Abstract:
A method of treating prolapse of a vagina includes inserting a shell into the vagina; contacting a convex exterior apex of the shell with an interior apical portion of the vagina; and securing a first portion of an anchor to the shell and securing a second portion of the anchor to a ligament or a sacrum exterior to and separate from the vagina.

Description:
BACKGROUND 
     Pelvic organs are those located inside of the pelvis and include the vagina, the uterus, the bladder, and the rectum. The pelvic floor (inferior) forms the foundation of support for the pelvic organs and the organs are supported from above (superior) by ligaments and other connective tissue. 
     Some women experience a decrease in support to the pelvic organs. A decrease in pelvic organ support is sometimes attributed to child birth, hysterectomy, or to the natural aging process. Decreased pelvic organ support can contribute to one or more of the pelvic organs prolapsing from its natural position in the pelvis toward, or even through, the inferior pelvic floor. This condition is referred to as pelvic organ prolapse, and some women choose to have the condition treated through surgical intervention. 
     Surgeons and patients would welcome advances in the treatment of pelvic organ prolapse. 
     SUMMARY 
     One aspect provides a system for treating pelvic organ prolapse including a plug, a skirt, and an anchor. The plug includes a base opposite an apex with the base wider than the apex. An exterior surface of the apex is shaped to conform to an interior apical portion of a vagina. The skirt is attachable to the plug and includes multiple pores that are sized to allow tissue of the interior apical portion of the vagina to grow through the skirt. The anchor has a proximal portion that is insertable through the vagina and the skirt for attachment to the apex of the plug. The anchor has a length that allows a distal portion of the anchor to be attached to a sacrum of a patient. 
     One aspect provides a system for treating pelvic organ prolapse including a porous sheet of material, a plug, and an anchor. The porous sheet of material is positionable on an interior apical portion of a vagina. The plug is made of biodegradable material and is insertable into the vagina. The plug includes a body portion having a convex hemispherical shape that is configured to press the porous sheet of material into direct contact with the interior apical portion of a vagina. The plug is provided with a hole formed at a distal apex of the plug. The anchor has a proximal portion that is insertable into the hole formed at the distal apex of the plug, and a length that allows a distal portion of the anchor to be attached to a sacrum of a patient. 
     One aspect provides a system for treating pelvic organ prolapse including a shell and an anchor. The shell is made of biodegradable material that is insertable into a vagina. The shell has a convex exterior apex that is sized to contact an interior apical portion of the vagina. The anchor has a proximal portion that is attachable to the apex of the shell and a distal portion that is provided with a tissue fixation device that is attachable to tissue exterior the vagina such that the anchor and the shell combine to support and elevate the interior apical portion of a vagina. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings are included to provide a further understanding of embodiments and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts. 
         FIG. 1  is a perspective view of one embodiment of a system for treating pelvic organ prolapse. 
         FIG. 2  is a perspective view of one embodiment of a plug of the system illustrated in  FIG. 1 . 
         FIG. 3A  is a top view of one embodiment of a flat skirt of the system illustrated in  FIG. 1 . 
         FIG. 3B  is a top view of one embodiment of a different flat skirt of the system illustrated in  FIG. 1 . 
         FIG. 3C  is a perspective view of the flat skirt illustrated in  FIG. 3B  formed into a hollow three-dimensional shell. 
         FIG. 4  is a perspective view of one embodiment of an anchor of the system illustrated in  FIG. 1 . 
         FIG. 5A  is a schematic view of a patient with a prolapsed vagina. 
         FIG. 5B  is a schematic view of one embodiment for the placement of the skirt inserted into the vagina. 
         FIG. 5C  is a schematic view of one embodiment of the system illustrated in  FIG. 1  implanted in the patient. 
         FIG. 6A  is a perspective view of one embodiment of a plug suitable for use with the system illustrated in  FIG. 1 . 
         FIG. 6B  is a cross-sectional view of the plug illustrated in  FIG. 6A . 
         FIG. 7A  is a perspective view of one embodiment of a different plug suitable for use with the system illustrated in  FIG. 1 . 
         FIG. 7B  is a top view of the plug illustrated in  FIG. 7A . 
         FIG. 7C  is a schematic cross-sectional view of the plug illustrated in  FIG. 7A  implanted in the patient. 
         FIG. 8  is a side view of one embodiment of a different plug suitable for use with the system illustrated in  FIG. 1 . 
         FIG. 9A  is a perspective view of one embodiment of a support shell for use in a system for treating pelvic organ prolapse. 
         FIG. 9B  is a schematic view of one embodiment of the support shell illustrated in  FIG. 9A  implanted in the patient. 
     
    
    
     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 appended claims. 
     It is to be understood that the features of the various exemplary embodiments described herein may be combined with each other, unless specifically noted otherwise. 
     Tissue includes soft tissue, which includes dermal tissue, sub-dermal tissue, ligaments, tendons, or membranes. As employed in this specification, the term “tissue” does not include bone. 
     Individuals have anatomy of different sizes. For example as regards females, the vaginal vault can vary in length (depth). Some women having had a hysterectomy will have had all or some of the cervix removed (e.g., a cervical stump is at times left in place at the apex of the vagina). 
     This application relates to the surgical treatment of pelvic organs that are susceptible to prolapse through the inferior pelvic floor. Embodiments provide the surgeon with access to the apex of the vagina through the natural vaginal opening. 
     With this in mind, in this application the term “proximal” means that orientation that is closest to the surgeon in contrast to the term “distal” which means that orientation farthest from the surgeon. For example, the natural vaginal opening is located proximal to the apex of the vagina. 
     The surgical intervention to treat vaginal pelvic organ prolapse typically includes a support material that is attached proximally to an outside, exterior surface of the vagina and distally to the sacrum of the patient. For example, one suitable approach of treating vaginal prolapse includes attaching two adjacent and splayed legs of a Y-shaped support to the exterior surface of the vagina followed by the attachment of the remaining base portion of the Y-shaped support to the sacrum. This approach pulls the exterior surface of the apex of the vagina toward the sacrum and has proved to be effective in treating vaginal prolapse. 
     Embodiments described in this application provide a system for treating pelvic organ prolapse that provides internal support to the prolapsed organ. Embodiments provide a skirt of material that is inserted through the natural vaginal opening inward to the interior apical cuff of the vagina. A plug is provided that is inserted into the vagina to hold the skirt in contact with the interior wall the vagina in the region of the apical cuff. The plug ensures that the skirt remains in contact with the interior wall the vagina, which encourages and promotes tissue growth through the skirt. The skirt and the plug are secured to an anchor that extends from the plug (through the skirt and the wall of the vagina) to supporting tissue outside of the vagina, for example to the sacrum or ligaments attached to the sacrum. 
     In one embodiment, the plug is configured to biodegrade after tissue grows through the skirt. 
     In one embodiment, the plug and the skirt are configured to biodegrade after tissue growth is stimulated in the region of the skirt. 
     In one embodiment, the plug, the skirt, and the anchor are all configured to biodegrade after tissue growth occurs to support the vagina. 
       FIG. 1  is a perspective view of one embodiment of a system  20  for treating pelvic organ prolapse. The system  20  includes a plug  22 , a skirt  24 , and an anchor  26 . 
     The skirt  24  is porous and sized to be inserted inside of the vagina, and after prolonged contact with the tissue of the vagina, tissue will eventually grow through the skirt  24 . The skirt  24  is configured to be flexible (or drapeable) for improved conformance to the interior of the vagina. After implantation, the skirt  24  provides a resilient and durable support structure composed of tissue/skirt  24 . 
     The plug  22  is inserted into the vagina after the skirt  24  has been placed. The plug  22  is configured to apply pressure to the skirt  24  to ensure contact between the skirt  24  and the internal tissue surfaces of the vagina. One embodiment of the plug  22  is sized and shaped to mimic the mucous plug that forms at the vagina/cervix interface during pregnancy. Other shapes for the plug  22  that are different from the shape of a mucosal plug are also acceptable. In one embodiment, the plug  22  is provided as a thin-walled shell that is insertable into the vagina, where the shell has a convex exterior apex that is sized to contact an interior apical portion of the vagina. 
     The anchor  26  is sized to have one end portion attached to both the plug  22  and the skirt  24  inside of the vagina and a second end portion that extends outside the vagina to a suitable supporting tissue, such as a ligament or another tough structure. In this manner, system  20  allows the vagina to be supported across the entirety of its interior apical surface, which provides for a more natural conformation and improved distribution of the supporting forces applied to the vagina. In one embodiment, the plug  22  is configured to biodegrade out of the vagina leaving the anchor  26  attached to the skirt  24  at one end and attached at the other end to the supporting tissue. 
       FIG. 2  is a perspective view of one embodiment of the plug  22 . The plug  22  includes a wall  30  that forms a hollow hemispherical cap extending between a base  32  and an apex  34 . The apex  34  has a curved shape that is sized to conform to the interior apical surface of the vagina. In one embodiment, the apex  34  is a convex hemispherical distal nose of the plug  22  and is configured to maintain the porous skirt  24  in contact with an interior apical portion of a vagina. In this embodiment, the plug  22  (or hollow hemispherical cap) has a convex outside surface  36 , a concave inside surface  38 , and the wall  30  has a wall thickness T. In one embodiment, the wall thickness T is substantially uniform with a dimension between 0.2-2.0 cm. Embodiments provide for a more elliptically shaped the plug  22 . 
     In one embodiment, the plug  22  is a biodegradable plug. Biodegradable means that the plug  22  will degrade from a solid intact material to constituent components that are either absorbed by the tissue of the body or expelled from the body. The biodegradation is accomplished by hydrolysis of the biodegradable material or through enzymatic action, as examples. In any regard, the biodegradable plug  22  is configured to “go away” after a predetermined amount of time from implantation into the body. As examples, suitable biodegradable materials include polyglycolic acid, polylactic acid, collagen, or a polymer combination of polyglycolic and polylactic acid (sometimes represented as PGA/PLA). The collagen source may be a human source or an animal source. The substantially uniform wall thickness T allows all portions of the plug  24  to degrade uniformly, e.g., at the same time. 
     With reference to  FIG. 2 , in one embodiment the plug  22  is provided as a shell with a wall thickness T in the region of the apex  34  is thicker than the wall thickness T in the region of the base  32 , which provides the plug  22  with more material near the apex  34 , thus strengthening the apex  34  at a location where the anchor  26  ( FIG. 1 ) is attached. 
     The plug  22  is shaped to mate inside of the interior apical cuff of a vagina and includes a width Wb at the base  32  that is wider than a width Wa at the apex  34 . It is desirable that the plug  22  conforms to the inside surface of the vagina and yet accommodate activities such as intercourse. In one suitable example of this style of plug, the plug  22  is provided with a recess or open cavity  40  that is configured to accommodate sexual activity. In addition, the recess  40  provides an engagement feature that allows an insertion tool to engage with the plug  22  when placing the plug  22  into the vagina. 
     The plug  22  has a through-going hole  42  formed through the wall  30  in the region of the apex  34 . The hole  42  is sized to receive an end portion of the anchor  26  ( FIG. 1 ). One hole  42  is illustrated, but other useful embodiments include two or more through-going holes  42  formed in the apex  34 . 
       FIG. 3A  is a top view of one embodiment of the skirt  24 . The skirt  24  is a thin, flexible, and drapeable fabric-like material having a perimeter  50 . The skirt  24  is configured to conform to the inside apical surface of the vagina and drape freely and uniformly over the plug  22  ( FIG. 2 ). Suitable embodiments include the skirt  24  formed of fabric or of a film of a selected thickness that allows the skirt  24  to drape freely away from the plug  22  when the plug  22  and the skirt  24  are implanted in a patient. 
     In one embodiment, the skirt  24  is fabricated from an elastic material that will stretch and fit between the plug  22  and the apex of the vagina. In one embodiment, the perimeter  50  forms a substantially circular shape and the skirt  24  is fabricated from a sufficiently elastic material that allows the circular skirt  24  to be conformed to the hemispherical shape of the plug  22 . In one embodiment, the perimeter  50  is formed by combination of arcs  52   a , . . .  52   d , the combination of which allows the skirt  24  to conform or be fitted into the interior apex of the vagina. 
     In one embodiment, the skirt  24  is formed from autograft material (the patient&#39;s own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic material such as woven fabrics, meshes, nonwoven fabrics, or fibrous sheets. In one embodiment, the skirt  24  is porous and has openings or voids (pores) that are configured to allow tissue ingrowth into the skirt  24 . The pores are open areas that are generally larger, on average, than 75 μm. In one suitable example, the skirt  24  is a knitted polypropylene mesh with a basis weight of between 15-200 g/m 2  and an open pore structure where at least some of the pores have an open dimension between 60-300 μm. 
     In one suitable example, the skirt  24  is a biodegradable fabric having a basis weight of between 15-200 g/m 2  and an open pore structure where at least some of the pores have a dimension between 60-300 μm. 
     In one embodiment, the skirt  24  is integrated with the plug  22  to provide a monolithic plug-skirt component. For example, a central portion of the skirt  24  is connected/integrated with the plug  22  to provide a one-piece plug and skirt implantable component. 
       FIG. 3B  is a top view of one embodiment of another skirt  24 ′ suited for use with the system  20  ( FIG. 1 ). The skirt  24 ′ has an outside edge perimeter provided with relief portions  62  that are configured to allow the skirt  24 ′ to conform to the curved inside (concave) surface of the vagina and the curved exterior (convex) surface of the plug  22  ( FIG. 2 ). The relief portions  62  provide the skirt  24 ′ with petals  64  that allow the skirt  24 ′ to drape uniformly over the curved three-dimensional surface of the plug  22  without forming puckers or gathers of material in the skirt  24 ′, which ensures that the plug  22  uniformly presses the skirt  24 ′ against the interior apical cuff of the vagina when implanted. 
       FIG. 3C  is a perspective view of the flat skirt  24 ′ illustrated in  FIG. 3B  formed into a hollow three-dimensional shell suitable for placement anterior to the apex of the vagina. 
       FIG. 4  is a perspective view of one embodiment of the anchor  26 . The anchor  26  includes a strand  71  provided with a proximal portion  70  and a distal portion  72 . The proximal portion  70  is attachable the plug  22  and the skirt  24  ( FIG. 1 ). In one embodiment, the proximal portion  70  is inserted through the skirt  24  and through the hole  42  ( FIG. 2 ) formed in the plug  22 . The proximal portion  70  is suitably fixated upon implantation by attachment to tissue of the vagina or by suturing to the plug  22 . In one embodiment, the proximal portion  70  includes a reinforced area  74  that is tear-resistant and configured to resist the stress of sutures or other attachments mechanisms that are employed to secure the proximal portion  70  of the anchor  26  to the plug  22 /skirt  24 . 
     The distal portion  72  of the anchor  26  is attachable to supporting tissue of the patient, such as the tissue surrounding the sacrum or to ligaments within the pelvis. In one embodiment, the distal portion  72  includes a fixation device  76  that is insertable into the supporting tissue. Embodiments of the fixation device  76  provide for adjustment of the anchor  26 , for example by sliding the distal portion  72  of the anchor  26  though a slot  78  or opening formed in the fixation device  76 . Adjustment of the strand  71  relative to the fixation device  76  allows the tension in the anchor  26  to be adjusted and also allows the distance between the proximal portion  70  and the fixation device  76  to be shortened/lengthened. In one embodiment, the strand  71  has a length of between about 2-16 cm, which allows the strand  71  to be sized to fit between the apex of the vagina and the sacrum for a variety of differently sized patients. The excess portion of the strand  71  that is pulled through the slot  78  of the fixation device  76  may be removed after implantation. 
     In one embodiment, all of the components of the anchor  26  are biodegradable and are formed from, as examples, polyglycolic acid, or polylactic acid, or a polymer combination of polyglycolic and polylactic acid. In one embodiment, the anchor  26  is not biodegradable and is formed of a polypropylene mesh strand  71  attached to a non-biodegradable, plastic fixation device  76 . In one embodiment, the anchor  26  is provided as a strip of collagen without the optional fixation device  76 , and the strip of collagen is sutured at the proximal end  70  to the plug  22  and sutured at the distal end  72  to the tissue surrounding the sacrum. 
       FIGS. 5A-5C  illustrate the system  20  employed to treat a prolapsed vagina V. 
       FIG. 5A  is a schematic view of a patient positioned in a lithotomy position, or an elevated lithotomy position, with the pelvis elevated above the head. The patient&#39;s vagina V has undesirably prolapsed and presents with an apex A of the vagina V that has descended from its natural position. The sacrum S is illustrated relative to the patient&#39;s abdomen Ab. Treatment of the prolapsed vagina V includes supporting and maintaining the apex A of the vagina V in its natural position, for example through attachment to ligaments or other structures in the pelvis or through attachment to the sacrum S. 
       FIG. 5B  is a schematic view of the skirt  24  placed in an interior apical portion A of the vagina V. In one approach, the skirt  24  is inserted into the vagina V through the natural vaginal opening without forming an incision. The skirt  24  is placed on the interior surface of the vagina V to support and maintain the natural extended position of the apex A of the vagina V. The plug  22  is subsequently inserted into the vagina V to support the skirt  24  and to ensure that the skirt  24  remains in contact with the tissue along the interior surface of the vagina V.  FIG. 5C  is a schematic view of the system  20  implanted in the patient. 
     The skirt  24  is held in contact with the interior apical tissue of the vagina V through the placement of the plug  22 , and the plug  22  and the skirt  24  are supported in position by the anchor  26  that is connected between the plug  22  and the sacrum S. In one exemplary approach, the proximal portion  74  of the anchor  26  projects through the wall of the vagina V and the skirt  24  and is inserted through the hole  42  of the plug  22 . The surgeon may elect to place a suture through the proximal portion  74  of the anchor  26  into the interior tissue of the vagina. The opposite end of the anchor  26  is attached to the sacrum S, for example by the fixation device  76 . Excess material in the strand  71  that is located distal of the fixation device  76  is removed. In one embodiment, the plug  22 /skirt  24  are placed into the vagina and the anchor  26  is implanted in the patient, for example laparoscopically in a transabdominal approach. 
     The apex  34  of the plug  22  is shaped to conform to the natural curvature of the apex A of the vagina V. In one embodiment, the plug  22  is provided as a biodegradable thin-walled shell of material that encourages and maintains contact between the skirt  24  and the tissue the vagina V. The plug  22  is configured to biodegrade away and out from the vagina leaving the skirt  24  incorporated into and supporting the tissue at the apex A of the vagina V. For embodiments where the skirt  24  is not biodegradable, the skirt  24  will be incorporated into the tissue of the vagina V, for example through tissue ingrowth into the skirt  24 . For embodiments where the skirt  24  is biodegradable, both of the plug  22  and the skirt  24  will biodegrade away from the vagina leaving the repaired and strengthened apex A of the vagina V supported by the anchor  26 . 
       FIG. 5C  illustrates the patient in an upright position with the apex A of the vagina supported by the system  20 . The plug  22  holds the skirt  24  in position until the tissue of the vagina V grows through the porous structure of the skirt  24 . The recess  40  formed in the plug  22  is configured to allow the patient to resume normal activity, including intercourse. The plug  22  is configured to degrade away out of the body after an appropriate and selected amount of time sufficient to allow tissue ingrowth to the skirt  24 . Thereafter, the skirt and the anchor  26  combine to support the apex  34  of the vagina V. In this embodiment, a system  20  for treating pelvic organ prolapse includes a porous sheet of material in the form of the skirt  24 ; the anchor  26  having the proximal portion  74  that is attachable to the porous skirt  24  and a distal portion that is provided with the tissue fixation device  76 ; and means in the form of the plug  22  for maintaining the porous skirt  24  in contact with an interior apical portion of a vagina. The plug  22  maintains an entirety of a surface area of at least one side of the porous skirt  24  in contact with the interior portion of a vagina. 
     In one embodiment, both the plug  22  and the skirt  24  eventually biodegrade away from the body leaving the anchor  26  attached between the sacrum S and the repaired and strengthened apex A of the vagina. In one such example, the plug  22  is made of a first biodegradable material having a first rate of degradation and the skirt  24  is made of a second biodegradable material having a rate of degradation different from the first rate of degradation. This allows both the plug  22  and the skirt  24  to eventually biodegrade away from the body, but at different rates (and thus at different times). 
     In one embodiment, all of the components of the system  20  are selected to be biodegradable. The system  20  is implanted into the patient to encourage tissue ingrowth into the skirt  24  and the anchor  26 . The tissue growth is substantial and will support the vagina, and in this sense all of the components of the system  20  are allowed to biodegrade and the vagina will be supported by the new tissue that has grown into place. 
     For example, the plug  22  is fabricated of a first biodegradable material, the anchor  26  is fabricated of a second biodegradable material, and the skirt  24  is fabricated of a third biodegradable material, where each of the biodegradable materials is suitably selected to have a different rate of degradation. The biodegradation of any one of the components is a factor of the mass of the biodegradable component, the selected biodegradable material and its rate of biodegradation, and the thickness of the material. These factors may be adjusted to achieve a desired time of degradation for each component individually. 
     The different rates of degradation allow, for example, the skirt  24  to remain in place within the vagina V for a longer period of time than the plug  22 , and after suitable incorporation into the tissue of the vagina, the skirt  24  biodegrades away leaving the anchor  26  supporting the apex A of the vagina. Embodiments provide for the eventual biodegradation of the anchor  26  after the apex A of the vagina has been repaired and strengthened by the system  20 . 
       FIGS. 6A-8  illustrate other means for maintaining the porous skirt  24  in contact with an interior apical portion of a vagina. 
       FIG. 6A  is a perspective view and  FIG. 6B  is a cross-sectional view of one embodiment of a plug  122  suitable for use with the system  20  illustrated in  FIG. 1 . The plug  122  includes a body  130  extending from a base  132  to a shoulder  134  with an apex  136  extending from the shoulder  134 . In contrast to the hollow hemispherical cap  22  described above, embodiments of the plug  122  provide the body  130  formed as a substantially solid sphere of biodegradable material. The shoulder  134  is provided opposite the base  132  and the apex  136  extends away from the shoulder  134 . The plug  122  is configured for insertion into the interior apical region of the vagina, and the apex  136  is designed to penetrate through the vaginal wall. The body  130  is provided with a lateral dimension that is wider than a lateral dimension of the apex  136 . In one embodiment, the apex  136  is formed to include a through-going hole  138  that allows the plug  122  to engage with an anchor device, such as the anchor  26  described in  FIG. 4  above. 
       FIG. 7A  is a perspective view and  FIG. 7B  is a top view of one embodiment of a plug  222  suitable for use with the system  20  illustrated in  FIG. 1 . The plug  222  includes a body  230  extending from a base  232  to a shoulder  234  with an apex  236  extending from a shoulder  234 . In one embodiment, the body  230  is formed as a substantially solid kidney shaped disk that includes a curved convex distal surface  240  and a curved concave proximal surface  242 . The apex  236  extends from the shoulder  234  and is configured to penetrate through the wall of the vagina with the body  230  supporting the interior apical portion inside of the vagina. The apex  236  includes a through-going hole  238  that is provided for engagement with an anchor or other fixation device. 
       FIG. 7C  is a schematic cross-sectional view of the plug  222  implanted in a vagina to hold the skirt  24  in contact with the interior tissue of the vagina V. The strand  71  described above is attached at one end to the plug  222  and secured at an opposing end to the sacrum S. In one embodiment, the apex  236  of the plug  222  projects through the apex A of the vagina for attachment to the strand  71 . The body  230  of the plug  222  distributes the supporting force across a wide area of the apex A of the vagina V. 
     In one embodiment, the skirt  24  is a biodegradable skirt and the plug  222  and the anchor strand  71  are not biodegradable. In this manner, the skirt  222  is absorbed into the wall of the vagina V leaving the anchor strand  71  applying an upward supporting force to the plug  222 , which elevates the apex A of the vagina V. 
       FIG. 8  is a side view of one embodiment of a plug  322  suitable for use with the system  20  illustrated in  FIG. 1 . The plug  322  includes a body  330  extending from a base  332  to a shoulder  334  with an apex  336  extending from the shoulder  334 . In one embodiment, the body  230  is formed as a thin-walled circular hanger that includes a curved convex distal surface  340  and a curved concave proximal surface  342 . The apex  336  extends from the shoulder  334  and is configured to penetrate through the wall of the vagina with the body  330  supporting the interior apical portion inside of the vagina. The apex  336  includes a through-going hole  338  that is provided for engagement with an anchor or other fixation device. 
       FIG. 9A  is a perspective view of one embodiment of a support shell  402  for use in a system for treating pelvic organ prolapse. The shell  402  is provided as a thin-walled structure having a base  410  and a convex exterior apex  412 . The apex  412  includes a convex exterior  414  that is sized to contact an interior apical portion of the vagina. The shell  402  includes a concave interior portion  416  on a side opposite from the convex exterior  414 , and in one embodiment the shell  402  is a substantially hollow hemispherical cap provided with an open base portion  420 . The shell  402  includes an attachment feature  422  on the convex exterior apex  412  that is configured to couple with an anchor device, for example the anchor device  26  illustrated in  FIG. 4 . 
     In one embodiment, the shell  402  has a wall thickness Tb at the base  410  that is less than a wall thickness Ta of the apex, which configures the shell  402  to have more mass at the apex  412 . The shell  402  encourages tissue growth from the wall of the vagina into the shell  402 , which strengthens and supports the vaginal apex. In one embodiment, the shell  402  is biodegradable and absorbs or disintegrates after the vaginal tissue has grown in the region of the vaginal apex. The tissue growth at the vaginal apex strengthens that region of the vagina, which allows the anchor to better support the vagina. While not bound to this theory, it is thought that providing the apex  412  of the shell  402  with more mass compared to the base that improved support is provided to the apical portion of the vagina, particularly as the thinner base  410  will biodegrade/bioabsorb ahead of the thicker apex  412 . 
     In one embodiment, a region  430  of the apex  412  is reinforced to provide added strength to the apex  412  of the shell  402 . Suitable reinforcing structures include providing a net or screen or mesh that is encapsulated in a wall  432  of the shell  402 . The net or screen or mesh couples with the anchor and can be configured as biodegradable or non-biodegradable. Another suitable reinforcing structure includes a waffle pattern pressed into the wall  432  of the shell  402 . 
     In one embodiment, the exterior of the shell  402  is textured and so configured to allow tissue of the vagina to grow into the shell  402 . 
     In one embodiment, the apex  412  of the shell  402  is porous and so configured to allow tissue of the vagina to grow into the shell  402 . 
     In one embodiment, the apex  412  of the shell  402  has a plurality of open areas and is so configured to allow tissue of the vagina to grow into the shell  402 . 
     In one embodiment, the shell  402  is fabricated from collagen and is configured to biodegrade after implantation into the human body. 
       FIG. 9B  illustrates the patient in an upright position with the apex A of the vagina supported by the implanted shell  402 . The shell  402  supports the vagina V in position until the tissue of the vagina V grows in place in the apical region of the vagina V. 
     The shell  402  is supported by, for example, the anchor  26  ( FIG. 4 ). The anchor  26  has the proximal portion  74  attached to the attachment feature  422  and the distal portion with the tissue fixation device  76  is secured to support tissue, for example, the sacrum S. The anchor  26  and the shell  402  combine to support and elevate the interior apical portion of the vagina V. Eventually, the shell  402  is either absorbed into the body or disintegrates away, leaving the apex A of the vagina V strengthened by tissue growth in the apical region of the vagina. The strengthened tissue near the apex of the vagina is well suited for allowing the anchor  26  to elevate the apex A of the vagina V. supported by the anchor  26 . 
     Although specific embodiments have been illustrated and described in this patent application, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the invention. This patent application is intended to cover any adaptations or variations of medical devices, as discussed above. Therefore, it is intended that this invention be limited only by the claims and their equivalents.