Surgical articles and methods for treating pelvic conditions

• US 9,585,739 B2
• Filed: 06/06/2014
• Issued: 03/07/2017
• Est. Priority Date: 10/26/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Ogdahl, Jason W., Jimenez, Jose W., Khamis, Chaouki A., Roll, Jessica L., Solari, Michelle L., Otte, John F., Dahdah, Mona N.
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US14/298,471
• Publication Number:
  US 20140309485A1
• Time in Patent Office: 1,005 Days
• 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 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Described are devices, implants, insertion tools, combinations, and associated methods, that involve placement of a self-fixating tip at tissue of the pelvic region, wherein an insertion tool includes one or more of an aperture for engaging a guide and an extension guard, the method optionally allowing for initial placement of a self-fixating tip at tissue of the pelvic region and adjustment of the location of the self-fixating tip.

Claims

1. In combination, a pelvic implant and insertion tool,

the implant comprising a support portion, an extension portion, and a self-fixating tip fixedly connected to an end of the extension portion,

the self-fixating tip comprising

a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion, and

a lateral extension extending from the base along a length of the base between the proximal base end and the distal base end, and comprising a trailing surface extending from the base to a tip of the trailing surface spaced from the base,

the insertion tool comprising

a handle,

a needle extending from the handle,

the needle comprising

a proximal end attached to the handle and

a distal end that includes a needle tip configured to engage the self-fixating tip, and

the insertion tool comprising an extension guard comprising a distal surface extending from the needle to a tip of the distal surface spaced from the needle such that when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the distal surface is located on a proximal side of the lateral extension to reduce the force required to move the self-fixating tip in a proximal direction through muscle tissue.

2. A combination according to claim 1 wherein the distal surface corresponds to the trailing surface of the lateral extension.

3. A method of treating a pelvic condition in a patient, the method comprising

providing a combination according to claim 1,

engaging the self-fixating tip with the needle tip,

inserting the needle tip and self-fixating tip through an incision in a patient into a pelvic region,

using the needle to insert the self-fixating tip into tissue in the pelvic region,

with the needle tip engaging the self-fixating tip located in the pelvic tissue, using the needle to reduce the amount of penetration of the self-fixating tip into the tissue.

4. A combination as recited at claim 1 wherein the trailing surface extends from the base to a width dimension of about 0.5 to 3 millimeters.

5. A combination as recited at claim 1 wherein the implant comprises the support portion, the extension portion extending from a first side of the support portion, a second extension portion extending from a second side of the support portion, and a second self-fixating tip fixedly connected to a distal end of the second extension portion.

6. A combination as recited at claim 5 wherein the support portion, extension portion, and second extension portion, are an integral mesh strip.

7. A combination as recited at claim 1 wherein a cross sectional profile of the distal surface corresponds to a cross sectional profile of the trailing surface of the lateral extension.

8. A combination as recited at claim 7 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.

9. A combination as recited at claim 1 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.

10. A combination according to claim 1 wherein the extension guard is removable from the insertion tool.

11. A combination according to claim 1 wherein the implant is selected from the group consisting of:

a urinary incontinence sling,

two, four, or six-legged implant useful to treat vaginal prolapse, and

an implant useful for treating a condition of the pelvic floor.

12. A method according to claim 3 wherein the implant is a urethral sling comprising

the support portion,

the extension portion extending from a first side of the support portion,

a second extension portion extending from a second side of the support portion, and

a second self-fixating tip fixedly connected to a distal end of the second extension portion,

wherein the method comprises:

placing the support portion below a urethra of the patient,

using the insertion tool to place the self-fixating tip at tissue of a right obturator foramen, and

placing the second self-fixating tip at tissue of a left obturator foramen.

13. A method according to claim 12 wherein the support portion, extension portion, and second extension portion, are constructed of an integral mesh.

14. A method as recited at claim 3 wherein at least a portion of the distal surface abuts a portion of the trailing surface as the needle tip engages the self-fixating tip.

15. A method according to claim 3 wherein the pelvic condition is selected from the group consisting of:

urinary incontinence, fecal incontinence, enterocele, cystocele, rectocele, vaginal vault prolapse, a condition of the perineal body, a condition of the pelvic floor, and a condition of the levator hiatus.

16. A method according to claim 3 wherein the pelvic condition is urinary incontinence.

17. A method according to claim 3 comprising supporting tissue selected from vaginal tissue, a urethra, a rectum, coccygeous, levator ani, iliococcygeus, pubococcygeous, perineal body, and levator hiatus.

18. A method according to claim 3 wherein the pelvic condition is a condition of the pelvic floor, and the method comprises supporting tissue of the pelvic floor.

19. In combination a pelvic implant and insertion tool,

the implant comprising a support portion, an extension portion, and a self-fixating tip fixedly connected to an end of the extension portion,

the self-fixating tip comprising

a base comprising a proximal base end and a distal base end, the proximal base end being connected to the extension portion and an aperture extending longitudinally along a length between the proximal base end and the distal base end, and

a lateral extension extending from the base and comprising a trailing surface extending from the base to a tip of the trailing surface spaced from the base,

the insertion tool comprising

a handle,

a needle extending from the handle,

the needle comprising

a proximal end attached to the handle and

a distal end that includes a needle tip configured to engage the self-fixating tip, the needle tip comprising a pin extending distally from the distal end tip and adapted to engage the aperture as the distal end engages the self-fixating tip, and

the insertion tool comprising an extension guard comprising a distal surface extending from the needle to a tip of surface spaced from the needle such that when the needle tip engages the self-fixating tip to allow the needle to push the self-fixating tip for surgical installation, the distal surface is located on a proximal side of the lateral extension to reduce the force required to move the self-fixating tip in a proximal direction through muscle tissue.

20. The combination according to claim 19 wherein the distal surface corresponds to the trailing surface of the lateral extension.