# Patent

## Title
Fecal incontinence treatment device and method

## Abstract

Various embodiments of an implant system for treating fecal incontinence are provided. The devices and systems can include a mesh or like device that can include a variable porosity to control the degree of expansion of the anal canal. The mesh can be constructed at least in part of patterned strut members allowing for various geometric configurations, with varying load and tension properties for the designated portions of the device according to the needs for a particular patient application.

## Background
PRIORITY
This Application claims priority to and the benefit of U.S. Provisional Patent Application No. 61/529,132, filed Aug. 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 surgically implantable fecal incontinence devices and methods for forming and using the same.
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.
Fecal or anal incontinence is a condition characterized by involuntary defecation or passage of feces through the anal canal due to injury to or weakness of one or more of the internal anal sphincter, the external anal sphincter, and the levator ani. Fecal incontinence can be the result of an atrophied or damaged anal sphincter muscle or a sphincter muscle that incorrectly responds to neural signals. The problem is to restore the radial closing force of the disrupted sphincter muscle in order to restore fecal continence.
More recently, an artificial anal sphincter has been used to bypass these muscles, though this surgery involves fairly extensive dissection and requires the patient to depress a subcutaneous valve which temporarily deflates the sphincter cuff and allows voluntary defecation. This procedure is performed in very few centers in the U.S., and even in experienced hands, complications occur frequently. In addition, sacral nerve stimulation has been used with some success to treat fecal incontinence, though the mechanism of success in these patients remains unclear, and may not be appropriate in women with obvious anatomic abnormalities, such as anal sphincter or levator muscle disruptions.
Further, many women report other symptoms of bowel dysfunction, such as constipation and incomplete bowel emptying. For some women, these symptoms are due to either an anterior rectocele (a hernia of the rectum into the vaginal canal), or due to a defect in the levator ani muscles, which results in descent of the levator plate and/or perineum with abdominal straining. In addition, patients may be noted to have a defect in the posterior aspect of the rectum, or a posterior rectocele. There are very few treatment options for this condition, though retrorectal levatorplasty has been used in the past. In this procedure, an incision is made between the anus and the coccyx and the levator muscles are exposed bilaterally. Sutures are then placed in the levator muscles to plicate them together in the midline.
There is a desire to obtain a minimally invasive yet highly effective implantable member or mesh that can be used to treat incontinence, and/or pelvic organ prolapse and other conditions.
SUMMARY OF THE INVENTION
The present invention describes devices, systems and methods for treating incontinence, including fecal incontinence. The devices and systems can include a cylindrically shaped member, such as mesh, that can include a variable porosity to control the degree of expansion of the anal canal. Pores or openings in the member can be shaped and patterned to allow for resistance to expansion (hold sphincter closed), yet also allow expansion or elongation during the passage of material through the sphincter. The mesh can be constructed at least in part of patterned strut members allowing for multiple geometric configurations, with varying load and tension properties for the designated portions of the device. The mesh device can be placed around or within the anal sphincter muscle. At least one incision may be used to place the implant and then ends of the implant can be joined to form a cylindrical shape to surround and restrict the sphincter muscle. As a result, an adaptable, e.g., limited expansion and restriction, implant device is included to provide variable expansion control to promote continence without the use of inflatable devices or related complicated mechanisms and systems.
Various embodiments of the implant device can include a plurality of segments. The segments can be spaced and connected by one or more extension members. The segments and/or the extension members can be constructed of mesh filament members, unitary strut members, or like constructs.
In other embodiments, a variable spring-sleeve implant can be included. A variable wound spring, in a sleeve, can be inserted into the anal canal in order to restore continence. Alternatively, the spring-sleeve may be implanted around the anal sphincter muscle. Still further, the spring can be implanted without a sleeve portion to promote continence. The sleeve isolates the spring from the surrounding tissues, allowing it to radially expand without interference from tissue in-growth. In its “resting state” the spring would have a smaller diameter at the same level of the sphincter. As the patient bears down to pass material through the sphincter, the diameter of the spring expands to allow material passage. Such a solution will allow passive closure of the anal sphincter to restore continence to the patient, and active expansion during the passage of material through the anal canal. For insertion into the anal canal, the spring-sleeve may be wound down and inserted into a catheter. For implantation, a similar delivery catheter would be used. The outer surface would allow for suture placement and tissue in-growth if desired.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 shows various relevant anatomical structures of the rectum, anus and internal anal sphincter muscles.
FIG. 2 is a schematic view of an implant device wrapped around a portion of the anal sphincter to promote fecal continence, in accordance with embodiments of the present invention.
FIGS. 3-7 are schematic views of an implant device being connected at opposing ends to provide a generally cylindrical configuration to promote continence, in accordance with embodiments of the present invention.
FIGS. 8-9 are schematic views of elongate implant devices having distinct patterned cell portion to promote continence, in accordance with embodiments of the present invention.
FIGS. 9a-9b are partial schematic views of exemplary patterned struts and cell portions for use with an implant device, in accordance with embodiments of the present invention.
FIG. 10 is a schematic view of a generally cylindrical implant device having distinct patterned cell portions to promote continence, in accordance with embodiments of the present invention.
FIGS. 11-14 are schematic views of various implant devices having segments and extension members to promote continence, in accordance with embodiments of the present invention.
FIG. 15 is a schematic view of a spring and sheath implant device for deployment within the anal canal to promote continence, in accordance with embodiments of the present invention.
FIG. 16 is a partial sectional schematic view showing a spring attached within a wall of a sheath for an implant device in accordance with embodiments of the present invention.
FIG. 17 is a schematic view of a collapsed sheath for an implant device in accordance with embodiments of the present invention.
FIG. 18 is a schematic top view of a collapsed sheath for an implant device in accordance with embodiments of the present invention.
FIG. 19 is a top schematic view of a bi-leaflet like valve implant device for use to promote continence in accordance with embodiments of the present invention.
FIG. 20 is a side schematic view of a bi-leaflet like valve implant device for use to promote continence in accordance with embodiments of the present invention.



DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring generally to FIGS. 1-20, various embodiments of implantable devices or systems 10 and methods for treating fecal incontinence are shown.
The devices 10 can be joined to form a cylindrically shaped member or mesh (e.g., cuff) structure that can include a variable porosity attributes to control the degree of expansion of the anal canal. Pores or openings can be shaped and patterned to allow for resistance to expansion (e.g., hold sphincter closed), yet also allow some expansion or elongation during the passage of material through the sphincter, thereby better mimicking the natural anatomical structure and behavior.
FIG. 1 one shows typical anatomical structures of the patient, including the rectum R, internal anal sphincter muscles or tissue S, and the anus A.
In various embodiments, as shown in FIGS. 2-14, the implant device 10 is a generally elongate device in its initial state. The elongate device 10 can include a first end portion 12a and a second end portion 12b, as well as a central support or restriction portion 13. Before or after deployment to the target site for restriction, such as the sphincter, the device 10 wraps around the sphincter muscle and the end portions 12a, 12b are engaged or interlocked to retain the device 10 in place to provide the desired restriction to promote continence.
As shown in FIGS. 3-7, the device 10 can be generally flat or elongate in its initial form or state, and wrapped around a portion of the internal anal sphincter muscle, and connected via the mechanisms 18, to create a generally cylindrical cuff configuration around the muscle, or a proximate anatomical area, to promote continence.
As illustrated in FIGS. 8-10, the device 10 can be constructed at least in part of patterned strut members 14 allowing for multiple geometric or mesh configurations, with varying load, compression, elasticity, tension and like properties for the designated portions of the device 10. As such, at least a portion of the implant device 10 can have a generally consistent homogenous or unitary patterned cell construct 16. The entire device 10 can be constructed of the unitary patterned cells or just a designated section, or sections, can include the patterned strut configuration attached to or integrated with interwoven mesh filament portions.
The device 10 can be placed around or within the anal sphincter muscle S (e.g., FIG. 2). In certain embodiments, one or more incisions can be made to provide access to the pelvic space, e.g., between the anus and the vagina or scrotum, and the end portions of the implant 10 can be joined together around the anal sphincter to form a cylindrical restriction structure around the sphincter to promote continence. As shown in FIG. 10, the cylindrical implant 10 can be generally tapered along a portion thereof to control continence.
For those embodiments employing a mesh construct having one or more unitary patterned cells 16 defined from struts 14 (e.g., undulating struts), the implant devices 10 can be formed by way of a molding, die casting, laser etching, laser cutting, extruding, and the like. Exemplary patterns and strut 14 configurations for the patterned cell portions 16 are depicted in FIGS. 9a-9b. Such a pattern cut or formed implant can be constructed of a polymer material to provide a lattice support structure of repeated cells. The various implant devices, device patterns and properties, techniques, systems and methods disclosed in U.S. Patent Application Publication Nos. 2011/014417 and 2011/0124956 can be implemented with the embodiments of the present invention and as a result, the above-referenced publications are incorporated herein by reference in their entireties. In other embodiments, all or a part of the device 10 can also be constructed of interwoven or knitted members to form a mesh implant.
The patterned cell portions 16 can be formed into sinusoid or other waveform strut members 14 (e.g., FIGS. 9a-9b) to promote controlled elongation or expansion along single or multiple axes. As such, controlled and designated stress, tension and compression distribution is better controlled across specific or localized areas of the device 10. Consequently, the muscle is restricted to prevent fecal incontinence while still allowing for limited expansion or elongation during the passage of material through the sphincter S and out the anus A. Further, any of the devices 10 can be formed such that regions or portions can include the connection mechanisms or devices 18 to facilitate attachment.
For those embodiments that have at least a portion of the implant 10 defined by patterned cells, uniquely shaped or cut strut members 14 are configured to define cell voids 15, to optimize or increase tissue in-growth, to promote load bearing along select portions of the implant, to compensate for stiffness, elongation, compression, and tensile strength. The material and cell construct 16 of the implant device 10, or a portion thereof, can be configured to promote flexibility while still providing optimal strength and restriction to promote continence. Further, the stable and consistent geometrical and dimensional attributes of the implant provide a flexible device that can be easily positioned and deployed while also avoiding undesirable implant warping or bunching.
In addition to molding and laser cutting the struts 14 and other features of the implant device 10, punching, 3-D printing and other methods and techniques can be employed in making the implant. Further, the struts 14 or other portions of the implant device 14 can be coated to provide additional control over expansion, compression, and to protect from or promote tissue in-growth.
The mechanisms or devices 18 of various embodiments can include hooks, tabs, joints, locking members, button-like features, snaps, interlocking extensions, sutures and like connection structures or members, to engage, connect or join the first and second end portions 12a, 12b of the device 10. As shown in FIGS. 3-5, for instance, the first end portion 12a of the device 10 can include extending hooks or arrow-shaped members 18a, with the second end portion 12b including slotted members 18b, or features with one or more apertures 19, adapted to receive and retain the members 18a. FIGS. 11-12 show an embodiment having a button-like member 18a provided with the first end portion 12a and adapted to connect with a receiving aperture 12b provided with the second end portion 12b. 
Various embodiments of the implant device 10 can include a plurality of segments 20, as shown in FIGS. 11-14. The segments 20 can be spaced and connected by one or more extension members 22. The segments 20 can assume the construct of the various filament mesh structures, unitary patterned cells, generally elastic elements, or other like designs or configurations disclosed herein. Further, the extension members 22 can include sutures, mesh extensions, elastic members, unitary patterned cells, or a myriad of other elements or members adapted to span between, and in certain embodiments provide variable expansion for the segments 20. In certain embodiments, a single extension member 22 can be employed such that the segments 20 are positioned are provided along a length of the member 22. A kit or other system can be provided with a predefined number of segments depending on the specific anatomical dimensions and restriction requirements of the implant device 10 around the sphincter to promote continence. Moreover, certain embodiments can include segments 20 selectively added or removed from the length of the implant device 10, or a length of an extension member 22, according to the particular restriction, anatomical or dimensional needs of the procedure. In particular embodiments, the segments 20 can be constructed of a non-porous and compatible material, such as polymer material. Further, the segments 20 can include channels or like features to allow for sliding or movement of the segments 20 along a length of an extension member 22. The extension members 22 can be generally elastic in certain embodiments to facilitate deployment and adjustment, while still retaining a desirable restriction on the sphincter to promote continence upon implantation.
Embodiments of, or portions of, the implant 10 can be constructed of a material (e.g., polymer) having surface features or textured regions adapted to facilitate tissue engagement and/or tissue in-growth. Further, portions or all of the implant 10 can include coatings or other features to promote tissue in-growth, engagement, or treatment. For those embodiments adapted to promote treatment, various agents, drugs, biologics, or treatment or therapeutic substances can be included to facilitate healing, tissue strengthening or improvement.
In certain other embodiments, as shown in FIGS. 15-20, a variable spring-sleeve implant device 30 can be utilized in the treatment of fecal incontinence. A variable wound spring 32, in a sleeve 34, can be inserted into, and/or engaged within (e.g., force fit, sutured or anchored), the anal canal in order to restore continence. The device 30 includes openings at each end and a potential passageway therethrough. Alternatively, the spring-sleeve may be implanted around the anal sphincter muscle.
The sleeve 34 isolates the spring 32 from the surrounding tissues, allowing it to radially expand without interference from tissue in-growth. In other embodiments, the device 30 can simply include the spring 32, without a sheath 34. In its “resting state” the spring 32 can have a smaller diameter at the same dimension or level as the sphincter S. As the patient bears down to pass material through the sphincter, the diameter of the spring 32 expands to allow material passage through the interior of the device 30 and ultimately the canal. Such a solution will allow passive closure of the anal sphincter S to restore continence to the patient, yet active expansion during the passage of material through the anal canal (via the device 30). For insertion into the anal canal, the implant 30 may be wound down or collapsed (e.g., FIG. 17) and inserted into a catheter or like delivery tool. For implantation, a similar delivery catheter can be used. The outer surface of the device 30 or spring 32 can allow for suture placement and tissue in-growth if desired—e.g., including textured surfaces, coatings, mesh portions, and the like. As shown in FIG. 16, certain embodiments of the device 30 can include portions of the spring 32 extending into the wall portion of the sheath 34 to better provide the desired interconnectivity with the spring 32 and sheath 34 for increased operation and control. In use for various embodiments, a single perianal or full radius incision of the anal canal can be performed, followed by blunt dissection. The sleeve 34 can then be sutured in placed within the canal.
As shown in FIGS. 19-20, a valve-like implant 40 can serve as, or be modified to provide a desirable valve configuration when inserted into the anal canal. Accordingly, the implant 30 can be configured to act like a bi-leaflet valve device that folds or closes (e.g., FIG. 20 showing closing motion) to prevent material flow through the lumen until the patient sufficiently bears down.
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. 2012/0215060; 2011/0144417, 2008/0242918, 2008/0021264, 2002/151762 and 2002/147382. Accordingly, the above-identified disclosures are fully incorporated herein by reference in their entirety.
Embodiments of the present invention can be constructed of known compatible materials, including polymers and metals (Nitinol, titanium, stainless steel, etc.).
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 as disclosed in the previously-incorporated references are envisioned for use with the present invention as well.
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 device for treating fecal incontinence in a patient, comprising:
a restriction member having a first end portion, a second end portion, and an intermediate restriction portion adapted to wrap around a portion of an anal sphincter of the patient;
two separately spaced first connector elements provided at the first end portion, the first connector elements having a base portion extending out from the first end portion and a connector member extending from the base portion along an axis of the connector member, the axis of the connector member generally transverse from an axis of the base portion, the axis of the base portion being parallel to a central axis of the restriction member that extends from the first end portion to the second end portion; and
two separately spaced second connector elements each having at least one aperture and provided at and extending out from the second end portion and adapted to connect with a respective first connector element by receiving at least a portion of the first connector member through the at least one aperture in a direction generally transverse from the axis of the base portion to retain the restriction member around the anal sphincter of the patient to promote continence.

2. The device of claim 1, wherein the restriction member is generally elongate.

3. The device of claim 1, wherein the restriction member is constructed at least in part of woven filaments.

4. The device of claim 1, wherein the restriction member is constructed at least in part of strut members defining a unitary patterned cell configuration.

5. The device of claim 1, wherein at least the intermediate portion of the restriction member includes a plurality of distinct segments connected by one or more extension members.

6. The device of claim 1, wherein the two first connector elements include a hook member.

7. The device of claim 1, further including at least one unitary patterned cell configuration extending substantially along a length of the restriction member to permit limited expansion of the restriction member adapted to wrap around the anal sphincter.

8. The device of claim 1, wherein the two first connector elements are selected from the group consisting of: a tab, a clip, a snap device, a hook, and a button member.

9. The device of claim 1, wherein the restriction member includes a first section having a first pattern and a second section having a second pattern different than the first pattern.

10. An implant device for treating fecal incontinence in a patient, comprising:
a restriction mesh member having a first end portion, a second end portion, and an intermediate restriction portion adapted to wrap around a portion of an anal sphincter of the patient;
first and second spaced hook members provided at the first end portion, the hook members having a base portion extending out from the first end portion, an extension portion extending from the base portion along an axis of the extension portion, the axis of the extension member generally transverse from an axis of the base portion, the axis of the base portion being parallel to a central axis of the restriction mesh member that extends from the first end portion to the second end portion, the hook members having a hook connector member extending from the extension portion; and
first and second spaced receiving elements each having at least one aperture and provided at and protruding out from an edge of the second end portion and adapted to connect with respective hook members to retain the intermediate restriction portion around the anal sphincter of the patient to promote continence.

11. The device of claim 10, wherein the restriction mesh member is generally elongate.

12. The device of claim 10, wherein the restriction mesh member is constructed at least in part of woven filaments.

13. The device of claim 10, wherein the restriction mesh member is constructed at least in part of strut members defining a unitary patterned cell configuration.

14. The device of claim 10, wherein the intermediate restriction portion includes a plurality of separate segments connected by one or more extension members.

15. The device of claim 10, further including at least one unitary patterned cell configuration extending substantially along a length of the restriction mesh member to permit limited expansion of the restriction mesh member wrapped around the anal sphincter.

16. The device of claim 10, wherein the restriction member includes a first section having a first pattern and a second section having a second pattern different than the first pattern.