Implants, tools, and methods for treatment of pelvic conditions

• US 8,808,162 B2
• Filed: 03/28/2012
• Issued: 08/19/2014
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Gindele, Paul J., Crank, Justin M., Finlay, Matthew S., Rissmann, William J.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/432,632
• Publication Number:
  US 20120253107A1
• Time in Patent Office: 874 Days
• Field of Search: 600 29- 31, 600/37
• US Class Current: 600/37
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2250/0007 for adjusting length

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 an adjusting tool, the combination useful to treat a pelvic condition,

the implant comprising:

a tissue support portion,

a first extension portion extending from a proximal end connected to the tissue support portion to a distal end,

a second extension portion extending from a proximal end connected to the tissue support portion to a distal end,

a first adjusting mechanism at the distal end of the first extension portion, and

a second adjusting mechanism at the distal end of the second extension portion,

wherein the implant has a length to allow the first adjusting mechanism and the second adjusting mechanism to each be placed subcutaneously in a patient at a location adjacent the patient'"'"'s epidermis with the central support portion supporting tissue of a urethra or an anus,

wherein the first adjusting mechanism is adapted to rotate to reduce a length of the first extension portion, and

wherein the second adjusting mechanism is adapted to rotate to reduce a length of the second extension portion,

the adjusting tool comprising a surface capable of engaging the first adjusting mechanism or the second adjusting while the first or second adjusting mechanism is implanted subcutaneously in the patient adjacent the patient'"'"'s epidermis.

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 1 wherein the first and second extension portions have lengths to passthrough opposing obturator foramen.

4. A combination as recited at claim 1 wherein the first and second extension portions have lengths to pass behind a pubic symphysis.

5. A combination as recited at claim 1 wherein the adjusting tool is capable of engaging the adjusting mechanism transcutaneously through a patient'"'"'s intact skin, while the adjusting mechanism is implanted subcutaneously in a patient.

6. A combination as recited at claim 1 wherein the adjusting tool is capable of engaging the adjusting mechanism percutaneously through an incision in a patient'"'"'s skin, while the adjusting mechanism is implanted subcutaneously in a patient.

7. A combination as recited at claim 1 wherein the adjusting mechanism comprises a motor.

8. A combination as recited at claim 5 wherein the adjusting tool comprises a moveable surface selected from the group consisting of:

a plurality of hemi-spheres and a blade, the moveable surface being capable of being rotated against a surface of a patient'"'"'s skin without damaging the skin.

18. A combination as recited at claim 5 wherein the adjusting tool communicates with the adjusting mechanism by a mechanical engagement, magnetic engagement, or an electromagnetic engagement.

19. A combination as recited at claim 6 wherein the adjusting tool communicates with the adjusting mechanism by a frictional engagement or a magnetic engagement.

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

providing a pelvic implant useful to treat a pelvic condition, the implant comprising:

a tissue support portion,

a first extension portion extending from a proximal end connected to the tissue support portion to a distal end,

a second extension portion extending from a proximal end connected to the tissue support portion and a distal end, and

a first adjusting mechanism at the distal end of the first extension portion, and

a second adjusting mechanism at the distal end of the second extension portion,

wherein the implant has a length to allow the first adjusting mechanism and the second adjusting mechanism to each be placed subcutaneously in a patient at a location adjacent the patient'"'"'s epidermis with the central support portion supporting tissue of a urethra or an anus,

wherein the first adjusting mechanism is adapted to rotate to reduce a length of the first extension portion, and

wherein the second adjusting mechanism is adapted to rotate to reduce a length of the second extension portion,

providing an adjusting tool capable of engaging the first adjusting mechanism or the second adjusting mechanism while the first or second adjusting mechanism is implanted subcutaneously in a patient at a location adjacent the patient'"'"'s epidermis,

placing the implant in the patient to support tissue of the urethra with the first and second adjusting mechanisms located subcutaneously adjacent the patient'"'"'s epidermis, and

post-operatively engaging the adjusting tool with the first or second adjusting mechanism to actuate the first or second adjusting mechanism and adjust a length of the first extension portion or a length of the second extension portion.

10. A method as recited at claim 9 wherein the adjusting tool engages the adjusting mechanism transcutaneously through intact skin of the patient.

11. A method as recited at claim 9 wherein the adjusting tool engages the adjusting mechanism percutaneously through an incision in the skin of the patient.

12. A method as recited at claim 9 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.

13. A method as recited at claim 10 wherein the pelvic condition is selected from the group consisting of:

fecal incontinence, urinary incontinence, and vaginal prolapse.

14. A method as recited at claim 13 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 the first extension portion in a tissue path extending through a first obturator foramen of the patient,

placing the second extension portion in a tissue path extending through a second obturator foramen of the patient,

placing the first adjusting mechanism at a subcutaneous location adjacent the patient'"'"'s epidermis,

placing the second adjusting mechanism at a subcutaneous location adjacent the patient'"'"'s epidermis, and

closing the medial incision.

15. A method according to claim 14 comprising adjusting the length of the extension portion at a time in a range from 1 day to 3 weeks after closing the medial incision.

16. A method according to claim 9 for treating vaginal vault prolapse, the method comprising

placing the tissue support portion in the patient to support tissue of a vaginal vault, and

placing the adjusting mechanism in the patient subcutaneously at a location near a sacrum.

17. A method according to claim 16 comprising adjusting the length of the extension portion at a time in a range from 1 day to 3 weeks after closing the medial incision.