Applicator for delivering bulky devices

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

Reexamination Certificate

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Details

C604S011000

Reexamination Certificate

active

06582389

ABSTRACT:

FIELD OF THE INVENTION
The present invention provides an applicator for inserting an object such as a bulky device into a human or other mammalian body cavity. In particular, the invention provides an applicator having a cage for holding a bulky device. Upon insertion, the bulky device is able to expand to its full size. Expulsion of the bulky device from the applicator requires substantially reduced force.
BACKGROUND OF THE INVENTION
Applicators for inserting and delivering objects into a body cavity typically include an insertion member having an insertion end and a trailing end opposite thereof, and an expulsion member slideably fitted within the insertion member. The trailing end will generally incorporate some sort of a gripping feature to allow a user to more or less securely hold the applicator during use, which may include the following steps: inserting the applicator into a body cavity, delivering a substantially enclosed object contained by the applicator, and withdrawing the applicator from the body.
Some catamenial devices such as tampons and collection cups may be bulky in size and may need to be compressed to fit within the applicator. These particular devices may be difficult to expel from the applicator. Expulsion often requires higher forces due to friction of the device against the inner surface of the insertion member.
Additionally, users of the push type applicators typically experience discomfort when inserting a tampon. Even though the outer surface of the insertion member may be smooth and somewhat lubricious for easy and smooth insertion, the tampon usually has a rough and irregular surface as a consequence of its absorptive and material properties. These properties tend to cause frictional discomfort when the tampon is expelled out of the insertion member and against the delicate walls and folds of the vagina.
Some applicators utilize a hollow tube having an open insertion end through which the tampon is always exposed while other applicators utilize a completely closed or partially closed design. The partially or completely closed insertion tip can help prevent premature contamination or wetting and subsequent expansion of the absorbent tampon. A tampon that has a portion expanded due to premature wetting will be difficult to remove from the applicator.
Examples of applicators having a protected insertion end are shown in U.S. Pat. Nos. 5,087,239; 5,279,541; 5,348,534 and 5,569,177. Additionally, these applicators are shown having segmented insertion portions with a hinge region or a reduced thickness in the insertion portion.
Attempts have been made to reduce the amount of force to expel tampon. In particular, WO 9607383 discloses an applicator having an insertion tip that has at least some of the paper fibers stretched and/or broken so as to allow it to be opened with a minimum amount of expulsion force. U.S. Pat. Nos. 4,923,440, 4,318,404 and 4,286,594 use a sheath or a portion of the insertion member that convolutes back onto itself to deliver the catamenial device to the vaginal cavity.
An attempt to provide an applicator for a bulky device is disclosed in EP 0 616 797. This publication discloses an insertion tube for a vaginal cup that has an outer tube slideable on an inner tube. At the insertion end of the inner tube, there are two jaws into which the vaginal cup is folded and placed. The outer tube is then moved up over the jaws to secure the cup within the applicator. After insertion of the applicator into the vaginal cavity, the outer tube is slid away from the jaws, which causes the jaws to open and release the vaginal cup.
Additionally, U.S. Pat. No. 6,095,998 discloses an expandable bag catamenial tampon and an applicator, which spreads the tampon open within the vaginal cavity. The bag-like tampon is placed over the leading end of the applicator in its initial flaccid configuration, which defines an initial width. The applicator is used to spread the tampon to a greater deployed width.
The present invention reduces the amount of friction between a bulky device such as a catamenial device and the applicator barrel as well as reducing the friction between the bulky device and vaginal wall. This is accomplished by having a cage for containing the catamenial device that slides out the applicator barrel (insertion member) and then glides the bulky device inside the vagina up to the predetermined point at which it opens up and to release the bulky device. The bulky device is then free to expand.
SUMMARY OF THE INVENTION
This invention relates to an applicator for delivering an object into a body cavity, the applicator including a tubular insertion member having an outer surface, an inner surface, an insertion end, a first stop affixed to the inner surface proximate the insertion end, and a trailing end opposite the insertion end. The tubular insertion member contains a cage having an inner surface, an outer surface, a plurality of arms extending from an inner end portion toward the insertion end of the tubular insertion member, and a second stop affixed the outer surface proximate the inner end of the cage. The object is held within the cage until placement into the user's body, and the first and second stops are capable of engaging to allow the object to be delivered into the body cavity while the cage remains constrained within the insertion member.
Additionally, this invention relates to a method of delivering an object into a body cavity from an applicator. The method includes the steps of inserting the insertion end of an insertable member into the user's body; displacing the cage contained therein toward the insertion end; and expelling an object from the cage into the body cavity.


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PCT International Search Report PCT/US01/48798 dated Aug. 13, 2002.

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