Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical energy applicator
Reexamination Certificate
2001-07-20
2002-11-05
Getzow, Scott M. (Department: 3762)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Electrical energy applicator
Reexamination Certificate
active
06477430
ABSTRACT:
BACKGROUND OF THE INVENTION
In general, defibrillation therapy is a process used to treat a patient experiencing heart fibrillation (i.e., where the heart experiences potentially fatal arrhythmias). The defibrillation process involves placing electrodes on the patient's chest and applying defibrillation shock. The defibrillation shock is a brief biphasic pulse of electricity to the cardiac muscle applied to the patient's bare chest to stimulate the heart and correct the fibrillation. The electrodes generally comprise an anode and a cathode, and come either as a single-use pads, or reusable paddles. The single-use pads are adhesive so as to adhere to the patient, and are thus hands-free. In contrast, the paddles do not adhere to the patient, and are therefore not hands-free.
In addition to providing defibrillation, cardiac defibrillators often provide caregivers with monitoring and additional therapy capabilities. Generally, a monitoring capability involves a passive use of the defibrillator to record signals generated by the patient. In contrast, a therapy capability involves injecting electricity or other signals into the patient. A monitoring capability often included in a defibrillator is electrocardiograph (ECG) monitoring. Therapy capabilities often included in a defibrillator include defibrillation, external cardiac pacing, and cardioversion with or without pacing. In order to perform the ECG monitoring, pacing, cardioversion including a pacing function, or defibrillation where the defibrillator indicates when a shock is to applied, extended electrical contact needs to be made to the patient. This extended contact is provided using the single-use pads, or the reusable paddles to the extent this is possible. Further, extended contact is often more practical for other therapy and monitoring capabilities.
FIG. 1
shows a defibrillation and monitoring system using self-adhesive, single-use pads
10
. The defibrillator
1
is connected to the pads
10
by corresponding leads preconnected to the pads
10
, and the pads
10
are then placed on the chest of the patient in predetermined positions. For defibrillation, the preferred location is for one pad
10
to be located on the upper-right sternal border of a chest of the patient, with one end near the clavicle and the other end just over the right nipple. The other pad
10
is located on the left side of the patient, wrapped from the back to the front under the left nipple and across the left midaxillary line. In this way, the pads
10
are placed to maximize current flow through the myocardium.
The pads
10
are generally constructed of a flexible metallic conductor plate sandwiched between a protective polymer backing and a conductive hydrogel adhesive that is used to adhere the pads
10
to the patient. The pads
10
also typically have a molded connector, or will have the leads molded into the pads
10
, to connect corresponding leads to the defibrillator
1
. An example of the pads
10
are the Heartstream pads produced by Agilent Technologies (part no. M3713A).
An advantage of single-use pads
10
is that the caregiver can adhere the pads
10
to the patient, and then administer the defibrillation shock without being in contact with the patient. This hands-free ability reduces the chance that the caregiver will be shocked by or otherwise exposed to the electrical pulse passing through the pads
10
during defibrillation. However, the pads
10
have drawbacks in that they are expensive to use, and they do not allow the caregiver to perform a quick look of the patient ECG in order to better assess the condition of the patient. A quick look generally is when a caregiver makes a temporary or abbreviated connection to the patient in order to obtain a quick reading of the patient's heart rhythm or condition. Specifically, if the caregiver wants to use the pads
10
to check a condition of the patient, the pads
10
must be removed from their protective packaging (not shown), causing the hydrogel to become dehydrated and contaminated and making them unsuitable for an additional use.
FIGS. 2A and 2B
show a conventional reusable paddle
20
which is one of two that are used instead of the pads
10
shown in FIG.
1
. The paddles
20
include a handle
22
, which the caregiver grips in order to place and maintain the paddle
20
at a predetermined location on the patient, and a conductor plate
24
through which the defibrillation shock is applied. In order to reduce the impedance caused by dry skin or other factors related to the patient, a conductive medium
26
such as a gel is normally placed on the conductor plate
24
.
An advantage of using paddles
20
is that they are reusable. As such, the same pair of paddles
20
can be used again so long as the conductive medium
26
is removed and the paddles
20
are decontaminated and cleaned after use. However, the paddles
20
have drawbacks in that, in order to administer defibrillation, the caregiver must press the paddles
20
onto the patient. By having the caregiver be in close proximity to the patient, the caregiver is exposed to a shock hazard during defibrillation. In addition, the use of the conductive medium
26
creates a mess both on the paddles and the patient, increases the chance of shock to the caregiver, and makes the paddles
20
difficult to clean and decontaminate. Further, the paddles
20
are relatively large and heavy in comparison to the pads
10
. Lastly, since the paddles
20
are not attached to the patient, the paddles
20
cannot be used or are not practical for use in ECG monitoring, for external cardiac pacing, for cardioversion where pacing is performed, or for automatic ECG interpretive algorithms defibrillators (automatic external defibrillators) that indicate when a shock is to be delivered because these functions require the electrodes to be in extended contact and a motion free relationship with the patient. An example of the reusable paddles
20
is the part no. M4746A produced by Agilent Technologies.
For additional information on the use and placement of pads
10
and paddles
20
in conjunction with a defibrillator
1
having monitoring capabilities, reference is made to the Agilent M4735A Heartstream XL Defibrillator/Monitor User's Guide (Agilent Technologies) (Edition 1, September, 2000), which is incorporated herein by reference.
SUMMARY OF THE INVENTION
According to an embodiment of the present invention, a paddle for use with a defibrillator includes an applicator, a pad portion electrically connected to the applicator and having a conductive medium removably encased in the pad portion, and an electrical contact electrically connected to one of the applicator or the pad portion, the electrical contact being exposed while the conductive medium is encased in the pad portion.
According to another embodiment of the present invention, an applicator for use with an adhesive pad to form a paddle for use with a defibrillator includes a main body having a bottom, a connector on the bottom to electrically and mechanically attach the main body to the adhesive pad along a primary electrical path between a patient, the main body and the defibrillator, a handle attached to the main body, and an electrical contact attached to the main body to form a secondary electrical path between the patient, the main body and the defibrillator.
According to still another embodiment of the present invention, a pad portion for use with an applicator to form a paddle for use with a defibrillator includes a backing having a top and a bottom, a connector attached to the top to form a mechanical and electrical connection to the applicator, a conductive medium attached to the bottom, a lid to encase the conductive medium, and an electrical contact disposed on the lid to provide an electrical pathway to the applicator when the conductive medium is encased by the lid.
According to yet another embodiment of the present invention, a method of using a paddle with a defibrillator includes attaching a pad portion to an applicator portion to form the paddl
Borgenicht Fred
Bravo Karen Haas
Canfield Daniel C.
Feuersanger Robert A.
Freeman Curtis W.
Getzow Scott M.
Koninklijke Philips Electronics , N.V.
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