Surgical articles and methods for treating urinary incontinence

• US 9,226,809 B2
• Filed: 02/10/2010
• Issued: 01/05/2016
• Est. Priority Date: 02/10/2009
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: VanDeWeghe, Andrew, Wirbisky, Alan G., Lieser, Randall C.
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): Hyde, Eileen
• Application Number:
  US13/142,393
• Publication Number:
  US 20110288368A1
• Time in Patent Office: 2,155 Days
• Field of Search: 600/30
• US Class Current: 1/1
• 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 2017/06019 by means of a suture-receiving lateral eyelet machined in the needle lateral opening for attaching suture to suture anchor A61B2017/0414
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Described are devices, implants and kits for treating incontinence in a male or female. In particular an assembly comprising a multi-piece implant comprising a support portion piece (82) and two extension portion pieces (84) adjustably connected to the support portion piece, and an adjusting tool (92) to allow adjustment of extension portion pieces relative to the support portion piece, is described.

Claims

1. An assembly for treating urinary incontinence, the assembly comprising a multi-piece implant comprising a support portion piece, a first extension portion piece, and a second 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,

the first and second extension portion pieces each comprise a proximal end, a distal end, and a tissue fastener,

the first extension portion piece is adjustably connected to the support portion piece at a first adjustable connection,

the second extension portion piece is adjustably connected to the support portion piece at a second adjustable connection, and

the adjusting tool comprises a shaft, a yoke, and two adjusting surfaces located at the yoke, wherein the two adjusting surfaces are configured for simultaneous engagement with two spaced-apart surfaces of the support portion piece during simultaneous adjustment of a position of the first extension portion piece relative to the support portion piece at the first adjustable connection and a position of the second extension portion piece relative to the support portion piece at the second adjustable connection.

2. An assembly according to claim 1 wherein each of the two adjusting surfaces is adjacent to a slot or aperture adapted to engage the extension portion piece.

3. An assembly according to claim 1 wherein the yoke is stationary relative to the shaft.

4. An assembly according to claim 1 wherein the yoke can be moved relative to a length of the shaft.

5. An implant according to claim 1 wherein the adjustable connection comprises an aperture through which the extension portion piece extends to adjustably connect the extension portion piece to the support portion piece.

6. An implant according to claim 1 wherein the adjustable connection comprises a grommet.

7. An implant according to claim 1 wherein the extension portion piece comprises a tissue fastener.

8. An implant according to claim 1 wherein the implant comprises supportive portions consisting of the tissue support portion and two extension portions.

9. A method of treating urinary incontinence in a patient, the method comprising:

providing an assembly according to claim 1,

creating a medial incision in the patient,

dissecting from the medial incision to tissue below a urethra,

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,

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

connecting the first extension portion piece with the support portion piece at the first adjustable connection,

connecting the second extension portion piece with the support portion piece at the second adjustable connection,

engaging the adjusting tool with the spaced-apart surfaces of the support portion piece, and

simultaneously adjusting a position of the support portion piece relative to first and second extension portion pieces.

10. A method according to claim 9, wherein

the implant comprises a left-side extension portion piece connected to the support portion piece at an adjustable connection at a left end of the support portion piece to form a left extension portion, and the method comprises extending the left extension portion to engage supportive tissue at a left side of the patient, and

the implant comprises a right-side extension portion piece connected to the support portion piece at an adjustable connection at a right end of the support portion piece to form a right extension portion, and the method comprises extending the right extension portion to engage supportive tissue at a right side of the patient.

11. A method according to claim 9 wherein the patient is a male patient, the method comprising

exposing bulbospongiosus muscle,

dissecting bulbospongiosus muscle to expose corpus spongiosum, and

placing the tissue support portion to contact the corpus spongiosum.

12. A method according to claim 9, wherein the adjusting tool comprises a shaft and a yoke, the two adjusting surfaces are located at the yoke, the yoke can be moved relative to a length of the shaft, and the method comprises moving the yoke relative to the shaft.

13. In combination, an implant for treating urinary incontinence and an adjusting tool, the implant comprising

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

a first and second extension portion, each extension portion extending from an end of the tissue support portion, and

a tissue fastener located at a distal end of each extension portion, wherein each extension portion comprises an adjustable length between the tissue support portion and the tissue fastener

the adjusting tool comprising:

two adjusting apertures, a shaft, and a yoke, the two adjusting apertures located at a distal end of the yoke and configured for simultaneous engagement with the first and second extension portions during simultaneous adjustment of the first and second extension portions relative to the tissue support portion, wherein the yoke is axially movable relative to a length of the shaft.

14. An implant according to claim 13 wherein each of the two extension portions comprises a suture, and the tissue fastener is a self-fixating tip adjustably connected to the suture.

15. A method of treating urinary incontinence in a patient, the method comprising:

providing an implant and adjusting tool according to claim 13,

creating a medial incision in the patient,

dissecting from the medial incision to tissue below a urethra,

placing the tissue support portion to support the urethra,

placing the tissue fastener at the first extension portion in a tissue path extending toward a first obturator foramen of the patient,

placing the tissue fastener at the second extension portion in a tissue path extending toward a second obturator foramen of the patient, and

adjusting the adjustable length between the tissue support portion and the tissue fastener.