Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-06-11
2002-12-03
Coggins, Wynn Wood (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S019000, C604S289000, C604S310000, C401S205000, C401S132000
Reexamination Certificate
active
06488665
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to antimicrobial pre-operative skin-preparation delivery systems and more specifically, the present invention relates to antimicrobial, such as povidone iodine (PVP-I), alcohol pre-operative antimicrobial skin-prepataions in a gel form and delivery devices for the skin-preparations.
BACKGROUND OF THE INVENTION
Standard surgical procedures require the surgical site to be disinfected prior to surgery. Effective pre-operative cleansing of the surgical site is critical to reducing the risk of infection to the patient. Pre-operative skin preparation is therefore as important as the prophylactic antibiotic treatment in control of infection.
Microorganisms on the skin can be transient or resident. Transient microorganisms lie on the surface of the skin, while resident microorganisms are found at deeper sites in the skin, for example, in skin hair follicles. During pre-operative procedures it is desirable to initially kill the microorganisms relatively quickly to reduce the length of time to prepare the patient for surgery. It is also important that the antimicrobial activity can be sustained throughout the surgical procedure by the skin-preparation.
Iodophore has been widely used as a disinfectant and as a pre-operative skin preparation. Pre-operative skin-preparation liquid solutions such as PVP-I scrub and paint solutions are commonly used to disinfect the surgical site prior to surgery. Liquid pre-operative skin-preparations have been stored in liquid containers and dispensed from the liquid containers for application to the surgical site. Existing iodophore skin-preparation solutions typically include iodine, surfactant and a buffer system to provide appropriate pH in an aqueous system. The solutions typically contain an active ingredient of 7.5% to 10.0% povidone iodine. These concentrations of iodine are desirable to provide effective and extended killing of microorganisms.
The conventional method of application of a skin-preparation is to pour bottled skin scrub (7.5% PVP-I) onto a tray, dip a dry sponge into the skin-preparation and apply the soaked sponge to the surface of skin. The skin-preparation is applied from the center to the peripheral areas of the skin site with a circular motion for two to five (2-5) minutes. The sponge provides a physical force to spread the skin-preparation evenly and to remove dead skin cells and skin debris to help the delivery of the skin-preparation to the exposed bacteria. The site is then blotted dry and a skin-preparation paint (10% PVP-I) is applied to the site for two (2) minutes. Conventional skin-preparation systems include several parts and are rather cumbersome to handle. An improved skin-preparation delivery system which does not require the conventional multi-step operation and which requires a shorter time of application is highly desirable and will improve the efficiency and reduce waste.
One existing skin-preparation applicator includes a rigid plastic outer bottle and an applicator head having a sponge. A breakable glass ampule is contained within the rigid plastic bottle. The sealed glass ampule contains a liquid skin-preparation prior to use. The applicator is used by fracturing the glass ampule which releases the liquid skin-preparation. The applicator is tilted to point the applicator head downward such that the liquid skin-preparation travels from the fractured glass ampule to the applicator head. Flow control of the liquid skin-preparation is obtained by varying the amount of tilt of the applicator, and also to some degree, the sponge on the head of the applicator controls the liquid flow rate. A filter screen is provided at the applicator head to trap broken glass from the fractured ampule.
Aqueous iodophore skin-preparations tend to run on the patient's body to areas that don't require disinfection, for example, between the patient and the operating table, and may accumulate on those undesired areas where the iodine can cause skin irritation in certain patients. Gel has been added to povidone iodine to reduce running of the skin-preparation. It provides a film texture allowing the antimicrobial to localize at the desirable surgical incision site without reducing the thickness of iodine from the site. Typically, the iodine content of the gel form is about 10.0% w/v or the effect of antimicrobial activity would not be prominent. Povidone iodine containing gel has been stored in containers; however, such containers have not been designed for holding and effectively delivering the povidone iodine gel to a surgical site. In addition, it is desirable if the applicator can be designed such that the skin-preparation flow rate can be controlled to prevent free flow, particularly for liquid skin-preparations.
Although iodine gel provides the advantage as described, it kills microorganisms at a relative slower rate than other antimicrobial agents such as alcohol. Alcohol has long been recognized as a disinfectant which reduces bacteria, fungi, and some viruses at a great speed. However, alcohol alone evaporate quickly. The disinfection action of alcohol does not continue once the alcohol evaporates from the skin. Accordingly, alcohol alone lacks the prolonged ability to disinfect the surgical site.
Various existing containers have been used to store and dispense liquid products, for example, liquid products such as skin-preparation solutions. However, such liquid containers have not been designed for safely storing and effectively delivering antimicrobial alcohol gel skin-preparations. It is desirable to protect pre-operative skin-preparations from contamination while being stored in a container. Also, liquid dispensers typically restrict the flow of the liquid to reduce excessive or uncontrolled dispensing of the liquid. Such liquid dispensers may not adequately protect or provide adequate flow of gels because of the container structure and the different flow characteristics of gels compared to liquids. Furthermore, some existing containers and dispensers have relatively complex constructions which may require numerous components that can result in increased manufacturing costs.
The present invention beneficially provides antimicrobial gel skin-preparation delivery systems which hold and dispense antimicrobial alcohol gel skin-preparations. The delivery systems are capable of being manufactured and shipped with the skin-preparation protectively sealed within a flexible container while providing quick and easy penetration of the seal to open the container for delivery of the skin-preparation.
The present invention by adding alcohol to iodine gel provides further benefits of a rapid and sustained antimicrobial activity, localization of skin preparation by forming a film on the skin, and a single-step of shortened time period application. The invention also provides an opportunity to lower iodine concentration requirement thus reducing the incidence of irritation of certain patients. All these characteristics, in combination, are not described in the precedent skin-preparations or storage and delivery systems.
SUMMARY OF THE INVENTION
The present invention provides antimicrobial alcohol gel pre-operative skin-preparation delivery systems for storing and delivering skin-preparations. The skin-preparation delivery systems are easily, efficiently and cost effectively manufacturable and reliably store and deliver antimicrobial alcohol gel formulations. The antimicrobial alcohol gel formulation is protectively sealed within a flexible container until use of the formulation is desired. A gel formulation dispenser is activated to allow delivery of the antimicrobial alcohol gel formulation from the container to a desired site.
The opening to the container is induction sealed with an aluminum foil seal which provides a gas impermeable seal. The gel formulation dispenser has a shoulder hat abuts the sealed edge of the container. The shoulder provides additional integrity nd tightness to the seal between the aluminum foil and the edge of the opening to the container. The
Childers David A.
Jeng David K.
Severin Jane E.
Wilson Bruce H.
Allegiance Corporation
Coggins Wynn Wood
Maynard Jennifer
Nickey Donald O.
Rozycki Andrew G.
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