Surgery – Means for inserting fibrous or foraminous resident packing,... – With slidable ejector inside tubular inserting means
Reexamination Certificate
2000-06-23
2003-06-03
Ruhl, Dennis (Department: 3761)
Surgery
Means for inserting fibrous or foraminous resident packing,...
With slidable ejector inside tubular inserting means
Reexamination Certificate
active
06572577
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 has an outer diameter greater than a coincident trailing end outer diameter and a raised area. In one preferred embodiment, the gripping member has a length to inner diameter ratio of at least about 0.5. In another preferred embodiment, the gripping member has a length of at least about 5 mm.
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.
In another embodiment, the present invention relates to an applicator for inserting an object having a gripping member with at least one flexible arm extending from an inner surface thereof. The tubular insertion member trailing end is fitted between the gripping member inner surface and the at least one flexible arm. A tubular expulsion member may be slideably fitted within the trailing end, and this position of the expulsion member urges the flexible arm against the tubular insertion member to provide a more secure device. The flexible arm may also help to prevent the expulsion member from being separated from the insertion member prior to use.
In yet another embodiment, the present invention relates to an applicator having a tubular insertion member as described above with an aperture proximate its trailing end. The applicator also has a gripping member with an annular ring having a flexible arm substantially perpendicular to and extending from an inner peripheral edge of the ring. The flexible arm has a distally located protuberance, and this protuberance extends outwardly from the interior of the tubular insertion member and through the aperture when the gripping member is affixed to the insertion member. The annular ring and the extending protuberance form raised areas that resist movement of a user's manual digit in response to longitudinal forces on the insertion member.
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.
In a preferred embodiment of the present invention, a tubular insertion member is provided having an insertion end and a trailing end and a tubular expulsion member slideable the trailing end. A gripping member is coaxially aligned with the insertion and expulsion members. The tubular insertion member is clamped with a first clamping mechanism, and the gripping member is clamped with a second clamping mechanism. An optional internal stabilizing tool may be passed through the gripping member and into a portion of the expulsion member. A displacement tool, in a telescopic position over the internal stabilizing tool, then engages the gripping member, after which the second clamping mechanism is retracted. Through linear displacement of the displacement tool, the gripping-member is advanced over the expulsion member and onto at least a portion of the tubular insertion member trailing end. Lastly, displacement tool, the internal stabilizing tool, and the first clamping member are all retracted, thereby freeing the assembled applicator for any further processing steps.
REFERENCES:
patent: 3042040 (1962-07-01), Galik
patent: 3297031 (1967-01-01), Bray
patent: 3347234 (1967-10-01), Voss
patent: 3433225 (1969-03-01), Voss et al.
patent: 3572339 (1971-03-01), Voss et al.
patent: 3575169 (1971-04-01), Voss et al.
patent: 3683759 (1972-08-01), Voss et al.
patent: 4048998 (1977-09-01), Nigro
patent: D25
Binner Curt
Pierson Linda M.
Vogt Gary
Mc-Neil-PPC, Inc.
Ruhl Dennis
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