Surgical articles and methods

• US 9,381,076 B2
• Filed: 02/23/2011
• Issued: 07/05/2016
• Est. Priority Date: 02/23/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Wirbisky, Alan G., VanDeWeghe, Andrew P., Lieser, Randall C.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US13/579,811
• Publication Number:
  US 20120316386A1
• Time in Patent Office: 1,959 Days
• Field of Search: 600 29- 31, 600/37, 606/139, 606/151
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0408 Rivets other bone rivets A61B17/68; rivets for connecting prosthetic parts A61F2002/30433, A61F2220/0041
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0446 Means for attaching and blocking the suture in the suture anchor
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/2837 with a locking ratchet
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Described are devices, implants, kits, and related methods for treating pelvic conditions such as urinary in incontinence, in a male or a female patient. The invention includes, in one embodiment, a multi-piece implant, including a tissue support piece, extension portion, and one or more self-fixating tips. The device may be employed through a medial incision in the pelvic region of the patient.

Claims

1. A system for treating urinary incontinence, the system comprising a multi-piece implant comprising a support portion piece and an extension portion piece, and an adjusting tool, wherein

the support portion piece comprises a tissue support portion sized and shaped for placement to support a urethra, and

the extension portion piece comprises a proximal end, a distal end, an extension portion extending between the proximal end and the distal end, and a tissue fastener, and is adjustably connectable to the support portion piece at an adjusting engagement, and

the adjusting tool comprises

a surface at a distal end of a shaft capable of engaging the support portion piece, and

a holder attached to the shaft and capable of holding the proximal end of the extension portion piece and moving the proximal end by pulling the proximal end relative to the surface, in a proximal direction, while the support portion piece is engaged with the surface.

2. A system according to claim 1 wherein the surface is adjacent to an opening.

3. A system according to claim 1 wherein the adjusting tool comprises the shaft and a yoke, the surface is located at the yoke, the yoke is stationary relative to the shaft, and the moveable holder is moveable relative to the shaft.

4. A system according to claim 1 wherein the adjusting tool comprises a gauge to measure tension of the implant during placement of the implant in a patient.

5. A system according to claim 1 wherein the adjusting engagement comprises an aperture through which the extension portion piece extends to adjustably connect the extension portion piece to the support portion piece.

6. A system according to claim 1 wherein the adjusting engagement is selected from:

a one-way adjusting engagement, a two-way adjusting engagement, and a locking two-way adjusting engagement.

7. A system according to claim 1 wherein the implant comprises

a second extension portion piece comprises a proximal end, a distal end, a second extension portion extending between the proximal end and the distal end, and a tissue fastener, and is adjustably connectable to the support portion piece at an adjusting engagement, and

supportive portions consisting of the tissue support portion, the extension portion, and the second extension portion.

8. A method of treating urinary incontinence, the method comprising:

providing the system according to claim 7,

creating a medial incision in the patient,

dissecting from the medial incision to tissue below a urethra,

placing the support portion piece 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.

9. A system according to claim 7 wherein the extension portion piece is disconnected from the support portion piece, and wherein the second extension portion piece is disconnected from the support portion piece.

10. A system according to claim 9 wherein the adjusting tool comprises a second holder attached to the shaft and capable of holding the proximal end of the second extension portion piece and moving the proximal end of the second extension portion piece by pulling the proximal end of the second extension portion piece relative to the surface, in a proximal direction, while the support portion piece is engaged with the surface.

11. A method of treating urinary incontinence in a male or a female patient, the method comprising providing the system according to claim 1, placing the implant below a urethra of the patient, and placing the tissue fastener at supportive tissue.

12. A system according to claim 1 wherein the holder is slidably attached to the shaft.

13. A system according to claim 1 wherein the holder is slidably attached to the shaft through a rider, the rider being engaged with and capable of moving along a length of the shaft while remaining attached to the shaft and while the holder is holding the proximal end of the extension portion piece.

14. A system according to claim 1 wherein the holder is capable of holding the proximal end of the extension portion piece and moving the proximal end relative to the surface, while the holder remains attached to the shaft.

15. A system according to claim 1 wherein the extension portion piece is disconnected from the support portion piece.

16. A system for treating urinary incontinence, the system comprising an implant and a tool,

the implant comprising

a support portion, two extension portions, and two self-fixating tips, one self-fixating tip at an end of each extension portion, and

at least one guide tube comprising a proximal end and a distal end attached to one of the two self-fixating tips, the distal end being capable of being removed from the one self-fixating tip,

the tool comprising a handle and a shaft having a distal end capable of engaging the one self-fixating tip, and an optional release mechanism at the distal end, the optional release mechanism being capable of selectively engaging and releasing the one self-fixating tip,

wherein the shaft distal end is capable of being inserted into the proximal end of the at least one guide tube and engaging the guide tube to allow the shaft distal end to be moved distally within the guide tube to become engaged with the at least one self-fixating tip while the guide tube is attached to the one self-fixating tip.

17. A system according to claim 16 wherein the shaft is capable of being inserted into the guide tube.

18. A system according to claim 17 comprising two guide tubes, each guide tube comprising a distal end removably engaged with one of the two self-fixating tips.