ES2222080B1 - NEEDLE FOR SURGICAL TECHNIQUE FOR THE CORRECTION OF FEMALE INCONTINENCE. - Google Patents

Abstract

Needle for the surgical technique for the correction of female incontinence, which has a tip and a curved part that passes into the patient's body vaginally and is sized to extend from the inner surface of the vaginal wall over the back from the pubic bone to the outside of the abdominal wall, the interior of the needle being hollow in its curved part and said hollow interior having at least one anterior window arranged at the tip of the needle or in its vicinity, and a window posterior, so that if there was bladder perforation, the bladder fluid flows from the anterior window to the hollow interior and from the latter to the posterior window that witnesses the surgeon. Of application in surgery.

Description

Needle for surgical technique for correction of female incontinence.

This invention focuses on the field of surgery related to the surgical techniques used today for the correction of stress urinary incontinence (I.U.E.) of women.

Urinary incontinence is a problem medical and social for a large number of women and therefore has been a subject of study and research for many years, which has allowed progress in the field of its pathogenesis and treatment.

Pelvic floor muscle reeducation can improve or solve 50-60% of cases of I.U.E. mild or moderate, however surgery remains the only alternative for women who do not respond to treatment conservative or that by the intensity of your symptoms the surgery will poses as the first therapeutic option.

Burch's colposuspension, either by laparotomy or endoscopically, the technique of choice for the treatment of the I.U.E. in patients with urethral hyperemobility with long-term, superior results 80%, deserving the nickname of "Gold Standard" among more than 200 surgical techniques described for the correction of I.U.E.

The appearance of a new surgical technique "TVT or SUBURETAL TENSION FREE BAND" band in a new Foundation has revolutionized this field. The new foundation it consists of the hammock effect of the placed band, not the neck bladder, but in the middle urethra which allows a strengthening of the pelvic floor precisely where it falls during the effort and that causes the system to fail Sphincterian

The spectacular results achieved since ULMSTEN published the technique of T.V.T., object of EP Patents 0 778 749 and EP 0 854 691, among others, has allowed in this short space of time that is currently the most used in the correction of the I.U.E. in the centers that closely follow the Surgery advances in this field.

The T.V.T. (Tension-Free Vaginal Tape) uses a tape Polypropylene mesh (Prolene®) that is inserted vaginally by a special needle; this band is in the middle urethra and Self-set without suturing. The intervention is performed with anesthesia local or regional, inviting the patient to cough or strain during the surgical maneuver, which allows to assess the minimum tension needed to ensure continence, eliminating a excessive traction and thus avoid or reduce retention.

The first 5-year results provide cure rates between 85 and 90%. Results greater than those obtained with the best techniques available until this moment. With this technique little tissue destruction occurs, the intra and postoperative morbidity is low; therefore the stay hospitalization is reduced, the economic cost is low and the Recovery of the patient for her normal life is fast.

Following the promising results and with the expectation that this new concept for the management of the I.U.E. revolutionize your treatment, several commercial firms have systems similar to T.V.T., which with small variations in the type of mesh and in the form of application  they intend to improve these already good results or decrease the number of complications These include the SPARC system, which provides as variation that the introduction of the needles is performed through a suprapubic approach (which would attempt reduce the risk of bladder injury and although more rare of injury vascular).

Bladder perforation is the most complicated frequent in tension-free suburethral band techniques. This possibility requires the performance of a cystoscopy of control during the surgical procedure since if the Bladder lesion must be repositioned.

This complication is solved with the needle object of the invention.

The object of the present invention is a "Hollow or tunneled needle" to place the suburethral band tension free in such a way that prevents the realization of a control cystoscopy that until now was essential in this intervention.

The needle for the surgical technique for correction of female incontinence, of the present invention, It has a tip and a curved part that passes inside the the patient's body vaginally and being sized to extend from the inner surface of the vaginal wall over the back of the pubic bone to the outside of the abdominal wall, it is characterized because the inside of the needle is hollow in at least part of said curved part and disposing said hollow interior of at least one anterior window arranged in the needle tip or in its vicinity, and a rear window, so that if there were bladder perforation the bladder fluid flow from the previous window to the hollow interior and from this to the rear window

This initial and main objective translates into Three consequences of great practical interest.

1.- Reduction of surgical time

The tension-free suspension technique for correct the I.U.E. was described by ULF ULMSTEN with the essential probing of the bladder for the passage of the needles through the retro-pubic space and subsequent placement of the suburethral band After the passage of one of the needles or both there are have to perform a cystoscopy to check for bladder injury (Bladder perforation).

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The TVT technique has been modified later. This modification is based on the passage of the needles with a full bladder so that the tip of the needle slides better over the full bladder and remakes it more easily, reducing the number of perforations. The full bladder also moves away from the back of the pubis. It is in this modified TVT (full bladder) where this application has full application

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With the new needle tunneled or channeled if there would be bladder perforation, when the bladder hit the liquid flows through the needle and exits through the hole or window later, next to the terminal end of it, becoming evident the intraoperative accident, and thus avoiding the cystoscopy

The suppression of cystoscopy involves a significant reduction in the overall surgical time of the intervention estimated at approximately 30%.

2.- Reduction of morbidity

In the technique of T.V.T. after the passage of needles to fill the bladder to perform a cystoscopy and Discard a bladder lesion. If it shows that there are drilling (always two holes one inlet and one outlet), the needle must be removed, the bladder must be emptied again introduction of the needle, new probing to fill the bladder and new cystoscopy

In the case of the tunneled needle that presents, the intervention begins with a full bladder and in the if there was perforation, the serum of the bladder filling it would flow at the first moment through the rear window of the needle (only one hole is produced in the bladder, the entrance). In this moment the needle slightly recedes and again the retropubic step, slightly lateralizing the way forward. In no time must the patient be re-probed (fill-empty-fill). With this new needle avoid duplicating the holes in the bladder after the drilling of this and repeated drilling is eliminated during intervention.

Another important aspect in reducing morbidity is that frequently and in expert hands, after drilling bladder cystoscopy is completely normal without detecting the complication and it is, by completely passing the needle and taking out this the abdomen, when the serum that fills the bladder comes out after the last filling probe prior to cystoscopy. This piercing is the more complex since the band with the sheath also go through the bladder.

With the tunneled needle this case cannot be given because the serum enters the first bladder corresponding and the intervention is not continued.

3.- Increase in the dissemination of correction techniques from I.U.E. with tension free band

These techniques have displaced all made so far becoming the most used in the surgical treatment of the I.U.E.

Performing a control cystoscopy in Tension-free band techniques have not left many gynecologists, for not having the corresponding equipment (cystoscope) and / or for not being familiar with cystoscopy, begin in these techniques that on the other hand would still enjoy wider dissemination

To better understand the purpose of this invention, a preferred form of practical realization, susceptible to accessory changes that do not distort its foundation.

Figure 1 is a sectional view of a practical embodiment of the needle object of the invention.

An example of practical, non-limiting embodiment of the present invention.

The needle (1) can be externally similar to those represented in EP 0 778 749 and EP 0 854 691, that is, curved and so that it passes into the patient's body vaginally and being sized to extend from the internal surface of the vaginal wall on the back of the pubic bone to the outside of the abdominal wall.

This longitudinal dimensioning can be between 160 and 200 mm.

It is an object of the invention that the needle (1) bent, is hollow, that is, approximately tubular and preferably of circular section with an outside diameter of 3 to 7 mm.

At the tip (2) of the needle (1) or its proximities, there is at least one previous window (3) being the window (s) (3) in communication with the interior (4) needle hole (1) so that if there were bladder perforation bladder fluid flows through said window (s) (3) before the inside (4) of the needle (1) and through it can exit through a rear window (5) of the needle (1) that communicates subsequently the inside (4) of the needle with the outside and that Witness the surgeon.

Figure 1 shows two small windows (4) near the tip (2) one of them being in the curvature concave and the other in the convex curvature of the needle (1). In the near the distal end (6) the needle (1) has a window posterior (5) in the concave part, that is, facing the surgeon.

Preferably the hollow interior (4) is extend throughout the curved part of the needle (1).

The distal end (6) of the needle (1) that can being straight can be arranged in a known way for coupling to surgical instruments, tapes, sleeves, handles, etc., necessary for use in surgery.

The incorporation into the needle (1) of optical fibers (7) and vision means (8) that starting from the rear window (5) or another, and going through the hollow inside (4) of the needle (1) reach at least one of the anterior windows (3) so that the surgeon can arrange in screen, or similar means, a helpful view of the position of the tip (2) of the needle (1) inside the patient and a Continuous monitoring of surgical intervention.

Claims (5)

1. Needle for the surgical technique for the correction of female incontinence, which has a tip and a curved part that passes into the patient's body vaginally and is sized to extend from the inner surface of the vaginal wall over the posterior part of the pubic bone to the external part of the abdominal wall, characterized in that the interior of the needle is hollow in, at least part of said curved part and said hollow interior having at least one anterior window arranged at the tip of the needle or in its vicinity, and a posterior window, so that if there was bladder perforation the fluid from the bladder flows from the anterior window to the hollow interior and from this to the posterior window. 2. Needle for the surgical technique for the correction of female incontinence, according to the preceding claim, characterized in that it has an anterior window in the concave curvature and an anterior window in the convex curvature. 3. Needle for the surgical technique for the correction of female incontinence, according to previous claims, characterized in that the posterior window is arranged in the concave curvature. 4. Needle for the surgical technique for the correction of female incontinence, according to claim one, characterized in that the inside of the needle is hollow in the entire curved part. 5. Needle for the surgical technique for the correction of female incontinence, according to previous claims, characterized in that it comprises the hollow interior of the fiber optic needle that optically communicates at least one of the anterior windows with the outside so that the surgeon can continuously observe the surgical intervention.