Patent Description:
<CIT> discloses an implantable medical device including a first elongate member having a proximal end portion configured to be attached to a first portion of a bodily portion within a body of a patient. The device can include second and third elongate members that can be attached to a second portion of the bodily portion and to the first elongate member.

The invention provides a sacrocolpopexy support having a head section connected to a leg section. The head section is attachable to the sacrum or to ligaments attached to the sacrum and the leg section is attached to walls of the vagina. The head section is strong and suited for attachment to the sacrum. The leg section is supple and suited for attachment to the sensitive tissues of the vagina. The head section is formed from a material that has more weight and more strength than the leg section material. The invention provides a closed joint structure within the leg section that is configured to isolate or separate the heavier head section material away from the lighter weight leg section material that is attached to the sensitive vaginal tissues. Advantages of this include supporting the vagina with the more supple and lighter weight leg section of the support while anchoring the support to the tough tissue of the sacrum or the ligaments with the heavier weight material of the head section. Some advantages of the closed joint leg section structure include the reduction in the possibility of the heavier weight head section rubbing against the sensitive tissue of the vagina.

Embodiments of the invention provide a sacrocolpopexy support according to the appended claims.

The accompanying drawings are included to provide a further understanding of the invention. The drawings illustrate embodiments of the invention and together with the description serve to explain principles of the invention. Other embodiments and advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description.

In the following Detailed Description, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. In this regard, directional terminology, such as "top," "bottom," "front," "back," "leading," "trailing," etc., is used with reference to the orientation of the Figure(s) being described. Because components of embodiments can be positioned in a number of different orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the attached claims.

The various exemplary embodiments described in this application may be combined with each other, unless specifically noted otherwise.

The term "proximal" in this application means that part that is situated next to or near the point of attachment or origin or a central point; for example, as located toward a center of the human body. The uterus is proximal relative to abdominal skin of the patient.

The term "distal" in this application means that part that is situated away from the point of attachment or origin or the central point; for example, as located away from the center of the human body. The abdominal skin is distal relative to the internal organs, such as the vagina or the uterus of the patient.

End means endmost. A distal end is the furthest endmost location of a distal portion of a thing being described, whereas a proximal end is the nearest endmost location of a proximal portion of the thing being described. The portion next to or adjacent to an end is an end portion. For example, a <NUM>-inch ruler has a center at <NUM> inches, a first end at zero inches and a second, opposite end at <NUM> inches, an end portion adjacent to the first end and another end portion adjacent to the second end.

The term "basis weight" means weight per area. One acceptable unit for basis weight is expressed as g/m<NUM>.

A sacrocolpopexy support secures a prolapsed vaginal vault by anchoring or connecting the vaginal vault to one of the sacrum or ligaments associated with the sacrum. When the support is implanted, the previously prolapsed vaginal vault is supported or held up by the support that is connected between the tough sacrum/ligament tissues and the vagina. The sacrocolpopexy support described in this application has a head section connected to a leg section. The head section is attachable to the sacrum or to ligaments attached to the sacrum and the leg section is attached to walls of the vagina. The head section is strong and suited for holding the vagina in its anatomically correct position. The leg section is supple and suited for attachment to the sensitive tissues of the vagina. The head section is formed from a material that has more weight and more strength than the leg section material. Embodiments described in this application provide a closed joint structure within the leg section that is configured to isolate or separate the heavier head section material away from the lighter weight leg section material that is attached to the sensitive vaginal tissues. Some advantages of the closed joint leg section structure include the reduction in the possibility of the heavier weight head section rubbing against the sensitive tissue of the vagina. A first comparative example in providing the leg section with a closed joint structure is to secure a first leg portion to the head section with a first connector, and then fold an integrated second leg portion over the first leg portion and then secure the second leg portion to the first leg portion and to the head section with a second connector. Thus, the leg section has one connector through the first leg portion and the head section and a second connector through second leg portion and the first leg portion and the head section. The second connector closes off the space between the first and second leg portions and maintains the endmost part of the head section out from the closed space of the leg section. A second comparative example in providing the leg section with a closed joint structure is to secure a first leg portion to the head section with a first connector, and then fold an integrated second leg portion over the first leg portion and then secure the second leg portion to the first leg portion with a second connector. Thus, the leg section has one connector through the first leg portion and the head section and a second connector through second leg portion and the first leg portion and not through the head section. The second connector closes off the space between the first and second leg portions and maintains the endmost part of the head section behind the second connector and away from the closed space of the leg section. A third comparative example in providing the leg section with a closed joint structure is to secure a first leg portion and a separate and individual second leg portion to the head section with a first connector, and then secure the second leg portion to the first leg portion with a second connector. Thus, the leg section has one connector through the first leg portion and the second leg portion and the head section and a second connector through second leg portion and the first leg portion and not through the head section. The second connector closes off the space between the first and second leg portions and maintains the endmost part of the head section behind the second connector and away from the closed space of the leg section. A fourth comparative example in providing the leg section with a closed joint structure is to secure a first leg portion on one side and a separate and individual second leg portion to an opposite second side of the head section with a first connector, and then secure the second leg portion to the first leg portion with a second connector. The head section is located between the first leg portion and the second leg portion. Thus, the leg section has one connector through the first leg portion and the head section and the second leg portion, and a second connector through second leg portion and the first leg portion and not through the head section. The second connector closes off the space between the first and second leg portions and maintains the endmost part of the head section behind the second connector and away from the closed space of the leg section. Regarding these options, the first leg portion can be the same length as the second leg portion, such that a middle portion of the leg section is located equidistant between the first end and the second end of the leg section. Alternatively, the first leg portion can have a different length than the second leg portion. The connectors may be a polymer thread that is stitched to the materials, or an adhesive connection, or a thermal weld between polymer materials.

A sacrocolpopexy support according to the invention has a head section connected to a leg section. The head section extends from a first end portion to a second end portion. The leg section has a middle portion, a first leg portion extending from the middle portion to a first end of the leg section, and a second leg portion extending from the middle portion to a second end of the leg section. A fold is formed in the leg section such that the first leg portion is folded into contact with the second leg portion. A first connector secures the head section to the first leg portion and does not secure the head section to the second leg portion. A second connector secures the head section to the first leg portion and secures the head section to the second leg section. In one embodiment, an end of the second end portion of the head section terminates at a location between the second connector and an end of the first and second leg portions.

Another comparative example of a sacrocolpopexy support has a head section extending from a first end portion to a second end portion, and a leg section having a middle portion, a first leg portion extending from the middle portion to a first end of the leg section, and a second leg portion extending from the middle portion to a second end of the leg section. A fold is formed in the leg section such that the first leg portion is folded into contact with the second leg portion. A first connector connects the head section to the first leg portion, where the first connector is not coupled to the second leg portion. A second connector connects the first leg portion to the second leg portion, where the second connector is not coupled to the head section.

Another comparative example of a sacrocolpopexy support has a head section extending from a first end portion to a second end portion, and a leg section having a first leg portion placed on and in longitudinal alignment with a second leg portion. A first connector secures the leg section to the second end portion of the head section. The first connector secures at least one of the leg portions of the leg section to the second end portion of the head section. A second connector secures the first leg portion to the second leg portion. The second connector is not coupled to the head section, and an end of the second end portion of the head section terminates at and is located between the first connector and the second connector.

Another comparative example of a sacrocolpopexy support has a head section extending from a first end portion to a second end portion and a leg section having a first leg portion placed on and in longitudinal alignment with a second leg portion. A first connector secures the leg section to the second end portion of the head section. A second connector secures the first leg portion to the second leg portion to form a closed joint that defines a space between the first leg portion and the second leg portion. An end of the second end portion of the head section terminates at a location exterior to the closed joint outside of the space between the first leg portion and the second leg portion. One embodiment of this sacrocolpopexy support provides the leg section with a middle portion, with the first leg portion extending from the middle portion to a first end of the leg section and the second leg portion extending from the middle portion to a second end of the leg section; a fold is formed in the middle portion of the leg section such that the first leg portion is folded into contact with the second leg portion; the first connector is connected through the first leg portion and the second end portion of the head section and not connected to the second leg portion, and the second connector is connected through the first leg portion, the second end portion of the head section, and the second leg portion. One embodiment of this sacrocolpopexy support provides the leg section as a single integrated material with the first leg portion extending from and connected to the second leg portion, and a fold is formed in the leg section such that the first leg portion is folded into contact with the second leg portion; the first connector is connected through the first leg portion and the second end portion of the head section and not connected to the second leg portion, and the second connector is not coupled to the head section; an end of the second end portion of the head section terminates at and is located between the first connector and the second connector. One embodiment of this sacrocolpopexy support provides the first leg portion as separate from the second leg portion, with the first leg portion longitudinally aligned and in contact with the second leg portion; the first connector is connected through the first leg portion, the second leg portion, and the second end portion of the head section; the second connector is not coupled to the head section; an end of the second end portion of the head section terminates at and is located between the first connector and the second connector. One embodiment of this sacrocolpopexy support provides the first leg portion as separate from the second leg portion, with the first leg portion longitudinally aligned with the second leg portion and the second end portion of the head section is disposed between the first leg portion and the second leg portion; the first connector is connected through the first leg portion, the second end portion of the head section, and the second leg portion; the second connector is not coupled to the head section; an end of the second end portion of the head section terminates at and is located between the first connector and the second connector.

Another comparative example of a sacrocolpopexy support has a head section extending from a first end portion to a second end portion, and a leg section that is folded upon itself to provide a first leg portion and a second leg portion. One or more connectors are employed to secure the leg section to the second end portion of the head section. In one embodiment, three or more connectors are employed to secure the leg section to the head section.

The sacrocolpopexy support may be Y-shaped, where the first leg portion and the second leg portion combine to provide a V-shape and the head section is attached to the leg portions to form a combined Y-shape. When the sacrocolpopexy support is implanted, the head section is connected to the sacrum or sacral tissue, and the V-shape of the leg section engages the vagina with the first leg portion connected to the anterior wall of the vagina and the second leg portion connected to the posterior wall of the vagina. The advantage provided by the configurations described in this application is that the head section is spaced apart from and kept away from contacting the sensitive tissue of the vagina. A connector is provided to close the V-shape of the leg portions together in a way that maintains the end of the head section outside of the V-shape. The head section connected to the sacrum is generally coarser, stronger, and tougher than the leg section. It is desirable to prevent the head section from contacting the tissue of the vagina, as this could potentially lead to erosion of the vaginal tissue. The fold of the leg section, in combination with the first and second connector locations, ensures that only the softer leg section interacts with the delicate tissue of the vagina. In contrast, some supports have first leg attached to a first side of the head section and a second leg attached to a second side of the head section, which leaves the head section between the legs and located to possibly abrade the delicate tissue of the vagina. Again, in contrast, some supports provide one long head section (or tail) that extends from the sacrum to the vagina and a shorter leg section is attached to the head section, which also locates the heavier and stiffer head section in contact with the vagina.

In one embodiment of the invention, the head section has an anterior side opposite of a posterior side, and the first leg portion and the second leg portion are both located on only the anterior side of the head section. This configuration has the advantage of locating the leg section material for attachment to both sides of the vagina while also isolating the head section material away from the tissue of the vagina.

In one embodiment of the invention, the leg section is a single integrated piece of material with the middle portion located equidistant between the first end of the leg section and the second end of the leg section. This configuration has the advantage of providing the surgeon with a symmetrical leg section, so the surgeon does not have to spend time deciding "which end is up. " The surgeon may, of course, choose to trim or cut the first and second leg portions to different lengths.

In one embodiment of the invention, the leg section is a rectangle defined by a leg section length and a leg section width, and the first connector and the second connector are connected to the second end portion of the head section, with a width of the second end portion of the head section that is equal to the leg section width and is larger than a width of the first end portion of the head section. This configuration has the advantage of providing more width to the leg section, which aids the surgeon in the attachment of the leg section to the wall of the vagina and also provides excellent vaginal support. The narrower head section allows the surgeon to more easily pass the narrow end of the head section under the peritoneum for connection to the sacrum.

In one embodiment, the first connector is closer to the fold than the second connector is to the fold. This configuration has the advantage of locating the second connector farther from the fold compared to the first connector, which forms a vertex with leg section material on both sides of the vertex. When the leg section is connected to the tissue of the vagina, the vertex locates leg section material on either side of the vagina and isolates the head section material away from the tissue of the vagina.

In one embodiment of the invention, the first connector is a suture that is stitched through not more than two layers of material of the sacrocolpopexy support. This configuration has the advantage of allowing the third layer of material (the second leg portion) to fold over the first connector to provide a vertex of leg material that engages with the vagina, while also isolating the head section material away from the tissue of the vagina.

In one embodiment, the second connector is a suture that is stitched through three layers of material of the sacrocolpopexy support. This configuration has the advantage of forming a vertex of leg material that engages with the vagina, while also isolating the head section material away from the tissue of the vagina.

In one embodiment, a length of the first leg portion measured from the fold to the first end of the leg section is equal to a length of the second leg portion measured from the fold to the second end of the leg section. This configuration has the advantage of providing a symmetric leg portion.

In one embodiment, a distance measured from the second connector to the first end of the leg section is equal to a distance measured from the second connector to an end of the first end portion of the head section. This configuration has the advantage of providing a symmetric support with equal parts of a leg section attachable to the vagina and head section.

In one embodiment of the invention, a transverse width of the leg section is greater than a transverse width of the first end portion of the head section. This configuration has the advantage of providing a smoothly tapered and narrower head section.

In one embodiment of the invention, a basis weight of the leg section is less than <NUM>/m<NUM>, which advantageously provides a light weight support structure for attachment to the delicate tissue of the vagina.

In one embodiment, a basis weight of the first leg portion is equal to a basis weight of the second leg portion, which advantageously provides a uniform support structure for attachment to the delicate tissue of the vagina.

In one embodiment, a basis weight of the leg section is less than <NUM>/m<NUM>and a basis weight of the head section is greater than <NUM>/m<NUM>, which advantageously provides a light weight support structure for attachment to the delicate tissue of the vagina and a heavier support for connection to the tough sacral tissue.

In one embodiment of the invention, a single line is printed in ink on the first leg portion and is located longitudinally on a longitudinal center of the first leg portion to advantageously provide a guide or index that allows the surgeon to center the leg section relative to a wall of the vagina.

In one embodiment of the invention, a first line is printed in ink on the second leg portion and a second line is printed in ink on the second leg portion, with each of the first line and the second line located longitudinally on the second leg portion and offset away from a longitudinal center of the second leg portion. This configuration has the advantage of distinguishing the second leg portion from the first leg potion, while also providing the surgeon with a center location between the two printed lines.

Embodiments provide a sacrocolpopexy support having a head section connected to a leg section. The head section extends from a first end portion to a second end portion. The leg section has a middle portion, a first leg portion extending from the middle portion to a first end of the leg section, and a second leg portion extending from the middle portion to a second end of the leg section. A fold is formed in the middle portion of the leg section, with the middle portion of the leg section connected to the head section. The head section has an anterior side opposite of a posterior side, and in an embodiment both of the first leg portion and the second leg portion are located on only the anterior side of the head section.

Embodiments provide a sacrocolpopexy support having a leg section connected to a head section. The head section is knitted with a monofilament polypropylene fiber into a knit structure having a weight per area in a range from <NUM>-<NUM>/m<NUM>. The leg section is knitted with a monofilament polypropylene fiber into a knit structure having a weight per area in a range from <NUM>-<NUM>/m<NUM>, with the leg section having a first leg portion overlaying a second leg portion. A first connector connects the first leg portion to the second leg portion to form a closed space located between the first leg portion and the second leg portion. An entirety of the head section is located outside of the closed space located between the first leg portion and the second leg portion.

In one embodiment, the head section is located on a proximal side of the sacrocolpopexy support and the leg section is located on a distal side of the sacrocolpopexy support, and the entirety of the head section is located proximal relative to the first connector. This configuration provides the advantage of keeping the head section out of the closed space located between the first leg portion and the second leg portion. When implanted, the vagina is located within the closed space located between the first leg portion and the second leg portion, and thus the head section is isolated away from the sensitive tissues of the vagina.

<FIG> is a perspective view of one comparative example of a sacrocolpopexy support <NUM> (support <NUM>). The support <NUM> includes a head section <NUM> connected to a leg section <NUM>. The head section <NUM> is attached to the sacrum or its adjacent tissues during implantation and the leg section <NUM> is attached to an exterior wall of the vagina. The head section <NUM> is suitably attached to the bony sacrum or the soft tissues covering the bony sacrum or the connective tissues, such as ligaments, extending from the sacrum. Sutures, staples, or tacks, depending upon the preference of the surgeon, may be employed to secure the head section <NUM> to the sacral tissue. The leg section <NUM> is generally secured to an exterior surface of both the anterior wall and the posterior wall of the vagina, for example through the use of sutures.

The head section <NUM> has a first end portion <NUM> terminating in a first end <NUM> and a second end portion <NUM> terminating in a second end <NUM>.

The leg section <NUM> has a middle portion <NUM>, a first leg portion <NUM> extending from the middle portion <NUM> to a first end <NUM>, and a second leg portion <NUM> extending from the middle portion <NUM> to a second end <NUM>. The first leg portion <NUM> and the second leg portion <NUM> are connected to the head section <NUM>.

A portion of the leg section <NUM> is connected to the head section <NUM>, and a fold <NUM> is formed in the leg section <NUM> to place the second leg portion <NUM> over the first leg portion <NUM>. The leg section <NUM> is a single integrated piece of material with the middle portion <NUM> located between the first end <NUM> and the second end <NUM> of the leg section <NUM>. The fold <NUM> can be folded in a manual procedure by hand, or in an automated procedure by machine prior to securing the leg section <NUM> to the head section <NUM>, or after first securing a part of the leg section <NUM> to part of the head section <NUM>. In one example, the first leg portion <NUM> is the same length as the second leg portion <NUM>, such that the middle portion <NUM> is located equidistant between the first end <NUM> and the second end <NUM> of the leg section <NUM>. In one example, the first leg portion <NUM> has a different length than the second leg portion <NUM>.

A first connector <NUM> secures the head section <NUM> to the first leg portion <NUM>, and a second connector <NUM> secures the head section <NUM> to the first leg portion <NUM> and the second leg portion <NUM>. Suitable connectors for the first connector <NUM> and the second connector <NUM> include a polymer strand that is stitched through portions of the support <NUM>, ultrasonically welded lines, segments of glue, or combinations of glue and sutures. In one example, the first connector <NUM> and the second connector <NUM> are provided by a polypropylene monofilament strand that is stitched through portions of the head section <NUM> and the leg section <NUM>.

The support <NUM> is selected to be bio-compatible with implantation into a human body and is configured to allow tissue to grow through the head section <NUM> and the leg section <NUM> to anchor the support <NUM> in the body after implantation and healing. Suitable materials for the support <NUM> include autograft material (the patient's own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic materials such as knitted meshes, woven fabrics or meshes, nonwoven fabrics or meshes, fibrillated fibers, or spun and fibrillated fibers. The support <NUM> is provided with voids including major spaces and smaller pores. The voids allow tissue ingrowth into and through the support <NUM>. The major spaces have a size in a range from <NUM>-<NUM> and the pores have a size in a range from <NUM>-<NUM>.

In one example the support <NUM> is a knitted monofilament polypropylene mesh with the head section <NUM> provided with a heavier weight per area than the leg section <NUM>.

One suitable head section <NUM> is knitted with a <NUM> monofilament polypropylene fiber into a knit structure having a thickness in a range from <NUM>-<NUM> and a weight per area in a range from <NUM>-<NUM>/m<NUM>, and preferably with a weight per area of approximately <NUM>/m<NUM>. Other fibers formed from other material and having a diameter different from the <NUM> monofilament polypropylene fiber are also acceptable. For example, fiber having a <NUM> or a <NUM> diameter is acceptable.

One suitable leg section <NUM> is knitted with an <NUM> monofilament polypropylene fiber into a knit structure having a thickness in a range from <NUM>-<NUM> and a weight per area in a range from <NUM>-<NUM>/m<NUM>, and preferably with a weight per area of approximately <NUM>/m<NUM>. Other fibers formed from other material and having a diameter different from the <NUM> monofilament polypropylene fiber are also acceptable. For example, fiber having a <NUM> or a <NUM> diameter is acceptable. In one example, the leg section <NUM> is provided as a rectangle that is folded on a line about fold <NUM> such that the weight per area of the first leg portion <NUM> is equal to the weight per area of the second leg portion <NUM>.

The leg section <NUM> mesh is thin and light weight (i.e., the weight per area or basis weight is less than approximately <NUM>/m<NUM>) to provide a thin and comfortable mesh that is agreeable with the delicate vaginal tissue that contacts the mesh and is less likely to be sensed through the tissue layers by the patient.

The examples of the support provide a structure that keeps the heavier material of the head section <NUM> separated away from the sensitive tissue of the vagina. This is achieved by locating the heavier weight material of the head section <NUM> away from where the light weight material of the leg section <NUM> is attached (or attachable) to the vagina.

Suitable knitted monofilament polypropylene mesh is available from Coloplast Corp. , Minneapolis, MN.

<FIG> is a right side view of the support <NUM> and <FIG> is a view of the connectors <NUM>, <NUM> securing the head section <NUM> to the leg section <NUM>.

The fold <NUM> is formed in the middle portion <NUM> of the leg section <NUM>. The first connector <NUM> secures the head section <NUM> to the first leg portion <NUM> but does not secure the head section <NUM> to the second leg portion <NUM>. That is to say, the first connector <NUM> extends through the head section <NUM> and only the first leg portion <NUM> and does not extend through the second leg portion <NUM>. The first connector <NUM> is coupled to the head section <NUM> and only the first leg portion <NUM> and is not coupled to the second leg portion <NUM>. The second connector <NUM> secures the head section <NUM> to both the first leg portion <NUM> and the second leg portion <NUM>.

The leg section <NUM> and the head section <NUM> combine to provide a Y-shaped support when viewed from a side edge of the sacrocolpopexy support <NUM>, as illustrated in <FIG>. The Y-shaped support <NUM> has a V-shaped portion formed by the first leg portion <NUM> and the second leg portion, and the head section <NUM> is attached to the V-shaped portion to complete the Y-shaped conformation. When implanted, the V-shape of the leg section <NUM> engages the vagina with the first leg portion <NUM> connected to the anterior wall of the vagina and the second leg portion <NUM> connected to the posterior wall of the vagina. The head section <NUM> is spaced apart from and kept out of the interior of the V-shaped portion of the leg section <NUM>. Specifically, the second connector <NUM> has closed the V-shaped portion at its apex area. This configuration ensures that the head section <NUM> is kept away from contacting the sensitive tissue of the vagina since the head section <NUM> is maintained outside of the V-shaped portion of the leg section <NUM>.

In one example, the connector <NUM> connects the first leg portion <NUM> to the second leg portion <NUM> to form a closed space <NUM> located between the first leg portion <NUM> and the second leg portion <NUM>, and an entirety of the head section <NUM> is located outside of the closed space <NUM> located between the first leg portion <NUM> and the second leg portion <NUM>.

In one example, the head section <NUM> has an anterior side <NUM> opposite of a posterior side <NUM>, and the connectors <NUM>, <NUM> secure the folded leg section <NUM> to only one of the anterior side <NUM> or the posterior side <NUM> of the head section <NUM>. In the example illustrated in <FIG>, the first leg portion <NUM> and the second leg portion <NUM> are both located on only the anterior side <NUM> of the head section <NUM>.

With regard to the attachment, the first connector <NUM> is coupled to not more than two layers of material of the support <NUM> and second connector <NUM> is coupled to at least three layers (head section <NUM> and both leg portions <NUM>, <NUM>) of material of the support <NUM>. For example, the first connector <NUM> is a suture that is stitched through not more than two layers of material of the support <NUM> and the second connector <NUM> is a suture that is stitched through three layers, or more than three layers, of material of the support <NUM>. One suitable connector material is polypropylene monofilament, for example, an <NUM> monofilament polypropylene fiber. In one example, the first connector <NUM> is separate and distinct from the second connector <NUM>. In one example, the first connector <NUM> and the second connector <NUM> are formed by a sewn pattern that provides both connectors <NUM>, <NUM> where the first connector <NUM> extends through the head section <NUM> and only the first leg portion <NUM> and does not extend through the second leg portion <NUM> and the second connector <NUM> secures the head section <NUM> to both the first leg portion <NUM> and the second leg portion <NUM>. In one example, each of the connectors <NUM>, <NUM> is formed by an interlocking stitch that is stitched across the full width of the head section <NUM> and the leg section <NUM>. The interlocking stitch is placed in a transverse direction, preferably parallel with the second end <NUM> of the head section <NUM>.

The first connector <NUM> and the second connector <NUM> fixate the middle portion <NUM> of the leg section <NUM> to the second end portion <NUM> of the head section <NUM>. The first connector <NUM> is closer to the fold <NUM> than the second connector <NUM> is to the fold <NUM>, which is to say that the second connector <NUM> is closer to the second end <NUM> of the head section <NUM> than the first connector <NUM> is to the second end <NUM> of the head section <NUM>. In one example, a length of the first leg portion <NUM> measured from the fold <NUM> to the first end <NUM> is equal to a length of the second leg portion <NUM> measured from the fold <NUM> to the second end <NUM> of the leg section <NUM>.

It is acceptable to secure the leg section <NUM> to the head section <NUM> by, for example, securing first leg portion <NUM> to the head section <NUM> with adhesive or by thermal welding of the materials, and then to place a single mechanical connector, such as stitch line <NUM> or adhesive or thermal welding, to secure the first leg portion <NUM> to the second leg portion <NUM>, where the single connector closes the leg section <NUM> and isolates the end <NUM> of the head section <NUM> outside of the closed space formed between the leg portions <NUM>, <NUM>.

<FIG> are a top perspective views and <FIG> is an exemplary side schematic view of the first connector <NUM> and the second connector <NUM> securing the head section <NUM> to the leg section <NUM>.

The first connector <NUM> and the second connector <NUM> combine to provide what is termed a closed joint construction that separates the vaginal attachment portions of the lightweight structure of the leg section <NUM> away from the heavier structure of the head section <NUM>. The closed joint construction is provided by aligning the open pores or open holes of the first leg portion <NUM> with the open holes of the head section <NUM> and then stitching a monofilament fiber through the open holes of the first leg portion <NUM> and the head section <NUM> to provide the first connector, which is illustrated by the dotted line <NUM> since this stitch pattern would be covered over by the second leg portion <NUM> (and thus not visible from above). A separate second stitch, spaced apart from the first stitch of connector <NUM>, is passed through the aligned open holes of the first leg portion <NUM>, the second leg portion <NUM>, and the head section <NUM> to provide the second connector <NUM>, which is illustrated by the solid line <NUM> since this stich goes through all three layers and is visible from above and below.

The stitches of the first and second connectors <NUM>, <NUM> are formed in a path along a width of the support <NUM> in the aligned holes of the leg section <NUM> and the head section <NUM>. In one example, each stitch is formed in two passes, first in one direction across a width the support <NUM> and then in a reversed, second path across the width support <NUM>. The advantage of a two-pass stitch pattern is realized in that twice-stitched closed joint resists separation when the support <NUM> is trimmed or cut. The two-pass stitch pattern forms a strong joint that allows the surgeon to cut the support <NUM> without the undesirable consequence of the leg section <NUM> separating from the head section <NUM>.

In the illustrated example, the head section <NUM> has an anterior side <NUM> opposite of a posterior side <NUM>, and the first leg portion <NUM> and the second leg portion <NUM> are both located on only the anterior side <NUM> of the head section <NUM>. This configuration contributes to the keeping the heavier structure of the head section <NUM> away from the sensitive tissue of the vagina that is supported by and attached to the lightweight structure of the leg section <NUM>.

<FIG> is a front view of the support <NUM> and <FIG> is a back view of the support <NUM>. <FIG> is thus a view of the second leg portion <NUM> and <FIG> is a view of the first leg portion <NUM>.

The leg section <NUM> has a leg section length L and a leg section width WL (thus, the first leg portion <NUM> and the second leg portion <NUM> each have a length of L/<NUM>). The leg section <NUM> is folded at the fold <NUM> (See <FIG>). The first connector <NUM> and the second connector <NUM> are connected to the second end portion <NUM> of the head section <NUM>. A width WH2 of the second end portion <NUM> of the head section <NUM> is equal to the leg section width WL and is larger than a width WH1 of the first end portion <NUM> of the head section <NUM>. In this manner, the head section <NUM> diverges from a narrower width WH1 at the first end <NUM> to a wider width WH2 at the second end section <NUM>, and the width WH2 is equal to the width WL of the leg section <NUM>. Thus, a transverse width of the leg section <NUM> (WL) is greater than a transverse width of the first end portion <NUM> of the head section <NUM> (WH1).

In one example, the support <NUM> is configured such that a distance S/<NUM> measured from the second connector <NUM> to the first end <NUM> of the leg section <NUM> is equal to a distance S/<NUM> measured from the second connector <NUM> to the end <NUM> of the head section <NUM>. The total length of the support <NUM> is S (S/<NUM> plus S/<NUM>).

In one example, the support <NUM> has a single line <NUM> printed in ink on the second leg portion <NUM>, with the single line <NUM> located longitudinally on a longitudinal center LC of the second leg portion <NUM>.

In one example, the support <NUM> has dual lines printed on the first leg portion. For example, a first line <NUM> is printed in ink on the first leg portion <NUM> and a second line <NUM> is printed in ink on the first leg portion <NUM>, with each of the first line <NUM> and the second line <NUM> located longitudinally on the first leg portion <NUM> and offset away from the longitudinal center LC of the support <NUM> and the first leg portion <NUM>.

The printed lines provide a guide to allow the surgeon to place the leg section <NUM> in a desired orientation. The printed lines are an optional feature for the support <NUM>.

<FIG> is a schematic perspective view of the sacrocolpopexy support <NUM> implanted in a patient.

One acceptable procedure for implanting the support <NUM> into the patient is a trans-abdominal laparoscopic procedure. Some healthcare facilities employ robotically assisted laparoscopic procedures. During the trans-abdominal laparoscopic procedure, access ports (trocars) are placed in the abdomen of the patient. The laparoscope is inserted through one of the trocars into the abdomen for access to the vaginal cuff. An inert gas is pumped into a second of the trocars to inflate the abdominal region for improved access and viewing of the pelvic organs. The surgeon will often position the vagina by inserting a supporting device (sometimes referred to as a manipulator) into the natural vaginal opening to orient the vaginal cuff to a desired position suited for viewing of the vaginal cuff when attaching the support <NUM>. Other surgical procedures are also acceptable, depending upon surgeon preference.

The support <NUM> is inserted through a trocar. The head section <NUM> is secured to the sacrum and the leg section <NUM> is secured to the vaginal cuff. In the illustration of <FIG>, the second leg portion <NUM> has been attached to the anterior wall of the vagina and the first leg portion <NUM> has been attached to the posterior wall of the vagina. It is also acceptable to attach the head section <NUM> the sacrospinous ligament, depending upon the preference of the surgeon.

<FIG> is a schematic side view of the sacrocolpopexy support <NUM> secured to a vagina of a patient. The head section <NUM> extends superiorly to the where it is attached to the sacrum and the leg section <NUM> extends inferiorly where it is attached to the cuff of the vagina. The first leg portion <NUM> has been secured to the posterior wall of the vagina and the second leg portion <NUM> has been secured to the anterior wall of the vagina. Suitable securement devices such as sutures or staples are employed for fixation, depending upon the preference of the surgeon. The fold <NUM> in combination with the connectors <NUM>, <NUM> and their locations combine to ensure that lighter weight material of the leg portions <NUM>, <NUM> are the only portion of the support <NUM> that is in contact with the delicate tissue of the vagina. The head section <NUM>, fabricated from a heavier material than the leg section, is isolated and separated away from the delicate tissue of the vagina.

Sacrocolpopexy supports were fabricated and evaluated. The supports each have a head section and a leg section, and Table <NUM> below illustrates the physical properties of each of these portions of the support. The physical properties recited in Table <NUM> provide one example of performance characteristics for use as a sacrocolpopexy support in the treatment of pelvic organ prolapse.

<FIG> is a perspective view of an example of a sacrocolpopexy support <NUM> (support <NUM>).

The support <NUM> includes a head section <NUM> connected to a leg section <NUM>. The head section <NUM> is attached to the sacrum or its adjacent tissues during implantation and the leg section <NUM> is attached to an exterior wall of the vagina. The head section <NUM> is suitably attached to the bony sacrum or the soft tissues covering the bony sacrum or the connective tissues, such as ligaments, extending from the sacrum. Sutures, staples, or tacks, depending upon the preference of the surgeon, may be employed to secure the head section <NUM> to the sacral tissue. The leg section <NUM> is generally secured to an exterior surface of both the anterior wall and the posterior wall of the vagina, for example through the use of sutures.

<FIG> is a right side view and <FIG> are perspective views of the support <NUM>.

The leg section <NUM> has a middle portion <NUM>, a first leg portion <NUM> extending from the middle portion <NUM> to a first end <NUM>, and a second leg portion <NUM> extending from the middle portion <NUM> to a second end <NUM>.

A first connector <NUM> secures the head section <NUM> to the first leg portion <NUM>, and a second connector <NUM> secures the first leg portion <NUM> to the second leg portion <NUM> and is not coupled through the head section <NUM>. Suitable connectors for the first connector <NUM> and the second connector <NUM> include a polymer strand that is stitched through portions of the support <NUM>, ultrasonically welded lines, segments of glue, or combinations of glue and sutures. In one example, the first connector <NUM> and the second connector <NUM> are provided by an <NUM> monofilament polypropylene fiber.

This example of a sacrocolpopexy support <NUM> has a head section <NUM> extending from a first end portion <NUM> to a second end portion <NUM>, and a leg section <NUM> having a first leg portion <NUM> placed on and in alignment with a second leg portion <NUM>. A first connector <NUM> secures the leg section <NUM> to the second end portion <NUM> of the head section <NUM>. A second connector <NUM> secures the first leg <NUM> portion to the second leg portion <NUM>. The second connector <NUM> is not coupled to the head section <NUM>, and an end <NUM> of the second end portion <NUM> of the head section <NUM> terminates at and is located between the first connector <NUM> and the second connector <NUM>.

In one example, a fold <NUM> is formed in the leg section <NUM> such that the first leg portion <NUM> is folded into contact with the second leg portion <NUM>. The leg section <NUM> is a single integrated piece of material with the middle portion <NUM> located between the first end <NUM> and the second end <NUM> of the leg section <NUM>. In one example, the leg section <NUM> is provided as a rectangle that is folded on a line about fold <NUM> such that the weight per area of the first leg portion <NUM> is equal to the weight per area of the second leg portion <NUM>. The fold <NUM> can be folded in a manual procedure by hand or in an automated procedure by machine prior to securing the leg section <NUM> to the head section <NUM>. In an example, the first connector <NUM> is placed to secure the first leg portion <NUM> to the head section <NUM>, and the second leg portion <NUM> is folded to overlay the first leg portion <NUM> prior to securing the first leg portion <NUM> to the second leg portion <NUM> with the connector <NUM>.

In one example, the first leg portion <NUM> is placed on top of the second leg portion <NUM> and these components are not folded as an integral piece of material.

In one example, the first leg portion <NUM> is the same length as the second leg portion <NUM>, such that the middle portion <NUM> is located equidistant between the first end <NUM> and the second end <NUM> of the leg section <NUM>. In one example, the first leg portion <NUM> has a different length than the second leg portion <NUM>.

In one example, the support <NUM> is a knitted monofilament polypropylene mesh with the head section <NUM> provided with a heavier weight per area than the leg section <NUM>.

One suitable head section <NUM> is knitted with a <NUM> monofilament polypropylene fiber into a knit structure having a thickness in a range from <NUM>-<NUM> and a weight per area in a range from <NUM>-<NUM>/m<NUM>, and preferably with a weight per area of approximately <NUM>/m<NUM>.

One suitable leg section <NUM> is knitted with an <NUM> monofilament polypropylene fiber into a knit structure having a thickness in a range from <NUM>-<NUM> and a weight per area in a range from <NUM>-<NUM>/m<NUM>, and preferably with a weight per area of approximately <NUM>/m<NUM>.

The leg section <NUM> material is thin and light weight (i.e., the weight per area or basis weight is less than approximately <NUM>/m<NUM>) to provide a thin and comfortable mesh that is agreeable with the delicate vaginal tissue that contacts the mesh and is less likely to be sensed through the tissue layers by the patient.

The examples of the support provide a structure that keeps the heavier material of the head section <NUM> separated away from the sensitive tissue of the vagina. This is achieved by locating the heavier weight material of the head section <NUM> away from where the light weight material of the leg section <NUM> is attached (or attachable) to the vagina. Specifically, the end <NUM> of the second end portion <NUM> of the head section <NUM> terminates at and is located between the first connector <NUM> and the second connector <NUM>.

The first connector <NUM> secures the head section <NUM> to the first leg portion <NUM> but does not secure the head section <NUM> to the second leg portion <NUM>. That is to say, the first connector <NUM> extends through the head section <NUM> and only the first leg portion <NUM> and does not extend through the second leg portion <NUM>. The first connector <NUM> is coupled to the head section <NUM> and only the first leg portion <NUM> and is not coupled to the second leg portion <NUM>. The second connector <NUM> is coupled between the first leg portion <NUM> and the second leg portion <NUM>, and is not coupled to the head section <NUM>.

The leg section <NUM> and the head section <NUM> combine to provide a Y-shaped support when viewed from a side edge of the sacrocolpopexy support <NUM>.

In one example, the head section <NUM> has an anterior side <NUM> opposite of a posterior side <NUM>, and the connector <NUM> secures the leg section <NUM> to only one of the anterior side <NUM> or the posterior side <NUM> of the head section <NUM>.

The first connector <NUM> is coupled to not more than two layers of material of the support <NUM> and second connector <NUM> is coupled to not more than two layers (e.g., only the leg portions <NUM>, <NUM>) of material of the support <NUM>. For example, the first connector <NUM> is a suture that is stitched through not more than two layers of material of the support <NUM> and the second connector <NUM> is a suture that is stitched only the leg portions <NUM>, <NUM> of the support <NUM> and not through the head section <NUM>. One suitable connector material is polypropylene monofilament, for example, an <NUM> monofilament polypropylene fiber. In one example, the first connector <NUM> is separate and distinct from the second connector <NUM>. In one example, each of the connectors <NUM>, <NUM> is formed by an interlocking stitch that is stitched across the full width of the support <NUM>. The interlocking stitch is placed in a transverse direction, preferably parallel with the second end <NUM> of the head section <NUM>.

The first connector <NUM> attaches the leg section <NUM> to the second end portion <NUM> of the head section <NUM>. In one example, the second end <NUM> of the head section <NUM> is located equidistantly between the connectors <NUM>, <NUM>. In one example, the end <NUM> of the head section <NUM> is located closer to the first connector <NUM> that it is to the second connector <NUM>, which additionally serves to separate the end <NUM> away from the light weight material of the leg section <NUM> that is ultimately attached to the vaginal tissue.

In one example, the connector <NUM> connects the first leg portion <NUM> to the second leg portion <NUM> to form a closed space located between the first leg portion <NUM> and the second leg portion <NUM>, and an entirety of the head section <NUM> is located outside of the closed space located between the first leg portion <NUM> and the second leg portion <NUM>.

<FIG> is a side schematic view of the first connector <NUM> and the second connector <NUM> locations.

The first connector <NUM> and the second connector <NUM> combine to provide what is termed a closed joint construction that separates the vaginal attachment portions of the lightweight structure of the leg section <NUM> away from the heavier structure of the head section <NUM>. The closed joint construction is provided by aligning the open pores or open holes of the first leg portion <NUM> with the open holes of the head section <NUM> and then stitching a monofilament fiber through the open holes of the first leg portion <NUM> and the head section <NUM> to provide the first connector <NUM>. The first connector <NUM> passes through only two layers, namely one leg portion <NUM> and the head section <NUM>. A separate second stitch <NUM>, spaced apart from the first connector <NUM>, is passed through the aligned open holes of the first leg portion <NUM> and the second leg portion <NUM>. The second connector passes through only the two layers of the leg portions <NUM>, <NUM> and not through the head section <NUM>.

In one example, each stitch is formed in two passes, first in one direction across a width the support <NUM> and then in a reversed, second path across the width support <NUM>. The advantage of a two-pass stitch pattern is realized in that twice-stitched closed joint resists separation when the support <NUM> is trimmed or cut. The two-pass stitch pattern forms a strong joint that allows the surgeon to cut the support <NUM> without the undesirable consequence of the leg section <NUM> separating from the head section <NUM>.

<FIG> is a front view of the support <NUM> and <FIG> is a back view of the support <NUM>. <FIG> is thus a top view of the second leg portion <NUM> and <FIG> is a view of the first leg portion <NUM>.

The leg section <NUM> has a leg section length L and a leg section width WL (thus, the first leg portion <NUM> and the second leg portion <NUM> each have a length of L/<NUM>). The first connector <NUM> is connected to the second end portion <NUM> of the head section <NUM>. A width WH2 of the second end portion <NUM> of the head section <NUM> is equal to the leg section width WL and is larger than a width WH1 of the first end portion <NUM> of the head section <NUM>. In this manner, the head section <NUM> diverges from a narrower width WH1 at the first end <NUM> to a wider width WH2 at the second end section <NUM>, and the width WH2 is equal to the width WL of the leg section <NUM>. Thus, a transverse width of the leg section <NUM> (WL) is greater than a transverse width of the first end portion <NUM> of the head section <NUM> (WH1).

The support <NUM> is configured such that a distance S/<NUM> measured from the second connector <NUM> to the first end <NUM> of the leg section <NUM> is equal to a distance S/<NUM> measured from the second connector <NUM> to the end <NUM> of the head section <NUM>. The total length of the support <NUM> is S (S/<NUM> plus S/<NUM>).

In one example, the support <NUM> has dual lines printed on the first leg portion <NUM>. For example, a first line <NUM> is printed in ink on the first leg portion <NUM> and a second line <NUM> is printed in ink on the first leg portion <NUM>, with each of the first line <NUM> and the second line <NUM> located longitudinally on the first leg portion <NUM> and offset away from the longitudinal center LC of the support <NUM> and the first leg portion <NUM>.

<FIG> is a schematic side view of the sacrocolpopexy support <NUM> secured to a vagina of a patient. The head section <NUM> extends superior to the where it is attached to the sacrum and the leg section <NUM> extends inferior where it is attached to the cuff of the vagina. The first leg portion <NUM> has been secured to the posterior wall of the vagina and the second leg portion <NUM> has been secured to the anterior wall of the vagina. Suitable securement devices such as sutures or staples are employed for fixation, depending upon the preference of the surgeon. The lighter weight material of the leg portions <NUM>, <NUM> are the only portion of the support <NUM> that is in contact with the delicate tissue of the vagina. The head section <NUM>, fabricated from a heavier material than the leg section <NUM>, is isolated and separated away from the delicate tissue of the vagina by locating the end <NUM> of the head section <NUM> between the second connector <NUM> and the first connector <NUM>. The second connector <NUM> passes through and couples the leg portions <NUM>, <NUM> together to form the closed joint, and this ensures that the heavier weight head section <NUM> is separated away from the attachment location of the leg section <NUM> to the vagina, and thus only the light weight and comfortable material of the leg section <NUM> is in contact with the sensitive tissue of the vagina.

<FIG> is a schematic side view of one comparative example J of a sacrocolpopexy support <NUM>.

The support <NUM> has a head section <NUM> extending between a first end <NUM> and a second end <NUM> and a leg section <NUM>. The leg section <NUM> has a first leg portion <NUM> extending between ends <NUM> and <NUM>, and a second leg portion <NUM> extending between ends <NUM> and <NUM>. The leg portions <NUM>, <NUM> are aligned one on top of the other and secured by a first connector <NUM> and a second connector <NUM>. The first connector <NUM> passes through and couples the leg portions <NUM>, <NUM> to the head section <NUM>. The second connector <NUM> passes through and couples the leg portions <NUM>, <NUM>. The second connector <NUM> is not coupled to the head section <NUM> and operates to close off the head section <NUM> and separate the head section <NUM> from the sensitive tissues of the vagina. In one example, the second end <NUM> of the head section <NUM> is located between the first and second connectors <NUM>, <NUM> to isolate and separate the head section <NUM> from the location where the leg section <NUM> is attached to the sensitive vaginal tissue.

In one example, the second end <NUM> of the head section <NUM> is located on one side of the leg section <NUM>, for example on the side of the first leg portion <NUM> opposite from the second leg portion <NUM>, and the second connector <NUM> is placed to close off the possibility of the head section <NUM> from touching or abrading the sensitive vaginal tissue.

The support <NUM> provides a structure that keeps the heavier material of the head section <NUM> separated away from the sensitive tissue of the vagina. This is achieved by locating the heavier weight material of the head section <NUM> away from where the light weight material of the leg section <NUM> is attached (or attachable) to the vagina. Specifically, the end <NUM> of the head section <NUM> terminates at and is located between the first connector <NUM> and the second connector <NUM>, which ensures that the heavier head section is not able to contact the walls or tissue of the vagina.

<FIG> is a schematic side view of one comparative example of a sacrocolpopexy support <NUM>.

The support <NUM> has a head section <NUM> terminating at an end <NUM> and a leg section <NUM>. The leg section <NUM> has a first leg portion <NUM> and a second leg portion <NUM>. The leg portions <NUM>, <NUM> are aligned one on top of the other and secured by a first connector <NUM> and a second connector <NUM>. The first connector <NUM> passes through and couples the leg portions <NUM>, <NUM> to the head section <NUM>. The second connector <NUM> closes the leg portions <NUM>, <NUM> and isolates the end <NUM> of the head section <NUM> outside of the V-shape formed by the leg portions <NUM>, <NUM>. The second connector <NUM> is not coupled to the head section <NUM> and operates to separate the head section <NUM> away from the area where the V-shape of the leg section <NUM> engages with the sensitive tissues of the vagina. In one embodiment, the end <NUM> of the head section <NUM> is located between the first and second connectors <NUM>, <NUM> to isolate and separate the head section <NUM> from the location where the leg section <NUM> is attached to the sensitive vaginal tissue.

In one example, the second end <NUM> of the head section <NUM> is located, or sandwiched, between the first and second leg portions <NUM>, <NUM> and the second connector <NUM> is placed to close the head section <NUM> from entering the V-shape of the leg section <NUM> that engages with the sensitive tissues of the vagina.

Claim 1:
A sacrocolpopexy support (<NUM>, <NUM>) comprising:
a head section (<NUM>, <NUM>) extending from a first end portion (<NUM>) to a second end portion (<NUM>);
a leg section (<NUM>, <NUM>) having a first leg portion (<NUM>, <NUM>) placed on and in longitudinal alignment with a second leg portion (<NUM>, <NUM>);
a first connector (<NUM>, <NUM>) securing the leg section (<NUM>, <NUM>) to the second end portion (<NUM>) of the head section (<NUM>, <NUM>); and
a second connector (<NUM>, <NUM>) securing the first leg portion (<NUM>, <NUM>) to the second leg portion (<NUM>, <NUM>) to form a closed joint that defines a space between the first leg portion (<NUM>, <NUM>) and the second leg portion (<NUM>, <NUM>);
wherein an end (<NUM>, <NUM>) of the second end portion (<NUM>) of the head section (<NUM>, <NUM>) terminates at a location exterior to the closed joint outside of the space between the first leg portion (<NUM>, <NUM>) and the second leg portion (<NUM>, <NUM>); characterised in that
the leg section (<NUM>, <NUM>) has a middle portion (<NUM>), with the first leg portion (<NUM>, <NUM>) extending from the middle portion (<NUM>) to a first end (<NUM>) of the leg section and the second leg portion (<NUM>, <NUM>) extending from the middle portion (<NUM>) to a second end (<NUM>) of the leg section, and a fold (<NUM>) is formed in the middle portion (<NUM>) of the leg section (<NUM>, <NUM>) such that the first leg portion (<NUM>, <NUM>) is folded into contact with the second leg portion (<NUM>, <NUM>);
wherein the first connector (<NUM>, <NUM>) is connected through the first leg portion (<NUM>, <NUM>) and the second end portion (<NUM>) of the head section (<NUM>, <NUM>) and not connected to the second leg portion (<NUM>, <NUM>);
wherein the second connector (<NUM>, <NUM>) is connected through the first leg portion (<NUM>, <NUM>), the second end portion (<NUM>) of the head section (<NUM>, <NUM>), and the second leg portion (<NUM>, <NUM>).