Implants, tools, and methods for treatment of pelvic conditions

• US 9,737,388 B2
• Filed: 07/23/2015
• Issued: 08/22/2017
• Est. Priority Date: 03/28/2011
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Khamis, Chaouki A., Roll, Jessica L., Moosai, Shiva P.
• Primary Examiner(s): Matthews, Christine H
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US14/807,382
• Publication Number:
  US 20150327970A1
• Time in Patent Office: 761 Days
• Field of Search: 600 29- 31, 600 37
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

Described are various embodiments of surgical procedures, systems, implants, devices, tools, and methods, useful for treating pelvic conditions in a male or female, the pelvic conditions including incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, the devices and tools including devices and tools for anchoring an implant to supportive tissue and adjusting the implant.

Claims

1. A method of treating fecal incontinence, the method comprising

providing a pelvic implant comprising

a tissue support portion, a first extension portion, and a second extension portion, and

a self-fixating tip at an end of each extension portion,

providing a suture separate from the implant,

placing the implant in a patient to support tissue selected from an anus, anal sphincter, and rectum,

after placing the implant, placing a portion of a length of the suture through the first extension portion at two locations, each location being located between a medial end of the first extension portion and a distal end of the first extension portion, the suture being passed through the first extension portion to form at least one loop in the first extension portion such that pulling an end of the suture causes a length of the first extension portion to decrease, and

adjusting the length of the first extension portion by pulling the suture.

2. A method as recited at claim 1 comprising providing a second suture comprising a length and a loose end, and placing a portion of the length of the second suture through the second extension portion, at two locations, each location being located between a medial end of the second extension portion and a distal end of the second extension portion, the second suture being passed through the second extension portion to form at least one loop in the second extension portion such that pulling the loose end of the second suture causes a length of the second extension portion to decrease, and adjusting the length of second extension portion by pulling the loose end of the second suture.

3. A method as recited at claim 2 comprising adjusting the length of the first extension portion and the length of the second extension portion together to prevent the supported tissue from being moved in a left or a right direction within the patient.

4. A method as recited at claim 1 comprising:

creating a medial incision in the patient,

placing the tissue support portion to contact tissue to support the anus,

placing the distal end of the first extension portion in a tissue path extending toward a first obturator foramen of the patient, and

placing the distal end of the second extension portion in a tissue path extending toward a second obturator foramen of the patient.

5. A method as recited at claim 1, comprising creating a medial incision in a pathway selected from a transvaginal, suprapubic, and perineal floor.

6. A method as recited at claim 1, comprising providing a suture passer capable of passing the suture through the first extension portion.

7. A method as recited at claim 6 comprising using the suture passer to intraoperatively place the suture through the first extension portion.

8. A method as recited as claim 6, wherein the suture passer comprises a proximal and distal end, the distal end comprising a first and a second opposing jaws capable of passing intraoperatively through a surgical incision.

9. A method as recited at claim 6, wherein passing the suture through the first extension portion creates a desired reduction in length of the implant.

10. A method as recited at claim 6, wherein the suture passer is capable of passing the suture more than one time through the first extension portion.

11. A method as recited at claim 6, wherein the suture passer comprises a proximal and distal end, the distal end comprising a mesh cincher capable of grasping the implant and a first and a second opposing jaws capable of passing the suture through the first extension portion.

12. A method as recited at claim 1, comprising creating a tissue path from a medial incision to a region selected from a bulbospongiosus muscle, an obturator foramen, or a rectus fascia tissue.

13. A method as recited at claim 1, comprising creating a tissue path from a medial incision through an obturator foramen and around a pubic ramus bone.