# Patent

## Title
Adjustable applicator for urinary incontinence devices

## Abstract

An applicator for urinary incontinence devices has an insertion barrel, a deployment plunger, and an adjustable insertion depth indicator. The applicators are useful to correct for a consumer's body mass index to ensure that urinary incontinence devices are placed in the appropriate position to be effective.

## Background
This application is a divisional application of U.S. Ser. No. 12/059,774 filed on Mar. 31, 2008, the complete disclosure of which is hereby incorporated herein by reference for all purposes.


BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an applicator for urinary incontinence devices. The applicator is useful for placing the device in the vagina in the correct position to enable it to function effectively. The applicator is useful for women having varying labial depths, which correspond to her Body Mass Index (“BMI”).
2. Description of the Prior Art
Tampons are absorbent articles that are inserted into a woman's vagina to absorb blood while she is menstruating. Intravaginal urinary incontinence devices are inserted into a woman's vagina to reduce or inhibit urinary incontinence. Applicators may be used to ease the insertion of urinary incontinence devices and tampons. Applicators typically include a generally cylindrical barrel for holding the tampon or device and placing in the vagina, and a plunger for expelling the device or tampon into the vagina. Cardboard and plastic applicators are known in the art.
The placement and orientation of a urinary incontinence device is important in enabling the device to function properly. For some devices, it is important that the device is deployed in a position where pressure is applied to the urethra at the neck of the bladder. As some urinary incontinence devices expand to generate force, it is important that the device is oriented so that the force is directed toward the urethra. Therefore, the urinary incontinence device needs to be deployed in the right location. The depth of a woman's labia generally vary based on her BMI. Therefore, applicators that are intended for urinary incontinence device placement in the vagina may not properly place the device for all women.
Tampon applicators are known to contain finger grip portions. World Patent Application number WO2006/005009A1 discloses an applicator with indicia for low placement in the vagina on the barrel. There is a continuing need for a urinary incontinence applicator that deploys the device in the right location and addresses proper placement based on the depth of the woman's labia.
SUMMARY OF THE INVENTION
In one embodiment, the present invention provides a urinary incontinence device applicator. The applicator has an insertion barrel; a plunger slidable within the insertion barrel; adjustable means to indicate appropriate insertion depth of the insertion barrel associated therewith into a user's vagina; and a plurality of depth adjustment indicia, each of which is associated with a predetermined BMI range.
In another embodiment, the invention provides a system to deliver an intravaginal device. The system includes an applicator and an intravaginal device contained therein. The applicator includes a substantially tubular insertion barrel, a plunger, and an adjustable insertion depth indicator. The barrel has an insertion end, an opposite gripper end, and a longitudinal axis. The plunger extends from the gripper end of and is slidable within the insertion barrel. The insertion depth indicator is arranged and configured to bear against a user's labia majora extending from the insertion barrel proximate the gripper end. The intravaginal device is substantially contained within the insertion barrel, and the means to indicate appropriate orientation of the insertion barrel is arranged and configured to deliver the intravaginal device in an appropriate orientation into the user's vagina. The adjustable insertion depth indicator includes a plurality of depth adjustment indicia, each of which is associated with a predetermined BMI range.
In another embodiment, the invention provides a method of inserting an intravaginal urinary incontinence device. The method includes the steps of a) determining a BMI for a user; b) selecting a BMI range corresponding to the user's BMI; c) adjusting an insertion depth indicator associated with an applicator containing the intravaginal urinary incontinence device to the selected BMI range; d) inserting an insertion portion of the intravaginal device applicator into the user's vagina until the insertion depth indicator contacts the user's labia majora; e) expelling the intravaginal urinary incontinence device from the applicator into the vagina; and f) removing the applicator from the vagina.
In another embodiment, the invention provides a method of inserting an intravaginal urinary incontinence device. The method includes the steps of a) determining a BMI for a user; b) selecting a BMI range corresponding to the user's BMI; c) selecting an applicator having an insertion depth indicator and containing an intravaginal urinary incontinence device having the selected BMI range; d) inserting an insertion portion of the intravaginal device applicator into the user's vagina until the insertion depth indicator contacts the user's labia majora; e) expelling the intravaginal urinary incontinence device from the applicator into the vagina; and f) removing the applicator from the vagina.
In another embodiment, the invention provides a system for alleviating urinary incontinence. The system includes a plurality of applicators and means to select an appropriate applicator based upon the user's BMI. Each applicator contains an intravaginal urinary incontinence device and has dimensions suitable for delivering the intravaginal urinary incontinence device contained therein to a user's urethro-vesical junction. Each applicator has an insertion barrel, a plunger slidable within the insertion barrel, and an insertion depth indicator.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be more fully understood and further advantages will become apparent when reference is made to the following detailed description of the invention and the accompanying drawings in which:
FIG. 1 is a perspective view of an applicator of the present invention.
FIG. 2 is a front view of the applicator of FIG. 1.
FIG. 3 is a perspective view of a second applicator of the present invention.
FIG. 4 is a side elevation of the applicator of FIG. 3.
FIG. 5 is a front view of the applicator of FIG. 3.
FIGS. 6A-C is a series of partial side elevations of an alternative embodiment of the applicator of the present invention illustrating different angular positions of the insertion depth indicator.
FIGS. 7A-B are side elevations of another alternative embodiment of the applicator of the present invention illustrating different longitudinal positions of the insertion depth indicator.
FIG. 8 is a side elevation of the applicator of FIG. 7B as the urinary incontinence device is deployed.
FIG. 9 is a sagittal cross-section of the female pelvis illustrating relationship between the vagina, bladder, urethra, pubic bone, urethro-vesical junction, and labia.
FIG. 10A-C are side elevations of another alternative embodiment of the present invention having varied plunger lengths.



DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
With reference to FIGS. 1-2, applicators 10 according to the present invention include an insertion barrel 12. The insertion barrel is sized and shaped to contain the urinary incontinence device 14 within it, and it has an external insertion depth indicator 16. The length of the barrel (to the base of petals, if present, at the insertion end) may range from about 20 mm to about 100 mm, preferably about 40 mm to about 60 mm, most preferably about 50 mm. The diameter or the barrel may range from about 5 mm to about 20 mm, preferably about 18 mm to about 20 mm. The thickness of the barrel is sufficient to withstand the pressure exerted by the device, and may range, for example, from about 1 mm to about 3 mm. The barrel has an insertion end 18 to east the insertion of the applicator into the vagina, and an opposite, gripper end 20 into which the urinary incontinence device can be loaded. The insertion end 18 may be open, or as is known in the tampon art, may have petals 22 (not required) for easing insertion of the applicator and for retaining the device until deployment.
The insertion barrel may be made from any suitable material, such as polyethylene, polypropylene, acetal resins, styrene copolymers (including rubber-modified glassy plastics such as ABS [a two-phase system of styrene-acrylonitrile copolymer and styrene-budatidene copolymer]). The insertion depth indicator may be molded into the barrel or may be formed separately and attached to the applicator through conventional methods, such as adhesives, friction fits and the like.
The insertion depth indicator 16 is a raised element on the insertion barrel surface, oriented generally perpendicular to the longitudinal axis of the insertion barrel (and thus, the direction of insertion). This provides a tactile feedback when the insertion is completed, e.g., bearing against the user's labia majora 17. While a small height of discontinuity is sufficient to give a tactile feedback, the height of the discontinuity also defines a bearing surface that can be held against the body to maintain the correct insertion depth during deployment of the device. The height of the discontinuity may range from 2 mm to 20 mm.
The insertion depth indicator may be made from any suitable material, such as polyethylene, polypropylene, a variety of copolymers, silicone, and elastomeric materials, such as ethylene propylene diene monomer, and the like. The insertion depth indicator may be molded into the barrel or may be formed separately and attached to the applicator through conventional methods, such as adhesive, friction fit, and the like. The insertion depth indicator may also function as and/or incorporate a finger grip 24. The insertion depth indicator is positioned such that the device is deployed in the proper position within the vagina. The distance between the insertion end of the barrel 12 and the insertion depth indicator 16 may range from 40 mm to 80 mm, for example 60 mm. The amount that the insertion depth indicator extends about the circumference of the insertion barrel, the “angle of wrap,” α, may vary. An angle of wrap, α, of 360° shown in FIGS. 1-2, provides the largest and most stable bearing surface 26; however, smaller angles, e.g., about 90° as shown in FIGS. 3-5, require less material and are more convenient to stack and store. The bearing surface 26 can also consist of multiple segments spaced around the circumference of the insertion barrel. These multiple segments can also have different heights of the indicator.
The external depth indicator may be integral with the barrel (including permanently and immovably attached), or it may be adjustable, if desired. This may be helpful to improve comfort for the user. As exemplified in FIGS. 6A-C, it may be desirable to permit the indicator 16 to pivot about a hinge 28. FIG. 6B shows the indicator 16 pivoted into a forward position, and FIG. 6C shows it pivoted back toward the gripper end 20. The choice may depend upon the position of the woman during insertion of the device. The angle may depend on the woman's particular anatomy—the curves of her labia. In addition, the woman may desire to rotate the indicator 16 around the barrel 12 to bear differently on her body. Finally as shown in FIGS. 7A-B, the woman may desire to change the location of the indicator 16 along the length of the barrel 12 if she desires to fine-tune the insertion depth based upon her knowledge of her own anatomy. To aid in this adjustment, indicia 29 may be provided on the insertion barrel 12
Applicators according to the present invention also include a deployment plunger 30, an elongate device, designed to slidingly fit within the barrel 12. The plunger 30 has a leading end 32 to bear against and to deploy the incontinence device and an opposite end 34 having a stop 36 to prevent the plunger from being pushed too far and to ensure proper placement of the device in the vagina. The plunger 30 is moved axially into the insertion barrel 12 to deploy the device from the insertion end 18 into the vagina. The barrel 12 and plunger 30 may be made from any suitable material. For example, the barrel and plunger may be molded from conventional thermoplastic materials such as, but not limited to, polyethylene, polypropylene and a variety of copolymers.
Referring to FIG. 8, the insertion depth of the base 37 of the incontinence device will be determined by two dimensions when the applicator is fully inserted and deployed. Dimension “A” is the axial length of the plunger from the plunger stop 36 to the leading end 32 of the plunger 30 where it contacts the device 14. Dimension “B” is the axial length from the plunger stop 36 to the bearing surface 26 of the insertion depth indicator 16. The insertion depth of the base 37 of the device from the body exterior is A-B. The applicator is designed so that the portion of the device 14 in the vagina 100 that applies pressure to the urethra 102 is placed at the urethro-vesical junction 104, and/or the base 37 of the device 14 is at least 10 mm to 20 mm, for example 15 mm above the hymenal opening 106, as shown in FIG. 9 (dimension D1). To this dimension is added the distance D2 between the outer surface of the labia majora 17 and the hymenal opening.
The effective length (the length sufficient to place the incontinence device in the proper location) of the applicator may vary to correct for the BMI of the consumer. The BMI is a known measurement of the ratio between the weight and height of a human. The Index is calculated as follows:

BMI=m/h2 

wherein m is the person's weight (kilograms)

    
    
        h is the person's height (meters)
    
    


We have discovered that the proper insertion depth of the device is strongly influenced by the user's BMI. Among other things, the greater a woman's BMI, the greater the depth “D” of her labia majora 108.
The present invention enables the consumer to determine her BMI, then either adjust the applicator accordingly, or select the correct applicator for her BMI. There are two ways that this can be achieved. In a first embodiment, an adjustable finger grip is utilized. The barrel may have marks or ridges associated with different depth placement for different BMIs. The user will adjust the finger grip according to her BMI. If her BMI is 18.5 to 25, she can adjust the finger grip by sliding it or turning it to the appropriate mark or ridge, to shorten the barrel length that is inserted into her body (as shown in FIGS. 7A-B). The barrel and finger grip may be provided with a thread and a groove such that the finger grip is turned or twisted like a screw to adjust the depth of placement. For women who have a larger BMI, the finger grip can be adjusted down to the appropriate mark or ridge to accommodate the larger labial depth. Therefore, the consumer may purchase one applicator that can be adjusted for her BMI.
In a second embodiment shown in FIGS. 10A-C, the finger grip and plunger combination sets the correct placement depth. The user will select the proper size applicator based on her BMI. The applicators are sized appropriately by BMI. The plunger length and finger grip distances are calculated based on their labial depths so that the device pressure member is placed 10 mm above the hymenal ring and at the UV junction correspondingly. In this embodiment, the consumer may read the package to determine which of 3 different applicators is appropriate for her, based on her BMI, then purchase the appropriate applicator shown having e.g., plungers 30, 30′ 30′′. The applicators of the present invention are designed as shown in Table 1 to be suitable for various BMIs.













TABLE 1










Plunger
Plunger






Barrel
Length =
Depth =






Length in
FG +
Plunger





Finger
Body =
Barrel
Length −



Labial
Device
Grip
10+ labial
Length
Device


BMI
Depth
Length
Length
Depth
in Body
Length







18.5-25
30 mm
55 mm
25 mm
40 mm
65 mm
10 mm


  25-30
38 mm
55 mm
25 mm
48 mm
73 mm
18 mm


30+
42 mm
55 mm
25 mm
52 mm
77 mm
22 mm









Applicators according to the present invention may also include an orientation indicator 38. The orientation indicator 38 is utilized to place the incontinence device in the vagina such that when it is deployed, the portion of the device that applies pressure, exerts pressure on the urethra-vesical junction, and any anchoring members lie on the lateral sides of the vagina. The orientation indicator 38 clearly marks the orientation of the device within the applicator. The indicator may be a raised line, a colored line, dots, embossments, or any suitable mark or shape that indicates orientation. The orientation indicator may be on any or all of a conventional finger grip, the insertion depth indicator, and the barrel itself. If the device is aligned with the orientation indicator when it is within the applicator, then it will be aligned to the body after insertion. When the orientation indicator 38 is part of the insertion depth indicator 16, the orientation indicator 38 may be part of the shape of the insertion depth indicator 16. For example, the insertion depth indicator 16 may have an apex, which is the indicator.
Suitable urinary incontinence devices for use with the applicators of the present invention include, but are not limited to, devices taught in co-pending, U.S. application Ser. No. 11/456,376, filed, Jul. 10, 2006; U.S. application Ser. No. 11/776,178, filed, Jul. 11, 2007; U.S. application Ser. No. 11/456,390, filed, Jul. 10, 2006; U.S. application Ser. No. 11/456,402, filed, Jul. 10, 2006; U.S. application Ser. No. 11/456,424, filed, Jul. 10, 2006; U.S. application Ser. No. 11/776,185, filed, Jul. 11, 2007; U.S. application Ser. No. 11/456,433, filed, Jul. 10, 2006; and, U.S. application Ser. No. 11/456,442, filed, Jul. 10, 2006.
Examples are set forth below to further illustrate the nature of the invention and the manner of carrying it out. However, the invention should not be considered as being limited to the details thereof.
Example 1
Barrel and plunger components according to FIGS. 7A-B were molded out of linear low-density polyethylene (LLDPE) with a 1% modified polyethylene slip additive. Samples of these components were also molded out of high-density polyethylene (HDPE) and low-density polyethylene (LDPE). The LLDPE however was the material of choice for actual use testing. The collar and finger grip components also utilized single cavity injection molds. A finger-grip sleeve and the insertion depth indicator collar were both designed to be friction fit attached to the applicator, and the distance from the collar to the base of the petals was about 50 mm. The material utilized was a 65-durometer thermoplastic elastomer under the trade name of C-Flex® thermoplastic elastomer.
Example 2
A use test was performed with 20 women to mainly determine the ability of the applicators of the present invention to correctly place the device in the body. An intra-vaginal incontinence device prototype was inserted into the vagina utilizing the applicator of Example 1. The first test was for the subject to insert the device via the provided applicator and instructions. For this test, a physician checked the placement of the device post insertion and assessed whether the device was too high, at the correct location, or too low.
Referring again to FIG. 9, the device 14 was considered to be too high if the base 37 of the device 14 in the vagina 100 was located above the urethro-vesical junction 104. This was assessed by palpation and/or visualization. If the doctor could feel the pubic bone 110 before the base 37 of the device 14, the device was considered to be too high. The device 14 was considered to be at the correct location if a working portion of the device 14 was at the urethro-vesical junction 104. If the doctor could see that the device 14 was at least 10 mm into the vagina 100 past the hymenal ring 106, or if the doctor could feel the base 37 of the device before feeling the pubic bone 110, the device 14 was considered to be at the correct location. The device was considered to be too low if it was placed outside the hymenal ring 106 or less than 10 mm into the vagina 100 past the hymenal ring 106.
If the device was placed incorrectly (too high or too low), the subject was asked to re-insert the device with feedback on the initial placement. The results of this study of placement via applicator are shown in Table 2 below.










TABLE 2







Insertion
% With Correct Placement









Initial
75 (15/20)



Second
40 (2/5) 



Total
85 (17/20)










Based on the data above, it was determined that the devices of the present invention are effective at placing urinary incontinence devices in the proper position within the vagina, either initially or with guidance and practice.

## Claims

1. A method of inserting an intravaginal urinary incontinence device comprising the steps of:
a) determining a BMI for a user
b) selecting a BMI range corresponding to the user's BMI;
c) adjusting an insertion depth indicator associated with an applicator containing the intravaginal urinary incontinence device to the selected BMI range;
d) inserting an insertion portion of the intravaginal device applicator into the user's vagina until the insertion depth indicator contacts the user's labia majora;
e) expelling the intravaginal urinary incontinence device from the applicator into the vagina; and
f) removing the applicator from the vagina.

2. The method of claim 1, wherein the step of adjusting the insertion depth indicator comprises moving the insertion depth indicator along a longitudinal axis of the insertion portion.

3. The method of claim 1, wherein the step of adjusting the insertion depth indicator comprises moving the insertion depth indicator along a substantially helical path about the surface of the insertion portion.

4. The method of claim 1, wherein the step of adjusting the insertion depth indicator comprises moving the insertion depth indicator to one of a plurality of predetermined positions.

5. A method of inserting an intravaginal urinary incontinence device comprising the steps of:
a) determining a BMI for a user
b) selecting a BMI range corresponding to the user's BMI;
c) selecting an applicator having an insertion depth indicator and containing an intravaginal urinary incontinence device having the selected BMI range;
d) inserting an insertion portion of the intravaginal device applicator into the user's vagina until the insertion depth indicator contacts the user's labia majora;
e) expelling the intravaginal urinary incontinence device from the applicator into the vagina; and
f) removing the applicator from the vagina.