WO2010028242A1

WO2010028242A1 - System for combined anterior and posterior prolapse repair

Info

Publication number: WO2010028242A1
Application number: PCT/US2009/056037
Authority: WO
Inventors: Albert J. Enriquez
Original assignee: Enriquez Albert J
Priority date: 2008-09-04
Filing date: 2009-09-04
Publication date: 2010-03-11

Abstract

Systems are provided for treating pelvic conditions, such as vaginal prolapse, including the combined repair of anterior and posterior vaginal prolapse. The systems include an anterior implant (12) having a tissue support portion (30), a posterior implant (14) having a tissue support portion (40), and one or more branching extension portions (16a, 16b). The branching extension portions can include a first arm member (20) and a second arm member (22) extending from a tissue engagement portion (18) such that the first member is adapted for connectivity with the anterior implant and the second member is adapted for connectivity with. the posterior implant.

Description

SYSTEM AND METHOD FOR COMBINED ANTERIOR AND POSTERIOR PROLAPSE REPAIR

RELATED APPLICATION

This application claims priority to and the benefit of U.S. Provisional Application No. 61/094,157, filed September 4, 2008, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to apparatus, tools and methods for treating pelvic conditions, such as prolapse, by providing and using one or more pelvic implants to support pelvic tissue.

BACKGROUND OF THE INVENTION

Pelvic prolapse, including vaginal prolapse, can be caused by the weakening or breakdown of various parts of the pelvic support system, such as the pelvic floor or tissue surrounding the vagina. Due to the lack of support, structures such as the uterus, rectum, bladder, urethra, small intestine, or vagina, may begin to fall out of their normal positions. Prolapse may cause pelvic discomfort and may affect bodily functions such as urination and defecation. Pelvic prolapse conditions can be treated by various surgical and nonsurgical methods. Non-surgical treatments for vaginal prolapse include pelvic muscle exercises, estrogen supplementation, and vaginal pessaries. The Perigee® system, developed by American Medical Systems located in Minnetonka, Minnesota ("AMS) is a surgical technique for the repair of anterior vaginal prolapse. Additionally, the Apogee® system, developed by AMS is a surgical technique for the repair of vaginal vault prolapse and posterior prolapse. Further, AMS developed a single-incision technique, the Elevate® system, to treat cystoceles and vault prolapse. The Elevate® system includes a slim needle and low profile self-fixating tips designed to minimize tissue trauma and provide for a shorter recovery period for the patient.

SUMMARY OF THE INVENTION

The present disclosure identifies pelvic implants, components of implants, related devices, systems and kits containing these, and methods of using these for treating pelvic conditions such as 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.), conditions of the pelvic floor and resulting conditions from weakness or trauma of pelvic floor muscles such as the levator ("levator ani") or coccygeus muscle (collectively the pelvic floor), and other conditions caused by muscle and ligament weakness. Exemplary methods can involve treatment of vaginal prolapse, including anterior prolapse, posterior prolapse, and vault prolapse. A method can be transvaginal, involving one or more incisions in the vaginal tissue, with no external incision.

Any implants or methods described herein can involve tissue fasteners that are designed to secure an implant extension portion or an implant scaffold portion to soft tissue. These may be in the form of a soft tissue anchor, a self- fixating tip, a spring-biased fastener that can insert into tissue or that may grasp and hold tissue, a fastener that includes a male component that engages a female component, e.g., within tissue, or may involve extensions (tines or teeth) that can be extended from a delivery tool to splay laterally into soft tissue. Implants can include features such as adjusting engagement features (one-way or two-way). These implants and methods may further involve a grommet or eyelet management tool. Any implant as described, for use according to any pelvic treatment method, can be placed within a patient by a tool that includes an engagement portion at a length of the shaft, which allows control of a segment of the implant that is being manipulated by the tool.

In one aspect, the invention relates to a method for treating vaginal prolapse that includes: providing an implant comprising a tissue support portion and one or more extension portions, placing the tissue support portion in contact with vaginal tissue to support the vaginal tissue, extending an extension portion to engage a sacrospinous ligament, and extending another extension portion to engage an obturator foramen.

In another aspect, the invention relates to a kit that includes a pelvic implant and one or more introducer or insertion tools or components. The pelvic implant includes a support portion and one or more extension portions. The extension portion includes a mesh portion and/or a non-mesh portion. The insertion tool can be included to place a tissue fastener of a pelvic implant. The insertion tool can include a shaft having an engagement portion located along a length or proximate an end of the shaft. Further, an adjustment tool can be included to control and adjust the tension and support of the implant within the pelvis.

Other aspects of the invention can include an implant system for combined repair of anterior and posterior vaginal prolapse, comprising an anterior implant having a tissue support portion, a posterior implant having a tissue support portion, and one or more branching extension portions. The branching extension portions can include a first arm member and a second arm member extending from a tissue engagement portion such that the first member is adapted for connectivity with the anterior implant and the second member is adapted for connectivity with the posterior implant.

Still other aspects of the invention can include an implant system for combined repair of anterior and posterior vaginal prolapse, comprising an anterior implant having a tissue support portion and a receiving portion, a posterior implant having a tissue support portion and a receiving portion, and one or more branching extension portions. The branching extension portions can include a first arm member and a second arm member extending from a tissue engagement portion, with a free end of the first member being adjustably connectable to the receiving portion of the anterior implant and a free end of the second member being adjustably connectable with the receiving portion of the posterior implant. An insertion tool having a handle and a needle can be includes such that a distal end of the needle is adapted for selective connectivity with a portion of the one or more branching extension portions.

BRIEF DESCRIPTION OF THE DRAWINGS

Figs. 1-2 show exemplary implant devices and branching extension portions in accordance with embodiments of the present invention.

Fig. 3 shows an exemplary implant device, e.g., anterior implant device, with anchoring and receiving portions in accordance with embodiments of the present invention.

Figs. 4-5 show exemplary implant devices in accordance with embodiments of the present invention.

Fig. 6 shows an exemplary dual branch extension portion in accordance with embodiments of the present invention.

Figs. 7-8 show exemplary introducer or insertion tools in accordance with embodiments of the present invention.

Fig. 9 schematically shows the deployment of an exemplary dual branch extension portion in accordance with embodiments of the present invention.

Fig. 10 schematically shows the anchoring, positioning and support provided with a combined anterior and posterior implant system in accordance with embodiments of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring generally to Figures 1-10, like reference numerals can designate identical, similar or corresponding parts throughout the views. The following description is meant to be illustrative only, and not limiting other embodiments of this invention that will be apparent to those of ordinary skill in the art in view of this description.

The invention involves surgical instruments, assemblies, and implantable articles for treating pelvic floor disorders such as fecal or urinary incontinence, including stress urinary incontinence (SUI), prolapse, etc. According to various embodiments, a surgical implant can be used to treat a pelvic condition, including the specific examples of surgically placing a pelvic implant to treat a condition such as vaginal prolapse or incontinence (male or female). Described herein are various features of surgical implants, surgical tools, surgical systems, surgical kits, and surgical methods useful for installing implants. An implant can be implanted in a male or a female patient to treat urge incontinence, stress urinary incontinence, mixed incontinence, overflow incontinence, functional incontinence, fecal incontinence, prolapse (e.g., vaginal or uterine), and various conditions or defects in the pelvic floor, muscles, ligaments or other tissue.

An implant system can include one or more tissue support portions that can be used to support pelvic tissue such as the urethra (which includes the bladder neck), bladder, rectum, vaginal tissue (Level 1, Level 2, Level 3, or combinations of these), pelvic floor tissue, etc. During use, the tissue support portion is typically placed in contact with tissue to be supported, such as by attachment using one or more anchoring devices and/or sutures. One or more extension portions can be attached to the tissue support portion. A tissue engagement fastener or device (e.g., anchoring device) can be included at an end of an extension portion and/or a portion of the tissue support portion. The tissue support portion can be sized and shaped to contact the desired tissue when installed, e.g., as a "sling" or "hammock," to support pelvic tissue. An extension portion can be generally elongate or otherwise extendable from a tissue support portion, to pass through or attach to tissue of the pelvic region to thereby provide support for the tissue support portion and the supported tissue. A plurality of extension portions can extend from a tissue support portion for attachment to tissue in the pelvic region, such as by extending to an internal anchoring point, or through a tissue path to an external incision.

The various implants can be sized, fixed or adjustable, and shaped to be sufficiently taut upon placement within a pelvic region to provide desired support, or to generally return the support tissue to its correct or original anatomical position. The portions or components of the implants can be integrally formed or separately attached.

As disclosed in International PCT Publication Nos. WO2009/017680 and WO2009/075800, which are incorporated herein by reference in their entirety, certain implant systems are adapted for treating anterior and posterior vaginal prolapse. The embodiments of such systems can include entirely separate tissue support portions, extension portions and anchoring devices and methods to perform the distinct anterior and posterior procedures. Specifically, there are generally two separate tissue support portions (one for anterior and one for posterior support) that are both separately anchored, e.g., via the extension portions, at one end to opposing sides of the sacrospinous ligament. As such, combined anterior and posterior procedures can generally require a total of four separate anchoring devices at separate target points in the ligament (e.g., two for the anterior support and two for the posterior support).

Embodiments of the present invention can include an implant system 10 configured to provide for combined treatment of anterior and posterior prolapse, while simultaneously reducing the procedural steps and anchoring points for repairing or treating both conditions. As such, a single tissue anchor device can be employed on each side of the sacrospinous ligament to provide a total of 2 anchoring points in the ligament to position both the anterior and posterior supports. Namely, the implant system 10 can include an anterior implant 12, a posterior implant 14, and one or more branching extension portions 16. Each branching extension portion 16 can include at least one tissue engagement portion 18 (e.g., anchor or fixation device), and a first arm member 20 and a second arm member 22, with both members 20, 22 extending from the tissue engagement portion 18. The arms 20, 22 can be attached to, integrated with or otherwise provided proximate or at an end of a tissue engagement portion 18 to branch out therefrom. In certain embodiments, the tissue engagement portion 18 can be configured as a tissue anchor having one or more tines or barbs 24 adapted to penetrate and/or engage target tissue within the pelvic region to facilitate fixation and implantation. Figs. 1-5 depict various embodiments of the implants and branching extension portions 16. One skilled in the art will understand that various other implants and branching extensions 16 of varying shapes, sizes and configurations can be employed as well in view of the teachings provided herein. Various systems, devices, structures, components and methods disclosed in the above-incorporated references can be implemented, in whole or in part, with the system 10, implants 12, 14 and branching extension portions 16 disclosed herein.

The anterior implant 12 (e.g., Fig. 3) can include an anterior tissue support portion 30 and one or more receiving or extension portions 32, with at least a portion of the implant 12 (e.g., support portion 30 or receiving portions 32) configured to connect with one or more of the branching extension portions 16, including the first or second arm members 22. The receiving portions 32 can be constructed or shaped as extending tabs, apertures, regions of the support portion 30, or other structures or features adapted to operatively and adjustably connect with the branching extensions 16. In general, the anterior implant 12 can be sized and shaped in accordance with the embodiments disclosed herein, or other like designs known or otherwise disclosed in the previously-incorporated patent publications. Corners or other portions of the anterior implant 12 can include an engagement portion 13 adapted to affix a portion of the Implant 12 within target tissue, such as the obturator foramen. Dimensions A and F of the embodiment of Fig. 3 demonstrate the potential curves and orientation of the implant profile, and placement and orientation of the receiving portions 32.

The posterior implant 14 can include a posterior support portion 40 and one or more receiving or extension portions 42, as shown in an exemplary embodiment of Fig. 5. Again, the branching extension portions 16 are adapted for connectivity or integration with the posterior support portion 40 or portions 42 of the implant 14, and the posterior implant 14 can be sized and shaped in accordance with the embodiment shown in the figures, or other like designs known or otherwise disclosed in the above-referenced patent publications.

The implants 12, 14, or portions thereof, can be constructed of compatible polymer or biological mesh materials capable of use for vaginal or pelvic tissue prolapse repair procedures. Further, the branching extension portions 16 can be constructed at least in part of similar polymer or biological mesh materials. In various other embodiments, the structures and components of the system 10 can be constructed of compatible mesh materials, non-mesh materials, polymers, combinations of mesh and non-mesh materials, or other acceptable materials and constructs.

As shown in Figs. 1-2 and 6, embodiments of the one or more branching extension portions 16 can include a first branching extension portion 16a and a second branching extension portion 16b. Each of the branching extensions 16a, 16b can include the arm members 20, 22 having a distal end provided with the tissue engagement device or anchor, and can include a trailing portion or end 17. In certain embodiments, the first arm member 20 can be connected to the second arm member 20, or vice-versa, such that both arm members 20 are in operative communication with the tissue engagement device 18. The trailing portions 17 can be constructed of the same or of a different material than other portions of the branching extension 16, and are adapted for operative or direct attachment with a portion of the implants 12, 14, such as the receiving portions 32, 42. In one embodiment, the trailing portion 17 can include a rod member 19. The rod member 19 can be selectively connected with various insertion tools, and can be cut off or otherwise removed upon deployment and placement of the respective implants 12, 14. The rod member 19 can also facilitate manipulation, adjustability and connectivity of the branching extension 16 with respective components of the implants 12, 14. The rod member 19 can be generally rigid to facilitate such connectivity and manipulation. Various devices or features 60, including grommets, eyelets, clips, connectors, tabs, fasteners, sutures, and other features, devices or techniques can be utilized to connect a portion of the arm members 20, 22 or trailing portion 17 to the corresponding implants 12, 14 or receiving portions 32, 42. In other embodiments the arms 20, 22 can be integral or otherwise provided with the corresponding implants 12, 14. One or more insertion or introducer devices or tools 50 can be used to deploy and implant one or both of the implants 12, 14, as shown in Figs. 7-8. The tools 50 are adapted for manipulation and insertion of the implants and/or the branching extension portions within the pelvic region of the patient, and for engaging and anchoring the implants within corresponding target tissue. The tools 50 can include a handle portion 52 and a needle portion 54. The needle portion 54 includes a distal end 56 configured to engage and manipulate the implants 12, 14, or a portion thereof. A proximal end of the needle portion 54 is connected to or provided with the handle portion 52. The needle portion 54 can be straight, curved, helical, or take on various other like shapes and configurations. Known sleeves or sheaths can be employed as well to cover components of the system 10, e.g. , the branching extensions 16, to facilitate handling of generally flexible components of the system 10 during deployment and anchoring. Further, the handle 52 can include one or more actuators in operative communication with the needle 54, or the distal end 56, to selectively engage and deploy the implants 12, 14 or anchoring devices of the system 10. Figs. 9-10 depict an embodiment of the combined anterior and posterior prolapse repair system 10 in use. The procedure can be performed transvaginally such that a posterior vaginal wall dissection or incision is performed to provide a path through the vagina and out the vagina wall. One of the branching extensions 16 (e.g., 16a) can then be inserted through the posterior vaginal incision, with the leading end of the extension 16 including the anchor 18. The anchor 18 can then be inserted and fixated within desired target tissue of the pelvic region, such as a portion of the sacrospinous ligament. The same process can be done with another posterior incision on the opposing posterior vaginal wall such that another of the branching extensions 16 (e.g., 16b) can be inserted through that incision, with the anchor 18 of the branching extension 16 being inserted and fixated within target tissue, such as the opposing portion of the sacrospinous ligament. In general, the branching extensions 16 will be deployed and fixated bilaterally, but alternative embodiments can include a single branching extension 16. The branching extensions 16, and/or anchors 18 can be fed and positioned for anchoring with known insertion or introducer tools, as described herein or disclosed in the incorporated patent references.

Upon fixation of the branching extensions 16a, 16b to tissue, such as the sacrospinous ligament, an anterior vaginal wall incision or dissection can be performed on each opposing wall of the vagina. The tool 50 (e.g., helical or curved) can then be passed from the anterior incision, under vaginal epithelial structures and into the posterior vaginal wall dissection. Various shaped needles 54 can be employed to facilitate traversal and positioning for attachment to a trailing portion 17 of one of the arms of the branching extension 16, such as the rod 19. In those embodiments having a rod member 19, the rod 19 is attached via a connector or other feature to the tool 50, with the arm member 20 (or 22) being directed through the anterior incision. Again, this step can be performed bilaterally with the other of the two branching extensions 16a, 16b. In one embodiment, the rod members 19 can be cut off or otherwise removed from the branching extension members 16 at a desired time in the procedure.

To position and anchor the anterior implant 12, the anchors 13 (e.g., provided along opposed corners of the implant 12) are inserted into proximate target tissue, such as the obturator foramen, bilaterally. Further, a portion of the arm members 20 (e.g., bilaterally) of branching extensions 16a are attached to the implant 12, e.g., at receiving portions 32. Again, attachment devices or features can be used to adjustably tension and connect the extension 16a to the implant 12 on both sides of the implant. Upon deployment and fixation, the tissue support portion 30 of the implant 12 will provide desirable anterior prolapse support (e.g., between the bladder and the vagina).

To position and anchor the posterior implant 14, a portion of the arms 22 of branching extensions 16b are attached to the implant 14, e.g., receiving portions 42. Like with implant 12, various attachment devices and features can be used to adjustably tension and secure the extension 16b to the implant 14, on both sides of the implant 14. The end of the implant 14 opposite or distal the receiving portions 42 can be further attached or sutured to target tissue to provide additional stability and fixation for the implant 14. Upon deployment and fixation, the tissue support portion 40 of the implant 14 will provide desirable posterior prolapse support.

For demonstrative purposes, Figs. 9-10 depict deployment and tissue fixation for the implants 12, 14 along a single side of the pelvis. As described herein, bilateral support (e.g., attachment to both opposing sides of the respective tissue, such as the sacrospinous ligament and obturator foramen) is generally preferred and the structures and procedures for performing such bilateral support are provided herein in detail.

Sutures or other anchoring devices and techniques can be implemented to further attach or affix various portions of the implants 12, 14, such as the tissue support portions 30,40, to lateral or proximate tissue in conjunction with the anchoring procedures disclosed herein. In addition, various adjustment devices, features or techniques can be included to provide positioning and tensioning adjustment for the implants 12, 14 and the branching extension portions 16 within the pelvis.

A variety of materials may be used to form portions or components of system 10, implants 12, 14 and branching extensions 16, including Nitinol, polymers, elastomers, porous mesh, thermoplastic elastomers, metals, ceramics, springs, wires, plastic tubing, and the like. The systems, components and methods may have a number of suitable configurations known to one of ordinary skill in the art after reviewing the disclosure provided herein.

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. An implant system for combined repair of anterior and posterior vaginal prolapse, comprising: an anterior implant having a tissue support portion; a posterior implant having a tissue support portion; and one or more branching extension portions having a first member and a second member in operative communication with a tissue engagement portion such that the first member is adapted for connectivity with the anterior implant and the second member is adapted for connectivity with the posterior implant.

2. The system of claim 1, wherein the one or more branching extension portions includes two branching extension portions.

3. The system of claim 1, wherein the anterior implant is at least partially constructed of a compatible mesh material.

4. The system of claim 1, wherein the posterior implant is at least partially constructed of a compatible mesh material.

5. The system of claim 1, wherein at least one of the first and second members is constructed of a compatible mesh material.

6. The system of claim 1, wherein the tissue engagement portion includes a tissue anchor having one or more extending barbs adapted to penetrate target tissue.

7. The system of claim 1, wherein the first member is adjustably connectable with the anterior implant.

8. The system of claim 1, wherein the second member is adjustably connectable with the posterior implant.

9. An implant system for combined repair of anterior and posterior vaginal prolapse, comprising: an anterior implant having a tissue support portion and a receiving portion; a posterior implant having a tissue support portion and a receiving portion; one or more branching extension portions having a first arm member and a second arm member operatively extending from a tissue engagement portion, with a free end of the first arm member being adjustably connectable to the receiving portion of the anterior implant and a free end of the second arm member being adjustably connectable with the receiving portion of the posterior implant; and an insertion tool having a handle and a needle, with a distal end of the needle adapted for selective connectivity with a portion of the one or more branching extension portions.

10. The system of claim 9, wherein the one or more branching extension portions includes two branching extension portions, with the tissue engagement portions of the two branching extension portions each adapted to engage respective opposing regions of the sacrospinous ligament.

11. The system of claim 9, wherein the distal end of the needle is adapted for selective connectivity with the tissue engagement portion of the one or more branching extension portions.

12. The system of claim 9, wherein the anterior implant is at least partially constructed of a compatible mesh material.

13. The system of claim 9, wherein the posterior implant is at least partially constructed of a compatible mesh material.

14. The system of claim 9, wherein at least one of the first and second arm members is constructed of a compatible mesh material.

15. The system of claim 9, wherein the tissue engagement portion is a tissue anchor having one or more extending barbs.

16. The system of claim 9, wherein the anterior implant includes one or more anchors adapted to engage respective opposing regions of the obturator foramen.

17. A method of combined repair of anterior and posterior vaginal prolapse, comprising: providing an anterior implant device having a tissue support portion; providing a posterior implant device having a tissue support portion; providing at least one branching extension having a tissue engagement portion, and a first arm member and a second arm member operatively connected with the tissue engagement portion; inserting at least a portion of the branching extension transvaginally; anchoring the tissue engagement portion into a portion of the sacrospinous ligament; operatively connecting the first arm member to a portion of the anterior implant; and operatively connecting the second arm member to a portion of the posterior implant.

18. The method of claim 17, wherein the at least on branching extension includes two branching extension, with each branching extension having a tissue engagement portion and first and second arm members.

19. The method of claim 17, wherein the anterior implant further includes one or more proximate tissue engagement portions adapted to anchor to a portion of the obturator foramen.

20. The method of claim 17, wherein the first and second arm members are at least partially constructed of a mesh material.

21. The method of claim 17, wherein at least a portion of the anterior and posterior implants are constructed of a mesh material.

22. The method of claim 17, wherein the tissue engagement portion is an anchor device having one or more extending tines.