first
and second threaded halves is urged into said cannula-mounting
position by said drive arms of said actuation means.
5. The needle holder of claim 4, wherein said housing means further
comprises: a bearing wall for opposing said resilient means of said
actuation means; and an end cap at one end of said holder for
maintaining at least a portion of said actuation mechanism within
said housing means, wherein said end cap includes said means
defining an aperture in said housing means.
6. The needle holder of claim 5, wherein said end cap of said
housing means is substantially planar and is slidably received in
said housing means in snap-fit fashion.
7. The needle holder of claim 6, wherein said end cap of said
housing means includes an extended portion which is substantially
congruent with said external element of said actuation means when
said actuation means is in said initial position.
8. The needle holder of claim 7, wherein each of said first and
second threaded halves includes a top surface adjacent to said end
cap of said housing means, and wherein engagement between said top
surfaces of said threaded halves and the hub disk of the cannula
hub limits further insertion of the cannula hub into said
holder.
9. The needle holder of claim 1 or claim 2, wherein the diameter of
said threaded passageway defined by said first and second threaded
surfaces is smaller than the diameters of both of said apertures in
said end cap and said end wall, and wherein the perimeter of said
threaded passageway does not subtend the perimeters of either of
said apertures of said end cap and of said end wall when said
threaded halves are in said cannula-mounting position.
10. The needle holder of claim 5, wherein the diameter of said
threaded passageway defined by said first and second threaded
surfaces is smaller than the diameters of both of said apertures in
said end cap and said end wall, and wherein the perimeter of said
threaded passageway does not subtend the perimeters of either of
said apertures of said end cap and of said end wall when said
threaded halves are in said cannula-mounting position.
11. A needle holder for use with a fluid collection and/or
injection system of the type having a needle assembly and a fluid
container, the needle assembly including a fluid passage bore
extending therethrough and a hub, the fluid container including a
fluid passage end and an opposing end, said needle holder
comprising: a hollow body having an end wall at a closed first end
thereof, said end wall having an aperture therethrough, said hollow
body also having an open second end opposite to said first end for
receiving a fluid container within said hollow body such that, upon
reception of the fluid container, the fluid passage end of the
fluid container is adjacent to said end wall; housing means
abutting said first end of said hollow body for maintaining at
least a portion of an actuation mechanism within said holder, said
housing means including means defining an aperture therethrough
which is generally coaxial with said aperture of said end wall; and
an actuation mechanism for detachably mounting a cannula hub
therein with one end of the cannula extending forwardly of said
actuation mechanism for venipuncture and the other end extending
rearwardly into said hollow body for engagement with the fluid
container, said actuation mechanism including: first and second
mounting jaws rotatably mounted within said housing means for
removably mounting the cannula hub upon inserting the cannula hub
into said actuation mechanism, said first and second mounting jaws
being pivotable between a cannula-mounting position wherein said
mounting jaws cooperate to define a passageway complementary in
cross-sectional shape to the cross-sectional shape of the cannula
hub, and a retracted position wherein said mounting jaws cooperate
to define an opening having a cross-sectional size which is greater
than the cross-sectional size of the cannula hub; a pivot axle for
rotatably mounting said first and second mounting jaws within said
housing means; and actuation means for urging said first and second
mounting jaws between said cannula-mounting and retracted
positions, said actuation means being slidably mounted to said
housing means for linear reciprocal movement between an initial
position wherein said first and second mounting jaws are urged into
said cannula-mounting position, and a secondary position wherein
said first and second mounting jaws are urged into said retracted
position.
12. The needle holder of claim 11 wherein said first and second
mounting jaws comprise first and second threaded halves.
13. The needle holder of claim 11 or claim 12, wherein each of said
first and second mounting jaws further comprises a torque member;
and wherein said actuation means comprises: a user-operable
external element; and first and second arms extending from said
external element, said first and second arms engaging respective
torque members to urge said first and second mounting jaws into
said retracted position in response to the application of linear
force to said user-operable external element.
14. The needle holder of claim 13, wherein said actuation means
further comprises: resilient means for biasing said actuation means
to said initial position wherein said first and second mounting
jaws are urged into said cannula-mounting position by said first
and second arms of said actuation means.
15. The needle holder of claim 14, wherein said housing means
further comprises: a bearing wall for opposing said resilient means
of said actuator; and an end cap at one end of said holder for
retaining at least a portion of said actuation mechanism within
said housing means, wherein said end cap includes said means
defining an aperture in said housing means.
16. The needle holder of claim 15, wherein said end cap of said
housing means is substantially planar and is slidably received in
said housing means in snap-fit fashion.
17. The needle holder of claim 16, wherein said end cap of said
housing means includes an extended portion which is substantially
congruent with said external element of said actuation means when
said actuation means is in said initial position.
18. The needle holder of claim 17, wherein each of said first and
second mounting jaws includes a top surface adjacent to said end
cap of said housing means, and wherein engagement between said top
surfaces of said mounting jaws and a hub disk of the cannula hub
limits insertion of the cannula hub into said holder.
19. The needle holder of claim 11 or claim 12, wherein the diameter
of said passageway defined by said first and second mounting jaws
is smaller than the diameters of both of said apertures in said end
cap and said end wall, and wherein the perimeter of said passageway
does not subtend the perimeters of either of said apertures of said
end cap and of said end wall when said mounting jaws are in said
cannula-mounting position.
20. The needle holder of claim 15, wherein the diameter of said
passageway defined by said first and second mounting jaws is
smaller than the diameters of both of said apertures in said end
cap and said end wall, and wherein the perimeter of said passageway
does not subtend the perimeters of either of said apertures of said
end cap and of said end wall when said mounting jaws are in said
cannula-mounting position..Iadd.
21. A holder for removably mounting an externally threaded needle
assembly, said holder comprising: a hollow body having an open
proximal end and a distal end closed by an end wall having an
aperture therethrough; first and second threaded jaws mounted at
the end wall; and an actuator assembly disposed at said distal end
and comprising an actuator slidably mounted to said holder and
operatively associated with at least one of said threaded jaws to
move said at least one of said threaded jaws between a needle
assembly mounting position in which said first and second threaded
jaws cooperate to define a threaded passageway aligned with said
aperture for receiving and securing such externally threaded needle
assembly, and a needle assembly release position in which said
passageway is sufficiently enlarged to free such externally
threaded needle assembly from said holder. .Iaddend..Iadd.
22. A holder for removably mounting an externally threaded needle
assembly, said holder comprising: a hollow body having an open
proximal end and a distal end closed by an end wall having an
aperture therethrough; first and second threaded jaws mounted at
the end wall; and an actuator slidably mounted to said holder at
said distal end and operatively associated with at least one of
said threaded jaws to move said at least one of said threaded jaws
between a needle assembly mounting position in which said first and
second jaws cooperate to define therebetween a threaded passageway
having a first cross-sectional area and aligned with said aperture,
and a needle assembly release position in which the threaded
passageway has a second cross-sectional area which is larger than
the first cross-sectional area. .Iaddend..Iadd.
23. The holder of claim 21 or claim 22 wherein said actuator is
integral with at least one of said threaded jaws.
.Iaddend..Iadd.
24. The holder of claim 21 or claim 22 wherein said needle assembly
comprises a double-ended cannula. .Iaddend..Iadd.
25. The holder of claim 24 further comprising an evacuated
container having a puncturable membrane which is penetrated by one
end of said double-ended cannula. .Iaddend..Iadd.
26. The holder of claim 21 or claim 22 wherein at least one of said
threaded jaws is slidable towards the other to position said jaws
in the mounting position, and is slidable away from the other to
position said jaws in the release position. .Iaddend..Iadd.
27. The holder of claim 21 or claim 22 wherein at least one of said
threaded jaws is dimensioned and configured to move slidably in a
single plane between the needle assembly mounted position and the
needle assembly release position. .Iaddend..Iadd.
28. The holder of claim 27 wherein said actuator is dimensioned and
configured to slidably move in a single plane. .Iaddend..Iadd.
29. The holder of claim 21 or claim 22 wherein said actuator is
dimensioned and configured to slidably move in a single plane.
.Iaddend..Iadd.
30. A method for mounting an externally threaded needle assembly to
a holder and thereafter releasing the needle assembly therefrom,
the holder having a distal end at which is disposed an actuator and
first and second threaded jaws, at least one of which jaws is
movable relative to the other, the first and second threaded jaws
cooperating to form therebetween a threaded passageway, and the
actuator being operatively associated with at least one of threaded
jaws, the method comprising the steps of: securing a needle
assembly into the threaded passageway; thereafter operating the
actuator to slide at least one of the threaded jaws in a single
plane away from the other threaded jaw to thereby sufficiently
enlarge the threaded passageway to release the needle assembly from
said holder. .Iaddend..Iadd.
31. The method of claim 30 including operating the actuator by
sliding it in the single plane. .Iaddend..Iadd.
32. The method of claim 30 or claim 31 wherein the step of securing
a needle assembly into the threaded passageway is carried out by
operating the actuator to slide at least one of the threaded jaws
away from the other threaded jaw to thereby sufficiently enlarge
the threaded passageway to position the needle assembly
therewithin, and then operating the actuator to slide at least one
of the threaded jaws towards the other threaded jaw to engage the
needle assembly within the passageway. .Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to the manipulation of devices
through which fluids are delivered to and/or withdrawn from an
animal through venipuncture. More particularly, this invention is
directed to a holder for use with a fluid collection and/or
injection system of the type including a double ended needle
assembly and associated fluid container and, specifically, to such
a holder having an actuation mechanism for selectively mounting or
detaching the needle assembly. Accordingly, the general objects of
the present invention are to provide novel and improved methods and
apparatus of such character.
2. Description of the Related Art
While not limited thereto in its utility, the present invention is
particularly well suited for use in fluid transfer systems of the
type which are used to inject fluids into and to draw blood
specimens from a patient. Current medical practice requires that
the fluid containers and needle assemblies used in such systems be
inexpensive and readily disposable. Consequently, existing blood
collection systems, for example, typically employ some form of
durable, reusable holder on which detachable and disposable needles
and fluid collection tubes may be mounted. A blood collection
system of this nature can be assembled prior to use and then
disassembled after usage. Thus, these blood collection systems
allow repeated use of the relatively expensive holder upon
replacement of the relatively inexpensive disposable needle and/or
fluid collection tube. In addition to reducing the cost of
collecting blood specimens, these blood collection systems also
help minimize the production of hazardous medical waste.
The most popular design configuration of previously available blood
collection systems includes a double ended needle assembly, an
evacuated collection tube, and a holder for maintaining the needle
assembly and the collection tube in fixed relation. The double
ended needle assembly, which is also referred to as a cannula, has
a bore extending therethrough and a hub near a central region
thereof. The evacuated fluid collection tube includes a puncturable
stopper at one end thereof. In this type of blood collection
system, the holder typically has a housing at one end thereof for
receiving the needle assembly. Likewise, the holder also has a
hollow body with an opening at an opposite end thereof for
receiving the collection tube. The needle assembly is rigidly
received within the housing of the holder such that a first end of
the needle extends forwardly of the holder for puncturing the vein
of a patient. The opposite, second end of the needle extends into
the hollow body of the holder. Upon assembly of the blood
collection system, the needle assembly is inserted into the housing
and the collection tube is inserted through the open end of the
hollow body until the second end of the needle pierces the
puncturable stopper of the collection tube, thereby allowing fluid
communication between the interior of the collection tube and the
bore which extends through the needle assembly. To draw a blood
specimen from a patient using one of these blood collection
systems, the evacuated collection tube is partially inserted into
one end of the holder, the first end of the needle is inserted into
a patient's vein and the collection tube is fully inserted into the
holder such that blood will be drawn through the bore of the needle
assembly and into the fluid collection tube. After drawing the
specimen, the collection tube is removed so that the blood
contained therein can be analyzed and the needle assembly is
detached for disposal. In addition to being capable of
accommodating blood collection tubes, the holders of some prior art
fluid transfer systems are compatible with fluid containers having
a fluid to be injected into a patient. Thus, such holders can be
used to inject fluid into, as well as draw blood specimens from, a
patient. Efforts to improve prior art fluid transfer systems of the
type briefly described above have largely focused on improving the
mechanism for removably mounting the needle assembly to the
holder.
One early, and extremely popular, type of mechanism for removably
mounting a needle assembly to a holder utilized a fixed threaded
passageway at one end of the holder designed to threadably receive
complementary threads on the hub of the needle assembly. With a
holder of this type, a threaded cannula could be screwed into
position prior to drawing a blood specimen from a patient,
subsequently unscrewed from the holder and discarded.
Blood collection systems employing a holder with a fixed threaded
passageway, however, suffer from a number of serious deficiencies.
The most serious of these deficiencies stems from the need for the
health care worker to physically handle the cannula after it has
been in contact with the patient's blood in order to unscrew the
threaded cannula from the holder. This handling typically entails
placing a protective cap on the externally extending portion of the
threaded cannula, twisting the threaded cannula to free it from the
fixed threaded passageway of the holder, and disposing of the used
cannula. Thus, removal of the needle from a blood collection device
of this type inevitably gives rise to the possibility of accidental
contact between the health care worker and the patient's blood.
Another deficiency of the above-described arrangement resides in
the relatively long period of time it takes a health care worker to
remove the needle from the holder. Nonetheless, due to widespread
usage of this type of blood collection system, health care workers
have now become accustomed to using threaded cannulas.
In response to the above-mentioned deficiencies of fixed threaded
passageway holders, holders have recently been developed which
employ unthreaded needle-locking mechanisms with a remote release
element for ejecting the needle assembly from the needle-locking
mechanism. This type of arrangement has generally been considered
to be a functional improvement over fixed threaded passageway
holders because, by operating the release element, a health care
worker may quickly remove a needle assembly from a holder without
the need to physically contact any portion of the needle assembly
directly. This reduces the risk that the health care worker will
accidentally contact the patient's blood. To date, however, most of
the blood collection devices with holders having releasable
needle-locking mechanisms have been incompatible with what has now
become the industry standard threaded cannula, i.e., a double
needle assembly with a threaded hub in a central region thereof and
a hub disk located at one end of the threaded portion of the hub.
Thus, most of these recently developed holders have required the
use of relatively expensive, custom designed needle assemblies.
Holders having a needle ejection feature which are compatible with
the standard double needle configuration have also been developed.
However, these holders have either suffered from overall poor
performance and/or have required the use of a separate adapter, for
accommodating a standard threaded cannula, which is discarded along
with the cannula upon removal of the cannula from the holder. In
addition to increasing the overall cost of the blood collection
system, the use of such an adapter can also unnecessarily
complicate assembly and/or disassembly of the blood collection
system.
In light of the foregoing, there exists a need in the health care
industry for a needle holder for use with a fluid transfer system
which (1) is compatible with standard threaded cannulas; (2) allows
a user to detach a threaded cannula from the holder without
physically handling any portion of the threaded cannula; and (3) is
capable of operating effectively without the need for any
additional components.
SUMMARY OF THE INVENTION
The present invention satisfies the above needs, and overcomes the
above-stated and other deficiencies of the prior art, by providing
a holder having a cannula actuation mechanism within a housing at
one end of the holder for removably mounting an externally threaded
cannula thereto. The actuation mechanism includes first and second
mounting jaws, which may comprise first and second threaded halves
with surfaces which cooperate to define a threaded passageway
therebetween when the threaded halves are in a cannula-mounting
position. At least one of the threaded halves is mounted within the
housing in such a manner as to allow movement thereof from the
cannula-mounting position to a retracted position wherein the
threaded surfaces define a gap which is appreciably greater than
the maximum cross-section of the cannula hub. The actuation
mechanism also includes an actuator with at least one structural
portion for normally maintaining the threaded halves in the
cannula-mounting position. The actuator is slidably mounted to the
holder and operably associated with the threaded halves such that,
upon user-operation of the actuator, at least one of the threaded
halves moves to the retracted position. To removably mount a
standard double ended cannula to a holder in accordance with the
present invention, a user simply inserts a standard threaded
cannula, with its protective cap in place, into the holder and
screws the threads of the cannula hub into the threaded passageway
defined by the threaded surfaces of the threaded halves until the
hub disk of the cannula hub abuts the top surfaces of the threaded
halves. To release a threaded cannula from a holder in accordance
with the present invention, the user simply orients the holder over
a "sharps disposal box" such that the first end of the cannula
extends vertically below the holder, and depresses the actuator to
retract the threaded halves thereby allowing the cannula to fall
from the holder under the force of gravity.
The cannula holder of the present invention is wholly compatible
with standard threaded cannulas. This compatibility is achieved by
pivotably mounting at least one of the threaded halves of the
actuation mechanism within a housing located at one end of the
holder. When these threaded halves are in the cannula-mounting
position, a standard threaded cannula can be threaded into the
threaded passageway in the same manner as a standard threaded
needle assembly would be threaded into a holder having a fixed
threaded passageway. However, upon user-operation of an actuator,
which is located on the holder in a position where it is unlikely
to be contaminated, at least one of the threaded halves pivots
apart to a retracted position, thereby detaching the threaded
cannula from the actuation mechanism. Thus, the present invention
is compatible with standard threaded needle assemblies and can be
used by health care workers in a manner substantially similar to
the prior art needle holders to which they are accustomed.
Another significant advantage of the present invention when
compared to previously available needle holders with an ejection
capability is reduced cost. Since the present invention is wholly
compatible with both standard threaded cannulas and standard fluid
collection tubes, holders in accordance with the present invention
do not require the use of expensive custom made cannulas and/or
additional custom made components.
Yet another advantage of the invention relative to previously
available fluid collection devices is improved reliability and ease
of operation. To assemble a fluid transfer device using a holder in
accordance with the present invention, a user simply threads a
standard cannula into the actuation mechanism at one end of the
holder and inserts a fluid container into an opening at the
opposite end of the holder. After use, the fluid container is
removed from the holder, the holder is positioned over a "sharps
disposal box", and the actuator is depressed thereby retracting the
threaded halves of the holder and allowing the cannula to fall into
the "sharps disposal box" under the force of gravity. This assembly
procedure is identical to the assembly procedure used with
conventional prior art holders. The disassembly procedure, on the
other hand, avoids the need to unscrew a cannula, twist a bayonet
mechanism or flip a lever as was necessary with various prior art
holders.
BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will be described below with reference to the
accompanying drawings, wherein like reference numerals represent
like elements in the several figures, and wherein:
FIG. 1 is a perspective view of one embodiment of a holder in
accordance with the present invention shown in combination with a
standard threaded cannula and a standard fluid collection tube;
FIG. 2 is an exploded perspective view of the holder shown in FIG.
1;
FIG. 3a is a cross-sectional view of the holder shown in FIGS. 1
and 2, illustrating the actuation mechanism in a cannula-mounting
position;
FIG. 3b is a view similar to FIG. 3a, illustrating the actuation
mechanism in the retracted position;
FIG. 4a is a fragmentary medial sectional view, taken along the
longitudinal axis, of the holder of FIGS. 1 and 2 shown in
combination with a cannula; FIG. 4a illustrating the actuation
mechanism in the cannula-mounting position; and
FIG. 4b is a fragmentary, medial sectional view, taken along the
longitudinal axis, of the holder of FIGS. 1 and 2 shown in
combination with a cannula; FIG. 4b illustrating the actuation
mechanism in the retracted position.
DESCRIPTION OF THE DISCLOSED EMBODIMENT
With reference to the drawings, FIG. 1 shows a perspective view of
a holder 10 in accordance with the present invention in combination
with a standard threaded cannula 40 and a standard collection tube
50. Holder 10 generally consists of a hollow body 14, a housing 11
having an end cap 60 at one end thereof, and an actuation mechanism
20. Body 14 of holder 10 defines a longitudinal axis 5. Threaded
cannula 40 is shown in axial alignment with axis 5 for insertion
into actuation mechanism 20. Threaded cannula 40 has a first end
42, a second end 43, and a threaded hub, indicated generally at 45,
intermediate the ends. A longitudinal bore 44 extends along the
length of cannula 40. Hub 45 of threaded cannula 40 includes a
threaded portion 48 which terminates, at one end thereof, at a hub
disk 46. When cannula 40 is mounted on holder 10, the first end 42
extends forwardly of holder 10 and the second end 43 extends into
hollow body 14.
Collection tube 50, when the system is assembled and in use, will
also be in axial alignment with hollow body 14 of holder 10 and
will be received therein. Collection tube 50, in the disclosed
embodiment, is a standard evacuated blood specimen collection tube
which consists of an elongated tube 52 having a rubber stopper 54
at one end thereof. The rubber stopper 54 has a puncturable
membrane 56 in a central region of the stopper 54. Upon insertion
of collection tube 50 into the hollow region of hollow body 14,
second end 43 of threaded cannula 40 pierces membrane 56 and
extends into the interior of tube 52. Thus, when the fluid transfer
system is fully assembled, bore 44 of cannula 40 is in fluid
communication with the interior of collection tube 50 and the
system can be used to draw a blood specimen from a patient.
Alternatively, the present invention may be used to inject a fluid
into a patient using a fluid container with a piston for injection
of a fluid into a patient. First and second grip tabs 19 and 19' on
holder 10 assist insertion of collection tube 50, or other fluid
container, into holder 10.
With primary reference now to FIG. 2, the various components of
holder 10 will be described in greater detail. As shown in FIG. 2,
actuation mechanism 20 generally consists of a spring biased
actuator, indicated generally at 30, a pivot axle 21 and first and
second threaded halves 22 and 22', respectively. Housing 11
includes a bearing wall 39, the end cap 60, sidewalls 18 and 18'
and end walls 15 and 15' (see FIGS. 3a and 3b). While bearing wall
39 and pivot axle 21 are preferably integrally formed with an end
wall 16 of hollow body 14, threaded halves 22 and 22', and actuator
30, are movably mounted to housing 11. Actuation mechanism 20 is
captured within housing 11 between end wall 16 and end cap 60. As
shown in FIG. 2, threaded halves 22 and 22' preferably include
apertured collars 25 and 25' which are pivotably mounted within
housing 11 via engagement with pivot axle 21. Alternatively, each
of threaded halves 22 and 22' can be pivotably mounted within
housing 11 for rotation about separate pivot axles. Threaded halves
22 and 22' also include first and second threaded surfaces 24 and
24', respectively, which generally face one another and which
cooperate to define a threaded passageway 23 (see FIG. 3a) having a
substantially circular cross-section when biased to the position
shown in FIGS. 3a and 4a. First and second threaded halves 22 and
22' further include substantially planar first and second top
surfaces 28 and 28', respectively, located substantially
perpendicularly to threaded surfaces 24 and 24'. First and second
torque members 26 and 26' extend from collars 25 and 25',
respectively, and define torque arms for driving threaded halves 22
and 22' in respective first directions about pivot axle 21.
Actuator 30 is generally in the form of a user-operable push-button
which is operably associated with first and second threaded halves
22 and 22'. Actuator 30 generally consists of an external element
38, first and second driver arms 32 and 32' extending therefrom,
resilient fingers 36 and 36', and a stop member 35. Additionally,
drive projections 34 and 34', respectively, extend from the free
ends of arms 32 and 32' for engagement with respective torque
members 26 and 26'.
As shown in FIG. 2, substantially planar end cap 60 has an extended
portion 64 at one end thereof, a recess 63 at an opposite end
thereof, and an aperture 62 therebetween. Upon assembly of holder
10, end cap 60 serves to retain most of actuator 30 and first and
second threaded halves 22 and 22' within housing 11. To secure end
cap 60 to holder 10, end cap 60 preferably engages sidewalls 18 and
18' of housing 11 at beveled regions 65 and 67 and a lip on bearing
wall 39 at a beveled region 66. Additionally, recess 63 of end cap
60 preferably engages pivot axle 21 in snap-fit fashion to prevent
end cap 60 from sliding from holder 10. As an alternative, end cap
60 may be secured to holder 10 with many other well known fixation
means such as adhesive bonding, affixation with fasteners or any
equivalent thereof. When holder 10 is assembled, aperture 62 of end
cap 60, aperture 17 of end wall 16 and threaded passageway 23
defined between threaded surfaces 24 and 24' are generally coaxial.
This relationship defines a continuous passageway through which a
threaded cannula 40 may pass upon insertion thereof into holder
10.
The operation of the various components of actuation mechanism 20
will now be described with joint reference to FIGS. 3a and 3b. FIG.
3a shows a cross sectional view of the holder of FIGS. 1 and 2
illustrating actuation mechanism 20 in the cannula-mounting
position. When actuation mechanism 20 is in this position, actuator
30 is urged radially outward with respect to housing 11 by the
cooperation of resilient fingers 36 and 36' and bearing wall 39. In
this position of actuator 30, external portion 38 thereof is
substantially aligned with grip tab 19 and (FIG. 2) extended
portion 64 of end cap 60. Furthermore, shoulders on drive
projections 34 and 34' contact exterior surfaces of threaded halves
22 and 22' and arms 32 and 32', respectively, contact side walls 18
and 18' of housing 11 to constrain threaded halves 22 and 22' from
pivoting apart. Thus, in the cannula-mounting position, cooperation
between drive projections 34 and 34' and threaded halves 22 and
22', ensures maintenance of a rigid threaded passageway 23 between
facing threaded surfaces 24 and 24'.
The movement of actuation mechanism 20 from the cannula-mounting
position into the retracted position occurs upon user-operation of
actuator 30. As described above, external element 38 of actuator 30
extends radially outwardly from holder 10 when actuation mechanism
20 is in the cannula-mounting position. Upon depression of external
element 38 of actuator 30 in the direction of arrow 7 (see FIG.
3b), arms 32 and 32' cooperate with side walls 18 and 18' to guide
actuator 30 linearly in the direction of arrow 7. Upon partial
depression of external element 38, drive projections 34 and 34'
temporarily disengage from threaded halves 22 and 22'. Thus,
threaded halves 22 and 22' are no longer constrained from rotation
about pivot axle 21. Upon further depression of external element
38, drive projections 34 and 34' engage torque members 26 and 26'
to urge threaded halves 22 and 22' to pivot in opposite directions
about pivot axle 21 from the cannula-mounting position to the
retracted position shown in FIG. 3b. Simultaneously with depression
of external element 38, resilient fingers 36 and 36' are bent
inwardly and the outer surface of external element 38 becomes
generally flush with the outer surface of holder 10. When actuator
30 is fully depressed, torque members 26 and 26' are pinched
between end walls 15 and 15' of housing 11 and drive projections 34
and 34' of actuator 30. Additionally, resilient fingers 36 and 36'
are pinched between bearing wall 39 and stop member 35 of actuator
30. Upon release of actuator 30, resilient fingers 36 and 36' and
bearing wall 39 cooperate to urge actuator 30 to slide back to its
initial position along a linear path in a direction opposite to
that of arrow 7. During return of actuator 30 to its initial
position, drive projections 34 and 34', once again, cooperate with
threaded halves 22 and 22' to return threaded halves 22 and 22' to
the cannula-mounting position. Optionally, a number of
operationally equivalent structures can be used to pivot threaded
halves 22 and 22' between the cannula-mounting and retracted
positions. For example, at least one of torque members 26 and 26'
can be positioned on top surfaces 28 and 28' of threaded halves 22
and 22', for engagement with at least one camming channel on
actuator 30. An additional option includes providing threaded
engagement between the various components of the actuation
mechanism 20 such as between torque members 26 and 26' and actuator
30.
The cooperation between actuation mechanism 20 and threaded cannula
40 will now be described in greater detail with reference to FIGS.
4a and 4b. FIG. 4a depicts a cross-sectional view of holder 10
illustrating actuation mechanism 20 in the cannula-mounting
position in combination with cannula 40. As shown therein, when
threaded cannula 40 has been fully threaded into threaded
passageway 23 of holder 10, threads 48 of cannula hub 45 engage
threaded surfaces 24 and 24' of threaded halves 22 and 22'.
Additionally, hub disk 46 of cannula hub 45 abuts top surfaces 28
and 28' to prevent further rotation of cannula 40. Since aperture
62 of end cap 60 and aperture 17 of end wall 16 are both
appreciably larger than threaded passageway 23, the only contact
between holder 10 and cannula 40 occurs between threads 48 and
threaded surfaces 24 and 24', and between hub disk 46 and top
surfaces 28 and 28'. Limiting contact between holder 10 and cannula
40 in this way helps ensure effective removal of cannula 40 from
actuation mechanism 20 upon retraction of threaded halves 22 and
22'.
Referring now to FIG. 4b, actuation mechanism 20 is shown therein
with threaded halves 22 and 22' in the retracted position and
threaded cannula 40 aligned with, but detached from, actuation
mechanism 20. As illustrated in FIG. 4b, the substantially thinner
driver arms 32 and 32' of actuator 30 are generally aligned with
threaded halves 22 and 22' to allow threaded halves 22 and 22' to
retract away from one another. Also as shown, when threaded halves
22 and 22' are in the retracted position, threaded surfaces 24 and
24' no longer define a threaded passageway. Since threaded surfaces
24 and 24' are now generally aligned with the perimeters of
apertures 62 and 17, threaded cannula 40 is detached from actuation
mechanism 20. Thus, if holder 10 is oriented vertically, cannula 40
is free to fall from holder 10 under the force of gravity and
holder 10 can be subsequently reused. The various components of
holder 10 can be made from a wide variety of materials. In one
reduction to practice, hollow body 14, housing 11, bearing wall 39
and pivot axle 21 are integrally formed from inexpensive, moldable
plastic. Additionally, in this embodiment first and second threaded
halves 22 and 22' and end cap 60 are also individually formed of
inexpensive plastic. The actuator 30, however, is preferably made
from an acetal, or equivalents thereof, because of its resilience,
its durability and its low coefficient of friction. These
properties enable resilient fingers 36 and 36' to provide
sufficient biasing force against movement of actuator 30 while
still allowing actuator 30 to freely glide against sidewalls 18 and
18' when depressed.
While a preferred embodiment of the present invention has been
illustrated and described in detail, it should be readily
appreciated that many modifications and changes thereto are within
the ability of those of ordinary skill in the art. Therefore, the
appended claims are intended to cover any and all of such
modifications which fall within the true spirit and scope of the
invention.
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