News Column

Patent Issued for Method of Attaching Electrode Patches to an Infant

July 7, 2014



By a News Reporter-Staff News Editor at Cardiovascular Week -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventor Huttner, James J. (Sylvania, OH), filed on September 26, 2012, was published online on June 24, 2014 (see also Bionix Development Corporation).

The patent's assignee for patent number 8761858 is Bionix Development Corporation (Toledo, OH).

News editors obtained the following quote from the background information supplied by the inventors: "Many infants, especially premature infants, require hospitalization in an intensive care unit for medical conditions surrounding their birth. Examples of disease conditions requiring such ICU care are sepsis, respiratory distress, low blood sugar, and those requiring surgical intervention, to name just a few. Premature infants are more likely to require intensive care hospitalization than their term counterparts.

"Infants hospitalized in the intensive care setting are monitored closely for heart rate, respiratory rate, pulse oximetry, and other vital signs. Of these, heart rate and respiratory rate are most often monitored using an EKG monitor. An EKG monitor displays heart rate and rhythm by detecting electrical signals coming from an infant's heart. Respiratory rate is displayed, as well, by detecting electrical impedance changes in the infant's chest wall. These electrical signals are picked up by electrodes affixed to the chest wall of the infant.

"Typically, three electrodes are used for routine monitoring purposes. By convention, one electrode is placed over the upper right chest wall, another over the upper left chest wall, and one over the lower left chest wall. However, different electrode placement patterns can provide adequate EKG and respiratory rate detection for monitoring purposes, as long as the current path is sufficiently long to provide sufficient signal amplitude, and as long as convention is followed to produce wave-forms of the correct shape and vector.

"The most critical factors in obtaining a satisfactory EKG tracing are skin resistance and electrode/skin contact. Current EKG electrodes use ionic, conductive materials designed to minimize skin impedance in order to acquire an adequate signal. State of the art electrodes have a highly conductive hydrogel or paste to maximize signal detection. Conductive hydrogels are also adhesive in nature. The hydrogel composition can be manipulated to enhance its adhesive properties to produce a sticky electrode that maintains tight fixation to the patient's chest to minimize noise from chest wall and electrode movement, and to prevent the electrode from detaching and interrupting the signal.

"Other electrodes utilize a non-adhesive conductive paste to reduce skin resistance and detect the EKG signal; most often these electrodes are constructed with the conductive paste portion centered in an adhesive pad that provides for tight adherence to the patient's skin. All-metal EKG electrodes exhibit good conductivity, but must be securely attached to the skin to ensure good signal pickup and minimize motion artifact and detachment. Metal electrodes are usually simply taped to the skin to provide good electrode/skin contact.

"A well recognized problem in the neonatal intensive care unit (NICU) is that often the adhesive nature of electrodes (either sticky hydrogel or adhesive backing) causes significant skin breakdown and injury. This problem is especially severe in the premature infant, whose thin skin is very fragile and subject to trauma. Also, chemical dermatitis caused by the skin adhesive can be unpredictable, leading to contact dermatitis and bullous skin lesions. Placement and removal of EKG electrode patches has been found to be a significant source of skin trauma in these patients; the skin tears and abrasions caused by electrode patch removal cause significant pain, and expose the baby to life threatening infections.

"The current invention is designed to alleviate the problem of skin injury in newborn infants through a novel method of attaching EKG electrodes without the use of adhesive gels or materials."

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventor's summary information for this patent: "The current invention describes novel EKG electrodes, and a novel method of placing EKG electrodes on the newborn infant for the purposes of displaying or recording a cardiac rhythm and or respiratory rate.

"Current convention utilizes three electrodes for routine monitoring purposes in the NICU. By convention, one electrode is placed over the upper right chest wall, another over the upper left chest wall, and one over the lower left chest wall. However, different electrode placement patterns can provide adequate EKG and respiratory rate detection for monitoring purposes, as long as the current path is sufficiently long to provide sufficient signal amplitude, and as long as convention is followed to produce wave-forms of the correct shape and vector.

"Currently available EKG electrodes are constructed using an adhesive material to maintain good skin contact and proper positioning of the EKG patch. The adhesive material may be in the form of an adhesive hydrogel, or may be an adhesive foam or fabric tape material. Low impedance skin contact, essential for proper sensing of the cardiac rhythm and respiratory rate is provided by a conductive hydrogel, gel, or paste that couples the electrode to the skin. The typical construction of an EKG electrode surrounds this conductive medium with the adhesive material, although some use only the adhesive properties of the hydrogel itself to maintain good electrode/skin contact.

"The current invention involves the use of EKG electrodes that have a conductive portion that has the properties of low impedance and high conductivity to adequately detect and transmit the EKG signal, but do not have any skin contact adhesive materials or properties that might cause skin breakdown or injury. The conductive portion may be comprised of non-adhesive conductive pastes, gels, or hydrogels, or may be dry, metalized or conductive carbon electrodes. Alternatively, non-contact, capacitively coupled electrodes may be utilized to detect the EKG signal.

"A problem with non-adhesive EKG electrodes is that they are subject to motion artifact and positional failure (i.e. falling off the chest wall). To prevent these problems and to ensure good electrode/skin contact, the EKG electrodes described in this invention have an adhesive means on their outer, non-skin contact surface. This adhesive means on the outer, non-skin contact surface of the EKG electrodes would adhere to the inner surface of the patient's diaper to serve to keep the electrodes securely in place, while the diaper itself would hold the EKG electrodes firmly against the infant's skin. Such adhesive means might take the form of a standard removable adhesive, or alternatively a low-profile hook-and-loop (Velcro) type material might be used.

"In use, at least two EKG electrodes would be placed in the lower abdominal/inguinal regions--one on the left and one on the right--under the upper portion of the diaper. The adhesive or Velcro-like surface of the EKG electrodes would adhere to the inner surface of the diaper to serve to keep the electrodes securely in place, while diaper itself would hold the EKG electrodes firmly against the infant's skin.

"The third electrode is constructed similarly to the other two, having a skin contact surface with conductive gel or paste, but no skin adhesive properties. The outer, non-skin contact surface of this electrode is designed with an adhesive or Velcro-like surface, and is intended to be held in place by affixing it to the underside of the infant's garment, or wrap. Alternatively, a sash-like strip of non-wicking material may be provided that extends from the front of the diaper, across the infant's shoulder, and down to the back of the diaper. Alternatively, a strip of material fashioned into a wrist or arm-band might be used. The third electrode would then be affixed to the underside of this sash in the area of the right shoulder or under the wrist or arm-band in a manner similar to that used to affix the other two electrodes in the diaper area.

"The three electrodes would be connected in the usual fashion to the NICU monitor unit to display cardiac rhythm and respiratory rate.

"There is also the possibility that an adequate EKG signal tracing could be obtained from only two EKG electrodes instead of the typical three-electrode set-up. In that case, only the two electrodes affixed to the underside of the diaper (as described above) would be needed and used."

For additional information on this patent, see: Huttner, James J.. Method of Attaching Electrode Patches to an Infant. U.S. Patent Number 8761858, filed September 26, 2012, and published online on June 24, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8761858.PN.&OS=PN/8761858RS=PN/8761858

Keywords for this news article include: Cardiology, Premature Birth, Bionix Development Corporation.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Cardiovascular Week


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