Surgery: splint – brace – or bandage – Bandage structure
Reexamination Certificate
2001-09-27
2003-02-25
Lucchesi, Nicholas D. (Department: 3764)
Surgery: splint, brace, or bandage
Bandage structure
C128S126100, C606S201000, C606S202000, C606S203000
Reexamination Certificate
active
06525238
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to the field of healthcare. More particularly, the present invention relates to a DISPOSABLE protective wrap which can be secured to the upper arm of a patient to prevent transfer of pathogens between a blood pressure cuff and the patient, and which is severed or otherwise disabled in the process of removal to assure the wrap is not reused.
BACKGROUND OF THE INVENTION
Transfer of pathogens patients and devices used for medical diagnosis or treatment is both a longstanding and resurgent concern among healthcare professionals. Bacteria such as streptococcus are not only infectious but are increasingly prevalent in forms which are resistant not only to antibiotics but also to antimicrobials of the type relied on to disinfect surfaces. HIV and blood borne pathogens such as HCV (hepatitis-C) may be capable of remaining virulent for significant periods of time after having been deposited, by blood spatter or otherwise, onto surfaces outside the body. Effective prevention of cross-contamination and spread of these and other disease causing agents, particularly in a hospital or other clinical setting, requires scrupulous attention and is crucial to the well being of patients and staff alike.
It has been recognized in the prior art that the inflatable cuffs of the ubiquitous sphygomomanometer or “blood pressure cuff” used for measuring blood pressure have significant potential to serve as a vehicle for inadvertent transfer of pathogens from one person to another. Blood pressure cuffs are traditionally re-used many times in care of multiple patients and do not lend themselves to decontamination. A variety of approaches have been proposed in the prior art to prevent blood pressure cuffs from serving as a vehicle for the transfer of pathogens.
Premature infants have been recognized to be among those at acute risk of becoming infected by pathogens transferred via a sphygmomanometer. Accordingly, disposable sphygmomanometers have been developed and used while these infants are hospitalized. However, disposable sphygmomanometers are expensive and as a result not generally used in the cause of follow-up care after discharge from the hospital.
Another approach has been to manufacture only the cuff portion of the sphygmomanometer, a disposable article. For example, U.S. Pat. No. 5,678,558 to Johnson discloses a disposable blood pressure cuff intended for use only on a single patient. Other examples of disposable cuffs are shown in U.S. Pat. No. 3,473,525 to Hanafin; U.S. Pat. No. 3,757,772 to Goldblat et al. and U.S. Pat. No. 5,396,894 to Eide et al. Though intended to be inexpensive, these disposable cuffs are reasonably complex and would not be a trivial matter to manufacture economically in large numbers. Moreover, most patients have their blood pressure taken at least once and often multiple times during every visit to a physician and often many times during a single hospital stay. Disposal of the entire cuff seems wasteful and would generate a considerable bulk of material whose proper disposal as biohazardous waste would not be inexpensive. Though intended and perhaps even labelled as disposable, the structure of such cuffs does not preclude the possibility of their re-use.
Rather than fabricating the blood pressure sphygmomanometer or its cuff as a disposable article, it has also been proposed in the prior art to provide structurally simpler and less expensive and bulky disposable article to serve as a physical hygienic barrier between the patient and an otherwise conventional blood pressure cuff. Typically, these disposable barriers consist of at least one layer of non-porous plastic sheeting to block the passage of pathogens and body fluids, which may carry them. In some instances one or more layers of a non-woven or other absorbent material is provided on the side of the article which faces the patient in use. Such a layer serves both to improve patient comfort and to absorb and retain blood or sweat thus reducing the possibility of contaminant leakage. Various forms of such protective barriers are known in the prior art.
U.S. Pat. No. 5,669,390 to McCormick et al. discloses a disposable protective barrier in the form of a tubular sleeve of fluid impervious material into which the arm of the patient is inserted to above the elbow. Once the sleeve is in place, the blood pressure cuff can be applied over the lower end of the sleeve in the usual way. Afterward, the upper end of the tubular sleeve is then drawn down over the cuff to cover it prior to use. Although tubular sleeves of this type would be relatively simple to manufacture, applying them to the arm of an unconscious or struggling patient might be difficult and relatively slow. These drawbacks could be particularly problematic in an emergency setting in which even a few seconds delay could be critical to the well being of the patient.
Rather than a tubular sleeve, certain types of protective barriers in the form of a sheet of material, which wraps around the upper arm and is affixed there by detachable fasteners are also known in the prior art. For example, U.S. Pat. No. 5,513,643 to Suite shows a protective wrap in the form of a sheet having a layer of polyethylene or other non-porous material which may be overlaid with a liquid absorbing layer to be deposed facing the skin of the patient for comfort and absorbing blood or other contaminants. Mating strips of hook and loop type fastener material are disposed near opposite ends of the sheet on opposing faces of the sheet. These strips are fastened together when the sheet is wrapped around the upper arm. After the wrap is secured to the arm of the patient, a blood pressure cuff is applied over the sheet and a blood pressure reading taken in the conventional way. Once the reading is completed, the blood pressure cuff is removed and the sheet is removed by detaching the hook and loop fasteners and unwrapping it.
Protective barriers of the wrap around type just described are easy to apply even to an unconscious or uncooperative patient and are capable of providing an effective barrier to pathogens. However, though they may be manufactured in a disposable or single use form and perhaps even labeled such and provided with instructions for single use, the physical structure of these articles provides no affirmative assurance that they will not be re-used and thus rendered ineffective for their intended hygienic purpose. Since the fasteners associated with all prior art wrap around barriers for use under a blood pressure cuff of which Applicant is aware can be fastened and unfastened as many times as desired. The sleeve type barriers and “disposable” cuffs described above suffer from the same drawback. Their physical structures do not preclude the possibility of their re-use. As a result these devices may become vehicles for the transfer of pathogens from one person to another.
Since even disposable articles can be costly, especially when used in large numbers, a financial incentive to re-use such articles may exist if re-use is possible. There is also a possibility that re-use could occur inadvertently especially in a trauma center or hospital emergency room where several patients are typically under the care of overlapping or different teams of health care specialists working simultaneously in relatively small treatment areas.
Accordingly, there is a need for a protective wrap for use with a blood pressure cuff which is not only effective as a barrier to pathogens, but also provides assurance that the wrap cannot be used again once it has been used on a single occasion.
There is also a need for a protective wrap which not only provides an effective pathogen barrier and can be used only once but which is also able to be applied and removed from a patient quickly and easily.
There also exists a need for a single-use protective wrap which not only provides all of the characteristics just mentioned, but which may also include a layer of absorbent material to enhance patient comfort as well as to absorb blood or other fluids which might otherwi
Hamilton Lalita M.
Holland & Knight LLP
Lucchesi Nicholas D.
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