Deployment rods for use with implantable hernia prostheses

An implantable prosthesis device and system for insertion, deployment, and fixation of a hernia prosthesis. The system includes two or more deployment rods removably affixed to the prosthesis. Each rod extends across a majority of a width of the prosthesis and beyond one end of the width of the prosthesis. The rods are arranged generally parallel to one another when in a rolled configuration. The rods are separate, physically noncontiguous wire rods that are not operably coupled to one another. The rods provide structural reinforcement and increased rigidity across the width of the implantable hernia prosthesis while maintaining the ability of the prosthesis to experience bends in its length. In this way, the rods allow a user to separately manipulate discrete portions of the prosthesis while to maintaining the ability of the prosthesis to be rolled up and inserted into the body of a patient through, e.g., a trocar.

FIELD OF THE INVENTION

The present invention relates to deployment devices suitable for use with implantable prostheses used in hernia repair. More particularly, the present invention relates to deployment rods configured to facilitate handling and deployment of implantable hernia prostheses during laparoscopic surgical procedures.

BACKGROUND OF THE INVENTION

In laparoscopic hernia repair, implantable hernia prostheses are utilized to provide reinforcement and support at the hernia defect. Such implantable hernia prostheses or other sheet-like prostheses (e.g., films, surgical fabrics, and the like) are rolled up and inserted (e.g., housed within a trocar cannula) through a small incision cut into the skin and abdominal wall. Generally, such implantable hernia prostheses are flat sheets (e.g., of woven or knitted surgical fabric) that are trimmed to fit the anatomy of the defect site as needed prior to being rolled up and inserted through the incision. Once inserted, the implantable hernia prosthesis can be unrolled and affixed to the defect site using sutures, tacks, or the like. The implantable hernia prosthesis can integrate into the surrounding tissue via tissue ingrowth.

However, manipulating implantable hernia prostheses during laparoscopic procedures presents numerous challenges to a surgeon. For example, trocars only provide a limited range of motion and require the user to grip small instruments such as graspers when manipulating (e.g., unrolling, positioning, etc.) the implantable hernia prosthesis. Moreover, in many instances, the mechanical and physical conditions of many implantable hernia prostheses change upon exposure to bodily conditions and environments, such as bodily temperatures, body fluids, and the like. In particular, when exposed to moisture, such implantable hernia prostheses can hydrate and become less stiff, making them more difficult to deploy or unroll. Additionally, in some instances, the implantable hernia prosthesis may include a tissue separating layer intended to minimize visceral tissue attachment to the prosthesis. Such tissue separating layers can hydrate, warm up, and soften, making them more fragile and prone to tearing, abrasions, or rupture, thereby complicating a user's ability to handle and place the implantable hernia prosthesis during surgery and implantation. Such self-adhering layers can further complicate a user's ability to handle and place the implantable hernia prosthesis during surgery and implantation.

Additionally, in abdominal and pelvic laparoscopic procedures, the insertion, placement, and fixation of such implantable prostheses prove even more challenging. Due to the use of extremely delicate prostheses in such surgical procedures, the aforementioned concerns are magnified by the increased risk of rupture or tear. As such, even routine handling of the extremely delicate prostheses can be associated with risk of failure of the delicate prosthesis in such procedures as currently performed by doctors.

SUMMARY

There is a need in the art for a deployment device that enables the convenient delivery, deployment, and placement of implantable hernia prostheses (e.g., meshes, films, patches, fabrics, etc.). The present invention is directed toward solutions to address this and other needs, in addition to having other desirable characteristics that will be appreciated by one of skill in the art upon reading the present specification.

In accordance with an example embodiment of the present invention, a system is provided. The system can include a prosthesis including a first flexible mesh sheet structure. Two or more elongate rods each can be removably coupled with the prosthesis and each can be more rigid than the mesh sheet structure, in such a way that the combination of the two or more elongate rods with the mesh sheet structure rigidifies the mesh sheet structure along a length of each of the two or more elongate rods. The system can be configured to be rolled in a direction substantially orthogonal to central longitudinal axes of the two or more elongate rods in such a way that all or substantially all of the mesh sheet structure forms one or more rolls without bending the two or more elongate rods.

In accordance with aspects of the present invention, the two or more elongate rods can be separate and distinct from each other and two of the two or more elongate rods can be independently moveable relative to each other. One or more fastening mechanisms can couple the two or more elongate rods to the first mesh sheet structure of the prosthesis. Each one of the two or more elongate rods can be slidable out of the one or more fastening mechanisms in a direction generally along the central longitudinal axis of that one of the two or more elongate rods. The one or more fastening mechanisms can be configured to be cut to release the two or more elongate rods and can be adapted to be removed from the mesh sheet structure. A second flexible mesh sheet structure can be coupled to and can form a layer on the first mesh sheet structure. The two or more elongate rods can be disposed between the first and second mesh sheet layers which removably couple the two or more elongate rods to the sheet in such a way that the two or more elongate rods are slidable out from between the first and second mesh sheet structures. The prosthesis can include a second flexible mesh sheet structure coupled to and forming a layer on the first mesh sheet structure, and each of the two or more elongate rods can be affixed to the first flexible mesh sheet structure or the second flexible mesh sheet structure.

In accordance with yet further aspects of the present invention, at least one of the two or more elongate rods coupled to the prosthesis can extend beyond and exterior to a perimeter edge of the prosthesis. At least one of the two or more elongate rods coupled to the prosthesis can be graspable and maneuverable by a laparoscopic grasper or other separate tool. Each of the two or more elongate rods can extend across a majority of a dimension of the prosthesis. A first of the two or more elongate rods can be disposed at a first end of the prosthesis and a second of the two or more elongate rods is disposed at a second end of the prosthesis, the second end of the prosthesis being opposite the first end. The two or more elongate rods further can include a third rod disposed between the first and second rods at a central portion of the prosthesis. The two or more elongate rods can have a rigidity suitable for using the two or more elongate rods to manipulate and position the prosthesis at a target site (e.g., pushing, pulling, rotating, pivoting, lateral movement, raising, lowering, and the like). Each of the two or more elongate rods can include a wire rod, a plastic rod, or a rod constructed of another material.

In accordance with an example embodiment of the present invention, a method for deploying a mesh prosthesis using a system comprising a prosthesis comprising a first flexible mesh sheet structure, and two or more elongate rods each being removably coupled with the prosthesis and each being more rigid than the mesh sheet structure in such a way that the combination of the two or more elongate rods with the mesh sheet structure rigidifies the mesh sheet structure along a length of each of the two or more elongate rods, is provided. The method can include providing a rolled prosthesis in which, using the two or more elongate rods, the prosthesis is rolled in a direction substantially orthogonal to a central longitudinal axes of the two or more elongate rods in such a way that all or substantially all of the mesh sheet structure forms one or more rolls without bending the two or more elongate rods. The method can continue with inserting the prosthesis into a bodily cavity, unrolling the prosthesis, using the two or more elongate rods, and removing the two or more elongate rods from the prosthesis.

In accordance with aspects of the present invention, wherein the two or more elongate rods can be separate and distinct from each other and two of the two or more elongate rods can be independently moveable relative to each other. One or more fastening mechanisms can be provided coupling the two or more elongate rods to the first mesh sheet structure of the prosthesis.

In accordance with aspects of the present invention, the step of removing the two or more elongate rods can include sliding the two or more elongate rods out of the one or more fastening mechanisms in a direction generally along the central longitudinal axis of each respective rod of the two or more elongate rods.

In accordance with aspects of the present invention, the prosthesis can further include a second flexible mesh sheet structure coupled to and forming a layer on the first mesh sheet structure. The two or more elongate rods are can be disposed between the first and second mesh sheet layers which removably couple the two or more elongate rods to the sheet in such a way that the step of removing the two or more elongate rods can include sliding the two or more elongate rods out from between the first and second mesh sheet structures.

In accordance with aspects of the present invention, at least one of the two or more elongate rods coupled to the prosthesis can extend beyond and exterior to a perimeter edge of the prosthesis. At least one of the two or more elongate rods coupled to the prosthesis can be graspable and maneuverable by a laparoscopic grasper or other separate tool. The two or more elongate rods can have a rigidity suitable for using the two or more elongate rods to manipulate and position the prosthesis at a target site, and the method can further include manipulating and positioning the prosthesis at the target site using the two or more elongate rods.

In accordance with aspects of the present invention, the prosthesis may be rolled at a point of manufacture or may be rolled by a user at the time of performing the deployment method.

In accordance with an example embodiment of the present invention, a system includes a prosthesis having a first flexible mesh sheet structure. Two or more elongate rods can each be removably coupled with the prosthesis and each be more rigid than the mesh sheet structure, in such a way that the combination of the two or more elongate rods with the mesh sheet structure rigidifies the mesh sheet structure along a length of each of the two or more elongate rods. The system can be configured to be rolled in a direction substantially orthogonal to a central longitudinal axes of the two or more elongate rods in such a way that all or substantially all of the mesh sheet structure forms one or more rolls. The two or more elongate rods can be separate and distinct from each other and two of the two or more elongate rods can be independently moveable relative to each other.

In accordance with one example embodiment of the present invention, a system includes a prosthesis having a first flexible mesh sheet structure. Two or more elongate rods can each be removably coupled with the prosthesis and each be more rigid than the mesh sheet structure, in such a way that the combination of the two or more elongate rods with the mesh sheet structure rigidifies the mesh sheet structure along a length of each of the two or more elongate rods. The system can be configured to be rolled in a direction substantially orthogonal to a central longitudinal axes of the two or more elongate rods in such a way that all or substantially all of the mesh sheet structure forms one or more rolls. The two or more elongate rods can be separate and distinct from each other and two of the two or more elongate rods can be independently moveable relative to each other. The two or more elongate rods can have a rigidity suitable for using the two or more elongate rods to manipulate and position the prosthesis at a target site.

DETAILED DESCRIPTION

An illustrative embodiment of the present invention relates to a system for insertion, deployment, and/or fixation of an implantable hernia prosthesis. For example, the implantable hernia prosthesis can include a flexible mesh sheet structure, in singular form, or layered, as would be appreciated by one of skill in the art. In addition to the implantable hernia prosthesis, the system also can include two or more (e.g., three, in an example embodiment described herein) elongate deployment rods removably coupled with the implantable hernia prosthesis. The deployment rods can be substantially rigid relative to the mesh sheet structure. Each of the deployment rods can have a central longitudinal axis, and the system, in particular the implantable hernia prosthesis, can be configured to be rolled in a direction substantially orthogonal to the central longitudinal axes of the two or more deployment rods in such a way that all or substantially all of the implantable hernia prosthesis (e.g., including the mesh sheet structure) forms one or more rolls without bending the two or more elongate rods.

In general, the deployment rods provide the implantable hernia prosthesis with structural reinforcement and increased rigidity along the lengths of the deployment rods, without hindering the ability of the implantable hernia prosthesis to bend orthogonally to the central longitudinal axes of the deployment rods. For example, in one illustrative embodiment, the deployment rods extend across the width of the prosthesis, in such a way as to rigidify the width of the prosthesis without sacrificing the ability of the prosthesis to experience bends in its length. Stated differently, the deployment rods of such an illustrative embodiment increase the rigidity of the implantable hernia prosthesis along the width, but not the length, dimensions as indicated in the figures. Accordingly, as stated previously, the system is capable of being rolled up in a direction substantially orthogonal to the central longitudinal axes of the deployment rods, thereby allowing the system to pass through one or more trocars (e.g., during implantation). It should be noted that the phrase “substantially orthogonal”, or “orthogonal”, when referring to the direction of roll of the prosthesis around the deployment rods, is intended to capture a direction of roll that is sufficient to result in the prosthesis actually wrapping about the deployment rod substantially overlapping itself without spiraling in one direction or another. Sufficient illustration of this orthogonal arrangement, direction, and movement, are provided in the figures to enable one of skill in the art to appreciate the general nature of the terms and phrases without undue experimentation, such that the present invention is fully enabled.

As described in greater detail herein, the implantable hernia prosthesis can include a mesh sheet structure that is more flexible than the deployment rods. In particular, each of the deployment rods can be an elongate rod that is more rigid than the mesh sheet structure, in such a way that the deployment rods rigidify the mesh sheet structure along a length of each of the deployment rods. Accordingly, the elongate rods can be configured in this way to maintain the shape of the sheet mesh structure (e.g., and of the implantable hernia prosthesis generally) along the central longitudinal axes of the deployment rods. Furthermore, in accordance with in illustrative embodiments of the present invention, the deployment rods can have a rigidity that is sufficiently high to allow the deployment rods to: (a) support the weight of the sheet mesh structure (e.g., and of the implantable hernia prosthesis generally), and (b) serve as tools for manipulating the shape and/or position of the sheet mesh structure (e.g., and of the implantable hernia prosthesis generally) during rolling, insertion, deployment, and placement thereof.

In accordance with an illustrative and non-limiting embodiment of the present invention, the deployment rods are separate, physically noncontiguous, wire rods that are independently movable relative to one another. Furthermore, the deployment rods can be separately removable, in such a way as to enable piecewise deployment and fixation of discrete portions of the implantable hernia prosthesis, as described in greater detail below.

FIGS. 1 through 9, wherein like parts are designated by like reference numerals throughout, illustrate example embodiments of a system for deploying an implantable hernia prosthesis, according to the present invention. Although the present invention will be described with reference to the example embodiments illustrated in the figures, it should be understood that many alternative forms can embody the present invention. For example, although for purposes of clarity the example embodiments are described with reference to an implantable hernia prosthesis, the present invention alternatively can be implemented in accordance with any other suitable prosthesis. Accordingly, the present invention is not limited exclusively to implantable hernia prostheses, as would be appreciated by one of skill in the art upon reading the present specification. One of skill in the art will additionally appreciate a variety of ways to alter the parameters of the embodiments disclosed, such as the size, shape, or type of elements or materials, in a manner still in keeping with the spirit and scope of the present invention. All such alternatives and modifications are contemplated within the scope of the present invention.

FIGS. 1 and 2depict a perspective view and a top view, respectively, of a system10for inserting, deploying, and positioning an implantable hernia prosthesis12, in accordance with an example embodiment of the present invention. As shown in the example embodiment ofFIGS. 1 and 2, the implantable hernia prosthesis12includes a generally flat, flexible sheet of mesh, as would be appreciated by one of skill in the art. More specifically, in the example embodiment ofFIGS. 1 and 2, the implantable hernia prosthesis12is constructed of a single layer of a polypropylene filament knitted mesh. Examples of polypropylene meshes suitable for use with the present invention include, but are not limited to, C-QUR™ Mesh, C-QUR™ Mosaic Mesh, C-QUR™ Film, C-QUR FX™ Mesh, ProLite™ and ProLite Ultra™, all manufactured by Atrium Medical Corporation of Hudson, N.H. Additional meshes manufactured by other sources are also suitable for use with the present invention, as would be appreciated by one of skill in the art.

The implantable hernia prosthesis12has a length20and a width22. The length20may be greater than the width22, as illustrated inFIGS. 1 and 2. Alternatively, in some embodiments, the width22is greater than the length20. In yet other embodiments, the length20and the width22are equal in magnitude. The implantable hernia prosthesis12generally is sized and shaped to have a surface area that is larger than that of a hernia (or other bodily defect). In this way, the implantable hernia prosthesis12can be sized, shaped, and dimensioned to completely cover the hole or defect upon implantation and proper placement at the defect site. As stated previously herein, the implantable hernia prosthesis12generally is flexible, as would be appreciated by one of skill in the art. In particular, the implantable hernia prosthesis12generally is capable of being rolled up into a single-roll configuration or a double-roll configuration, e.g., prior to implantation during use thereof.

The implantable hernia prosthesis12may be uncoated or may include a coating. For embodiments of the present invention in which the implantable hernia prosthesis12includes a coating, the coating may be any suitable coating, including as a non-limiting example a hydrolysable bioabsorbable cross-linked fatty acid based material that includes a partially or fully cured fish oil or omega-3 fatty acid. Such a coating can be applied to the implantable hernia prosthesis12with sufficient thickness to serve as a physical protective layer between surrounding tissue and the surface of the implantable hernia prosthesis12. Additionally, the hernia prosthesis12is preferably sterilized by a suitable sterilization process such as e-beam, cobalt60gamma irradiation, and ethylene oxide gas.

In addition to the implantable hernia prosthesis12, the system10ofFIGS. 1 and 2also includes two or more elongate deployment rods configured to facilitate insertion, placement, deployment, and fixation of the implantable hernia prosthesis12. In the example embodiment ofFIGS. 1 and 2, the system10includes a first deployment rod14, a second deployment rod16, and a third deployment rod18. In the example embodiment ofFIGS. 1 and 2, each of the deployment rods14,16,18is a substantially straight (e.g., non-curved), elongate rod having a length that extends across at least a majority of the width22of the implantable hernia prosthesis12. In some embodiments, the deployment rods14,16,18have a flexibility sufficient to enable the deployment rods14,16,18to bend and conform to the contour of the shape of the abdominal wall or other hernia defect site, while still being more rigid than the mesh hernia prosthesis12. In the example embodiment ofFIGS. 1 and 2, each of the deployment rods14,16,18extends across substantially all of the width22of the implantable hernia prosthesis12. The deployment rods14,16,18can be generally cylindrical in shape (as shown inFIGS. 1 and 2), or can have a shape generally resembling a rectangular prism, triangular pyramid, or any other suitable shape, as would be appreciated by those of skill in the art. The deployment rods14,16,18can be tapered at one or both of their ends. In the example embodiment ofFIGS. 1 and 2, the deployment rods14,16,18are arranged substantially parallel to one another, as depicted. The phrase “substantially parallel” as utilized herein is intended to have the ordinary meaning as would be understood by those of skill in the art. In particular, the underlying motivation for the deployment rods14,16,18to be arranged “substantially parallel” is so that when the prosthesis is rolled as described herein, the deployment rods14,16,18are in sufficient parallel alignment with each other so as to not hinder or interfere in the rolling process in a way such that either (i) the rolling process becomes unduly difficult or impossible as a result of such interference and/or the prosthesis; or (ii) limits the ability for the rolled prosthesis to accommodate a size (e.g., maximum diameter when rolled) sufficient for its intended usage (e.g., to fit through a trocar port). As noted in a later described embodiment, the substantially parallel arrangement of the deployment rods14,16,18can result upon rolling the prosthesis and not when the prosthesis is flat (e.g., seeFIG. 5and corresponding description).

Each of the deployment rods14,16,18extends beyond an edge of the implantable hernia prosthesis12. Specifically, in the example embodiment ofFIGS. 1 and 2, each of the deployment rods14,16,18extends beyond the same end28of the width22of the implantable hernia prosthesis12. Furthermore, in the example embodiment ofFIGS. 1 and 2, the deployment rods14,16,18do not extend beyond the opposite end30of the width22of the implantable hernia prosthesis12.

With embodiments such as depicted inFIGS. 1 and 2, it should be appreciated that the deployment rods14,16,18can extend beyond the end28of the width22of the implantable hernia prosthesis12in the same amount or in differing amounts. Furthermore, the deployment rods14,16,18can span or occupy the same amount or different amounts of the width22of the implantable hernia prosthesis12. In some alternative embodiments, one, some, or all of the deployment rods14,16,18extend beyond two opposite edges of the implantable hernia prosthesis12(e.g., extend beyond both ends28,30of the width22of the implantable hernia prosthesis12).

In the example embodiment ofFIGS. 1 and 2, the first deployment rod14is positioned proximate a first end24of the length20of the implantable hernia prosthesis12and spaced inward from the first end24of the length20(e.g., by a small amount relative to the full length20, as would be appreciated by one of skill in the art upon reading the present specification). The second deployment rod16is positioned proximate or at a center or midpoint of the length20of the implantable hernia prosthesis12. The third deployment rod18is positioned proximate a second end26of the length20of the implantable hernia prosthesis12that is opposite the first end24of the length20of the implantable hernia prosthesis12. The third deployment rod18is spaced inward from the second end26of the length20of the implantable hernia prosthesis12, e.g., by a small amount relative to the full length20of the implantable hernia prosthesis12, as would be appreciated by one of skill in the art upon reading the present specification. Accordingly, as shown inFIGS. 1 and 2, the deployment rods14,16,18can be separate and noncontiguous with one another (e.g., not in physical contact with one another) when the implantable hernia prosthesis12is in the unrolled, substantially flat configuration. Furthermore, in accordance with illustrative embodiments of the present invention, the deployment rods14,16,18are not operably connected to one another (e.g., by support bars, etc.). Thus, the two outer deployment rods14,18are independently movable within a range of motion. Stated differently, each one of the two outer deployment rods14,18has a range of motion through which movement of the deployment rod14,18along a given distance does not have an affect on movement of the other of the two outer deployment rods14,18.

The deployment rods14,16,18can be spaced apart from one another along the length20of the implantable hernia prosthesis12, e.g., can be spaced apart in equal amounts as depicted inFIGS. 1 and 2. Alternatively, the deployment rods14,16,18can be separated by non-equal amounts. The positions of the deployment rods14,16,18depicted and described herein are illustrative and in no way limit the present invention. In general, the deployment rods14,16,18can be disposed at any suitable positions allowing the deployment rods14,16,18to aid in the handling of the implantable hernia prosthesis12(e.g., during insertion, deployment, placement, and the like).

The deployment rods14,16,18are removably coupled with the implantable hernia prosthesis12. In illustrative embodiments, the deployment rods14,16,18are coupled with the implantable hernia prosthesis12independently of one another. Stated differently, the coupling of one of the deployment rods14,16,18does not depend upon the coupling of any other of the deployment rods14,16,18. For example, separate and distinct fixation mechanisms can be utilized to affix each of the deployment rods14,16,18. In general, any suitable mechanism or method may be used to affix the deployment rods14,16,18to the implantable hernia prosthesis12in a removable and replaceable manner allowing the subsequent removal of the deployment rods14,16,18from the implantable hernia prosthesis12. In illustrative embodiments, each of the deployment rods14,16,18are securely removably and replaceably affixed to the implantable hernia prosthesis12by one or more fastening mechanisms32(e.g., in the form of loops, stitches, slits, or the like). The fastening mechanisms32can be removable (e.g., by cutting, unstitching, unfastening, etc.), so as to facilitate the removal of the deployment rods14,16,18. Alternatively and/or additionally, the deployment rods14,16,18can be slideable out from the fastening mechanisms32. Additionally and/or alternatively to including the one or more fastening mechanisms32, the deployment rods14,16,18can be affixed to the implantable hernia prosthesis12by glue or other adhesive(s), staple(s), tack(s), welding, sintering, or the like, so long as the fastening mechanism enables easy removal of the deployment rods14,16,18without damaging the prosthesis. As yet a further addition or alternative, the deployment rods14,16,18include barbs that protrude through the implantable hernia prosthesis12(e.g., through the mesh) and thereby fixedly maintain the deployment rods14,16,18to the implantable hernia prosthesis12, as would be readily understood by those of skill in the art.

In illustrative embodiments, the fastening mechanisms32affixing the first deployment rod14, the fastening mechanisms32affixing the second deployment rod16, and the fastening mechanisms32affixing the third deployment rod18are all separately removable from the implantable hernia prosthesis12. Accordingly, the fastening mechanisms32securing the first deployment rod14to the implantable hernia prosthesis12are enabled to be removed without also removing the fastening mechanisms32securing the second deployment rod16or the fastening mechanisms32securing the third deployment rod18. Likewise, the fastening mechanisms securing the second deployment rod16to the implantable hernia prosthesis12are enabled to be removed without also removing the fastening mechanisms32securing the first deployment rod14or the fastening mechanisms32securing the third deployment rod18. Similarly, the fastening mechanisms securing the third deployment rod18to the implantable hernia prosthesis12are enabled to be removed without also removing the fastening mechanisms32securing the first deployment rod14or the fastening mechanisms32securing the second deployment rod16. In this way, the deployment rods14,16,18can be provided as separately removable from one another.

The deployment rods14,16,18can be of identical sizes and/or shapes or can have differing sizes and/or shapes. In general, each of the deployment rods14,16,18has a central longitudinal axis15,17,19. In the example embodiment ofFIGS. 1 and 2, the deployment rods14,16,18are more rigid than the implantable hernia prosthesis12(e.g., and thus can be substantially rigid relative to the flexible mesh sheet structure forming the implantable hernia prosthesis12). As such, the deployment rods14,16,18can be configured to maintain the shape of the implantable hernia prosthesis12along the central longitudinal axes15,17,19of the deployment rods14,16,18. The deployment rods14,16,18can be constructed of any suitable material enabling the deployment rods14,16,18to have a rigidity that is sufficiently high to support the weight of the implantable hernia prosthesis12during insertion, deployment, and placement of the implantable hernia prosthesis12. For example, the deployment rods14,16,18each can be a wire rod formed of a medical grade metal. The particular size and shape of the deployment rods14,16,18similarly can be selected (in combination with the materials) to provide the desired rigidity.

Due to their shape and rigidity, the deployment rods14,16,18provide the implantable hernia prosthesis12with structural reinforcement and increased rigidity along only a single dimension of the implantable hernia prosthesis12. In particular, the deployment rods14,16,18reinforce and rigidify along the axis of the width22of the implantable hernia prosthesis12in the rolled configuration, thereby causing the implantable hernia prosthesis12to exhibit greater resistance to bending along the axis of its width22when included in the system10in the rolled configuration than it would when used as a stand-alone device—without disrupting the natural or inherent flexibility along the axis of the length20of the implantable hernia prosthesis12when considered as a stand-alone device. As such, the system10exhibits greater resistance to bends along the axis of the width22of the implantable hernia prosthesis12than it does to bends along the axis of the length20of the implantable hernia prosthesis12. Stated yet another way, in accordance with the example embodiments described herein, the deployment rods14,16,18effectively provide structural reinforcement in such a way as to rigidify the implantable hernia prosthesis12only in the transverse direction, and not in the longitudinal direction, as they have been illustrated in the corresponding figures. Accordingly, when included in the system10in the rolled configuration, the implantable hernia prosthesis12as a whole is capable of bending in a first direction (e.g., along its length20, in the example embodiment ofFIGS. 1 and 2) while simultaneously being hindered from bending in a second direction (e.g., along its width22, in the example embodiment ofFIGS. 1 and 2) that is perpendicular to the first direction. When rolled, the increased rigidity provided by the deployment rods14,16,18assists with insertion of the implantable hernia prosthesis12through the trocar cannula or incision. Furthermore, in some embodiments, the deployment rods14,16,18can have a relatively small diameter that does not significantly add to the thickness of the system10. In this way, the total diameter of the system10when rolled can remain relatively small, as would be desired in some medical applications where smaller trocar cannulas and/or incisions are utilized.

In operation (as shown inFIG. 9), the system10can be used in laparoscopic hernia repair, as would be appreciated by one of skill in the art upon reading the present specification. In particular, given that the natural flexibility of the length20of the implantable hernia prosthesis12is maintained even when included in the system10, the system10can be rolled up (step100) in a direction substantially orthogonal to the central longitudinal axes15,17,19(e.g., along the length20of the implantable hernia prosthesis12in the example embodiment ofFIGS. 1 and 2) without bending (i.e., with at most very minimal or inconsequential bending) of the deployment rods14,16,18. The step of rolling necessitates the previous placement of the deployment rods14,16,18in the prosthesis, which could occur at any time prior to rolling (e.g., at the point of manufacture, by the user just prior to rolling, or at any point in-between), such that it may or may not be a step prior to the step of rolling. As utilized herein, the phrase “without bending” refers to an overall requirement that the deployment rods of the present invention be essentially or substantially rigid, such that the provide structure to the system10that enables manipulation and placement of the prosthesis. As such, a rod that experiences minimal, inconsequential (to the desired function), bending would be considered to be a rod that performs “without bending” in accordance with the present invention, as would be appreciated by those skilled in the art. Once rolled in this way, the system10can be inserted into a patient, e.g., through one or more trocars (step102). For example,FIG. 3depicts the system10in such a rolled configuration (with the deployment rods14,16,18each unbent by the roll) prior to being implanted in a patient, in accordance with an example embodiment of the present invention. The rolled configuration ofFIG. 3can be produced by gripping the system10at the second end26of the length20of the implantable hernia prosthesis12and rolling the implantable hernia prosthesis12toward the first end24of the length20of the implantable hernia prosthesis12until all or substantially all of the length20of the implantable hernia prosthesis12is formed into a roll.

The system10is inserted into the body of a patient and advanced through one or more trocars to the site of the hernia defect (step104), during which time a user can grip and manipulate the deployment rods14,16,18using graspers. For example, by gripping the deployment rods14,16,18, a user can deploy (e.g., unroll) the system10and position the system10against the abdominal wall for fixation, as would be appreciated by one of skill in the art. In one illustrative embodiment, the system10is entirely unrolled by the user into the substantially flat configuration depicted inFIG. 1and subsequently positioned against the defect site (step106). Once adequately positioned, the system10can be affixed (step108), e.g., using sutures and/or tacks, if desired (this step is optional depending on whether it is desirable or not to affix the prosthesis to the tissue). The deployment rods14,16,18then can be detached/removed from the implantable hernia prosthesis12(step110) and removed from the patient (step112), e.g., leaving behind only the affixed implantable hernia prosthesis12.

In an alternative illustrative embodiment of the present invention, the system10is deployed and affixed in a piecewise and step-by-step manner, e.g., by repeating a process of unrolling and affixing discrete portions of the implantable hernia prosthesis12. In particular, and as depicted inFIG. 4, a portion of the system10can be unrolled, after which (a) the fastening mechanisms32coupling the first deployment rod14to the implantable hernia prosthesis12can optionally be removed and (b) the unrolled portion can be affixed to the surrounding tissue or muscle wall at the defect site. The unrolled portion can be affixed using one or more surgical sutures or tacks34, as described previously herein. Next, subsequent to removing the fastening mechanisms32securing the first deployment rod14, the first deployment rod14can be removed from the implantable hernia prosthesis12. This process of affixing only a portion of the implantable hernia prosthesis12at a time can be repeated for remaining rolled portions of the implantable hernia prosthesis12(e.g., for those portions proximate the second and third deployment rods16,18). In particular, after removing the first deployment rod14, a medial portion of the implantable hernia prosthesis12can be unrolled and affixed, and the second deployment rod16can be removed from the implantable hernia prosthesis12. Subsequent to removing the second deployment rod16, the remaining portion of the implantable hernia prosthesis12disposed at the second end26of the length20can be unrolled and affixed, and the third deployment rod18can be removed from the implantable hernia prosthesis12. In this way, the implantable hernia prosthesis12can be inserted into a patient, placed appropriately at the target site using the deployment rods14,16,18, and unrolled and affixed in a piecewise fashion using the deployment rods14,16,18.

Although three deployment rods14,16,18are illustrated in the example embodiment ofFIGS. 1 through 4, it is alternatively contemplated that two, four, five, or more such deployment rods can be included in the system10. For example,FIG. 5depicts an embodiment of the system10in which only the first and second deployment rods14,16are included. In the example embodiment ofFIG. 5, the system10includes a prosthesis12that is formed of a single flexible, substantially arch or fan-shaped mesh sheet structure. As with the embodiment ofFIGS. 1 and 2, the deployment rods14,16ofFIG. 5are disposed across a majority of a dimension of the prosthesis12. However, unlike the example embodiment ofFIGS. 1 and 2, in the example embodiment ofFIG. 5, each of the deployment rods14,16is disposed across a majority of a radius39of the prosthesis12. Furthermore, as with the example embodiment ofFIG. 1, the system10according to the example embodiment ofFIG. 5is configured to be rolled in a direction substantially orthogonal to the central longitudinal axes15,17of the deployment rods14,16in such a way that all or substantially all of the prosthesis12(e.g., and thus all of the mesh sheet structure) forms one or more rolls without substantially or consequentially bending the deployment rods14,16. However, in the example embodiment ofFIG. 5, the prosthesis12is configured to be rolled along in an angular direction40, which is substantially orthogonal to the central longitudinal axes15,17of the deployment rods14,16. As alluded to earlier herein, the deployment rods14,16, while not substantially parallel prior to the rolling operation, nonetheless result in a substantially parallel relative orientation to each other when in the rolled configuration. This has to do with curved shape of the prosthesis12, as would be appreciated by those of skill in the art.

Although the implantable hernia prosthesis12of the example embodiments ofFIGS. 1 through 5include only a single mesh sheet structure forming only a single layer, the implantable hernia prosthesis12alternatively can include two or more mesh sheet structures forming multiple layers. For example,FIG. 6depicts the system10in which the implantable hernia prosthesis12includes a first flexible mesh sheet structure36and a second flexible mesh sheet structure38coupled to the first flexible mesh sheet structure36. As depicted, the first and second mesh sheet structures36,38are coupled together near their outer peripheries. The second mesh sheet structure38is smaller in area than and substantially similar in shape to the first mesh sheet structure36. However, in some alternative embodiments, the first and second mesh sheet structures36,38are not similar in shape and/or size. The second mesh sheet structure38forms a layer on the first mesh sheet structure36, and a pocket is formed between the first and second mesh sheet structures36,38. The first and second deployment rods14,16are disposed within the pocket in such a way as to be removably coupled with the implantable hernia prosthesis12. Accordingly, the pocket formed by the first and second mesh sheet structures36,38is open at least at the positions where the first and second deployment rods14,16enter the pocket. In the example embodiment ofFIG. 6, the first and second deployment rods14,16are disposed near the ends24,26of the length20of the implantable hernia prosthesis12, as illustrated.

In some embodiments, the implantable hernia prosthesis12includes the two or more mesh sheet structures forming stacked layers and the deployment rods14,16are removably affixed to the implantable hernia prosthesis12by the one or more fastening mechanisms32. For example,FIG. 7depicts an embodiment according to the present invention, in which the deployment rods14,16are affixed to the second mesh sheet structure38.FIG. 8depicts an embodiment according to the present invention, in which the deployment rods14,16are affixed to the first mesh sheet structure36. In some embodiments, the deployment rods14,16are affixed to both the first mesh sheet structure36and the second mesh sheet structure38in such a way that the deployment rods14,16and the fastening mechanisms32appear substantially as shown inFIG. 7orFIG. 8with the fastening mechanisms32instead passing through both the first and second mesh sheet structures36,38. In this way, in embodiments in which the implantable hernia prosthesis12includes two mesh sheet structures, the deployment rods14,16generally can be coupled to the first mesh sheet structure36, the second mesh sheet structure38, or both.

Notably, the system10according to embodiments of the present invention provides a user with greater facility and ease of handling during operation. By providing two or more separate deployment rods14,16,18removably affixed to the implantable hernia prosthesis12in a substantially parallel arrangement, the system10permits users to roll the implantable hernia prosthesis12and separately control and manipulate various portions of the implantable hernia prosthesis12. This has the beneficial effect of providing greater handling capabilities than known deployment devices presently utilized in the art with hernia patches. Furthermore, providing that the deployment rods14,16,18are separately removable allows a user to more easily work with discrete portions at a time, thereby reducing likelihood of tearing or rupturing unrolled portions, which remain protected in the rolled configuration (e.g., as illustrated inFIG. 4).

In addition, in accordance with embodiments of the present invention, the deployment rods14,16,18are configured to be manipulated independently of one another. Accordingly, the first deployment rod14(disposed at the first end24of the length20of the implantable hernia prosthesis12) is provided with a range of motion, the passage within which does not inherently or necessarily effect motion of the second and/or third deployment rods16,18. Similarly, the third deployment rod18(disposed at the second end26of the length20of the implantable hernia prosthesis12) is provided with a range of motion, wherein passage of the third deployment rod18within the range of motion does not inherently or necessarily effect motion of the first and/or second deployment rods14,16. This capability for some independent motion and control over the different deployment rods14,16,18provides a user with greater handling capabilities by enabling more focused control over smaller and more discrete portions of the implantable hernia prosthesis12. Upon reading the present specification, one of skill in the art will appreciate yet further benefits not described herein.

Numerous modifications and alternative embodiments of the present invention will be apparent to those skilled in the art in view of the foregoing description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the best mode for carrying out the present invention. Details of the structure may vary substantially without departing from the spirit of the present invention, and exclusive use of all modifications that come within the scope of the appended claims is reserved. Within this specification embodiments have been described in a way which enables a clear and concise specification to be written, but it is intended and will be appreciated that embodiments may be variously combined or separated without parting from the invention. It is intended that the present invention be limited only to the extent required by the appended claims and the applicable rules of law.