Implants, tools, and methods for treatment of pelvic conditions

• US 9,179,992 B2
• Filed: 08/18/2014
• Issued: 11/10/2015
• Est. Priority Date: 03/28/2011
• Status: Expired due to Fees

• 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:
  US14/462,154
• Publication Number:
  US 20140357940A1
• Time in Patent Office: 449 Days
• Field of Search: 600 29- 32, 600/37
• US Class Current: 1/1
• 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, an extension portion, and an adjusting mechanism at a distal end of the extension portion,

the adjusting tool comprising a frictional engagement surface capable of engaging the adjusting mechanism transcutaneously through a patient'"'"'s intact skin while the adjusting mechanism is implanted subcutaneously in the patient adjacent to an epidermis of the patient such that movement of the adjusting tool transcutaneously engaged with the adjusting mechanism causes movement of the adjusting mechanism.

2. A combination as recited at claim 1 wherein the implant comprises a second extension portion and a second adjusting mechanism at a distal end of the second extension portion, and the adjusting tool is capable of engaging the second adjusting mechanism transcutaneously through the patient'"'"'s intact skin while the adjusting mechanism is implanted subcutaneously in the patient adjacent to an epidermis of the patient such that movement of the adjusting tool transcutaneously engaged with the second adjusting mechanism causes movement of the second adjusting mechanism.

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

4. A combination as recited at claim 3 wherein the implant has a length to allow the adjusting mechanisms to be placed subcutaneously with the central support portion supporting tissue of a urethra or an anus and the extension portions passing through opposing obturator foramen.

5. A combination as recited at claim 3 wherein the implant has a length to allow the adjusting mechanisms to be placed subcutaneously with the central support portion supporting tissue of a urethra or an anus and the extension portions passing behind a pubic symphysis.

6. A combination as recited at claim 1 wherein the implant has a length to allow the adjusting mechanism to be placed subcutaneously near a sacrum, with the tissue support portion supporting tissue of a vaginal vault.

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

8. A combination as recited at claim 1 wherein the frictional engagement surface is selected from the group consisting of:

a plurality of hemi-spheres and a blade, the frictional engagement surface being capable of being rotated against a surface of a patient'"'"'s skin while transcutaneously engaging the adjusting mechanism and causing movement of the adjusting mechanism, without damaging the skin.

17. A combination as recited at claim 1 wherein the frictional engagement is capable of engaging a complementary frictional engagement surface of the adjusting mechanism transcutaneously through the patient'"'"'s skin while the adjusting mechanism is implanted subcutaneously in a patient adjacent to an epidermis of the patient.

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, an extension portion, and an adjusting mechanism at a distal end of the extension portion, the adjusting mechanism capable of being actuated to adjust a length of the extension portion,

providing an adjusting tool capable of frictionally engaging the adjusting mechanism transcutaneously through a patient'"'"'s intact skin while the adjusting mechanism is implanted subcutaneously in the patient adjacent to an epidermis of the patient,

placing the implant in a patient to support tissue with the adjusting mechanism located subcutaneously adjacent to an epidermis of the patient, and

post-operatively using the adjusting tool to frictionally engage the adjusting mechanism transcutaneously through the patient'"'"'s intact skin to cause movement of the adjusting mechanism and adjust a length of the extension portion.

10. A method as recited at claim 9 wherein the implant comprises a second extension portion and a second adjusting mechanism at an end of the second extension portion, the second adjusting mechanism capable of being actuated to adjust a length of the second extension portion, and method comprising

placing the second adjusting mechanism subcutaneously adjacent to the epidermis of the patient, and

post-operatively using the adjusting tool to frictionally engage the adjusting mechanism transcutaneously through the patient'"'"'s intact skin to actuate the second adjusting mechanism and adjust a length of the second extension portion.

11. A method as recited at claim 10 comprising adjusting the length of the first extension portion and the length of the second extension portion to prevent supported tissue from being moved in a left or a right direction within the patient.

12. A method as recited at claim 9 wherein the pelvic condition is selected from the group consisting of fecal incontinence, urinary incontinence, and vaginal prolapse.

13. A method as recited at claim 12 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 within two inches of an external surface of the patient'"'"'s skin,

placing the second adjusting mechanism at a subcutaneous location within two inches of an external surface of the patient'"'"'s skin, and

closing the medial incision.

14. A method according to claim 13 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.

15. 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.

16. A method according to claim 15 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.

18. A method as recited at claim 9 wherein the pelvic condition is selected from the group consisting of:

fecal incontinence and vaginal prolapse.

19. A method as recited in claim 9 comprising placing the adjusting mechanism at a subcutaneous location within one inch of an external surface of the patient'"'"'s skin.