Implants, tools, and methods for treatment of pelvic conditions

• US 10,039,629 B2
• Filed: 11/04/2015
• Issued: 08/07/2018
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Gindele, Paul J., Crank, Justin M., Finlay, Matthew S., Rissmann, William J.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/932,584
• Publication Number:
  US 20160051356A1
• Time in Patent Office: 1,007 Days
• Field of Search: 600 29- 32, 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, and an adjusting mechanism at the distal end of the first extension portion,

the adjusting tool capable of communicating with the adjusting mechanism while the adjusting mechanism is implanted subcutaneously in a patient.

2. A combination as recited at claim 1 wherein the implant comprises a second adjusting mechanism at the distal end of the second extension portion.

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 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 within one inch of the outer surface of the patient'"'"'s epidermis.

8. 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 within one inch of the outer surface of the patient'"'"'s epidermis.

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

10. A combination as recited at claim 6 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 according to claim 1 wherein the adjusting tool communicates with the adjusting mechanism by a mechanical, magnetic, or electromagnetic coupling.

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

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

placing the implant in the patient to support tissue with the adjusting mechanism located subcutaneously at a location adjacent the patient'"'"'s epidermis, and

engaging the adjusting tool with the adjusting mechanism to actuate the adjusting mechanism and adjust a length of the first extension portion.

12. A method as recited at claim 11 wherein the implant comprises a second adjusting mechanism at the distal 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 implant in the patient with the second adjusting mechanism located subcutaneously adjacent the patient'"'"'s epidermis, and

engaging the adjusting tool with the second adjusting mechanism to actuate the second adjusting mechanism and adjust a length of the second extension portion.

13. A method as recited at claim 11 wherein the adjusting tool engages the adjusting mechanism transcutaneously through intact skin of the patient.

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

15. 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 epidermis,

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

closing the medial incision.

16. A method according to claim 11 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 at a location near a sacrum.

17. A method according to claim 11 comprising placing the adjusting mechanism at a location within one inch of the outer surface of the patient'"'"'s epidermis.