U.S. patent application number 11/711670 was filed with the patent office on 2008-08-28 for sterile packaging of medical devices with enhanced tamper evident, transportation, functional and disposal features.
This patent application is currently assigned to Inviro Medical, Inc.. Invention is credited to Fraser R. Sharp.
Application Number | 20080202961 11/711670 |
Document ID | / |
Family ID | 39714663 |
Filed Date | 2008-08-28 |
United States Patent
Application |
20080202961 |
Kind Code |
A1 |
Sharp; Fraser R. |
August 28, 2008 |
Sterile packaging of medical devices with enhanced tamper evident,
transportation, functional and disposal features
Abstract
A syringe assembly (or other medical device) includes a single
syringe entirely enclosed and sealed within a shrink-wrap film
package, with one of the syringe or package formed so as to
facilitate removal of at least a portion of the shrink wrap
package. A related method of packaging, using and disposing of a
syringe includes enclosing and sealing a single syringe assembly
within a shrink wrap package, the syringe assembly including a
barrel, a plunger slidable within the barrel, a thumb press at one
end of the plunger projecting rearwardly of the barrel, and a
needle at an opposite end of the barrel; removing a portion of the
shrink wrap package enclosing the needle; using the syringe in a
liquid injection or removal mode while leaving a remaining portion
of the shrink wrap package on the syringe assembly; and disposing
the used syringe assembly with the remaining portion of the shrink
wrap package in place on the syringe. Because of the closely
applied packaging film reduced volume and weight of secondary
packaging and consequent, reduced sterilization, transportation,
and disposal costs. Use of distinctive shrink-wrap color, structure
or other characteristic prevents simple deceptive duplication.
Applicability to other devices which require internal sterility,
but do not require external sterility in use.
Inventors: |
Sharp; Fraser R.;
(Vancouver, CA) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Assignee: |
Inviro Medical, Inc.
Duluth
GA
|
Family ID: |
39714663 |
Appl. No.: |
11/711670 |
Filed: |
February 28, 2007 |
Current U.S.
Class: |
206/364 |
Current CPC
Class: |
A61M 5/002 20130101 |
Class at
Publication: |
206/364 |
International
Class: |
B65D 65/32 20060101
B65D065/32 |
Claims
1. A syringe package comprising a single syringe entirely enclosed
and sealed within a shrink-wrap film or package.
2. The syringe package of claim 1 wherein said syringe includes a
barrel, a plunger slidable within the barrel, a thumb press at one
end of the plunger projecting rearwardly of the barrel, and a
needle at an opposite end of the barrel.
3. The syringe package of claim 1 wherein said shrink-wrap package
is formed with at least one pull tab for removing at least a
portion of said shrink-wrap package.
4. The syringe package of claim 1 wherein said shrink-wrap package
or pull tab is formed of materials of distinctive, easily
recognized color or structure.
5. The syringe package of claim 3 wherein said shrink-wrap package
is formed with a pair of pull tabs at opposite ends of said
package.
6. The syringe package of claim 2 wherein said shrink-wrap package
is formed with at least one pull tab for removing at least a
portion of said shrink-wrap package, said pull tab connected to a
partial tear or weakened strip extending axially along the barrel
of the syringe.
7. The syringe package of claim 3 wherein said pull tab is
connected to a line of weakening extending annularly about the
syringe at a distal end thereof, rearward of said needle.
8. The syringe package of claim 3 wherein said pull tab is
connected to a line of weakening extending annularly about the
syringe at a proximal end thereof, forward of said thumb press.
9. The syringe package of claim 2 wherein said syringe is also
provided with a needle cap formed with a radially outwardly
directed flange engaged by said shrink-wrap package.
10. The syringe package of claim 2 wherein said barrel is formed
with a flange of a proximate end thereof, adjacent said thumb
press.
11. A syringe package comprising a single syringe entirely enclosed
and sealed within a shrink-wrap package, wherein said syringe
includes a barrel, a plunger slidable within the barrel, a thumb
press at one end of the plunger projecting rearwardly of the
barrel, and a needle at an opposite end of the barrel, and wherein
said shrink-wrap package is formed with at least one pull tab
connected to an annular line of weakening located at a distal end
of said syringe but rearward of said needle.
12. A syringe package comprising a single syringe entirely enclosed
and sealed within a shrink-wrap package, wherein said syringe
includes a barrel, a plunger slidable within the barrel, a thumb
press at one end of the plunger projecting rearwardly of the
barrel, and a needle at an opposite end of the barrel, at least one
of said syringe and said shrink wrap package provided with means
for facilitating removal of at least a portion of said shrink wrap
package.
13. A tamper-evident syringe package comprising a single syringe
entirely enclosed and sealed within a shrink-wrap package, wherein
said syringe includes a barrel, a plunger slidable within the
barrel, a thumb press at one end of the plunger projecting
rearwardly of the barrel, and a needle at an opposite end of the
barrel, at least one of said syringe and said shrink wrap package
provided with means for facilitating removal and destruction of at
least a portion of said shrink wrap package.
14. A method of packaging, using and disposing of a syringe
comprising: enclosing and sealing a single syringe assembly within
a shrink wrap package, the syringe assembly including a barrel, a
plunger slidable within the barrel, a thumb press at one end of the
plunger projecting rearwardly of the barrel, and a needle at an
opposite end of the barrel; removing a portion of the shrink wrap
package enclosing the needle; removing a portion of the shrink wrap
package enclosing the end of the plunger using the syringe in a
liquid injection or removal mode while leaving a remaining portion
of the shrink wrap package on the syringe assembly; and disposing
the used syringe assembly with the remaining portion of the shrink
wrap package in place on the syringe.
15. The method of claim 14 including providing one of said syringe
and said shrink wrap package with means for facilitating removal of
at least a portion of said shrink wrap package.
16. The method of claim 15 wherein said means may annularly or
axially oriented.
Description
BACKGROUND
[0001] This invention relates to sterile packaging and disposal of
medical devices and particularly to the packaging and disposal of
individual syringes, needles, cannulae and the like.
[0002] Large numbers of disposal medical devices are manufactured,
sterilized, transported, used and disposed of worldwide. Most are
used one time only and then discarded. The production,
sterilization, packaging, transportation and disposal criteria for
syringes create significant resource consumption for manufacturers,
and improper disposal can have a large negative impact on the
environment. Further, serious diseases can be spread by the re use
of single use disposable syringes which are improperly reused then
repackaged without sterilization. In some developing countries many
or even most syringes are re-used in this way with disastrous
consequences.
[0003] For decades, the design, manufacture, and disposal of
plastic hypodermic syringes has remained relatively unchanged. It
is estimated that at least 20 billion are used and disposed of
annually. In recent years many syringe designs have emerged with
specific features to prevent reuse, to allow pre-filling with
medication, and to prevent needlestick injuries. However, there has
been little change in the packaging, sterilization, transportation
and disposal methodologies. Syringes are used for many functions,
e.g., vaccination, reconstitution, therapeutic injections and fluid
transfer in many sites, e.g., hospitals, clinics, rural and in all
countries. These different uses allow development of more
use-specific, cost effective means of packaging, sterilization,
transportation and disposal. As syringes are almost invariably
required to be internally sterile for use, the design and integrity
of the packaging is essential. This same principle applies to many
medical devices and hence this packaging is applicable to a variety
of medical devices in addition to syringes.
[0004] Some syringes are used in the sterile field environment of
the operating room. In this situation it is necessary that the
external surfaces of the syringe and needle as well as the internal
structure of the syringe be sterile. On the other hand, in
situations such as vaccination programs, while it is necessary for
the needle and the interior of the syringe to be sterile, the
external surfaces of the syringe need not be sterile during syringe
filling or during injection. In such vaccination programs, ease of
transportation to remote vaccination sites and safe storage under
difficult environmental situations may be very important.
[0005] Recently, attention has been paid to the social and
environmental impact of the disposal of contaminated syringes,
needles and the associated packaging after use. In the developed
world, the priority has been protection of the healthcare worker
from the contaminated syringe and the inherent possibility of
accidental needlestick injury. In the developing world, a major
priority has been the safe and environmentally friendly disposal of
both the used syringe and its packaging. To date, however, little
attention has been paid to packaging and disposal in developed
countries. In both developed and developing countries, an improved
method of transporting and disposing of syringes and related
packaging materials would have economic and environmental
advantages.
[0006] Traditionally, individual syringes and needles have been
packaged in form, fill and seal blister packages or pouches from
which the syringe can be removed manually or ejected onto a sterile
field in a manner which allows the external surfaces of the syringe
to be maintained sterile. This is absolutely necessary if the
syringe is to be used in a sterile operating room field. However
most syringes are not used in circumstances where it is necessary
to maintain the external sterility of the syringe. In addition, the
traditional form fill and seal package is deliberately designed to
allow easy opening by peeling apart the two webs from which the
package is made. These webs are usually heat sealed and after the
syringe is removed it is not difficult to re use the package and
obtain a second heat seal of the package as was done in the
manufacturing plant. Many inexpensive easily obtained home food
packaging machines can effect such a seal and obtain a result not
easily distinguishable from the factory seal. This fact then allows
inappropriate repackaging of used, washed but not sterilized
syringes simply and cheaply. The packaging taught herein is
effectively destroyed when opened which acts as a tamper evident
control on repackaging intended to replicate the original sterile
syringe.
[0007] While traditional individual primary packaging, form fill
and seal or similar pouches, are designed to ensure both external
and internal sterility, the current configurations are not usually
designed to minimize the volume or weight. of the packaging. The
syringe in its primary packaging requires secondary packaging,
i.e., boxes and cartons for transportation. Sterilization of
syringes is carried out with the individually packaged syringes
inside the secondary packaging, including both storage boxes and
transportation cartons. Therefore, any decrease in individual
syringe packaging will be reflected in the secondary packaging
storage boxes and transportation cartons being of smaller size
also. This will reduce the total volume of syringes inside primary
and secondary packaging presented to the sterilization facility. It
is expected that this will decrease time for processing and
therefore reduce the cost of sterilization.
[0008] During syringe use, it is often necessary to measure
accurately the volume of solution within the syringe. At other
times, however, such as flushing an intravenous line, the precise
volume of fluid used is not usually measured. Similarly, if the
entire contents of a vial of fluid is transferred to another vial,
it may not be necessary or common practice to read the index
markings on the syringe barrel. This obviously makes visualization
of the index markings of little importance. This may be relevant
if, as is proposed in one embodiment of this application, the
packaging may be intended to remain on the syringe during use or if
the syringe is pre filled with medication.
[0009] Therefore, there appears to be an opportunity for improved
possibly, use-specific packaging for single use disposable medical
devices such as syringes and needles. The described but
non-limiting embodiments described herein address many of the
issues related to the transport, use, and disposal of sterile
disposable medical devices. The proposed packaging is intended to
be used primarily for syringes in situations where the absolute
sterility of the external surface of the syringe is not necessary
but internal sterilization is. Some of the described packaging may
remain on the syringe during use (the same packaging could also be
used for syringes which require sterility both internally and
externally). The volume of packaging requiring separate disposal is
thereby reduced.
[0010] If this new individual primary packaging is used in
conjunction with secondary packaging incorporating a combined
transportation and disposal system (the subject of the authors
patent U.S. Pat. No. 6,283,909), a further reduction in volume for
transportation, and syringe disposal volume will be realized.
BRIEF DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0011] An exemplary but non-limiting embodiment described herein
relates to applying shrink-wrap packaging material or film to
individual syringes. This approach impacts and simplifies the
sterilization, maintenance of internal sterility and transportation
of medical devices, such as hypodermic syringes, prior to use. It
allows the use of a syringe without significantly compromising the
accuracy of the syringe. It also reduces the volume of waste
disposal after use. The resultant benefits will be a reduction in
some or all of: cost of production, sterilization, transportation
and disposal of medical devices such as syringes and needles. Safe
and effective packaging may be obtained with an expected reduction
in weight of packaging of 50%, and in volume of packaging requiring
disposal, significantly greater than 50%. Additionally, in some
embodiments, the ability to use the syringe without the need to
remove some or all of the packaging prior to use is enabled. This
will result in reduced waste packaging requiring disposal after use
with no appreciable increase in the volume of syringe waste
requiring disposal. This is achieved as much of the packaging is
retained closely or tightly applied to the syringe and is not
removed from the syringe.
[0012] Medical syringe or other device packaging including
individual closely applied such as shrink-wrapping, as described
herein, may include the following features and/or advantages:
[0013] Effective individual coverage (primary packaging) of the
syringe and needleguard (needlecap) to maintain internal and
external sterility of the syringe after sterilization and before
use.
[0014] Reduction in individual syringe/packaging volume over
traditional systems, thereby reducing size and cost of secondary
packaging, storage boxes and transportation cartons.
[0015] Reduction in individual syringe packaging and box and carton
volume, thereby reducing sterilization time and cost.
[0016] Reduction in individual syringe packaging and box and carton
volume, thereby reducing transportation costs and/or
difficulties.
[0017] The ability to remove some or all of the individual syringe
packaging prior to use (requiring external or internal sterility or
both, e.g., in the operating room use or in vaccination
programs).
[0018] Reduction in cost and environmental impact of disposal of
packaging through reduced individual syringe/packaging volume, box
and carton size.
[0019] Some packaging may remain on the syringe yet still allow
unrestricted plunger motion and essentially full use of injection
function of syringe. This can be accomplished with no significant
increase in disposal volume or disposal cost of syringe.
[0020] Packaging allows visualization of index markings while still
on the syringe, i.e., without need for complete removal.
[0021] Packaging will accommodate a variety of methods of removal,
e.g., axial or transverse pull tabs, complete or partial removal,
providing use-specific function.
[0022] The pull tabs described are incorporated with the shrink
wrap film during factory manufacture. This process requires
expensive equipment and cannot be easily replicated outside the
manufacturing facility thereby effectively preventing deceptive
repackaging of used syringes.
[0023] The use of specifically designed pull tabs or shrink wrap
film with peculiarities including for example specific structural
or color features will tend to thwart deceptive repackaging of used
syringes.
[0024] Ability of packaging to allow other safety syringe related
functions such as anti-needlestick needle retraction after use.
[0025] Optional syringe features simplify removal of individual
primary packaging, e.g., features on needle cap tent the film wrap,
allowing easier puncture and removal.
[0026] Improved resistance to accidental contamination of the
syringe, e.g., water, mold or fungal destruction when compared to
some traditional packages, e.g., Tyvek.RTM..
[0027] Accordingly, in one aspect, the invention relates to a
syringe package comprising a single syringe entirely enclosed and
sealed within a shrink-wrap film or package.
[0028] In another aspect, the invention relates to a syringe
package comprising a single syringe entirely enclosed and sealed
within a shrink-wrap film or package, wherein the syringe includes
a barrel, a plunger slidable within the barrel, a thumb press at
one end of the plunger projecting rearwardly of the barrel, and a
needle at an opposite end of the barrel, and wherein the
shrink-wrap package is formed with at least one pull tab connected
to an annular line of weakening located at a distal end of the
syringe adjacent to the needleguard syringe junction and rearward
of the needle tip.
[0029] In still another aspect, the invention relates to a syringe
package comprising a single syringe entirely enclosed and sealed
within a shrink-wrap package, wherein the syringe includes a
barrel, a plunger slidable within the barrel, a thumb press at one
end of the plunger projecting rearwardly of the barrel, and a
needle at an opposite end of the barrel, at least one of the
syringe and the shrink wrap package provided with means for
facilitating removal of at least a portion of the shrink wrap
package.
[0030] In still another embodiment, the invention relates to a
method of packaging, using and disposing of a syringe comprising:
enclosing and sealing a single syringe assembly within a shrink
wrap package, the syringe assembly including a barrel, a plunger
slidable within the barrel, a thumb press at one end of the plunger
projecting rearwardly of the barrel, and a needle at an opposite
end of the barrel; removing a portion of the shrink wrap package
enclosing the needle; using the syringe in a liquid injection or
removal mode while leaving a remaining portion of the shrink wrap
package on the syringe assembly; and disposing the used syringe
assembly with the remaining portion of the shrink wrap package in
place on the syringe.
[0031] The embodiments noted above can be construed to be
applicable to syringes whether empty or pre filled with medication
or other medical devices wherein the internal sterility of the
device is required; however the external surface need or cannot be
maintained as sterile during or before use.
[0032] The invention will now be described in detail in connection
with the drawing figures identified below and using a syringe as an
example of a relevant medical device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1 is a side elevation of a syringe, individually
packaged in accordance with an exemplary but non-limiting
embodiment;
[0034] FIG. 2 is a side elevation of a syringe, individually
wrapped in accordance with another exemplary embodiment; and
[0035] FIG. 3 is a side elevation of a syringe with yet another
exemplary embodiment.
DETAILED DESCRIPTION OF THE INVENTION
[0036] With reference to FIG. 1, a packaged individual syringe
assembly 10 includes a conventional syringe 12 having a syringe
barrel 14, a plunger 16 slidable within the barrel, a thumb press
18 at the proximal end of the plunger and projecting rearwardly of
the barrel, and a needle 20 at the distal end of the barrel. A
shrink-wrap package 22 encloses and seals the syringe assembly,
with closed ends at 24 and 26. The shrink wrap material may be
conventional material typically used for shrink wrap applications
or may have specific characteristics such as color radiation
tolerance, gaseous permeability or non toxic products when disposed
by incineration. The transparency of the material is significant
here in that the index markings on the syringe barrel are easily
visible when portions of the shrink wrap material remain on the
syringe during use, as described further herein. Adjacent the
proximate end of the syringe (adjacent the thumb press 18), an
integral and extended finger hold or pull tab 28 enables the
proximal portion of the shrink-wrap covering the thumb press to be
disrupted and removed with possibly with the aid of a partial tear
line 30. At the same time, a finger hold or pull tab 32 may be
located at the opposite or distal end of the syringe, again with a
partial tear line 34 extending from the pull tab, enabling the
distal end of the shrink wrap to be removed. It will be appreciated
that other techniques for facilitating tearing of the shrink wrap
material may be employed. For example, reducing the thickness of
the material along the desired tear pattern, will create a line of
weakening that will function in a manner similar to a partial tear
line.
[0037] By removing the two closed ends 24, 26 of the shrink-wrap
package, followed by removal of the needle cap 36, the syringe 12
may be used with unrestricted plunger motion, and with full use of
a liquid injection or removal function, while leaving a majority of
the shrink-wrap material in place on the barrel of the syringe. The
remaining portion of the shrink-wrap package may remain along the
barrel, but could be removed if desired.
[0038] In the FIG. 2 embodiment, a finger hold or pull tab 138
projects axially from the distal end 126 of the shrink-wrap package
122. The pull tab may be connected to a partial tear line (or other
line of weakening) 140 that extends axially substantially the
length of the syringe barrel 114. With this arrangement, the entire
shrink-wrap package 122, including the closed ends 124 and 126 may
be removed from the syringe 112 simply by pulling the finger hold
or pull tab 138 axially along the length of the syringe. Upon
removal of the needle cap 136, the syringe is ready for use.
[0039] FIG. 3 illustrates yet another exemplary embodiment, similar
to the embodiment in FIG. 2, but where the needle cap 236 is
provided with a lateral extension, edge or flange 242 at its open
end, engaged by the shrink-wrap cover 222 causing the shrink wrap
film to be tented over the flange. The user may run his/her
fingernail around the flange 242 of the needle cap 236, thereby
severing the closed distal end portion 224 of the shrink-wrap
package from the remainder of the package, permitting easy removal
of the closed-end 224 of cover forward of the flange 242. This
allows the film to be easily disrupted or rent adjacent this tented
area. Starting at this disruption the edge of the shrink wrap film
can be easily grasped and complete removal of the shrink wrap film
or cover is simplified. In this example the axial tab is also
included to simplify removal if desired as in the FIG. 2
embodiment. Removal of the proximal closed end portion 226 of the
shrink wrap package can be achieved in a similar manner, with the
user pressing about one of the edges presented by the fingerhold
244 at the proximal end of the syringe barrel 214, axially adjacent
the thumb press 218. Thus, the embodiment in FIG. 3 permits the
user to remove any or all of the distal end, proximal end and
intermediate portions of the shrink wrap package. Note in this
regard that the shrink-wrap cover may be formed with partial tear
strips or otherwise weakened annular lines about the flange 242
and/or flange 244. In a variation of this arrangement, the shrink
wrap package need not have any lines of weakening, insofar as the
user may use the needle cap flange 242 and/or barrel flange 244 to
facilitate removal of desired portions of the shrink wrap package
as described above. In all cases, removal of some or all of the
shrink wrap packaging effectively destroys the packaging, thereby
acting as a temper evident control on repackaging with the original
material.
[0040] It will be appreciated further that the syringes with
applied shrink-wrap packaging may be utilized under conditions
where both the interior and exterior of the syringe is required to
be sterile (by removing the entire shrink-wrap cover) or where just
the interior is required to be sterile (in which case, part of the
shrink-wrap cover may be left in the syringe). In the situation
where external sterility is also required, the shrink wrapped
syringes can be placed in an additional closed tray as is often
used for bulk sterilization of syringes to be used for example for
allergy testing. In this case, the shrink wrapped syringes from
this additional enclosed tray can be peeled and ejected onto a
sterile field and used safely. These sterilization techniques are
well understood by those of ordinary skill in the medical
sterilization field. In all cases, storage, shipping and disposal
volumes are significantly reduced with attendant decreases in
cost.
[0041] While the invention has been described in connection with
what is presently considered to be the most practical and preferred
embodiment, it is to be understood that the invention is not to be
limited to the disclosed embodiment, but on the contrary, is
intended to cover various modifications and equivalent arrangements
included within the spirit and scope of the appended claims.
* * * * *