Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
1999-12-13
2001-06-12
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128S878000, C128S879000
Reexamination Certificate
active
06244271
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of neonatal heath care procedures and devices in that field to facilitate neonatal health care.
BACKGROUND
Newborns often require specialized health care. For instance, it is common in neonatal care wards to use intravenous (“I.V.”) or intraarterial delivery methods to ensure that a sufficient quantity of nourishment or medicines are delivered to the infant. In fact, I.V./intraarterial delivery methods have been successfully incorporated into the accepted care procedures for most hospitals engaged in neonatal care. Equally common are catheter tubes or other monitoring equipment, some with accompanying sensors that are attached to the infant's skin via wires or leads.
Since introducing a neonatal I.V./intraarterial needle, or catheter into an infant is a sensitive procedure that can be traumatic for the infant and the infant's family that happens to be observing the procedure, it is important that an inserted I.V./intraarterial needle or catheter tube remain properly attached once it is correctly introduced into the infant. Properly attached I.V./intraarterial tubing ensures that the administered nourishment or medicine is continuously passed into the infant's veins or arteries. Similarly, a properly attached catheter tube ensures that the infant's waste is properly disposed of and accurately monitored as is sometimes necessary.
If the I.V./intraarterial catheter is dislodged from an infant, it will need to be reintroduced. The I.V./intraarterial catheter tube reintroduction procedure presents a substantial chance that the infant will be traumatized by the discomfort and increases the risk of infection. Moreover, the visual manifestations of the infant's trauma can also be traumatic to the infant's parents and hospital staff.
It is also common to monitor an infant's vital signs using monitoring equipment. The monitoring equipment is often coupled to the infant via wire leads and monitoring sensors that are attached to the infant's skin and provide feedback to the monitoring equipment or intravascular monitoring devices. The monitoring equipment is programmed to alert the hospital staff of abnormalities in the infant's vital signs who will in turn respond with an appropriate health care action and/or procedure. Such actions and/or procedures can often include several members of the hospital staff and require additional costly supplies and therefore be, accordingly, expensive.
One vital sign abnormality that requires an immediate response is an interruption of monitored vital sign input. And regardless of whether the interruption of monitoring is a result of either a health care emergency that requires a particular emergency health care procedure, or is a result of a dislodging of the monitoring sensors, the interruption of monitoring input requires an immediate response and action.
Commonly, it is the infants that tend to grasp and dislodge the, infusion lines, endotrachael tubes, I.V. needles, catheter tubes, or lead wires for monitoring equipment that is in contact with their body. For whatever reason, it is common for newborns to reach for, grasp, and pull on objects that are within reach of their body. Since health care devices such as I.V. tubes, Intraarterial lines, endotrachael tubes, chest tubes, feeding tubes, central lines, catheter tubes, and monitoring leads are among those objects typically within an infants reach, it is common for infants to grasp the tubes or leads of these health care devices. Often times, the pulling force from the infant is sufficient to either cause the complete removal of the I.V. needle, intraarterial catheter, or monitoring leads. Since the complete withdrawal or disorientation of an infant's health care device can be a health risk or at least undesirable, it would be advantageous to reduce the probability that an infant will grasp and remove the lines, tubes, or leads of their health care devices.
Previous inventions, such as disclosed in U.S. Pat. No. 2,693,794 issued to Neville, U.S. Pat. No. 2,744,526 issued to Saylors, and U.S. Pat. No. 4,481,942 issued to Duncan, disclose restraints that can be used to prevent infants from harming themselves. Restraints are, however, considered by some parents to be overly harsh, require a strict adherence to hospital policy and procedure for use, and are therefore used as a last resort for preventing a infant from indirectly causing harm to themselves. Moreover, restraints such as those disclosed in these patents would not completely immobilize the infants arms and could actually augment the likelihood that an infant swinging his arms might dislodge a tube or line of an attached health care device. Finally, the present inventions would be relatively expensive compared to the apparatus proposed for use with the present invention.
Other devices, such as those in U.S. Pat. No. 3,415,244, U.S. Pat. No. Re. 20,858, U.S. Pat. No. 1,984,613, and U.S. Pat. No. 3,476,108, completely encloses the hand. While these inventions can be useful for preventing an infant from grasping and removing the tubes or lines of their health care devices, these inventions block the infant's ability to touch and feel with their fingers thereby preventing any tactile exploration of their environment. Moreover, because these devices completely enclose the infant's hands, visual and tactile circulation assessment is not possible with the devices disclosed in these patents. Finally, some parents might consider such restraining devices an overly harsh manner of preventing infant's from harming themselves.
Finally, inventions in U.S. Pat. No. 3,736,926, U.S. Pat. No. 3,724,456, and U.S. Pat. No. 5,327,918 each discloses structures that occupy the palm area of a wearer. However, none of these devices disclose, or remotely suggest, using the inventions therein to perform the method of the present invention.
Thus, it would be beneficial to have a method of using an apparatus that humanely prevents infants from grasping and removing the lines or tubes of their health care devices. The present invention comprises a method of using a structure to humanely impede infants from grasping, pulling and dislodging the lines, tubes or leads of health care devices that are connected or attached to an infant's body.
SUMMARY OF THE INVENTION
The present invention is useful for humanely preventing infants from grasping and removing health care devices such as I.V./intraarterial lines, chest tubes, endotrachael tubes, feeding tubes, central lines, or catheter tubes and monitoring lead lines that have been introduced or attached to the infant's body. The invention comprises a method of using a grasp-impeding apparatus that has a palm-pad and a strap coupled to the palm-pad that retains the palm-pad in the palm of the infant. The palm-pad provides sufficient resistance to the infant such that a infant's hand cannot fully form a grasping fist.
The novel features that are considered characteristic of the invention are set forth with particularity in the appended claims. The invention itself, however, both as to its structure and its operation together with the additional object and advantages thereof will best be understood from the following description of the preferred embodiment of the present invention when read in conjunction with the accompanying drawings. Unless specifically noted, it is intended that the words and phrases in the specification and claims be given the ordinary and accustomed meaning to those of ordinary skill in the applicable art or arts. If any other meaning is intended, the specification will specifically state that a special meaning is being applied to a word or phrase. Likewise, the use of the words “function” or “means” in the Description of Preferred Embodiments is not intended to indicate a desire to invoke the special provision of 35 U.S.C. §112, paragraph 6 to define the invention. To the contrary, if the provisions of 35 U.S.C. §112, paragraph 6, are sought to be invoked to defin
Turner Deborah A.
Turner Wayne D.
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