US20190216587A1

US20190216587A1 - Transperitoneal prolapse repair system and method priority

Info

Publication number: US20190216587A1
Application number: US16/104,505
Authority: US
Inventors: Mickey Karram
Original assignee: Lumenxt LLC
Current assignee: Lumenxt LLC
Priority date: 2012-02-23
Filing date: 2018-08-17
Publication date: 2019-07-18
Also published as: WO2013126908A2; US20150025309A1; AU2016277767A1; AU2016277767B2; US10105203B2; AU2013222113B2; CA2865294A1; AU2013222113A1; HK1204907A1; EP2816960A2; EP2816960A4; WO2013126908A3

Abstract

A prolapse repair system and procedure are provided. The system can include one or more anchor devices and one or more extending members, such as a suture. The system can further include a mesh or like support or suspension structure provided intermediate the one or more anchor devices and the one or more extending members. The anchors can be directed to the coccygeous sacrospinous ligament or complex via a transperitoneal approach, wherein the one or more anchor devices are engaged directly into the target ligament or tissue complex and the one or more sutures extend back through the thickness of the vaginal wall to provide vaginal wall support.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 14/380,373, filed Feb. 25, 2013, entitled “Transperitoneal Prolapse Repair System and Method,” which is a national stage application filed under 35 U.S.C. § 371 of International Application No. PCT/US2013/027686, filed Feb. 25, 2013, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/602,288, filed Feb. 23, 2012, which are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to surgical methods and apparatus and, more specifically, to systems and methods of treating pelvic conditions, such as urinary or fecal incontinence and female vaginal prolapse conditions, including enterocele, rectocele or posterior prolapse.

BACKGROUND OF THE INVENTION

Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor via a transperitoneal procedure.
Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Posterior prolapse, or rectocele, can occur when the fascia that separates the rectum and the vagina weakens or tears, thereby causing a bulge of the vaginal wall. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems.
Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.
Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) occurs when the patient is physically stressed.
A variety of treatment options are currently available to treat incontinence. Some of these treatment options include external devices, behavioral therapy (such as biofeedback, electrical stimulation, or Kegal exercises), injectable materials, prosthetic devices and/or surgery. Depending on age, medical condition, and personal preference, surgical procedures can be used to completely restore continence. Types of procedure found to be an especially successful treatment option for SUI in both men and women can include sling or implant procedures. There are a variety of different sling procedures. Slings used for pubovaginal procedures differ in the type of material and anchoring methods.
One such implant procedure is the Elevate® anterior or posterior implant systems sold by American Medical Systems, Inc. of Minnetonka, Minn. The Elevate® posterior implant system utilizes self-fixating tips that allow for mesh placement in the sacrospinous ligament through a single vaginal incision to treat apical and/or posterior vaginal prolapse.
There is a desire to provide a system for repairing apical support and posterior vaginal wall support based on sound anatomic concepts and long term outcome advantages.

SUMMARY OF THE INVENTION

The present invention provides prolapse repair system and procedure for treating incontinence and prolapse by repairing vaginal apical support and posterior vaginal wall support. The system can include one or more anchor devices and one or more extending members, such as a suture. The system can further include a mesh or like support or suspension structure provided intermediate the one or more anchor devices and the one or more extending members.
To facilitate the repairs, anchoring can be directed to the coccygeous sacrospinous ligament or complex, or other like anatomical structures, via a transperitoneal (through the peritoneum) approach, wherein the one or more anchor devices are engaged directly into the target ligament or tissue complex. The one or more extending suture members can be constructed of an absorbable, or continuous delayed absorbable, material. With such a transperitoneal approach, improved bilateral suspension can be achieved with less deviation of the vaginal axis resulting.
A vaginal retractor can be employed to keep the small bowel from dropping into the field, as well as to provide adequate lighting and displacement of the sigmoid colon. The retractor can include an inflation member or device (e.g., via fluid inflation internal or external to the retractor) that upon intraperitoneal insertion can occupy the upper pelvis to lift the intestinal contents out of the pelvis.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-2 are views of anchor devices having one or more extending suture members, in accordance with embodiments of the present invention.

FIGS. 3-4 are views of anchor devices having a mesh portion and one or more extending suture members, in accordance with embodiments of the present invention.

FIG. 5 is a schematic anatomical view showing access to the target tissue sites for a transperitoneal approach, in accordance with embodiments of the present invention.

FIG. 6 is a schematic anatomical view of transperitoneal access to the C-SSL complex by making a window in the peritoneum, in accordance with embodiments of the present invention.

FIGS. 7-8 are schematic anatomical views of a plurality of suture members extending out through the vaginal wall after transperitoneal deployment of anchor devices, in accordance with embodiments of the present invention.

FIG. 9 is a schematic anatomical view of suture members cut and tied off to create tension and create support and posterior vaginal wall elevation, in accordance with embodiments of the present invention.

FIG. 10 is a schematic anatomical view of a retractor device having an inflation member deployed to keep the small bowel from dropping into the procedure field, in accordance with embodiments of the present invention.

FIG. 11 is a schematic view of a retractor device having an illumination feature, in accordance with embodiments of the present invention.

FIG. 12 is an anchor deployment tool, in accordance with embodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 1-12, a prolapse repair system 10 and methods are shown. Various embodiments of the system 10 can include anchor support devices 12 having one or more anchors 14 and one or more members 16 extending from the one or more anchors 14. The one or more anchors can include angled tines 15 to promote engagement and fixation within tissue of the patient. The one or more members 16 can be a suture member. The suture members 16 can be constructed of a material adapted to absorb into the body over time (e.g., continuous delayed absorption). In certain embodiments, the one or more members 16 can include two or more suture members extending from the anchor, as shown in FIGS. 2 and 4. The anchor 14 can be constructed of a polymer or like material. The system 10 provides a device and procedure that can position the vaginal apex so that it is not distorted, or at least reduces any distortion.
Various embodiments of the anchor support device 12 can include a mesh portion or member 18 provided intermediate the anchor 14 and the one or member 16 s, as shown in FIGS. 3-4. As such, the mesh member 18 can support or reinforce tissue upon deployment. The mesh member 18 can be constructed of polymer filament materials, or can be molded or otherwise formed into a generally planar structure or from a thin generally planar film or sheet material. Examples of acceptable polymer materials available in constructing or forming portions of the anchor device 12 and its components can include polypropylene, polyethylene, fluoropolymers, metals or like materials. The various implants or systems, anchors, mesh, tools, devices, features and methods disclosed in U.S. Patent Application Publication No. 2011/0112357 are envisioned, in whole or in part, for use with embodiments of the present invention. Accordingly, the above-identified publication is fully incorporated herein by reference in its entirety.
The anchor support device 12 can be deployed and provided to repair vaginal apical support and posterior vaginal wall support via a transperitoneal (through the peritoneum P) approach. Namely, the physician can access the coccygeous muscle-sacrospinous ligament complex (C-SSL complex), or the sacrospinous ligament, via a transperitoneal access approach TPA (e.g., FIG. 6, via small peritoneum P window or opening(s)) and insert one or more of the anchors 14 directly into the target ligament, on each side of the patient, with the suture members 16 extending from the anchors 14 to serve as suspension members to the vaginal wall. A transperitoneal access approach allows for easy bilateral suspension with less deviation of the vaginal axis and provides an advantageous route for the procedure.
A needle device 20, as shown in FIG. 12, can be included with the system 10 to deploy and fixate the anchors 14 at the target site. The needle device 20 can include a handle portion 22 and a needle portion 24. The needle portion 24 can be straight or curved and a distal tip 26 is adapted to selectively engage and disengage with the anchors 14. The tip of the anchors 14 and/or the distal 26 of the needle device 20 can facilitate passing the anchors 14 and the attached members 14 through (e.g., pushing through) a tissue pathway, tissue, and eventually the target tissue site. One or more actuators or like mechanisms can be included to facilitate the release or disengagement of the anchor 14 from the distal tip 26.
Once the anchors 14 are engaged with the target tissue site, the suspension sutures 16 are brought out through the full thickness of the posterior vaginal wall (e.g., including the peritoneum P), as demonstrated in FIG. 7-9. As depicted in FIG. 7, two anchors 14 can be fixated in the target ligament site on each side of the patient, thereby providing four suspension sutures 16 extending through the posterior vaginal wall on each side (e.g., total of eight). Other embodiments can use a single anchor 14 on each side, or three or more anchors on each side, depending on the repair needs and the anatomical structure of the patient. The suspension sutures 16 can be tied together (e.g., to another adjacent suture) for tensioning, thereby recreating level 3 support and facilitating posterior wall support and correction of the high rectocele (FIG. 9). In other embodiments, the anchor 14 can be passed with the suture members 16 directly into the upper portion of the uterosacral ligament in lieu of or in addition to another target site such as the C-SSL complex.
It can be a challenge to obtain adequate exposure to all safe passages of the anchors 14 and sutures 16 in the respective ligaments (uterosacral or sacrospinous) with a intraperitoneal suspension as is disclosed herein. However, a vaginal retractor 30 can be employed (e.g., through the vagina V) to keep the small bowel from dropping into the field, as well as to provide adequate lighting and displacement of the sigmoid colon, as demonstrated in FIG. 10. The retractor 30 can include an inflation member or device 32 (e.g., via fluid (gas or liquid) inflation internal or external to the retractor 30) that upon intraperitoneal insertion can occupy the upper pelvis to lift the intestinal contents out of the pelvis. As shown in FIG. 11, the end of the retractor 30 including the device 32 can include firm but generally flexible extensions 34 provided and positioned on the retractor 30 to prevent bowel from slipping down around the balloon device 32 during use. The long, generally flat retractor 30 can include an illumination device 36 to promote visualization in the field during deployment and use.
All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.
Obviously, numerous modifications and variations of the present invention are possible in light of the teachings herein. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced other than as specifically described herein.

Claims

1. A prolapse repair system, comprising:

at least one anchor support device comprising at least one anchor and at least one member extending from the anchor, the anchor having tines to engage target tissue, wherein the anchor is deployed through a transperitoneal access approach and fixated in the coccygeus muscle-sacrospinous ligament complex and the one or more members are directed back through the vaginal wall to provide vaginal wall support.

2. The system of claim 1, wherein the at least one member extending from the at least one anchor is a suture members.

3. The system of claim 2, wherein the suture member is members is absorbable and optionally absorbs into the body over time.

4. (canceled)

5. (canceled)

6. The system of claim 1, wherein the at least one anchor comprises a first anchor and a second anchor wherein each of the first anchor and the second anchor has at least one member extending therefrom.

7. The system of claim 6, wherein the at least one member extending from each of the first anchor and the second anchor includes a plurality of suture members.

8. The system of claim 1, wherein the at least one anchor support device further comprises a mesh member between the at least one anchor and the at least one members extending from each anchor.

9. The system of claim 8, wherein the mesh member comprises materials chosen from polymer filament, a planar structure, thin film, and sheet material.

10. The system of claim 1, further including a retractor having an inflation member adapted to lift intestinal contents out of the pelvis.

11. The system of claim 10, wherein the retractor further includes an illumination device.

12. A prolapse repair system, comprising:

a first anchor support device having a first anchor and a pair of suspension sutures extending from the first anchor such that the first anchor is adapted to engage a sacrospinous ligament site on a first side of a patient, wherein the pair of sutures of the first anchor support device may extend back through the peritoneum to provide vaginal wall support; and

a second anchor support device having a second anchor and a pair of suspension sutures extending from the second anchor such that the second anchor is adapted to engage a sacrospinous ligament site on a second side of the patient, wherein the pair of sutures of the second anchor support device may extend back through the peritoneum to provide vaginal wall support.

13. The system of claim 12, wherein the pair of suspension sutures of the first and second anchor support devices are absorbable and optionally absorb into the body over time.

14. (canceled)

15. The system of claim 12, wherein each anchor support device further includes a mesh member between each anchor and the respective pair of suspension sutures.

16. (canceled)

17. (canceled)

18. (canceled)

19. The system of claim 12, further including a retractor having an inflation member adapted to lift intestinal contents out of the pelvis.

20. The system of claim 19, wherein the retractor further includes an illumination device located at a distal tip and a plurality of firm and flexible extensions.

21. The system of claim 1, wherein the at least one anchor comprises at least one material chosen from polypropylene, polyethylene, fluoropolymers, polymers, metals, and like materials.

22. The system of claim 10, wherein the retractor further comprises firm and flexible extensions extending in opposite directions from a distal end of the retractor.

23. The system of claim 1, further comprising a needle device to deploy and fixate the at least one anchor; wherein the needle device includes a handle and a distal tip adapted to selectively engage and disengage the anchor.

24. The system of claim 23, wherein the needle device further comprises an actuator to facilitate disengagement of the anchor from the distal tip.

25. The system of claim 19, wherein the retractor further comprises firm and flexible extensions.

26. The system of claim 12, further including a needle device having a handle and a needle portion with a distal tip configured to deploy and fix the anchors.

27. The system of claim 1 further comprising a retractor having a distal end with a plurality of extensions, extending in opposite directions.

28. A prolapse repair system comprising:

at least one anchor support device comprising:

a distal anchor,

at least one tine,

at least one mesh portion, and

at least one proximal suture member;

a needle device having a handle and a distal tip; and

a retractor having a distal tip, with at least one firm and flexible extension extending from the distal tip.

29. The system of claim 28, wherein the distal tip of the needle device selectively and releasably engages with the at least one anchor support device, in order to push the anchor through a tissue pathway.

30. The system of claim 29, further comprising an actuator to facilitate an engagement or disengagement of the needle with the at least one anchor support device.

31. The system of claim 28 wherein the at least one firm and flexible extension further comprises a plurality of extensions spaced equidistantly about the distal tip.