Surgical instrument for treating female urinary incontinence

(54) (56) (57)

Assignee

INVENTOR'S OFFICE

Medscand AB, Box 20047 200 74 Malmö KB Ulmus, Box 60201 216 09 Malmö SE

SEE

Ulf Ulmsten, Danderyd SE, Jan Clarén, Lund SE Ström & Gulliksson AB

NAME Instrumentarium for the treatment of urinary incontinence in women and methods for such treatment

CALLED PUBLICATIONS:

EP A2 598 976 (A61B 17/04), WO Al 90/03766 (A61B 17/42)

SUMMARY:

The invention relates to an instrument and method for treating urinary incontinence in women.

The instrumentation comprises a shank (10) with a handle (11) at one end and two curved hinge-like elements (21A, 21B) connected at one end to each end of a band (26) intended to be implanted in the body. These elements are interconnectable with the shaft at the other end of it to form a curved end portion of the shaft and are intended to be inserted into the body via the sheath, each element being sized to extend from the inside of the sheath wall to the outside of the abdominal wall.

In applying the method, the band (26) is inserted into the body via the sheath (28) first with one end and then with the other end on one and the other side of the urethra (30) to form a bend below the urethra. The strap is advanced over the pubic bone (31) and through the abdominal wall (32) and eaten to bring the urethra into the steering wheel relative to the pubic bone. The tape is then left in the body.

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The numbers in brackets indicate international identification code, INID code. Letters in clamps indicate international document code.

Γ ·, Λ;

The invention relates to instruments and methods for treating urinary incontinence, ie inability to control urinary output, in women.

Urinary incontinence can be caused by the tissue or ligaments connecting the abdominal wall to the abdominal wall being in poor condition.

US-A-5 112 344 discloses a method for treating urinary incontinence in women without having to open the abdomen, which would require a hospital stay of maybe four days, inserting a band into the body and implanting between the abdominal wall and abdominal wall extending over the pubic bone. and on both sides of the urethra. The band is tightened to bring the abdominal wall and urethra into the correct position relative to the pubic bone and is quarantined to form scar tissue around the band, which acts as a supporting ligament in the soft tissue. When such scar tissue is formed, which takes about two months, the band is removed from the body.

It is also proposed a specially designed instrumentation for carrying out this method, including a shank with a handle at one end and a curved portion at the other end, intended to be inserted into the body via the sheath.

The result obtained in such operations is not always satisfactory because not enough scar tissue is formed due to the poor condition of the soft tissue between the abdominal wall and abdominal wall.

The invention aims to provide an improved and simplified surgical technique with significantly better prognosis with regard to the restoration of urinary incontinence, and in

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For this purpose, an instrument of the above type is proposed with the features set forth in claim 1.

According to the invention, there has also been provided a method of treating urinary incontinence in women according to claim 17. In this way, too, a band is inserted into the tissue between the abdominal wall and the abdominal wall, but this band not only serves to stimulate the appearance of scar tissue, but must remain permanently in the body to form itself as an artificial ligament the reinforcement of the tissue required for that urinary incontinence should be restored, or to provide this enhancement through stimulation of fibroblast formation.

The invention will be explained in more detail with reference to the accompanying drawings, which show the instrumentation according to the invention and various operating steps in practicing the method according to the invention using this instrument, whereby

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<td colspan="2">of the same,</td><td></td><td></td><td></td><td></td><td></td>

<td>Figure</td><td> 2</td><td>is</td><td>one</td><td>plan view of</td><td>the surgical instrument,</td><td></td>

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scale of a coupling in the instrumentation for attaching a replaceable portion thereof;

FIGS. 4-10 schematically illustrate various operating steps in the method of the invention and

FIG. 11 similarly shows the final step of the method.

The instrumentation comprises a cylindrical tubular shaft 10 having at one end a handle 11, forming two opposite wings in the same plane protruding wings 12 and an opening 13. At the other end of the shaft is a sleeve 14 partially pushed onto the shaft. and is soldered or welded thereto, a portion of the sleeve projecting from the shaft at its other end. A cylindrical shaft 15 is pivotally mounted in the shaft and can be rotated manually by means of an externally threaded steering wheel 16 which is secured to one end of the shaft and accommodated in the opening 13, while the other end of the shaft forms a cylindrical portion 17 with a smaller outer diameter than the shaft. in an externally threaded portion 18, to which is joined a smooth end portion 19 of further reduced diameter, forming a guide pin at this end of the shaft. The portions 18 and 19 are received in the shaft 14 protruding portion of the sleeve 14, and a shaft 20 projecting protrusion 20 is also accommodated therein.

The part of the instrumentation now described is intended for multiple use and should therefore consist of a material that can be sterilized by autoclaving, for example stainless steel.

The instrumentation also includes a disposable element 21 for single use, which is to be called a needle. It is fixed with a straight portion to the shaft at one end and extends over substantially a quarter of a circular arc to its other free end to substantially follow the profile of the pubic bone between the vagina and abdominal wall. The needle has a circular cross-section and smooth, preferably smooth exterior, and it tapers slightly toward the free end, where, through faceting, it forms a tip 22, but it can also be blunt and have a transversely cut end. The practical use of the instrumentation may show which design is preferred. The needle should be made of tissue-friendly plastic, and a suitable material is polycarbonate.

For attaching the needle 21 to the shaft 10, the needle at said one end, where the needle forms a straight portion to be accommodated therein in the sleeve 14, is formed with an axial bottom hole extending from the end surface with a threaded portion 23 and an inner portion thereof. narrower, cylindrical portion 24. The guide pin 19 is dimensioned to receive guide in the latter portion as the threaded portion 18 for attaching the needle 21 with the other portion of the instrumentation is screwed into the threaded portion 23 of the bottom hole by rotating the shaft 15 by manual rotation of the steering wheel 16. whereby the end surfaces of the shaft and needle are pressed against each other. The needle should be oriented in a predetermined pivot position relative to the shaft, namely, to project perpendicularly to the plane of the handle 16, and this pivot position is ensured by accommodating the lug 20 on the shaft in a corresponding recess 25 in the needle surface of the needle.

The portion 23 of the needle 21 may be without threads and be so sized that the threaded portion 18 of the shaft 15 cuts a thread in the plastic material of the needle at the screw of ice.

When both parts of the instrumentation are screwed together in the manner described, they form a rigid unit which can be controlled with great precision at the handle 11 when used to carry out an operation using the method of the invention.

In practicing the method of the invention, two needles 21A and 21B of the disclosed nature shall be connected to each end of a tape 26, FIG. 4, and this connection may be effected by threading the tape through a hole 27, FIG. 3, in the needle adjacent to it. the end attached to the shaft, or by the tape being pasted or ultrasonically welded to the needle or by baking the tape end into the plastic material of the needle during injection molding of the needle.

The band should be a woven band with openings between the weft and warp of the order of 0.1 mm in order for fibroblasts to grow into the band for anchoring this to the surrounding tissue. A suitable material for the band is polypropylene, which may be coated with a fibroblast stimulating agent, for example an enamel protein derivative. The band is preferably 6 to 7 mm wide and about 1 mm thick. When the belt surgery is to begin, one needle 21A is attached to the shaft 10, while the other needle 21B hangs loosely in the belt 26, as shown in FIG. 4th

In FIGS. 4 - 11, the affected parts of the woman's abdomen are shown very schematically, the vagina being designated 28, bladder 29, urethra 30, pubic bone 31 and abdominal wall 32.

The first step in the operation of the tape 26 is shown in FIG. 4 and consists of the needle 21A being inserted through the abdominal wall, after first making a cut therein, and through the soft tissue on one side of the urethra 30 and then being inserted through the abdominal wall according to FIG. above the pubic bone

31st An incision can be made through the abdominal wall for the passage of the needle through the same, but if the needle is pointed, it may suffice to insert the needle into the abdominal wall from the inside thereof and make an oncoming incision in the abdominal wall on the outside thereof.

The shaft of the instrumentation is now disconnected from the needle 21A, FIG. 6, by rotating the shaft 15 at the steering wheel 16 so that the threaded portion 18 of the rod is unscrewed from the threaded portion 23 of the needle 21A, after which the needle 21A is pulled out with a pin or the like. by the abdominal wall and the band 26 is drawn into and through the tissue, as illustrated in FIG. 7th

The second needle 21B is now attached to the shaft, FIG. 8, and passed through a cut in the abdominal wall to pass through the soft tissue on the other side of the urethra 30. The needle 21B is passed through the abdominal wall, FIG. 9, and then pulled away from the abdominal wall. the shaft, out through the abdominal wall, FIG. 10, all in the same way as previously done with the needle 21A.

The strap 26 is now placed on either side of the urethra 30, as shown in FIG. 10, and is tightened with the bow formed by the strap located on the inside of the abdominal wall, FIG. of the band on the outside of the abdominal wall is cut off and the band ends by suture are attached to the abdominal wall. The band is then left in the body as an implant to form an artificial ligament, which is attached to the abdominal wall and provides the support for the urethra needed to restore urinary incontinence.

Another type of tape which can be used in the method of the invention may be denser woven than the above tape and may be of such material that the tape undergoes complete resorption after a short or longer period. However, the fibroblast formation stimulated by the band achieves the desired tissue reinforcement required to restore urinary incontinence.