The present invention generally relates to an introducer for a Urinary Incontinence (UI) device.
By way of background, urinary incontinence is the involuntary leakage of urine; in simple terms, it means a person urinates when he or she does not want to. Control over the urinary sphincter is either lost or weakened.
It is, therefore, an object of the present invention to provide an introducer used to insert a urinary incontinence device into a vagina. The introducer includes a housing including a vaginal insertion tube at a proximal end of the housing and a storage section at a distal end of the housing. The storage section is shaped and dimensioned for storage of the urinary incontinence device prior to insertion and the vaginal insertion tube is shaped and dimensioned for the passage of the urinary incontinence device therethrough. The dimensions of the storage section are such that the urinary incontinence device contained therein is in its deployed non-compressed state allowing the urinary incontinence device to be stored in its non-compressed state prior to use. The introducer also includes a plunger which travels within the housing.
It is also an object of the present invention to provide an introducer used to insert a urinary incontinence device into a vagina including a housing having a vaginal insertion tube at a proximal end of the housing and a storage section at a distal end of the housing. The storage section is shaped and dimensioned for storage of the urinary incontinence device prior to insertion, while the vaginal insertion tube is shaped and dimensioned for the passage of the urinary incontinence device therethrough. The introducer also includes a plunger which travels within the housing. The plunger includes a top wall, a bottom wall, and lateral side walls extending between the top wall and the bottom wall. The top wall, bottom wall, and lateral side walls define an internal cavity extending from a proximal first end of the plunger for housing part of the urinary incontinence device.
It is another object of the present invention to provide an introducer used to insert a urinary incontinence device into a vagina including a housing having a vaginal insertion tube at a proximal end of the housing and a storage section at a distal end of the housing. The storage section is shaped and dimensioned for storage of the urinary incontinence device prior to insertion, while the vaginal insertion tube is shaped and dimensioned for the passage of the urinary incontinence device therethrough. The introducer also includes a plunger which travels within the housing. The plunger is an elongated member and includes a proximal first end and a distal second end with a handle secured thereto. The plunger includes a first plunger portion adjacent the distal second end thereof and a second plunger portion adjacent the proximal first end thereof with a gripping area at an intersection of the first plunger portion and the second plunger portion. The gripping area allows pushing of the plunger in two steps.
It is a further object of the present invention to provide a method of introducing a urinary incontinence device into a vagina. The method includes the steps of obtaining (for example, from a drug store) an introducer with a urinary incontinence device stored within a storage section of the introducer therein, inserting an insertion tube of the introducer within the vagina, pushing a plunger of the introducer to move the urinary incontinence device from the storage section of the housing into the insertion tube, and pushing the plunger farther to force the urinary incontinence device from the insertion tube and into the vagina wherein resilience of the urinary incontinence device forces the urinary incontinence device toward deployment once more than half of the urinary incontinence device is exposed.
Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as a basis for teaching one skilled in the art how to make and/or use the invention.
Referring to
The introducer 10 includes a housing 12 and a plunger 20 which travels within the housing 12. The housing 12 includes a proximal end 40 and a distal end 50. The housing 12 further includes a vaginal insertion tube 14 at the proximal section of the housing 12. The housing 12 also includes a storage section 16 at the distal section of the housing 12. The storage section 16 is shaped and dimensioned for storage of the UI device 100, 200 prior to insertion, while the vaginal insertion tube 14 is shaped and dimensioned for the passage of the UI device 100, 200 therethrough in a manner that will be discussed below in greater detail. As the UI device 100, 200 is stored within the storage section 16 and passed through the vaginal insertion tube 14, both the storage section 16 and the vaginal insertion tube 14 are hollow and they are in communication with each other such that the UI device 100, 200 may be passed from the storage section 16 into the vaginal insertion tube 14 and out of the housing 12.
The vaginal insertion tube 14 includes a proximal first end 14a which coincides with the proximal end 40 of the housing 12 and a distal second end 14b that is secured to the storage section 16. The vaginal insertion tube 14 is in the shape of a soft triangle and increases in size as it extends back from the proximal first end 14a toward the distal second end 14b and the storage section 16.
As mentioned above, the vaginal insertion tube 14 has the shape of a soft triangle or unique transitional shape other than oval. This means that when the vaginal insertion tube 14 is viewed along an axis aligned with the longitudinal axis of the housing 12 (see
The storage section 16 is disc shaped and includes a proximal first end 16a (that is coupled to the distal second end 14b of the vaginal insertion tube 14) and a distal second end 16b (that coincides with the distal end 50 of the housing 12). The distal second end 16b of the storage section 16 is provided with an aperture 17 shaped and dimensioned for receiving the plunger 20 such that the plunger may be moved within the housing 12 in a manner discussed below in greater detail. The storage section 16 also includes an upper wall 16c, a lower wall 16d, and a side wall 16e extending between the upper wall 16c and the lower wall 16d.
The storage section 16 has a diameter of almost 2 inches. In addition, the storage section has a height of 0.80 inches adjacent the proximal first end 16a thereof and a height of 0.50 inches adjacent the distal second end 16b thereof. The transition in height from the proximal first end 16a to the distal second end 16b is not gradual. Rather, the transition is abrupt at the proximal first end 16a where the storage section goes from a height of 0.80 inches to a height of 0.50 inches over a very short distance to define a finger abutment surface 19 along the outer surface 16s of the storage section 16 adjacent the proximal first end 16a thereof. As will be appreciated as the operation of the present introducer 10 is explained, the finger abutment surface 19 allows a user to push the introducer 10 forward while holding the storage section 16 without worrying that fingers will slide onto the vaginal insertion tube 14 and inhibit insertion of the vaginal insertion tube 14 into the vagina.
Still further, the fact that the diameter of the storage section 16 is greater than the width dimension of the vaginal insertion tube 14 means that the storage section 16 extends laterally beyond the vaginal insertion tube 14. This lateral extension at the junction of the storage section 16 and the vaginal insertion tube 14 results in a vaginal abutment surface 27 along the proximal first end 16a of the storage section 16 that prevents the storage section 16 from entering the vagina when the vaginal insertion tube 14 is inserted into the vagina.
With the foregoing dimensions in mind, it is appreciated that the housing 12 increases in height from its distal end 50 until the intersection of the vaginal insertion tube 14 and the storage section 16 and then decreases in height as it extends proximally to proximal end 40 (that is, from the distal second end 16b of the storage section 16 to the proximal first end 16a of the storage section 16 the housing 12 increases in height and from the distal second end 14b of the vaginal insertion tube 14 to the proximal first end 14a of the vaginal insertion tube 14 the housing 12 decreases in height). The increasing height functions to guide the compression of the UI device 100, 200 as it is pushed proximally (that is, toward the proximal first end 14a of the vaginal insertion tube 14) by the plunger 20. The increase in height also helps to minimize the pushing force required on the plunger 16 to start the travel of the UI device 100, 200 proximally. The dimensions of storage section 16 are such that the UI device 100, 200 contained therein is in its deployed orientation, that is, it is in its non-compressed state. This allows the UI device 100, 200 to be stored in its non-compressed state prior to use, thus not affecting its performance after being stored for long periods of time prior to introduction. With this in mind, it should be appreciated the term “non-compressed state” is meant to refer to the UI device 100, 200 when it is not compressed sufficiently to pass through the vaginal insertion tube 14. As such, and while the UI device 100, 200 is held in the storage section 16 it is either fully extended or it is slightly constricted in a manner not adversely affecting its long-term viability. With the foregoing in mind, it is considered the UI device 100, 200 is in its compressed state when it has been reduced to a size sufficient to pass through the vaginal insertion tube 14 and it is in its non-compressed state when it is too large to pass through the vaginal insertion tube (and is not adversely affected with regard to its long-term viability).
Also the size of the storage section 16 provides a generous gripping area for a user. With this in mind, it is appreciated the storage section 16 may be provided with a tactile grip pattern on the exterior thereof (not shown). Preferably the housing 12 is made from a plastic such as polypropylene or polyethylene, but other materials could be used.
The UI devices 100, 200 are stored within the storage section 16 of the housing 12 of the introducer 10 in their expanded or non-compressed state and during insertion are compressed as they pass within vaginal insertion tube 14. In accordance with the embodiment disclosed with reference to
The plunger 20 is an elongated member and includes a proximal first end 20a and a distal second end 20b with a handle 26 secured thereto. The plunger 20 is hollow and includes a top wall 20c, a bottom wall 20d, and lateral side walls 20e, 20f extending between the top wall 20c and the bottom wall 20d. The top wall 20c, bottom wall 20d, and lateral side walls 20e, 20f define an internal cavity 20g extending from a first opening 20h at the first end 20a of the plunger 20 to a second opening 20i at the distal second end 20b of the plunger 20. The internal cavity 20g allows a cord 110, 210 connected to the UI device 100, 200 to pass through the plunger 20 (that is, pass through the first opening 20h at the first end 20a of the plunger 20, the internal cavity 20g, and the second opening 20i at the second end of the plunger 20) and exit the plunger 20 at the second end 20b thereof. Preferably the plunger 20 is made from a plastic such as polypropylene or polyethylene, or paper, but other materials could be used.
The plunger 20 includes a first plunger portion 22 adjacent the distal second end 20b thereof and a second plunger portion 24 adjacent the proximal first end 20a thereof. The first plunger portion 22 and the second plunger portion 24 together have a length slightly less than 4 inches. The first plunger portion 22 is longer than the second plunger portion 24 and is at the maximum comfortable reach for a typical user. The overall length of the plunger 20 is greater than the overall length of the housing 12. The internal cavity 20g of plunger 20 that sits within the second plunger portion 24 is dimensioned to house part of the UI device 100, 200 to minimize the size of storage section 16. In particular, it is dimensioned to house the tab 120, 220 of the UI device 100, 200. This is best seen in
The first proximal end 20a of the plunger 20, that is, the free end 24a of the second plunger portion 24 is also in contact with the UI device 100, 200 to push it forward during insertion of the UI device 100, 200 into the vagina. In particular, each of the UI devices 100, 200 includes an abutment surface 122, 222 that is slightly larger in height than the opening defined by the top wall 20c and the bottom wall 20d of the plunger 20 at the free end 24a of the second plunger portion 24. As a result, the free end 24a of the second plunger portion 24 engages the abutment surface 122, 222 of the UI devices 100, 200 in a manner allowing the plunger 20 to push the UI devices 100, 200 forward as the plunger 20 is moved forward.
In accordance with a first embodiment as shown with reference to
In accordance with an alternate embodiment as shown in
At the intersection of first plunger portion 22 and second plunger portion 24 is a gripping area 25. The gripping area 25 allows pushing of the plunger 20 in two steps. A user first contacts the gripping area 25 and pushes the second plunger portion 24 into housing 12 until her finger(s) abuts the distal end 50 of the housing 12. Thereafter, the user contacts the handle 26 and continues to push the first plunger portion 22 into the housing 12 until the handle 26 abuts the distal end 50 of housing 12. The two-step insertion permits the introducer 10 to be used by women with varying dexterity, hand strength, and hand size. The two steps provide optimal location of the “press areas” at all times during use for most, if not all, users. The length of the housing 12 and plunger 20 are longer due to the functional size needed to store the UI device in a non-compressed state.
Turning to
As seen in
Next, and as seen in
Similar, and with reference to
While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, it is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Application Ser. No. 62/490,364, entitled “INTRODUCER FOR URINARY INCONTINENCE DEVICE,” filed Apr. 26, 2017.
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