System and method of anchoring support material to tissue

A method of anchoring a support material to tissue includes forming an incision in a urogenital triangle of a patient for access to a pelvis of the patient; inserting a body portion of an anchor into a lumen in a cannula and having a spine portion of the anchor extending radially out of a wall of the cannula; and inserting a leading end of the cannula and the anchor into the incision. The method includes pushing the leading end of the cannula into periosteum tissue of the pelvis; engaging the spine portion of the anchor with the periosteum tissue; withdrawing the leading end of the cannula from the incision and leaving the anchor engaged in the periosteum tissue; and securing the support material to a suture that is attached to the anchor. The method includes delivering the support material through the incision to the pelvis.

BACKGROUND

Intracorporeal suturing of tissue during surgery presents challenges to the surgeon in that the surgeon is called upon to manipulate suturing instruments within the confines of a relatively small incision formed in the patient's body. In some cases, the surgeon is unable to see the suture site. In such a case, the surgeon will digitally palpate with a finger to locate a landmark within the intracorporeal site, and then deliver the suture near at or near the landmark. Tying of the suture inside the patient at the intracorporeal site can be challenging since the surgeon is unable to see the site.

Improved suturing instruments and improved methods of delivering sutures would be welcomed by the surgical staff.

SUMMARY

One aspect provides a surgical system including an anchor and an introducer provided to deliver the anchor into tissue. The anchor includes a body having a pointed leading end that is configured to pierce the tissue, a spine projecting radially away from the body and having a width and a height configured to allow the spine to engage with the tissue, an eyelet attached to a trailing end of the body, and a length of suture attached to the eyelet. The introducer includes a cannula with a pointed distal end, an opening formed in the cannula that is sized to receive the body of the anchor, and a slot formed in a wall of the cannula at a distal end portion of the cannula and sized to receive the width of the spine. When readied for use, the anchor is secured in the introducer with the body of the anchor inserted into the opening of the cannula with the pointed leading end of the body located proximal of the pointed distal end of the cannula. The spine of the anchor is inserted into the slot of the cannula such that the anchor does not rotate relative to the cannula.

One aspect provides a method of anchoring a support material to tissue. The method includes forming an incision in a urogenital triangle of a patient for access to a pelvis of the patient; inserting a body portion of an anchor into a lumen in a cannula and having a spine portion of the anchor extending radially out of a wall of the cannula; and inserting a leading end of the cannula and the anchor into the incision. The method additionally includes pushing the leading end of the cannula into periosteum tissue of the pelvis and engaging the spine portion of the anchor with the periosteum tissue. The method further includes withdrawing the leading end of the cannula from the incision and leaving the anchor engaged in the periosteum tissue; and securing the support material to a suture that is attached to the anchor. The method includes delivering the support material along the suture and through the incision and into the patient to the pelvis.

DETAILED DESCRIPTION

The features of the various exemplary embodiments described in this application are suitable and intended to be combined with each other, unless specifically noted otherwise.

Anterior means “forward” or “front,” and posterior means “rearward” or “back.” Relative to surfaces of an organ in the human body, an anterior surface of an instrument inserted into the organ will be oriented forward toward the belly and a posterior surface will be oriented rearward toward the spine.

End means an end most location and end portion means that segment adjacent to and near the end of an object. For example, two opposing ends of an object are each equidistant from a mid-point of the object and between the mid-point and each end of the object is an end portion of the object.

Embodiments provide a surgical system including an introducer that is configured to deliver an anchor to an intracorporeal tissue site. The introducer includes a cannula that allows placement of an anchor at a landmark in tissue deep within an incision site, which may be out of the field of vision of the surgeon. The anchor is configured to be secured within the cannula so that it does not rotate or fall out of the cannula during insertion into the tissue. A length of suture is provided that is attached to the anchor, where the suture may be tied or otherwise terminated to itself outside of the incision site and then subsequently directed to the intracorporeal landmark.

Some incontinence treatment devices have several arms, including some form of arms that traverse the obturator foramen (called transobturator arms) and other arms that are implanted anterior to the pubic bone (called pre-pubic arms). A first set of tools is used to place the transobturator arms and a second, different set of tools is used to place the pre-pubic arms. The pre-pubic arms are tunneled anterior to the pelvis and exit the skin of the abdomen.

In contrast, embodiments of the system described in this specification provide a support with two transobturator arms and a system to attach a portion of the support directly and efficiently to the periosteum tissue. The system obviates the use of additional pre-pubic arms and additional tools that tunnel the pre-pubic arms under the skin. The system is easier to implant compared to a four arm or six arm support, and reduces the amount of time that the patient is in the operating room.

One approach to treating urinary incontinence places a support inferior to the urethra and directs arms upward from the support alongside the bladder along a U-shaped pathway. A significant advance over the U-shaped pathway was provided by Dr. Emmanuel Delorme as described in his U.S. Pat. No. 6,638,211 and included placing arms of a support through the obturator foramen along a V-shaped pathway. This application provides another advance in supporting the pelvic anatomy by recognizing that support material can be robustly attached to the periosteum tissue through the use of an anchoring system. The anchoring system allows the surgeon to place the support inside of the patient and directly fixate the support to periosteum tissue that is present over the exterior of the bones. This approach does away with needles and other tools that tunnel the arms of a support through tissue. The anchoring system described in this application is compatible with a true single (only one) incision formed in the patient.

FIG. 1is a perspective view of one embodiment of a surgical system20. The surgical system20(system20) includes an anchor22attached to a length of suture23and an introducer24adapted to deliver the anchor22to an intracorporeal landmark. The anchor22is sized to be inserted into the introducer24, and the introducer24is sized to be inserted through a single incision to push or direct the anchor22into tissue. The suture23trails behind the anchor22and is available for subsequent ligation of the tissue, or for subsequent attachment of a support to the tissue.

The anchor22includes a body30having a pointed leading end32that is configured to pierce tissue, a spine34projecting radially away from the body30and configured to engage with or anchor to tissue, and an eyelet36attached to a trailing end37of the body30. The length of suture23is inserted through the eyelet36.

The introducer24includes a cannula40extending from a handle42. The cannula40has a pointed distal end44and an opening46formed in the cannula40. The opening46or lumen46is sized to receive the body30of the anchor22. The handle42includes a gripping surface48formed on at least one side of the handle42. It is acceptable to provide the handle42with several gripping surfaces or with no gripping surfaces. During a suturing procedure, the anchor22is loaded into the opening46of the cannula40and the surgeon grips the handle42and directs the pointed distal end44of the cannula to a targeted tissue landmark. Force delivered to the handle42in a distal direction will drive the pointed distal end44of the cannula40into the tissue, such that a subsequent withdrawal of the introducer24in a proximal direction will allow the introducer24to exit the tissue. The spine34(and in some cases the eyelet36) engages with the tissue, thus leaving the anchor22engaged with and deposited in the tissue after the cannula40is withdrawn.

In one embodiment, the introducer24includes a pair of cannulas, including a second cannula50having a pointed distal end54and an opening56formed in the cannula50. The second cannula50is provided to receive a second, separate anchor. With this in mind, a second anchor62is provided having a body70having a pointed leading end72, a spine74projecting radially from the body70, an eyelet76attached to a trailing end77of the body70, and a second length of suture78attached to the eyelet76. In this embodiment, the introducer24is operable to deliver the first anchor22out of the first cannula40and to subsequently deliver the second anchor62out of the second cannula50. The gripping surface48is configured to allow the translation or rotation of the instrument to selectively move each of the cannulas40,50to a forward facing proximal position.

FIG. 2Ais a perspective view of the anchor22andFIG. 2Bis an end view of the anchor22. The anchor22includes multiple spines34extending from the body30. In one embodiment, the spines34project radially away from a center longitudinal axis A of the body30, with each spine34shaped as a shark fin having a curved leading edge80that meets with a curved trailing edge82at a point P. The curved leading edge80is oriented to diverge away from the pointed leading end32of the body30to allow the anchor22to glide into tissue and prevent the anchor from pulling out of the tissue. Although three spines34and one eyelet36are illustrated, the anchor22is also suitably provided with a single spine34and one eyelet36. The anchor22is also suitably provided with more than three spines34.

The eyelet36projects radially away from the center longitudinal axis A of the body30and as such is also configured to engage with tissue. For example, the eyelet36is provided with a height HE that is substantially equal to the height of the spines34(the distance that the point P is away from the center axis A). The eyelet has a width substantially equal to the width W of the spine34.

The body30of the anchor22is substantially circular in lateral cross-section (FIG. 2B). The anchor22is configured to slide in an entry direction through the tissue, and is shaped to prevent withdrawal of the anchor22in the direction that is opposite of the entry direction. The curved leading edge80of the shark fin shape of the spines34facilitate the easy sliding of the anchor22through the tissue in the entry direction, and the curved trailing edge82of the spines34configure the anchor to resist being pulled out of the tissue in the direction that is opposite of the entry direction. In one embodiment, the body30of the anchor22has a diameter D, and the spine34has a width W that is less than about 25% of the diameter D (FIG. 2B).

FIG. 2Cis a perspective view of one embodiment of an anchor22′ provided with an eyelet36′ that is disposed on the center longitudinal axis A of the body30. The spines34of the anchor22′ are provided to engage with tissue, and the eyelet36′ is streamlined to follow the body30into the tissue channel that is formed when the anchor22′ is driven into the tissue by the introducer24(FIG. 1).

FIG. 3is a perspective view of the anchor22positioned for insertion into the cannula40of the introducer24andFIG. 4is a perspective view of the anchor22inserted into the cannula40. The body30of the anchor22is sized to slide into the opening46(also called a lumen46) of the cannula40with the spine34projecting out of the cannula40. With reference toFIG. 3, the inside diameter of the lumen46of the cannula40provides a cannula diameter CD, and the spine34has a height HS that is greater than the cannula diameter CD. The height HS the spine34is at least 5% greater than the cannula diameter CD. For example, the height HS of the spine34is in the range of 5-100% greater than the cannula diameter CD.

It is acceptable for the height HE (FIG. 2A) of the eyelet36to be equal to the height HS of the spine34. It is also acceptable for the height HE (FIG. 2A) of the eyelet36to be different from and not equal to the height HS of the spine34.

The cannula40includes a tapered distal end portion84that tapers to the pointed distal end44, where the tapered distal end portion84provides the cannula40with a needle-like point adapted for insertion through tissue. In some applications, the pointed distal end44of the cannula40is sharp and needle-like and is so configured to enter the periosteum tissue covering a boney surface and glide under the periosteum tissue and over the bone. In this manner, the cannula is configured to deliver the anchor22between the periosteum tissue and the bone.

The cannula40has a wall90that forms or defines the lumen46and a slot92formed through the wall90. The slot92is proximal of the tapered distal end portion84and extends through the wall90to communicate with the lumen46. The slot92includes a pair of opposed longitudinal side edges94that extend from a proximal lateral edge96in a distal direction to the distal end portion84. The width of the slot between the longitudinal side edges94is sized to receive the width W of the spines34. The cannula diameter CD is sized to receive the diameter D (FIG. 2B) of the body30of the anchor22.

With reference toFIG. 4, when the anchor22is loaded into the cannula40, the pointed leading end32of the body30is located proximal of the pointed distal end44of the cannula40, and the spines34and the eyelet36extend outside of the cannula40and are positioned to engage with tissue during implantation of the anchor22. The proximal lateral edge96of the slot92is positioned to push against the eyelet36and drive the anchor22into the tissue. The opposed longitudinal side edges94of the slot92provide a stanchion that restrains the spines34and prevents the anchor22from rotating relative to the cannula40. The spines34and the eyelet36slide in a longitudinal direction relative to the slot92to allow the cannula40to be removed from the tissue while leaving the anchor22implanted.

Suitable materials for fabricating the anchor22include plastics, or metal, or sintered material. One suitable material for fabricating the anchor22is polypropylene. Another suitable material for fabricating the anchor22is a bioabsorbable polymer that configures the anchor22to be absorbed into the body over a period of several weeks.

Suitable materials for fabricating the length of suture23include bio-inert components that do not bioabsorb, or bioabsorbable components that are configured to be absorbed or resorbed by the body. One suitable material for fabricating the length of suture23is polypropylene. Other suitable materials for fabricating the length of suture23include dissolvable sutures available from Ethicon™, a J&J Company located in Somerville, N.J., and include Monocryl™ (polyglycaprone 25) sutures, coated Vicryl™ (polyglactin 910) sutures, Ethicon Plus™ Sutures, or polydioxanone sutures as examples.

Suitable materials for fabricating the cannula40and include plastics or metal. One suitable material for fabricating the cannula40is stainless steel. Other suitable materials are acceptable.

With reference toFIG. 1, the anchor22is useful for fixating a support material within a patient's body. The introducer24is sized to place the anchors22through a single incision and into the periosteum tissue that covers the pubic bone, examples of which are described below.

FIG. 5is a schematic view of one embodiment of a support100attachable to a pelvis of a patient.FIG. 5provides an anterior view of the pelvis with the sacrum S located in a posterior portion of the view, with the pubic symphysis PS centered relative to the pubic bone PB, and an obturator foramen OF on each bilateral side of the pelvis. Each obturator foramen OF provides an opening or a window that is covered by a membrane M. Nerves and arteries traverse the upper reaches of the obturator foramen OF. The membrane M generally includes several layers of muscle and at least one layer of ligament-like tissue that connects the muscles in the membrane M to the pelvis. The ischial pubic ramus IR is located inferior to the pubic bone PB and the obturator foramen OF.

The support100is provided to elevate and compress the male urethra and includes a body102, a first arm104extending from the body102, a second arm106extending from the body102, and a pre-pubic portion108that is oriented in a generally orthogonal position relative to the arms104,106. The illustrated embodiment is a two-arm device.

Suitable materials for fabricating the support100include porous materials that allow tissue ingrowth throughout the support structure to anchor the support100in the body after implantation and healing. Suitable such porous materials include autograft material (the patient's own tissue), allograft material (tissue from a cadaver), xenograft material (tissue from another species), or synthetic materials such as woven fabrics, meshes, nonwoven fabrics, meshes, fibrillated fibers, or spun and fibrillated fibers that are provided with voids (pores) configured to allow tissue ingrowth into the support100. The pores are generally larger, on average, than 75 μm.

The support100is attached to the pelvis with each arm104,106inserted into one of the respective obturator foramen OF, and with the pre-pubic portion108attached to the periosteum tissue that lines the exterior of the pubic bone PB. The following surgical procedure is one example of the suitable implantation of the support100into a male patient.

The patient is positioned on a surgical operating table in a lithotomy, or modified lithotomy position, and is anesthetized. A vertical midline perineal incision110(seeFIG. 6) is formed between the scrotum and the anus. Tissue is dissected to expose the bulbous muscle around the urethra. A suitable tool is used to direct the arm104into and through the first obturator foramen OF, and this procedure is repeated on the contralateral side to place the arm106into and through the second obturator foramen OF.

One suitable approach of placing the arms104,106through the obturator foramen OF is described as an “outside-in” approach. The outside-in approach includes directing a needle or other device through the skin of the groin area of the patient external of the obturator foramen OF along a curved path through the membrane M and around the ischial pubic ramus R such that the tool exits the midline perineal incision110. One of the arms104,106is attached to the tool, and the tool is withdrawn along its curved pathway back around the ischial pubic ramus IR, through the membrane M, out of the obturator foramen OF, and out of the skin at the groin area. In this manner, each arm104,106is directed through and placed in one of the obturator foramen OF. The arms104,106are trimmed to a subcutaneous level. A holding stitch is placed to hold the arm104,106relative to the groin tissue, as determined by the surgeon.

A different approach is the “inside-out” approach in which the needle or tool is coupled to the support and directed from the perineal incision (inside) outward to the skin at the groin area (outside). Placement of the arms104,106with the inside-out approach is also acceptable.

One acceptable single incision approach includes the formation of a single (exactly one) incision in the urogenital triangle. Tissue is dissected distal the incision to access the urethra and the pelvis. The arms104,106of the support100are directed into the single incision and anchored to the membrane M of the obturator foramen OF, for example with the anchor22(FIG. 1). The pre-pubic portion108is inserted into the single incision and fixed to the periosteum tissue over the pubic bone PB by the anchor22as delivered by the introducer24. In this manner, a treatment for urinary incontinence is provided to the patient by forming exactly and only one incision and implanting the support100through that single incision.

FIG. 6is a schematic view of the surgical system20employed to fixate the pre-pubic portion108of the support100to the periosteum tissue of the pubic bone PB. The cannula40of the introducer24is inserted into the perineal incision110and directed to the pubic bone PB anterior to the pelvis.

In one suitable approach, the anchor22is driven through the material of the support100and into the periosteum tissue that covers the pubic bone PB. The cannula40pierces the periosteum tissue and slides along the bone of the pelvis without entering or penetrating the bone. The anchor22is engaged under the periosteum tissue and the suture23extends through the support100out through the perineal incision110. The surgeon, depending upon surgeon preference, will place at least one anchor22through the pre-pubic portion108an each side of the pubic symphysis PS. The suture23extends from each anchor out through the perineal incision110and is available for subsequent tying or other termination.

In a different suitable approach, the anchor22is loaded into the introducer24and the cannula40is introduced in the perineal incision110up to the pubic bone PB anterior to the pelvis. The introducer24is employed to drive the anchor22under the periosteum tissue of the pubic bone PB and the cannula40is withdrawn through the perineal incision110. The suture23trails behind the anchor22and exits the body at the incision110. An end of the suture23is inserted through the pre-pubic portion108of the support100, and the pre-pubic portion108is guided along the suture23, through the incision110, and up to the pubic bone PB. Thereafter, the suture23is tied or terminated to hold the pre-pubic portion108against the pubic bone.

FIG. 7is a schematic view of the anchor22secured to the periosteum tissue and the support100secured to the suture23. In one embodiment, the system20described above includes a stopper150that is attached to the suture23, where the stopper150is configured to slide along the suture23and direct the support100into the patient's body and against the tissue. In one embodiment, the stopper150has a first orifice152and a second orifice154. One or more of the anchors22is engaged with the periosteum tissue of the pubic bone PB, and a first end156of the suture23extends from the anchor22through the first orifice152, and a second end158of the suture23extends to the second orifice154. The stopper150slides along the suture23and is operable to push or otherwise deliver the support100against the pubic bone PB. In one embodiment, a slip knot160or other termination device is provided to tie the suture23against the stopper150after the stopper150and the support100has been delivered to the pubic bone PB. The stopper150is located between the anchor22and the slip knot160.

Suitable materials for fabricating the stopper150include plastics or metal. One suitable material for fabricating the stopper150includes polypropylene. Another suitable material for fabricating the stopper150includes stainless steel. In one embodiment, the stopper150is fabricated to be bioabsorbable.

FIG. 8is a schematic view of two anchors22secured to tissue T and coupled with a suture170. The anchors include a first anchor22aand a second anchor22b. The anchors22are engaged with the tissue T, for example through the use of the introducer24(FIG. 1). A suture170is provided having a first end180terminated to the eyelet36of the anchor22a, a mid-portion182of the suture located between the first anchor22aand the second anchor22b, and a portion184of the suture in sliding engagement with the eyelet36of the second anchor22b. A free end186of the suture170is provided, and pulling on the free end186of the suture170cinches the mid-portion182of the suture between the first anchor22aand the second anchor22b. In one embodiment, a slide knot190or sliding engagement feature190is coupled to the suture170and is so configured to secure or lock the mid-portion182of the suture in a desired position relative to the anchors22. The slide knot190operates to cinch the suture170tightly against the support100(FIG. 6) against the tissue T.

Some male incontinence treatment devices have several arms, including some form of arms that traverse the obturator foramen and other arms that are implanted anterior to the pubic bone (called pre-pubic arms). The pre-pubic arms are tunneled anterior to the pelvis and exit the skin of the abdomen.

In contrast, embodiments of the system described above provide a support with two arms that are A) secured to the periosteum alongside the obturator foramen or B) secured to the membrane M covering the obturator foramen or C) secured through the obturator foramen and a system20to attach a portion of the support directly and efficiently to the periosteum tissue over the pubic bone. The system obviates the use of additional pre-pubic arms that are tunneled under and affixed to the skin. The system is easier to implant and reduces the amount of time that the patient is in the operating room.

FIGS. 9-17are schematic views illustrating embodiments of a method of anchoring a support material to tissue.

FIG. 9is a schematic view of a pelvis. The view has been simplified by not illustrating certain extraneous aspects of human anatomy such as certain of the organs and certain of the muscle and other connective tissues. The view is oriented from a location anterior to the pelvis and shows the sacrum S in the background and the pubic symphysis PS in the foreground.

The patient is prepared for surgery according to the accepted procedures of the hospital or clinic, suitably anesthetized, and placed in a lithotomy position with the feet elevated above the level of the hips and the perineum at the edge of the surgical table. An incision200is formed in the urogenital triangle of the patient. The urogenital triangle is that region on a female patient where a base leg of the urogenital triangle is oriented in a horizontal manner between the vagina and the anus, and the pair of generally equilateral legs of the urogenital triangle extending from the base leg meets at an apex above the vertex of the labia. The urogenital triangle is that region on a male patient between the scrotum and the anus. Tissue is dissected away from the incision200to access the urethra, and in some procedures, the ischial pubic rami IR.

The method of anchoring a support material to tissue includes first forming the incision200in the urogenital triangle of a male patient or a female patient for access to the pelvic anatomy. Thereafter, one of the anchors22is placed in the tissue (i.e., not in the bone) leaving the suture23trailing out of the incision. The support is delivered along the suture23in a distal direction (e.g., along an inward direction) to the location of the anchor22. The suture23is terminated to the support to fixate the support inside the patient. Consistent with this description, the anchor22is inserted into the cannula40of the introducer24. Specifically, the body portion30(FIG. 2A) of the anchor22is inserted into the lumen46such that the spine34extends radially out of the wall90of the cannula40. In one embodiment, the eyelet36extends radially out of the wall90of the cannula40to provide both a pushing/driving surface for the cannula40and a tissue engagement surface. The introducer24is now readied to affix the anchor22to the tissue.

FIG. 10is a schematic view of the leading end44of the cannula40inserted into and guided through the incision200. The surgeon palpates for the surface of the pelvis and thereafter pushes the leading end44of the cannula40into the periosteum tissue PT of the pelvis until the spine portion34of the anchor22is engaged with (e.g., under) the periosteum tissue PT. Periosteum tissue is a thin sheet of dense fibrous connective tissue that is attached at the outer surface of all bones. The periosteum tissue PT is represented as a hashed area and it is understood that the periosteum tissue PT covers the exterior of the boney pelvis.

FIG. 11is a schematic view of the anchor22engaged with the periosteum tissue PT. The cannula40(FIG. 10) has been withdrawn from an incision200leaving the anchor22embedded or engaged with the periosteum tissue PT. The anchor22is under the periosteum tissue PT and over (or above or superior) to the bone of the pelvis. The anchor22is not inserted into the bone of the pelvis. The suture23is connected to the anchor22, and a portion of the suture23extends out of the incision200and is available (for example as a conduit) to allow the surgeon to deliver support material along the suture23to the anchor22. In this manner, since the anchor22is embedded in the periosteum tissue PT a support can be delivered to the anchor and fixed against nearly any bone in the body. Thus, the surgeon need not “aim” for the obturator foramen or other specific tissue landmark; the surgeon simply anchors the anchor22into periosteum tissue PT.

FIG. 12is a schematic view of support material202coupled in sliding engagement with the suture23. The support material202is illustrated in a generalized form. The support material202includes an area of a support. In some embodiments, one or more arms or one or more legs extend from the area of support material202. In some embodiments, the support material202is just an area of material without arms or legs, for example a trapezoid or a rectangle of material that allows the surgeon to trim a desired shape (i.e., a “trim-to-size” support). The support material202is acceptably fabricated from the material of the support100described above.

The surgeon secures the support material202to the suture23, for example by guiding the suture23through a pore or other opening of the support material202. If the support material is a solid and does not have an opening, the surgeon employs a needle to direct the suture23through the support material202. The portion of the suture23that extends out incision200allows the surgeon to conveniently couple the support material202to the suture23outside of the patient's body.

FIG. 13is a schematic view of the support material202having been delivered along the suture23, through the incision200, in a distal direction to the patient's pelvis. The surgeon uses an instrument, or perhaps a finger, to guide the support material202through the incision200inward toward the pelvis. The anchor22is buried or otherwise implanted into the periosteum tissue PT, and the support material202is proximal to the anchor22.

FIG. 14Ais a schematic view of the support material202located between the anchor22and a stopper210. The support material202has been delivered through the incision200to the pelvis of the patient, and the stopper210is configured to engage with the suture23and fixate the support material202against the pelvis. The anchoring of the support material202to the pelvis will support the urethra of the patient. The stopper210is configured such that sliding the stopper210along the suture23will forcibly affix the support material202to the patient. In one embodiment, the stopper210is configured for one-directional sliding along anchor23, for example, only in a direction into the patient. The stopper210includes fingers that prevent the stopper210from moving in the direction out of the patient's body.

FIG. 14Bis a schematic side view of the stopper210and the fingers212. The fingers212are deflected to diverge away from the patient's body, which allows the stopper210to move along the suture23in the direction into the patient's body as indicated by the arrows. The stopper210is configured as a unidirectional stopper that is allowed to move in one direction along the suture23. Attempted movement of the stopper210in the opposite direction causes the fingers212to impinge against the suture23, which prevents movement of the stopper210of the patient's body.

FIG. 15is a schematic view of one embodiment of a stopper220provided to secure the support material202within the patient. The stopper220, also referred to as a button220, includes a first orifice222and a second orifice224. The suture23includes a first strand25that is inserted through the first orifice222and a second strand27that is inserted through the second orifice224. The button220is operable to slide along the suture23as the strands25,27slide through the orifices222,224, respectively. In this manner, the button220is operable to be delivered through the incision200and into the patient. It is desirable to secure the button220against the support material202. In one embodiment, the first strand25is tied to the second strand27to provide a slip knot226. Pulling on the free end (e.g., strand25) drives the slip knot226in a distal direction into the patient until the slip knot is secure against the button220. Eventually, that portion of the suture23that is proximal of the button220is tied or otherwise terminated, and the excess suture23is removed by the surgeon.

FIG. 16is a schematic view of the support material202secured to the patient and located between anchor22and the stopper220(or button220). The excess portion of the suture23has been removed. Other portions of the support material202may also be secured to other tissue of the patient, for example in a bilateral manner by using the introducer24and the anchor22as described above.

FIG. 17is a schematic view of the support material202secured to the periosteum tissue PT of the patient on either lateral side of the pubic symphysis PS. The support material202is secured or fixated at two locations, a left side location (relative to the view ofFIG. 17) and a right location. Each fixation location has the support material202positioned between the anchor22lodged in the periosteum tissue and the stopper220, with the excess portion of the suture23removed. When the surgeon is satisfied that the support material202is appropriately placed and fixated, the incision200is closed.

In the case of a male patient, the support material202has a trapezoidal shape that is sized to support the bulbar urethral complex230(muscle and other tissue) and elevate and support the male urethra. The support material202in the case of the male patient is typically secured in more than two bilateral locations to allow substantial support and elevation to the longer male urethra.

In the case of a female patient, the support material202has a rectangular (e.g., “sling”) shape of about 1 cm wide by 5-10 cm long that is sized to extend across the descending rami to support the short (˜2 cm) female urethra230. The support material202in the case of the female patient is typically secured in two bilateral locations to provide support without compression (or with reduced compression to the urethra).

FIGS. 18-23are schematic views illustrating embodiments of a method of anchoring a support310to tissue. The support310is a rectangular sling-style of support as is appropriate for treating female urinary incontinence.

FIG. 18is a schematic view of the system20employed to secure the support310to the pelvis. The system20includes the first anchor22inserted into the first cannula40, the second anchor62inserted into the second cannula50, and a length of suture300connected between the first anchor22and the second anchor62. The suture300is provided to slide relative to the first anchor22and includes a stopper302that fixes the suture300in a position selected by the surgeon.

Aspects of the surgical procedure include forming an incision200in a urogenital triangle, for example in the upper wall of the vagina and dissecting tissue to identify each of the two descending ischial pubic rami IR. The support310is inserted in the incision200after suitable dissection of the tissue. The system20is employed to anchor or fixate the support310in a position inferior to (under) the urethra U.

The anchor22is loaded into the first cannula40and the cannula40is introduced into the incision200.

FIG. 19is a schematic view of the support310relative to the pelvis and illustrates the first cannula40inserted through the incision200, posterior the ramus IR, and through the support300until the leading end of the cannula40slides under the periosteum tissue PT. The leading end of the cannula40is sharp and so configured to pierce the periosteum tissue PT and deliver the anchor22between the bone and under the periosteum tissue PT.

FIG. 20is a schematic view of the first cannula40withdrawn from the incision200leaving the first anchor22embedded in or secured to the periosteum tissue PT. The suture300trails away from the first anchor22out of the patient through the incision200.

FIG. 21is a schematic view of the second cannula50inserted into the incision200, posterior to the ramus IR, and through the support310. The surgeon directs the introducer24in a distal direction until the sharp distal end of the cannula50pierces the periosteum tissue PT and delivers the anchor62. The suture300remains connected between the first anchor22and the second anchor62, and the stopper302is outside of the patient's body.

FIG. 22is a schematic view of the support310secured on a first side by the first anchor22and secured on an opposite second side by the second anchor62. The suture300is looped through the first anchor22and includes a first segment304between the anchor22and the stopper302, a second segment306between the stopper302and the anchor62, and the trailing portion300. Pulling on the trailing portion300operates to cinch the stopper302into a supporting configuration against the support310.

FIG. 23Ais a schematic view of the support310secured relative to the pelvis, andFIG. 23Bis a bottom view of the support310as secured between the opposed descending rami IR. The trailing portion300of the suture has been pulled by the surgeon in a proximal direction resulting in the stopper302being guided up to the support310. The stopper302is configured to engage with the suture300and maintain the support310in position relative to the urethra U.

FIG. 23Billustrates the first segment304of the suture with the slack removed and tightened against the support310, and the second segment306of the suture with the slack removed and tightened against the support310. The stopper302secures the segments304,306against the support310.

Embodiments described above include pushing the pointed leading end of the cannula40through both the support310and the periosteum tissue PT to secure the anchor22in the patient. The trailing suture300is accessible by the surgeon outside of the patient's body to allow the surgeon to direct the stopper302upwards (or inwards) to the support310.

In an alternative embodiment of this approach, the surgeon pushes the leading end of the cannula40into the periosteum tissue PT of the first ramus IR and engages the spine portion34of the first anchor22in the periosteum tissue, while leaving a single strand of suture300trailing from the first anchor22and out of the vaginal incision200. The surgeon completes a similar process on the contralateral side by pushing the leading end of the cannula40into periosteum tissue PT of the second ramus IR and engaging a second, different anchor22with the periosteum tissue PT. A second, separate suture strand is left trailing from the second anchor and out of the vaginal incision200. Along these two trailing suture strands the surgeon delivers a first end portion of a sling310along the first suture strand, through the vaginal incision200and to the first ramus IR of the pelvis, and a second end portion of the sling310along the second suture and through the vaginal incision200to the second ramus IR of the pelvis. The surgeon subsequently secures each suture strand, for example by tying the strand to form a knot at the sling310.

Embodiments described above include pushing the pointed leading end of the cannula40through both the support310and the periosteum tissue. The trailing suture300is accessible by the surgeon outside of the patient to allow the surgeon to direct the stopper302upwards (or inwards) to the support310. In an alternative embodiment of this approach, the surgeon fixates a support material310between opposed membranes M of the opposed obturator foramen OF. In such a procedure, the surgeon guides the leading end of the cannula40through a first end portion of the sling310, through the vaginal incision200, and into the membrane M of the first obturator foramen OF to engage the first anchor with the membrane M, thus leaving a suture connected to the first anchor. The surgeon performs a similar procedure on the contralateral side by loading another anchor into the cannula40and guiding the leading end of the cannula40through a second end portion of the sling310, through the vaginal incision200, and into a membrane M of a second obturator foramen OF. The surgeon engages the second anchor with the membrane M, where the suture is coupled to the second anchor. The surgeon pulls on a free end of the suture and secures the first end portion of the sling310to the first membrane M of the first obturator foramen OF and secures the second end portion of the sling310to the membrane M of the second obturator foramen OF.

FIGS. 24-28are schematic views of embodiments of a method of anchoring a support to tissue.

FIG. 24is a schematic view of a trans-obturator TO path that is followed by the cannula40to place the anchor22into the membrane M of the obturator foramen OF. The trans-obturator TO path extends from the incision200posterior to the ramus (i.e., behind the ramus) and into the membrane M. It is desirable to place the anchor22in a lower quadrant of the membrane M. In one approach, the surgeon palpates along the inferior portion of the ramus IR and guides the cannula40along and behind the ramus IR into the membrane M.

FIG. 25is a schematic view of the cannula40introduced along the trans-obturator TO path posterior to the ramus IR and into the membrane M. The surgeon provides a pushing distal force that drives the anchor22into, but not through, the membrane M. It is not necessary to drive the anchor22all the way through the membrane M from the posterior side to the anterior side. However, in one embodiment the anchor22is inserted entirely through the obturator foramen OF from the posterior side to the anterior side of the membrane M.

FIG. 26is a schematic view of the anchor22inserted into the membrane M with the suture23extending posterior to the ramus IR and out of the incision200. In this configuration, the suture23is available to deliver support material or other materials along the trans-obturator TO path posterior to the ramus IR upwards to the membrane M that covers the obturator foramen OF.

FIG. 27is a schematic view after the surgeon completes the process described inFIGS. 24-26on the contralateral side. The cannula40of the introducer24has been directed along the trans-obturator TO path posterior to the ramus IR until the anchor62is positioned and inserted into the membrane M covering the obturator foramen OF. The suture78trails away from the anchor62and exits the incision200. With this configuration, the first suture23is connected to the first anchor22that secured in a first one of the membranes M of the obturator foramen OF, and the second suture78is connected to the second anchor62that is secured in the membrane M of the opposed second obturator foramen OF. The sutures23,78extend out of the incision200and are available to deliver the support material through the incision200to support the urethra or other body organ.

FIG. 28is a schematic view of a support400inserted into a patient. A first end of the support400has been engaged with and delivered along the entire length of the first suture23to the anchor22. A second end of the support400has been engaged with and delivered along the entire length of the second suture78up to the second anchor62. The support400thus extends like a hammock from the first anchor22in the first membrane M of the first obturator foramen OF across the midline of the patient to the second anchor62in the second membrane M of the second obturator foramen OF. The surgeon terminates the first suture23at the support400, for example by tying a knot, and likewise terminates the second suture78at the support400. The excess length of suture23,78is removed and the incision200is closed.

FIG. 29is a schematic view illustrating embodiments of methods of anchoring the support100to the pelvis of a male patient. The pre-pubic side108of the support100is anchored at a superior location of the pelvis to the periosteum tissue anterior the pubic bone PB. The arms104,106of the support100are suitably anchored to the periosteum tissue PT of the inferior ischial pubic ramus IR (anterior or posterior) or to the membrane M of the pelvis.

The method includes elevating and compressing the bulbar urethra of the male patient and includes:

forming a perineal incision110in the male patient;

inserting a first arm104located on a first side of the support100into the perineal incision110, directing an end portion of the first arm104toward an obturator foramen OF of the pelvis, and fixing the end portion of the first arm104to either Location A) the membrane M of the obturator foramen OF or Location B) the periosteum tissue of the ramus IR adjacent to the obturator foramen OF; and

inserting a second arm106located on a second side of the support100into the perineal incision110, directing an end of the second arm106toward a second obturator foramen OF of the pelvis, and fixing the end portion of the second arm106to one of C) the membrane M of the second obturator foramen OF or D) the periosteum tissue of the ramus IR adjacent to the second obturator foramen OF; and

inserting a pre-pubic side108of the support100into the perineal incision110and directing the pre-pubic side108of the support100anterior to the pelvis towards a pubic bone PB of the pelvis; and

pushing the anchor22(seeFIG. 2A) through the pre-pubic side108of the support100and into periosteum tissue PT over the pubic bone PB and engaging the spine portion34of the anchor22in the periosteum tissue PT of the pubic bone PB; and

securing the pre-pubic side108of the support100against the periosteum tissue PT of the pubic bone PB.

The arms104,106of the support100are suitably anchored to the periosteum tissue PT posterior to (i.e., behind) the ischial ramus IR or anterior to the ischial ramus IR. Mindful of this, and as examples,FIG. 29illustrates the arm104anchored to the membrane M at a posterior location relative to the ischial ramus IR (Location A) and the arm106anchored to the anterior surface of the ischial ramus IR (Location B). It is suitable to attach either arm104,106to the inferior edge of the ischial pubic ramus IR.

An addition to the method of anchoring the support100relative to the pelvis includes: inserting a body portion30(seeFIG. 3) of the anchor22into a lumen46in a cannula40and having the spine portion34of the anchor22extending radially out of a wall90of the cannula40; inserting a leading end40of the cannula40and the anchor22into the perineal incision110; and pushing the leading end44of the cannula40and the anchor22into the periosteum tissue PT of the pubic bone PB.

An addition to the method of anchoring the support100relative to the pelvis includes: leaving a suture23attached to the anchor22trailing from the anchor22and out of the perineal incision110; and tying the suture23against the pre-pubic108side of the support100and fixing the pre-pubic side108of the support100against the periosteum tissue PT of the pubic bone PB.

With reference toFIGS. 7 and 29, an addition to the method of anchoring the support100relative to the pelvis includes: leaving the suture23attached to the anchor22trailing from the anchor22and out of the perineal incision110; and sliding a stopper150attached to the suture23from the perineal incision110inward toward the pubic bone PB and fixing the pre-pubic side108of the support100against the periosteum tissue PT and between the stopper150and the pubic bone PB.

An addition to the method of anchoring the support100relative to the pelvis includes: inserting a body portion30(FIG. 3) of the anchor22into a lumen46in a cannula40and having the spine portion34of the anchor22extending radially out of a wall90of the cannula40; inserting a leading end44of the cannula40and the anchor22into the perineal incision110; pushing the leading end44of the cannula40and the anchor22into the membrane M of the first obturator foramen OF; and fixing the end portion of the first arm104to the membrane M of the first obturator foramen OF.

An addition to the method of anchoring the support100relative to the pelvis includes: inserting a body portion30(FIG. 3) of the anchor22into a lumen46in a cannula40and having the spine portion34of the anchor22extending radially out of a wall90of the cannula40; inserting a leading end44of the cannula40and the anchor22into the perineal incision110; pushing the leading end44of the cannula40and the anchor22into the periosteum tissue PT of the ramus IR adjacent to the first obturator foramen OF; and fixing the end portion of the first arm104to the periosteum tissue PT of the ramus IR adjacent to the first obturator foramen OF.

Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of medical devices as discussed herein. Therefore, it is intended that this invention is limited only by its claims and their equivalents.