Suburethral support assembly in treatment of female urinary stress incontinence

• US 6,685,629 B2
• Filed: 05/22/2002
• Issued: 02/03/2004
• Est. Priority Date: 10/05/2000
• Status: Expired due to Term

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Therin, Michel
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US10/151,982
• Publication Number:
  US 20030004395A1
• Time in Patent Office: 622 Days
• Field of Search: 600/29, 600/30, 600/37, 128/DIG.25, 128/897, 128/898, 606/118-119, 606/138, 606/139, 606/140, 606/141, 606/145, 606/222, 606/223-228
• 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

An assembly includes a suburethral supporting strip and a needle or similar sharp part designed to pass through the skin, and a composite band including at least a flat protective sheath, the suburethral supporting strip being disposed for example freely inside this sheath; the flat sheath including, in its lengthwise direction, two parts disposed on either side of a central separation area and at each of its two ends the composite band has a single part of a lockable and unlockable connecting device, while the needle has at least one other part of a connecting device, the connecting device of the composite band and each connecting device of the needle enabling the needle to be connected releasably to at least one of the ends of the composite band.

Claims

1. Surgical assembly for supporting the urethra of a female patient, comprising a composite band, a suburethral supporting strip and a percutaneous needle or similar sharp part designed to pass through the skin of the patient, wherein:

a) the composite band comprises at least the suburethral supporting strip and a flat protective sheath;

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

c) each of two ends of the flat sheath of the composite band has a single part of a lockable and unlockable connecting means, and 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.

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

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

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

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

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

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

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

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

10. Assembly according to claim 8, wherein each gripping means includes a means for stapling one end of the supporting strip.

11. Assembly according to claim 10, wherein said means for stapling one end of the supporting strip comprises a pin to pass through the strip with a head snappable onto said pin.

12. Assembly according to claim 1, wherein the supporting strip includes a filet stitch fabric, made of monofilaments or multifilaments of a biocompatible synthetic material.

13. Assembly according to claim 12, wherein said biocompatible synthetic material is at least one member selected from the group consisting of polypropylene and polyester.

14. Assembly according to claim 12, wherein said assembly additionally includes a flat, flexible piece for joining two pieces of the supporting strip obtained by cutting said strip transversely, said flexible piece including two opposite gripping means for gripping two adjacent ends of the two pieces, respectively.

15. Assembly according to claim 1, wherein the supporting strip is fully or partially made of biological tissue or material.

16. Assembly according to claim 15, wherein said biological tissue or material is collagen.

17. Assembly according to claim 15, wherein said assembly additionally includes a flat, flexible piece for joining two pieces of the supporting strip obtained by cutting said strip transversely, said flexible piece including two opposite gripping means for gripping two adjacent ends of the two pieces, respectively.

18. Assembly according to claim 1, wherein the protective sheath is obtained from a synthetic material with a low coefficient of friction.

19. Assembly according to claim 18, wherein said synthetic material is PTFE.

20. Assembly according to claim 18, wherein said assembly additionally includes a flat, flexible piece for joining two pieces of the supporting strip obtained by cutting said strip transversely said flexible piece including two opposite gripping means for gripping two adjacent ends of the two pieces, respectively.

21. Assembly according to claim 1, wherein each 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.

22. Assembly according to claim 21, wherein at least the proximal end of the needle has a conical terminal part whose diameter increases towards a central area of the needle, and a cylindrical portion with a smaller diameter than a base diameter of the conical portion, said cylindrical portion thus delimiting a shoulder with the base of the conical portion, said 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 a wall of the tubular portion, said conical portion also having a steep slope and a small cross section such that said conical portion is able to pierce the bodily tissues of the patient.

23. Assembly according to claim 21, wherein the needle is formed of a curved, sharp part of an instrument, able to pass through bodily tissues of the patient by passing through the foramen of the pelvis of the patient until it emerges through a vaginal incision.

24. Assembly according to claim 23, wherein said curved, sharp part has a rigid outer portion and a flexible inner portion that can slide along a radially inner face of said rigid outer portion, said rigid outer portion and said flexible inner portion having distal ends;

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

wherein 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 bodily tissues of the patient; and

wherein in said 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 having a proximal notch delimiting a sharp edge giving it a harpoon shape and, in this retracted position, is able to penetrate into the wall of said tubular portion when this tubular portion is engaged therewith.

25. Assembly according to claim 21, wherein said assembly additionally includes a flat, flexible piece for joining two pieces of the supporting strip obtained by cutting said strip transversely, said flexible piece including two opposite gripping means for gripping two adjacent ends of the two pieces, respectively.

26. Assembly according to claim 1, wherein said strip is disposed freely inside said flat sheath.

27. Method for placement or implementation of a surgical assembly according to claim 1, comprising:

connecting the needle to a first end of the composite band;

inserting the needle and first end through the vagina of the patient, whereby the needle is caused to penetrate upward, on one side of the patient, bypassing the bladder of the patient, and the composite band is engaged in a path in the body thus created;

disconnecting the needle from the first end of the composite band and connecting the needle to the second end of the composite band;

inserting the needle and second end in an upward direction, on the other side of the patient, bypassing the bladder, whereby the composite band is engaged in the bodily path thus created;

disconnecting the needle from the second end of the composite band; and

extracting the two parts of the sheath, thus releasing the supporting strip below the urethra.

28. Method for placement or implementation of a surgical assembly according to claim 1, comprising:

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

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

disconnecting the needle from the composite band; and

extracting the two parts of the sheath, thus releasing the supporting strip below the urethra.

29. Method for placement or implementation of a surgical assembly according to claim 8, comprising:

inserting the needle downward, on a first side of the patient, through the abdominal wall of the patient, bypassing the bladder of the patient and emerging through the vagina of the patient, thus engaging the composite band in the bodily path thus created when the connecting means is outside the vagina;

cutting one side of said composite band to create two parts, one part remaining inside said path and the other part outside the vagina;

inserting the needle connected to the other part of the composite band downward from the second side of the abdominal wall, bypassing the bladder and emerging through the vagina, thus engaging said other part of the composite band in the bodily path so created;

cutting the emerging portion of said other part of the composite band;

pulling on the two parts of the sheath, thus stripping the two parts of the composite band and putting said flexible piece in place;

applying subpubic traction to the two parts of the composite band in order to bring the flexible piece to a suburethral position; and

withdrawing the two parts of the sheath to release the supporting strip.

30. Method for placement or implementation of a surgical assembly according to claim 14, comprising:

a) inserting the needle through the abdominal wall of the patient from a subpubic incision until it emerges from the vagina of the patient;

b) connecting the distal end of the needle emerging from the vagina to said tubular portion of one of the two ends of the composite band;

c) retracting the needle so as to engage the composite band through the bodily path that the needle has created until the composite band emerges at a subpubic level;

d) repeating steps a)-c) on the other side of the pelvis of the patient; and

e) withdrawing the two sheath parts thus putting the strip in place.

31. Method for placement or implementation of a surgical assembly according to claim 17, comprising:

a) inserting said curved, sharp part through the bodily tissues through the foramen of the pelvis until the curved, sharp part emerges from the vagina of the patient, said flexible inner portion being in the advanced position,

b) retracting said flexible inner portion;

c) engaging the tubular portion of one end of the composite band with the harpoon-shaped distal end of said rigid outer portion;

d) withdrawing said curved, sharp part in order to engage the composite band through the bodily path created by the curved, sharp part;

e) repeating steps a)-d) on the other side of the pelvis;

f) withdrawing the two sheath parts; and

g) setting the strip in place by pulling on the strip'"'"'s emerging ends.

32. Method for placement or implementation of a surgical assembly according to claim 14, comprising:

inserting the needle downward, on a first side of the patient, through the abdominal wall of the patient, bypassing the bladder of the patient and emerging through the vagina of the patient, thus engaging the composite band in the bodily path thus created when the connecting means is outside the vagina;

cutting one side of said composite band to create two parts, one part remaining inside said path and the other outside the vagina;

inserting the needle connected to the other part of the composite band downward from a second side of the abdominal wall, bypassing the bladder and emerging through the vagina, thus engaging said other part of the composite band in the bodily path so created;

cutting the emerging portion of said other part of the composite band;

pulling on the two parts of the sheath, thus stripping the two parts of the composite band and putting said flexible piece in place;

applying subpubic traction to the two parts of the composite band in order to bring the flexible piece to a suburethral position; and

withdrawing the two parts of the sheath to release the supporting strip.

33. Method for placement or implementation of a surgical assembly according to claim 17 comprising:

inserting the needle downward, on a first side of the patient, through the abdominal wall of the patient, bypassing the bladder of the patient and emerging through the vagina of the patient, thus engaging the composite band in the bodily path thus created when the connecting means is outside the vagina;

cutting one side of said composite band to create two parts, one part remaining inside said path and the other outside the vagina;

inserting the needle connected to the other part of the composite band downward from second side of the abdominal wall, bypassing the bladder and emerging through the vagina, thus engaging said other part of the composite band in the bodily path so created;

cutting the emerging portion of said other part of the composite band;

pulling on the two parts of the sheath, thus stripping the two parts of the composite band and putting said flexible piece in place;

applying subpubic traction to the two parts of the composite band in order to bring the flexible piece to a suburethral position; and

withdrawing the two parts of the sheath to release the supporting strip.

34. Method for placement or implementation of a surgical assembly according to claim 20, comprising:

inserting the needle downward, on a first side of the patient, through the abdominal wall of the patient, bypassing the bladder of the patient and emerging through the vagina of the patient, thus engaging the composite band in the bodily path thus created when the connecting means is outside the vagina;

cutting one side of said composite band to create two parts, one part remaining inside said path and the other outside the vagina;

inserting the needle connected to the other part of the composite band downward from a second side of the abdominal wall, bypassing the bladder and emerging through the vagina, thus engaging said other part of the composite band in the bodily path so created;

cutting the emerging portion of said other part of the composite band;

pulling on the two parts of the sheath, thus stripping the two parts of the composite band and putting said flexible piece in place;

applying subpubic traction to the two parts of the composite band in order to bring the flexible piece to a suburethral position; and

withdrawing the two parts of the sheath to release the supporting strip.

35. Method for placement or implementation of a surgical assembly according to claim 25, comprising:

inserting the needle downward, on a first side of the patient, through the abdominal wall of the patient, bypassing the bladder of the patient and emerging through the vagina of the patient, thus engaging the composite band in the bodily path thus created when the connecting means is outside the vagina;

cutting one side of said composite band to create two parts, one part remaining inside said path and the other outside the vagina;

inserting the needle connected to the other part of the composite band downward from a second side of the abdominal wall, bypassing the bladder and emerging through the vagina, thus engaging said other part of the composite band in the bodily path so created;

cutting the emerging portion of said other part of the composite band;

pulling on the two parts of the sheath, thus stripping the two parts of the composite band and putting said flexible piece in place;

applying subpubic traction to the two parts of the composite band in order to bring the flexible piece to a suburethral position; and

withdrawing the two parts of the sheath to release the supporting strip.