Surgery – Body inserted urinary or colonic incontinent device or... – Implanted
Reexamination Certificate
2003-09-25
2004-10-26
Lacyk, John P. (Department: 3736)
Surgery
Body inserted urinary or colonic incontinent device or...
Implanted
C600S037000
Reexamination Certificate
active
06808487
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to an implant for holding the female bladder, which can be used in particular for, treating a cystocele (cystoptosis) in association with stress incontinence.
BACKGROUND
To treat a cystocele, it is customary to suspend the bladder of a patient in a surgical procedure at four points using sutures. Two front sutures are made at the pubo-cervical fascia and the urethro-pelvic ligament, by which the bladder neck is held, whilst two rear sutures relate to the cardial ligaments and, if possible, the utero-sacral ligament, by which the bladder base is held. The bladder then comes to rest on the extended pubo-cervical or vesico-pelvic fascia. Such a surgery is costly, however, and stressful for the patient.
An implant is known from DE 195 44 162 C1 for suspending the female bladder in the case of bladder incontinence, which has an areal, flexible basic structure. Two first extensions and two second extensions start from a triangle-like-to-oblong-oval base. The two first extensions run on opposite sides of the longitudinal axis of the base, as do the two second extensions which are, however, aligned opposite to the two first extensions.
After such an implant has been inserted in open surgery, the bladder rests over a wide area of the implant, which enables a stable bilateral fixing of the bladder to be achieved both in the bladder neck area and the bladder vertex area. However, in this case the surgical procedure is also expensive and can be stressful for the patient.
A surgical instrument for treating female incontinence is described in WO 96/06567 and WO 97/13465, in which a strong bent surgical needle is attached to both ends of a tape made of polypropylene, which is guided using a detachable grip. The two needles are guided on opposite sides of the urethra of a patient via the vagina along the rear of the pubic bone to the outside of the abdominal wall. The tape comes to rest in a bend below the urethra. The two ends of the tape are pulled through the abdominal wall and cut off. They do not normally need to be sewn up, as the tape grows into the tissue relatively quickly. In the area of the urethra, the tape acts as a support without directly touching the urethra. The surgery is facilitated if the tape is provided with two covers which increase the sliding capacity in the tissue and are removed from the tape at the end of the surgery via the two outlets of the tape. With this method, bladder incontinence can be treated quickly, effectively and causing little stress. However, the method does not help in the case of a cystoptosis.
The object of the invention is to provide a possibility with which a cystocele which is associated with stress incontinence can be treated quickly, effectively and causing little stress to the patient.
SUMMARY OF THE INVENTION
This object is achieved by an implant for holding the female bladder with the features of claim
1
. Advantageous versions of the invention emerge from the dependent claims.
The implant according to the invention for holding the female bladder has an areal, flexible basic structure which has a base and two extensions. The base contains a front area and a rear area and has a longitudinal axis running from the front (anterior) to the rear (posterior). The two extensions start from the front area of the base and extend forwards, the distance between them increasing. Two front supports start from the free end areas of the two extensions and extend transversely with respect to the longitudinal axis of the base. There is a connection between the free end areas of the two extensions, a free space being formed between the connection, the two extensions and the base. Furthermore, two rear supports are provided which start from opposite sides in the rear area of the base and extend transversely with respect to the longitudinal axis of the base.
When the implant is inserted into a patient, the connection and the two front supports support the central urethra without lying directly against it, similar to what is known from WO 96/06567 and WO 97/13465. The front part of the bladder is also held via the two extensions and the front area of the base. The bladder neck lies in the free area between the connection, the two extensions and the base and thus has a freedom of movement such as is required for micturition. The two rear supports and the rear area of the base serve to support the bladder base. Whilst the two front supports are preferably guided relatively loose in the implanted state, the two rear supports can be taut in order to lift the bladder base up to the extent that a cystoptosis is eliminated. Using the implant according to the invention, stress incontinence and a cystocele can thus be treated simultaneously.
The implant according to the invention can be inserted relatively easily via the vagina, as described in more detail below. Essentially the same effect is thus achieved as with the operation technique mentioned at the outset in which fascia and ligaments are tightened by four sutures, but in a manner that is less stressful for the patient. The surgical procedure can be carried out under local anaesthetic, is relatively swift and entails less post-operative pain. The implant also ensures a long-lasting and secure holding of the bladder. Using the two front supports and the two rear supports, the support of the urethra and of the bladder base can be optimized.
Preferably, the base has a concavely rounded front edge which merges in a U-shape into the two extensions. This design is particularly advantageous for guaranteeing the bladder neck the required freedom of movement. Via the two front supports and the connection, the central urethra can be nevertheless supported, such that a bladder incontinence is effectively treated.
In a preferred version of the implant, the rear area of the base extends behind the two rear supports and there preferably has a convexly rounded rear edge. This zone enables an enterocele (intestinal hernia) to be treated (or an enterocele to be prevented) by closing the recto-vaginal sack. If necessary, this area of the base can be cut to size shortly before the surgery or during the surgery so that it is optimally matched to the anatomy of the patient. If it is not required, it can also be separated completely from the rest of the implant.
The implant can be supplied together with two surgical needles, one needle being attached to the free end of one front support and to the free end of the rear support located on the same side of the longitudinal axis of the base, whilst the other needle is attached to the free end of the other front support and to the free end of the other rear support. These surgical needles are preferably designed as strong bent needles and can be used with the help of additional gripping parts, similar to what is known from WO 96/06567 and WO 97/13465. In the case of the implant according to the invention, however, each needle is connected not only to one tape end but to two supports, namely one of the front and one of the rear supports. In this way, upon guiding of the needle through the tissue, the front support and the rear support can simultaneously be pulled into the tissue on one side of the implant. This facilitates and shortens the surgery and is advantageous for the patient because of the smaller number of puncture points.
Preferably, the two front supports and two rear supports are provided with movable covers. These covers are preferably made of smooth plastics material, e.g. of polyethylene or polypropylene film material, so that they facilitate the pulling-through of the front supports and the rear supports through tissue. As soon as the implant as reached its proposed position, the covers can be removed via the free ends of the front supports and the rear supports and therefore do not remain in the patient's body.
The two front supports are preferably marked in a different colour from the two rear supports. In this way, the surgeon can distinguish with certainty the free ends of the supports pulled through the tissue and the
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