Applicator for catamenial device having improved gripper end

Surgery – Means for inserting fibrous or foraminous resident packing,... – With slidable ejector inside tubular inserting means

Reexamination Certificate

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Reexamination Certificate

active

06648846

ABSTRACT:

FIELD OF THE INVENTION
The present invention provides an applicator comprising a tubular insertion member and a retrofitted gripping member. The applicator is particularly useful for delivering a catamenial device into the vaginal canal, such as a tampon or menstrual collection cup.
BACKGROUND OF THE INVENTION
Applicators for inserting and expelling objects into a body cavity typically comprise a tubular insertion member having an insertion end and a trailing end opposite thereof, and an expulsion member slideable within the tubular insertion member. The trailing end generally incorporates features to allow a user to more or less securely hold the applicator during use—inserting the applicator into a body cavity, expelling a substantially enclosed object contained by the applicator, and withdrawing the applicator from the body. Unfortunately, many applicators known in the art comprise a gripping section that exhibits a weakness during at least one of the three above-identified steps of using the applicator.
Voss, U.S. Pat. No. 4,361,150, and Sartinoranont, U.S. Pat. No. 4,447,222, incorporates projections, such as a ring, at the trailing end of the applicator member. These projections provide resistance to rearward finger slippage during the expulsion step of using an applicator, and they may help the user to remove the applicator from her body.
Whitehead, U.S. Pat. No. 4,508,531, reduces the diameter of the applicator in the vicinity of the tubular insertion member trailing end. The reduced diameter creates a shoulder near the insertion end to resist finger slippage toward the insertion end during the insertion step.
Both of these approaches suffer from providing resistance to finger slippage in only one direction. Efforts to provide resistance in two directions, as disclosed in the art, suffer from shortcomings as well.
First, Voss, U.S. Pat. No. 3,575,169, increases the friction on the trailing end of the tubular insertion member by coating it with pulverized stone or sand. This may be especially helpful as applicator manufacturers are moving toward the use of higher gloss surfaces, which are purported to aid in ease of applicator insertion into a body cavity.
Second, Hagerty, U.S. Pat. No. 5,709,652, employs a plurality of finger-accepting apertures in the applicator to provide relatively abrupt, finger-accepting edges. These edges frictionally resist movement of a user's finger in response to longitudinal forces on the device. Although a useful contribution to the art, the finger-accepting edges disclosed by Hagerty, are generally limited to the wall thickness of the applicator.
Finally, Suzuki et al., U.S. Pat. No. 4,921,474, discloses a sanitary tampon applicator comprising a plastic outer sleeve having a diameter-reduced section along a length adjacent its rear end so as to form an annular shoulder, and a annular rib at its rear open end. This device has two or more physical restraints as a means for the user to hold the applicator securely during all of the steps of use. It is noteworthy that the Suzuki applicator is limited to a “plastic” outer sleeve. One skilled in the art would recognize that it would be difficult to form similar physical restraints (shoulder and rib) on a paperboard applicator. Plastic applicators incorporating such design features traditionally employ sophisticated molds and processes in injection molding operations, e.g., comprising split cores and/or side slides. The resulting mold designs and processing steps can add significant costs to the final product.
Accordingly, what is needed, is an applicator that can be manufactured by low-cost, high-speed equipment and retrofitted with a superior gripping member that has features to help during insertion of the applicator into a body cavity, expulsion of a contained object, and withdrawal of the applicator from the body.
SUMMARY OF THE INVENTION
The present invention relates to applicators for inserting objects into body cavities, and to methods for making the same. The applicators are particularly useful for inserting catamenial and prophylactic devices into a vaginal canal. The applicators comprise a tubular insertion member and a retrofitted gripping member affixed to the tubular insertion member.
The tubular insertion member has an insertion end, an oppositely disposed trailing end, and a trailing end outer diameter. The gripping member extends beyond the trailing end in a direction away from the insertion end.
The maximum outer diameter of the gripping member greater than the maximum coplanar trailing end outer diameter. Preferably, a minimum outer diameter of the gripping member is at least equal to the maximum coplanar trailing end outer diameter. Finally, the gripping member has a leading end directed toward the insertion end of the tubular insertion member and a trailing edge disposed distal the insertion end of the tubular insertion member, as assembled.
The gripping member comprises at least one raised area on its outwardly disposed surface. This raised area resists movement of the user's manual digit in response to longitudinal forces on the insertion member. Longitudinal forces are created during both the insertion step of use, as well as the expulsion step delivering the contained object from the insertion member into the body cavity.
The present invention also provides methods for making applicators having retrofitted gripping members, including affixing gripping members as disclosed above, to the trailing end of a tubular insertion member.


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U.S. patent application Ser. No. 09/602,950.
McNeil, PPC. Inc. PCT/US01/20208 Search Report.

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