Surgical instrument for treating female urinary incontinence

- 28036 Madrid

IS 2 170 880 T3

DESCRIPTION

Surgical instrument to treat female urinary incontinence.

The invention relates to a surgical instrument for treating female urinary incontinence, of the type described in document WOA-9003766, which comprises a stem equipped with a handle at one of its ends, and an element in the form of a curved needle that is made to join the stem to form a curved portion.

Document WO-A-9606567, which corresponds to the prior art, according to Article 54 (3) EPC, describes a surgical device for incontinence that allows to alleviate female urinary incontinence, while restoring continence through the union of two needles curved to a tape, intended to be permanently implanted within the tissue located between the vaginal wall and the abdominal wall of the patient, thus reinforcing the tissue necessary to alleviate urinary incontinence. The surgical instrument according to the present application is an improvement of said instrument, in which the tape comprises a net or mesh enclosed in a thin plastic wrap, which facilitates insertion while avoiding irritation or damage to the body tissue.

We will explain the invention in greater detail with reference to the accompanying drawings, which disclose the surgical instrument according to the invention and in which fig. 1 is a side view of the surgical instrument according to the invention, fig. 2 is a plan view of the surgical instrument, fig. 3 is an exploded side view of one of the needles and of the tape, as well as of the flexible contraction tube intended to be attached to said needle, fig. 4 is a side view of the needle of FIG. 3, with the tape attached thereto, fig. 5 is a fragmentary view in axial section of a coupling of the instrument for connection with an interchangeable needle, and fig. 6 is a side view of two needles and a tape that interconnects said needles.

In the description that follows, the same reference numbers are used as in WO-A-9606567 for the corresponding details of the instrument.

The surgical instrument comprises a tubular cylindrical stem 10 having at one end a handle 11. At the other end of the stem is a sleeve 14. There is a cylindrical shaft 15 mounted in a rotatable arrangement within the stem, which can be manually rotated by means of a knob 16 mounted on one end of the shaft. The other end of the shaft forms a cylindrical portion 17, fig. 5, with a smaller outside diameter than that of the shaft, which is joined to a threaded portion 18, a smooth end portion 19 of a smaller diameter being attached to the threaded portion 18, and the terminal portion 19 forming a guide pin in the other end of the shaft. Portions 18 and 19 are received in the portion of sleeve 14 that projects from the stem. The described surgical instrument matches the instrument described in WO-A-9606567, except that the end portion 14 'of the sleeve 14 is flattened from opposite sides (see Figs. 1 and 2), whereby the cross section of said end portion is not circular.

The surgical instrument also includes a disposable, changeable needle 21 that is attached at one end to the stem and projects at its free end substantially in a quarter of a circle, to practically follow the profile of the pubis between the vagina and the abdominal wall. The needle has a uniform circular cross section and has a smooth, preferably polished outer surface. At its free end, the needle ends at a point 22, the end of a koanic portion.

For the union of the needle 21 to the stem 10, the needle forms at said first end a straight part 30, which is cylindrical but has flat rolled faces 31 on that part of said portion 30, which extend from the adjacent end. of the needle, received in the portion 14 'of the sleeve. The needle must be oriented in a predetermined rotary position relative to the stem, and more particularly will project at right angles to the plane of the handle 11. This rotary position is ensured by the non-circular shape of the sleeve portion 14 'and by the fact that the terminal portion of the needle has the flat faces 31 that fit into the sleeve portion 14 '. The end portion of the needle provided with the flats 31 is attached to the body of the needle by a tapered portion 32, which tapers towards a support flange 33.

An axial blind hole projects from the terminal surface of the needle, this hole having a threaded portion 23 and towards its interior a narrower cylindrical portion 24. The guide pin 19 is dimensioned to be received in a displaceable arrangement in said last portion when the threaded portion 18 for the connection of the needle 21 to the rest of the surgical instrument is screwed into the threaded portion 23 of the blind hole by means of rotation of the shaft 15 by manual rotation of knob 16, pressing together the terminal surfaces of the stem and needle. Also this coupling coincides with that described in document WO-A-9606567.

When the procedure is put into practice, they will continue to be described in document WO-A-9606567, two needles 21A and 21B are connected, fig. 6 of the embodiment described, one at each end of a tape 26. According to the present invention, the tape of the preferred embodiment comprises a mesh or net with openings of the order of 1 mm. A suitable material for making the tape is PROLENE®, a woven polypropylene mesh having a thickness of 0.7 mm, manufactured by Ethicon, Inc., Sommerville, New Jersey, USA. This material is approved by

IS 2 170 880 T3

FDA in the United States for implantation within the human body. The mesh (tape) preferably has a width of about 10 mm and is within a thin polyethylene wrap 34 which in flattened condition has substantially the same width as the tape, although a difference in width has been depicted in FIG. 2 to more clearly present the existence of the envelope. The length of the mesh will be approximately 400 mm. The mesh and the sheath are interconnected by means of two rows 35 of stitches. The terminal portion of the sheath is attached to the conical portion 32 of the water by means of a suitable strong glue and the intercommunication of the needle and the sheath is covered by a flexible contraction tube 36 made of rubber extending from the Support flange 33 on the conical portion 32 and partially on the cylindrical end portion 30 of the needle. The contraction hose is substantially flush with the surface of the needle at the support flange portion. By this arrangement, the mesh is firmly attached to the needle.

The purpose of the wrap 34 is above all to facilitate the insertion of the mesh in the manner described in document WO-A-06567, that is, when the ends of the mesh are pulled from the vaginal wall towards the abdominal skin. and to prevent rough edges of the mesh from irritating or injuring body tissues.

Once the tape was placed in the correct position as a suspension band around the urethra, the polyethylene wrap was removed and to facilitate its removal, it was perforated in its longitudinal center, as indicated by a mixed lone37 in the figure. 6, so that the two halves of the casing could be removed from the body by pulling the respective outer ends of the casing, separating the halves by perforation under the influence of the pulling force.

The purpose of the polyethylene wrap is also to protect the mesh during attachment to the needles and during handling prior to, and in the course of, insertion into the body.

The longitudinal center of the tape and of the wrap should be indicated by a visible color mark 38, fig. 6, so that the surgeon can easily appreciate when the mesh remains symmetrically located with reference to the urethra during the surgical operation.