Patent Application
20080236596
The present invention pertains to an infection control device for a pressure cuff. In particular, the present invention pertains to a cuff shield that attaches to an inner surface of a pressure cuff to reduce the spread of biological contaminants between patients.
Toxic shock syndrome, flesh eating bacteria and the bird flu have all created an acute awareness, if not outright panic, regarding the world of infectious diseases. Whether or not this panic is warranted, prevention and treatment of infections and infectious diseases are major concerns for the healthcare industry.
Nosocomial infections, infections that originate in hospitals or health care settings, have been an issue ever since Ignaz Semmelweis discovered in the 1840's that the lack of hand washing lead to a high mortality rate in postpartum women. Since then there has been significant progress, especially in the last 30 years, in the prevention of nosocomial infections. In 1976 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) published standards for infection control and in 1985 the Center for Disease Control and Prevention (CDC) reported that hospitals with infection control programs had reduced nosocomial infections by one third. Since then, however, the nosocomial infection rate has remained fairly stable at 5 to 6 hospital acquired infections for every 100 hospitalizations as estimated by the CDC's National Nosocomial Infection Surveillance system (NNIS). It is estimated that nosocomial infections cost approximately $4.5 billion and contribute to 88,000 deaths per year, or 1 death every 6 minutes.
Recent research has found that potentially harmful bacteria can be cultured from many surfaces in hospital environments, from computer keyboards to neckties. Medical devices, however, including pressure cuffs, are of particular concern because they regularly come into contact with patients, often without cleaning or some sort of infection control procedure when used from patient to patient. In addition, the health of patients in a hospital or clinic setting is typically already compromised, thereby placing them at further risk for nosocomial infections.
Based on the foregoing, an infection control means should be an integral part of pressure cuffs used in skin perfusion pressure systems. Just as a surgeon would not perform surgery without sterile gloves, healthcare providers should not use a pressure cuff when determining skin perfusion pressure without first using some sort of infection control device. In an effort to lower the nosocomial infection rate to the lowest possible level, infection control precautions are essential.
The prior art includes infection control means attempting to address the problem of transmitting nosocomial infections via pressure cuffs. In particular, single use pressure cuff liners were developed that are temporarily attached to the inner surface of the cuff before being placed on a measurement site of a patient. Also, more complex cuff protectors are found in the prior art. Even with the awareness of the need for a protective measure, the use of these liners or protectors is not widespread. The two main reasons are cost and cumbersome application. Many cuff protectors cover the entirety of the cuff, require a large amount of material, and generally include a fastening means to replace that found on the cuff itself.
Conventional cuff liners are not user friendly and result in waste requiring disposal prior to application of the cuff shield to the cuff. In particular, the adhesive surface on the cuff shield includes a “peel-off” protective strip that covers the adhesive layer until the physician is ready to apply the cuff shield to the pressure cuff. When the physician is ready to take a skin perfusion pressure reading, the cuff shield must be grasped with one hand and the protective strip removed with the other hand, thus resulting in wasted time and, moreover, the protective strip then requires disposal. Other methods may require folding, multiple components, and/or insertion of the cuff into the protector. Accordingly, there exists a need for an infection control device that can be obtained and used quickly and easily, with minimal waste, while providing complete protection of the entire (patient) contact surface of the pressure cuff.
The present invention solves the foregoing problems by providing a cuff shield for a pressure cuff comprising a liquid impervious layer and an absorbent layer. The liquid impervious layer includes an outer surface and an inner surface. The outer surface of the liquid impervious layer has an adhesive portion for removably securing the cuff shield to the pressure cuff. The absorbent layer is secured to the liquid impervious layer and includes an outer surface, an inner surface, and a release strip on the outer surface of the absorbent layer. The release strip on the absorbent layer is configured to serve as a protective cover for an adhesive portion on a second cuff shield.
An alternate embodiment of the invention is comprised of a liquid impervious layer and an absorbent having openings formed therethrough. The absorbent layer has a release strip on an outer surface. The release strip includes an adhesive portion on an inner surface that is exposed through the openings in the absorbent and impervious layers for removably securing the cuff shield to the pressure cuff. An outer surface of the release strip is configured to serve as a protective cover for the exposed adhesive portion on a second cuff shield.
The present invention also provides a method for applying the cuff shield to the pressure cuff. The method generally includes: providing a dispenser roll having a plurality of cuff shields wound around a core; removing one of the cuff shields from the dispenser roll; aligning the removed cuff shield with an inner surface of the pressure cuff; and attaching the adhesive portion of the liquid impervious layer of the removed cuff shield to the inner surface of the pressure cuff (such that is does not interfere with the cuff fastening means).
Referring to
Cuff shield 16 is disposed between the skin of the patient's limb 21 and an interior surface of pressure cuff 14. In particular, and as will be discussed in more detail to follow, cuff shield 16 is designed to be temporarily attached to pressure cuff 14 in order to avoid direct contact between the patient's skin and pressure cuff 14. As a result, the risk of transmitting various infections between patients is minimized.
Cuff shield 16 of the present invention may be particularly useful, for example, in conjunction with a pressure system such as that described in U.S. patent application Ser. No. 11/468,203, filed Aug. 29, 2006, the entirety of which is hereby incorporated by reference. However, it will be obvious to one skilled in the art that cuff shield 16 may be used with numerous other types of pressure systems and pressure cuffs.
Now that a general overview of one embodiment of a system that takes a measurement using a cuff has been provided, the focus of the discussion will now shift to the inventive design of cuff shield 16. In particular,
First layer 30 is preferably formed from a liquid impervious material that prevents fluids from penetrating through the layer. The liquid impervious material may be, for example, a polymer film, although numerous other materials that form a barrier to liquids are also contemplated. Second layer 32 is preferably formed from an absorbent material capable of absorbing and/or wicking away moisture from the patient's skin. The absorbent material may be, for example, a non-woven web, although numerous other materials that have absorbent and/or wicking properties are also contemplated. In addition, second layer 32 may include a plurality of silver fibers disposed within the absorbent material for use as an anti-microbial agent.
Cuff shield 16 is designed to act as a barrier such that moisture on the patient's skin may be absorbed by second layer 32 without penetrating through first layer 30. This type of barrier is effective to minimize the possibility that harmful biological contaminants and bacteria on a patient's body may be transferred to an inner surface of pressure cuff 14, and subsequently, to the body of another patient.
As shown in
As shown in
Prior to applying pressure cuff 14 to the patient's limb, cuff shield 16 is first removed from a cuff shield dispenser as will be described in more detail in subsequent paragraphs. In order to temporarily secure the removable cuff shield 16 to pressure cuff 14, outer surface 38 of first layer 30 is first positioned at a desired cuff location with respect to inner surface 56 of pressure cuff 14. Then, adhesive portion 34 on outer surface 38 of first layer 30 is pressed against inner surface 56 of pressure cuff 14 to temporarily adhere cuff shield 16 to pressure cuff 14. Next, the physician wraps pressure cuff 14 around the patient's limb and couples first fastening means 60 to second fastening means 62 as illustrated in
A first set of edge markers 64A and 64B are configured to align with first outer edge 72 of pressure cuff 14, while a second set of edge markers 64C and 64D are configured to align with second outer edge 74 of the pressure cuff. Although one skilled in the art will appreciate that it may be possible to align cuff shield 16 with both first and second outer edges 72 and 74 of pressure cuff 14 with only one set of edge markers, having both first and second sets of edge markers may make the task of aligning cuff shield 16 both easier and faster for the physician. However, it should be understood that embodiments of cuff shield 16 that include only one set of edge markers are contemplated and within the intended scope of the present invention.
One skilled in the art will also appreciate that although the foregoing discussion focused on “sets” of edge markers, a single edge marker may be used to properly position and align cuff shield 16 with an outer edge of pressure cuff 14. For example, a single edge marker 64A may be sufficient to align cuff shield 16 with first outer edge 72 of pressure cuff 14. However, having multiple edge markers near opposing corners of first outer edge 68 of cuff shield 16 (i.e., edge markers 64A and 64B) helps the physician to ensure that first outer edge 68 of cuff shield 16 is substantially parallel with first outer edge 72 of pressure cuff 14 across the entire length of the cuff shield. As a result, the possibility that the physician will apply cuff shield 16 to pressure cuff 14 in a “crooked” fashion (i.e., wherein first outer edge 68 of cuff shield 16 is not substantially parallel with first outer edge 72 of pressure cuff 14) is greatly reduced.
Therefore, while it is desirable to have an edge marker near each corner of second layer 32 for many reasons, including those stated above, such a configuration is not necessary to achieve proper placement of cuff shield 16 at the desired location with respect to pressure cuff 14. Thus, embodiments of cuff shield 16 that include a larger or smaller number of edge markers, as well as edge markers placed at various other locations on second layer 32 of the cuff shield, are also contemplated.
Edge markers 64A-64D are shown in
As shown in
Sensor marker 66 is designed to align with sensor 12 after sensor 12 is positioned on the patient's limb as discussed above in reference to
Dispenser roll 80 is designed such that the adhesive portion of a cuff shield on a first layer is protected by the release strip on a cuff shield in a second layer adjacent to the first layer. As shown in
As shown in
The cuff shields forming the successively stacked layers 84 of dispenser roll 80 are shown without edge markers 64 or sensor marker 66 for purposes of example and not for limitation. Therefore, it should be understood that dispenser roll 80 may alternatively include cuff shields having either edge markers 64, sensor marker 66, or both. Furthermore, although not depicted in
Once again, cuff shields 216A-216H are shown without edge markers 64 or sensor marker 66 for purposes of example and not for limitation. Therefore, it should be understood that dispensing means 90 may alternatively include cuff shields having either edge markers 64, sensor marker 66, or both. In addition, although dispensing means 90 is depicted as including eight cuff shields stacked on top of base 92, dispensing means 90 may include any number of cuff shields without departing from the intended scope of the present invention. One skilled in the art will also appreciate that although cuff shields 216A-216H have a design similar to that of cuff shield 16, dispenser means 90 may alternatively be formed using other cuff shield designs, such as cuff shield 16A shown and described in reference to FIGS. 5 and 6.The cuff shield embodiments in the foregoing figures were shown and described with reference to a pressure cuff for a perfusion pressure monitoring system for purposes of example only. One skilled in the art will appreciate that cuff shields in accordance with the present invention may be used as protective barriers with other types of pressure cuffs such as, for example, sphygmomanometer cuffs.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.
