U.S. patent application number 11/562247 was filed with the patent office on 2008-05-22 for packing and sterilizing a pen in a kit.
Invention is credited to Randy Fratto, Jesse Hansen, Fred Lampropoulos, Matt Wold.
Application Number | 20080116106 11/562247 |
Document ID | / |
Family ID | 39415845 |
Filed Date | 2008-05-22 |
United States Patent
Application |
20080116106 |
Kind Code |
A1 |
Lampropoulos; Fred ; et
al. |
May 22, 2008 |
PACKING AND STERILIZING A PEN IN A KIT
Abstract
Sterile packaging of pens for use in a medical environment may
include labels packaged along with a pen in a pen and label (PAL)
kit. The present invention also relates to methods of packaging a
pen and/or the PAL kit. In particular, the method of packaging
includes the steps of placing a writing instrument into packaging
configured to be sealed such that the writing instrument is
contained in a sealed portion of the packaging, sealing the
package, and sterilizing the writing instrument and the package
using gamma sterilization such that all portions of the writing
instrument are sterilized.
Inventors: |
Lampropoulos; Fred; (Sandy,
UT) ; Fratto; Randy; (Layton, UT) ; Wold;
Matt; (South Ogden, UT) ; Hansen; Jesse;
(Eagle Mountain, UT) |
Correspondence
Address: |
MERIT MEDICAL SYSTEMS, INC.;C/O STOEL RIVES, LLP
ONE UTAH CENTER, 201 SOUTH MAIN STREET -- SUITE 1100
SALT LAKE CITY
UT
84111
US
|
Family ID: |
39415845 |
Appl. No.: |
11/562247 |
Filed: |
November 21, 2006 |
Current U.S.
Class: |
206/570 ;
206/223; 53/425 |
Current CPC
Class: |
B65B 55/02 20130101;
A61B 2050/0065 20160201; A45C 11/24 20130101; A61B 50/30
20160201 |
Class at
Publication: |
206/570 ; 53/425;
206/223 |
International
Class: |
B65D 71/00 20060101
B65D071/00; B65B 55/02 20060101 B65B055/02 |
Claims
1. A method for packaging a pen, comprising: placing a writing
instrument into packaging configured to be sealed such that the
writing instrument is contained in a sealed portion of the
packaging; sealing the packaging; and sterilizing the writing
instrument and the packaging using gamma sterilization, such that
all portions of the writing instrument are sterilized.
2. The method of claim 1, wherein the writing instrument is a
permanent ink pen.
3. The method of claim 1, wherein the packaging is one of a
multivac blister packaging and a foil packaging.
4. The method of claim 1, wherein the writing instrument is
non-sterile prior to the sterilizing using gamma sterilization.
5. The method of claim 1, wherein the sealing includes vacuum
sealing.
6. The method of claim 1, wherein the packaging is an inner
packaging, and wherein the method further comprises the steps of:
placing the sealed inner packaging into an outer packaging; placing
at least one other item into the outer packaging; sealing the outer
packaging such that the sealed inner packaging and the additional
items are contained in a sealed portion of the outer packaging; and
sterilizing the contents of the outer package using EtO
sterilization.
7. The method of claim 6, wherein the inner packaging is
impermeable to the EtO gas.
8. The method of claim 7, wherein the inner packaging is foil
packaging.
9. The method of claim 6, wherein the outer packaging is multivac
blister packaging.
10. The method of claim 6, wherein the at least one other item
includes labels configured to be written on with the writing
instrument.
11. The method of claim 10, wherein the at least one other item
also includes at least one item configured to be used with a
medical procedure.
12. The method of claim 6, wherein labels configured to be written
on with the writing instrument are included in at least one of the
inner packaging and the outer packaging.
13. The method of claim 1, further comprising the step of printing
on the packaging simultaneous to sealing the packaging.
14. The method of claim 6, further comprising the step of printing
on the outer packaging simultaneous to sealing the outer
packaging.
15. A kit comprising: packaging; a writing instrument; and labels
configured to be written on by a user with the writing instrument,
wherein at least the writing instrument is sealed in the packaging,
and wherein at least the packaging and the writing instrument are
sterilized using gamma sterilization.
16. The kit of claim 15, wherein the packaging is inner packaging,
and further comprising: outer packaging; and at least one other
item, wherein the writing instrument sealed in the inner packaging,
the labels, and the at least one other item are sealed in the outer
packaging, and wherein the outer packaging and the contents of the
outer packaging are sterilized using EtO sterilization.
17. The kit of claim 15, wherein the writing instrument is a
permanent ink pen.
18. The kit of claim 15, wherein the packaging is one of a multivac
blister packaging and a foil packaging.
19. The kit of claim 15, wherein the labels are sealed in the
packaging.
20. The kit of claim 16, wherein the inner packaging is impermeable
to air such that the EtO gas does not penetrate the inner
packaging.
21. The kit of claim 16, wherein the at least one other item is an
item configured to be used in medical treatment.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to sterilized medical
packaging. In particular, the present invention relates to
packaging a sterilized writing instrument, such as a pen, and
labels, which may be contained in a pen and label kit (PAL)
kit.
[0002] One problem often encountered in modern medicine relates to
the need to identify and correctly label medical devices and
products in a sterile fashion. Such medical devices and products
may include therapeutic agents, (i.e., saline infused with a
medicine), tissue samples, blood samples, used medical implements,
and other medically related devices and products. The use of a
sterile pen in such environments can prevent infection that might
otherwise occur due to handling of a non-sterile implement. Because
pens are routinely used by medical personnel, the risk of
unintended exposure to dangerous agents resulting from the use of a
non-sterile pen has been identified as problematic in the medical
field.
[0003] Similarly, using sterile labels may reduce the risk of
exposure or contamination by dangerous agents in a sterile
environment, or by health-care professionals wearing sterile
gloves. In some instances, touching a seemingly innocuous label
that is not sterile may put patients at risk of infection. Such
risks may be overlooked by the medical professionals because of the
common use of such labels and because such labels must be used to
correctly identify certain objects and materials.
[0004] One approach to addressing this problem has been to provide
sterile PAL kits or pens along with certain medical products, or
alone, for use by medical personnel. Some traditional methods of
sterilization may include heat, chemical dipping and/or ultrasonic
treatment. These traditional methods of sterilization may cause
problems when used in attempts to sterilize a pen and labels, as
the heat may melt the pen and the label adhesive, chemical dipping
may damage the pen and labels, and ultrasonic treatment may not be
as effective as other processes in killing all dangerous
agents.
[0005] Sterilization using EtO (Ethylene Oxide) gas effectively
kills bacteria and has been used to sterilize medical products
since the 1960's. In a typical EtO cycle, a product is placed in an
air tight chamber from which the air can be evacuated. EtO gas is
then pumped into the chamber for an extended period of time.
Temperature (heat) and humidity are also part of the cycle to
enhance the kill time. After a certain period of time, the chamber
recycles and pulls the EtO out and replaces it with clean air, as
EtO gas is harmful to breathe. EtO sterilization usually requires
about a day to prepare for a cycle, a day to run through the
sterilizer, and about a week to wait for sterilization confirmation
using a Petri dish sample test, making the EtO sterilization
somewhat time consuming and expensive. Another problem with
sterilizing pens using EtO sterilization is that drawing a vacuum
in a volume containing a pen may cause the pen to leak, creating a
mess.
[0006] What is needed is a sterilized PAL kit that can be processed
quickly, while minimizing losses due to damaged or leaking
pens.
BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION
[0007] Embodiments of the present invention relate to packaging a
writing instruments, such as a pen, including the steps of placing
the writing instrument into packaging configured to be sealed such
that the writing instrument is contained in a sealed portion of the
packaging, sealing the package, and sterilizing the writing
instrument and the package using gamma sterilization such that all
portions of the writing instrument are sterilized. Gamma
sterilization is effective at sterilizing all components of the PAL
kit, including the interior of any pen cap or lid and even the ink
inside of a pen. Similarly, gamma irradiating labels ensures that
the labels, including any adhesive layer, are sterilized
throughout.
[0008] In some embodiments, the packaging is an inner packaging,
and the method further includes the steps of placing the sealed
inner packaging into an outer packaging, placing at least one other
item into the outer packaging, sealing the outer packaging such
that the sealed inner packaging and the additional items are
contained in a sealed portion of the outer packaging, and
sterilizing the contents of the outer packaging. In some
embodiments, EtO sterilization is employed.
[0009] Another embodiment of the present invention is directed to a
kit that includes packaging, a writing instrument, and labels
configured to be written on by a user with the writing instrument.
At least the writing instrument is sealed in the packaging, and at
least the packaging and the writing instrument are sterilized using
gamma sterilization.
[0010] In some embodiments, the packaging may be inner packaging,
the kit further including outer packaging and at least one other
item. The writing instrument is sealed in the inner packaging. The
labels, and the at least one other item are sealed in the outer
packaging, and the outer packaging and the contents of the outer
packaging are sterilized, such as by using EtO sterilization, for
example.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] To further clarify the above and other aspects of the
present invention, a more particular description of the invention
will be rendered by reference to specific embodiments thereof which
are illustrated in the appended drawings. It is appreciated that
these drawings depict only typical embodiments of the invention and
are therefore not to be considered limiting of its scope. The
invention will be described and explained with additional
specificity and detail through the use of the accompanying drawings
in which:
[0012] FIG. 1A is a top view of a PAL kit including a pen and
labels in a package according to one embodiment of the
invention;
[0013] FIG. 1B is a top view of the PAL kit including a pen and
labels in a package of FIG. 1A according to one embodiment of the
invention;
[0014] FIG. 2 is a view of a PAL kit including a pen in a package
according to one embodiment of the invention;
[0015] FIG. 3 is view of a kit including a PAL kit and additional
packaging and components according to one embodiment of the
invention; and
[0016] FIG. 4 is a process diagram of packaging a PAL kit according
to one embodiment of the invention.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0017] The present invention relates to sterile packaging of
writing instruments, such as pens, for use in a medical
environment. The sterile packaging may include labels packaged
along with a pen in a pen and label (PAL) kit. The present
invention also relates to methods of packaging a pen and/or the PAL
kit. In particular, the method of packaging includes the steps of
placing a writing instrument into packaging configured to be sealed
such that the writing instrument is contained in a sealed portion
of the packaging, sealing the package, and sterilizing the writing
instrument and the package using gamma sterilization such that all
portions of the writing instrument are sterilized.
[0018] In some embodiments, the packaging is an inner packaging,
and the method further includes the steps of placing the sealed
inner packaging into an outer packaging, placing at least one other
item into the outer packaging, sealing the outer packaging such
that the sealed inner packaging and the additional items are
contained in a sealed portion of the outer packaging, and
sterilizing using EtO sterilization such that the contents of the
outer package are sterilized.
[0019] Some embodiments of the present invention relate to a kit
including packaging, a writing instrument, and labels configured to
be written on by a user with the writing instrument. In such
embodiments, at least the writing instrument is sealed in the
packaging, and at least the packaging and the writing instrument
are sterilized using gamma sterilization.
[0020] In some embodiments, the packaging may be inner packaging,
the kit further including outer packaging and at least one other
item. In such embodiments, the outer packaging is sealed to include
the sealed inner packaging containing the writing instrument,
labels, and the at least one other item. The outer package contents
are sterilized using EtO sterilization.
[0021] FIGS. 1A and 1B show a PAL kit 100 according to one
embodiment of the present invention. The PAL kit 100 includes
packaging 110, pen 120, and labels 130. Packaging 110 has a first
layer 112 and a second layer 114 that may be sealed together at or
adjacent to their respective peripheries. First layer 112 may be
made of semi-permeable material such as Tyvek.RTM. or other
gas-permeable material that would allow gasses to flow in and out
without allowing contaminants to penetrate the material,
maintaining the sterility of the interior and contents of PAL kit
100. The material of first layer 112 may also allow printing on the
surface of first layer 112. Such printing may include, for example,
identification and/or instructions. One example of such printing is
shown in FIG. 1B.
[0022] Second layer 114 may be made of a gas and liquid impermeable
transparent plastic material or any other suitable material. Second
layer 114 may have a depression formed in the material to create a
pocket or space for pen 120 and labels 130. Similarly a pocket may
be formed in first layer 112. Alternatively, the pocket may be
defined by neither layer, and may be implemented as a space defined
between joined layers 112 and 114.
[0023] First layer 112 and second layer 114 of packaging 110 may be
joined at a periphery to create a hermetically sealed interior
pocket capable of holding contents such as pen 120, or labels 130,
or both. Such packaging may be multivac blister packaging. The
layers 112 and 114 may be joined using any conventional joining
processes including adhesives, welding, etc. In some embodiments,
layers 112 and 114 may also be joined together to form more than
one interior pocket allowing for production of several packages
with continuous sheets of material, or allowing pen 120 and labels
130, or other objects, to be placed in separate pockets.
[0024] Layers 112 and 114 may also be joined such that on at least
one side, the joined portion is located in from an edge of
packaging 110 to enable a user to grasp the layers 112 and 114
individually and then separate the joined layers. In other
embodiments, a periphery of packaging 110 may include a notch to
allow the package to be easily torn open for use.
[0025] Pen 120 may be any conventional pen, such as a fine-tip,
permanent ink pen. Pen 120 may be provided in a non-sterile initial
state, prior to being placed and packaged in packaging 110 and
sterilized. While pen 120 is illustrated in the Figures, any
suitable writing instrument may be substituted for pen 120, such as
a marker, pencil, electronic writing instrument, etc.
[0026] Labels 130 may be any labels that would accept and hold ink
from pen 120, or otherwise lend themselves to being marked by a
writing instrument. Labels 130 may include printing directed to the
anticipated use of PAL kit 100. For example, as shown in FIG. 1A,
at least one of labels 130 may be pre-printed with "HEP./SALINE" or
other lettering such as "CONTRAST," "SALINE," "PREP SOLUTION,"
"LIDOCAINE," or any other printing. Similarly, labels 130 may be
pre-printed with designated spaces for writing, such as spaces for
date and initials to indicate when a product was prepared or
administered, or when a sample was taken, and who completed the
procedure. More generally, labels 130 may include any printed
information that may be useful to a medical professional using a
PAL kit.
[0027] In preparing PAL kit 100 as shown in FIGS. 1A and 1B, pen
120 and labels 130 are placed in packaging 110. Packaging 110 is
then sealed to encapsulate pen 120 or labels 130, or both, in
packaging 110. Packaging 110 may be hermetically sealed. After
packaging 110 is sealed to include pen 120 or labels 130, or both,
to create PAL kit 100, PAL kit 100 is sterilized using gamma
sterilization. A printing process may also be performed to label
PAL kit 100. The sealing and printing processes may be performed
simultaneously to reduce production time.
[0028] Gamma sterilization requires a short cycle time, typically
taking about one minute. PAL kit 100 is bombarded with gamma
radiation, which penetrates through all materials in packaging 110,
pen 120 and labels 130, sterilizing each component both internally
and externally. As some materials are sensitive to gamma radiation,
such that they become brittle and/or discolored, the materials
selected for PAL kit 100 may be selected for their resistance to
damage by gamma radiation. By using gamma sterilization, each
portion of the PAL kit is sterilized, including all inside portions
of pen 120, or other writing instrument, including the ink and
inside of any lid or cap covering pen 120. Gamma sterilization also
allows PAL kit 100 to be packaged without using a vacuum. This
approach to packaging may limit manufacturing loss due to pen
leakage and failure that can be caused by drawing a vacuum on pen
120. However, in some embodiments, vacuum packaged PAL kits may
also be sterilized using gamma sterilization.
[0029] In FIG. 2, PAL kit 200 includes packaging 210 and pen 220.
While labels may be included in PAL kit 200, PAL kit 200 as
illustrated does not include labels in packaging 210 along with pen
220. Packaging 210 includes first layer 212 and second layer 214.
In the embodiment illustrated in FIG. 2, layers 212 and 214 are
made from impermeable metal foil or semi-metallic material. Layers
212 and 214 may also be made from any other suitable material that
allows for gamma sterilization. Layers 212 and 214 are joined
around a peripheral edge such that a hermetically sealed interior
space is created for containing pen 220. Layers 212 and 214 may by
joined using any suitable conventional joining process including,
for example, adhesive, pressing, crimping, melting, and welding.
Similar to pen 120 of PAL kit 100, pen 220 may be any pen or
writing instrument, such as a fine-tip, permanent ink pen.
[0030] In preparing PAL kit 200 as shown in FIG. 2, pen 220 may be
placed in packaging 210. Excess air in the packaging may then be
withdrawn by drawing a vacuum on packaging 210. The vacuum may be a
relatively low vacuum sufficient to evacuate some or all of the
internal air from packaging 210, while minimizing manufacturing
losses due to pen failure. PAL kit 200 may then be hermetically
sealed and gamma radiated in a process similar to process described
in connection with PAL kit 100 above.
[0031] FIG. 3 shows medical kit 250. In this example embodiment,
medical kit 250 includes outer packaging 260, PAL kit 200, as
discussed above, labels 230 and additional components 240.
Packaging 260 includes a first outer layer 262 and a second outer
layer 264, first outer layer 262 may be made of semi-permeable
material such as Tyvek.RTM. or other suitable material to allow
gasses to flow in and out without allowing contaminants to
penetrate the material, thereby maintaining the sterility of the
interior and contents of medical kit 250 after performance of a
sterilization process. The material of first outer layer 262 may
also allow printing on the surface of first outer layer 262, so
that identification and/or instruction to be printed on the
packaging. The sealing and printing processes may be performed
simultaneously to reduce production time.
[0032] Second outer layer 264 may be made of a non-permeable
transparent plastic material or any other suitable material. Second
outer layer 264 may have a depression formed in the material to
create a pocket or space for PAL kit 200, labels 230, and
additional components 240. Similarly, a pocket may be formed in
first outer layer 262 or in neither layer, existing only as a space
between joined layers 262 and 264.
[0033] First outer layer 262 and second outer layer 264 of
packaging 260 may be joined at a periphery to create a hermetically
sealed interior pocket capable of holding contents such as PAL kit
200, labels 230, and additional components 240. Such packaging may
be multivac blister packaging. Outer layers 262 and 264 may be
joined using any conventional joining processes, such as adhesives
and welding. In some embodiments, layers 262 and 264 may also be
joined to form more than one interior pocket, allowing for
production of several packages with continuous sheets of material.
In some embodiments, each of the items contained in medical kit 250
may be placed in a separate respective pocket.
[0034] Outer layers 262 and 264 may also be joined such that on at
least one side, the joined portion is located in from the edge to
provide a user access to grasp outer layers 262 and 264 separately
and separate the joined layers. In other embodiments, a periphery
of packaging 260 may include a notch to allow the package to be
torn open for use.
[0035] In some embodiments, labels 230 may be included inside of
PAL kit 200, or may be included both inside PAL kit 200 along with
pen 220 and in outer packaging 260, separate from PAL kit 200.
Labels 230 may be conventional labels as discussed above with
regard to labels 130. Additional components 240 may include any
components for any medical kit that may require labeling, such as
with a PAL kit, and may be as numerous or as few as desired in the
particular medical kit 250. For example, additional components 240
may include a catheter kit including an introducer sheath,
syringes, tubing, guidewire, and collection receptacle.
[0036] In preparing medical kit 250 as illustrated in FIG. 3, PAL
kit 200, previously sterilized, labels 230, and additional
components 240 are placed in outer packaging 260. Outer layers 262
and 264 are then hermetically sealed. Sterilization is then
performed on the medical kit 250, such as by EtO sterilization.
Because PAL kit 200 includes foil packaging 210, EtO sterilization
does not penetrate PAL kit 200, but does sterilize the external
surfaces of packaging 210. During the EtO sterilization, EtO gas
penetrates through outer layer 262 and seeps through the open
lumens of any tubing and other components contained in medical kit
250.
[0037] In some embodiments, medical kit 250 may include PAL kit 100
as described above instead of PAL kit 200.
[0038] FIG. 4 shows a process diagram of process 400 listing some
exemplary steps to create a PAL kit. As shown, packaging is
provided in box 410. Box 420 includes the step of placing a writing
implement in the packaging. The packaging is sealed to contain the
writing instrument in box 430, creating a PAL kit. The PAL kit is
sterilized in box 440. Thus, a PAL kit may be created by including
at least a writing instrument in packaging, sealing the packaging
to contain the writing instrument, and sterilizing the PAL kit.
[0039] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *