System for treating pelvic organ prolapse including a shell and an anchor

A system for treating pelvic organ prolapse includes 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.

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.

DETAILED DESCRIPTION

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. 1is a perspective view of one embodiment of a system20for treating pelvic organ prolapse. The system20includes a plug22, a skirt24, and an anchor26.

The skirt24is 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 skirt24. The skirt24is configured to be flexible (or drapeable) for improved conformance to the interior of the vagina. After implantation, the skirt24provides a resilient and durable support structure composed of tissue/skirt24.

The plug22is inserted into the vagina after the skirt24has been placed. The plug22is configured to apply pressure to the skirt24to ensure contact between the skirt24and the internal tissue surfaces of the vagina. One embodiment of the plug22is sized and shaped to mimic the mucous plug that forms at the vagina/cervix interface during pregnancy. Other shapes for the plug22that are different from the shape of a mucosal plug are also acceptable. In one embodiment, the plug22is 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 anchor26is sized to have one end portion attached to both the plug22and the skirt24inside 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, system20allows 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 plug22is configured to biodegrade out of the vagina leaving the anchor26attached to the skirt24at one end and attached at the other end to the supporting tissue.

FIG. 2is a perspective view of one embodiment of the plug22. The plug22includes a wall30that forms a hollow hemispherical cap extending between a base32and an apex34. The apex34has a curved shape that is sized to conform to the interior apical surface of the vagina. In one embodiment, the apex34is a convex hemispherical distal nose of the plug22and is configured to maintain the porous skirt24in contact with an interior apical portion of a vagina. In this embodiment, the plug22(or hollow hemispherical cap) has a convex outside surface36, a concave inside surface38, and the wall30has 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 plug22.

In one embodiment, the plug22is a biodegradable plug. Biodegradable means that the plug22will 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 plug22is 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 plug24to degrade uniformly, e.g., at the same time.

With reference toFIG. 2, in one embodiment the plug22is provided as a shell with a wall thickness T in the region of the apex34is thicker than the wall thickness T in the region of the base32, which provides the plug22with more material near the apex34, thus strengthening the apex34at a location where the anchor26(FIG. 1) is attached.

The plug22is shaped to mate inside of the interior apical cuff of a vagina and includes a width Wb at the base32that is wider than a width Wa at the apex34. It is desirable that the plug22conforms to the inside surface of the vagina and yet accommodate activities such as intercourse. In one suitable example of this style of plug, the plug22is provided with a recess or open cavity40that is configured to accommodate sexual activity. In addition, the recess40provides an engagement feature that allows an insertion tool to engage with the plug22when placing the plug22into the vagina.

The plug22has a through-going hole42formed through the wall30in the region of the apex34. The hole42is sized to receive an end portion of the anchor26(FIG. 1). One hole42is illustrated, but other useful embodiments include two or more through-going holes42formed in the apex34.

FIG. 3Ais a top view of one embodiment of the skirt24. The skirt24is a thin, flexible, and drapeable fabric-like material having a perimeter50. The skirt24is configured to conform to the inside apical surface of the vagina and drape freely and uniformly over the plug22(FIG. 2). Suitable embodiments include the skirt24formed of fabric or of a film of a selected thickness that allows the skirt24to drape freely away from the plug22when the plug22and the skirt24are implanted in a patient.

In one embodiment, the skirt24is fabricated from an elastic material that will stretch and fit between the plug22and the apex of the vagina. In one embodiment, the perimeter50forms a substantially circular shape and the skirt24is fabricated from a sufficiently elastic material that allows the circular skirt24to be conformed to the hemispherical shape of the plug22. In one embodiment, the perimeter50is formed by combination of arcs52a, . . .52d, the combination of which allows the skirt24to conform or be fitted into the interior apex of the vagina.

In one embodiment, the skirt24is formed from autograft material (the patient'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 skirt24is porous and has openings or voids (pores) that are configured to allow tissue ingrowth into the skirt24. The pores are open areas that are generally larger, on average, than 75 μm.

In one suitable example, the skirt24is a knitted polypropylene mesh with a basis weight of between 15-200 g/m2and an open pore structure where at least some of the pores have an open dimension between 60-300 μm.

In one suitable example, the skirt24is a biodegradable fabric having a basis weight of between 15-200 g/m2and an open pore structure where at least some of the pores have a dimension between 60-300 μm.

In one embodiment, the skirt24is integrated with the plug22to provide a monolithic plug-skirt component. For example, a central portion of the skirt24is connected/integrated with the plug22to provide a one-piece plug and skirt implantable component.

FIG. 3Bis a top view of one embodiment of another skirt24′ suited for use with the system20(FIG. 1). The skirt24′ has an outside edge perimeter provided with relief portions62that are configured to allow the skirt24′ to conform to the curved inside (concave) surface of the vagina and the curved exterior (convex) surface of the plug22(FIG. 2). The relief portions62provide the skirt24′ with petals64that allow the skirt24′ to drape uniformly over the curved three-dimensional surface of the plug22without forming puckers or gathers of material in the skirt24′, which ensures that the plug22uniformly presses the skirt24′ against the interior apical cuff of the vagina when implanted.

FIG. 3Cis a perspective view of the flat skirt24′ illustrated inFIG. 3Bformed into a hollow three-dimensional shell suitable for placement anterior to the apex of the vagina.

FIG. 4is a perspective view of one embodiment of the anchor26. The anchor26includes a strand71provided with a proximal portion70and a distal portion72. The proximal portion70is attachable the plug22and the skirt24(FIG. 1). In one embodiment, the proximal portion70is inserted through the skirt24and through the hole42(FIG. 2) formed in the plug22. The proximal portion70is suitably fixated upon implantation by attachment to tissue of the vagina or by suturing to the plug22. In one embodiment, the proximal portion70includes a reinforced area74that is tear-resistant and configured to resist the stress of sutures or other attachments mechanisms that are employed to secure the proximal portion70of the anchor26to the plug22/skirt24.

The distal portion72of the anchor26is 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 portion72includes a fixation device76that is insertable into the supporting tissue. Embodiments of the fixation device76provide for adjustment of the anchor26, for example by sliding the distal portion72of the anchor26though a slot78or opening formed in the fixation device76. Adjustment of the strand71relative to the fixation device76allows the tension in the anchor26to be adjusted and also allows the distance between the proximal portion70and the fixation device76to be shortened/lengthened. In one embodiment, the strand71has a length of between about 2-16 cm, which allows the strand71to 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 strand71that is pulled through the slot78of the fixation device76may be removed after implantation.

In one embodiment, all of the components of the anchor26are 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 anchor26is not biodegradable and is formed of a polypropylene mesh strand71attached to a non-biodegradable, plastic fixation device76. In one embodiment, the anchor26is provided as a strip of collagen without the optional fixation device76, and the strip of collagen is sutured at the proximal end70to the plug22and sutured at the distal end72to the tissue surrounding the sacrum.

FIGS. 5A-5Cillustrate the system20employed to treat a prolapsed vagina V.

FIG. 5Ais 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'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'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. 5Bis a schematic view of the skirt24placed in an interior apical portion A of the vagina V. In one approach, the skirt24is inserted into the vagina V through the natural vaginal opening without forming an incision. The skirt24is 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 plug22is subsequently inserted into the vagina V to support the skirt24and to ensure that the skirt24remains in contact with the tissue along the interior surface of the vagina V.

FIG. 5Cis a schematic view of the system20implanted in the patient. The skirt24is held in contact with the interior apical tissue of the vagina V through the placement of the plug22, and the plug22and the skirt24are supported in position by the anchor26that is connected between the plug22and the sacrum S. In one exemplary approach, the proximal portion74of the anchor26projects through the wall of the vagina V and the skirt24and is inserted through the hole42of the plug22. The surgeon may elect to place a suture through the proximal portion74of the anchor26into the interior tissue of the vagina. The opposite end of the anchor26is attached to the sacrum S, for example by the fixation device76. Excess material in the strand71that is located distal of the fixation device76is removed. In one embodiment, the plug22/skirt24are placed into the vagina and the anchor26is implanted in the patient, for example laparoscopically in a transabdominal approach.

The apex34of the plug22is shaped to conform to the natural curvature of the apex A of the vagina V. In one embodiment, the plug22is provided as a biodegradable thin-walled shell of material that encourages and maintains contact between the skirt24and the tissue the vagina V. The plug22is configured to biodegrade away and out from the vagina leaving the skirt24incorporated into and supporting the tissue at the apex A of the vagina V. For embodiments where the skirt24is not biodegradable, the skirt24will be incorporated into the tissue of the vagina V, for example through tissue ingrowth into the skirt24. For embodiments where the skirt24is biodegradable, both of the plug22and the skirt24will biodegrade away from the vagina leaving the repaired and strengthened apex A of the vagina V supported by the anchor26.

FIG. 5Cillustrates the patient in an upright position with the apex A of the vagina supported by the system20. The plug22holds the skirt24in position until the tissue of the vagina V grows through the porous structure of the skirt24. The recess40formed in the plug22is configured to allow the patient to resume normal activity, including intercourse. The plug22is configured to degrade away out of the body after an appropriate and selected amount of time sufficient to allow tissue ingrowth to the skirt24. Thereafter, the skirt and the anchor26combine to support the apex34of the vagina V. In this embodiment, a system20for treating pelvic organ prolapse includes a porous sheet of material in the form of the skirt24; the anchor26having the proximal portion74that is attachable to the porous skirt24and a distal portion that is provided with the tissue fixation device76; and means in the form of the plug22for maintaining the porous skirt24in contact with an interior apical portion of a vagina. The plug22maintains an entirety of a surface area of at least one side of the porous skirt24in contact with the interior portion of a vagina.

In one embodiment, both the plug22and the skirt24eventually biodegrade away from the body leaving the anchor26attached between the sacrum S and the repaired and strengthened apex A of the vagina. In one such example, the plug22is made of a first biodegradable material having a first rate of degradation and the skirt24is made of a second biodegradable material having a rate of degradation different from the first rate of degradation. This allows both the plug22and the skirt24to eventually biodegrade away from the body, but at different rates (and thus at different times).

In one embodiment, all of the components of the system20are selected to be biodegradable. The system20is implanted into the patient to encourage tissue ingrowth into the skirt24and the anchor26. The tissue growth is substantial and will support the vagina, and in this sense all of the components of the system20are allowed to biodegrade and the vagina will be supported by the new tissue that has grown into place.

For example, the plug22is fabricated of a first biodegradable material, the anchor26is fabricated of a second biodegradable material, and the skirt24is 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 skirt24to remain in place within the vagina V for a longer period of time than the plug22, and after suitable incorporation into the tissue of the vagina, the skirt24biodegrades away leaving the anchor26supporting the apex A of the vagina. Embodiments provide for the eventual biodegradation of the anchor26after the apex A of the vagina has been repaired and strengthened by the system20.

FIGS. 6A-8illustrate other means for maintaining the porous skirt24in contact with an interior apical portion of a vagina.

FIG. 6Ais a perspective view andFIG. 6Bis a cross-sectional view of one embodiment of a plug122suitable for use with the system20illustrated inFIG. 1. The plug122includes a body130extending from a base132to a shoulder134with an apex136extending from the shoulder134. In contrast to the hollow hemispherical cap22described above, embodiments of the plug122provide the body130formed as a substantially solid sphere of biodegradable material. The shoulder134is provided opposite the base132and the apex136extends away from the shoulder134. The plug122is configured for insertion into the interior apical region of the vagina, and the apex136is designed to penetrate through the vaginal wall. The body130is provided with a lateral dimension that is wider than a lateral dimension of the apex136. In one embodiment, the apex136is formed to include a through-going hole138that allows the plug122to engage with an anchor device, such as the anchor26described inFIG. 4above.

FIG. 7Ais a perspective view andFIG. 7Bis a top view of one embodiment of a plug222suitable for use with the system20illustrated inFIG. 1. The plug222includes a body230extending from a base232to a shoulder234with an apex236extending from a shoulder234. In one embodiment, the body230is formed as a substantially solid kidney shaped disk that includes a curved convex distal surface240and a curved concave proximal surface242. The apex236extends from the shoulder234and is configured to penetrate through the wall of the vagina with the body230supporting the interior apical portion inside of the vagina. The apex236includes a through-going hole238that is provided for engagement with an anchor or other fixation device.

FIG. 7Cis a schematic cross-sectional view of the plug222implanted in a vagina to hold the skirt24in contact with the interior tissue of the vagina V. The strand71described above is attached at one end to the plug222and secured at an opposing end to the sacrum S. In one embodiment, the apex236of the plug222projects through the apex A of the vagina for attachment to the strand71. The body230of the plug222distributes the supporting force across a wide area of the apex A of the vagina V.

In one embodiment, the skirt24is a biodegradable skirt and the plug222and the anchor strand71are not biodegradable. In this manner, the skirt222is absorbed into the wall of the vagina V leaving the anchor strand71applying an upward supporting force to the plug222, which elevates the apex A of the vagina V.

FIG. 8is a side view of one embodiment of a plug322suitable for use with the system20illustrated inFIG. 1. The plug322includes a body330extending from a base332to a shoulder334with an apex336extending from the shoulder334. In one embodiment, the body230is formed as a thin-walled circular hanger that includes a curved convex distal surface340and a curved concave proximal surface342. The apex336extends from the shoulder334and is configured to penetrate through the wall of the vagina with the body330supporting the interior apical portion inside of the vagina. The apex336includes a through-going hole338that is provided for engagement with an anchor or other fixation device.

FIG. 9Ais a perspective view of one embodiment of a support shell402for use in a system for treating pelvic organ prolapse. The shell402is provided as a thin-walled structure having a base410and a convex exterior apex412. The apex412includes a convex exterior414that is sized to contact an interior apical portion of the vagina. The shell402includes a concave interior portion416on a side opposite from the convex exterior414, and in one embodiment the shell402is a substantially hollow hemispherical cap provided with an open base portion420. The shell402includes an attachment feature422on the convex exterior apex412that is configured to couple with an anchor device, for example the anchor device26illustrated inFIG. 4.

In one embodiment, the shell402has a wall thickness Tb at the base410that is less than a wall thickness Ta of the apex, which configures the shell402to have more mass at the apex412. The shell402encourages tissue growth from the wall of the vagina into the shell402, which strengthens and supports the vaginal apex. In one embodiment, the shell402is 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 apex412of the shell402with more mass compared to the base that improved support is provided to the apical portion of the vagina, particularly as the thinner base410will biodegrade/bioabsorb ahead of the thicker apex412.

In one embodiment, a region430of the apex412is reinforced to provide added strength to the apex412of the shell402. Suitable reinforcing structures include providing a net or screen or mesh that is encapsulated in a wall432of the shell402. 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 wall432of the shell402.

In one embodiment, the exterior of the shell402is textured and so configured to allow tissue of the vagina to grow into the shell402.

In one embodiment, the apex412of the shell402is porous and so configured to allow tissue of the vagina to grow into the shell402.

In one embodiment, the apex412of the shell402has a plurality of open areas and is so configured to allow tissue of the vagina to grow into the shell402.

In one embodiment, the shell402is fabricated from collagen and is configured to biodegrade after implantation into the human body.

FIG. 9Billustrates the patient in an upright position with the apex A of the vagina supported by the implanted shell402. The shell402supports the vagina V in position until the tissue of the vagina V grows in place in the apical region of the vagina V.

The shell402is supported by, for example, the anchor26(FIG. 4). The anchor26has the proximal portion74attached to the attachment feature422and the distal portion with the tissue fixation device76is secured to support tissue, for example, the sacrum S. The anchor26and the shell402combine to support and elevate the interior apical portion of the vagina V. Eventually, the shell402is 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 anchor26to elevate the apex A of the vagina V. supported by the anchor26.

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.