Note: Descriptions are shown in the official language in which they were submitted.
CA 022~2131 1998-10-27
-
APPARATUS AND M~l~O~ FOR ORGANIZING AND RECAPPING
MEDICAL NEEDLES AND SYRINGES
Field of the Invention
5The present invention relates generally to medical
safety devices, and more particularly, to an apparatus
and method for holding and selectively positioning
medical needle and syringe assemblies.
10Backqround of the Invention
The use and handling of medical needle and syringe
assemblies are well-known in the art. In this regard,
such devices play a vital role in modern healthcare
practice by virtue of their simple mechanical means for
injecting or withdrawing fluids.
Despite their immense practicality, however, serious
issues continue to exist with respect to the proper
handling and disposal of such devices, and more
particularly the needle or stylet portion thereof. As is
well-known, once the needle has been exposed to bodily
fluids there is thus created a substantial risk that such
exposed needle portion will contain infective
microbiological agents. ~ore notably and commonly
associated with these blood-borne diseases are AIDS and
hepatitis B, which have the capability to infect an
individual via an inadvertent needle-stick experience.
To minimize the risk of a needle-stick experience,
capping devices, and in particular needle caps, are used
in combination with needle and syringe assemblies to
provide a protective covering over the needle portion
thereof once the same has come into contact with bodily
fluids. According to current practice, such capping
devices are removed and subsequently replaced upon the
exposed needle portion, often repeatedly, until the
medical procedure is completed.
Following use of a given needle and syringe
assembly, such needle portion, by virtue of its having
CA 022~2131 1998-10-27
come into contact with bodily fluids, must be disposed of
through special handling procedures. Perhaps the most
well-known and commonly utilized device to address the
problem posed by the disposal of contaminated needles is
referred to as the sharps container. Such device
typically comprises a container having a port formed
thereon into which a contaminated needle is inserted. A
pair of scissors formed upon the container is designed
and oriented to provide a cutting action across the
portal entry to thus clip the needle portion off and
thereafter safely house the same within the container.
While the sharps container and other similar devices
are effective in removing and isolating contaminated
needles and other contaminated sharps, substantial issues
arise when attempting to separate and dispose of
contaminated needles and other contaminated sharps from
the capping devices with which they are used. In this
regard, such capping devices must necessarily be utilized
with such contaminated needles and sharps to provide a
necessary protective covering over such contaminated
sharps when the latter is not in use. As is well-
recognized, such capping devices further the important
goal of minimizing needle-stick experiences, and thus
reduce the transmission of blood-borne diseases.
However, the use of such capping devices with
contaminated sharps has resulted in the concurrent
disposal of both the capping device and the contaminated
sharp, which are frequently disposed while interconnected
to one another.
Recent changes in the law, however, have now
prohibited the concurrent disposal of needles with needle
caps while the same are interconnected. Indeed, strict
fines and penalties are imposed for those healthcare
providers and organizations that specifically fail to
properly dispose of contaminated needles separate and
apart from the caps used therewith. While systems have
been developed, namely, needleless-type syringe systems,
CA 022~2131 1998-10-27
such systems are expensive and have not been well-
received in the medical community. Additionally, such
needless systems still necessarily employ the use of
needles as is necessary to establish an intravenous
connection.
In addition to the problems posed by proper
isolation and disposal of contaminated needles and the
capping devices used therewith has been the problem of
organizing the use of multiple needle and syringe
assemblies during a given medical procedure. In this
respect, a wide variety of medical procedures often
necessitate the use of multiple needle/syringe
assemblies. For example, a variety of drugs may need to
be administered throughout a given procedure. However,
there currently does not exist any recognized apparatus
or method for organizing the use of multiple
needle/syringe assemblies. Rather, common practice
typically comprises nothing more than arranging such
needle/syringe assemblies upon a medical tray with the
health care practitioner doing nothing more than grabbing
the appropriate syringe assembly therefrom. Such
technique, however, is exceptionally prone to
disorganization and can actually increase the risk of a
needle-stick experience insofar as improper orientation
of such needle/syringe assemblies, and more particularly
the needle portion thereof, can and often does come into
close contact with the hands of the healthcare provider.
Accordingly, there is a need in the art for a method
and apparatus for holding medical needles and syringes
that enables the same to ~e used for a given procedure
and thereafter provides means for substantially reducing
the risk that the contaminated needle portion is disposed
along with the cap with which it had been used. There is
additionally a need in the art for a method and apparatus
for holding medical needle and syringe assemblies that
facilitates and provides means for organizing the use
thereof during a given medical procedure. There is still
CA 022~2131 1998-10-27
further a need in the art for a method and apparatus for
holding medical needle and syringe assemblies that is
easy to use, may be easily and readily utilized with
virtually all types of needle and syringe devices, is of
simple construction, is space efficient, and inexpensive
to manufacture.
Summary of the Invention
The present invention specifically addresses and
alleviates the aforementioned deficiencies in the art.
Specifically, the present invention is directed to a
method and apparatus for holding and positioning a
plurality of needle and syringe assemblies during medical
procedures. The apparatus comprises the combination of
a housing and a retainer insert interconnectible
therewith. The retainer insert, which is preferably
fabricated from a rigid polymer material, includes a
plurality of retainer holes which are die-cut therein.
The retainer holes formed on the retainer insert are each
sized and configured to receive and frictionally retain
a needle cap extensible axially therethrough. The device
is specifically designed and configured to retain the
needle caps in a manner such that when the needle portion
of a needle and syringe assembly is axially advanced into
a respective one of the frictionally-retained needle
caps, the assembly will assume a recapped configuration
and be maintained in fixed position. Following use or
contamination of a needle, such needle is disposed of by
conventional means. The needle cap portion once used
therewith, on the other hand, remains frictionally
retained by the retainer hole formed on the retainer
insert to thus ensure isolation and separate disposal of
the needle caps from the needles.
In a preferred embodiment, the retainer insert is
formed to be disposable. The housing may also be formed
to be disposable or, alternatively, sterilizable for
reuse. The housing and retainer insert are further
CA 022~2131 1998-10-27
preferably configured to interconnect with one another
such that the plurality of needle caps held thereby are
oriented such that the respective distal ends thereof are
oriented toward the interior of the housing and the
proximal portions thereof extending outwardly to thus
enable easy access to the healthcare provider.
Additionally, in a preferred embodiment the plurality of
retainer holes formed upon the retainer insert are
arranged in a row-like fashion to provide means for
organizing the use of multiple needle and syringe
devices, as may be required for a given medical
procedure. Still further, the various retainer holes as
formed upon the retainer insert may be specifically
shaped and configured to engage with and frictionally
retain any of a variety of given needle caps.
It is therefore an object of the present invention
to provide a method and apparatus for holding a plurality
of medical needle and syringe assemblies such that
following the use thereof, the needle portion of such
assembly will be in a condition to be disposed without
having a needle cap affixed thereto.
Another object of the present invention is to
provide a method and apparatus for holding medical needle
and syringe assemblies that greatly facilitates the
organization and use thereof during a medical procedure.
Another object of the present invention is to
provide a method and apparatus for holding medical needle
and syringe assemblies that may be easily and readily
utilized with virtually all types of needles and syringes
currently in use.
Another object of the present invention is to
provide a method and apparatus for holding medical needle
and syringe assemblies that greatly facilitates the use
of such needle/syringe assemblies while minimizing the
risk of a needle-stick experience.
A still further object of the present invention is
to provide a method and apparatus for holding medical
.
CA 022~2131 1998-10-27
needles and syringes that is of simple construction, easy
and inexpensive to manufacture, is simple to use, and
facilitates compliance with current safety guidelines
regarding the disposal of contaminated needles and other
contaminated sharps.
Brief Descri~tion of the Drawinqs
These, as well as oth.er features of the present
invention, will become more apparent upon reference to
the drawings, wherein:
Figure 1 is a perspective view of a needle and
syringe holding device constructed in accordance with a
preferred embodiment of the present invention, the device
being shown retaining and selectively positioning a row
of needle caps and one needle and syringe assembly, the
latter shown in phantom;
Figure 2 is a perspective view of the components
comprising the needle/syringe holding device of the
present invention further perspectively illustrating a
needle and syringe assembly having a needle cap affixed
thereto;
Figure 3 is a frontal view of the retainer insert
component of the needle and syringe holding device of the
present invention;
Figure 4 is a side view of a needle/syringe assembly
having a needle cap affi.xed thereto shown axially
advanced into the needle and syringe holding device of
the present invention;
Figure 5 is a side view of a portion of a needle cap
shown frictionally retained within a retainer hole formed
on the retainer insert of the device of the present
invention;
Figure 6 is a perspective view of the retainer
insert of the device of the present invention shown
frictionally retaining a plurality of needle caps;
Figure 7 is a frontal view of a first preferred
retainer hole design formed upon the retainer insert
CA 022~2131 1998-10-27
component of the needle/syringe holding device of the
present invention;
Figure 8a is a frontal view of a second preferred
retainer hole design formed upon the retainer insert
component of the device of the present invention;
Figure 8b is a frontal view of a third preferred
retainer hole design formed upon the retainer insert
component of the device of the present invention;
Figure 8c is a frontal view of a fourth preferred
retainer hole design formed upon the retainer insert
component of the device of the present invention;
Figure 8d is a frontal view of a fifth preferred
retainer hole design formed upon the retainer insert
component of the device of t:he present invention;
Figure 8e is a fronta]. view of a sixth preferred
retainer hole design formed upon the retainer insert
component of the device of t:he present invention;
Figure 9 is a perspective view of a first embodiment
of a needle-bearing syringe holder with two syringes
therewith;
Figure 10 is a side elevation view of the holder of
Figure 9 additionally showing in phantom a larger
syringe;
Figure 11 is a perspective view of a second
embodiment of a needle-bearing syringe holder; and
Figure 12 is a side elevation view of the holder of
Figure 11 additionally show.ing in phantom a syringe in
place.
Detailed DescriPtion of the Preferred Embodiment
The detailed description set forth below in
connection with the appended drawings is intended merely
as a description of the presently preferred embodiment(s)
of the invention, and is not intended to represent the
only form(s) in which the present invention may be
constructed or utilized. The description sets forth the
functions and sequence of steps for construction and
CA 022~2l3l l998-l0-27
implementation of the invention in connection with the
illustrated embodiments. It is to be understood,
however, that the same or equivalent functions and
sequences may be accomplished by different embodiment(s)
that are also intended to be encompassed within the
spirit and scope of the invention.
Referring now to the Figures, and initially to
Figure 1, there is shown an apparatus 10 for holding and
selectively positioning a plurality of medical needle and
syringe assemblies, such as 50 shown in phantom. The
apparatus 10 comprises the combination of a housing 12
and a retainer insert 40 interconnectible therewith. As
illustrated, the housing 12 iS provided with a base
portion 14 upon which is formed a first upwardly
extending sidewall 16, the latter having an arm 18
protruding rearwardly therefrom. Arm 18 and sidewall 16
cooperate to define a first notch or slot 20 that is
designed and configured to mate with and hold a portion
of the peripheral edge of retainer insert 40.
Additionally formed on the base 14 of housing 12 iS a
second upwardly extending sidewall 22 from which extends
a ceiling or cover 24. Formed at the distalmost end of
ceiling 24 are depending flanges 26 and 28 which, in
combination with ceiling 24, define a second notch or
slot 30, the latter also being designed and configured to
mate with and hold a portion of the peripheral edge of
retainer insert 40. The housing 12, and more
particularly depending flange 28, has formed thereon an
anchor 32, preferably having a lever 34, for releasably
securing the retainer insert: 40 to the housing 12.
As discussed above, retainer insert 40 iS
specifically designed and configured to interconnect with
housing 12. In this regard, retainer insert 40, which is
preferably fabricated from a rigid polymer material such
as polyethylene and the like, is preferably formed to
have a peripheral edge that may be received within
notches 20 and 30 and securably held thereby. Formed
CA 022~2l3l l998-l0-27
upon the retainer insert 40 are a plurality of retainer
holes 42, the latter preferably being arranged in a row-
like fashion, as illustrated in Figure 3. As discussed
further below, such row-like arrangement of the retainer
holes 42 facilitates and organizes the use of multiple
needle/syringe devices during a given procedure. The
retainer insert 40 further preferably includes a registry
aperture 46 formed thereon for aligning and registering
with anchor 32 formed on the housing. In this regard,
and as shown in Figure 2, the retainer insert 40 iS
simply and easily attached to the housing 12 by sliding
the retainer insert 40 in the direction indicated by the
letter A into upper and lower slots 20 and 30 SO that
portions of the peripheral edge of the retainer insert 40
become nested therewithin.
As best illustrated in Figures 1 and 4, the retainer
insert 40, and more particularly the retainer holes 42
formed thereon, hold and maintain a plurality of needle
caps 44 in a selectively fixed position such that the
needle portion 52 of a needle and syringe assembly 50, as
shown in Figure 4, is maintained in a safely recapped
configuration. The needle caps 44, as strategically held
by the present invention, further positions such
needle/syringe assemblies 50 such that the latter may be
easily accessed and replaced within the selectively
positioned needle caps 44 during their use.
Additionally, by virtue of the row-like arrangement of
the retainer holes 42 formed upon the retainer insert 40,
there is further provided means for organizing the use of
multiple needle/syringe assemblies 50 during a given
medical procedure. As will be recognized by those
skilled in the art, devices for organizing the use of
multiple medical needle/syringe assemblies has been
lacking in the prior art.
To achieve the desired positioning of the plurality
of needle caps, and hence the needle and syringe
assemblies to be held thereby, the retainer insert 40 and
CA 022~2131 1998-10-27
- 10-
retainer holes 42 formed thereon are positioned by
housing 12 such that when a respective cap 44 is axially
extended through a given retainer hole 42, the distal end
44a of the cap 44 is angled downwardly into a chamber 54
defined by the base 14, sidewall 22 and ceiling 24 of the
housing 12, as illustrated in Figure 4. Advantageously,
by positioning the needle caps 44 in such a manner, there
is further minimized the risk of a needle-stick
experience insofar as the needle portion 52 of the needle
and syringe assembly 50 is selectively positioned and
oriented away from the healthcare practitioner and into
the chamber 54 formed on the housing 12, which thus
provides additional shielding of the needle portion 52
from exposure when not in use.
As further illustrated in Figure 4, each respective
cap 44 becomes frictionally retained within a given
retainer hole 42 by axially advancing the same therein in
the direction indicated by the letter B. In this regard,
each respective needle cap 44 may be retained within a
given retainer hole 42 by positioning the same about the
needle 52 of a needle and syringe assembly when in a
capped configuration. Due t;o the frictional engagement
between the needle cap 44 and the respective retainer
hole 42 within which it is inserted, the needle cap 44
thus becomes frictionally retained therein after the
syringe and needle device is axially withdrawn, as
indicated by the letter C in Figure 5. As shown, the
opening of the retainer hole 42, and more particularly
flap portions 42a created thereby, cause the retainer
insert 40 to radially compress about the barrel portion
of the needle cap 44 with the proximal end thereof
extending rearwardly therefrom. As will be appreciated
by those skilled in the art, the compressive force
radially exerted about the barrel portion of the needle
cap 44 will be substantially greater than the force that
would be necessary to retract the needle cap 44 from the
retainer hole 42 in which it is retained.
CA 022~2l3l l998-l0-27
Once so nested within a given retainer hole 42, the
cap 44 will be positioned in such a manner that a given
needle/syringe assembly will be outwardly positioned for
easy access to the healthcare provider. As discussed
above, each retainer hole 42 will form a tight enough fit
about a given needle cap 44 SO that such needle cap 44
remains firmly in place, irrespective of the number of
times and force by which a given needle/syringe assembly
is placed therewithin and withdrawn therefrom.
Accordingly, each of a plurality of needle/syringe
assemblies may be positioned upon and withdrawn from
respective ones of the needle caps 44 as the latter are
retained and positioned by the device 10 of the present
invention.
Once each retainer hole of each plurality of
retainer holes has become occupied with a needle cap 44,
as depicted in Figure 6, the retainer insert 40, with
needle caps 44 retained thereon, is removed from the
housing 12 and disposed of as an integral piece. To
disconnect the retainer insert 40 from the housing, the
anchor 32 need only be axially withdrawn from aperture 46
to enable the retainer insert 40 to slide away from the
housing to which it is attached. In an alternative
embodiment, the retainer insert 40 and housing may be
formed as an integral unit whereby the unit as a whole,
along with needle caps retained thereby, being disposed
of in its entirety.
Advantageously, the needle caps 44, by virtue of
their firm retention upon the retainer insert 40, will
remain separated from the medical needles 52 with which
the caps 44 are used during a procedure. In this regard,
the caps 44 will be so firmly imbedded within the
retainer insert 40 that such caps 44 will not disengage
to interconnect with a given medical needle and syringe
assembly 50. Accordingly, there is thus facilitated the
separation of the contaminated needle from the needle cap
....
CA 022~2131 1998-10-27
-12-
44 used therewith so that each respective component may
be disposed of separate and apart from one another.
To ensure that a given needle cap 44 remains
sufficiently retained within a given retainer hole 46, it
will be recognized by those skilled in the art that each
of such retainer holes 42 may be selectively shaped and
configured to provide the necessary frictional grasp
about a given needle cap 44 such that the same remains in
a fixed position therewithin as a given needle and
syringe device is axially inserted and withdrawn
therefrom. Additionally, each of the retainer holes 42
should be sized to accommodate differing sizes of needle
caps so that any of a variety of needle caps, as well as
the given needle/syringe assembly into which it is to be
affixed may be adequately retained and positioned
thereby. In this respect, it will be recognized by those
skilled in the art that such retainer holes 42 will be
capable of providing adequate frictional retention to
those needle caps 44 used in connection with, but not
limited to, hypodermic needles, caudal needles,
hemorrhoidal needles and spinal needles.
In a first preferred retainer hole design shown in
Figure 7, such retainer hole 60 comprises a generally
circular configuration having four elongate slots
emanating at right angles therefrom. Other preferred
retainer hole designs, as illustrated in Figures 8a-8e,
comprise a generally square-type retainer hole having
elongate slots extending from the respective corners
thereof, shown as 62 in Figure 8a; an X-shaped retainer
hole comprising two diagonally extending slots that
intersect one another at right angles, shown as 64 in
Figure 8b; a generally circular aperture bordered on
opposed sides thereof by two parallel-extending elongate
slots, shown as 66 in Figure 8c; and a central block
portion having elongate slots formed on opposed sides
thereof to form a generally H-shape aperture, shown as 68
in Figure 8d. A still further preferred retainer hole
CA 022~2131 1998-10-27
design 70 is shown in Figure 8e, which depicts the
generally H-shape shown in Figure 8d, but further having
generally triangular portions formed as mirror images of
one another formed in the general midportion thereof. As
will be recognized, however, the retainer holes formed
upon the retainer insert 40 of the present invention are
not necessarily limited to the aforementioned designs,
but rather may take any of a wide variety of shapes and
configurations so long as there is provided the necessary
frictional fit and retention of a given needle cap once
the same has been extended axially therethrough.
With respect to the method of the present invention,
such method comprises the steps of securably fastening a
retainer insert having a plurality of apertures formed
thereon to a housing member and axially inserting the
distal end of a needle cap into a respective one of the
apertures. The needle cap is held by the aperture formed
on the retainer insert 40 in such a manner that the cap
remains frictionally engaged therewithin and is held
thereby with sufficient strength so as to support a
needle/syringe assembly when the needle portion of such
assembly is axially nested within the needle cap. The
needle/syringe assembly may be removed and replaced from
the frictionally retained needle cap as may be necessary
for a given medical procedure. Once the needle portion
of the needle/syringe assembly comes into contact with
bodily fluid or otherwise becomes contaminated, such
needle is then disposed of through conventional means.
The needle cap remains frictionally retained upon the
retainer insert 40 and is discarded therewith as a unit,
separate and apart from the medical needles previously
nested therewithin. Alternatively, the entire apparatus,
namely, the housing 12 and the retainer insert 40 may be
formed as an integral unit and thus may be disposed, with
the needle caps retained therein, in its entirety.
Referring to Figures 9 and 10, an additional
embodiment of the invention is disclosed comprising a
CA 022~2131 1998-10-27
-14-
holder 110 for releasedly retaining sharps instruments
which is illustrated with two needle-bearing syringes
112, 114 in place. While the preferred embodiments
exemplify needle-bearing syringes, it is to be understood
that these syringes exemplify all other sharps
instruments (e.g. scalpels, trocars, etc.) as would be
recognizedly associated as sharps instruments by
medically skilled care givers. The holder 110 includes
a base 116 from which extends upwardly a wall 118 having
at its top location 120 U-shape cut-outs 122 generally
complimentary in shape to the circumferential surface of
the syringe 112, 114. The holder 110 has a guard
component 124 fabricated as a non-coreable wall 126
penetrable by needle tips 128 or any other sharp tips
found in a sharps instrument. Although not by way of
limitation, a preferred non-coreable material candidate
is poly-isoprine. This wall 126 is situated to accept
needle tips 128 when syringes 112, 114 are in place for
retention. The wall 126 is retained within grooves 130,
132, and can be removed by lateral sliding from the
grooves 130, 132 for disposal and subsequent fresh
replacement after a medical procedure utilizing the
holder 110 is completed.
Figures 11 and 12 show another embodiment of a
holder 140 for releasedly retaining sharps instruments.
In particular, the holder 140 has a plurality (here four)
of hollow cylinders 142 each diminishing in step-wise
regression to thereby provide a plurality of discrete
cross sections 144a, 144b, 144c, 144d. Each cylinder 142
has a proximal opening 146 and a distal opening 148, with
each cross section 144a, 144b, 144c, 144d generally
complimentary in size to accommodate an instrument
dimension such as a syringe diameter of an appropriate
volume capacity. In the embodiment shown, the diameter
of section 144a is 0.875 inch; that of section 144b is
0.75 inch; that of section 144c is 0.625 inch; and that
of section 144d is 0.5 inch. This exemplified sizing
CA 022~2l3l l998-l0-27
-15-
permits accommodation of syringes having capacities from
5 CC to 20 CC. The guard component 150 of the holder 140
is a holder-housing portion 152 disposed distally from
and proximate the distal opening 148 of the hollow
5 cylinders 142. As illustrated, the holder housing 154
includes an angularly formed upper sheet 156, a flat base
158, and a front wall 160. Figure 12 shows in phantom a
syringe 114 in place in the cylinder 142, with its needle
tip 128 isolated in the housing portion 152. As is
apparent, when a sharps instrument such as a scalpel (not
shown) is inserted within a cylinder 142, the sharp-
tipped blade thereof will isolatedly reside within the
housing portion 152.
When the holder is employed for needle-bearing
syringes, a care provider first places filled syringes in
the holder. As respective syringes are needed to
administer portions of their respective contents to a
patient, the care provider grasps the appropriate
syringes for patient application. Thereafter, the chosen
syringes are returned to the holder for safe and
effective retention until once again required for patient
treatment, at which time the syringes are again retrieved
for use. As would be recognized by the skilled artisan,
a substantially identical process is employed for other
2 5 sharps instruments being used. After the medical
procedure is completed, the holder is sterilized by
conventional techniques for subsequent use with another
patient. In the first embodiment presented above, the
non-coreable wall generally is discarded and replaced
with a fresh wall as described to thereby eliminate any
possibility of untoward survival and transfer of an
organism from patient to patient. The sharps instrument
holder of the present invention thus provides effective,
safe and practical handling procedures for the benefit of
both health care providers and patients being served.
While illustrative and presently preferred
embodiments of the invention have been described in
CA 022~2l3l l998-l0-27
-16-
detail herein, it is to be understood that the inventive
concepts may be otherwise variously embodied and employed
and that the appended claims are intended to be construed
to include such variations except insofar as limited by
the prior art.
Although the invention has been described herein
with specific reference to the presently preferred
embodiments thereof, it wi:ll be appreciated by those
skilled in the art that various additions, modifications,
deletions and alterations may be made to such preferred
embodiment without departing from the spirit and scope of
the invention. Accordingly, it is intended that all
reasonably foreseeable additions, modifications,
deletions and alterations be included within the scope of
the invention as defined in the following claims.
