# Patent

## Title
Expandable implant system

## Abstract

Various embodiments of a sling implant system are provided. Embodiments of the implants can include one or more collapsibility and expandability features or portions adapted to improve introduction and deployment of the implant within the patient. The implants can be folded, collapsed or otherwise reduced in size or construct to fit within a delivery tool or catheter for later expandability upon deployment of the implant.

## Background
PRIORITY
This Application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/469,512, filed Mar. 30, 2011, which is incorporated herein by reference in its entirety.


FIELD OF THE INVENTION
The present invention relates generally to surgical methods and apparatus and, more specifically, to a surgically implantable sling adapted for selective collapsibility and expandability.
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.
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. 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.
In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times.
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.
There is a desire to obtain a minimally invasive yet highly effective implantable mesh that can be used to treat incontinence, and/or pelvic organ prolapse and other conditions.
SUMMARY OF THE INVENTION
The present invention describes pelvic mesh slings or implants and methods 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.), and other conditions caused by muscle and ligament weakness. Embodiments of the implants can include features adapted to provide selective expandability and collapsibility of the implant.
The implant has an expanding member associated with the support portion. The expanding member maintains a collapsed state until deployed into the anchoring tissue. The implant can thereby be inserted utilizing a smaller incision and no dissecting. Once at the target tissue, the implant is released and the expansion member expands to its expanded state. The expanded state provides a bulking area near the urethra and aids in preventing migration.
Embodiments of the present invention may be incorporated into or provided with various commercial products marketed by American Medical Systems of Minnetonka, Minn., as the MiniArc® Single-Incision Sling and like implant or anchoring systems.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a perspective view of an embodiment of the implant according to an aspect of the present invention.
FIG. 1B is a perspective view of FIG. 1A.
FIG. 2A is a schematic view of the implant of FIG. 1A in vitro.
FIG. 2B is a lateral schematic view of the implant of FIG. 1A in vitro in a flexed state.
FIG. 3A is a perspective schematic view of the implant of FIG. 1A in vitro.
FIG. 3B is a lateral view of FIG. 3A.
FIG. 3C is a superior view of FIG. 3A.
FIG. 4 is an embodiment of the implant of the present invention.
FIG. 5 is another embodiment of the present invention.
FIG. 6 is another embodiment of the present invention.
FIG. 7 is another embodiment of the present invention.
FIG. 8A is a collapsed view of another embodiment of the present invention.
FIG. 8B is a side view of the implant of FIG. 8A in an expanded state.
FIG. 8C is a perspective view of FIG. 8B.
FIG. 9 is another embodiment of the present invention.
FIG. 10 is another embodiment of the present invention.
FIG. 11 is yet another embodiment of the present invention.
FIG. 12A is an illustration of an embodiment of an insertion device.
FIG. 12B is another embodiment of an insertion device.
FIG. 13 is another embodiment of an insertion device.



DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
The following description is meant to be illustrative only and not limiting. Other embodiments of this invention will be apparent to those of ordinary skill in the art in view of this description. The present invention is particularly suitable for treating stress urinary incontinence (SUI) diagnosed with urethral hypermobility or intrinsic sphincter deficiency in both men and women. Although the invention as disclosed herein generally refers to SUI, treatment of other urological disorders, such as urge incontinence, mixed incontinence, overflow incontinence, functional incontinence, prolapse (e.g. vaginal), enteroceles (e.g. of the uterus), rectoceles and other non-urological disorders, are also included within the scope of the present invention. It is contemplated that the present invention may also be utilized in conjunction with other procedures, such as, but not limited to, procedures for addressing cystocele prolapse, vaginal prolapse and anatomic hypermobility.
In general, the implant systems 10 can include an implant and a delivery device. The implant can include a support portion 12, and end portions 26 having anchors 16 provided therewith. Various portions of the implant systems 10 can be constructed of polymer materials, such as a film or sheet material of polypropylene, polyethylene, fluoropolymers or like compatible materials.
The various implants 10 or systems, features and methods detailed herein are envisioned for use with many known implant and repair systems (e.g., for male and female), features and methods, including those disclosed in U.S. Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,691,711, 6,648,921, and 6,612,977, International Patent Publication Nos. WO 2008/057261 and WO 2007/097994, and U.S. Patent Publication Nos. 2010/0105979, 2002/151762 and 2002/147382. Accordingly, the above-identified disclosures are fully incorporated herein by reference in their entirety.
Referring generally to FIGS. 1-3, an embodiment of the implant systems 10 can be constructed of a mesh polymer 22 hybrid and a nitinol coil 20 or like material construct that collapses into a needle for deployment and delivery. The expanding design eliminates or reduces the need for dissection during implantation. The shape and configuration of the implant systems 10 will resist migration forces lateral to or with respect to the urethra, thereby maintaining the treatment location of a bulking feature proximate to a sphincter of a patient. In various embodiments, the implant system 10 is delivered percutaneously.
As shown in FIGS. 1A & 1B, an example embodiment of implant systems 10 has a support portion 12 and one or more end portions 26. The support portion 12 may also include a Nitinol or like coil or expanding member 40 that can be included within or with a mesh tube 22. Various attributes, sizes, shapes and like characteristics can be provided for the implant systems 10 and mesh tube 22. In various embodiments, the implant system 10 defines a generally figure-eight structure with a hinge point at the support portion 12 and two end portions 26. A segment of the support portion 12 may be narrower in size than the end portion 26.
As shown in FIG. 2, the implant system 10 may be deployed proximal to the urethra and capable of expanding to provide a desired level of force against the urethra. In one embodiment, the support portion 12 or a portion thereof may flex to provide movement with the urethra.
FIG. 3 demonstrates an alternative embodiment of the implant systems 10. The implant system 10 may include a support portion 12 and one or more end portions 26. An expansion member 40 may be coupled to support portion 12 to provide a bulking mechanism positioned proximal to a sphincter.
Other embodiments of the implant systems 10 can include a mesh design and configuration adapted to provide folding or collapsibility to facilitate insertion and deployment of the implant within the patient. As shown in FIGS. 4-11, various collapsibility and expansion features 40 can be included with the implant. FIG. 4 shows an embodiment of implant system 10. Implant system 10 has a support portion 12 and end portion 26. End portion 26 may be coupled to a fixation device 16. Fixation device 16 may be a soft tissue anchor, suture, or other similar structure. Implant system 10 may be constructed of a collapsible mesh material to facilitate compression within an insertion device.
FIG. 4 shows an alternative embodiment of implant system 10. Implant system 10 has a support portion 12 and end portion 26. End portion 26 may be coupled to a fixation device 16 such as a soft tissue anchor or suture. The implant system 10 may be configured to fold or collapse to facilitate deployment and implantation within the patient.
As depicted in FIG. 4-7, an alternative embodiment of the implant systems 10 can include a widened portions or segments of the support portion 12 (FIGS. 5, 10), narrowing segment of the support portion 12 (FIGS. 6-7, 11), or other ribbed, folded or otherwise defined support portion 12 segments (FIG. 8) to facilitate collapsibility and expansion upon deployment. Various embodiments can include a biodegradable or absorbable sections to promote the described expansion of the implant features.
FIG. 5 illustrates another embodiment of implant system 10. Implant system 10 has support portion 12 and one or more end portions 26 coupled to a fixation device 16. Fixation device 16 may be a soft tissue anchor, suture, or other anchoring mechanism. The support portion 12 or portions thereof may be narrower than the end portions 26 to aid in insertion into and deployment out of a flat needle. Implant 10 may be comprised of a mesh or other similar material that can collapse or fold into an insertion tool 32.
In yet another embodiment, the implant system 10 of FIG. 6 is comprised of support portion 12 coupled to one or more end portions 26. End portions 26 may be coupled to a fixation device 16 such as a soft tissue anchor or other like mechanism. Implant system 10 may be comprised of a mesh or other similar material that can collapse or fold into an insertion tool 32. End portions 26 and/or expansion member 40 may be comprised of a tubular mesh that may expand upon deployment. Support portion 12 may be comprised of an absorbable or non-absorbable material.
FIG. 7 illustrates an implant system 10 where a segment of the support portion 12 is less than the width of the expansion portions 40. The support portion 12 and associated end portions 26 may be composed of absorbable, non-absorbable mesh or a combination. Support portion 12 and expansion member 40 may be narrower than end portions 26 before deployment and widen once placed in the patient. End portions 26 may be operatively coupled to a fixation device 16 capable of anchoring within a target tissue.
FIGS. 8A-C show an implant system 10 that may fold into a flat needle. Support portion 12 and end portions 26 may be made from mesh or a similar material. Support portion 12 may fold, i.e., like an accordion to fit in a needle, ideally 4 mm in width. The implant would be compressed to fit into the flat needle and upon deployment support portion 12, end portion 26, and/or expansion feature 40 would unfold to provide a wider implant section proximal to the urethra.
FIGS. 9-11 show various alternative embodiments of the collapsible and expandable implant system 10. Each can be folded, collapsed or otherwise provided within or with a delivery tool for deployment. FIG. 9 shows an embodiment wherein the mesh slides along a suture placed in the target tissue. The suture may be woven within the end portions 26. The implant system 10 of FIG. 10 may include one or more expansion elements 40 in the form of tubular mesh. The expansion elements 40 may be circular or ovular is shape. It will be obvious to one skilled in the art that other shapes and configurations may be employed without departing from the spirit and scope of the invention. The expansion elements 40 are adapted to fit within and deploy from the needle 34 of the delivery tool 32. FIG. 11 depicts an alternative embodiment of the implant system 10 wherein a segment of the support portion 12 may include an absorbable or non-absorbable material or containing an absorbable coating. The expansion members 40 would be adapted to fit within the needle or catheter device.
An embodiment of a delivery tool 32 is shown in FIGS. 12A & B. The delivery tool 32 comprises a needle 34 coupled to the distal end of a handle 39. The needle 34 would allow for the implant to be loaded therein. An alternative insertion tool 32 embodiment is illustrated in FIG. 12B. Insertion tool 32 may have indicia 41 located on handle 39 to aid in implantation. Additionally, a shaft 35 may include a catheter 36 with a balloon located on the distal end. The insertion tool 32 and its respective components are designed to provide selective insertion, ejection and expansion of the implant system 10 within the patient for deployment at the patient's urethra. FIG. 12B illustrates associated implantation tool 32. Insertion tool 32 has a handle 39 on proximal end and a needle 34 on the distal end. The needle 34 may embody a substantially flat shape. Support portion 12 and expansion member 40 can be folded to fit into the needle 34.
In general, the support portion 12 can be configured to fit within a 0.090′′ ID delivery tool, for deployment from the tool. Other support portions 12 can fit into a 4 mm wide delivery tool. Other various implant and tool designs and shapes can be used as well. With such an implant and tool system, the need for an incision and lateral dissection is eliminated, because the implant can be delivered and deployment from within the tool. As such, tissue disruption and bleeding is reduced.
The implant systems 10, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulating implants to treat incontinence and prolapse as disclosed in the previously-incorporated references are envisioned for use with the present invention as well. Further, the system and its components or structures can be constructed of known and compatible materials know to those skilled in the art, including metals, polymers, and the like.
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 to treat incontinence, comprising:
a support portion positionable proximate a urethra and constructed of a plurality of mesh filaments;
at least two mesh expansion members, each including a nitinol coil and constructed of a plurality of mesh filaments to define a generally tubular shape, and wherein the at least two mesh expansion members are selectively expandable and collapsible, the at least two mesh expansion members being operatively coupled to the support portion and defining a bulking area positionable near the urethra to operatively engage a portion of the urethra;
at least two end portions coupled to the support portion, each extending generally away from a respective expansion member, and each end portion having a free end positionable proximate anchoring tissue; and
at least one anchor coupled to the free end of the end portions to anchor the implant into the anchoring tissue.

2. The implant of claim 1 wherein at least one of the expansion members is adjustable between a collapsed state and an expanded state.

3. The implant of claim 1 wherein a segment of the support portion has a width less than a width of the end portions.

4. The implant of claim 3 wherein the segment of the support portion having a width less than a width of the end portions is disposed between the expansion members.

5. The implant of claim 3 wherein the segment is constructed of a flexible material.

6. The implant of claim 1 wherein the support portion is composed of an absorbable or nonabsorbable material.

7. The implant of claim 1 wherein the implant comprises holes that are sized and shaped to encourage tissue ingrowth.

8. The implant of claim 1 where in the support portion is foldable during implantation.

9. The implant of claim 1, wherein the support portion comprises a porous woven mesh material.

10. The implant of claim 1 made from a material selected from the group consisting of polypropylene, polyurethanes, acetal materials, polytetrafluorethylene materials, silicones, or other curable materials.

11. The implant of claim 1 further comprising a suture weaved through the implant.

12. A method of treating incontinence in a patient, the method comprising the steps of:
creating an incision through the vagina;
providing an elongate insertion tool;
providing an implantable sling having a support portion constructed of a plurality of mesh filaments, at least two end portions, and a mesh expanding member having a nitinol coil and constructed of a plurality of mesh filaments to define a generally tubular shape that is selectively collapsible and expandable provide;
passing a portion of the sling to an anchoring tissue;
removing the insertion tool via the vaginal incision, leaving the sling in place; and
repeating the procedure on the patient's other side.

13. The method of claim 12 wherein the sling is provided in a collapsed state and expands to an expanded state.

14. The method of claim 12 further comprising the step of providing a suture coupled to an anchor whereby the sling is threaded along the suture to the anchoring tissue.