Surgery – Body protecting or restraining devices for patients or infants – Restrainers and immobilizers
Reexamination Certificate
2000-01-12
2004-05-25
Brown, Michael A. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Restrainers and immobilizers
C128SDIG008
Reexamination Certificate
active
06739340
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to devices for prevention of involuntary urination, in particular devices comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder, combinations of such devices and applicators for use in insertion of the devices into the vagina and methods of manufacturing such devices.
2. Description of the Related Art
The present invention relates to a device for prevention of involuntary urination in a female, comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra, in which the body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end, and in which the body is made from a compressive and elastically deformable material.
Stress incontinence is a nuisance experienced by up to a third of all women at some time or other during their lives.
Stress incontinence is often due to hypermobility of the bladder neck because of insufficient support thereof. Treatments of stress incontinence are aimed at improving the closure of the urethra by better support of the pelvis.
Severe cases of stress incontinence are normally relieved by surgical intervention, while less severe cases of stress incontinence can often be fully or partially relieved by training or retraining of the pelvic musculature.
Training or retraining of a pelvic muscle may, however, extend over many months, and as mentioned, may not in all cases relieve the problem completely.
Thus, there is still a need to find a product which can relieve stress incontinence. The use of sanitary towels and napkins for relieving the inconveniences connected with involuntary urination is generally known. This, however, is a method associated with great disadvantages for the woman, as the sanitary towels are unhandy and voluminous, among other things.
Furthermore, it is known that stress incontinence may be relieved by the use of a tampon-like device which is arranged in the vagina for compressive action and support of the neck of the bladder.
Such a device for relief of stress incontinence is discussed in, for example, U.S. Pat. No. 4,019,498. This device consists of a body of compressible elastic material in the form of a mushroom which is compressed and then placed in a bag. The bag with the body is inserted in the vagina, whereupon the bag is punctured. The body will then press against the neck of the bladder and support this. This method partly involves a cost-increasing component—the bag—and partly there is a risk of damaging the vagina and adjacent tissue when puncturing the bag. The device excerts sufficient pressure on the anterior wall of the vagina to close the urethra and the woman has to remove the device when she has to urinate. Removing of the device is facilitated by the stem portion of the mushroom which is projecting toward the vagina opening.
Furthermore, it is impossible or difficult to adjust the position of the body after the placing in the vagina. Additionally, the body acts purely by the compressibility of the material, for which reason it is necessary to manufacture it in several sizes.
EP-A-363421 also describes a device for arrangement in a woman's vagina with the object of relieving incontinence. This device also has the disadvantage that it acts as a support of the bladder neck merely in consequence of the compression taking place depending on the size of the vagina and the size of the body. It is therefore also in this case necessary to manufacture different sizes to compensate for the different vaginal diameter.
Still further, EP-A-264258 describes an incontinence device—specifically for use in vaginal and rectal prolapse—designed as a U-shaped body, which acts by lifting the neck of the bladder, as, after being arranged, the body returns to its rest position, and one leg of the U bears against the bladder neck of the bladder, which is lifted, whereby continence is obtained. This is thus a relatively rigid structure which is also designed in rather large dimensions.
This device, as well, is required to be manufactured in several different sizes to compensate for the different vaginal diameters, as its lift is exclusively due to its shape, just as it is uncomfortable to wear owing to its rigid and fairly large structure.
A common feature of the above incontinence products is thus that it is necessary to manufacture the product in many different sizes to compensate for the various vaginal diameters.
This is partly economically inappropriate and partly the body will not have an optimum function even after careful selection of size according to a woman's vaginal diameter, as the support by the bodies of the bladder neck will vary according to the physical posture of the woman and the state of tension of her pelvic muscle. There is thus a great risk that by use of the above mentioned devices, the woman will suffer from involuntary urination, and/or that the device will cause inconvenience, cause pain or even damage the vaginal mucous membrane when the woman is in physical movement or tightens her pelvic musculature.
Thus, the above-mentioned devices are economically unsuitable, just as they do not have an optimum function throughout their service life.
Published international application No. WO95/05790 discloses a device having a body comprising two or more legs which are joined in a flexible base. The body of the device is inserted into the vagina in an elastically deformed state with the legs bent in a direction towards each other. Due to the compressive and elastic properties of the body in combination with its properties of restitution deriving from the deformation of the legs, the device will provide support for the bladder neck without blocking the urethra for varying spatial conditions in the vagina.
Although this known device alleviates the drawbacks of the above-mentioned devices, it still has rather large dimensions and furthermore, the two-legged design has a risk of improper placement during insertion.
It is the object of the present invention to provide an improved device of the kind mentioned in the introduction, which comfortably relieves the nuisances indicated and thus secure the woman an optimum support regardless of her physical condition and which is at the same time easy to handle. Just as important, the woman shall be able to urinate normally without having to remove the device. Eventually, the device should be easy to manufacture.
BRIEF DESCRIPTION OF THE INVENTION
The present invention relates, in its broadest aspect, to a device for prevention of involuntary urination in a female, comprising a body for arrangement in the vagina for compressive action on and support of the neck of the bladder and optionally the urethra, in which the body has a substantially elongated shape with a longitudinal axis extending, in the intended direction of insertion, from a proximal to a distal end, and in which the body is made from a compressive and elastically deformable material, said device being characteristic in that the body comprises at least one part protruding from the outer surface of the body and providing at least one pressure area for contact with the neck of the bladder and optionally the urethra and in that the body is provided with at least one string extending from the distal end.
The protruding part(s) ensure a higher pressure during movements and thereby a better support of the neck of the bladder. The device seems relatively small and appealing to the user although it performs the same pressure as larger and already known products. Also it assures that no involuntary urination will occur while at the same time voluntary urination is possible.
The device according to the invention for prevention of involuntary urination in a female may be symmetric with respect to the longitudinal axis of the body, preferably axisymmetric. Symmetric and in particularly axisymmetric products have the ad
Baht Birgitte
Benzon Suzanne Eis
Jensen Hanne
Markersen Karina
Mortensen Anna
Brown Michael A.
Codan Steritex ApS
Jacobson & Holman PLLC
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