Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
1999-01-22
2002-07-16
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Bandage structure
C604S378000, C604S385010, C428S167000, C428S212000, C428S213000, C428S913000
Reexamination Certificate
active
06420622
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to articles that have the capability to control or transport fluids, especially biological fluids. In one embodiment this invention relates to medical wound dressings and drains and intravenous access site
BACKGROUND OF THE INVENTION
The control and/or transport of biological fluids poses many problems at different stages in treatment or diagnosis processes. During surgery, steps are undertaken in an effort to control and/or transport the fluids which result from the surgery. In some instances these fluids are needed to be recycled back to the patient. For example, vital blood lost from the patient may be returned in emergency situations. In other instances fluids are needed to be controlled so that an aseptic and safe operating room environment is maintained. It is often times desired, for example, to avoid spillage of fluids onto the operating room floor where it would create an unsafe situation and mess. After surgery, the need to control and/or transport fluids remains. For example, wound exudate can pose problems in the treatment and care of the wound site and needs to be handled. Also, the delivery of fluid medicaments to a wound site can present challenges.
Several surgical drapes and pouches have been designed in an attempt to control fluids generated during surgery. Many of these devices utilize absorbent padding or plastic pouches to collect the fluid. In many situations, however, there does not exist enough room at the site where the fluid is emanating from to adequately control the fluid.
Suction tubes, optionally connected to a central vacuum line or remote vacuum source, may also be employed to collect fluids from a wound site. These tubes have a significant number of limitations which inhibit the desired management of the fluid. For example, post operative wound drain tubes create significant patient discomfort and can be a source of infection. Furthermore, many wounds require multiple drain tubes.
In the treatment of many wounds it is beneficial to keep the wound moist while removing excess exudate. This environment provides an optimum wound healing environment, reduces pain, and provides an environment for autolytic debridement and re-epilethlialization. Excess fluid, however, can lead to problems such as maceration (skin breakdown) and microbial infection of the wound site. For this reason, many wound dressings are sometimes designed to have absorbent pads and/or high moisture vapor transmission rates (hereinafter “MVTR”), i.e. the excess fluid is allowed to transmit or evaporate through the wound dressing.
Fluid can be a particular problem when dealing with highly exuding wounds, IV sites, as well as sites for gatric (G), jejunostomy (J) and nasal gastric (NG) tubes. For example, many commercially available intravenous access site dressings (hereinafter “I.V. Dressings”) do not have sufficient MVTR to permit rapid evaporation of moisture through the dressing. Consequently, in some instances this can result in fluid pockets forming beneath the dressing around the puncture site. This fluid can result in one or more problems such as “bandage lift” (which reduces the ability of the bandage to secure the IV line to the skin), skin maceration, or bacterial infection.
A stated advantage to certain of these dressings is transparency of part or all of the dressing. This allows for direct visual observation of the wound healing progress. For example, thin film adhesive coated dressing having a site revealing “window” surrounded by an absorbent such as a hydrocolloid have been tried. Unfortunately, however, these dressings require that the “window” be relatively small to ensure that the fluid be in sufficient direct contact with the absorbent to prevent fluid build up. Even so, these small dressings may not absorb fluid rapidly enough to prevent fluid build up around the IV puncture site.
Alternatively, attempts have been made to place a gauze absorbent or an “island dressing” (i.e., a dressing having an “island” of absorbent fabric or hydrophilic foam contained therein) directly over the wound. Island dressings are able rapidly to absorb fairly high amounts of wound exudate and, therefore, are useful for highly exuding wounds. Unfortunately, however, the presence of the absorbent directly over the wound prevents visual observation of wound healing. Finally, certain transparent hydrocolloid dressings are also available that absorb the fluid into a polymeric matrix. These dressings can absorb large volumes of fluid but generally the absorption is not very rapid and hydrocolloids tend to break down in the wound.
Drug delivery dressings have been developed that contain a reservoir of a suitable medicament. The reservoir is placed in contact with the skin and the medicament is allowed or assisted to permeate the skin. Unfortunately, the amount of drug contained within the dressing is limited for a particular size of dressing and these dressings do not have a capability to be recharged from a remote reservoir. Many of these dressings are not suitable for application over open wounds. For example, many transdermal drug delivery devices rely on the barrier provided by the dermis to regulate drug delivery rate.
Otitis media, inflammation of the middle ear, accounts for more visits to pediatricians than any other illness. Otitis media is generally regarded as a complication of eustachian tube dysfunction. The normal eustachian tube is closed, except during swallowing, when it allows pressure equalization between the middle ear and nasopharynx. When it does not close properly, due to inflammation due to a cold, for example, the eustachian tube can act as a conduit for movement of bacteria into the middle ear from the nose. Gram-positive microorganisms, most prevalently
S. pneumoniae
and
S. pyogenes
, constitute the bacterial origin of otitis media. Furthermore, if the eustachian tubes are subsequently blocked so that negative pressure develops inside the middle ear, serum may leave the blood vessels in the middle ear under hydrostatic pressure and accumulate there, a condition known as otitis media with effusion.
Treatment of otitis media involves observation and antibiotic therapy, and for infections that persist, surgical placement of ear tubes. Antibiotic treatment of otitis media involves systemic administration of antibiotics such as amoxicillin. Increasingly, the use of antibiotic therapy for treatment of this disease is coming into question due to knowledge that widespread use of antibiotics allows for selection of resistant strains of bacteria. However, most physicians continue to prescribe antibiotics because it is difficult to predict which patients will get well without treatment and which will proceed to chronic otitis media and potentially fatal sequelae such as meningitis.
Installation of ear tubes is another treatment for otitis media. The tubes are grommets that are placed in the tympanic membrane so that a ventilation hole is maintained for fluid to escape from the middle ear. Occasionally, ear tubes are removed by the surgeon after the infection has cleared. More frequently, the ear tubes fall out of the ear after the infection has resolved. In either case, the tympanic membrane usually (in 60-70% of cases) heals with little or no hearing dysfunction. An unresolved problem with current ear tube designs is that they may fall out before the ear infection has resolved; this occurs in up to 25% of cases, increasing total cost of treating otitis media.
Suction tubes have been used in dentistry to help control and remove fluids from the oral cavity. Generally these tubes are pretty simple devices. Unfortunately, however, the tubes in use suffer from some drawbacks. First, they can be very noisy, causing the patient, dentist and/or assistant to become agitated or annoyed. Second, they generally suck fluid from only one point in the cavity. To remove fluid from other areas the tube must be manually repositioned. Moreover, positioning the tube into small openings or isolating individual teeth or regions is precluded. Add
Heinecke Steven B.
Hentzen Charles A.
Johnston Raymond P.
Scholz Matthew T.
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