# Patent

## Title
Method of treating vaginal prolapse

## Abstract

A method of treating prolapsed vagina by tacking the prolapsed vagina to tissue proximate the obturator foramens with anchor mechanisms applied from inside the vagina.

## Background
This application is a continuation of U.S. patent application Ser. No. 10/841,594, entitled SYSTEM FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONE AND PERIOSTEUM, filed May 10, 2004, which is a continuation-in-part of U.S. patent application Ser. No. 10/679,131, entitled SYSTEMS FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONE AND PERIOSTEUM, filed on Oct. 3, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 10/466,330 entitled SYSTEMS FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONE A PERIOSTEUM, filed Aug. 23, 2003, which is a continuation-in-part of U.S. patent application Ser. No. 09/733,455 entitled SYSTEM AND METHOD FOR SECURING SUTURES TO BONE AND TISSUE, filed Dec. 8, 2000, which is a continuation-in-part of U.S. patent application Ser. No. 09/197,938 entitled SYSTEMS FOR SECURING SUTURES, GRAFTS AND SOFT TISSUE TO BONE AND PERIOSTEUM, now issued as U.S. Pat. No. 6,200,330, and further relies upon Disclosure Document No. 547,586 entitled Percutaneous Dart, filed Feb. 17, 2004; Disclosure Document No. 463,908 entitled Transvaginal Rectus-Fascia Anchor, filed Oct. 21, 1999; Disclosure Document No. 479243 entitled Adjustable Soft Tissue Attachment Device and System, filed Sep. 5, 2000; Disclosure Document entitled Transvaginal Rectus-Fascia Attachment, filed Mar. 1, 2000, disclosure document number not assigned; Disclosure Document entitled Transvaginal Attachment Delivery Tool, filed on or about Mar. 1, 2000, disclosure document number not assigned; Disclosure Document No. 463,825 entitled Transvaginal Anchor Delivery Tool, filed on Oct. 21, 1999; Disclosure Document No. 458,659 entitled Transvaginal Adjustable System, filed Jul. 6, 1999; and Disclosure Document No. 480,805 entitled Adjustable Suture Soft Tissue Attachment System, filed Oct. 6, 2000, the teachings of all of which are incorporated herein by reference.


STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT
Not Applicable
BACKGROUND OF THE INVENTION
The use of surgical suture anchors for use in attaching soft tissue to bone is well known in the art. In this regard, such anchoring mechanisms have found widespread applicability for a number of surgical procedures, and in particular orthopedic, gynecologic and urologic procedures. Exemplary of such devices include bone screws or anchors that are implantable within bone which further have formed thereon an eyelet or other type of assembly to which may be affixed suture lines or a segment of soft tissue. Exemplary of such devices include those devices disclosed in U.S. Pat. Nos. 5,370,662, and 5,443,482 to Stone, et al. and U.S. Pat. No. 4,738,255 to Gobel, et al.
Generally, prior art anchor systems take one of two forms. The first configuration typically comprises a self-tapping bone screw, typically made of titanium, having an eyelet formed thereon to which the sutures or other material may be attached. In the alternative prior art configuration, the device comprises an anchor member, which may take the form of an arrowhead or similar conical configuration, which further includes a shaft or attachment member extending therefrom, the latter being formed to have one or more apertures to which the sutures or other material may be attached.
With respect to the surgical installation of such devices, bone-screw mechanisms must necessarily be screwed in position, typically by a battery-powered screwdriver, at a target site upon a particular bone. Anchor devices of the other aforementioned variety typically must be “shot” into position at a particular site within a bone, typically via a spring-loaded delivery mechanism. Exemplary of such bone-anchor insertion devices include the In-Fast and In-Tac bone screw and bone anchor fixation devices previously produced by Influence, Inc. of San Francisco, Calif., now a division of American Medical Systems, Inc.
Although such prior art anchor devices generally provide sufficient support to the various sutures and grafts affixed thereto, such fixation devices suffer from numerous drawbacks. In this regard, it is difficult for the surgeon to accurately deploy the insertion device such that the anchor is correctly inserted at the target site. Moreover, substantial difficulty arises in removing and adjusting such devices. This latter task is especially problematic with respect to bone-screw devices insofar as the surgeon attempting to remove the same must take great care to insure that the removal device, also typically comprising a battery-powered screwdriver, properly unscrews the anchor member from its seated position. Other prior art anchor devices are even further problematic insofar as the same are often irretrievable once deployed, especially in situations where the same are deployed too deeply into the bone mass.
Additional problems exist with prior art bone fixation systems insofar as the same have a tendency to become dislodged over time from their seated position. In this regard, due to the repetitive application of stress or strain upon the bone anchor via the suture or soft tissue attached thereto, such anchors can eventually become loose and slip out of engagement from their fixed position. This tendency is especially likely to the extent repetitive and persistent application of strain and stress is applied in one specific direction or orientation. In this regard, many fixation techniques are susceptible to failure with misplacement or pull-out of anchors and eventual dislodgement of the structure/graft supported thereby with coughing, vomiting or other violent activity. Moreover, even to the extent such bone anchoring systems remain securely in position, recent study tends to indicate that such bone fixation devices may actually have a tendency to cut the sutures sought to be held thereby.
Separate and apart from the drawbacks associated with the use of prior art bone anchoring systems is the fact that often times anchor systems provide far more structural support than is necessary for a given surgical application. In this respect, numerous surgical procedures requiring the fixation of sutures and/or soft tissue require only a minimal degree of tension. Exemplary of, and perhaps most well-known of such procedures include pelvic prolapse surgery, also known as colpopexy, colporrhaphy or vaginofixation, and transvaginal sling surgery, the latter of which is performed to treat incontinence. The former procedures typically involve the anchoring of all or a portion of the prolapsed vagina to adjacent or nearby structures such as the sacrum whereas sling surgery essentially involves the formation of a graft positioned beneath the urethra with the opposed ends thereof being secured to either one of the abdominal fascia, Cooper's ligament or pubic bone. While such slings typically require little to no tension once fixed into position, due to the lack of alternative means for affixing the opposed ends of such sling into position relative to the pubic bone, such prior art bone anchor devices must necessarily be deployed.
As a result, time spent in surgery is increased and the patient undergoing such procedures in subjected to a far more traumatic experience and has a possibly greater susceptibility of becoming infected by virtue of the deployment of such anchor devices than would otherwise occur to the extent alternative, less traumatic affixation devices could be deployed. Along these lines, a substantial risk exists simply by utilizing a retropubic route to gain access to the surgical site where such sling is affixed into position. In this regard, accessing such surgical site via a retropubic route can increase the risk of bleeding and/or intestinal injury due to the proximity of blood vessels existing within and above the pubocervical fascia and the intestines.
Accordingly, there is a need in the art for systems, devices and methods for affixing sutures, grafts, soft tissues, synthetic materials, and the like to bone and soft tissue that are easier to deploy, manipulate and can remain more firmly seated into position than prior art devices, especially in the performance of suburethral sling, colporrhaphy and colpopexy procedures. There is additionally a need for such devices that can be utilized in a wide variety of surgical applications and may be further customized for use for particular applications such that an optimal degree of support or leverage can be provided thereby. There is further a need in the art for affixation systems, devices and methods that can provide for means for affixing sutures, grafts, soft tissues, synthetic materials, and the like into position that are less traumatic, easier to deploy and adjust, and may be readily removed and repositioned at a particular site than prior art systems and devices. There is yet additionally a need in the art for systems and methods that, in certain applications, such as urinary incontinence, can easily and readily enable a sling to be surgically deployed and secured into position percutaneously, and especially within the epithelium of a body cavity, such as vaginal epithelium, that can thus enable such procedures to be performed in a medical office setting, as opposed to a surgical center or hospital.
BRIEF SUMMARY OF THE INVENTION
The present invention specifically addresses and alleviates the above-identified deficiencies in the art. In this regard, the present invention is directed to novel devices, systems and methods for the attachment of sutures, grafts and other types of tissues and materials to bone, periosteum, ligaments, fascia and other soft tissue as may be warranted in a given surgical procedure. The devices of type present invention are particularly well suited for the secure placement of one or both of the opposed ends of a suburethral sling for use in suburethral sling surgery, but are by no means limited to such particular application.
In a first preferred embodiment, the invention comprises an implant implantable within bone, ligaments, fascia and other soft tissue at a desired location. The implant comprises a piton portion designed to pierce into and engage with the bone, or tissue, and a support structure coupled therewith, the latter of which may take the form of a post, hook or eyelet to which the suture, graft, or tissue may be attached. The implants of the present invention may further include a handle member formed thereon to facilitate the insertion and removal of the implant from its fixed or seated position within the bone/tissue.
The piton portion of the implant is specifically designed to become more firmly embedded within the bone or other tissue when pressure is applied to the support structure in a first direction, but may be dislodged or removed when the implant is pulled in an opposed or second direction. The piton member may be further selectively sized and adapted for use in a particular application, and may be particularly designed to penetrate up to certain depths and/or be capable of supporting a specific quantity of mass or weight. In this regard, the implants may be designed to have two or more piton members, that each respectively provide means for securely attaching such implant to a desired side. Such implants may be further configured such that multiple implants may be deployed upon a length of a suture, such that the suture may be selectively pulled and anchored into position along a desired pathway. In this respect, the piton members may be formed such that the same are operative to facilitate movement through tissue in one direction, yet perform an anchoring function in an opposite direction.
Such embodiment further advantageously allows for post-operative adjustment whereby the suture with piton members attached thereto can be selectively pulled along the desired pathway to the extent necessary to adjust the suture position and/or introduce a greater degree of tension thereto. Along these lines, such embodiment has the additional advantage of being completely removable from the patient's body by virtue of its ability to selectively move through and out of tissue.
In a second preferred embodiment, the invention comprises a disc anchoring system that is operative to serve as a platform to which sutures, graphs and the like may be secured or, alternatively, serve as a support for forming a suture “bridge”. According to one preferred version, the affixation device comprises a disc or anchor plate which is positionable upon a layer to tissue, such as a layer of muscle, fascia, or ligament, and in particular, the rectus fascia layer. The anchoring plate is preferably formed to be generally circular in nature and comprised of an inner plate member encased within an annular outer plate member. The inner and outer plate members are further preferably formed such that at least one, and preferably two, diametrically opposed apertures are formed respectively therein for receiving suture lines insertable therethrough. The inner plate and outer annular member are formed relative one another such that the inner plate is rotational relative the outer annular ring and operative to transition between a first open configuration, wherein said apertures formed upon the respective plates are open to receive suture lines therethrough and a second closed configuration, wherein rotation of the inner plate relative to the annular ring causes the apertures to close and lock, (i.e., crimp) any suture line extending therethrough to become rigidly secured in position. To the extent desired, those portions of the sutures extending through the anchor plate may be affixed to one another to thus form a bridge or adjoining suture link.
In an alternative configuration, the disc anchoring system comprises a disc or anchor plate which is likewise positionable upon a layer of tissue (e.g., muscle, fascia, or ligament) that includes at least one, and preferably two to four, channels for receiving suture lines insertable therethrough. The channel or channels are configured such that the same are crimpable such that when the suture line or lines are ideally positioned therein or impart the necessary degree of support to an object (i.e., sling, graft, etc.), the crimping of such channel or channels affixes such length of suture or sutures into position. To achieve that end, it is contemplated that any of a variety of conventional crimping devices may be deployed to impart the necessary crimp in the channel or channels. As per the aforementioned embodiment, to the extent multiple suture lines extend through such plate, the same may be tied, linked, crimped or otherwise joined to one another to form a suture bridge.
The disc anchoring system may further take the form of a system whereby a suture, having a plurality of protuberances formed therealong, is engageable with an anchor plate, the latter having an aperture formed therein for receiving the suture line. As respective ones of the protuberances extend through and rest against the anchor plate, the suture line may thus be maintained in a fixed position relative a desired target site. Such embodiment advantageously provides for post-operative adjustment should it become necessary to reposition the suture or increase the tension within the suture line secured by the disc anchoring system.
In all embodiments, the disc anchoring systems are particularly well suited for the use in pubovaginal sling surgery where it is necessary to secure a sling such that the sling extends a desired distance from the urethra or exerts a desired degree of supportive pressure thereto, which thus necessitates that such sling be selectively secured into position via the suture extending through the anchor plate. It will be recognized, however, that such disc anchoring systems may be utilized for a wide variety of medical applications and further, may be formed to be permanently affixed into position or formed from a bio-absorbable material to the extent such anchoring systems need only remain resident for a limited duration. Still further, it is contemplated that each of the aforementioned disc anchoring system may incorporate a load-bearing object, such as a washer, mesh or other like structure, as part of or in conjunction with the disc anchoring system to facilitate the distribution of stress and strain imparted thereto. As with the disc system, such load distributing apparatus may be formed to be permanently secured into position or formed from an absorbable material.
In a third preferred embodiment, the invention comprises an affixation device designed to secure sutures, grafts, tissues, synthetic materials, and the like to periosteum (i.e., the thick fibrous membrane covering the surface of bones) and other soft tissue. According to a preferred embodiment, the affixation device includes a backing or base member having at least one, and preferably a multiplicity of hook members that are sized and adapted to hook into and ensnare with the periosteum or tissue. The hook members may be specifically designed to become partially embedded within the periosteum tissue, to thus provide relatively loose connection that is easier to remove, or adjust, and may be designed to penetrate deeper within the periosteum tissue to thus provide a more secure method of attachment. An attachment member formed upon the base member is further provided to which may be attached a suture or a portion of a graft.
In an alternative preferred embodiment, the invention comprises an implantable tack consisting of a hub member having at least one, and preferably two or more hook members formed thereon, the latter being designed to extend through the graft or tissue and become ensnared with and embedded in the periosteum such that the graft or tissue becomes interposed between and affixed into position relative the tack and periosteum. The affixation devices according to such embodiments are specifically designed for selective attachment and detachment, and are further designed to provide more atraumatic means for the attachment of the suture or graft to a target location via the periosteum and soft tissue. Such a fixation device, however, may be adapted such that the same are designed to pierce into and become embedded with the bone, as per the other aforementioned embodiments.
In yet another embodiment of the present invention, there is provided a novel surgical staple that is also designed to secure a graft or other types of tissues and materials to the bone, periosteum, or other soft tissue at a specific site or location. The staples of the present invention are preferably formed from plastically deformable materials having opposed ends that are designed to penetrate through the graft/tissue and hook into the bone, periosteum or soft tissue at a selected site of fixation. Once secured in position, the staples are operative to assume an expanded configuration such that the hooks formed thereby become more firmly embedded within the bone/tissue at the target site of fixation to thus further secure attachment of the graft thereto. Preferably, such staples may be fabricated from a shape-memory material, such as nitinol, which thus enables the staple to assume the compressed configuration when at room temperature, but transition to the operative, expanded configuration when warmed to body temperature, as will occur when the device is deployed. Such materials further enable the staples of the present invention to be removed, as may be necessary, during a given procedure or later procedures. Conversely, such staples may be formed from material that enable the same to compress or contract once secured into position to thus provide for a more secure means of attachment.
The present invention further comprises novel surgical approaches for the secure placement of a transvaginal sling during transvaginal sling surgery. More particularly, such surgical procedure involves securing such sling into position, namely, beneath the urethra, with the opposed ends thereof being secured to the posterior portion of the pubic bone, whether it be either the pubic bone itself or the periosteum surrounding the same, in the retropubic space. The opposed ends of the sling may be attached to either the periosteum over the pubic bone or to the pubic bone itself using the novel affixation devices of the present invention. Advantageously, such surgical procedure eliminated the needs to form an abdominal incision, which typically must be made utilizing conventional surgical procedures. The novel affixation method of the present invention during such surgery further provides for the ingrowth of the opposed ends of the graft to a target site near or on the pubic bone or the periosteum thereabout that eliminates any intervening pelvic fascia that would otherwise become interposed between the anchor and opposed ends of the sling sought to be secured into position.
As an alternative to the aforementioned approaches, the present invention further comprises novel systems and surgical techniques that can deploy anchoring systems for the placement of radio opaque markers, such as the TINED lead system of radio opaque markers produced by Medtronic, Inc., and pelvic floor reconstruction for support of pelvic organs, such as through the use of slings affixed thereto, that are fixed into position via trans-obturator placement, as opposed to conventional retropubic surgical placement. Such surgical techniques, devices and systems utilized therewith are positioned utilizing a single percutaneous incision made in the vaginal epithelium which enables a sling to be anchored into position in a target tissue, such as rectus and/or pubocervical fascia, via sling placement toward or through the obturator foramen. To achieve that end, there is preferably provided a deployment system operative to selectively deploy and securely place into position a self-anchoring sling comprised of an elongate sling having opposed ends. Formed on each opposed end of such sling are dedicated anchor mechanisms that are each operative to penetrate into and become embedded within a target site of soft tissue, such as the obturator membrane situated within or around the obturator foramen.
Each respective anchor mechanism is operatively configured such that each anchor mechanism is advanceable in a first direction through the soft tissue at the target site but selectively adjustable to resist movement in an opposed direction, (i.e., such anchor mechanisms are configured such that the opposed ends of the sling are capable of being advanced in opposed directions but resisting or preventing contraction or other similar type of motion drawing the ends towards one another). To facilitate such movement, it is contemplated that the anchor mechanisms may take the form of screws, arrowheads, prongs, and in particular generally Y-shaped or chevron shaped prongs, or any other structure that is capable of being advanced in one direction yet resists or is biased against movement in an opposed direction. In further refinements such anchor mechanisms may further be selectively configured to penetrate to a desired depth within a tissue mass, as well as may be selectively configured to assume a first compressed or deployment configuration such that the same will be operative to be positioned within a specific target site, and a second operative configuration whereby the anchor mechanism expands or otherwise assumes a locking configuration that enables the anchor to become affixed into position. In this regard, it is contemplated that the anchor mechanism may be formed to have an outwardly expanding spring bias such that once released from a confined position automatically expands or anchors in an automatic fashion.
With respect to the deployment of such slings, it is contemplated that the same will be deployed through a manually operable deployment mechanism. Preferably, such deployment mechanism will include a handle having a deployment member extending distally therefrom. With respect to the latter, the deployment member will preferably be configured for insertion through and under the vaginal wall to thus enable the slings with anchor mechanisms formed thereon to be deployed via a trans-obturator or other route. To facilitate that end, it is contemplated that the deployment member may be provided with a sharpened distal end capable of forming an incision within the vagina and thereafter be extensable under the vaginal wall to thus deploy the slings of the aforementioned variety within or near the obturator foramen. In use, the sling having the anchoring mechanisms formed upon the opposed ends thereof will be coupled to or mounted upon the deployment member such that a respective one of the anchor mechanisms can be positioned by the deployment member at a specified site within the target tissue (e.g., the pubocervical fascia or within the obturator foramen). In this regard, it is contemplated that the deployment member may be configured such that the anchor mechanisms will be deployed in a sequential manner such that a first anchor is deployed in one target site and the other opposed anchor member deployed at a second site such that the sling disposed intermediate the anchor members can be selectively positioned to provide an optimal degree of support to the urethra. In order to manipulate such device, it is contemplated that the deployment system will include an actuation member that enables the surgeon to manually direct the advancement of the anchor mechanism coupled with or mounted upon the deployment member of the mechanism to thus enable the self-anchoring sling to be controllably fixed into position. To facilitate such placement, it is contemplated that the deployment member may be selectively curved or shaped to gain access more readily within a particular anatomical site, such as the obturator foramen.
There is further disclosed herein novel systems and surgical techniques that advantageously allows for the percutaneous deployment of a sling, to thus provide for very rapid, secure and atraumatic sling placement. In the first of two such preferred techniques, an elongate implant or sling having opposed ends with anchoring mechanisms formed thereon, which may comprise any of the aforementioned variety that are operative to assume an insertion configuration and anchoring configuration, is surgically implanted by merely deploying the anchoring mechanisms percutaneously with the sling portion extending externally across from the respect points at which the opposed ends are percutaneously anchored. In one specific application, particularly well suited for the treatment of urinary incontinence, the anchoring mechanisms formed upon opposed ends of such sling will each be percutaneously driven through a target site within the vaginal wall anchored within a mass of soft tissue, such as into the obturator foramen. In this respect, the anchoring mechanisms will be percutaneously driven across the upper vaginal wall such that the sling portion extends thereacross and in a generally perpendicular orientation relative to the urethra, extending thereabove. Such externally extending portions of the sling will be operative to provide the necessary degree of urethral support. Advantageously, however, such sling need only extend across the external surface of the vaginal wall and need not be surgically embedded, as per prior art surgical techniques. Presently, it is contemplated that such externally extending sling portion will eventually be completely or partially encompassed by tissue ingrowth and thus safely remain implanted within the patient. Alternatively, it is contemplated that such sling may be caused to erode through the epithelium more rapidly into place, such as through electrocauterization The sling may also be treated with a suitable antimicrobial agent to ensure that the same minimizes the risk of infection.
In a second preferred embodiment of such novel percutaneous surgical technique, a sling-like implant or support is provided having opposed ends, the latter having one or more anchor mechanisms formed on the opposed ends thereof, that are designed to be placed either under the vaginal epithelium or over the epithelium and allowed to erode or pass therethrough. With respect to the latter two, such process can be facilitated by the application of an electrocauterizing current, radiofrequency energy or any other treatment known in the art that will facilitate the penetration or ingrowth of such strip. As per the aforementioned embodiment, such suburethral strip is deployed and anchored into position percutaneously, thus eliminating the need to surgically implant the sling internally and in closer proximity to the urethra. In this second embodiment, the ends of the sling containing the anchors can be pulled out from the tissue and moved if initial adjustment becomes necessary.
Such novel percutaneous surgical techniques and systems utilized therewith are further believed to be operative for any of a variety of conditions, such as prolapse In this regard, any type of surgical procedure whereby a sling or fixation system is deployed to support a given anatomical structure, that utilizes one or more anchoring mechanisms that can be percutaneously secured into position with the sling portion providing the necessary support extending externally from such percutaneous anchoring sites, can be deemed to fall within the scope of the present invention.
Related to the foregoing techniques and further encompassed within the scope of the present invention are surgical techniques, slings and anchoring devices for performing vaginal reconstruction surgery, such as vaginal prolapse surgery. According to such technique, the prolapsed vagina in inverted such that the same attains its proper anatomical orientation and, as per the aforementioned technique regarding the deployment of anchoring mechanisms within the obturator foramen, at least one, and preferably an opposed pair of anchoring mechanisms are deployed through the vaginal wall and into the obturator foramen, thus causing the vaginal wall to remain anchored in its proper anatomic orientation. To that end, it is contemplated that the anchoring mechanisms are operative to penetrate into and become embedded within a target site of soft tissue within or around the obturator foramen in a second platform or mesh portion which remains embedded or compressed against the vaginal wall to thus support and retain such structure into position. To facilitate that end, it is contemplated that such anchor members will include a platform surface formed from mesh or other like material to thus provide sufficient surface area to support the vaginal wall into proper positioning.
It is therefore an object of the present invention to provide surgical implantation devices to facilitate the attachment of sutures, grafts, tissues and the like to bone, periosteum and soft tissue that are easier to implant and remove than prior art devices, and are further capable of providing greater support or leverage to the structures coupled therewith than prior art devices.
Another object of the present invention is to provide surgical implantation devices for the attachment of sutures, grafts, tissues and the like to bone, periosteum and soft tissue that can be utilized in a wide variety of surgical procedures, and in particular colpopexy, colporrhaphy, suburethral sling or other pelvic support surgery, and that may be further designed to provide an optimal degree of support for a given quantity of mass or weight as may be necessary for a given surgical procedure.
Another object of the present invention is to provide devices for the affixation of sutures, grafts, tissues and the like to periosteum and soft tissue at a specific site or location that does not require any anchoring mechanism to be inserted into the bone.
Another object of the present invention is to provide devices for the attachment of sutures, grafts, tissues and the like to bone, periosteum and soft tissue at a specific location that are less traumatic than other prior art affixation devices.
Another object of the present invention is to provide devices for the attachment of sutures, grafts, tissues and the like to bone periosteum and soft tissue at a specific location that are easily attachable to and detachable from a point of fixation than prior art devices and re-attachable as may be necessary for a given procedure or future procedures.
Still further objects of the invention include methods and devices for securing sutures, grafts, tissues and the like to bone, periosteum and soft tissue that are of simple construction, may be easily and readily utilized for a variety of surgical procedures, may be readily adapted for use in a wide variety of surgical procedures, and provide an equal, if not greater degree of support or leverage than prior art devices.
Another object of the present invention is to provide a self-anchoring sling that enables the sling to be securely affixed into position within a site of soft tissue such that the same resists sag or otherwise lessens its ability to provide support that can further preferably be deployed via a trans-obturator route, and preferably via a system and method that enables the same to be deployed via a single access route, such as a single vaginal incision, to thus eliminate risks associated with sling delivery via a retro-pubic route.
Another object of the present invention to provide a novel surgical procedure for the formation and affixation of a suburethral sling whereby the opposed ends of the sling are secured near or at the posterior side of the pubic bone in the retropubic space with the opposed ends of the sling being secured to either the periosteum, Cooper's ligament, fascia or the pubic bone itself.
It is another object of the present invention to provide a novel surgical procedure for performing vaginal prolapse surgery, as well as provide devices for performing vaginofixation such that the vagina is surgically positioned according to its proper physiological orientation by anchoring the same in or around a target site of soft tissue, preferably situated at or near the obturator foramen.



BRIEF DESCRIPTION OF THE DRAWINGS
These, as well as other features of the present invention will become more apparent upon reference to the drawings wherein:
FIG. 1 is a frontal, cross-sectional view of the rectus fascia, pubic bone, urethra and vagina further depicting a sling member positioned about the urethra or in which the respective ones of opposed ends of the sling are secured to the pubic bone.
FIG. 2 is a side cross-sectional view of the anatomical structures depicted in FIG. 1 and further depicting the fastening arrangement by which the sling is anchored to the posterior portion of the pubic bone.
FIG. 3 is a prior art surgical instrument utilized to secure the anchor member depicted in FIG. 2 to the posterior of the pubic bone.
FIG. 4 is a cross-sectional view of the pubic bone having a prior art anchor device secured thereto.
FIGS. 5a and 5b are perspective views of prior art anchor devices.
FIGS. 6 and 6a are a perspective view of a surgical implant constructed in accordance with a preferred embodiment of the present invention for use in attaching sutures, grafts, tissues and the like to bone, periosteum, and soft tissue, and a side view of the same being inserted into bone.
FIG. 7a is a perspective view of a surgical implant constructed in accordance with a second preferred embodiment of the present invention for use in attaching sutures, grafts, tissues and the like to bone, periosteum, and soft tissue. Such figure depicts the surgical implant assuming a pre-insertion configuration.
FIG. 7b is a perspective view of the surgical implant of FIG. 7a with the implant assuming an expanded, anchoring configuration.
FIG. 8 is a perspective view of a surgical implant constructed in accordance with a third preferred embodiment of the present invention for use in attaching sutures, grafts, tissues and the like to bone, periosteum, and soft tissue.
FIG. 9 is a cross-sectional view of the pubic bone and periosteum thereof having an affixation device affixed with the latter, said affixation device being constructed in accordance with a fourth preferred embodiment of the present invention useful for securing sutures, grafts, tissues and the like to bone, periosteum and soft tissue.
FIG. 10 is a perspective view of the affixation device depicted in FIG. 9.
FIG. 11 is a cross-sectional view of the pubic bone and periosteum formed thereabout having an opposed end of a graft being secured thereto with an implantable tack, the latter being constructed in accordance with a fifth preferred embodiment of the present invention.
FIG. 12 is a cross-sectional view of the pubic bone and periosteum formed thereabout showing the graft depicted in FIG. 11 being secured thereto via the implantable tack.
FIG. 13 is a frontal view of the graft depicted in FIGS. 11 and 12 as secured to the periosteum via the implantable tack of the present invention.
FIG. 14 is a cross-sectional view further depicting an expanded view of the pubic bone with periosteum formed thereabout having an opposed end of the surgical sling affixed to the periosteum via a surgical staple, the latter being constructed in accordance with a sixth preferred embodiment of the present invention, the staple assuming a first insertion mode.
FIG. 15 is a side-view depicting the surgical staple depicted in FIG. 14 securing an opposed end of the sling to the periosteum, the staple assuming a second, affixation configuration.
FIG. 16 is a cross-sectional view of a suture having a plurality of affixation devices secured thereto, the latter constructed in accordance with a preferred embodiment of the present invention, for use in securing the suture along a desired pathway through tissue.
FIG. 16a is a perspective side view of FIG. 16.
FIG. 17 is a frontal, partially cross-sectional view of a sling being secured beneath a urethra and selectively secured into position to layers of muscle/rectus fascia via an anchoring plate fixation device as constructed in accordance to a preferred embodiment of the present invention.
FIGS. 17a and 17b are top views of the fixation device utilized in FIG. 17, the fixation device being shown in a first operative configuration in a second locking or closed configuration.
FIG. 18 is a perspective view of an anchoring system constructed in accordance with another preferred embodiment of the present invention.
FIG. 19 is a perspective view of an anchoring system constructed in accordance with another preferred embodiment of the present invention.
FIG. 19a is a partial cross-sectional view of the system depicted in FIG. 19 shown with a suture line extending through a channel defined thereby.
FIG. 19b is the cross-sectional view of FIG. 19a wherein the channel of said anchoring system is shown in a crimped configuration, the crimp maintaining the suture disposed within the channel in fixed position.
FIG. 19c is a cross-sectional view of the anchoring system depicted in FIG. 19 with one channel extending therethrough, said channel having two suture lines extended therethrough.
FIG. 20 is a perspective view of a sling deployment system comprised of a self-anchoring sling member comprised of an elongate sling having anchoring mechanisms formed on the opposed sides thereof, a respective one of the anchoring mechanisms being coupled with a manually operable sling deployment mechanism constructed in accordance with a preferred embodiment of the present invention.
FIG. 20a is a perspective view of the sling member depicted in FIG. 20.
FIG. 20b is a perspective view of the sling deployment mechanism depicted in FIG. 10.
FIG. 21 is a perspective illustration of the sling deployment system and components thereof as depicted in FIGS. 20, 20a and 20b wherein a respective anchor mechanism of the sling component is advanced into an incision made in a vaginal wall.
FIG. 22 is a perspective view of the self-anchoring sling depicted in FIGS. 20, 20(a) and 21 as positioned within the obturator foramen and operative to support the patient's urethra.
FIG. 22a is a perspective view of an embodiment anchoring mechanism as incorporated within the self-anchoring slings of the present invention as constructed in accordance with a preferred embodiment.
FIG. 22b is a perspective view of an embodiment anchoring mechanism as incorporated within the self-anchoring slings of the present invention as constructed in accordance with another preferred embodiment.
FIG. 22c is a screw-type anchor for use with the self-anchoring slings of the present invention as constructed in accordance with yet a further preferred embodiment.
FIG. 23 is a frontal view of a prolapsed vagina and the positioning of the obturator foramen relative thereto.
FIG. 24 depicts the vaginofixation of the prolapsed vagina in FIG. 23 utilizing a fixation device constructed in accordance with a preferred embodiment of the present invention.
FIG. 25 is an enlarged perspective view of the fixation device depicted in FIG. 24.
FIG. 26 is a perspective view of the fixation device of FIG. 25 as constructed in accordance with an alternative preferred embodiment of the present invention.
FIG. 27 is a perspective view of a percutaneously deployed sling for use in supporting the urethra for purposes of treating incontinence whereby the sling is delivered and deployed within the vagina.
FIG. 28 is a perspective view of the sling of FIG. 27 wherein one end of the sling is shown percutaneously anchored within the obturator foramen through the vaginal wall.
FIG. 29 is a perspective view of the sling of FIGS. 27 and 28 wherein each respective end of the sling is percutaneously secured to the obturator foreman with the sling positioned across the vaginal wall and underneath the urethra.
FIG. 30 is a side perspective view of a preferred percutaneous anchoring mechanism for percutaneously securing an end of a sling depicted in FIGS. 27-29 wherein the anchor is shown positioned within the lumen of a needle or cylinder and assuming a first compressed configuration.
FIG. 31 is a side perspective view of the anchoring mechanism of FIG. 30 wherein said anchoring mechanism is shown delivered through the lumen of the needle or over the needle and assuming a second anchoring configuration.
FIG. 32 is a perspective view of a suburethral support shown deployed within and anchored to the vaginal wall and operative to support the urethra extending thereabove.
FIG. 32a is a perspective view of the suburethral support of FIG. 31 shown under the vaginal epithelium to provide support to the urethra extending thereover.
FIG. 33 is a top perspective view of a sling having preferred anchoring mechanisms formed thereon shown with the anchoring mechanisms assuming a first insertion or ready state and a second anchoring or active state.
FIG. 34 is a perspective view of a syringe shown deploying a sling, the latter having anchoring mechanisms formed thereon one of which is mounted atop the distal end of the needle in a first insertion configuration and also shown in a second deployed state, an enlarged view of which is shown in FIG. 34a. 



DETAILED DESCRIPTION OF THE INVENTION
The detailed description as set forth below in connection with the appended drawings is intended as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the functions and sequences of steps for constructing and operating the invention in connection with the illustrated embodiments. It is understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments and that they are also intended to be encompassed within the scope of this invention.
Referring now to the drawings, and particularly FIGS. 6-15, there are shown various embodiments of the devices and systems of the present invention for securing sutures, grafts, tissues and synthetic materials, and the like to bone, periosteum and other soft tissue. As is well known in the practice of medicine, a wide variety of surgical procedures often necessitate the use of anchoring devices for purposes of attaching suture lines and grafts to bone. Exemplary of such anchoring devices include those disclosed in U.S. Pat. Nos. 5,370,662 and 5,443,482, the teachings of which are expressly incorporated herein by reference as frequently deployed in orthopedic, gynecologic, and urologic surgical procedures.
Among the more well-known surgical procedures incorporating the use of such anchoring devices include transvaginal sling surgery. As illustrated in FIGS. 1 and 2, such surgical procedure 10 involves the formation of a sling 12, which may comprise a harvested graft from a donor, or the patient's own tissue or an elongate strip of fabricated synthetic material or some combination thereof, that is introduced via an opening made to the vaginal wall 14 selectively positioned beneath the urethra 16. Once properly positioned, the sling 12 is secured into position. Unlike conventional transvaginal sling surgery, however, the sling 12 as depicted in FIGS. 1 and 2 is secured within the retropubic space via an anchoring mechanism 20, more clearly depicted in FIG. 2. As will be appreciated by those skilled in the art, the method by which the opposed ends 12a, 12b of the sling 12 are secured, namely to the posterior side of the pubic bone 18, represents a novel approach insofar as such sling 12 is stitched into position in the retropubic space 22, as opposed to the suprapubic space which is conventionally utilized. Unlike alternative methods of performing suburethral sling procedures, such transvaginal sling surgical procedure advantageously dispenses with the need to form an incision in the patient's lower abdomen 24 to thus enable the surgeon to gain access to the various anatomical structures, such as the abdominal fascia, pubic bone, or Cooper's ligament, to which the opposed ends of such sling are to be attached. As is well known, performing such abdominal incision increases operative time, increases the chances of infection, delays recovery time, and leaves undesirable scarring. Moreover, such sling procedure as depicted does not require that the sutures or opposed ends of the grafts be caused to penetrate through the intervening pubocervical fascia 28, depicted in FIG. 1, present in the retropubic space 22 which, as will be appreciated by those skilled in the art, prevents ingrowth of the opposed ends 12a, 12b of the sling 12 sought to be secured in position.
As a result of the support imparted by the sling 12 to the urethra 16 during such times as the patient makes provocative gestures, as occurs during coughing, such sling 12 serves as support that prevents incontinence occurring during such provocative event. To insure that the sling 12 is positioned such that the same imparts an optimal degree of support to the urethra 16, it is contemplated that a tension/pressure monitor 26, as depicted in FIG. 1, may be utilized during the performance of such surgical procedure. Such tension/pressure monitors 26 may take any of a variety of forms such as those disclosed in Applicant's co-pending U.S. patent application Ser. No. 09/157,466, the teachings of which are expressly incorporated herein by reference.
In order to provide an anchoring mechanism necessary to secure the sling into position during transvaginal sling procedures, however, there must be deployed the aforementioned anchoring device 20. As depicted in FIG. 3, there is shown one such anchor deployment device 30, also known in the practice of medicine as a bone screw inserter, which allows for bone-screw fixation. Perhaps the most well-known of such devices include the In-Fast and In-Tac bone screw and bone anchor fixation devices previously produced by Influence, Inc. of San Francisco, Calif. Such affixation devices are formed to have a generally “U” shape as shown that enables the distal-most end 32 thereof to be easily inserted into the vagina and be correctly positioned on the posterior portion of the pubic bone. As will be appreciated by those skilled in the art, the distal-most end 32 of such fixation deployment devices 30 are designed to deploy an anchoring device by screwing or embedding the same into bone at a specific site.
As more clearly seen in FIG. 4, once deployed, the anchor devices 34 are advanced through the periosteum 36 and become embedded into the bone. To provide means for affixing the suture lines or grafts thereto, there is typically formed on the anchor devices a post, hook or eyelet, as shown. Among the more well-known designs of such anchoring devices currently in use include those depicted in FIGS. 5a and 5b. The first such prior art device 34 depicted in FIG. 5a comprises a self-tapping bone screw 40, typically made of titanium, having an eyelet 42 formed thereon to which the sutures 44 or other material may be attached, as shown in FIG. 4. In the alternative prior art configuration 50 depicted in FIG. 5b, the anchor fixation device comprises an anchor portion 52, which may take the form of a conical member having a shaft or attachment member 54 extending therefrom, the latter being formed to have one or more apertures 56 thereon to which sutures 58 or other material may be attached. Such devices are typically “shot” into position via spring-loaded insertion devices, such as the In-Tac device discussed above.
Although such prior art anchor devices, such as those depicted in FIGS. 5a and 5b, generally provide sufficient support to the various sutures and grafts affixed thereto, such fixation devices 34, 50 suffer from numerous drawbacks. With respect to the bone-screw fixation devices 34, such devices are difficult to deploy and fix into position. In this regard, such screw fixation devices 34 require the battery-operated inserters 30 depicted in FIG. 3 that must necessarily drill the fixation device 34 into position. Removing such devices 34 is further problematic insofar as the same must necessarily be unscrewed from their position, which as those skilled in the art will appreciate requires meticulous precision.
Anchor devices 50 are also problematic insofar as the same are not only difficult to deploy, typically via a spring-loaded gun mechanism, but are often times irretrievable once deployed. In this regard, once such fixation device 50 is sufficiently embedded within the bone, the anchor portion 52 thereof cannot be reversibly extracted from its embedded position within the bone. As such, to the extent such anchoring devices 50 have been inappropriately deployed (e.g., deployed at a wrong location), there is little, if any, recourse to retrieve the same. Additionally, such prior art bone screws 34 and anchors 50 have the ability to become loosened and dislodged from their position once a sufficient amount of pressure is applied thereto over time. The probability of becoming dislodged is further increased in those situations where a persistent strain is applied to such devices in a single direction, as can occur when a suture or graft is hung upon the anchoring device. In such circumstances, surgical intervention is necessary to not only retrieve the dislodged screw or anchor, but also deploy yet another of such devices as per the original surgical procedure.
Referring now to FIGS. 6-8, there are shown three embodiments 60, 70, 80 of a surgical implant insertable into bone (as well as periosteum, ligaments, and other soft tissue) which are useful in providing means to secure sutures, grafts, tissues, synthetic materials, and the like to bone, as may be necessary for a given surgical procedure. Each of the embodiments depicted have the advantage of being easy to insert and remove, as well as provide an equal, if not greater, degree of support than prior art devices. Such novel implants further have the ability to remain more firmly seated into position once embedded in bone than such prior art devices.
Referring now to FIG. 6, there is shown a first embodiment 60 of the surgical implant. As illustrated, the implant 60 comprises a piton member 62 having an eyelet 64 formed thereon. The piton member 62 preferably comprises an arcuate blade having proximal and distal ends, the latter being designed to be inserted into bone such that as the same is advanced therein, there is defined a penetration pathway as indicated by the latter “A”. Once inserted into the bone tissue at the target site of fixation, the eyelet portion 64 of the implant will extend therefrom as illustrated in FIG. 6a, which will thus provide the necessary structure to which the sutures 66, grafts and the like may be attached. Although the embodiment shown depicts the use of an eyelet 64, it will be recognized that other substitute support or attachment structures, such as posts, hooks and the like, including even sledged-on fixation of the suture or graft to the piton, may be utilized as may be necessary for a given application.
As will be appreciated by those skilled in the art, by inserting the implant in the direction indicated by the letter “A”, it will be appreciated that to the extent a force is applied thereto, such as by suture 60 or graft, via a vector having an orientation in the general direction of letter “B”, such force will necessarily cause the implant to wedge deeper and become more secure into position within the bone 38, and will thus cause the same to become more rigidly affixed into position unlike prior art devices which have a tendency to become loose and potentially dislodged with the application of greater amounts of pressure and strain thereto.
Such implant further provides the advantage of being easy to remove. In this regard, due to its orientation within the bone, to the extent a pulling force is applied to the implant in the direction indicated by the letter “C”, such implant 60 will be caused to become easily dislodged from its seated position to the extent it becomes necessary to remove and/or reposition such implantable fixation device. Such ease of removal advantageously provides for a simpler, less traumatic procedure than those procedures involving prior art screw and anchor fixation devices.
Referring now to FIGS. 7a and 7b, there is shown a second embodiment 70 of a surgical implant designed to be embedded within bone or soft tissue to which may be attached sutures, grafts and the like. Such embodiment 50, similar to the embodiment 60 depicted in FIG. 6, is specifically designed such that the same becomes more firmly seated into position within the bone to the extent a force is applied in a first direction, as indicated by the letter “D”. FIG. 7a depicts the surgical implant 70 assuming an insertion configuration which enables the same to be implanted into bone at a target site selected by the surgeon. Such implant is provided with a piton member 72 having opposed flanges 72a, 72b formed at the distal end thereof that are designed to spread apart in the directions “Y” and “Z” and become more deeply embedded within the bone to the extent a pressure is applied in a direction indicated by the letter “D”. Although the specific embodiment 70 shown depicts that the opposed flanges 72a, 72b flare outwardly, it is to be understood that such flanges can be designed to curve inwardly. Moreover, although such embodiment depicts two opposed flanges, it should be recognized that such implant may have three or more flanges and that each respective flange may be designed to flare outwardly, as shown, or hook inwardly as may be needed to a specific application.
Once firmly embedded within the bone, the eyelet portion 74 of such implant may be utilized to attach sutures and the like. Of additional advantage, similar to the embodiment shown in FIG. 6, is the fact that such implant 70 may further be easily removed to the extent a pulling or opposed force is applied in the direction indicated by the letter “E”. As such, to the extent it becomes necessary to remove or otherwise reposition such anchoring device, such anchoring device 70 may be easily dislodged by application of such force. As will be appreciated, such design allows for easier and less traumatic removal than prior art anchor and screw fixation devices.
Referring now to FIG. 8, there is shown a third embodiment 80 of a surgical tissue implant useful as a fixation device to attach sutures, tissues, and grafts to bone, periosteum, and soft tissue. As per the other embodiments, such implant 80 includes a piton member 82, preferably formed as a sickle-shaped member, having an eyelet 84 formed on the proximal end thereof. Such implant 80 is designed to be embedded into the bone or other tissue in the direction indicated by the letter “F”. Once so secured into position, forces may be applied thereto, via eyelet 84 in the direction indicate by the letter “G”, which will thus work to further embed the piton member 82 into the bone via the penetration pathway defined by the distal end of the piton member 82 so that the implant becomes more secure therewithin. Likewise, to the extent it becomes necessary to remove such device 80, such device may be removed by pulling or otherwise rearwardly retracting the implant in the direction indicated by the letter “H” which, as discussed in the other embodiments, provides for simpler and less traumatic procedure than prior art methodology.
Although each of the aforementioned embodiments 60, 70, 80 are particularly well-suited for insertion into bone, it should be recognized by those skilled in the art that the same may be utilized to affix sutures, grafts, tissues, synthetic materials and the like to connective tissue, and in particular, periosteum as per the further embodiments discussed more fully below. In this respect, each of the aforementioned embodiments 60, 70, 80 may be designed such that the piton portion thereof pierces into and becomes embedded within such tissue and remains firmly seated thereat so that the attachment mechanism formed thereon can provide a service to which the sutures, grafts and the like may be attached.
As will further be appreciated, in each of the embodiments 60, 70, 80 depicted in FIGS. 6-8, the orientation of each of the implants as the same are embedded into the bone or tissue is crucial for the necessary operation thereof. In this regard, it will be appreciated that the implant must be oriented such that the resultant tension or strain applied thereto will cause the piton portion thereof to advance in the penetration pathway defined thereby. Otherwise, to the extent tension is applied in an opposed direction, such implant may be caused to dislodge from its seated position. As a consequence, it will be appreciated that the implants of the present invention must be selectively positioned, and that the surgeon must take great care in making certain that the ultimate tension applied thereto is oriented to facilitate the attachment of the implant to the bone, as opposed to casing the same to become dislodged therefrom.
Referring now to drawings 16 and 16a, there is shown an additional surgical tissue implant 500 useful as a fixation mechanism to attach sutures, tissues, and grafts to soft tissue. In the embodiment depicted, which is shown being deployed for use in securing a sling 502 into position to provide support to a urethra 504, the implant 500 comprises a plurality of dual-prong anchoring mechanisms 506 disposed linearly about a suture-like cord or line 508, which enables such line to advance through the tissue in one direction, but resists rearward movement in the opposite direction. As shown, the implants can be configured to have a generally V-orientation such that the suture 508 bisects such implant and extends therethrough. As will be recognized, each respective implant will have an eyelet or other aperture through which the suture, which may be a suture line or suture-like cord, may be extended. As will be further recognized, although depicted as having a generally V-orientation, it will be appreciated that the anchoring mechanisms 506 may be arranged in a staggered configuration, extend along only one side of the suture 508, or otherwise be radially disposed about a length of the suture 508. Accordingly, it will be recognized that numerous other designs are contemplated that fall within the scope of the present invention.
By linearly disposing the implants along the suture line, the suture line may be advanced in a direction indicated by the letter “X”, but yet resist movement in the direction indicated by the letter “Y”. Advantageously, such arrangement enables the suture line 508 to be pulled into a desired position such that the sling 502 supported thereby can be caused to provide a selective degree of support to the urethra 504 or otherwise maintain a desired distance therefrom. Furthermore, to the extent the suture line 508 with implants 506 or the sling 502 supported thereby are inappropriately positioned, it will be recognized by those skilled in the art that, if necessary, the suture line 508 can be cut and the suture with implants affixed thereto extracted completely from the patient's body (and replaced, if necessary or desired). Such design further advantageously permits for the adjustment of the suture line and/or the sling supported thereby not only intro-operatively, but also post-operatively insofar as the suture line 508 can be extended further, for example, in the direction indicated by the letter “X”, as may be desired to the extent it is necessary to add extra tension to the suture line 508. Moreover, as discussed above, the suture line 508 can be removed entirely from a patient's body. In such circumstances, a second suture line 508 having such implants attached can be substituted in its place.
An example of the application of such system is illustrated in the side-perspective view of FIG. 16a. As illustrated, the sling 502 is positioned about the urethra 504 and supported upwardly by the suture-like cord 508 having the fixation devices 506 linearly disposed upon the length thereof.
In this regard, each respective suture, cord, etc. 508 supporting each respective side of the sling 502 may be selectively caused to remain securely embedded at a desired position within the rectus fascia 510 or other soft tissue. As will be appreciated by those skilled in the art, due to the ability of the suture lines or suture-like cords 508 with the novel implant fixation devices 506 affixed thereto, the surgeon can incrementally increase the pressure exerted by the sling 502 against the urethra 504 or the distance by which the sling 502 extends from the urethra 504 merely by incrementally advancing the suture line/cord 508 through the rectus fascia 510. As will be appreciated, there has not heretofore been available any mechanism available which provides a surgeon with the ability to merely advance a suture through tissue and have the same remain firmly secured into position. Rather, and as discussed more fully in the background, surgeons have had to identify a target site to which such sling can be anchored and thereafter tie the same into position such that the sling maintains the desired degree of support or distance from the urethra. As is widely recognized, malposition of the sling has been deemed the cause for creating a significant problem and substantially high morbidity for those patients having undergone sling surgery.
In a similar, yet further advanced variation of the embodiment depicted in FIGS. 16 and 16a, there is shown in FIGS. 20-22c a system 800 comprised of the combination of a deployment mechanism 804 and surgical implant 802, the latter being configured as per tissue implant 500 that enables a sling portion 806 to be secured into position via the use of anchor mechanisms 808a, 808b, the latter of which are operative to advance through tissue in one direction but resist rearward movement in an opposite direction. In this regard, and as more clearly depicted in FIG. 20a, implant 802 will preferably be comprised of an elongate sling portion 806, which as those skilled in the art will appreciate may take any of a variety of natural tissues, synthetic material or some combination thereof operative to become implanted within the body and support a specified anatomical structure. Affixed on the opposed ends of the sling 806 are dedicated anchor mechanisms 808a, 808b which are affixed to the respective ends of the sling 806 via a coupling apparatus 810, which may likewise comprise any of a variety of attachment mechanisms known in the art.
Each respective anchor mechanism 808a, 808b may be configured per a variety of embodiments, discussed more fully below, that can enable each mechanism to be advanced into a target site of tissue in one direction yet resist movement when pulled in an opposed direction. In this regard, each respective anchor mechanism 808a, 808b, will be preferably formed upon the opposed ends of the sling 806 such that the anchor mechanisms 808a, 808b can be advanced through a target site of tissue in dissimilar directions, such as opposed directions, to thus enable the sling 806 to stretch beneath and ultimately support the target anatomical structure as previously discussed above with reference to FIGS. 1 and 16 (as well as FIG. 22 more fully below). To achieve that end, anchor mechanisms 808a, 808b may be provided with generally arrowhead-shaped members, V-shaped members, Y-shaped members, or any structure well-known in the art that facilitates the ability of the anchor mechanisms 808a, 808b to cut through and become positioned or embedded within a target site of tissue such that the same can become resident or fixed in position. In this regard, it is contemplated that the anchor mechanisms 808a, 808b, may be provided with a textured surface or otherwise be provided with materials to facilitate the ingrowth of tissue about the same to thus enable the anchor mechanisms to remain firmly seated into position once implanted into the body. Illustrative of such an embodiment would include the use of a mesh material cut such that the strands of the fabric of such mesh facilitate movement when advanced in a first direction but resist rearward movement due to the frayed, outwardly-flaring strands of the mesh that would be oriented to cause such loose ends to resist or become biased against rearward movement.
To facilitate the ability of the implant 802 to be accurately and securely placed into position within the body, a deployment mechanism 804, more clearly depicted in FIG. 20b, may be utilized. Although the implant 802 may be surgically implanted into position utilizing a variety of well-known surgical techniques, it is believed that deployment mechanism 804 may be useful to more quickly, accurately and atraumatically position and securely affix such implant 802 into position. As illustrated, the mechanism 804 comprises a manually operable handle 812 having a deployment member 818 extending distally therefrom. An actuator mechanism 814 is disposed within the handle 812 and includes an elongate shaft portion 816 disposed axially within the deployment member 818 such that the distal-most end thereof 816a is caused to selectively protrude through a distal-most opening 818a of the deployment member 818. The actuator 814, and more particularly the shaft 816 thereof may be selectively coupled to an anchor mechanism such as 808a depicted in FIG. 20 to thus direct and position the anchor mechanism 808a at a target site within the body. Such deployment member 818 may be configured to have a variety of sizes and shapes, and may be specifically configured for deployment of an implant 802 at a particular target site within the body. For use in deploying implants, such as 802, to provide suburethral support for the treatment of incontinence, it is contemplated that the deployment member 818 will have a generally arcuate shape and may further be preferably configured to deploy the implant 802 within the obturator foramen of a patient via a trans-obturator route, discussed more fully below.
To facilitate the interconnection between the implant 802, and more particularly an anchor mechanism 808 thereof, with the deployment mechanism 804, it is contemplated that such anchor mechanism 808 may be pre-loaded in a cartridge, not shown, the latter being selectively inter-connectable with the deployment member 818. In such embodiment, it is contemplated that such cartridge will be operative to form a rigid casing about the anchor mechanism 808 to thus enable the anchor mechanism to be easily affixed into position on the deployment member 818 and thereafter surgically guided into position such that once a target site has been accessed, the anchor mechanism 808 can be selectively deployed from the cartridge. To help enable the cartridge to reach such desired target site, it is contemplated that such cartridge may be provided with a cutting apparatus or sharpened cutting edge to thus enable the same to cut and advance through tissue. To that end, it will be readily appreciated by those skilled in the art that many possible designs and configurations will be readily apparent to effectuate that end.
Referring now to FIG. 21, there is shown the use of the system 800 to deploy the implant 802 via the deployment mechanism 804. In the procedure illustrated, such implant 802 is being deployed through an incision 822 formed within the vaginal wall 820 to thus enable a urethra 824 to ultimately become supported thereby. To that end, it is contemplated that such deployment may take one of two forms. According to a first embodiment, the anchor mechanisms 808 housed within the deployment mechanism are compressed to assume a first deployment configuration and, once released therefrom, assume an expanded configuration that enables the same to remain fixed in position. Alternatively, the anchor mechanisms may simply assume a single state and deploy directly into tissue at a desired surgical site. As will be appreciated, however, other techniques will be readily apparent to those skilled in the art for use in deploying the anchor mechanisms of the present invention.
In this regard, the procedure depicted in FIG. 21 represents deployment of a suburethral sling via a trans-obturator route. As is well-known, most slings are currently delivered via a retropubic route, and although the implants 802 and deployment mechanisms 804 can readily be adapted and utilized for such procedures, current methodology suggests that implant or sling deployment made via a trans-obturator route substantially minimizes well-known risks associated with bleeding and/or intestinal or bladder injury associated with surgical sling implant procedures utilizing a retropubic route to gain access to the surgical site. In this regard, current medical literature strongly suggests that a trans-obturator route substantially avoids the blood vessels existing within and above the pubocervical fascia, bladder and the intestines. Moreover, securing slings into position according to conventional methodology utilizing retropubic access often times results in sling dislodgement or misplacement, especially so when conventional sling anchoring fails due to the pull or dislodgement of anchors and/or mesh when the patient engages in a violent provocative event, such as coughing, vomiting or some other violent activity.
As shown, the deployment mechanism 804 is selectively positioned such that an anchor mechanism 808a of the sling is advanced into the incision 822 via distally-extending deployment member 818. The actuator 814, and more particularly the shaft 816 extending therefrom, is operative to advance the anchor member 808a away from the distal end 818a of the member and through the soft tissue until the same becomes within a target site of tissue. To facilitate the ability of the mechanism to gain access to the target site, it is contemplated that the distal-most end 818a of deployment member 818 may be provided with a sharpened cutting surface to thus enable the same to be advanced through tissue via single incision 822. In an alternative approach, the distal-most end 818a will cooperate with anchor mechanism 808a to thus enable the implant to be advanced into and positioned through percutaneous incision 822 made in the vaginal wall 820. Along these lines, it is contemplated that once an anchor mechanism 808a is sufficiently positioned, the second anchor mechanism 808b will be affixed to the distal-most end of the deployment member 818 of mechanism 804 and likewise be secured into position by selectively advancing the anchor mechanism 808b through the same incision but in an opposed direction relative the first anchor mechanism 808a, the latter having been secured into position and thus operative to resist rearward movement.
As will be readily appreciated by those skilled in the art, by merely advancing the anchor mechanisms 808a, 808b, in generally opposed directions, the anchor mechanisms will thus be operative to stretch out the sling portion 806 such that the same can selectively and accurately be positioned about a target anatomical structure. In this respect, it is contemplated that the sling portion 806 can be positioned such that the same maintains a specified degree of tension or support to an anatomical structure, such as the urethra 824 or some part of the vagina as in a colporrhaphy or colpopexy, or may otherwise be positioned such that the same maintains a desired spatial relationship and orientation relative an anatomical structure. Of additional advantage is the fact that each respective opposed anchor mechanism 808 of the implant 802 can be positioned within the body via a single incision or point of access, which thus eliminates the need for a second incision or access point to be formed in the body, as is known per conventional sling placement which typically requires that separate access points or incisions be made for each fixation point, (i.e., the points at which the opposed ends of the sling are fixed into position within the body).
As a consequence, and shown more clearly in FIG. 22, the implant 802 may be selectively positioned such that the sling 806 component thereof properly supports the urethra 824 as is desired to achieve a favorable outcome. In the placement of the implant 802 as depicted, however, the same illustrates the fixation of the implant 802, and more particularly the sling 806 thereof, within the obturator foramen of pelvis 830, as defined by the pubis 834 and ishium 832 regions thereof. In this regard, each respective anchor mechanism 808a, 808b becomes embedded within a target tissue site, such as the pubocervical fascia, toward or through the obturator foramen and ultimately positioned in the desired locale relative the bladder 828 and, more particularly, urethra 824 extending therefrom.
As discussed above, anchor mechanisms 808a, 808b will preferably be formed or attached to the opposed ends of the sling 806 to thus enable the opposed ends to be stretched out and positioned in the desired manner. To achieve that end, it is important that the anchor mechanisms 808a, 808b be configured to thus enable the same the be easily advanced into position, to thus achieve the desired goal of fast, accurate and atraumatic placement, but at the same time provide the necessary degree of anchoring support to thus define a secured point of fixation from which the sling 806 can extend and ultimately impart the desired degree of support. FIGS. 22a-22c depict various embodiments of the anchor mechanism 808 that are contemplated to achieve those objectives.
Referring now to FIG. 22a, there is shown an enlarged view of an anchor mechanism 808 similar to that depicted in FIG. 22. As illustrated, the anchor mechanism comprises a plurality of anchor bodies 840 each having opposed, outwardly extending anchor members or arms 842 which thus define a generally Y-shaped body. Each respective anchor mechanism 840 is disposed upon elongate cord 844, which may take the form of a suture or other implantable material well-known to those skilled in the art. To facilitate the ability to manipulate anchor mechanism 808, elongate cord 844 may be formed to have a desired stiffness, and may be formed as a cable having reinforced material therein operative to provide some structural rigidity as may be desired in some applications.
FIG. 22b represents a similar embodiment whereby a plurality of generally chevron-shaped anchor members 850 are disposed upon the length of an elongate cord 854. Each respective chevron-shaped member 850 is provided with outwardly-extending members or arms 852 that provide a means to anchor the same into tissue. Both the embodiments depicted in FIGS. 22a and 22b, similar to those discussed above in relation to the embodiment depicted in FIGS. 16 and 16a, essentially comprise a plurality of dual-pronged anchor mechanisms disposed linearly about a cord-like suture of various malleability to thus enable the same to advance through tissue in one direction, either by pushing or pulling, but resist rearward movement in an opposite direction. In this respect, the generally Y-shaped and generally chevron-shaped embodiments depicted in FIGS. 22a and 22b are similar to the generally V-oriented embodiment depicted in FIGS. 16 and 16a to thus enable a plurality of anchoring members to be disposed upon a length of cord, suture and the like, to be linearly disposed there along. It will be recognized, however, that numerous other designs are contemplated that fall within the scope of the present invention. As discussed above, such anchor mechanism may comprise selectively oriented segments of mesh material that are selectively oriented such that the loose or frayed fiber ends of the mesh extend in a rearward configuration to thus resist rearward movement.
Referring now to FIG. 22c, there is shown a similar type embodiment whereby the anchor mechanism 808 is defined by a screw mechanism 862, having a distal-most end 860 operative to advance into tissue along a central axis 864, the latter of which may be a cord or cable having a requisite stiffness. Alternatively, screw mechanism 862 and central axis 864 may comprise a firm yet malleable material suitable for implantation within the body. In such embodiment, it is contemplated that the screw-anchor mechanism 862 can be advanced into a target site of tissue by either blunt advancement or rotational advancement, the latter being facilitated by use of a deployment system 804 whereby the deployment member 818 is operative to selectively position the same within a tissue mass.
As will be appreciated, alternative anchoring mechanisms are contemplated and will be readily known to those skilled in the art. Along these lines, it is contemplated that the anchor mechanisms may be formed to be operatively transitional between a first compressed state whereby one or more of the anchor members, and more particularly the outwardly extending prongs thereof as depicted in FIGS. 22a, 22b are advanced into position within a target site of soft tissue and a second operative configuration whereby the anchor members and/or prongs thereof expand to become fixed into position at the appropriate target site of soft tissue.
Although not shown, in order to achieve such selective placement of the anchoring mechanisms capable of operatively transitioning between such first and second configurations, it is contemplated that such anchor mechanisms may be selectively positioned via the use of conventional deployment techniques and devices, such as catheters, needles, and/or guide wires. Exemplary of the latter, as utilized to position such operatively transitional anchor mechanisms for use in sling surgery, would be accomplished via the introduction of the guide wire through and then under the vaginal wall and then into the tissue adjacent to the vagina. Once properly positioned, an expansion is then effectuated along the guide wire within the vaginal, via the use of conventional coaxial or balloon systems or other well-known spreading devices that, following deployment, are thereafter removed. As per the procedures discussed above, it is understood that once a first anchor mechanism is deployed, a similar procedure must necessarily be followed to deploy the second respective anchor mechanism such that the sling disposed therebetween is operatively positioned to impart the desired support or positioning at a specified anatomical site.
Another example for use in deploying such operatively transitional anchor mechanisms would include the use of an elongate sheath that is focused as a portion of the deployment member 818 is operative to retain a multiplicity of anchor mechanisms, and in particular a plurality of anchor bodies, such as 840 depicted in FIG. 2, within an elongate lumen thereof. It is contemplated that such sheath will have a sharpened distal end to thus enable the same with anchor bodies retained therein to be selectively positioned such that the prongs or other attachment elements thereof do not cut, engage with or otherwise become prematurely deployed. Along these lines, it is contemplated that such sheath deployment member would ideally be utilized to selectively position a multiplicity of anchor members positioned along a suture line or other cord-like structure, and may further include mechanisms to facilitate the deployment of such anchor mechanisms to either extend from or be withdrawn within the lumen of such sheath. It is likewise contemplated that such sheath can be used to deploy a plurality of linearly-arranged radio opaque markers, such as the TINED lead system of radio opaque markers produced by Medtronic, Inc. which have a configuration similar to that of the anchor bodies depicted in FIG. 22A. In use, it is contemplated that such sheath may be provided with an elongate slot formed along a portion the length thereof that enables the cord-like structure having one or more anchor mechanisms formed thereon to be pulled or pushed into the sheath as well as allow the sheath to be removed following the placement of the anchor mechanism deployed thereby.
Referring now to FIGS. 27-34a, and initially to FIG. 27, there is shown yet a further novel surgical implant 300 and method of deploying the same that advantageously allows for the percutaneous attachment of such implant into position to thus enable an anatomical structure to be properly supported thereby yet without having the need to surgically place the implant entirely within a patient's body. As illustrated, the implant 300 will comprise an elongate sling of the aforementioned variety having first and second ends 302, 304. Attached to each respective end 302, 304 are anchoring mechanisms 306, 308, which may take any of the aforementioned configurations discussed herein, and in particular those embodiments depicted in FIGS. 11-16a and FIGS. 20-22c and FIGS. 23-26. In this regard, such anchoring mechanisms are preferably configured such that the same are operative to be inserted and advanced through tissue in a first direction yet resist rearward movement when pulled in an opposed direction. Such anchoring mechanisms 306, 308 will further preferably be provided with a sharpened distal tip to facilitate the ability of the same to be positioned percutaneously, as discussed below and in other embodiments disclosed herein.
Unlike prior art slings, the implant 300 as shown in FIG. 27, is operative to be anchored into position percutaneously, and is specifically illustrated in FIG. 27 for the purpose of providing suburethral support. To that end, a respective one of the ends 302 of the implant 30 will be advanced into the vagina 310, which extends underneath and in generally parallel relation to the urethra 312 extending from bladder 314. Once sufficiently advanced into the vagina, the anchoring mechanism 306 will be pierced through the vagina through percutaneous entry site 318 and allowed to anchor within a soft tissue mass, bone, or periosteum, as per any of the aforementioned embodiments. In one particularly preferred embodiment, the anchoring mechanism 306 will be advanced through the vagina 310 to a point sufficient to where the same can be secured within the obturator foreman 316. As will be readily appreciated by those skilled in the art, the term percutaneous or percutaneously, as used herein, is meant to encompass anything passing through the skin, and in particular epithelium, and expressly includes the epithelium of any particular body cavity, such as the vaginal epithelium as referenced in the drawings.
The respective other anchor mechanism 308 attached to the other respective end 304 of implant 300 is similarly pierced the vaginal wall at percutaneous entry site 320 and likewise advanced therethrough to where the same preferably can be anchored within the obturator foreman 316, as illustrated in FIG. 29.
As further illustrated in FIG. 29, once secured into place, the implant 300 will thus have the opposed ends 302, 304 thereof anchored via dedicated anchoring mechanisms 306, 308 in a percutaneous manner. The elongate strip or sling portion of the implant 300, however, will extend across the vaginal wall and exterior to the points at which the implant 300 are secured into position. As such, the sling can be secured into position and thereafter provide suburethral support without the main body of the implant 300 having to be surgically implanted within the patient. In this regard, the suburethral support is provided by that portion of the implant 300 extending across the vaginal wall itself.
As will be readily appreciated by those skilled in the art, by securing the implant 300 in such a manner advantageously allows for very rapid affixation that substantially minimizes the trauma, bleeding, time and precise surgical skill necessary to the extent the implant 300 were to be secured into position via prior art surgical techniques. Accordingly, it is contemplated at the present time that the implant 300, by virtue of its percutaneous attachment mechanism, can be secured into position in a medical office based setting, as opposed to the need for a hospital or surgical facility where sling implantation must typically be performed. In addition, anesthesia may be administered locally at the site of implantation of the anchoring mechanism to avoid general or regional anesthesia.
With respect to the implant 300, the same may be fabricated as per any conventional sling, graft, support as is currently practiced in the art or developed hereafter. Along these lines, the implant 300 can be formed from mesh, wire, synthetic material, absorbable material, natural material (i.e., tissues harvested from the patient or donor), or any other material well-known to those skilled in the art. Along these lines, it is contemplated that the implant 300 may be modified to facilitate the ingrowth of tissue to thus enable the same to be permanently seated in position, or may be scarred in place, which can be accomplished by a wide variety of techniques known in the art, such as through electrocauterization. With respect to the latter, the electrocautery energy will likely cause the implant 300 to cut or pass into or through the vaginal epithelium.
Referring now to FIGS. 30 and 31, there is shown a preferred embodiment of a percutaneous anchor mechanism for use in the implants discussed above with respect to FIGS. 27-29. Per the other types of anchoring mechanisms disclosed in the present application, it is contemplated that the percutaneous anchoring mechanism 306a, depicted in FIG. 30, will be operative to be advanced in one direction and resist movement in a rearward direction. One preferred method of deploying such anchoring mechanism 300a is through delivery by needle or cylinder whereby the anchoring mechanism 306a is disposed within the lumen of the needle 330 such that the prongs 307 thereof are shown assuming a compressed or retracted configuration. Once the needle 330 is sufficiently advanced to the target site to which the anchoring mechanism 306a is to be deployed, the anchoring mechanism 306a is deployed from the needle 330 which thus enables the prongs 307 to assume a second, expanded anchoring configuration, as shown in FIG. 31. To achieve that end, it is contemplated that the prongs 307 of anchoring mechanism 306a may be formed from a plastic deformable material or possibly formed from a transitional metal such as nitinol, which is operative to transition to a second configuration upon exposure to a higher temperature, such as regular body temperature, as discussed above.
In addition to being disposed and delivered through a needle or cylinder, it is contemplated that the anchor mechanism may be designed to be deployed over a needle or through a needle, as depicted in FIG. 34. In this regard, a respective one of anchor mechanisms will be deployed over a needle and released therefrom. In such embodiment, as depicted in FIG. 34a, the end of such anchoring mechanism may be caused such that the prongs or other attachment devices formed on such anchor mechanism spring open upon release from the needle.
When the anchoring mechanism 306a assumes its expanded configuration, as shown in FIG. 31, the extended nature of the prongs 307 can further preferably function as a screw, such that when rotated in the direction shown, provides yet a further post-delivery mechanism to enable the anchor 306a to advance in a forward or rearward direction by merely twisting or screwing the anchor in one direction or the other. As will be readily appreciated by those skilled in the art, there has not heretofor been available any type of anchoring mechanism that is operative to be selectively adjusted in both forward and rearward directions once implanted within the body, especially within soft tissue.
In a similar embodiment depicted in FIG. 33, each respective anchoring mechanisms formed upon the sling can be formed to have a first screw-type configuration shown in the top portion of FIG. 33, which depicts a ready state or insertion configuration. While in such configuration, the same may be selectively advanced forwardly or rearwardly within a mass of soft tissue by simply rotating such anchoring mechanism. To the extent the same has been secured at a target site, the same may be caused to assume an active state, shown in the lower portion of FIG. 33, which thus enables the anchoring mechanisms to deform in such a manner whereby the same remains secured into position. Such transition between the ready state and active state can be accomplished by a variety of means, such as by the use of a transitional metal, such as nitinol or by physically deforming the anchor mechanisms, such as pulling or retracting the anchor mechanisms such that the same deform as shown.
Referring now to FIGS. 32 and 32a, there is shown a second embodiment of a percutaneously delivered support mechanism operative to impart urethral support for the treatment of incontinence. As illustrated, the implant 340 is comprised of an elongate backing or sling portion 342 having anchoring mechanisms or elements 344 formed on the respective ends thereof. As per the embodiment discussed with respect to FIGS. 27-31, the implant 340 is positioned within the vagina and underneath the urethra extending thereabove. The anchoring elements 344 are thus percutaneously compressed into the vagina which causes the implant 340, and more importantly the support portion 342 thereof to remain secured into position and provide support to the urethra 312. With respect to such anchoring mechanisms 344, the same may take any of those anchoring mechanisms disclosed herein suitable for such procedure, and in particular those disclosed in FIGS. 9 and 10. As will be readily appreciated by those skilled in the art, the implant 340 can thus enable a suburethral support to be quickly and accurately secured into position without ever having to form any type of incision within the patient, which thus dispenses with the traditional surgical procedures associated with performing sling surgery and the like.
To better facilitate the ability of the implant 340 to remain in position and provide the desired degree of support, there is shown in FIG. 32a the surgical implantation of the implant within the vaginal epithelium. In this regard, an incision is made in the vaginal epithelium whereby the backing 342 with anchoring mechanisms 344 formed thereon is inserted therewithin such that the anchoring mechanisms extend within and become attached to the upper vaginal epithelium. The lower epithelium will, in time, scar over and grow about the backing 342 thus causing the same to remain in its seated position indefinitely. To the extent desired, it is contemplated that backing 342 may be operative to receive an electrocauterizing current to thus facilitate the ability of the same to cause scarring to thus facilitate the ability of the backing 342 to remain secured within the vaginal epithelium.
With respect to both of the preferred embodiments discussed above with respect to FIGS. 27-32a, it is contemplated that the same may not be utilized only for the use in treatment of incontinence, but can be used in other parts of the body. Similarly, it is contemplated that in such embodiments, and in particularly the embodiment depicted in FIGS. 27-29, can be used in the treatment of prolapse. Accordingly, it is contemplated that such percutaneously anchored sling may be utilized in a significant number of medical procedures.
Referring now to FIG. 17, there is shown yet another embodiment of a device 600 for attaching sutures, grafts, tissues and the like into position in the human body. As illustrated, such embodiment comprises an anchoring disc or plate 602 which may be secured to or rest upon an anatomical structure, and more particularly a layer of muscle 604 or rectus fascia 606 as shown. As illustrated, which again is in the context of securing a sling 502 into position such that the urethra 504 is supported thereby, suture lines or suture-like cords 508 on each opposed end of the sling 502 are secured by dedicated anchoring plates 602, the latter being supported by a layer of muscle and/or layer of rectus fascia. As shown, the anchoring plates 602 are operative to secure the suture lines 508 into position such that the same are allowed to selectively advance therethrough and remain secured in position thereby without requiring that the sutures 508 be ties (i.e., at the fascia level 606).
To achieve that objective, there is shown in FIGS. 17a and 17b the mechanism by which the anchoring plate 602 is operative to secure the suture lines 508 thereto. As shown in 17a, the anchoring plate 602 comprises the combination of a first inner plate member 610 having at least one, and preferably two diametrically opposed apertures 612 formed therein. Encased about the first plate member 610 is a second annular plate member 614 which also includes at least one, and preferably two, apertures 616 formed therein, such apertures 616 being selectively alignable with the apertures 612 formed upon the first inner plate 610. The first inner plate member 610 is rotationally mounted within the outer anchoring plate member 614, such that the same is operative to transition between a first open configuration, wherein the apertures 612 of the first inner plate 610 are alignable with those formed on the outer annular plate 614, and a second closed configuration, as shown in FIG. 17b, wherein the apertures formed on the inner and outer plates 612, 615, respectively, are not aligned with one another, such that a closure is formed.
In use, the anchoring plate 602 may be secured into position, via prongs or some other type of anchoring mechanism (not shown) to a desired site. Alternatively, it will be appreciated that such anchoring plate 602 may only need be placed on the rectus fascia and, as discussed more fully below, due to the downward force exerted upon the anchoring plate 602 via the sutures held thereby, such anchoring plate will be caused to remain resident at the desired deployment site. Once positioned, the inner and outer plate members 610, 614 are maintained in the first operative configuration such that the apertures 612, 616, respectively formed thereon form the opening or openings through such anchoring plate 602. The suture lines 508 may then be extended through apertures defined by the first and second plate members such that the sling 502 held thereby is maintained in a desired orientation or provides a desired degree of support to the urethra 504. Once so positioned, the inner and outer plate members 610, 614 are rotated relative one another such that second closed configuration is maintained, which thus serves to secure the suture lines 508 into position. To facilitate that end, a knob 618 or other turning mechanism formed upon the inner plate may be provided to facilitate the insertionability to secure the suture lines 508 into position. As discussed above, such design advantageously dispenses with the need to tie down the suture lines or cords at the fascia level. To the extent desired, such anchoring system further enables the suture lines, and more particularly the suture lines extending through the anchor plate, to be secured to one another to thus form a suture “bridge”. As shown in phantom, each respective suture line extending through the anchor plate can be linked to one another as shown. To achieve that end, it will be appreciated that such suture lines may be either tied, fused, crimped, linked or joined to one another via any of a wide variety of methods and devices well known to those skilled in the art.
Referring now to FIG. 18, there is shown a further refinement of the system utilized to secure a suture line at a desired location such that a sling, graft or other object supported thereby is maintained at a desired location. As illustrated, such system 640 comprises the combination of a suture-like cord 642 having a plurality of protuberances 644 formed therealong and an anchoring plate 646. The suture-like cord 642 with protuberances 644 is formed such that the same is extensible through tissue. As will be appreciated by those skilled in the art, attached to an opposed end of such suture-like cord 642 with protuberances 644 is a graft, sling 502 or some other object to be held thereby. The suture-like cord 642 is extensible through the anchoring plate 646, the latter being secured at a desired target site, which may include a bone, periosteum, soft tissue, or a layer of rectus fascia 606 as shown. The suture 642 is extensible through such anchoring plates 646 such that respective ones of the protuberances 644 engage with a locking aperture 648 formed on such plate 646. As illustrated, each respective protuberance 644 can be pulled through such aperture 648 and thereafter caused to lock the suture 642 into position. As will be appreciated, as the sutures 642 pull through the anchoring plate 646, the suture line 642 will become progressively shorter and thus raise the object (i.e., sling 502) held thereby to the desired location. Advantageously, such system accommodated movement in both directions, and by pulling the suture in the rearward direction can cause the suture to experience an increase in slack, which thus consequently can lower or lessen the tension in the object supported thereby. As per the embodiment depicted in FIG. 17, these suture-like cords with protuberances, to the extent multiple cords are utilized, may be linked to one another to thus form a suture bridge, as may be desired for certain applications.
Referring now to FIGS. 19-19c, and initially to FIG. 19, there is shown an additional embodiment 700 of an anchoring system for securing a suture-like cord or line 508 at a desired location. As per the embodiments depicted in FIGS. 17 and 18, the embodiment shown includes an anchor plate 702 having at least one, and preferably two to four, channels 704 extending therethrough for receiving suture-like cords 508. As per the aforementioned embodiments, the anchor plate 702 may likewise be secured into position with a fastener mechanism or, alternatively, merely be positioned at a desired site upon fascia or soft tissue with the ultimate tension imparted thereto by the sutures 508 held thereby causing the same to remain resident at such site. As to the embodiment shown, the anchoring plate 702, once positioned, is operative to receive the suture line or lines 508 through the channels 704 defined thereby. As more clearly illustrated in the cross-sectional view of FIG. 19a, the suture-like cord 508 can be pulled upwardly or downwardly until the same attains the desired position and/or imparts the desired tension to an object held thereby. Once such proper position and/or tension is attained, the channel 704 within which the suture-like cord 508 is disposed may be crimped, as depicted in FIG. 19b, such that the suture line 508 is compressively held thereby. As will be appreciated by those skilled in the art, the channel 704 defined by the anchor plate 702 will be formed from a suitable deformable material well-known to those skilled in the art which can not only be easily crimped, but once so crimped, will impart the necessary compressive force to hold the suture 508 in position. It will likewise be recognized that the crimp made to the channel 704 may be formed by any of a variety of surgical crimping mechanisms well-known and commercially available.
In an alternative configuration depicted in FIG. 19c, the anchor plate 710 is designed such that the same only has one channel 712 formed therethrough through which one or more suture-like cords 508 may be received. As may be desired for certain procedures, particularly where it is advantageous to simplify such procedures, the channel 712 defined in the anchor plate 710 will preferably be centrally disposed upon the anchor plate such that the same is adapted to receive multiple suture-like cords therethrough (e.g., four (4) suture lines to accommodate two (2) opposed ends of a sling). Once the cord or cords 508 have been received therethrough and optimally positioned, the channel 712 may be crimped such that the cords are compressively held as desired. Any length of the sutures extending therethrough may be linked or connected to one another to thus form a suture bridge, which is again in phantom in FIG. 19.
As will be recognized by those skilled in the art, by providing such a simplistic, atraumatic mechanism for securing sutures, grafts and the like into position substantially reduces suture erosion, greatly minimizes operative time, patient recovery time and further minimizes the risk of infection by minimizing the degree of invasiveness typically associated with securing slings and the like into an optimal position.
As will further be readily appreciated by those skilled in the art, the aforementioned anchoring systems, particularly those mechanisms depicted in FIGS. 17-19c, such may be formed from a bio-absorbable material, such that the anchoring system becomes absorbed over time. As will be appreciated by those skilled in the art, to the extent the anchoring system is fabricated to become absorbed over time, the aforementioned discussion regarding the suture bridge may be deemed optimal should it become necessary to maintain the suture lines at a desired location following absorption of such anchoring system.
Alternatively, the anchoring systems may be formed from a non-absorbable material such that the same remains permanently embedded within the body. Moreover, it will be recognized that those mechanisms depicted in FIGS. 17-19c may further incorporate a tension spreading mechanism, such a washer or mesh of fabric, that may be deployed with or integrated as part of such anchoring system. In this respect, it will be appreciated that due to the fact that the suture holding mechanisms depicted in FIG. 17-19c will necessarily have a stress and strain imparted thereto via the sutures held thereby, such plate may dissipate the stress and strain over a larger surface area via the incorporation of such tension spreading mechanism. As per the anchor plates themselves, such tension spreading mechanism may be formed from an absorbable or non-absorbable material and may be formed integral with or separate from the anchor plate.
Referring now to remaining drawings 9-15, and initially to FIG. 9, there are depicted further embodiments of the present, invention that are directed to devices for attaching sutures, grafts, tissues and the like to periosteum 36 (i.e., the thick fibrous membrane covering the surface of bones), as well as other types of soft tissue. In this regard, each of the embodiments herein preferably do not penetrate or otherwise become embedded within the bone 38, but rather are attachable to the periosteum 36 at a specific site thereof. However, it should be expressly understood that such embodiments may be modified or otherwise adapted to penetrate and become embedded within the bone 38, as may be necessary or ideal for a given medical procedure.
As will be appreciated by those skilled in the art, a wide variety of surgical procedures requiring fixation of sutures, grafts and the like, such as transvaginal sling surgery, particularly when performed in accordance with the procedure depicted in FIGS. 1 and 2, frequently do not necessitate the use of devices, such as those depicted in FIG. 5, that must necessarily be screwed or anchored within the bone. Quite unexpectedly, it has recently been reported at a meeting sponsored by the American Uro-Gynecologic Society that by utilizing the periosteum 36 as a point of affixation, such affixation can be made more or equally secure than prior art bone screws and anchors, but at the same time achieving satisfactory, if not superior, structural support. In this regard, deployment of such prior art bone-screw/anchor devices is generally considered an excessive measure insofar as such devices are known to frequently provide an excess amount of support than what is typically required or suitable for such particular purpose. However, due to the fact that no feasible alternative had been available until now, such bone screw and anchor devices are utilized, which can substantially complicate such surgical procedures as well as cause the patient to endure unnecessary trauma, possibly delayed recovery time, and possibly higher risk of infection.
In the first of such embodiments depicted in FIGS. 9 and 10, there is provided an affixation device 90 comprised of at least one, and preferably a multiplicity of piton members 92 mounted upon a base member. Each one of the multiplicity of pitons 92, which may take the form of a hook as shown, is designed to ensnare with and become embedded in a target site of soft tissue of the periosteum 36, as depicted in FIG. 9, but not penetrate or otherwise disrupt the outer surface of the bone 38 therebeneath. In this respect, the piton members 92 may be designed such that with light pressure the same only penetrate within a certain limited depth of the periosteum 36 or tissue, such that the same provide a moderate degree of fixation and can be easily removed, or with greater pressure the same penetrate deeper so that the device 90 can become more securely embedded within the periosteum 36 or tissue to thus provide for a more secure base or attachment. Formed on the base member 94 is an attachment means, which may comprise a post or eyelet 96 as shown, to which may be attached the suture 98 or graft. As will be appreciated, the affixation device 90 need only be placed against the periosteum 36 at a target location such that the piton members 92 thereof become embedded there within. Because the piton members 92 of the affixation device are caused to only become embedded within the periosteum 36, such novel fixation device may be easily removed and repositioned as may be necessary in a given surgical procedure to insure that an optimal degree of support or positioning is attained.
Once so optimally positioned, the suture 98 or graft may be attached to the device 90 as per conventional surgical procedures. Alternatively, due to the ease by which the affixation device 90 may be detached and reattached, the surgeon is provided with the option of securing the suture 98 or graft to such affixation device 90 and thereafter positioning the affixation device 90 at a target site for best positioning. Advantageously, although the affixation device 90 is specifically designed to provide for easy dislodgment and repositioning, it is believed that once the same is secured into position, due to the eventual overgrowth of tissue about such device 90, the affixation device will continue to provide firmer and stronger support over time.
Referring not to FIGS. 11-13, there is shown another embodiment 100 of an affixation device useful in the attachment of sutures, grafts, tissues and the like to periosteum, soft tissue, and bone. In the embodiment shown, such affixation device 100 comprises a tack member having a hub portion 102 and at least one, and preferably two or more, prong members 104 formed thereon. As illustrated, the implantable tack 100 may be utilized to affix a graft 106 or other like tissue to the periosteum 36 by merely interposing the graft 106 between the periosteum and the tack 100 and compressing such tack 100 there against such that the prongs 104 thereof extend therethrough and become embedded in the periosteum 36 as systematically shown in FIGS. 11 and 12.
As will be recognized, the prong portions 104 of such tack 100 will be specifically designed and configured to extend through a given layer of tissue or graft material 106 and become embedded into the periosteum 36, but not otherwise extend to or penetrate the bone 38 lying therebeneath (although the embodiment may be modified for such applications). It will further be appreciated that such prongs 104 may vary in number and may take any of a variety of shapes and configurations necessary to achieve that end. As discussed above, it is contemplated that the prong members 104 may be designed to penetrate within the soft tissue, periosteum 36, or even bone 38 at specified depths to thus provide for selective degrees of attachment thereto. In this regard, it is specifically contemplated that such prong members 104 may be formed to have a straight, hook or arcuate shape such that the same facilitate the affixation of a graft 106 to the target site of fixation. For example, in FIG. 12 it will be recognized that due to the arcuate shape of the prong members 104 of the implantable tack 100, when a force is applied in a direction indicated by the letter “I”, such force will actually cause the prong members 104 of such implantable tack 100 to penetrate further within the periosteum 36 to thus cause the affixation to become more secure with increased tension. Furthermore, by utilizing a hub member 102 as part of the implantable tack 100, as illustrated in FIG. 13, such implantable tack 100 can be easily accessed and removed in later surgical procedures. To facilitate such removal, a grip, protrusion or an aperture formed upon the hub may be provided. For example, it is contemplated that an attachment material, such as a synthetic mesh “extension” or sleeve may be formed upon the hub 102.
Referring now to FIGS. 14 and 15, there is shown yet another preferred embodiment 110 of the present invention that comprises a novel surgical staple for securing sutures, tissues or grafts 112, to the periosteum 36. As illustrated, the staple 110 is operative to penetrate through a segment of tissue or graft 112 and become embedded within the periosteum 36 such that the graft or tissue is caused to become affixed therewith. As illustrated in the top view portion of FIG. 14, the staple is operative to assume a first insertion configuration whereby the prongs 110a, 110b or such staple 110 are advanced through the graft 112 and ultimately into the periosteum 36. Thereafter, as illustrated in the top view of FIG. 15, the prongs 110a, 110b are caused to embed within the periosteum 36 to enhance the attachment therewith. As may be necessary for a certain application, such prongs 110a, 110b may even be caused to embed within the bone 38 lying there underneath to thus provide a more secure attachment.
To facilitate the ability of the staple 110 to secure the graft 112 to the periosteum 36 in the aforementioned manner, it is contemplated that such staple 110 may be formed of resilient, self-expanding or self-contracting material which is biased to the operative configuration shown in FIG. 15 such that when unconstrained, the opposed ends of the staple 110 will become further embedded into the periosteum. Similarly, such staple may be fabricated from a plastically deformable material which is initially formed to assume the insertion configuration depicted in FIG. 14, but can subsequently be deformed to assume the operative configuration depicted in FIG. 15. As a still further alternative, such staple 110 may be formed from a shape-memory material, such as nitinol, which thus enables the staple to assume the insertion configuration depicted in FIG. 14 when at room temperature, but transition to the operative, more secure configuration depicted in FIG. 15 when warmed to body temperature, as will occur such staple is deployed. As a further advantage, to the extent it becomes necessary to remove or otherwise reposition such staple 110, it will be recognized by those skilled in the art that removal of such staple 110 may be facilitated by merely cooling the same down by any of a variety of well-known methods, including applying cold saline thereto.
All of the affixation devices discussed herein, although having widespread applicability and substantial advantage over prior art anchor devices, and more particularly bone screws and bone anchors, are particularly well suited in gynecologic, urologic and orthopedic surgical applications. It is believed that such affixation devices are particularly well suited for transvaginal sling surgery insofar as much of the medical literature tends to indicate that in a vast majority of patients, the sling that is utilized in such procedures should be placed with little to no tension at all, with the tension vector emanating therefrom being oriented in a direction well-suited to the piton portion of those embodying as depicted in FIGS. 6-8. Indeed, considerable authority exists that optimal placement of the sling in transvaginal sling surgery occurs when the sling merely comes near or into contact with the urethra. Affixation by attaching the sling merely to the periosteum and not to the bone is thus believed to provide more than sufficient leverage or support to the sling in such applications, but yet have the further advantage of being exceptionally easy to secure and re-secure into position in a much less traumatic manner than the prior art devices.
Exemplary of such applications, as illustrated in FIGS. 23-26 is the use of the anchor mechanisms disclosed herein in vaginofixation. Such procedure, also known as colpopexy or colporrhaphy is closely related to the aforementioned surgical techniques related to transvaginal sling placement insofar as the same relies upon fixation devices, anchors and various sling-like materials that are operative to position and maintain the vagina in its proper orientation. In this regard, FIG. 23 illustrates vaginal prolapse whereby the vaginal apex 906 is shown extending outwardly from the vagina of a patient. Such Figure further illustrates the relative positioning of the obturator foramen 908, and more particularly the membrane 910 extending about the obturator foramen 908, the latter as discussed above now being widely considered as the optimal zone within which to anchor slings and the like for the treatment of urinary incontinence.
Referring now to FIG. 24, there is shown the use of an anchor mechanism 900 constructed in accordance with a preferred embodiment of the present invention shown positioning the vagina according to its proper orientation whereby the apex of the vagina 906 is shown extending upwardly within the body. To achieve that end, the fixation device 900 is shown securing the vaginal wall 907 to the membrane 910 extending about the obturator foramen. To accomplish that end, the fixation device 900 is provided with a harpoon or barbed portion 904 operative to extend through the vaginal wall 907 and into a mass of soft tissue, such as membrane 910. To secure vaginal wall 907 in proximity to such soft tissue, there is preferably provided a large platform or head portion 902 that preferably possesses sufficient surface area to hold the vaginal wall 907 according to its proper orientation such that the vaginal apex 906 remains properly positioned within the patient's body. As will be appreciated by those skilled in the art, the barbed portion 904 will be configured as per any of the aforementioned embodiments such that the barb 904 will be operative to be inserted into a mass of soft tissue into a first direction but resist rearward movement when pulled in the opposite direction. It is further contemplated that such fixation device 900 may be deployed through any surgical technique known in the art whether it be manually or by deployment via a surgical instrument such as those discussed above or otherwise known in the art. For example, such fixation device 900 may be deployed via a coaxial system whereby a conventional guide wire is first deployed to identify the location the obturator membrane with the device 900 being deployed thereafter. Advantageously, such procedure eliminates the risks associated with blindly deploying such fixation device 900.
With respect to the preferred embodiments of such anchoring mechanism 900 for use in vaginofixation, two such embodiments are depicted in FIGS. 25 and 26 respectively. Referring initially to FIG. 25, (which is an enlarged figure of the fixation device depicted in FIG. 24), such fixation device includes a head portion 902 having a sufficient surface area operative to compress and hold a portion of vaginal wall tissue. As will be appreciated by those skilled in the art, such head portion 902 may preferably be formed from mesh or other biocompatible material to facilitate the ability of the device to secure a tissue mass (i.e., vaginal wall) securably into position. The anchor portion 904, as discussed above, may take any of a variety of self-anchoring mechanisms discussed herein. As depicted, such anchor portion 904 includes a plurality of linearly-arranged arrows or V-shaped members operative to extend into tissue in a first direction but resist movement in an opposite direction.
Referring now to FIG. 26, there is depicted an alternative embodiment whereby the head portion 902 is comprised of a plurality of wire or claw members operative to grab and securably hold a portion of soft tissue. The anchor portion 904 is configured as per the embodiment discussed above with respect to FIG. 25 and may include any anchoring mechanism operative to be advanced into tissue in a first direction but resist movement in an opposite direction, as would be achieved by the linearly arranged arrow members as depicted. As should be readily understood, however, the head portion 902 depicted in FIGS. 25 and 26 may take a variety of alternative configurations as will be readily appreciated by those skilled in the art. In this respect, so long as the anchor portion 902 is operative to attach to and securably hold a mass of soft tissue, the same should be deemed to fall within the scope of the present invention. Also, head portion 902 may further include a member formed thereon, such as a post, eyelet, or other structure, to facilitate manipulation or attachment thereto.
Although the invention has been described herein with specific reference to a presently preferred embodiment thereof, it will be appreciated by those skilled in the art that various modifications, deletions, and alterations may be made to such preferred embodiment without departing from the spirit and scope of the invention. For example, it will be recognized that the piton portion of any of the surgical implants disclosed herein may take any of a variety of forms such that the same are caused to become more thoroughly seated in a position via the application of force in one direction, but yet become more easily withdrawn when pulled rearwardly in a second direction. It is further contemplated that such embodiments may be formed from plastically deformable or shape-memory material to thus facilitate fixation of such devices at a selected target site. Moreover, it should be recognized that the affixation devices disclosed herein designed to affix sutures, grafts, tissues, synthetic materials, and the like to periosteum may further be modified so that the same additionally penetrate into and become embedded within the bone lying thereunderneath. Specifically, with respect to the embodiment depicted in FIG. 10, one or more of the hooks may be sized and adapted to penetrate into the bone, similar to the prongs formed on the implantable tack depicted in FIGS. 11-13. Likewise, the prongs of the staple element depicted in FIGS. 14 and 15 may be designed to penetrate and embed within the bone. Accordingly, it is intended that all reasonably foreseeable additions, modifications, deletions and alterations be included within the scope of the invention as defined in the following claims.

## Claims

1. A method for supporting a prolapsed vagina comprising the steps of:
a) providing a pair of anchor mechanisms each having an elongate barb portion extending outwardly from a head portion, the barbed portion being configured to be extended into soft tissue in a first direction at a target site and being resistant to movement in an opposite direction;
b) advancing each one of the anchor mechanisms through a vaginal wall on opposed sides of the vagina; and
c) advancing each one of the anchor mechanisms toward a respective target site such that each one of the anchor mechanisms becomes embedded within soft tissue at the target site;
wherein the target sites are located such that the anchor mechanisms provide vaginofixation to the prolapsed vagina.

2. The method of claim 1 wherein the target sites are the obturator foramen area and the soft tissue is the membrane located therewithin.

3. The method of claim 1 wherein the barb portion includes a plurality of linearly arranged V-shaped members.

4. The method of claim 1 wherein the head portion is configured to provide an amount of surface area operative to compress and retain a portion of the vaginal wall in fixed position relative to the membrane within the obturator foramen.

5. The method of claim 1 wherein the head portion is fabricated of mesh material.

6. The method of claim 1 wherein the head portion is comprised of a plurality of radially extending claw members configured to engage a portion of the vaginal wall.

7. A method of treating a prolapsed vagina in a patient, said method comprising
providing an anchor mechanism for securing the vaginal wall to tissue proximate the obturator foramen, said anchor mechanism comprising:
a head portion; and
an elongate barb portion extending outwardly from the head portion, the barb portion being configured to be positioned in tissue proximate the obturator foramen by being extended through the vaginal wall and into the s tissue in the obturator foramen in a first direction and being resistant to movement in an opposite direction,
the head portion and elongate barb portion being sized and configured with respect to one another such that, when installed such that the barb portion is anchored in tissue proximate the obturator foramen, the head portion functions to compress and retain a portion of the vaginal wall in fixed position relative to in tissue proximate the obturator foramen;

inserting the anchor mechanism from the vagina, through the vaginal wall and into the tissue proximate the obturator foramen, such that the barb portion penetrates the vaginal wall and lodges in the tissue proximate the obturator foramen while the head portion impinges on the vaginal wall.

8. The method of claim 7, wherein the anchor mechanism provided comprises a head portion comprising a mesh.

9. The method of claim 7, wherein the anchor mechanism provided comprises a head portion comprising a plurality of radially extending claw members.

10. The method of claim 7, wherein the anchor mechanism provided comprises a head portion is sized and dimensioned with sufficient surface area operative to compress and hold a portion of the vaginal wall.

11. The method of claim 7, wherein the anchor mechanism provided comprises a head portion is sized and dimensioned with sufficient surface area operative to compress and hold a portion of the vaginal wall.

12. The method of claim 7, wherein the anchor mechanism provided comprises barb portion comprises a plurality of linearly arranged arrows.

13. The method of claim 7, wherein the anchor mechanism provided comprises barb portion comprises a plurality of linearly arranged V-shaped members.