Prolapse repair

• US 7,347,812 B2
• Filed: 03/19/2004
• Issued: 03/25/2008
• Est. Priority Date: 09/22/2003
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Mellier, Georges
• Primary Examiner(s): Gilbert; Samuel G.
• Application Number:
  US10/804,718
• Publication Number:
  US 20050065395A1
• Time in Patent Office: 1,467 Days
• Field of Search: 600 29- 31, 600/37, 128/897, 128/898, 606/1
• US Class Current: 600/29
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• 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 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 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor

Abstract

Surgical instruments for prolapse repair are disclosed. The surgical instruments have straight portions and helical portions.

Claims

1. A surgical instrument for inserting an implant for treating female prolapse, the surgical instrument comprising:

a handle;

a needle portion having a straight portion emerging from the handle and a generally helical portion having a distal end region, wherein the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion, and

wherein the needle portion is sized and shaped so that the distal end region may initially be moved through a patient'"'"'s obturator foramen toward the region of the patient'"'"'s ischial spine, and then toward a vaginal incision in the region of the vaginal apex, so that an implant may be received by the distal end of the needle and moved from the vaginal incision through the patient'"'"'s obturator foramen.

2. A surgical instrument according to claim 1 wherein the generally helical portion comprises a left handed helical portion.

3. A surgical instrument according to claim 1 wherein the generally helical portion comprises a right handed helical portion.

4. A surgical instrument according to claim 1 wherein the needle portion has a generally circular cross section with a diameter of less than about 5.5 mm and more than about 0.5 mm.

5. A surgical instrument according to claim 1 wherein the straight portion of the instrument has a longitudinal axis and the helical portion has a length, measured along the longitudinal axis of the straight portion, of more than 2 inches and less than twelve inches.

6. A surgical instrument according to claim 1 wherein the helical portion has a width of more than about 1 inch and less than about nine inches.

7. A surgical instrument according to claim 6 wherein the helical portion has a pitch of at least 2 inches and a radius of at least 0.5 inches.

8. A surgical instrument according to claim 1 wherein the axis of the straight portion and the axis of the helical portion form an angle of about 8 degrees.

9. A surgical instrument according to claim 1 wherein the distal end portion of the instrument points away from the handle and at an acute angle relative to a plane that is perpendicular to the longitudinal axis of the straight portion of the instrument.

10. An assembly of surgical instruments for treating female prolapse, the assembly comprising:

a first surgical instrument comprising a handle;

a needle portion having a straight portion emerging from the handle and a generally right handed helical portion having a distal end region, wherein the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion, and wherein the needle portion is sized and shaped so that the distal end region may initially be moved through a patient'"'"'s obturator foramen toward the region of the patient'"'"'s ischial spine, and then toward a vaginal incision in the region of the vaginal apex;

a second surgical instrument comprising a handle;

a needle portion having a straight portion emerging from the handle and a generally left handed helical portion having a distal end region, wherein the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion, and wherein the needle portion is sized and shaped so that the distal end region may initially be moved through a patient'"'"'s obturator foramen toward the region of the patient'"'"'s ischial spine, and then toward a vaginal incision in the region of the vaginal apex; and

an implant for treating the prolapse; and

an implant suitable for the treatment of vaginal prolapse.

11. An assembly of surgical instruments according to claim 10 further including a pair of dilating connectors and insertion sleeves surrounding the implant.

12. A surgical procedure for correcting human vaginal prolapse comprising:

providing a first surgical instrument comprising a handle;

a needle portion having a straight portion emerging from the handle and a generally right handed helical portion having a distal end region, wherein the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion;

providing a second surgical instrument comprising a handle;

a needle portion having a straight portion emerging from the handle and a generally left handed helical portion having a distal end region, wherein the straight portion of the instrument has a longitudinal axis and the helical portion has an axis that is not parallel to the axis of the straight portion;

providing an implant suitable for the treatment of vaginal prolapse;

creating a vaginal incision;

incising the patient'"'"'s skin in the region of the patient'"'"'s obturator foramen on a first side of the patient,

passing the distal end portion of the first surgical instrument through the obturator foramen and then through the vaginal incision;

associating the implant with the first surgical instrument;

incising the patient'"'"'s skin in the region of the patient'"'"'s obturator foramen on a second side of the patient,

passing the distal end portion of the second surgical instrument through the obturator foramen and then through the vaginal incision;

associating the implant with the second surgical instrument;

moving the distal end portion of the first surgical instrument from the vaginal incision through the patient'"'"'s obturator foramen with an end of the implant associated with the distal end portion;

moving the distal end portion of the second surgical instrument from the vaginal incision through the patient'"'"'s obturator foramen with an end of the implant associated with the distal end portion; and

attaching the implant to the vagina.

13. A method according to claim 12 wherein the step of creating a vaginal incision includes the step of creating a vaginal incision in a region of the apex of the vagina.

14. A method according to claim 12 wherein the step of passing the distal end portion of the first surgical instrument through the obturator foramen and then through the vaginal incision includes the step of passing the distal end of the instrument through the inferior part of the obturator membrane in the region of the obturator foramen above the ischio-pubic ramus.

15. A method according to claim 12, wherein said straight portion of said provided first and second surgical instruments each have a longitudinal axis, and said helical portion of said provided first and second surgical instrument each have an axis that is not parallel to the axis of the straight portion.