Patent Description:
A hernia is a condition in which part of the intestine bulges through a weak area in muscles of the abdomen. The main treatment for inguinal hernia is surgery to block the protrusion of abdominal content through the muscle wall. This surgery is called herniorrhaphy, and typically involves suturing the muscle layers and fascia together to reinforce the wall or blocking the defect with a flat polypropylene mesh.

As understood herein, the mesh must be sufficiently flexible and resilient to be pushed through a hole in a muscular wall for. e.g., hernia repair, pelvic floor prolapse, and other muscular repairs, and then assume a flat configuration against the posterior side of the wall as applicable.

International Patent Application Publication No. <CIT>, without any admission being imputed to its inclusion in this specification, describes a method and system for the repair of hernias through laparoscopic techniques using a tubular sheath and tubular plunger located within and moveable with respect to the sheath.

<CIT> discloses a hernial plate comprising a pocket formed from two textile layers and expansion means for ensuring the deployment of the pocket. The expansion means are received in a removable manner in the pocket and pass by reversible deformation from a deployed configuration to a compact ball configuration. One of the textile layers has an orifice allowing the withdrawal of the expansion means out of the pocket after deployment of the pocket.

As critically recognized herein, current meshes may not completely unfold into a flat configuration after being pushed through the muscle wall, and this condition is difficult to identify and/or remedy owing to poor visibility and/or access of the posterior side of the wall. As further recognized herein, increasing the resiliency of the mesh by increasing the filament diameter throughout the mesh can decrease the resiliency of the mesh and moreover increases the mass of the mesh to the point where tissue reaction with the mesh can increase undesirably.

Accordingly, an apparatus includes a flexible mesh having an insertion configuration, in which the mesh is smaller than a muscle hole to be repaired to facilitate advancing the mesh through the hole, and an implanted configuration, in which the mesh is substantially flat and larger than the hole to block the hole. A strengthening member can be engaged with the mesh.

In some embodiments the strengthening member is removable from the mesh when the mesh is disposed against the hole in the implanted configuration. The strengthening member may be made of nitinol. The mesh can include a flexible mesh body and the strengthening member can include at least one filament engaged with the mesh body. Without limitation the filament may be a wire or a flat ribbon.

Plural filaments may be engaged with the mesh body. The filaments can be arranged on the mesh body in, e.g., a spoke configuration, a petal configuration, a spiral configuration, or a circular configuration. Filament ends may be exposed such that the ends can be grasped and the filaments pulled away from the mesh body.

In other embodiments the strengthening member can include strands of a thickness that is greater than the thickness of strands of the mesh body. The strengthening member may be made of one and only one (relatively thick) strand, or it may be made of plural strands and with a tighter weave than the weave of the strands of the mesh body.

In this latter embodiment the strengthening member can be disposed on at least one and preferably both of the surfaces of the mesh body. Or, it may be disposed around the periphery of the body. Yet again, it may be disposed on or between the surfaces and may be sinusoidal shape if desired. Plural strengthening members may be spaced from each other on the mesh body and may otherwise have different configurations from each other. The strengthening members may be concentric with each other or formed as a spiral.

In another aspect, a method (not forming part of the invention as claimed) includes providing a mesh body established by plural mesh strands. The mesh body is engaged with at least one strengthening member that is not a mesh strand. The method includes deforming the mesh body to a first configuration in which the mesh body can be advanced through a hole in a muscle wall. The method then includes advancing the mesh body through the hole and allowing the mesh body to assume a second configuration at least partially under influence of the strengthening member in which the mesh body expands to be larger than the hole and to be substantially flat. It is then ensured that the strengthening member does not subsequently fracture within the patient to contaminate or otherwise injure the patient.

In another aspect, a device to repair a hole in a muscle wall includes a resilient mesh body and fortifying structure. The fortifying structure may be mesh portions of greater thickness than portions of the mesh body, effectively forming ribs to provide greater strength to provide a leaf spring-like force without having to use a separate leaf spring, which might otherwise break away or fracture. Alternatively the fortifying structure may be strengthening members engaged with the mesh body and removable from the mesh body once the mesh is placed over the hole.

The details of the present invention, both as to its structure and operation, can best be understood in reference to the accompanying drawings, in which like reference numerals refer to like parts, and in which:.

<FIG> shows a device <NUM> that includes a round deformable thread mesh <NUM> designed to lay against a muscle wall and a ribbon or thread plug <NUM> engaged with the mesh <NUM> and designed to fill a hole in the muscle wall. The plug <NUM> is formed of a ribbon of mesh strands in a flower petal configuration as shown. The plug <NUM> alternatively may be a plug disclosed in the present assignee's <CIT>.

The plug <NUM> and optionally the mesh <NUM> is provided with strengthening members in accordance with disclosure below. Briefly, in the example shown strengthening members 202a are provided around the periphery of the mesh <NUM> while strengthening members 204a are provided around the peripheries of the tops and bottoms of each "petal" of the plug <NUM>.

In the example shown, the strengthening members 202a, 204a are established by thread fibers that are more closely knitted together than the fibers of the mesh <NUM>/plug <NUM>. The fibers of the strengthening members 202a, 204a, which individually may be the same size or smaller (e.g., a mil in diameter smaller) than the fibers of the mesh <NUM> and plug <NUM>, are woven (including as by knitting or sewing) into the fibers of the mesh <NUM> and plug <NUM>, respectively. This creates additional stiffness by concentrating more material in one area, resulting in increased fiber density, increased thickness, or both.

In example non-limiting embodiments the mesh <NUM> can be knitted in an open weave pattern, using polypropylene fibers three to eight mils in diameter. The mesh <NUM> can have a pore size of between eight-tenths of a square millimeter and sixteen square millimeters (<NUM><NUM> - <NUM><NUM>). To establish the strengthening member 202a, polypropylene fibers of, e.g., three to eight mils in diameter are sewn around the edge of the mesh <NUM> in a close knit sewing pattern and/or multiple passes can be made around the edge to build up additional fiber density. For example, the fiber density of the strengthening member 202a may be ten to one hundred times the fiber density of the remainder of the mesh <NUM>.

As an alternate means of construction stiffer regions with additional fibers, additional fiber material can be welded to the mesh material. Similarly to when the additional fibers are woven into the material, the additional fibers are integrated to the mesh material and cannot be easily removed.

For instance, a polypropylene mesh ring can be constructed of fibers three to eight mils in diameter. One to four additional rings, each one-tenth of an inch to a half an inch in width, of the same material and of the same outer diameter as the mesh <NUM> can then be welded onto the mesh <NUM>. This creates additional fiber density (as viewed from the top) on the edge of the mesh <NUM>, creating a stiffer material in selected locations, biasing the material in a wrinkle free condition.

Likewise, present principles set forth above contemplate that the plug <NUM> can have both stiffness and elasticity, so that the combination of structure has a resistance to crush, but can still return to an original configuration if deformed. In some embodiments the overall amount of material may be minimized, and the stiffness can be anisotropic. This may be achieved by increasing the fiber density in specific regions in the same manner as described above.

In greater detail, a knitted mesh material can be knitted into a strip with a more open knit in the middle (pore size of between eight-tenths of a square millimeter and sixteen square millimeters (<NUM><NUM> - <NUM><NUM>) and significantly greater fiber density (length of fiber in a given area) at the edges (fiber density ten to one hundred times greater than in the base material) using a polypropylene fiber three to eight mils in thickness. This strip can then be heat set into a final weave configuration and further heat set into a petal configuration. This particular method creates resistance to circumferential crush on the sides of the petals, but minimal resistance to crush from the top.

As the fiber thickness increases, tire stiffness increases, but the elasticity (i.e. the ability to return to a given shape after being deformed) decreases. Therefore, the amount of fibers and fiber thickness can be established to obtain the desired combination of stiffness and elasticity. Specifically, in example non-limiting embodiments the mesh <NUM>/plug <NUM> can be knitted of a polypropylene fiber of between four to eight mils in diameter while the fibers that establish the strengthening members 202a, 204a can be one-half mil to three mils smaller in diameter than those used in the mesh <NUM>/plug <NUM>, and can be knitted to the edges of the mesh <NUM>/plug <NUM> in a denser configuration to produce specific material properties. To increase the resistance to crush from the top, additional fibers may be knitted in a sinusoidal pattern into the middle of the plug <NUM>.

Referring now to <FIG>, a device according to the invention is shown, generally designated <NUM>, for blocking an opening <NUM> of a muscle wall <NUM> that may have an anterior surface <NUM> and a posterior surface <NUM>. As shown, the device <NUM> includes a mesh body <NUM> and one or more stiffening members <NUM> for fortifying the body <NUM>. The device <NUM> may be established by any of the specific embodiments described below. Without limitation the mesh can be made of polypropylene, expanded polytetrafluoroethyleiie (PTFE), polyester, biodegradable materials, the material marketed as "dualmesh", a trademark of W. Gore, or even metal such as stainless steel or nitinol, or some combination thereof. It is to be understood that the device <NUM> may include the plug <NUM> described above, with the plug being omitted in this and subsequent views of mesh embodiments for clarity only.

The device <NUM> can be moved between an insertion configuration (<FIG>), in which the device <NUM> is smaller than the hole <NUM> to facilitate advancing the device <NUM> through the hole <NUM>, and an implanted configuration (<FIG>), in which the device <NUM> is substantially flat and unwrinkled/unfolded and is larger than the hole <NUM> to block the hole <NUM>. As will be clearer after disclosure below, the device <NUM> is biased to the implanted configuration at least by the strengthening member <NUM> and in some implementations by the mesh body <NUM> as well. Thus, the device <NUM> is resilient and is materially biased to the implanted configuration.

The wall <NUM> may be, as an example, a wall of an abdomen muscle in which the hole <NUM> has formed as a hernia. Typically, the device <NUM> may be deformed to the insertion configuration, advanced through the hole <NUM> from the anterior surface <NUM> until it clears the hole <NUM>, and then permitted (as by releasing the device <NUM>) to assume the implanted configuration in which the device <NUM> lies flat against the posterior surface <NUM> of the wall <NUM>, blocking the hole <NUM>. In examples not forming part of the invention, defects in other muscle walls may be similarly resolved using the device <NUM>. Other muscle wall defects such as pelvic floor prolapse may be similarly resolved.

<FIG> shows a first embodiment of the device <NUM> that includes a mesh body <NUM> composed of a matrix of strands <NUM> that are relatively thin in diameter and that may be knitted or woven together usually although not exclusively in a symmetric mesh pattern. It is to be understood that the structure of <FIG> may also be used to establish the above-described plug <NUM> with strengthening members 204a.

Without limitation the strands <NUM> may be a polymer such as but not limited to polypropylene or a biodegradable material. The strands <NUM> may alternatively be metal such as nitinol or stainless steel or a combination of metal and polymer. The strands <NUM> typically have the same diameter as each other but may have differing diameters.

In the example embodiment shown in <FIG>, the mesh body <NUM> defines opposed surfaces <NUM>, <NUM> that are flat in the implanted configuration shown. A first strengthening member <NUM> may be engaged along the edge of the surface <NUM> of the mesh body <NUM> as shown. In some embodiments a second strengthening member <NUM> may be engaged with the edge of the other surface <NUM>.

As contemplated by the embodiment of <FIG>, each strengthening member includes one or more segments that are thicker than the strands <NUM> of the mesh body <NUM>, either by virtue of being individually thicker strands or by virtue, as described above, of being a combination of more tightly woven strands. Thus, in one implementation each segment of the strengthening member is a single relatively thick strand; in other implementations each segment of the strengthening member may be plural relatively thin strands that are woven together in a tighter weave than are the strands <NUM> of the mesh body <NUM> to form a single composite strand, although the strands of a multi-strand segment may be larger than the strands of the unfortified portions of the mesh. In any case, the strengthening members <NUM>, <NUM> may be engaged with the mesh body <NUM> by weaving the strands of the strengthening members into strands <NUM> of the mesh body <NUM>. The effect is to increase the stiffness and elasticity/resiliency of the resulting mesh compared to what it would be without the strengthening members.

<FIG> shows that a mesh body <NUM> may be engaged with surface strengthening members <NUM>, <NUM> that are in all essential respects identical in configuration and function to the members <NUM>, <NUM> shown in <FIG>, and in addition a third strengthening member <NUM> may be provided between the surfaces of the mesh body <NUM> as shown. The third member <NUM> may be non-linear and in the embodiment shown may be sinusoidal. Or, as shown in <FIG> a mesh body <NUM> may be engaged with only a single internal strengthening member <NUM> disposed between surfaces <NUM>, <NUM> of the mesh body <NUM>, omitting strengthening members on the outer surfaces of the mesh body.

<FIG> shows that a mesh body <NUM> may be engaged with plural internal strengthening members <NUM> that are spaced from each other on the mesh body <NUM>. The members <NUM> in <FIG> are generally hourglass-shaped with each having a respective relatively narrow waist <NUM> as shown, although other shapes may be used. The strengthening members <NUM> furthermore may each be of a different configuration than other strengthening members, e.g., of a different shape, size, width, height, and weave pattern.

<FIG> shows a mesh body <NUM> that defines a periphery, and a strengthening member <NUM> is disposed on the periphery as shown by, e.g., weaving the strengthening member into the periphery. The periphery may be circular, ovular, polygonal, or other closed form.

As yet another alternative, <FIG> shows a mesh body <NUM> that is engaged with plural concentric strengthening members <NUM>. One of the members <NUM> may be woven into the periphery of the mesh body and internal, smaller members <NUM> may be woven into the interior of the mesh body as shown. While the members <NUM> are shown as forming closed circles, they need not be complete circles in some embodiments.

The structures shown in <FIG> may be made in a single knitting/weaving process to establish the mesh body and the strengthening members. Alternatively the mesh body may be knitted/woven and the strengthening members may be knitted or woven separately, and then a second step of weaving/knitting can be used to weave the strengthening members into the mesh body to incorporate the strengthening members into the mesh body. Heat engagement such as by welding/melting may alternatively be used. Additional material processing such as heat treating/annealing may be used in accordance with principles known in the art.

While <FIG> illustrate strand-based strengthening members that are interwoven with the mesh body to strengthen the mesh while reducing the risk of a strengthening member breaking off into the patient's body, <FIG> illustrate flexible filament-like strengthening members (configured as round wires or flat ribbons or other cross-sectional shape) that are removed from the mesh body after implantation (when the mesh is disposed against the hole in the implanted configuration) to reduce the same risk. In <FIG> and <FIG>, a mesh body <NUM> that in all substantial respects may be identical to the mesh bodies described previously is engaged with plural spoke-like strengthening members <NUM> that extend from the middle <NUM> of the mesh body <NUM> along respective radials. Without limitation, the members <NUM> may be made of a shape memory material such as nitinol, or they may be made of other metal or polymer; the same comment applies to the strengthening members described in the ensuing figures.

As shown best in <FIG>, each member <NUM> may be disposed in a respective channel <NUM> of the mesh body <NUM>, it being understood that the mesh body <NUM> may be composed of two disk-shaped layers between which the channels <NUM> are formed. The members <NUM> alternatively may be disposed in respective seams or grooves. In the embodiment shown in <FIG>, each member <NUM> includes a radial member 66a extending in the mesh body <NUM> along a radial dimension defined by the mesh body, and an axial segment 66b extending axially down from a hole formed in the middle <NUM> of the mesh body. The ends <NUM> of the axial segments 66b may be grasped and pulled as shown by the arrow <NUM> to remove the members <NUM> from the mesh body <NUM> after implantation of the mesh body over the muscle hole and assumption of the mesh body <NUM> of the implantation configuration, in which the mesh body substantially is flat and is not folded or wrinkled.

<FIG> respectively show alternative strengthening members <NUM>, <NUM>, <NUM> that are petal-shaped. In <FIG>, a strengthening member <NUM> is configured as orthogonal "<FIG>"s having four lobes <NUM> staggered azimuthally by <NUM>°. In <FIG>, three strengthening members <NUM> are provided as thirds of a pie-like structure, with adjacent members <NUM> being separated by narrow channels <NUM>. in <FIG>, a strengthening member <NUM> has four V-shaped lobes <NUM> staggered by <NUM>° such that the long side <NUM> of one "V" is parallel to and closely spaced from a long side of an adjoining "V" as shown.

As another alternative, in <FIG> a spiral-shaped strengthening member <NUM> may be engaged with a mesh body of the present invention. In another alternative, a circular strengthening member <NUM> in <FIG> may include two straight co-parallel segments <NUM> extending radially inwardly on the mesh body and having respective ends <NUM> that may be grasped at the center of the member <NUM> for removing the member <NUM> from the mesh body, as indicated by the arrow <NUM>. Or, a circular strengthening member <NUM> in <FIG> may include two short segments <NUM> extending radially that may be grasped at or near the periphery of the member <NUM> for removing the member <NUM> from the mesh body, as indicated by the arrow <NUM>.

<FIG> illustrate operational aspects of the filament-type devices using as an example the device shown and described in reference to <FIG> and <FIG>. The mesh body <NUM> may be deformed into the insertion configuration shown in <FIG>, in which the mesh body <NUM> is folded into an umbrella-like shape. The body can be collapsed by pushing it against, into, and through the hole sought to be covered.

Once positioned as desired over the surface of the wall having a hole sought to be covered, the mesh body <NUM> is released, e.g., by clearing the hole, to assume the implanted configuration shown in <FIG>, with the axial segments 66b extending back through the hole in one embodiment. A removal member <NUM> may then be used to grasp the ends of the axial segments 66b as shown and pulled as indicated in <FIG> to pull the strengthening members <NUM> out of the implanted mesh body <NUM> to ensure that the strengthening members do not subsequently fracture within the patient to contaminate or puncture the patient. In some embodiments the strengthening members <NUM> may not be installed in the mesh until the mesh is in place on the posterior side of the wall, at which point they may be installed to reform the mesh into the flat configuration and then removed.

The strengthening members may be removed simultaneously with each other as shown or one at a time. Removal can be effected by pulling at one end as shown or by pulling from multiple locations.

Claim 1:
Apparatus, comprising:
a flexible mesh (<NUM>) having an insertion configuration, in which the mesh is smaller than a muscle hole (<NUM>) to be repaired to facilitate advancing the mesh through the hole (<NUM>), and an implanted configuration, in which the mesh is substantially flat and larger than the hole (<NUM>) to block the hole (<NUM>), the apparatus being characterised in that the apparatus further comprises:
a ribbon or threads plug (<NUM>) engaged with the mesh (<NUM>) to fill the muscle hole when the mesh (<NUM>) is in the implanted configuration, the plug (<NUM>) being formed in a petal configuration and extending away from a plane defined by the mesh when the mesh is in the implanted configuration; and
at least one strengthening member (204a) engaged with at least one periphery of the plug, wherein:
said muscle hole (<NUM>) to be repaired is an opening of a muscle wall (<NUM>), said muscle wall (<NUM>) being a wall of an abdomen muscle in which the muscle hole has formed as a hernia.