Implantable article and method for treating urinary incontinence using means for repositioning the implantable article

• US 6,652,450 B2
• Filed: 07/27/2001
• Issued: 11/25/2003
• Est. Priority Date: 01/23/2001
• Status: Expired due to Term

• Current Assignee: David Staskin
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Neisz, Johann J., Westrum, John W. Jr., Porter, Christopher H.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/917,562
• Publication Number:
  US 20020107430A1
• Time in Patent Office: 851 Days
• Field of Search: 600/29, 600/30, 600/37, 128/885
• US Class Current: 600/30
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06014 spring-loaded
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06085 having a blunt tip
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

An implantable article and method of use are disclosed to treat urological disorders. The biocompatible device includes a sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the position of the sling to be permanently changed during and/or after implantation.

Claims

1. A sling for treating urinary incontinence in a patient comprising:

first and second major surfaces,

a pair of end portions,

a support portion for placement in a therapeutically effective position relative to a physiological environment intended to be supported, the support portion having an axially elongate mesh, and a pair of ends, and

repositioning means, associated with the sling, for transferring sling tightening or sling loosening forces along the sling to afford effective, permanent repositioning of the sling without adversely affecting the therapeutic effect of the sling;

wherein the sling includes a removable sheath and the repositioning means affords permanent tightening of the sling when the sling is partially implanted and the sheath is removed, by pulling on the sling and repositioning means at a suprapubic location.

2. A sling according to claim 1 wherein the sling is constructed for treating female incontinence with a surgical procedure that includes a vaginal incision, and the repositioning means is without any structure that extends through the vaginal incision.

3. A sling according to claim 1 wherein the sling is initially placed via an access incision such as a vaginal incision, and the repositioning means affords post operative loosening of the sling after the vaginal incision is closed without any subsequent vaginal incision and without any structure extending through the original vaginal incision.

4. A sling according to claim 1 wherein the repositioning means transfers sling tightening or sling loosening forces along the sling while avoiding permanent deformation of the sling.

5. A sling according to claim 1, wherein the repositioning means comprises at least one filament threaded along the mesh.

6. A sling according to claim 5, wherein the filament is attached to the mesh at the ends of the support portion.

7. A sling according to claim 1, wherein the repositioning means comprises at least one filament integrally woven in the mesh.

8. A sling according to claim 1, wherein the mesh has a length, and the repositioning means comprises a plurality of filaments that are each threaded along substantially the entire length of the mesh.

9. A sling according to claim 8 wherein the filaments extend from an edge of the support portion to the other edge of the support portion.

10. A sling according to claim 1, wherein the mesh of the support portion is woven and the repositioning means comprises a portion of the support portion that is more tightly woven than another portion of the support portion.

11. A sling according to claim 1, wherein the sling comprises a woven mesh and the repositioning means comprises a portion of the mesh that is more tightly woven than another portion of the sling.

12. A sling according to claim 1, wherein the repositioning means is constructed to afford transfer of at least some of a repositioning force applied to the sling to an end of the support portion.

13. A sling according to claim 1 wherein the sling includes synthetic material.

14. A sling according to claim 1, wherein the repositioning member includes a coating selected from the group consisting of medicaments, hormones, antibiotics, antimicrobials, dyes, silicone elastomers, polyurethanes, radiopaque substances, anti-bacterial substances.

15. A sling according to claim 1 wherein the sling includes a coating selected from the group consisting of medicaments, hormones, antibiotics, antimicrobials, dyes, silicone elastomers, polyurethanes, raidopaque substances, anti-bacterial substances.

16. A sling according to claim 1 wherein at least a portion of the sling is constructed from a bioabsorbable material constructed to retain predetermined properties after implantation for at least a predetermined amount of time.

17. A sling according to claim 1 wherein at least a portion of the repositioning member is a resorbable material constructed to retain predetermined properties after implantation for at least a predetermined amount of time.

18. A sling according to claim 1 wherein the repositioning member is woven in a weave pattern along the mesh so that the weave pattern affords an indication of proper sling orientation after implantation.

19. A sling according to claim 18 wherein a majority of the repositioning member protrudes above the second major side of the support portion of the sling.

20. A sling according to claim 1 further including a sheath.

21. A sling according to claim 20 wherein the sheath includes indicia means for assisting the surgeon in properly orienting the sling relative to the urethra.

22. A sling according to claim 21 wherein the sheath includes separation means selected from the group consisting of tear scores, perforations or holes.

23. A sling according to claim 20 wherein the sheath comprises first and second sections that overlap adjacent the support portion of the sling.

24. A sling according to claim 1 wherein the sling and repositioning means are of contrasting colors and each of the sling and the repositioning means are of a color that contrasts with the physiological environment in which they will be implanted to assist a surgeon in identifying and distinguishing between the sling, the repositioning means and the physiological environment.

25. A sling according to claim 1 wherein the sling mesh is braided.

26. A sling according to claim 1 wherein the sling mesh is knitted.

27. A sling according to claim 1 wherein the sling has a length, the repositioning means comprises a one piece, elongate member threaded in the mesh and extending axially along substantially the entire length of the sling, and wherein the one piece, elongate member is attached to the sling at the ends of the support portion.

28. A sling according to claim 27 wherein the sling includes a means for locating and detaching the one piece, elongate member.

29. A sling according to claim 28 wherein the means for locating and detaching the one piece, elongate member comprises loops in the elongate, one piece member at the ends of the support portion.

30. A sling according to claim 1 wherein the repositioning means comprises a handle situated in the support portion.

31. A sling for treating urinary incontinence in a patient comprising:

first and second major surfaces,

a pair of end portions,

a support portion for placement in a therapeutically effective position relative to a physiological environment intended to be supported, the support portion being constructed of autologous material, and having a pair of ends, and

repositioning means, associated with the sling, for transferring sling tightening or sling loosening forces along the sling to afford effective repositioning of the sling without adversely affecting the therapeutic effect of the sling, wherein the sling includes a removable sheath and the repositioning means affords permanent tightening of the sling the sling is partially implanted and the sheath is removed, by pulling on the sling and repositioning means at a superpubic location.

32. A method of treating urinary incontinence in a patient comprising the steps of:

establishing a pathway in tissue on both sides of a patient'"'"'s urethra, the pathways extending between an abdominal wall of the patient and a pubic space of the patient;

atraumatically dilating the pathways after the establishment of the pathways;

introducing a sling material having repositioning means into the pathways while the pathways are being atraumatically dilated;

positioning the sling material in the pathways in a therapeutic relationship relative to the urethra, and so that the sling extends upward toward the abdominal wall; and

repositioning the sling, using the repositioning means, to support the urethra of the patient.

33. A method according to claim 32, wherein the step of positioning the sling comprises the step of positioning the sling proximate the patient'"'"'s urethra.

34. A method according to claim 32 wherein the step of establishing a pathway comprises making an original vaginal incision and the step of repositioning the sling occurs after the vaginal incision is closed and is accomplished without any structure passing through the original vaginal incision.

35. A method according to claim 32 wherein the step of repositioning the sling occurs during the surgical procedure.

36. A method of treating urinary incontinence in a patient comprising the steps of:

providing a sling with repositioning means;

creating a pathway in tissue extending between an abdominal wall of the patient and a pubic region of the patient;

positioning a sling material into the pathways so that the sling material is in a therapeutic relationship relative to the urethra of the patient and so that the sling extends upwards toward the abdominal wall; and

loosening the sling material by using the repositioning means.