Surgical prep solution dispenser and method

Surgery – Swab including handle with absorbent material at end thereof – Body treating material fed to absorbent material

Reexamination Certificate

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Details

C118S266000, C118S270000, C401S152000, C206S361000

Reexamination Certificate

active

06248085

ABSTRACT:

TECHNICAL FIELD
The invention relates generally to the application of surgical prepping solutions to the body, and more specifically to an apparatus and method for dispensing the solution into an applicator in a controlled manner.
BACKGROUND OF THE INVENTION
Antiseptic preparation of patients for surgery conventionally includes a 3-10 minute scrubbing of the affected area with an antimicrobial soap solution followed by the application of a water-soluble antiseptic paint solution. The solutions are conventionally applied with saturated gauze or sponges that are attached to a handle or held with forceps. The sponges are saturated by soaking in open pans of solution.
This procedure has the drawback that the solution can drip and pool unseen in locations hidden by the patient's body. Pooling of the antimicrobial solution can result in skin irritation and even chemical bums if strong iodine solutions are employed. Furthermore, it is desirable to prevent pooling of flammable antiseptics, such as those based on alcohol/water solutions.
One way of dealing with this drawback is to provide the solution in a sealed ampoule within an applicator. For example, co-assigned U.S. Pat. No. 5,658,084 “Liquid applicator with frangible ampoule and support” describes such an applicator. While providing clean and efficient dispensing, such an applicator is somewhat expensive to provide.
A less expensive expedient is to provide an applicator having a sponge and a handle within a sealed pouch that also contains a free quantity of prepping solution. For example, the E-Z Preps product commercially available from Becton Dickinson and Company, Franklin Lakes, N.J., provides two eight-inch sponge sticks immersed in Povidone-iodine topical solution. The sponges are supplied presaturated with excess solution that distributes freely within the pouch, completely coating the handle. Therefore, these applicators are messy to use in practice.
SUMMARY OF THE INVENTION
This invention provides a kit or apparatus for applying surgical prepping solution to a patient. The invention facilitates loading an inexpensive applicator with an adequate, but substantially dripless dose of solution immediately before use from a liquid container. Preferably, the liquid container is a bulk container holding multiple doses of solution, e.g., at least 10 and preferably at least 20 doses.
Liquid loading is controlled by filling a resilient porous applicator pad in a semi-compressed state. As the applicator pad is removed it expands ensuring that the antimicrobial solution occupies no more than the saturation level of the pad in order to minimize dripping. Alternatively, the applicator pad could be filled in the applicator in a non-compressed state and pulled or pushed through a narrow opening that compresses to wring or squeeze excess solution from the pad. It is preferred that the applicator pad be resilient to allow for compression and subsequent expansion. In this manner, by controlling the amount of compression the amount of liquid impregnated into the applicator pad may be precisely controlled for any given substrate material.
The pad contracts and expands between a compressed or semi-compressed state and an uncompressed state, and the pad is capable of holding more surgical prepping solution in its uncompressed state than in its compressed or semi-compressed state. Surgical prepping solution may saturate the pad in its compressed or semi-compressed state, but will be held by the pad at less than a saturation level when the pad is not compressed.
Generally, a kit of the invention comprises an applicator having a resilient, porous pad attached to a handle, a bottle for a surgical prepping solution, and a receptacle attached to the bottle. The receptacle defines an internal space having a size relative to the pad such that when the pad is placed within the space, the pad is compressed to a predetermined degree. A passageway extends between the bottle and the internal space of the receptacle through which surgical prep solution can flow from the bottle into the internal space to load the pad with surgical prepping solution.
In a second aspect of the invention, the kit generally comprises an applicator having a resilient, porous pad attached to a handle, and a receptacle adapted to be attached to a bottle of surgical prepping solution. The receptacle defines an internal space having a size relative to the pad such that when the pad is placed within the space, the pad is compressed to a predetermined degree. A passageway is provided into the internal space of the receptacle through which surgical prep solution can flow from a bottle attached to the receptacle into the internal space to load the pad with surgical prepping solution.
Preferably, an inlet or dip tube extends from the receptacle into the bottle, the dip tube defining the passageway as having an inlet near the bottom of the bottle. Most preferably, the dip tube also extends into the internal space of the receptacle, and has outlet openings or slots into the internal space along the sides of the dip tube. The outlet openings or slots help prevent blockage of surgical prepping solution by the compressed material of the pad. These outlet openings or slots constitute one preferred means for preventing blockage of solution. Other embodiments of such means include providing a stop in the internal space to limit insertion of the pad into the internal space, or in some applications having the handle extend all the way through the pad to provide a stop function.
In a third aspect of the invention, an apparatus is provided generally comprising a receptacle having an internal space such that when the pad is placed within the space, the pad is compressed to a predetermined degree, a bottle containing surgical prepping solution, and an inlet tube extending into the internal space. The inlet tube defines a passageway in fluid communication with the bottle for dispensing surgical prepping solution into the pad while the pad is within the receptacle. The inlet tube has outlet slots into the internal space along the sides of the inlet tube.
In at least one embodiment, the receptacle is releasably attached to the bottle. This facilitates reuse of the receptacle with multiple bottles.
In at least one embodiment the receptacle is disposable and may be provided to the customer with the pad preloaded and precompressed within the disposable receptacle.
In one preferred embodiment a reusable receptacle is used along with an applicator pad that is sealed into a preferably sterile disposable plastic package. The receptacle further comprises one or more spikes that pierce the applicator pad as the applicator is inserted into the receptacle. Preferably, the applicator handle is provided with a slot within the pad such that the spike enters the slot.
Preferably, the pad is sized and configured relative to the internal space so that the pad is compressed within the receptacle to between 40-90% of its non-compressed post-wetting volume. Most preferably, this compression is between 60-80% of the pad's non-compressed post-wetting volume. Also, preferably, the entire pad is compressed within the internal space of the receptacle.
In one preferred aspect of the invention, the pad further includes a binder holding the pad in a compressed configuration before the pad is inserted in the receptacle. The binder dissolves, erodes, swells or otherwise releases after the pad is loaded with surgical prepping solution to allow the pad to expand after it has been loaded with surgical prepping solution.
Most preferably, the pad has a generally polyhedron configuration with two generally parallel major surfaces. The handle is elongate and extends from the pad in a direction generally parallel to the two major surfaces. The internal space of the receptacle has a polyhedron configuration corresponding to the configuration of the pad but smaller than the pad so that the pad is compressed when it is inserted in the internal space.
Also preferably, a flared opening is provided in the receptacle to the internal space

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