Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
2000-02-02
2001-09-18
Dvorak, Linda C. M. (Department: 3739)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S391000, C600S393000
Reexamination Certificate
active
06292679
ABSTRACT:
CROSS REFERENCES TO RELATED APPLICATIONS
STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT
BACKGROUND OF THE INVENTION
The present invention relates to electrical connectors in general, and more particularly to disposable devices for connecting the leads of medical sensors.
The condition and disposition of the infant in the late stages of labor can give important signals to medical personnel concerning the appropriate steps to safely deliver the baby. In some situations, a continuous readout of the infant's heart rate is provided in the time leading up to birth. By reference to this information, the doctor can make a determination as to whether to go ahead with a particular course of action, or whether specialized procedures are called for.
In one common technique, a fetal electrode, such as the one disclosed in U.S. Pat. No. Re. 28,990, is attached to the fetal epidermis, with a twisted pair of wires leading out to an electrode which is strapped or adhesively attached to the mother's leg or abdomen. The electrical signals from the single electrode on the mother's skin and the two wires from the fetal electrode are then conducted through a cable to an electronic processor, known as a fetal heart rate monitor, which determines the instantaneous heart rate of the fetus based on the inputs of the three electrical signals.
Because it is important that the heart rate information not be interrupted at a critical period in the course of labor, the wire leads from the fetal electrode should be securely attached to the body electrode mounted to the mother. Moreover, for the convenience and comfort of the mother, and the expedient treatment by the medical personnel, the attachment of the leads should not require advanced technical skill and should take little time to complete.
A number of devices which satisfy some of these demands are available on the market. However, many of them employ injection molded parts, solder joints, mechanical attachments, and the like which add to the cost of each unit. Because of the time and expense required to clean or sterilize any medical device, it is particularly desirable that devices which come in close contact with patient body fluids be disposable. Hence a device which would securely retain the leads from the fetal electrode, be easy to apply, and be of low-cost, would be very desirable.
SUMMARY OF THE INVENTION
The leg plate of the present invention is economically produced in a continuous sheet or web converting operation. The device has an electrically insulative polyester substrate with a first contact strip adhered to the underside of the substrate. An electrically conductive hydrogel layer extends beneath the first contact strip and serves to adhesively attach the device to the skin of a mother in labor. The hydrogel also makes electrical contact between the mother's skin and the first contact strip forming a body electrode. The hydrogel layer is covered with a peel away plastic release liner until ready for use. Two contact strips are affixed to the upper surface of the substrate and are spaced from one another sidewardly to be electrically insulated from one another. Two parallel, but non-engaging, regions of electrically conductive adhesive are disposed over the two upper surface contact strips. The adhesive regions are, in turn, covered by resilient foam strips. Prior to use, the front portions of the electrically conductive adhesive regions are kept from adhesive engagement with the foam strips by removable release liners. The device is deployed by removing the release liner from the hydrogel and attaching the device to the inner thigh or lower abdomen of the mother. The twisted wire pair from the fetal electrode is extended from the fetus through the birth canal to the mounted device. The release liners are removed from between the foam strips and the substrate and the foam strips are folded back while the two leads from the fetal electrode wire pair are positioned, one lead on each electrically conductive adhesive region, to thereby independently make contact with a respective contact strip. The foam strips are provided with a downwardly facing adhesive and are pressed downward onto the positioned leads to securely hold the leads in place. The two contact strips on the tipper surface, and the single contact strip on the lower surface of the substrate extend onto the connection tab, uncoated with adhesive, where they are positioned to be received within an electrical connector which extends to a fetal heart rate monitor.
The device is equally suited to receive the fetal electrode leads which have been mounted in a single connector having two axially spaced ring contacts. The foam strips may be provided with indicia which direct the user in properly positioning such a single connector.
It is an object of the present invention to provide a leg plate which is of low-cost.
It is also an object of the present invention to provide a leg plate which can alternatively receive bare leads or a braided wire having a plug type connector with two ring contacts, extending from the fetal electrode.
It is another object of the present invention to provide a leg plate device which may be manufactured in a continuous sheet or web conversion process.
It is an additional object of the present invention to provide a leg plate with connectors which is simple to use, and requires minimal training.
Further objects, features and advantages of the invention will be apparent from the following detailed description when taken in conjunction with the accompanying drawings.
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“Life ♥ Trace™ Disposable Leg Plate”, Medical Products, 189 Van Rensselaer Street, Buffalo, NY 14210, ©1994 Graphic Controls Corporation.
Exhibit A —Photographs and Instruction Sheet on RedyPlate® Disposable Leg Plate, Medical Accessories, Inc., 92 Youngs Rd., Trenton, NJ 08619.
Dvorak Linda C. M.
Lathrop & Clark LLP
Ruddy David M.
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