Systems, implants, tools, and methods for treatments of pelvic conditions

Described are various embodiments of surgical procedure systems, devices, tools, and methods, useful for treating pelvic conditions such as vaginal prolapse and other conditions caused by muscle and ligament weakness, the devices and tools being useful for accessing a posterior region of pelvic anatomy, and related methods. Such devices can include retractors, introducers, and other devices for accessing desired areas of a patient's anatomy.

FIELD OF THE INVENTION

The present invention relates to tools and related methods for treating pelvic conditions by use of a pelvic implant to support pelvic tissue. The pelvic treatments include, for example, treatment of vaginal prolapse by laparoscopic, abdominal, and transvaginal procedures, and treatment of urethral incontinence (e.g., stress urinary incontinence) by a single incision retropubic procedure.

BACKGROUND

Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary incontinence), pelvic tissue prolapse (e.g., female vaginal prolapse), and other conditions that affect the pelvic floor. Pelvic disorders such as these can be caused by weakness or damage to normal pelvic support systems. Common etiologies include childbearing, removal of the uterus, connective tissue defects, prolonged heavy physical labor, and postmenopausal atrophy.

Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (STA), urge urinary incontinence, mixed urinary incontinence, among others. Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed.

Pelvic floor disorders include cystocele, rectocele, and prolapse such as anal, uterine, and vaginal vault prolapse. Vaginal vault prolapse is a condition that occurs when the upper portion of the vagina loses its normal shape and moves downwardly into the vaginal canal. In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. Vaginal vault prolapse may occur alone, such as can be caused by weakness of the pelvic and vaginal tissues and muscles, or can be associated with a rectocele, cystocele and/or enterocele. A rectocele is caused by a weakening or stretching of tissues and muscles that hold the rectum in place, which can result in the rectum moving from its usual location to a position where it presses against the back wall of the vagina. A cystocele is a hernia of the bladder, usually into the vagina and introitus. An enterocele is a vaginal hernia in which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. All of these conditions can represent challenging forms of pelvic disorders for surgeons to treat. Some of these treatments include, for example, abdominal sacralcolpopexy (SCP), which may be performed laparoscopically, and transvaginal sacralcolpopexy (TSCP), wherein these procedures are performed using a variety of different instruments, implants, and surgical methods. It is known to repair vaginal vault prolapse by suturing the vaginal vault (e.g., by stitches) to the supraspinous ligament or by attaching the vaginal vault through mesh or fascia to the sacrum.

There is ongoing need to provide physicians with improved methods and associated instruments for treating pelvic conditions including incontinence, vaginal prolapse (e.g., vaginal vault prolapse), and other pelvic organ prolapse conditions, wherein such methods can include those that are minimally invasive, safe, and highly effective.

SUMMARY

Devices, systems, and methods as described can be used to treat pelvic conditions such as incontinence (various forms such as fecal incontinence, stress urinary incontinence, urge incontinence, mixed incontinence, etc.), vaginal prolapse (including various forms such as enterocele, cystocele, rectocele, apical or vault prolapse, uterine descent, etc.), and other conditions caused by muscle and ligament weakness, hysterectomies and the like.

Certain described embodiments of devices and methods involve the use of a refractor or “expansion member” adapted to provide port access and guidance to a surgical site. These embodiments involve placement of an elongate expansion member through a body orifice or incision and to a surgical site, to create an access space from the exterior of the patient to the surgical site. The expansion member is useful to retract tissue, create an access space, and allow surgical instruments such as sharp tools to safely access the surgical site. Certain of these described embodiments relate generally to various means, devices, and techniques for providing a clear view of a surgical site in a region of a sacrum, and nearby anatomy, through a vaginal incision. In several examples, this is provided by way of a device that can be inserted into a vaginal incision and then used to expand or dilate tissue.

In described examples, desired retraction functionality is provided by a device that can be changed in its size or shape, to contact and then move, expand, or dilate (e.g., retract) tissue. An expansion member may include two or more pieces (e.g., longitudinal panels or blades) that are optionally hinged or slidably connectable and able to move laterally or longitudinally relative to each other. The pieces can be moveable relative to each other in a manner that allows the pieces to define a space (access space) therebetween, the space being capable of being varied in size, e.g., “expandable.” In specific embodiments, the device can be inserted into a vaginal incision and then expanded, dilated, manipulated, or otherwise used for tissue retraction to create a working space between the vaginal introitus and the vaginal apex, a posterior location of a pelvic region, or a region of sacral anatomy. Certain preferred versions of these tools can include distal end functionality to add efficiency to a surgical procedure, such as a lighting feature, an anchor driving feature, an optical feature that allows viewing of the surgical site, or hooks and/or other attachment features.

Certain described embodiments relate to surgical tools having one or more surfaces capable of retracting tissue (a retractor, such as an expansion member), and adapted to provide access and guidance to a surgical site. These embodiments involve various surgical tools and related methods designed to provide improved and safer access to a surgical site or anatomy, for example so that sharp objects and tools can be passed to a surgical location without having to make multiple attempts from an incision to an anatomical target area. Certain of these described embodiments relate generally to various means, devices, and techniques for providing a clear view and unobstructed access to a surgical site. In several examples, this is provided by way of an expandable device, or other devices capable of being used to retract tissue, that can be inserted into an incision site and then expanded, dilated, manipulated, or otherwise used for tissue retraction. Certain preferred versions of these tools can include distal end functionality to add efficiency to a surgical procedure.

DETAILED DESCRIPTION

Pelvic floor disorders include cystocele, rectocele, enterocele, uterine and vaginal vault prolapse, urinary and fecal incontinence, among others, in men and women. These disorders typically result from weakness or damage to normal pelvic support systems. The most common etiologies include childbearing, removal of the uterus, connective tissue defects, prolonged heavy physical labor, and postmenopausal atrophy.

Vaginal vault prolapse is often associated with a rectocele, cystocele, or enterocele. It is known to repair vaginal vault prolapse by suturing to the supraspinous ligament or to attach the vaginal vault through mesh or fascia to the sacrum. Many patients suffering from vaginal vault prolapse also require a surgical procedure to correct stress urinary incontinence that is either symptomatic or latent.

A sacral colpopexy is a procedure for providing vaginal vault suspension. It may be performed through an abdominal incision, a vaginal incision, or laparoscopically and entails suspension (by use of an implant such as a strip of mesh) of the vaginal cuff to a region of sacral anatomy such as the sacrum (bone itself), a nearby sacrospinous ligament, uterosacral ligament, or anterior longitudinal ligament at the sacral promontory. In some sacral colpopexy procedures that also involve a hysterectomy, an implant can attach to posterior vaginal tissue remaining after removal of the uterus and cervix, and attaches also to anatomy to support the vaginal tissue, at or around the sacrum such as to uterosacral ligaments or to the sacrum itself (i.e., to a component of the sacral anatomy).

As used herein, the term “anchor” refers non-specifically to any structure that can connect an implant to tissue of a pelvic region, to secure the implant to that tissue. The tissue may be bone, or a soft tissue such as a muscle, fascia, ligament, tendon, or the like. The anchor may be any known or future-developed structure, or a structure described herein, useful to connect an implant to such tissue, including but not limited to a clamp, a suture, a soft tissue anchor such as a self-fixating tip, a helical anchor such as a screw-type or corkscrew-type anchor that can be driven into bone or soft tissue using rotation, a bone anchor (e.g., screw), or other structures known or later developed for connecting an implant to soft tissue or bone of a pelvic region.

Traditional pelvic implant installation procedures (e.g., sacral colpopexy procedures) may be performed through an abdominal opening or laparoscopically. As such, special skills and equipment are needed to complete the procedure effectively. And abdominal wounds are created. According to methods described herein, a tissue expander or other retractor devices and tools can be used according to minimally invasive sacral colpopexy procedures with no abdominal wounds or potential organ perforation or dissection. Examples of similar methods and tools, expansion members, and soft tissue anchors (which may include structures or features similar to those herein) are described in Assignee's co-pending International Patent Application having International Patent Application number PCT/US2010/062577, filed Dec. 30, 2010, the entirety of which is incorporated by reference.

As described, a retractor or expansion member may include distal end functionality such as an anchoring functionality, viewing and lighting functionalities, size adjustability, suction, dissection, anchor delivery, implant delivery, and fluid delivery, among others. By use of a retractor or expansion member having viewing and lighting functions, clear visualization of internal tissue is provided for placement and anchoring of an implant, e.g., to a region of sacral anatomy. A physician is able to guide a distal end or shaft of an implant delivery tool (i.e., “needle”) to a surgical location, with direct viewing, is able to visually identify potential areas of risk and guide or steer the tool to a desired target tissue site, e.g., for placing an anchor or implant. With a visualization feature, a faster learning curve is provided for physicians to safely pass the needle with the aid of a scope and optical viewing, and the knowledge from scope usage in surgery is applied to and benefits surgical procedures.

According to presently described systems, devices, and methods, an expansion member, “retractor,” or “speculum,” or the like can be useful for accessing a male or female pelvic anatomy during a pelvic procedure, especially a female pelvic anatomy, to access tissue of the posterior pelvic region such as to perform a sacral colpopexy procedure. An expansion member or other tool can optionally have a length to allow such access when placed transvaginally, e.g., a length to allow a distal end of the tool to access pelvic tissue while a proximal end of the tool extends through a vaginal opening and to a location external to the patient. The proximal end of the tool remains external to the patient during use to allow a surgeon or other user to access and manipulate the proximal end and access a surgical site at the distal end. A shaft extends between the distal and the proximal ends, and may optionally include an enclosure or tube along some or all of the length.

According to certain embodiments, a retractor or expansion member can optionally include a shaft portion that includes a full or partial enclosure or “tube” (whether a partial tube or complete tube) to provide partial or continuous structure and support along a length of the tool between the distal end and proximal end, to separate tissue from a working space. The structure may extend lengthwise along a partial or complete length of the device, and in a lateral direction the structure can be a complete or partial structure; the structure may be in the form of a tube, having structure extending around a complete circumference, e.g., a circular or non-circular “tube”; or a structure that extends partially around a circumference, such as in the form of a partial circular or non-circular “tube.” A diameter of such a structure can be useful to allow the device to be inserted and placed with reduced trauma. Optionally, as described elsewhere herein, a diameter of the tube can be variable, such as by being expandable after placement of the tube within a patient, to allow increased and expanded access to tissue at a surgical site.

Exemplary tools that can be used in combination with various retractors or expansion members can include one or more functional features at a distal end that allow the tool to be useful to carry out functions such as dissection (a mechanical dissection using a sharp blade, a blunt dissection device using an expandable structure such as a balloon, hydrodissection, etc.), blunt dissection, viewing (visualization) of a surgical location, illumination of a surgical location, fluid delivery at a surgical location, irrigation at a surgical location, suction at a surgical location, expandability, and placing anchors (bone anchors, soft tissue anchors such as a self-fixating tip, sutures, etc.) into a desired target tissue at a surgical location.

Various embodiments of tools (e.g., retractors, expansion members, etc.) are described hereinbelow, and may have general structural and operational features that allow one or more flexible, rigid, or semi-rigid, distal retracting structure to be introduced through an incision (e.g., a vaginal incision), to retract internal tissue. In certain (but not all) embodiments the tool can be introduced through an incision in a closed, compressed, or reduced-size or reduced-diameter state, then be moved, assembled, or expanded to enlarge a cross-sectional size or related space or opening to push tissue aside to create space in and access to a pelvic region with access to desired anatomy. In other embodiments, the tool may have a variable diameter along the length, tapered from a smaller diameter at a distal end to a larger diameter at a proximal end.

For tools of variable diameter, a preferred size of a device can include a cross sectional dimension (e.g., a width or diameter associated with an opening along a length of the device) in the range from 1 to 5 centimeters, such as from 2 to 4 centimeters, when retracting structures are in their a reduced-size configuration. Upon opening, un-compressing, expanding, or assembling, etc., the retracting structures, a preferred dimension (e.g., a width or diameter associated with an opening along a length of the device) associated with these structures can be in the range from 2 to 10 centimeters, such as from 3 to 7 centimeters.

Various embodiments of devices (“expansion members,” “retractors,” or “speculums”) are contemplated for use in providing access to internal tissue of a pelvic region through an incision in a male or female patient, e.g., as a tissue retractor used to gain access to a posterior region of a pelvic anatomy. Any of these may be useful according to methods for placing an implant to support pelvic tissue, for example a SCP procedure, using any desired or useful implant, insertions tool, multi-functional tool, anchor, etc.

According to certain embodiments, an expansion member can be designed to have a reduced cross-sectional size and profile in closed or compressed state for easy entry into a patient (e.g., vaginally), and the expansion member can be opened or expanded to open and retract the surrounding tissue for improved viewing of the surgical area to keep tissue from interfering with the procedure. In particular such embodiments, a device can include multiple (e.g., three) retractor surfaces, each surface being separated longitudinally by a hinge. The hinge extends partially or fully along the length of the expansion member, between a distal and a proximal end, and a hinge may be straight or curved.

Referring now to the Figures, where like structure may be described with like reference numbers and/or terms, and initially toFIG. 1, an embodiment is illustrated of a retractor assembly that includes an introducer10and a retractor12. The introducer10is a component that can be inserted into a patient (e.g., through a vaginal introitus) to provide an initial opening of a surgical space. The retractor12can then be placed within the installed introducer10, and the introducer can be removed. In the illustrated embodiment, the introducer10includes a first section14and a second section16, which may roughly be configured such that each of the sections14,16comprises one half of the total width of the introducer10, although the division of size between the two sections may be different. All or portions of the introducer10can be made of a transparent or translucent material in order to be able to view the insertion of a retractor or other components into its internal area, for example. The introducer10may further include a proximal end18and a polished tip19at the opposite end from the proximal end18to allow for viewing at the distal end during insertion of the introducer10. Once the introducer10is placed within a patient in a desired location, the retractor12can be placed inside of the introducer10at its proximal end22and then the introducer10can be removed. The retractor12can include handles20, which can optionally be foldable relative to the retractor body and positioned at or adjacent to its proximal end28. In certain embodiments, the introducer10can be disassembled and removed from the patient as separate pieces (e.g., first and second sections14,16). The retractor12can then be opened or expanded to create a larger surgical space. The expandable retractor12can be expanded (opened) and contracted (closed) by any desired mechanism, as described herein or otherwise.

FIG. 2shows an example of a method and a device40useful to retract tissue internal to a patient, including a speculum44having a “blunt dissection device”46at its distal end42. The device40can be used in combination with a viewing apparatus capable of viewing the distal end during placement. The viewing apparatus may be any apparatus capable of optically accessing the distal end while the distal end is being placed within a patient (e.g., a fiber optic device or a mirror at the end of an extension arm). The distal end includes the blunt dissection feature46or surface that can be used to contact tissue, to cause dissection or otherwise move or retract tissue by manipulation of the handle at the proximal end. The blunt dissection surface may include one or a combination of a rigid, curved or flat paddle, and an optional expandable structure or surface. A preferred expandable structure may be an inflatable balloon (e.g., air, carbon dioxide, nitrogen, etc.), which in use can be placed in contact with tissue and expanded to adjust the position of tissue, e.g., retract the tissue during a surgical procedure. The distal end can also optionally and preferably include a light, for better viewing of a surgical space by a surgeon.

FIG. 3shows another embodiment of a retractor60having an expandable surface, and which optionally includes a fiber optic feature such as a fiber optic wand62that can be used to view the distal end of the retractor during use in a surgical procedure. The distal end of the wand62is shown as being positioned next to the sacrum68of a patient, although the wand62can instead be used in another location in the patient. The fiber optic wand62can also be used as an introducer that is inserted into a surgical site as a guide for subsequent placement of a retractor. The retractor may be of the type that can be inserted in a collapsed or closed state, as shown with the configuration of retractor60in a non-expanded retractor configuration64. The retractor60can then be expanded within the patient to create a surgical space, as shown with the configuration of retractor60in an expanded retractor configuration66.

FIGS. 4A and 4Billustrate another exemplary embodiment of an expandable retractor70, which includes a structure that is configured similar to the general configuration of a pair of scissors. In particular, retractor70includes handles and arms74extending proximally from a pivot point76, and also includes elongate arms72extending distally from pivot point76. Due to the configuration of the handles and arms, movement of the arms74toward each other will cause the elongate arms72to move away from each other, and movement of the handles74away from each other will cause the elongate arms72to move toward each other. The retractor70is further provided with a sheet of material78operatively attached to the elongate arms72so that the material78will be compressed or compacted when the arms72are relatively close to each other, and so that the material78will be extended or spread to cover at least a portion of the space between the arms72when the arms are moved away from each other. The sheet of material78can be a mesh material, a net (e.g., light fabric), or other film (e.g., polymeric) material. In operation, the retractor70can be inserted into a patient, such as in a location adjacent to a sacrum75, for example, and then expanded to retract the surrounding tissue. When the retractor is in its expanded configuration, the material78will be spread between the arms72to control or retract tissue.

FIGS. 5A-5Cillustrate a collapsible tissue retractor80, which generally includes an outer frame88surrounding a thin flexible material piece86. The frame88may be made of a separate material, such as a thin wire or other flexible material, or the frame may instead be provided as a reinforced area that surrounds the material piece86. That is, the structure of the retractor80can include a perimeter (edges) along a length that includes structural reinforcements such as a folding scaffold or collapsible wire. In any case, the retractor80is one that in a collapsed form is folded, twisted, or spirally wound, and that can be expanded by unfolding or by expanding the spiral. For one example, one corner area82of the retractor80can be folded or twisted toward an opposite corner area84, as is shown by the arrow inFIG. 5A.FIGS. 5B and 5Cillustrate other exemplary manipulations of the retractor80that can be performed to reduce its outer dimensions. In one exemplary use of the retractor80, retractor80is compressed to a desired size so that it can be inserted into a particular area that is to be expanded. After it is in place, retractor80can be untwisted or uncoiled so that it expands to cover a larger area and also causes corresponding movement of the surrounding tissue (e.g., bowel tissue)

FIGS. 6A-6Dillustrate an expansion member or retractor90that comprises multiple sections that extend from each other to form a ring-like structure. In this illustrated embodiment, the retractor90includes four of such sections, shown as sections91-94inFIGS. 6A and 6B, wherein sections91and92are on opposite sides of retractor90, and wherein sections93and94extend between the sections91and92and are also opposite sides of the retractor from each other. Adjacent sections of the retractor90can be attached to each other in any number of different ways, such as with a mechanical connection (e.g., dovetailed ends, frictional fit, and the like), an adhesive connection (e.g., with a breakable adhesive bond between edges of adjacent sections), or another connection method or combination of connection methods. The sections of the retractor90can be assembled or attached to each other somewhere that is external to the patient, and then the retractor90can be inserted into a target location where it is desired to retract tissue. In this way, the retractor will have a relatively smooth outer surface that does not have exposed free edges that can interfere with tissue that is encountered during insertion of the retractor into the patient.

As illustrated inFIGS. 6C and 6D, one of the sections (e.g., section92) can be removed to create a length-wise opening or slot along a side of the retractor90that allows access to tissue of the patient along a length of the expansion member, when installed. Removal of this section can be accomplished by breaking any seals on both edges of sections that are adjacent to the section to be removed, and then sliding that section out of the patient. The illustrated embodiment includes a substantially circular cross-section, but other non-circular shapes may also be useful.

FIG. 7shows an expansion member or retractor100that includes a shaft102with a hollow interior having a distal end and a proximal end, and a blunt tip member104, which includes a blunt distal tip106, that can be removably mounted to the distal end. The expansion member100can be placed into a patient with the blunt tip member104attached to the distal end, then the blunt tip member104can be removed and withdrawn through the shaft. Optionally and as illustrated, the shaft102may include lights108that are provided to illuminate a surgical space at the distal end, wherein such lights108can be mounted on the inside of the shaft102. At least a portion of the blunt tip member104may optionally be transparent, and can have an open or closed tip. The illustrated embodiment includes a substantially circular cross-section, but other non-circular shapes may also be useful.

FIGS. 8A and 8Billustrate a combination of an introducer122and an inflatable retractor120. Introducer122includes a distal tip128, which can be guided and held in position relative to a target tissue of a patient. The introducer and retractor combination can be inserted into a patient (e.g., through a vaginal introitus) to provide an initial opening of a surgical space. A pump124of the retractor120can then be activated to inflate and expand the outer tubular shape of the retractor120to create a surgical space in the patient. After inflation of the retractor120, the introducer122can be removed from the target tissue of the patient.

FIG. 9illustrates an introducer140with a self-expanding (e.g., nitinol) or shape-memory stent or structure142extending from its distal end. To maintain the structure142in a compressed configuration, it can be kept in a deployment tube or other structure of the introducer that can be moved relative to the structure142when it is desired to allow it to expand. This embodiment further includes a dissolvable or disposable tip144(e.g., rounded) that can also help to maintain the stent142in a closed (collapsed) state during introduction into a patient. The stent142is biased toward an open (i.e., non-collapsed, or “deployed”) state, which has a reduced length and increased diameter, and can be collapsed and extended to a non-deployed state having a greater length and reduced diameter. The non-collapsed (deployed) stent142can be collapsed (closed) and lengthened by placing lateral pressure on the stent surface, such as at an end or a location along the length of the stent. For example, the stent142can be placed and maintained in the collapsed state using the introducer, and by the use of a removable or dissolvable tip144at one end (e.g., the distal end). In use, an introducer can be used to place the stent142in a patient in the collapsed state. The introducer can be withdrawn, and the tip144can be removed or dissolved, allowing the stent142to expand within the patient. The stent142can be designed to provide a working depth and a working space as described herein.

FIG. 10illustrates an example of a retractor150that includes a retractor body152that may be shaped as an elongated cylinder, for example, and one or more distal end extensions156adjacent to a distal end154of the body152. The extensions156can be fixed or moveable relative to the body152, and can be used to push tissue aside without damaging it when inserting the distal end of the retractor150into a patient at a surgical site. The extensions156can be shaped like a fin, a paddle, or another extension structure that can be manipulated by rotating the body152within the patient to gently push tissue aside. The extensions156can have a wide variety of shapes, such as straight, curved, or bent, and may extend directly away from the body152or may be angled toward or away from the distal end or the proximal end. The structure of the extensions156can be sufficiently rigid to move tissue, but can optionally be soft or malleable enough to avoid damaging the tissue, such as can be accomplished by using extensions that have a shape that is relatively blunt and without sharp edges. Optionally, the extensions156can be moveable relative to the body152by manipulation of an actuator at or near the proximal end of the retractor150.

FIG. 11illustrates another exemplary embodiment of an expansion member or retractor160. Retractor160includes multiple sections or segments of different cross-sectional size (e.g., diameter) along its length, each of which has a proximal end and a distal end arranged so that the sections can be assembled by connecting a distal end of one section to a proximal end of an adjacent section. In this particular illustrated embodiment, the retractor160includes four segments162,164,166,168, each of which has a progressively smaller cross-sectional diameter than the previous segment. It is understood that a retractor of this type can have more or less than four of such segments. The multiple segments can be assembled in a “telescoping” manner, with the most distal segment168having the smallest diameter and the most proximal segment162having the largest diameter. The distal segment168can optionally include a lens170at its distal tip, wherein this lens170can be a clear, polymeric material, for example, and can include a fisheye or wide-angled configuration.

The assembled expansion member160can be inserted into a patient until it is positioned with its distal end segment168is located at a desired surgical site (e.g., near a sacrum). Optionally, the smaller-diameter segments can be removed, and one of the larger-diameter, or the largest-diameter segment162can be placed to extend to the surgical site. For example, the smaller sections can be removed through the largest section and the largest diameter section can be advanced to extend to the surgical site, so the site is expanded to the larger diameter of the largest-diameter section.

FIGS. 12A and 12Billustrate an exemplary embodiment of an expansion member180, whereinFIGS. 12A and 12Bshow the expansion member180in its collapsed state, and whereinFIGS. 13A and 13Bshow the expansion member180in its expanded or open state. Expansion member180includes longitudinal segments or sides184of an expandable member (e.g., balloon), and other longitudinal members or sides182of a rigid material. The two opposing rigid sides182are connected to each other at their end areas by the two opposing expandable sides184(e.g., comprising inflatable balloons). In use, the expansion member180in a closed or collapsed state can be inserted into a patient to place a distal end at a surgical site. During or upon insertion, the expandable sides184can be expanded (e.g., inflated) to move the expansion member to an open or expanded state, which will include moving the rigid sides182outwardly in response to the expansion of the expandable sides184.

FIGS. 14A and 14Billustrate a system that includes an introducer200and a retractor202, wherein the introducer200is expandable. For example, the expandable introducer200can include a balloon204or other expandable structure that is capable of being expanded (e.g., inflated) within a patient to displace or retract tissue. In use, the introducer200can be inserted into a patient in a non-expanded state, as shown on the left side ofFIG. 14A. The introducer200can then be expanded, as shown on the right side ofFIG. 14A. Thereafter, the retractor202, which may comprise a rigid tube, for example, can be placed over the expanded introducer200. The introducer200can then be collapsed (e.g., deflated) and removed from the patient, leaving the rigid retractor202in place to provide access to a surgical site.

FIGS. 15A and 15Billustrate another embodiment of a system that includes an introducer220and a retractor222, the introducer220including a dilating tip224, which may have a curved or blunt distal end and a circular or curved cross-section (when viewed in a longitudinal direction), such as in the shape of a curved “bullet” or blunt-tipped “cone”. Such a configuration of the dilating tip224is provided so that when it is advanced into tissue, it will deflect and displace the tissue laterally to expand an opening for introducing the retractor222. The dilating introducer220can be advanced into tissue, through an incision to displace or retract tissue extending to a surgical site. The rigid expansion member (e.g., tube)222can closely following the dilating tip224, or can subsequently be placed into the opening made by the dilating tip224. The introducer220can then be removed, leaving the rigid retractor222in place to provide access to a surgical site.

FIGS. 16A and 16Billustrate an example of an expansion member230that includes an expanding portion232and a blunt dilating tip236. Generally, the structure includes an introducer having an inner shaft234and an expandable structure232(e.g., expandable retractor) removably attached to the inner shaft234. The introducer carries the expandable structure232to a desired location (e.g., a sacrum237), at which location the expandable structure232can be expanded and the inner shaft can be withdrawn. The expandable structure232can have a number of different expandable configurations, such as a coiled surface that can expand laterally as it uncoils, or an inflatable surface (e.g., balloon), such that the expanding structure can be inserted into a patient and expanded laterally to displace tissue to create a surgical incision. The distal end may include an optional blunt or dilating tip236that can deflect and displace tissue as the tip is advanced through a surgical incision and toward a surgical site. As illustrated, the expandable structure232can be expanded to produce an expansion member or retractor that can be left behind in the patient to allow access to the surgical site.

In use, the expansion member230can be inserted into an incision with the expandable structure232in a collapsed or closed state, and the dilating distal end can be advanced through tissue and positioned at a surgical site (e.g., a region of a sacrum237). The distal end may optionally include fiber optics, an electronic camera, or other mechanism to allow visualization at the distal end for guiding the expansion member during insertion. Once placed as desired, the expandable structure232can be expanded to displace tissue along the length of the shaft, which can generally correspond to a path leading to a surgical site. The expandable structure232can be separated from the blunt tip and inner shaft, and the inner shaft and blunt tip can be removed, leaving the expanded structure to function as a retractor to provide access to the surgical site.

FIG. 17illustrates an expansion member240, which may include features and structures of any of the expansion members or retractors described herein, and that includes a Doppler probe or transducer246at a distal end of a structure242that communicates with a proximal end of the expansion member240and a user. In a surgical procedure, the Doppler probe246can be useful to detect and avoid certain anatomical bodies, such as blood vessels and nearby nerves or other sensitive tissues. In this way, safe surgical locations can be discerned in order to avoid damaging those sensitive tissues. Alternately or additionally, an expansion member may be equipped at a distal end with infrared radiating or sensing functionality, for communication with a proximal end and a user, and for detecting and avoiding anatomical bodies such as blood vessels and arteries. Either or both of these features can be used in conjunction with any embodiments or features of devices, tools, implants, and methods described herein.

Retractors or expansion members of the invention can be structured to retract tissue of the small bowel, such as during a sacral colpopexy that places a component of an implant at a region of pelvic anatomy, or nearby. The structure, features, and functionality of the retractor can be as described herein, additionally with the distal end being structured to provide access to a sacrum while displacing tissue of a small bowel. The distal end feature can be in a retracted (i.e., collapsed or closed) state when positioned near the sacrum, beyond the peritoneum. Upon such placement, the distal end feature can be extended or opened, and additionally manipulated if necessary, to displace tissue including tissue of the small bowel.

Another method of controlling the position of a small bowel during a sacral colpopexy procedure involves placement of a component of an implant of the invention at a region of pelvic anatomy, or nearby. With such a method, the small bowel may be pressurized in a manner that is used in laparoscopic procedures. By placing a port inside the vagina, the small bowel can be pressurized to control the tissue and positioning of the tissue during placement of an implant at a region of sacral anatomy, for supporting vaginal tissue. The procedure could be performed through a single port, similar to a laparoscopic procedure.

FIG. 18illustrates a system for retracting tissue during a sacral colpopexy procedure, including an introducer250, as described herein, and a fixture252that includes a guide253. The fixture252can fit externally to the patient, over the patient's skin and pubic bone254, to be used as a guide for the expansion member. In particular, the external fixture252can be aligned with a centerline of the patient, externally, and can act to hold, manipulate, and guide a tool for use in a sacral colpopexy procedure, for example, by placing the tool or relevant structure of the tool on the same centerline, to align or position a distal feature of the tool at a desired location at or near a centerline of a sacrum. The tool may be a retractor, expansion member, speculum, etc., as described herein, or any other tool useful in a sacral colpopexy procedure.

FIGS. 19A-19Cillustrate a peritoneum management system for use in a sacral colpopexy procedure (e.g., using a retractor or other tool or system as described herein). According to this system, a surface of a retractor260includes frictional structure268to engage a peritoneum (e.g., to create a barrier or seal at the interface), alternately or additionally to use the tool to grasp and manipulate the position of the peritoneum during the procedure. The retractor260further includes an outer curved surface264from which the frictional structure268extends and/or to which the frictional structure is attached, and a handle262extending outwardly from curved surface264. The frictional structure268of retractor260can include small hooks, pins, channels, teeth, or other structure that can frictionally engage and grasp or hold tissue of the peritoneum270. The frictional structure268may be fixed, or extendable and retractable by manipulation of an actuator at a proximal end of the tool. The frictional structure268may also extend from a series of hollow channels266, as is illustrated inFIG. 19A, for example.

In use, frictional structure268at the distal end272of the tool260engages tissue of a peritoneum270, wherein the peritoneum is severed as part of the procedure. The distal end continues to grasp the severed tissue of the peritoneum, to control the position of the severed tissue. The frictional surface can be located at the distal end tip of the tool and along a length, especially along a length of an opening, e.g., at edges of an opening that extends in a longitudinal direction along a length of the shaft of the tool, as is shown in the figures. For example, the distal end and a portion of a length of the tool may, during use, be located adjacent to a peritoneum. Edges or surfaces of these locations may include the described frictional surface features. The procedure may include making an incision of the peritoneum between the sacrum and the vaginal apex, and the frictional surfaces can be used to maintain the position of the peritoneum (adjacent to the tool) during the procedure.

FIGS. 20A and 20Billustrate an exemplary sacral colpopexy procedure, as described, optionally using a tool, implant, system, or method as described, with placement of an implant284(e.g., mesh) at a location above the peritoneum286. This may be facilitated by a perforation288of the perineum near the apex. Instead of placing an implant below the peritoneum, at least a portion of an implant is placed above (superior to) the peritoneum286(seeFIG. 20B) and adjacent to the sacrum282, and optionally attached to the peritoneum. This placement can reduce or eliminate the possibility of bowel obstruction and/or kinks. Fixation between the implant and peritoneum can be accomplished in any desired and useful manner, such as by suture, staple, hooks, pins, clips, Velcro, adhesive, etc.

Another embodiment of a sacral colpopexy method involves management of peritoneum tissue by use of a shaped implant or implant portion or component, such as a retractor described herein or elsewhere. In this embodiment, a shape of the implant conforms to the surface of a sacrum, so that when placed at the sacrum, the implant abuts against the sacrum and conforms to the shape of the sacrum. The peritoneum, adjacent to the sacrum, is thereby forced against the sacrum, between the sacrum and the implant, and is not able to become an obstruction to the surgeon. The implant may be rigid, semi-rigid, flexible, and may be prepared of mesh or a molded polymer. In somewhat more detail, the curved shape of the implant conforms to or hugs the sacral curve, e.g., to prevent bending, banding, binding, or obstruction of the small bowel. The placement of the implant and peritoneum forces the peritoneum to follow the sacral curvature and will prevent the bowel from becoming positioned beneath the implant, which could potentially cause a bowel obstruction.

Another sacral colpopexy method of the invention that involves management of peritoneum tissue involves using a retractor to manage an incision in the peritoneum. The retractor can be as described herein, e.g., two separate pieces that can be separated or moved in different directions relative to one another, optionally with frictional surfaces capable of engaging a peritoneum. For example, an expandable retractor can be placed so that the distal end can contact and engage a peritoneum, and to manage an incision made in the peritoneum by maintaining a separation between the two portions of a severed peritoneum. The peritoneum is severed generally to produce a right portion on a right side of the patient and a left portion on a left side of the patient, and each of the two sides of an expandable retractor can engage one portion, maintaining a separation between the right and left portions. Maintaining this separation also maintains the opening between the portions, at the cut, to improve access to the opening between the portions and the surgical site below the peritoneum, to facilitate placement of an implant below the peritoneum.

FIGS. 21A-21Dillustrate an example of a method of using an expansion member or retractor300to gain access to a surgical site, to place a guide310(e.g., a guidewire) at a peritoneum306, and to use the guide310to place a component of an implant. Accordingly, a method of the invention can involve placing a retractor (shown herein as retractor300, but can be as described) to access a surgical site at a posterior pelvic region, such as at a region of sacral anatomy. Using a surgical tool such as a forceps308, through the retractor300, a surgeon grips the peritoneum306and inserts a guidewire310into the peritoneum306. The guidewire310is advanced beneath the peritoneum306by a predetermined distance, then exits the peritoneum306at a more distal location. The guide310is deflected or re-directed to be pulled back out of the patient through the retractor300, and an implant component312attached to the guide310is advanced into position underneath the peritoneum. The implant component can be useful to support tissue of a vaginal apex, or other tissue, e.g., in a sacrocolpopexy procedure.

FIG. 22illustrates an expansion member or retractor320as described herein, as it can be used with a light324located at a position along a shaft to illuminate a peritoneum326, while the expansion member320is placed in a patient. For example, in a procedure that includes an apical vaginal incision and a posterior vaginal incision, the light324can be placed through the posterior incision, either connected to or separate from the expansion member. The light can be placed internally on the “external” side of the peritoneum, which is the side opposite of the location of the expansion member (i.e., inferior to or below the peritoneum). The light can be used to illuminate the peritoneum, shining through the peritoneum to identify any critical or sensitive structures before cutting or advancing a delivery tool. The procedure or tool may also include a feature for visualizing the peritoneum, e.g., electronically or through the expansion member. The expansion member can also include an opening (e.g., an elongate opening or slot) along a length of the expansion member shaft that allows access (including visual access) to the peritoneum.

FIG. 23shows an example of an expansion member or retractor340that includes hooks346or another frictional structure capable of engaging and grasping a peritoneum, which is located at an edge or outer surface of the expansion member340. These structures340are also discussed herein relative toFIGS. 19A-19C. With continued reference toFIG. 23, the retractor340includes three longitudinal sections342that are connected to each other by longitudinal hinges344. It is understood that more or less than three sections342may be used, with a hinge344located between each adjacent pair of sections342. In any case, the hinges344allow the retractor340to be expanded and contracted by folding the sections342relative to each other at the hinges344to thereby “open” or “close” the structure.

The hooks346are located at an edge of an elongate longitudinal opening348that is located between the distal ends of the first and last sections342of the retractor340on one side of and along a length of an expansion member. When the expansion member340is positioned with the distal end at a region of a sacrum, for example, one side (e.g., an inferior side or “bottom”) of the shaft includes the length-wise opening or slot348that provides access to a peritoneum, located inferior to the shaft. Adjacent to that opening348(e.g., at a surface of the shaft, or at an edge of the opening) are the multiple hooks or other engagement structures346that are capable of engaging and grasping the peritoneum to allow the peritoneum to be controlled during a surgical procedure. For example, the hooks346may grasp the peritoneum for maintaining the position of the peritoneum as the peritoneum is severed along a centerline of the patient, to gain access to the underside of the peritoneum and a region of sacral anatomy. After the cut is made, hooks346on each side of the tool will maintain the position of the two portions of severed peritoneum.

Another embodiment of a sacral colpopexy procedure involves the use of peritoneum tissue, which is pulled together and used as a material to provide support for vaginal tissue. As a substitute for mesh, this method relies on the use of, e.g., multiple layers of peritoneum tissue that are pulled and secured together to create a material that will support the vaginal apex. Alternately, a small piece of mesh may be useful in combination with one or two layers of peritoneum, the combined mesh and peritoneum tissue being placed and attached to support tissue of a vaginal apex.

FIGS. 24A and 24Billustrate an embodiment of a method of attaching an implant to a component of sacral anatomy, using a tool360, an implant362in the form of a tubular mesh, and an anchor364. The implant362includes an anchor delivery mechanism for delivering a soft tissue anchor from the distal end, and frictional surfaces to engage tissue of a peritoneum366, similar to that described herein relative toFIGS. 19A-19C and 23. In use, the tubular implant362is inserted to position the distal end at a region of a sacrum. The tubular implant362contains an elongate portion of an implant (e.g., mesh), having an anchor attached at the distal end. The soft tissue anchor attached to the implant is secured to a region of sacral anatomy. The frictional surfaces are used to engage the peritoneum366. The tubular implant362is then rotated to pull the peritoneum366around it, thereby creating a tunnel of the peritoneal tissue. The peritoneum366can then be sutured or otherwise secured to itself to maintain the “tunnel” shape and opening around the implant (e.g., mesh). The tubular implant362can be withdrawn slightly, and the tool can again be used to grasp and rotate peritoneum tissue to form a tunnel, which is held together by another suture. These steps can be repeated to form a desired length of tunnel made of the peritoneal tissue, surrounding the implant. The tool can then be removed and the mesh implant remains behind within the peritoneal tunnel.

FIGS. 25A and 25Billustrate another example of a method and device for securing an implant material380directly to tissue of a peritoneum. The implant material380comprises a base material sheet382from which a frictional surface extends, which surface may comprise extension members384(e.g., clips, barbs, extensions, needles, hooks, “mushroom heads,” Velcro-type (hook-and-loop) frictional structures, etc.). In order to engage this implant material380with a tissue, such as a peritoneum tissue, the implant can be positioned with its frictional surface in contact with the tissue, and then the material can be pressed toward and into the tissue until the frictional surface is sufficiently engaged with the tissue.

FIG. 26illustrates an example of a method, implant, and retractor that can be used to secure an implant at a region of a peritoneum and sacrum. The implant is passed, multiple times, through the peritoneum, from above to below, back to above, etc., “snaking” along a length of the peritoneum until it reaches the sacrum. An exemplary path that the implant can take is illustrated with arrows as path404. Alternating the position of the implant on either side of the peritoneum mitigates, reduces, or eliminates, the need for additional fixating elements between the implant and the peritoneum, peritoneal closing devices, and potential banding that may occur. Friction between the implant and the peritoneum will provide securing force between the two. The implant may be placed as shown and described using a tool that can be passed alternately above, then below, the peritoneal tissue, e.g., “snaking” alternately above and below the tissue, then fixing the implant at a region of sacral anatomy such as an anterior longitudinal ligament. The tool can be withdrawn to leave the implant, placed as described.

FIGS. 27A and 27Billustrate another exemplary embodiment of a retractor420that includes a closing feature for closing an opening previously made in the peritoneum. As illustrated, the retractor420is a generally tubular shape and includes first and second sections422,424attached at a longitudinal hinge426along the length of the retractor420so that the retractor420can open along its length on the side opposite the hinge (e.g., along a length of the retractor420that will be adjacent to a peritoneum when the retractor is installed in a sacral colpopexy procedure). Retractor420includes frictional structures for engaging tissue of a peritoneum, which are located along the length of the retractor adjacent to the peritoneum when installed.

In use, the retractor420can be used to close the surgical opening in the peritoneum. After a surgical procedure, the retractor420is opened along the hinge426, and the frictional structures located longitudinally on opposite edges of the opening contact opposite sides of a severed peritoneum. The retractor420is then closed, squeezing the opposite sides of severed peritoneum between the edges, which may include catching the opposite sides of the peritoneum with the clips to hold the sides together for healing.

FIG. 28illustrates another embodiment of a retractor440that includes frictional structures442(e.g., pins, wires, etc.) on the inside of the retractor440for engaging tissue of a peritoneum on exterior surface of the retractor. In this way, after the peritoneum is cut open, the peritoneum can be pushed to either side and stick to the walls of the retractor440. In one embodiment, the frictional structures442can be angled upwardly so that the peritoneum does not slide off during mesh placement.

The methods, tools, expansion members, and implants described can be used in conjunction with any type of anchor for securing an implant to tissue, such as at a region of sacral anatomy using a soft tissue anchor.FIGS. 29A-29C and 30A-30Bshow a system450for securing a pincher-type soft tissue anchor to soft tissue, e.g., a peritoneum, a ligament, muscle, etc., optionally at a region of sacral anatomy. The assembly includes a pincher anchor452, a ring454, and an insertion tool456. The ring and insertion tool are used together to position the pincher anchor452at a location of soft tissue, and to close the jaws of the pincher anchor452to grip into and become secured to the soft tissue, leaving behind the pincher anchor452and the ring454secured to the soft tissue, for supporting an implant.

FIG. 30Aillustrates the elongate tool456with a shaft) and the pincher-anchor and ring (collar) at the distal end of the tool456with jaws open. In use, the target soft tissue can be identified and the assembly can be positioned adjacent to soft tissue with jaws open, as illustrated inFIG. 30A. Next, the outer ring is slid distally relative to the jaws, causing the jaws to pivot together and close. To close the jaws, the ring may be pushed distally relative to the shaft, the pincher-anchor can be pulled proximally relative to the shaft, or a combination of these movement may be used.

After the jaws are closed on the soft tissue, the tool456can be disengaged and withdrawn, leaving the pincher anchor and ring (collar)456in place secured to soft tissue. Any release mechanism can be useful. As illustrated, an actuator at the delivery tool handle can be moved (e.g., rotated) to release an engagement between the ring and delivery tool bars by spreading the bars apart, as shown inFIG. 30B. The inner supports can be rotated to align with channels in the ring, the tool can be withdrawn.

Extending between the handle and the distal end is an elongate shaft section, which is connected to the moveable retractor surfaces through hinges. A removable retractor section can be engaged with the shaft to produce an inner space along a length of the retractor, which can be a working space of the retractor to allow access to a surgical site. The removable retractor section can include an opening (e.g., slot) at the distal to allow lateral access to a surgical site.

In cross section, the shaft includes two abutments along a length of the shaft; each abutment is capable of engaging a structure of the removable section to allow a removable engagement between the shaft and the removable section. For example, as illustrated, two opposing longitudinal edges or lips (continuous or interrupted), each located along a length of the removable section, can be fit behind the to abutments to place the removable section of in a working engagement with the shaft. In cross-section the removable section is semi-circular, and the spine is curved, such that when engaged the two sections of the expansion member produce a curved space.

The moveable retractor surfaces at the distal end can function to retract tissue at a surgical location by moving laterally upon rotating or pivoting about the hinges. The moveable retractor surfaces can be located along a length of the shaft at the distal end, optionally not extending along the entire length of the shaft but only along a partial length of the shaft at the distal end. The moveable retractor surfaces can be of any cross-sectional shape or form, such as curved or straight (flat).

Expansion member devices as described and illustrated herein, sometimes referred to interchangeably as “tubes,” “speculums,” “retractors,” etc., can be used and useful according to methods of inserting the device into a surgical incision, and moving, retracting, displacing, or expanding tissue to provide access to desired anatomy. For performing certain surgical procedures, a tube or retractor can be placed in a non-expanded, collapsed state. The device or a related structure can then be expanded while in place to create access to desired anatomy such as the posterior of a pelvic region, e.g., to gain access to a region of sacral anatomy; to create a workspace between a vaginal introitus and a region of a sacrum, such as an anterior longitudinal ligament, sacral promontory, or peritoneum. A surgeon can perform a surgical procedure by use of the access, which provides working space to pelvic anatomy such as the sacrum and surrounding tissue as described.

Methods of utilizing devices of the invention can optionally also involve a tool, multi-functional tool, implant, adjustable implant, anchor (soft tissue anchor or bone anchor), or other device or method described herein. Optional features and structures (e.g., fiber optics) to allow viewing or illumination, or any other functionality at the distal end can be incorporated into any of these types of devices. For example, if a structural component of the device is made of a plastic or polymeric light-conductive material, light can be transmitted through that material from a proximal end to a distal end at the surgical site. Alternately, a fiber optic cable can be incorporated into a length of the device, extending from a proximal to or toward a distal end, to allow light to be transmitted from the proximal end to the distal end, or to allow images to be transmitted from the distal end to the proximal end. Light could alternately be generated and shone from the distal end.

The implants, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references, or as described herein. Various methods and tools for introducing, deploying, anchoring and manipulating implants to treat incontinence, prolapse, or another pelvic condition, as disclosed in the previously-incorporated references are envisioned for use with the present invention as well as those methods and tools identified and described herein.

Also according to embodiments of the methods, implants, tools, and devices described herein, any of the described tools can be used for placing any desired pelvic implant in a male or a female patient, and for any of a large variety of conditions, such as a pelvic condition. The implant can include any structural features useful for such treatment, including any desired size, shape, and optional features such as adjustability and anchoring systems. Any of these features may be previously known, future developed, described herein, or described in documents incorporated herein, for any particular implant and method. For example, some figures and discussions include examples of features of “anchors” (e.g., soft tissue or bone anchors, as these terms are generically and inclusively used) that can be useful according to the methods of placing a surgical implant. An implant that includes or is otherwise secured by any of the anchors described can be useful to treat a pelvic condition in a male or a female patient.

Various devices and methods described herein are advantageous because they facilitate reduction of total procedural time if the patient needs a urinary sling, levator floor support, high apical support (fixation to the sacrum), and anterior or posterior prolapse by combining multiple products into one. The pelvic floor support reduces the long term prolapse recurrence as well as improve the patient's sexual function with the high apical support due to the sacral fixation. Moreover, the various tools and methods allow a physician to use a transvaginal approach, an abdominal approach, or a laparoscopic approach to achieve a similar tension as what is currently only achievable for sacral colpopexy procedures.

The various systems, apparatus, and methods detailed herein are envisioned for use with many known implant and repair systems (e.g., for male and female), features and methods, including those disclosed in U.S. Pat. Nos. 7,500,945, 7,407,480, 7,351,197, 7,347,812, 7,303,525, 7,025,063, 6,691,711, 6,648,921, and 6,612,977, International Patent Publication Nos. WO 2008/057261, WO 2007/097994, WO 2007/149348, and U.S. Patent Publication Nos. 2002/151762, 2010-0174134, 2010-0298630, and 2002/147382. Accordingly, the above-identified disclosures are fully incorporated herein by reference in their entirety.

The disclosed systems, their various components, structures, features, materials and methods may have a number of suitable configurations as shown and described in the previously-incorporated references. Various methods and tools for introducing, deploying, anchoring and manipulate device, implants, and the like as disclosed in the previously-incorporated references are envisioned for use with the present invention as well.

All patents, patent applications, and publications cited herein are hereby incorporated by reference in their entirety as if individually incorporated, and include those references incorporated within the identified patents, patent applications and publications.