Suburethral support assembly in treatment of female urinary stress incontinence

• US 20030004395A1
• Filed: 05/22/2002
• Published: 01/02/2003
• Est. Priority Date: 10/05/2000
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Therin, Michel
• Granted Patent: US 6,685,629 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

This assembly includes a suburethral supporting strip and a needle or similar sharp part designed to pass through the skin.

According to the invention:

a) the assembly includes a composite band comprised of at least the suburethral supporting strip and a flat protective sheath, said strip being disposed for example freely inside this sheath;

b) the flat sheath includes, in its lengthwise direction, two parts disposed on either side of a central separation area;

c) at each of its two ends the composite band has a single part of a lockable and unlockable connecting means, while the percutaneous needle has at least one other part of a connecting means, the connecting means of the composite band and each connecting means of the needle enabling the needle to be connected releasably to at least one of the ends of said composite band.

Claims

1. Surgical assembly for supporting the female urethra, comprising a suburethral supporting strip and a needle or similar sharp part designed to pass through the skin, characterized in that:

a) it includes a composite band comprised of at least the suburethral supporting strip and a flat protective sheath, said strip being disposed for example freely inside this sheath;

b) the flat sheath includes, in its lengthwise direction, two parts disposed on either side of a central separation area;

c) at each of its two ends the composite band has a single part, for example a single female part, of a lockable and unlockable connecting means, while the percutaneous needle has at least one other part, for example a male part, of a connecting means, the connecting means of the composite band and each connecting means of the needle enabling the needle to be connected releasably to at least one of the ends of said composite band.

2. Assembly according to claim 1, characterized in that the needle has connecting means at its proximal and distal ends.

3. Assembly according to claim 1, characterized in that the composite band has two end pieces each including or incorporating the same part of the connecting means.

4. Assembly according to claim 1, characterized in that the connecting means has two elements, one male and the other female, snappable into each other.

5. Assembly according to claim 4, characterized in that the blunt proximal end of the percutaneous needle is spatulate and in that each end piece of the flat sheath has a slot designed for penetration of said spatulate proximal end, with a means for holding said end that is manually lockable and unlockable.

6. Assembly according to claim 5, characterized in that the blunt proximal end of the percutaneous needle has a through-slot for penetration of the holding means.

7. Assembly according to claim 1, characterized in that the central portion of the composite band has a breakable linking means formed by an adhesive outer sleeve that can be torn off by a shearing force for example, connecting the two inside ends of the two parts of the flat sheath both of which are adjacent to the separating area.

8. Assembly according to claim 1, characterized in that it additionally includes a flat, flexible piece for joining two pieces of the supporting strip, obtained by cutting said strip transversely, said piece including two opposite means for gripping two adjacent ends of the two pieces, respectively.

9. Assembly according to claim 8, characterized in that each gripping means includes a means for gripping one end of the supporting strip.

10. Assembly according to claim 8, characterized in that each gripping means includes a means for stapling one end of the supporting strip, for example a pin to pass through the strip with a head snappable onto said pin.

11. Assembly according to claim 1, characterized in that the supporting strip includes a filet stitch fabric, made of monofilaments or multifilaments of a biocompatible synthetic material, for example polypropylene or polyester.

12. Assembly according to claim 1, characterized in that the supporting strip is fully or partially made of biological tissue or material, for example collagen.

13. Assembly according to claim 1, characterized in that the protective sheath is obtained from a synthetic material with a low coefficient of friction, for example PTFE.

14. Assembly according to claim 1, characterized in that each band-connecting means has an axial finger provided with projecting circular ribs, forming bulges, and an elastically deformable tubular portion whose inside diameter is slightly less than the diameter of the finger.

15. Assembly according to claim 14, characterized in that at least the proximal end of the needle has a conical terminal part whose diameter increases in the direction of the central area of the needle, and a cylindrical portion with a smaller diameter than the base diameter of the conical portion, this cylindrical portion thus delimiting a shoulder with the base of the conical portion, the base of said conical portion having a larger diameter than the inside diameter of the tubular portion and being frictionally engageable in said tubular portion, causing circumferential stretching of the wall of this tubular portion, said conical portion also having a relatively steep slope and a small cross section such that it is able to pierce the bodily tissues of the patient.

16. Assembly according to claim 1, characterized in that the needle is formed of a curved, sharp part of an instrument, able to pass through the bodily tissues of the patient, passing through the foramen of the pelvis until it emerges through the vaginal incision.

17. Assembly according to claim 16, characterized in that said curved, sharp part has a rigid outer portion and a flexible inner portion that can slide along the radially inner face of said rigid outer portion, this rigid outer portion and flexible inner portion having distal ends;

said flexible inner portion is movable relative to said rigid outer portion between an advanced position and a retracted position;

in said advanced position, the distal end of said flexible inner portion forms, with the distal end of said rigid outer portion, a conical portion with a steep slope and relatively small cross section enabling engagement of said curved, sharp part through the bodily tissues of the patient;

in the retracted position, the distal end of the flexible inner portion is retracted from the distal end of the rigid outer portion;

the distal end of the rigid outer portion has a proximal notch delimiting a sharp edge giving it a “

harpoon”

shape and, in this retracted position, is able to penetrate slightly into the wall of said tubular portion when this tubular portion is engaged therewith.

18. Method for placement or implementation of a surgical assembly according to claims 1 to 15, wherein:

by inserting the needle through the vagina, the needle is caused to penetrate upward, on one side of the patient, bypassing the bladder;

hence, the composite band is engaged in the path in the body thus created;

the needle is disconnected from the end of the composite band and connected to the other end of the same band;

then the needle is inserted in the upward direction, on the other side of the patient, still bypassing the bladder;

thus, the composite band is engaged in the bodily path thus created, the needle is disconnected from the composite band, then the two parts of the sheath are extracted and the supporting strip is released below the urethra.

19. Method for placement or implementation of a surgical assembly according to one of claims 1 to 15, wherein:

the needle is inserted downward, on one side of the patient, bypassing the bladder and emerging through the vagina;

the needle is inserted upward, on the other side of the patient, bypassing the bladder and emerging at the subpubic level;

the needle is disconnected from the composite band then the two parts of the sheath are extracted and the supporting strip is released below the urethra.

20. Method for placement or implementation of a surgical assembly according to one of claims 8 to 15, wherein:

the needle is inserted downward, on one side of the patient, through the abdominal wall, bypassing the bladder and emerging through the vagina;

the composite band is thus engaged in the bodily path thus created when the linking means is outside the vagina, and the composite band is cut on either side thereof to create two parts, one part remaining inside said path and the other outside the vagina;

the needle connected to the other part of the composite band is then inserted downward from the abdominal wall, on the left side, bypassing the bladder and emerging through the vagina;

thus, said other part of the composite band is engaged in the bodily path so created, then the emerging portion of said other part of the composite band is cut;

by pulling on the parts of the sheath of said parts of the composite band, the latter parts are stripped then said joining part is put in place;

subpubic traction is applied to the parts of the composite band in order to bring the joining piece to the suburethral position, then the two parts of the sheath are withdrawn to release the supporting strip.

21. Method for placement or implementation of a surgical assembly according to one of claims 14 or 15, wherein:

the needle is inserted through the abdominal wall from a subpubic incision until it emerges from the vagina;

the distal end of the needle emerging from the vagina is connected to said tubular portion of one of the ends of the composite band;

the needle is retracted so as to engage the composite band through the bodily path that the needle has created until the composite band emerges at the subpubic level;

the same steps are repeated on the other side of the pelvis then the sheath parts are withdrawn and the strip is put in place.

22. Method for placement or implementation of a surgical assembly according to one of claims 16 to 17, wherein:

said curved, sharp part is inserted through the bodily tissues passing through the foramen of the pelvis until it emerges from the vagina, said flexible inner portion being in the advanced position,

said flexible inner portion is retracted then the tubular portion of one end of the composite band is engaged with the harpoon-shaped distal end of said rigid outer portion;

said curved, sharp part is withdrawn in order to engage the composite band through the bodily path created by means of this curved, sharp part,

the same steps are repeated on the other side of the pelvis then the two sheath parts are withdrawn and the strip is set in place by pulling on its emerging ends.