Surgery – Respiratory method or device – Means for supplying respiratory gas under positive pressure
Reexamination Certificate
1999-07-12
2002-04-09
Sykes, Angela D. (Department: 3763)
Surgery
Respiratory method or device
Means for supplying respiratory gas under positive pressure
C128SDIG008, C248S124100, C248S125800, C248S345000, C135S121000
Reexamination Certificate
active
06367476
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to a support apparatus for a medical canopy and medical tubes, and more particularly, to such a support apparatus for use with an incubator/isolette bed and/or warming bed for a premature baby.
BACKGROUND OF THE INVENTION
Medical patients occasionally have the need for a generally transparent canopy positioned over them to provide a sterile environment to protect them from potentially infectious airborne agents and to provide a controlled environment with temperature, moisture, oxygen, and like conditions best suited for patient skin and respiratory system treatment, function, and support. Such canopies are especially common for use with premature babies and other persons in serious condition. In such uses, canopies may be flexible or rigid and are typically provided with two openings, one for accepting standard sized tubes for providing the heat, moisture, and/or oxygen as is needed in a given situation and another opening for the exhaust of carbon dioxide produced by the respiring patient.
There are several situations in which it is extremely beneficial for a premature infant to be placed in a controlled environment under such a canopy. Infants commonly suffer from respiratory inflammations and/or maladies such as a sore throat, croup, and the like. In such cases, moisture may be provided in cooled or heated air through tubing and into the space formed under the canopy as desired to treat a given condition.
Another situation where a canopy is commonly employed is to provide oxygen therapy to an infant where there is a need for upper or lower respiratory support. In this situation, oxygen rich air is provided through the tubing to obtain and maintain the desired level of oxygen content in the air under the canopy. This method of oxygen therapy is preferable to the common alternative of using a mask covering the infant's mouth and/or nose.
An additional common alternate is to provide nasal cannula inserted into the infant's nose. This therapy is problematic, however, in that it tends to dry the mucus membranes of the nose even when providing humidified air through the cannula.
The method of creating an oxygen rich airspace under a canopy is preferable to the two alternatives just described because no uncomfortable tubes or mask are needed. The disadvantage to the oxygen rich environment method, however, is that the oxygen level of the air under the canopy fluctuates whenever the canopy is removed and reinstalled, or even merely disturbed, causing potentially severe physical distress to the premature infant. Conventional canopies must be removed for many routine matters requiring access to the infant such as examinations, repositioning blankets, pacifiers, and other comfort measures, and for any emergency situation.
Additionally, very low birth weight infants often experience a high degree of insensible water loss and heat loss as they have difficulty generating and maintaining adequate body heat because of their extremely small size and underdeveloped bodily systems. In such cases, heat and moisture may be provided through the tubing into the space under the canopy to create and maintain the desired temperature and humidity levels. However, removing and reinstalling the canopy causes fluctuations in the temperature and humidity of the air therein which can be distressful to the infant, as is the case with fluctuations in the oxygen level.
It is a common practice to place an infant under a canopy with controlled heat and moisture therein and with cannula tubes inserted into the infant's lungs for oxygen therapy. Furthermore, there are other situations where infants and other medical patients commonly have tubes inserted into them, such as cannula tubes for draining fluids, intravenous tubes for supplying medication or nourishment directly into the blood, and the like. Such tubes are sometimes attached to a frame to secure the tubes in place and prevent entanglement and/or dislodgment caused by movement of the patient. It is therefore desirable in certain situations, particularly in the care of premature infants, to have available a flexible canopy support apparatus that also provides a tube support structure. While several known canopy support devices and several known tube support devices provide certain benefits, there remain a number of deficiencies in the art as discussed hereinbelow.
There are several known apparatus for supporting a drape over a medical patient. U.S. Pat. No. 3,530,515 to Jacoby provides a patient guard for use during surgery having an adjustable support loop for surgical protective sheeting and tubing. U.S. Pat. No. 4,377,112 to Whitt provides a surgical breathing apparatus having an adjustable support frame for surgical drapes and oxygen supply tubing. U.S. Pat. No. 4,321,917 to Campbell provides a surgical drape support and oxygen supply device having an adjustable support rod for a surgical drape and tubing. These apparatus are provided for use during surgery, generally on adults, and accordingly have specific mounting requirements for the supports and/or for attachment of oxygen lines or the like, and are not well-suited for use with a premature baby in an incubator bed or warming bed.
Also, there is a known pediatric aerosol tent provided by Ohmeda, Inc., providing a tent having access openings and supported by a tent support arm mounted on a stand. A cooling and moisture system is also provided and connected to the tent by tubing. This apparatus has several disadvantages with regards to use with premature infants. The tent support arm is stationary, such that for use with a warming bed, when the tent is moved away to one end of the tent support arm the arm can be an obstruction to doctor and/or nurses leaning over and attending to the infant. In practice, therefore, the entire apparatus is generally moved away to the side in order to access the infant. Additionally, the apparatus does not provide a support for cannula tubing. Furthermore, this apparatus is specifically designed for a large infant bed or crib for larger and more developed infants and is too large to use for newborn infants, as many may be very small, and which is especially disadvantageous for use in neonatal wards which may not be able to accommodate the larger beds. Because of the large size of the stand and support arm, the unit will not fit into and thus can not be used in conjunction with a conventional incubator or warming bed as used in neonatal wards. This lack of flexibility is a significant limitation to more widespread use of the apparatus.
There are also known tents, hoods, and canopies provided by Nova Health Systems, Inc., having rigid cuboidal shapes with built-in support frames. These framed canopies have several disadvantages. They provide a rigid frame with a fixed top and sides, generally having only one side that provides access to the infant. Because of the fixed sides, they are not adjustable and they provide only limited access to the infant when covered by the canopy. Because of the lack of adjustability of the rigid framed apparatus of Nova Health Systems, Inc., neonatal units generally must either stock a number of different sizes of the units to accommodate for small and large babies, or stock only one size which will then only cover a larger infants head and not its torso and lower body. Where units of multiple sizes are stocked, this disadvantage is compounded because these are single patient units discarded after being used by one infant, such that an entire new unit having a canopy and frame must be purchased for each infant instead of just a new canopy. Where only one size is stocked, the aforementioned disadvantage is compounded because the larger of these units do not fit easily inside conventional incubator beds, and the smaller of these units can not be used with many of the currently available tube supports commonly placed inside the canopy, as will be discussed in more detail hereinafter.
The aforementioned disadvantage of limited access to the infant results in diffi
Bernstein Jason A.
Berstein & Associates, P.C.
Sykes Angela D.
Thissell Jeremy
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