See-through electrode-pad package and method for using a...

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Reexamination Certificate

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C607S152000, C600S372000

Reexamination Certificate

active

06675051

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to electrode pads, and more particularly to a see-through package for storing an electrode pad of a medical device such as an automatic or semi-automatic external defibrillator (AED). In one embodiment of the invention, at least a portion of the package is see-through so that one can view the electrode pad, or instructions printed on the pad, before opening the package.
2. Description of the Prior Art
AEDs have saved many lives in non-hospital settings, and, as a result of advances in AED technology, the number of lives saved per year is rising. Typically, an AED analyzes a patient's heart rhythm and instructs an operator to administer an electrical shock to the patient if appropriate. For example, a shock can often revive a patient who is experiencing ventricular fibrillation (VF). Because older models of AEDs include only basic diagnostic and safety features, they are often difficult to operate. Therefore, only specially trained persons such as emergency medical technicians (EMTs) can use these older models to administer shocks to a patient. Newer models, however, often include advanced diagnostic and safety features that allow minimally trained persons to administer shocks to patients. Consequently, more people are using AEDs to save lives.
Because a heart rhythm that responds to an electrical shock can cause permanent damage or death within a short time if left untreated, an AED operator should be able to set up and use an AED to shock a patient within seconds after the operator arrives at the scene. Statistically, for each minute that a person is in cardiac arrest and is not receiving cardiopulmonary resuscitation (CPR), his/her chance of survival decreases by 10%. And in most cases, there is no chance for resuscitation after 10 minutes. Unfortunately, many people do not know how to administer CPR. And, even in the best of circumstances, it can take a few minutes to retrieve the AED and a few additional minutes for the AED to diagnose and shock the patient. Therefore, even if the patient is discovered immediately, the operator often has little time to remove the defibrillator electrode pads from their package, attach the pads to the patient, connect the pads to the AED, and activate the AED without further decreasing the patient's chance of survival. Clearly, the faster the operator can set up and activate the AED, the better the chances that the patient will survive.
FIG. 1
is a perspective view of a conventional defibrillator-electrode-pad storage system
10
, which includes a package
12
and two defibrillator electrode pads
14
a
and
14
b
(shown in phantom line) stored within an interior
16
of the package
12
. Electrode-pad leads
18
a
and
18
b
, which electrically connect the electrode pads
14
a
and
14
b
to an AED (not shown in FIG.
1
), extend from a sealed opening
20
in the package
12
, although the leads
18
a
and
18
b
may be stored entirely within the package
12
.
FIGS. 2A and 2B
are front and rear views, respectively, of the electrode pad
14
a
of
FIG. 1
, it being understood that the front and rear views of the electrode pad
14
b
are similar.
Referring to
FIG. 2A
, the front of the defibrillator electrode pad
14
a
is typically nonconductive to insulate the AED operator (not shown in
FIG. 2A
) from defibrillation shocks, and typically has instructions that indicate where to attach the electrode pad
14
a
to the patient (not shown). For example, the front of the electrode pad
14
a
has an instruction picture
22
a
, which illustrates the proper locations
24
a
and
24
b
for attachment of the two electrode pads
14
a
and
14
b
on a patient (not shown in
FIG. 2A
or
2
B). A dashed-line circle
26
a
and a bold arrow
28
a
indicate that the location
24
a
is the appropriate location for attaching the electrode pad
14
a
to the patient. Similarly, the front of the pad
14
b
(not shown in
FIG. 2A
) has a similar picture
22
b
with a dashed-line circle
26
b
around and an arrow
28
b
pointing to the location
24
b
, which is the appropriate location for attaching the electrode pad
14
b
to the patient. Indicating which electrode pad
14
a
and
14
b
is attached at which location
24
a
and
24
b
reduces operator confusion, and thus decreases the time it takes the operator to attach the electrode pads to the patient. The pictures
22
a
and
22
b
and accompanying written instructions are described in U.S. Pat. No. 5,951,598, to Bishay et al., which is incorporated by reference.
Referring to
FIG. 2B
, the rear of the defibrillator electrode pad
14
a
includes a conductive layer
30
a,
which is typically coated with a contact gel
32
a
. The gel
32
a
provides electrical conduction between the patient and the conductive layer
30
a
and helps adhere the electrode pad
14
a
to the patient.
Referring to
FIGS. 1 and 2B
, the package
12
is typically formed from an opaque material that provides a moisture barrier sufficient to maintain the viability of the defibrillator electrode pads
14
a
and
14
b
for a predetermined period or longer. Typically, the electrode pads
14
a
and
14
b
are viable only while the contact gels
32
a
and
32
b
(not shown) maintain respective moisture levels that are at or above a predetermined threshold. Therefore, the manufacturer specifies that the package
12
will limit moisture loss from the package interior
16
to a rate sufficient for maintaining adequate moisture in the gels
32
a
and
32
b
for a predetermined period such as one year. Many of the best materials for providing such a moisture barrier, and thus for composing the package
12
, are opaque.
Unfortunately, referring to
FIGS. 1-2B
, an opaque package
12
often increases the time it takes an operator (not shown in
FIGS. 1-2B
) to attach the defibrillator electrode pads
14
a
and
14
b
to the patient (not shown), and thus often increases the time it takes the operator to set up the AED (not shown in
FIGS. 1-2B
) and shock the patient. The operator looks at the circles
26
a
and
26
b
(not shown in
FIGS. 1-2B
) to determine which electrode pad goes where. But because the package
12
is opaque, the operator cannot look at the circles
26
a
and
26
b
until after he/she removes the electrode pads
14
a
and
14
b
from the package. This increases the time it takes for the operator to determine which electrode pad goes where, and thus increases the time it takes for the operator to attach the electrode pads
14
a
and
14
b
to the patient. Furthermore, different electrode pads
14
a
and
14
b
are often recommended for different patients. For example, adult electrode pads
14
a
and
14
b
are recommended for adults, and pediatric electrode pads are recommended for children. Even though the pad type may be labeled on the outside of the package
12
, the operator may overlook this label in his/her haste to rescue the patient and not consider the type of the electrode pads
14
a
and
14
b
until after opening the package. Therefore, if the electrode pads
14
a
and
14
b
are inappropriate for the patient, then the operator must retrieve and open at least one more set of electrode pads, thus increasing the time it takes the operator to attach the appropriate electrode pads to the patient. In addition, because electrode pads that are removed from a package should be discarded whether or not they are used, pads that are removed from package and are then found to be inappropriate for the patient typically go unused, and are thus wasted.
Consequently, there is a need for a package that maintains the viability of electrode pads such as defibrillator electrode pads and yet facilitates an operator's understanding of the pad type and of which pad goes where.
SUMMARY OF THE INVENTION
A package is provided for storing one or more electrode pads. The package includes an interior for storing the electrode pad or pads and a window that provides a view into the interior.
Because it has a window, the package often reduces the

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