Surgery – Body inserted urinary or colonic incontinent device or...
Reexamination Certificate
2000-12-28
2003-04-01
Shaver, Kevin (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
C128SDIG008
Reexamination Certificate
active
06540665
ABSTRACT:
BACKGROUND OF INVENTION
The present invention relates to a urinary incontinence device.
Urinary incontinence in the aged population is an enormous problem. Approximately 50% of the patients residing in nursing homes were placed there because of problems with urinary incontinence. It is estimated that there are 20 million incontinent patients in the United States alone, and that only 10% of these people ever seek medical assistance. Sufferers from this condition can become social hermits because of the fear of accidents due to sudden loss of urine and the embarrassment associated with urine odours. Most patients have been convinced that incontinence is a natural aging phenomenon and many wear protective padding. This arrangement is extremely primitive and demeaning for the patients.
The majority of urinary incontinence occurs in the female. Recently there has been an increase in post prostatectomy incontinence, since radical prostate surgery has increased dramatically in the last five years.
A distinction must be made as to whether the problem occurs in an active healthy person or in someone who is institutionalized in either a chronic care facility or in a nursing home. The treatment approaches will necessarily be different. In the case of the institutionalized person suffering from urinary incontinence, they are often unable to have any surgical procedure to correct their condition so that non-invasive (non-surgical) approaches are required. The common practice in most nursing homes at present is to have the patients fitted with an absorbent diaper-like material. These antiquated arrangements account for the malodorous environment found in nursing homes as well as the high incidence of local skin problems due to the constant exposure to urine. For various reasons, most nursing homes will not accept patients with catheters.
Many devices have been designed to deal with the problem of urinary leakage and the various difficulties associated with the use of these devices are well known. The basic problem found in many of the females with urinary incontinence is that there is a descent of the bladder neck and an associated wide open bladder neck and upper third of urethra, the so-called funnel-shaped urethra. To correct the incontinence without surgery, one must have a device which either occludes the urethra or elevates the bladder neck and occludes the upper ½ of the urethra. Many of the proposed devices are designed to be placed in the vagina but retaining the device has been one of the main problems associated with their use. In an effort to increase the obstruction to the flow of urine, various other techniques have been used. More recently periurethral injections with various compounds have been used. The purpose of these injections is to obliterate the lumen of the urethra and thus reduce the urinary incontinence. Some of the substances injected include periurethral Teflon, injections of collagen and more recently periurethral injections of autogous fat. In some instances, urethral catheterization has been used to control incontinence. This carries a risk of significant infection. More recently, there have been various urethral plugs designed for inserting in the urethra to occlude the lumen. These plugs are disposable and have to be re-inserted after each voiding. Some of the plugs are retained by means of a balloon arrangement and these all carry the risk of urethral irritation and infection.
In summary, females are incontinent of urine for several reasons and there are various classifications of the problem. As a general observation, the condition- can be controlled by several non-surgical approaches. One can insert a urethral plug to retain the urine or a device can be used to elevate the bladder neck and occlude the upper half of the urethra. This will restore continence in most instances.
In German Patent Application No. 3139811, there is described a device in which a magnetic plate is surgically attached to the pubic bone. A tampon containing a magnet is inserted into the vagina and it is intended that the magnetic force between the plate and magnet will occlude the urethra. Test results indicate that this procedure has not been successful in all instances, possibly because of the spacing between the plate and magnet. Moreover, it is clearly desirable for the tampon to be disposable so that the inclusion of the magnet renders the procedure prohibitively expensive.
There have been other proposals to utilize magnetic attraction to retain a medical device, such as that shown in U.S. Pat. No. 4,154,226 or U.S. Pat. No. 3,952,726, both to Hennig, and U.S. Pat. No. 4,258,705 to Sorenson but these have not specifically addressed devices that are intended to overcome the practical problems associated with incontinence.
U.S. Pat. No. 3,926,175 shows a mechanical device intended to supplement bladder control but requires surgical implantation about the neck of the bladder and the application of an external mechanism to open or close the device. As such, its installation and operation is unduly complicated.
A further device is shown in U.S. Pat. No. 2,649,086, which includes a resilient ring with a radial protrusion that is inserted in the vagina and bears against the urethra. However, the careful placement of this device is critical to its successful operation and its retention is dependent purely upon the resilience of the ring.
There are several basic requirements that must be satisfied in the design of these incontinent devices. The device must be held in place and this applies whether. the urethra is occluded internally or the bladder neck and upper urethra are occluded by a vaginal device. In either instance of the device, provision must be made for the bladder to be emptied on a regular basis. In some circumstances it is preferable that this should be done without having to remove the appliance. The devices presently available do not meet such requirements satisfactorily and it is therefore an object of the present invention to obviate or mitigate the disadvantages present in such devices.
SUMMARY OF THE INVENTION
In general terms, the present invention provides an incontinence device which may be positioned to occlude the urethra and is retained in position by magnetic forces.
Although magnetic materials have had widespread industrial and domestic applications, they have had limited application in the design of biomedical devices principally because they lost magnetic power when implanted. The discovery of rare earth magnets has opened up a new area for biomedical research. These magnets containing neodymium boron and other compounds are readily available. Their attractiveness lies in the fact that they are up to 50 times stronger than the strongest ferrite or alnico magnets. The rare earth magnets are non-toxic and can be coated with biocompatible materials. This will allow them to be placed in the body and they do not lose their magnetic properties when coated.
The preferred embodiment of devices to be described utilize the power of the neodymium magnets and the numerous biocompatible materials which are available to design effective anti-incontinence devices. To complete the magnetic attachment, metallic depots can be established in various areas in the tissues of the female pelvis by injecting metallic material coated with biocompatible compounds. During the last 10 years, there are many reports of Teflon, collagen or fat being injected around the bladder neck and upper urethra in the female in an attempt to correct urinary incontinence. It is now possible to create metallic depots which will serve as anchoring stations for magnetic attachments of the incontinence devices. It is also possible to establish metallic depots in the vagina without injection by means of a pasted or incorporated into a small tampon.
In one preferred embodiment, a malleable support is provided to retain a tampon within the vagina. The support is retained by deposits of magnetic material injected into the vaginal wall and co-operating with magnets carried by the support. Accordingly,
Astorino Michael
Ladas & Parry
Shaver Kevin
LandOfFree
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