Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
2002-02-13
2004-03-23
Cohen, Lee (Department: 3739)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S386000, C600S391000, C600S392000, C607S149000, C607S152000, C607S153000
Reexamination Certificate
active
06711427
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to electrocardiogram monitoring electrodes, and more specifically to an improved integral mounting and packaging system for the electrodes.
BACKGROUND OF THE INVENTION
In order to monitor the condition of a patient, electrocardiogram or ECG monitoring electrodes are positioned on the body of a patient in the vicinity of the heart. The electrodes pick up electric signals generated by the heart and transmit the signals to a monitor which provides a visual representation of the heart signals to a physician for analysis of the condition of the heart. The electrodes are designed for a single use and are individually packaged in disposable packages that allow quick access to the electrode contained therein.
In order to provide an accurate representation of the signal for analysis by the physician, the electrodes must be placed in direct electrical contact with the skin of the patient. For the electrodes to be placed in direct electrical contact with the skin, it is desirable to remove the hair and a portion of the epidermis or external skin layer prior to the application of the electrode to the skin of the patient. This is normally accomplished by first cleaning the site to which the electrode is to be applied using rubbing alcohol on a cotton ball. This will remove oils secreted from the skin from the site. After the site is cleaned, a razor is used to remove the hair on the site. Finally, an abrasive pad or equivalent is rubbed against the skin of the individual on the location where the electrode is to be positioned to remove a portion of the epidermis, or the outer layer of the skin. After the hair and epidermis portion have been removed by razor and rubbing the pad against the skin, the electrode may then be positioned on the skin in the prepared location.
To further enhance the electrical contact of the electrode with the skin, an amount of an electrically-conductive gel is utilized with the electrode. The gel can either be applied to the contact side of the electrode or incorporated within the electrode. When the electrode and gel are positioned on the skin, the gel spreads outwardly between the electrode and the skin to provide a conduit between the skin and the electrode to enhance the transmission of electrical signals emitting from the heart of the patient to the electrode.
While the use of the separate abrasive pad and ECG electrode is adequate to provide sufficient electrical contact between the electrode and the skin of the patient, in certain situations the speed of the preparation of the skin using the separate abrasive pad is not fast enough to adequately serve the needs of the patient. For example, in situations where the patient is in cardiac arrest, the application of the ECG electrodes to the skin of the patient in a proper manner needs to be accomplished as fast as possible. As a result, the time needed to properly prepare the skin of the individual using the abrasive pad increases the time needed to properly apply the electrodes to the patient, possibly to the detriment of the patient.
Therefore, it is desirable to develop a simple mounting and packaging system for an ECG electrode which allows a physician or other medical personnel to quickly prepare the skin of the patient and apply the electrode. The improved system should entail a minimal number of steps in preparing the skin, unpackaging the electrode and applying the electrode, so that the minimal amount of time is needed for the application of the electrode to the patient.
Furthermore, since it has recently been found that it is only necessary to abrade or prepare the skin on an electrode application site in order to obtain good electrical contact between the electrode and the skin, it is desirable to develop a self-prepping electrode that can easily prepare the skin of a patient through the hair of the patient.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide an improved mounting and packaging system for an ECG electrode which enables the skin of the patient to be prepared through the hair of a patient and the electrode to be applied to the skin in a single step.
It is another object of the present invention to provide an improved mounting and packaging system for an ECG electrode that can be formed in conjunction with other separable mounting and packaging systems for separate ECG electrodes such that a number of electrodes can be packaged together in a single unit.
It is still another object of the invention to provide an improved mounting and packaging system for an ECG electrode that also contains an amount of an electrically conductive gel that is applied to the skin with the electrode.
It is still a further object of the invention to provide an improved mounting system for an ECG electrode that can be readily modified to accommodate ECG electrodes of various configurations and sizes.
The present invention is an improved mounting and packaging system for an ECG electrode that allows medical personnel to prepare the skin of the patient and apply the electrode in a single step. The system includes at least one carrier formed of a single sheet of a flexible material that includes an upper panel and a lower panel joined to one another by a fold. The upper panel includes a depression over which the electrode is releasably attached. An amount of an electrically conductive gel is disposed within the depression and covered by the electrode. Opposite the electrode, the lower panel includes an abrasive surface that is used to contact and prepare the skin of the patient for the application of the electrode. Opposite the fold, the lower panel of the system further includes a tab that is grasped by an individual in order to utilize the mounting and packaging system and prepare the skin and apply the electrode to the individual in a single step.
To apply the electrode to the patient, the individual places the mounting and packaging system against the skin of the patient such that the abrasive surface of the lower panel of the system contacts the skin of the patient. The individual grasps the electrode to hold the electrode in the desired position over the skin. The individual then grabs the tab on the lower panel and pulls the tab such that the abrasive surface on the lower panel is dragged along the patient's skin, removing a portion of the epidermis from the skin of the patient. Continued pulling of the tab removes the upper panel and exposes the conductive gel disposed within the depression and the electrode such that the gel and electrode are subsequently positioned in contact with the prepared surface of the skin of the individual.
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Boyle Fredrickson Newholm Stein & Gratz S.C.
Cohen Lee
Milwaukee Electronics Corporation
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