Implants, tools, and methods for treatment of pelvic conditions

• US 9,089,393 B2
• Filed: 03/28/2012
• Issued: 07/28/2015
• 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): Cheng, Jacqueline
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US13/432,624
• Publication Number:
  US 20120253106A1
• Time in Patent Office: 1,217 Days
• Field of Search: 600 29- 31, 600/37, 60 29- 31, 60/37
• US Class Current: 1/1
• 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 combination comprising a pelvic implant and a suture passer assembly, the combination useful to treat a pelvic condition,

the implant comprising a tissue support portion and two opposing mesh extension portions,

the suture passer assembly comprising a proximal end, a shaft, and a shaft distal end, the shaft distal end comprising a suture passer comprising a set of opposed suture passer jaws and a mesh holder comprising a set of mesh holder jaws different from the suture passer jaws,

wherein the mesh holder jaws are located between the opposed suture passer jaws and are capable of engaging the mesh, pulling the engaged mesh in a proximal direction to a location between the suture passer jaws, forming a length-reducing loop in the mesh, and holding the mesh and formed loop between the suture passer jaws, and

the suture passer is capable of passing a suture through the mesh held between the suture passer jaws in a manner to maintain the formed loop.

2. A combination as recited at claim 1 wherein the implant comprises supportive portions consisting of the central support portion and the two extension portions.

3. A combination as recited at claim 2 wherein the implant comprises a self-fixating tip at an end of each extension portion, the implant having a length to allow the self-fixating tip to be placed at tissue of opposing obturator foramen of a patient, with the central support portion supporting tissue of an anus.

4. A combination as recited at claim 3 further comprising one or more insertion tools capable of engaging one or more of the self-fixating tips, passing the one or more self-fixating tips through a medial incision in the patient, and placing the one or more self-fixating tips at the opposing obturator foramen.

5. A method of treating a pelvic condition, the method comprising

providing an implant comprising a tissue support portion, a first mesh extension portion, and a second mesh extension portion,

providing a suture passer assembly comprising a proximal end, a shaft, and a shaft distal end, the shaft distal end comprising a suture passer comprising a set of suture passer jaws and a mesh holder comprising a set of mesh holder jaws,

wherein the mesh holder jaws are located between the opposed suture passer jaws and are capable of engaging the mesh, pulling the engaged mesh in a proximal direction to a location between the suture passer jaws, forming a length-reducing loop in the mesh, and holding the mesh and formed loop between the suture passer jaws, and

the suture passer is capable of passing a suture through the mesh held between the suture passer jaws in a manner to maintain the formed loop,

placing the implant in a patient to support tissue,

using the suture passer assembly to form a loop in the first extension portion and place a suture at the first extension portion to maintain the loop.

6. A method as recited at claim 5 comprising using the suture passer assembly to place a second suture at the second extension portion, and adjusting a length of the second extension portion by tightening the second suture.

7. A method as recited at claim 6 comprising adjusting the length of the first extension portion and the length of the second extension portion together to prevent supported tissue from being moved in a left or a right direction within the patient.

8. A method as recited at claim 7 wherein the pelvic condition is selected from the group consisting of:

fecal incontinence and urinary incontinence.

9. A method as recited at claim 8 for treating urinary incontinence, the method comprising:

creating a medial incision in the patient,

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

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

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

10. A method as recited at claim 8 for treating fecal incontinence, the method comprising:

creating a medial incision in the patient,

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

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

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