CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of the following applications, the entire contents of each of which are incorporated by reference herein:

U.S. Provisional Application No. 63/455,824, filed March 30, 2023 and entitled “Urinary Incontinence Support Elements and Related Delivery Devices and Methods;” and

U.S. Provisional Application No. 63/420,840, filed October 31, 2022 and entitled “Urinary Incontinence Support Elements and Related Delivery Devices and Methods.”

FIELD

[0002] This application generally relates to urinary incontinence support elements.

BACKGROUND

[0003] A variety of treatments for female urinary incontinence have been developed, including nonsurgical treatments such as Kegel exercises or pessaries; and surgical treatments such as injections to tighten the opening of the bladder neck, or slings such as midurethral slings, or traditional slings. Slings may be implanted using incisions through the abdominal wall, which can be traumatic and increase the risk of complications. Additionally, slings may be held in place through friction with tissue, and therefore run the risk of inadvertently being displaced from the intended location, reducing the efficacy of the treatment.

SUMMARY

[0004] Examples of urinary incontinence support elements, delivery devices, and methods are provided herein, and described in the appended figures and claims. [0005] Some examples herein provide a device for treating urinary incontinence. The device may include an expandable clip. The device may include an elongated support element removably attached to the expandable clip. The device may include a tubular delivery device configured to house the expandable clip and the elongated support element. The tubular delivery device may include a linear proximal section, a linear distal section, a curved section between the linear proximal and distal sections, and a retractable sheath distal of the linear distal section. The device may include a bulbous protrusion extending radially from the linear distal section of the tubular delivery device and about at least a portion of an outer circumference thereof; and a mechanism for retracting the retractable sheath at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device.

[0006] In some examples, the expandable clip includes a shape memory material. In some examples, the shape memory material is nitinol.

[0007] In some examples, the expandable clip includes a biodegradable material.

[0008] In some examples, the expandable clip has a compressed configuration when housed within the tubular delivery device and an expanded configuration when released from the tubular delivery device. In some examples, the expandable clip includes two elongated leg sections connected by a curved clip section. The two leg sections may form a first acute angle with respect to each other in the compressed configuration. In some examples, when the expandable clip is in the expanded configuration, the two leg sections of the expandable clip form an angle with respect to each other that is larger than the first acute angle.

[0009] In some examples, the mechanism for retracting the retractable sheath includes an open ring at a proximal end of the tubular delivery device, the open ring configured to receive the thumb of a user.

[0010] In some examples, the elongated support element includes a suture.

[0011] In some examples, the elongated support element includes a sling.

[0012] In some examples, the elongated support element includes a mesh structure. [0013] In some examples, the device further includes a mechanism for applying tension to the elongated support element.

[0014] Some examples herein provide a method for treating urinary incontinence. The method may include taking a transvaginal incision, and inserting a device through the transvaginal incision and along a posterior face of a pelvic bone. The device may include an expandable clip having a compressed configuration and an expanded configuration. The device may include an elongated support element removably attached to the expandable clip. The device may include a tubular delivery device configured to house the expandable clip and the elongated support element. The tubular delivery device may include a linear proximal section, a linear distal section, a curved section between the linear proximal and distal sections, and a retractable sheath distal of the linear distal section. The retractable sheath retains the expandable clip in the compressed configuration. The device may include a bulbous protrusion extending radially from the linear distal section of the tubular delivery device and about at least a portion of an outer circumference thereof. The device may include a mechanism for retracting the retractable sheath at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device. The method may include advancing the tubular delivery device until the bulbous protrusion is in contact with a pelvic rim. The method may include retracting the retractable sheath to expand the expandable clip from the compressed configuration to the expanded configuration. The method may include retracting the tubular delivery device to engage the expandable clip, in the expanded configuration, with the pelvic rim. The method may include removing the tubular delivery device from the incision.

[0015] In some examples, the transvaginal incision is made in vaginal tissue on one lateral side of a urethra. In some examples, the method further may include the steps of making a second transvaginal incision in vaginal tissue on a second lateral side of the urethra, inserting a second tubular delivery device through the transvaginal incision and along a posterior face of a pelvic bone; advancing the second tubular delivery device until the bulbous protrusion is in contact with the pelvic rim; retracting the retractable sheath of the second tubular delivery device to thereby expand a second expandable clip into the expanded configuration; retracting the tubular delivery device to engage the expandable clip, in the expanded configuration, with the pelvic rim; from the tubular delivery device; and removing the tubular delivery device from the second transvaginal incision.

[0016] In some examples, the expandable clip includes a shape memory material. In some examples, the shape memory material is nitinol.

[0017] In some examples, the expandable clip includes a biodegradable material.

[0018] In some examples, the expandable clip includes two elongated leg sections connected by a curved clip section. The two leg sections may form a first acute angle with respect to each other in the compressed configuration. In some examples, when the expandable clip is in the expanded configuration, the two leg sections of the expandable clip form an angle with respect to each other that is larger than the first acute angle.

[0019] In some examples, the mechanism for retracting the retractable sheath includes an open ring at a proximal end of the tubular delivery device, the open ring configured to receive the thumb of a user. The step of retracting the retractable sheath may include retracting the open ring along an axis parallel to a longitudinal axis to the linear proximal section of the tubular delivery device.

[0020] In some examples, the elongated support element includes a suture.

[0021] In some examples, the elongated support element includes a sling.

[0022] In some examples, the elongated support element includes a mesh structure.

[0023] Some examples herein provide an elongated support element configured for placement proximate a patient’s urethra. The elongated support element may include a proximal portion, a central portion, and a distal portion. A width of the central portion may be larger than a width of the proximal portion and a width of the distal portion.

[0024] In some examples, the width of the central portion is between 3 cm and 5 cm.

[0025] In some examples, the central portion includes a top surface, a bottom surface, and a plurality of first openings extending between the top and bottom surfaces. In some examples, at least one of the proximal and distal portions include a plurality of second openings. In some examples, the first openings are substantially the same size as the second openings. In some examples, the first openings are a different size than the second openings. In some examples, the first and second openings are substantially circular. In some examples, at least one of the first and second openings are elongated. In some examples, the first and second openings have substantially the same aspect ratio. In some examples, the first and second openings have different aspect ratios.

[0026] In some examples, at least one of the proximal and distal portions is connected to a needle.

[0027] In some examples, at least one of the proximal and distal portions is connected to an electrode including a blunt tip.

[0028] Some examples herein provide an elongated support element configured for placement proximate a patient’s urethra. The elongated support element may include a proximal portion, a central portion, and a distal portion. One or both of the proximal and distal portions include a surface including an adhesive material.

[0029] In some examples, the adhesive material includes 2-octyl cyanoacrylate.

[0030] In some examples, the elongated support element further may include a removable sheath covering the adhesive material.

[0031] In some examples, at least a portion of the elongated support element includes a thermoplastic material.

[0032] In some examples, at least a portion of the elongated support element includes a foam material.

[0033] In some examples, at least a portion of the elongated support element includes a biodegradable material.

[0034] In some examples, at least a portion of the elongated support element includes a cadaveric material. [0035] In some examples, at least a portion of the elongated support element includes an antibiotic material.

[0036] In some examples, at least a portion of the elongated support element includes a material that promotes ingrowth of tissue through at least one of the proximal, distal, and central portions.

[0037] Some examples herein provide an elongated support element configured for placement proximate a patient’s urethra. The elongated support element may include a proximal portion, a central portion, a distal portion. A first suture may connect the proximal portion to the central portion. A second suture may connect the distal portion to the central portion. Each of the proximal, central, and distal portions may include a mesh structure.

[0038] In some examples, at least one of the proximal and distal portions include a barbed surface.

[0039] In some examples, at least one of the proximal and distal portions include a raised chevron structure.

[0040] Some examples herein provide a method of treating urinary incontinence in a patient.

The method may include making a first incision in the patient’s vaginal wall on a first lateral side of the patient’s urethra, and making a second incision in the patient’s vaginal wall on a second lateral side of the patient’s urethra. The method may include inserting the proximal portion of an elongated support element of any of the above examples into the first incision. The method may include inserting the distal portion of the elongated support element into the second incision. The method may include anchoring the proximal and distal portions of the elongated support element to the patient.

[0041] In some examples, the method further includes the step of advancing the proximal and distal portions of the elongated support element towards an abdominal wall of the patient. In some examples, the method further includes the step of advancing the proximal and distal portions of the elongated support element through the abdominal wall. In some examples, each of the proximal and distal portions of the elongated support element extend through an obturator intemus of the patient. [0042] In some examples, the method further includes the step of applying heat to at least one of the proximal and distal portions of the elongated support element to anchor the at least one of the proximal and distal ends to the patient. In some examples, the step of applying heat includes applying radiofrequency energy to the at least one of the proximal and distal portions of the elongated support element. In some examples, the proximal portion of the elongated support element is attached to a first anchor, and the distal portion of the elongated support element is attached to a second anchor. In some examples, prior to inserting the proximal portion of the elongated support element into the first incision, at least a portion of the elongated support element is provided within an inserter tool. The inserter tool may include a tool proximal end and a tool distal end. The inserter tool may include a channel between the tool proximal end and the tool distal end, the channel configured to receive the proximal portion of the elongated support element. The inserter tool may include a blunt tip portion at the tool distal end. The blunt tip portion may be configured to house the first anchor. When the first anchor is housed within the blunt tip portion of the inserter tool, the anchor may be closer to the tool proximal end than at least a portion of the proximal portion of the elongated support element.

[0043] In some examples, the method further includes the step of placing the anchor in proximity to a pectineal ligament of the patient.

[0044] In some examples, the blunt tip portion is configured to emit radio frequency energy.

[0045] Some examples herein provide a method of treating urinary incontinence in a patient. The method may include making an incision in the patient’s vaginal wall. The method may include inserting both of the proximal and distal ends of the elongated support element of any of the above examples into the incision.

[0046] In some examples, the method further includes the step of advancing the proximal and distal portions of the elongated support element towards an abdominal wall of the patient. In some examples, the method further includes the step of advancing the proximal and distal portions of the elongated support element through the abdominal wall. In some examples, each of the proximal and distal portions of the elongated support element extend through an obturator internus of the patient. In some examples, the proximal and distal portions of the elongated support element are attached to a single tissue anchor. In some examples, the method further includes the step of applying heat to at least one of the proximal and distal portions of the elongated support element to secure the at least one of the proximal and distal portions to surrounding tissue. In some examples, the step of applying heat includes applying radiofrequency energy to the at least one of the proximal and distal portions of the elongated support element.

[0047] Some examples herein provide an anchor configured for attachment to an elongated support element configured for placement proximate a patient’s urethra. The anchor may include a body portion and plurality of barbs radially extending from the body portion. The plurality of barbs may have a collapsed configuration in which at least one of the plurality of barbs is separated from the body portion by a first distance, and an expanded configuration in which the at least one of the plurality of barbs is separated from the body portion by a second distance, the second distance being larger than the first distance.

[0048] In some examples, the plurality of barbs form a star shape when in the expanded configuration.

[0049] Some examples herein provide an anchor configured for attachment to an elongated support element configured for placement proximate a patient’s urethra. The anchor may include proximal portion and a distal portion. The distal portion may form a planar, semi-circular shape. At least a portion of the proximal portion may be substantially orthogonal to a plane of the planar, semi-circular shape.

[0050] Some examples herein provide a system for treating urinary incontinence. The system may include an introducer including a proximal handle and an elongated member extending from the handle. The elongated member may include a straight portion and a curved portion. The system may include a tubular sheath including an open end, a closed end terminating in a blunt tip, a sidewall, and a lumen extending from the open end towards the closed end. The lumen may be configured to receive a portion of the elongated member. The system may include an elongated support element including a first end and a second end, and configured for removable attachment to the tubular sheath. [0051] In some examples, the system further includes a first pledget attached to the elongated support element adjacent to the first end thereof. In some examples, the system further includes a second pledget attached to the elongated support element adjacent to the second end thereof. In some examples, the tubular sheath includes a recess in the sidewall configured for receiving the first pledget. In some examples, the tubular sheath includes a living hinge in the sidewall for providing access to the recess.

[0052] In some examples, the first pledget includes an opening extending through a thickness of the first pledget, the opening configured for receiving the first end of the elongated support element.

[0053] Some examples herein provide a method of treating urinary incontinence in a patient. The method may include making an incision in a vaginal wall of the patient, and introducing, through the incision in the vaginal wall, the introducer of a system of any of the above examples. The first end of the elongated support element may be to the tubular sheath. The distal end of the elongated member of the introducer may be within the lumen of the tubular sheath. The method may include extending the blunt tip of the tubular sheath towards an abdominal wall of the patient. The method may include making an incision in the abdominal wall. The method may include moving the tubular sheath through the incision in the abdominal wall such that the tubular sheath is outside of the patient. The method may include retracting the introducer from the patient while maintaining the tubular sheath outside of the patient. The method may include detaching the first end of the elongated support element from the tubular sheath.

[0054] In some examples, the elongated support element includes a first portion including the first end, a second portion including the second end, and a third portion between the first and second ends, the third portion having a width greater than either of the first or second portions. In some examples, the third portion of the elongated support element includes a synthetic material. In some examples, the third portion of the elongated support element includes a biodegradable material.

[0055] In some examples, the system further includes a second tubular sheath including an open end, a closed end terminating in a blunt tip, a sidewall, and a lumen extending from the open end towards the closed end, the lumen configured to receive a portion of the elongated member. In some examples, the method further includes the steps of: placing the distal end of the elongated member of the introducer into the lumen of the second tubular sheath; introducing the introducer through the incision in the vaginal wall and extending the blunt tip of the second tubular sheath towards the abdominal wall of the patient; moving the second tubular sheath through the incision in the abdominal wall, or through a second incision in the abdominal wall, such that the second tubular sheath is outside of the patient; retracting the introducer from the patient while maintaining the second tubular sheath outside of the patient; and detaching the second end of the elongated support element from the second tubular sheath.

[0056] In some examples, the method further includes attaching the second end of the elongated support element to the second tubular sheath.

[0057] In some examples, the method further includes attaching the first end of the elongated support element to the tubular sheath.

[0058] In some examples, the method further includes placing the distal end of the elongated member of the introducer within the lumen of the tubular sheath.

[0059] Some examples herein provide a device for treating urinary incontinence. The device may include an expandable clip; an elongated support element removably attached to the expandable clip; and a tubular delivery device configured to house the expandable clip and the elongated support element. The tubular delivery device may include a linear proximal section, a linear distal section, and a curved section between the linear proximal and distal sections. The device may include a bulbous protrusion extending radially from the linear distal section of the tubular delivery device and about at least a portion of an outer circumference thereof. The device may include a mechanism for releasing the expandable clip from the tubular delivery device.

[0060] In some examples, the device further includes a retractable sheath distal of the linear distal section, wherein the mechanism is for retracting the retractable sheath at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device. [0061] In some examples, the mechanism is for pushing the expandable clip out of the tubular delivery device.

[0062] In some examples, the expandable clip includes a shape memory material. In some examples, the shape memory material is nitinol. In some examples, the expandable clip includes a biodegradable material.

[0063] In some examples, the expandable clip has a compressed configuration when housed within the tubular delivery device and an expanded configuration when released from the tubular delivery device. In some examples, the expandable clip includes two elongated leg sections connected by a curved clip section, and the two leg sections form a first acute angle with respect to each other in the compressed configuration. In some examples, when the expandable clip is in the expanded configuration, the two leg sections of the expandable clip form an angle with respect to each other that is larger than the first acute angle.

[0064] In some examples, the mechanism for releasing the expandable clip from the tubular delivery device includes an open ring at a proximal end of the tubular delivery device, the open ring configured to receive the thumb of a user.

[0065] In some examples, the elongated support element includes a suture. In some examples, the elongated support element includes a sling. In some examples, the elongated support element includes a mesh structure.

[0066] In some examples, the device further includes a mechanism for applying tension to the elongated support element.

[0067] Some examples herein provide a method for treating urinary incontinence. The method may include taking a transvaginal incision; and inserting a device through the transvaginal incision and along a posterior face of a pelvic bone. The device may include an expandable clip having a compressed configuration and an expanded configuration; an elongated support element removably attached to the expandable clip; and a tubular delivery device configured to house the expandable clip and the elongated support element. The tubular delivery device may include a linear proximal section, a linear distal section, and a curved section between the linear proximal and distal sections. The device may include a bulbous protrusion extending radially from the linear distal section of the tubular delivery device and about at least a portion of an outer circumference thereof. The device may include a mechanism for releasing the expandable clip from the tubular delivery device to thereby expand the expandable clip from the compressed configuration to the expanded configuration. The method may include advancing the tubular delivery device until the bulbous protrusion is in contact with a pelvic rim. The method may include expanding the expandable clip from the compressed configuration to the expanded configuration. The method may include retracting the tubular delivery device to engage the expandable clip, in the expanded configuration, with the pelvic rim. The method may include removing the tubular delivery device from the incision.

[0068] In some examples, the device further includes a retractable sheath distal of the linear distal section, wherein the mechanism is for retracting the retractable sheath at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device.

[0069] In some examples, the mechanism is for pushing the expandable clip out of the tubular delivery device.

[0070] In some examples, the transvaginal incision is made in vaginal tissue on one lateral side of a urethra.

[0071] In some examples, the method further includes making a second transvaginal incision in vaginal tissue on a second lateral side of the urethra, inserting a second tubular delivery device through the transvaginal incision and along a posterior face of a pelvic bone; advancing the second tubular delivery device until the bulbous protrusion is in contact with the pelvic rim; expanding a second expandable clip into the expanded configuration; retracting the second tubular delivery device to engage the expandable clip, in the expanded configuration, with the pelvic rim; and removing the second tubular delivery device from the second transvaginal incision.

[0072] In some examples, the expandable clip includes a shape memory material. In some examples, the shape memory material is nitinol. In some examples, the expandable clip includes a biodegradable material. [0073] In some examples, the expandable clip includes two elongated leg sections connected by a curved clip section. In some examples, the two leg sections form a first acute angle with respect to each other in the compressed configuration. In some examples, when the expandable clip is in the expanded configuration, the two leg sections of the expandable clip form an angle with respect to each other that is larger than the first acute angle.

[0074] In some examples, the mechanism for retracting the retractable sheath comprises an open ring at a proximal end of the tubular delivery device, the open ring configured to receive the thumb of a user; and wherein the step of retracting the retractable sheath comprises retracting the open ring along an axis parallel to a longitudinal axis to the linear proximal section of the tubular delivery device.

[0075] In some examples, the elongated support element includes a suture. In some examples, the elongated support element includes a sling. In some examples, the elongated support element includes a mesh structure.

BRIEF DESCRIPTION OF DRAWINGS

[0076] FIGS. 1A-1B schematically illustrate an example device for treating urinary incontinence.

[0077] FIGS. 2A-2H schematically illustrate operations in an example method for treating urinary incontinence.

[0078] FIGS. 3A-3C schematically illustrate example support elements.

[0079] FIG. 4 schematically illustrates an example support element.

[0080] FIGS. 5A-5E schematically illustrate views of an example support element implanted in a patient.

[0081] FIGS. 6A-6C schematically illustrate an example anchor.

[0082] FIGS. 7A-7C schematically illustrate another example anchor.

[0083] FIGS. 8A-8B schematically illustrate another example anchor. [0084] FIGS. 9A-9B schematically illustrate another example anchor.

[0085] FIGS. 10A-10B schematically illustrate another example anchor.

[0086] FIGS. 11A-11C schematically illustrate operations in an example method for anchoring a support element in a patient.

[0087] FIGS. 12A-12C schematically illustrate operations in an alternative example method for anchoring a support element in a patient.

[0088] FIG. 13 schematically illustrates components of an example system for treating urinary incontinence.

[0089] FIGS. 14A-14E schematically illustrate operations in an example method for treating urinary incontinence.

[0090] FIG. 15 schematically illustrates an example configuration of the device described with reference to FIGS. 1 and 2A-2H.

[0091] FIGS. 16A-16D schematically illustrate another example configuration of the device described with reference to FIGS. 1 and 2A-2H.

DETAILED DESCRIPTION

[0092] Examples of urinary incontinence support elements, delivery devices, and methods are provided herein, and described in the appended figures and claims.

[0093] Some examples herein provide devices for treating urinary incontinence. The devices may be used to atraumatically and transvaginally deliver and implant an expandable clip that engages the pelvic rim and may be used to securely retain a support element (such as a sling) within the pelvic girdle. Because the delivery device has an atraumatic design, there is minimal to no risk of perforation. Additionally, the delivery device uses a transvaginal approach without needing abdominal exit incisions, thus reducing patient trauma and the risk of infection. The expandable clip provides significantly more robust anchoring than a free-floating sling that solely relies on sling friction with tissue. Furthermore, the device may have a single delivery handle, and may be manufactured with relatively low cost. As additional benefits, the implanted clip, as well as the support element (e.g., sling) and/or anchor (e g., clip or hook) thereof, may be fully synthetic, fully resorbable, and/or a hybrid.

[0094] FIGS. 1A-1B schematically illustrate an example device for treating urinary incontinence. Device 100 may include expandable clip 10 (hook) and an elongated support element 11 (such as a suture, sling, and/or mesh structure) that is removably attached to the expandable clip. In a manner such as will be described, device 100 may be used to implant expandable clip 10 over the pelvic bone of a patient, such that the expandable clip may be used to securely retain the support element at a desired location within the pelvic girdle. In some examples, the expandable clip includes a shape memory material, such as nitinol, or a biodegradable material that may dissolve and be absorbed by the body over time.

[0095] In some examples, the expandable clip 10 has a compressed configuration when housed within the tubular delivery device 110 (FIG. 1 A) and an expanded configuration when released from the tubular delivery device 110 (FIG. IB). In the nonlimiting example illustrated in FIGS. 1A-1B, the expandable clip includes two elongated leg sections 12, 13 connected by a curved clip section 14. When the expandable clip 10 is in the compressed configuration such as illustrated in FIG. 1A, the two leg sections 12, 13 form a first acute angle with respect to each other. When the expandable clip 10 is in the expanded configuration such as illustrated in FIG. IB, the two leg sections 12, 13 of the expandable clip form an angle with respect to each other that is larger than the first acute angle. For example, when moving from the compressed configuration (FIG. 1A) to the expanded configuration (FIG. IB), the free end of leg section 13 may spring outwardly in the expanded configuration responsive to release of a compressive force that retractable sheath 14 applies to leg section 13. The free end of leg section 12 may include an aperture (not specifically illustrated) through which elongated support element 11 is threaded.

[0096] As illustrated in FIGS. 1 A-1B, device 100 may include a tubular delivery device 110 configured to house the expandable clip 10 and the elongated support element 11. The tubular delivery device 110 may include a linear proximal section 111, a linear distal section 112, a curved section 113 between the linear proximal and distal sections, and a retractable sheath 114 distal of the linear distal section 112. Tubular delivery device 110 may be formed of any suitable material or materials. For example, tubular delivery device 110 may include a stiff delivery tube 117 (see inset of FIG. 2C) that defines the overall shape of delivery device 110, such as aluminum, stainless steel, or the like. Retractable sheath 114 may be formed of any suitable, flexible material (such as polytetrafluoroethylene (PTFE) or polyethylene) and is sized so that the sheath may be smoothly translated and/or rotated relative to tubular delivery device 110. The device 100 may include a bulbous protrusion 120 (sheath catch) extending radially from the linear distal section 112 of the tubular delivery device 110 and about at least a portion of an outer circumference thereof. As shown in the inset of FIG. 2C, the bulbous protrusion 120 may be mounted on a flexible tube 121 (sheath catch tube) that surrounds the stiff delivery tube 117 of tubular delivery device 110, and allows the sheath catch to be rotated out of the way when pulling the expandable clip 10 into position in a manner such as will be described with reference to FIGS. 2C-2D. In some examples, flexible tube 121 and bulbous protrusion 120 are formed of the same flexible material as one another, such as PTFE or polyethylene, and are of unitary construction (that is, formed together out of a single piece of the flexible material).

[0097] Device 100 also may include a mechanism 130 for retracting the retractable sheath 114 at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device. Illustratively, in the nonlimiting example shown in FIGS. 1A-1B, mechanism 130 for retracting the retractable sheath 114 includes an open ring 131 at a proximal end of the tubular delivery device 110. Open ring 131 may be coupled through shaft 116 (push rod) to retractable sheath 114, such that distal movement of the open ring 131 from the position shown in FIG. 1 A to the position shown in FIG. IB retracts sheath 114. Responsive to retraction of sheath 114, the clip 10 opens to the expanded configuration. The open ring 131 may be configured to receive the thumb of a user (e.g., physician) so that the thumb remains in secure contact with the ring when pulling back on the open ring to retract the sheath 114, e.g., in a manner such as illustrated in FIGS. 2A-2H or 15, although it will be appreciated that many other handle shapes may be used. Optionally, mechanism 130 may include knob 132 to which flexible tube 121 is attached and that can be used to rotate the flexible tube 121 relative to the stiff delivery tube 117. Alternatively, in a manner such as will be described further below with reference to FIGS. 16A-16D, device 100 may omit the retractable sheath 114, clip 10 may be retained in the distal section 112, and ring 131 may be used to push clip 10 out of the distal section 112. [0098] In some examples, the device further includes a mechanism for applying tension to the elongated support element 11. For example, as illustrated in FIGS. 1A-1B, as noted above, elongated support element 11 may be threaded through an aperture at the free end of clip 10. The elongated support element 11 may be disposed along the length of tubular delivery device 110, and may be held under tension at the proximal end of tubular delivery device 110, e.g., may be pinned between the user’s finger and/or thumb in a manner such as illustrated in FIGS. 2A- 2H, and/or may be pinned by a clamp (clamp not specifically illustrated). In examples such as illustrated in FIGS. 1A-1B, the elongated support element 11 may be partially disposed within retractable sheath 114 and partially disposed outside of tubular delivery device 110, e.g., may pass through an aperture of tubular delivery device 110. In other examples (not specifically illustrated), the elongated support element 11 is disposed within retractable sheath 114 along the entire length of tubular delivery device 110. In still other examples (not specifically illustrated), the elongated support element 11 may pass entirely along the outside of tubular delivery device 110.

[0099] Device 100 described with reference to FIGS. 1A-1B may be used in any suitable method for treating urinary incontinence. For example, FIGS. 2A-2H schematically illustrate operations in an example method for treating urinary incontinence. Referring now to FIG. 2A, method may include the step of providing a device, e.g., device 100. For example, in a manner such as described with reference to FIGS. 1 A-1B, the device 100 may include an expandable clip 10, and an elongated support element 11 removably attached to the expandable clip 10. The expandable clip may have a compressed configuration (FIG. 1A) and an expanded configuration (FIG. IB). The device 100 may include a tubular delivery device 110 configured to house the expandable clip 10 and the elongated support element 11. The tubular delivery device 110 may include a linear proximal section 111, a linear distal section 112, a curved section 113 between the linear proximal and distal sections, and a retractable sheath 114 distal of the linear distal section. The retractable sheath retains the expandable clip 10 in the compressed configuration, e.g., until the clip is positioned for implantation in a manner which will be described. The device 110 may include a bulbous protrusion (sheath catch) 120 extending radially from the linear distal section 112 of the tubular delivery device 110 and about at least a portion of an outer circumference thereof. The bulbous protrusion 120 may be shaped to enable the user to feel the bulbous protrusion engage, or “grapple,” with the pelvic rim, e.g., in a manner such as described with reference to FIGS. 2A-2B. The device 100 may include a mechanism 130 for retracting the retractable sheath at least partially into the linear distal section of the linear distal section of the tubular delivery device to thereby release the expandable clip from the tubular delivery device, e.g., expand the clip 10 from the compressed configuration (FIG. 1A) to the expanded configuration (FIG. IB).

[00100] The method may include taking a transvaginal incision, for example in a manner such as will be described with reference to FIGS. 14A-14E. As illustrated in FIG. 2A, the method may include inserting the tubular delivery device 110 through the transvaginal incision and along a posterior face 21 of a pelvic bone 20. For example, as illustrated in FIG. 2A, the user may use one or more fingers of one hand to press the distal section 112 of the tubular delivery device 110 against the posterior face 21 of the pelvic bone 20, while pushing the tubular delivery device 110 forward using the other hand. The distal position of sheath 114 within tubular delivery device 110 may be maintained while the tubular delivery device is pushed through tissue. For example, the user’s hand may retain thumb ring 131 against knob 132 in a “stop” position in which the distal tangential face of the thumb ring contacts the proximal face of knob 132.

[00101] As illustrated in FIG. 2B, the method may include advancing the tubular delivery device 110 distally until the bulbous protrusion 120 is in contact with a pelvic rim 22. For example, when the user advances the tubular delivery device sufficiently far that the bulbous protrusion reaches the pelvic rim, a “pop-over” effect from the bulbous protrusion (sheath catch) will be felt. The user then may pull down slightly on the device shaft to confirm engagement of the bulbous protrusion with the pelvic rim, e.g., to feel a “grappling hook” effect.

[00102] The method may include retracting the retractable sheath 114 to thereby release the expandable clip 10 from the tubular delivery device 100. For example, as illustrated in FIG. 2C, while maintaining the grappled position of bulbous protrusion 120, the user may use open ring 131 (or other mechanism 130) to retract sheath 114 into tubular delivery device 110, for example by retracting open ring 131 to retract shaft 116 (and therefore sheath 114) proximally. In some examples, shaft 116 includes a mark to show where the shaft has been sufficiently retracted, and/or a tab to inhibit further “pull-out” of shaft 116. Responsive to retraction of sheath 114, expandable clip 10 is released and fully exposed. For example, expandable clip 10 expands to the expanded configuration such as described with reference to FIG. IB. For example, as illustrated in FIG. 2C, leg section 13 may spring outward responsive to release of a compressive force that retractable sheath 114 applies to leg section 13.

[00103] As illustrated in FIG. 2D, the method may include retracting the tubular delivery device 110 to engage the expandable clip 10, in the expanded configuration, with the pelvic rim 22. The user may maintain tension on elongated support element 11 (e.g., suture) while pulling the tubular delivery device 110 proximally, to keep the elongated support element 10 in contact with the tubular delivery device 110. Additionally, or alternatively, the user may pull on elongated support element 11 to grapple clip 10 over the pelvic rim 22 and/or to confirm that the elongated support element 11 is securely engaged with the pelvic rim 22. In some examples, before pulling back on the delivery device 110, the user may use the delivery knob 132 to rotate flexible tube 121 relative to stiff delivery tube 117 so as to rotate bulbous protrusion 120 off of the pelvic rim while the free leg 13 of clip 10 maintains a parallel position to the anterior face of the pelvis. In a manner such as illustrated in FIGS. 2E and 2F, after expandable clip 10 is engaged with pelvic rim 22, the tension on elongated support element 11 may be released and the tubular delivery device 100 may be moved proximally, away from clip 10. The method may include removing the tubular delivery device from the incision. The expandable clip 10 may be used to support any suitable elongated support element, e.g., such as described elsewhere herein, or otherwise known in the art. For example, as illustrated in FIG. 2G, the elongated support element to which expandable clip 10 is coupled may include a sling 11. A first end 15 of sling 11 may be coupled to expandable clip 10 via a first suture 11’, and a second end 15’ of sling 11 may be coupled to another expandable clip 10 (not specifically shown) via a second suture 11”.

[00104] Indeed, it will be appreciated that operations such as described with reference to FIGS. 2A-2G may be repeated, e.g., using multiple devices 100 or reusing the same device 100, to implant multiple clips 10 at the pelvic rim. In some examples, the transvaginal incision is made in vaginal tissue on one lateral side of a urethra. In some examples, the method further may include the steps of making a second transvaginal incision in vaginal tissue on a second lateral side of the urethra, inserting the same tubular delivery device or a second tubular delivery through the transvaginal incision and along a posterior face of a pelvic bone; advancing the second tubular delivery device until the bulbous protrusion is in contact with the pelvic rim; retracting the retractable sheath to thereby expand a second expandable clip into the expanded configuration; retracting the tubular delivery device to engage the expandable clip, in the expanded configuration, with the pelvic rim; and removing the tubular delivery device from the second transvaginal incision. In the nonlimiting example illustrated in FIG. 2H, elongated support element 11 thus may be securely coupled to two different points of the pelvic rim 22, so as to pass under (and therefore support) the bladder 23, proximate the patient’s urethra.

[00105] Device 100 may include any suitable mechanism for retracting the retractable sheath 114 at least partially into the linear distal section 112 of the tubular delivery device 110 to thereby release the expandable clip 10 from the tubular delivery device. For example, FIG. 15 schematically illustrates an example configuration of device 110 described with reference to FIGS. 1 and 2A-2H. More specifically, FIG. 15 illustrates example details at the linear distal section 112 of tubular delivery device 110, and at the linear proximal section 111 of tubular delivery device 110. The linear distal section 112 may include plunger rod 1501 which includes (or may be coupled to) platform 1502 on which clip 10 may be disposed. Plunger rod 1501 may be used to hold expandable clip 10 in place while retracting rod 116, which is coupled to retractable sheath 114, is retracted proximally to release the expandable clip, e.g., by pulling ring 131 proximally in a manner such as described with reference to FIGS. 1A and 2C. Note that suture 11’ may go through holes in plunger rod 1501 and retractable sheath 114, so that the suture 11 ’ can stay within delivery tube 117. Additionally, as illustrated in FIG. 15, retracting rod 116 may be off-centered in delivery tube 117, to provide additional space for plunger rod 1501 which may be held in place using pad 1503 at the proximal end of the delivery device. For example, ring 131 may be retracted with one hand to retract sheath 114, while the other hand uses pad 1503 to hold the plunger rod 1501 (and thus expandable clip 10) in place. Note that in examples such as described with reference to FIGS. 1, 2A-2G, and 15, sheath 121 may be formed of a very thin polymer, which is soft and flexible and goes over delivery tube 117. In a manner such as illustrated in FIGS. 2D-2E, knob 132 may be used to rotate bulbous protrusion out of the way.

[00106] While the nonlimiting examples of device 100 described with reference to FIGS. 1, 2A- 2G, and 15 include retractable sheath 114, it will be appreciated that device 100 may include any suitable mechanism for releasing the expandable clip 10 from the tubular delivery device 110. For example, the mechanism instead may be for pushing the expandable clip 10 out of the tubular delivery device 110. FIGS. 16A-16D schematically illustrate another example configuration of the device described with reference to FIGS. 1 and 2A-2H, in which expandable clip 10 may be pushed out of tubular delivery device 110. More specifically, as illustrated in FIG. 16A, retractable sheath 114 may be omitted and expandable clip 10, in the compressed configuration, may be disposed within linear distal section 112 of tubular delivery device 110. Device 100 also may include deployment plunger 1601 which extends through tubular delivery device 110 and is coupled to ring 131. Optionally, deployment plunger 1601 may include spacer 1603 that keeps deployment plunger 1601 approximately straight within tubular delivery device 110. The distal end of deployment plunger 1601 may include (or may be coupled to) platform 1602 on which clip 10 may be disposed. Leg 12 of expandable clip 10 may be coupled to suture 11’ which passes through tubular delivery device 110. As illustrated in FIG. 16A, device 100 may be used to position linear distal section 112 in the patient’s body in a similar manner as described with reference to FIGS. 2A-2B, e.g., so that bulbous protrusion 120 grapples over the pelvic rim 22. As illustrated in FIG. 16B, the user may advance ring 131 distally to push clip 10 out of the linear distal section 112. The clip then may be engaged with pelvic rim 22 in a manner such as described with reference to FIGS. 2D-2E, for example by retracting the tubular delivery device 110 to engage the expandable clip 10, in the expanded configuration, with the pelvic rim 22 in a manner such as illustrated in FIG. 16C. In a manner such as illustrated in FIG. 16D, after expandable clip 10 is engaged with pelvic rim 22, the tubular delivery device 100 may be moved proximally, away from clip 10. The tubular delivery device then may be removed from the incision. The expandable clip 10 may be used to support any suitable elongated support element, e.g., such as described elsewhere herein, or otherwise known in the art.

[00107] From the foregoing, it will be appreciated that device 100 has minimal or no risk of perforation due to its atraumatic delivery device design; the device utilizes a preferred transvaginal approach without needing abdominal exit incisions; the entire implant may be fully synthetic, fully resorbable, or hybrid (expandable clip, suture, and sling); the device provides more robust anchoring than a free-floating sling that solely relies on sling friction with tissue; and/or is a low cost, single delivery handle system. [00108] Nonlimiting examples of support elements that optionally may be implanted using system 100 and the method described with reference to FIGS. 2A-2H now will be described with reference to FIGS. 3A-3C, FIG. 4, and FIGS. 5A-5E. However, it will be appreciated that the present support elements may be implanted using any other suitable system or method.

[00109] FIGS. 3A-3C schematically illustrate example support elements, which may be configured for placement proximate a patient’s urethra, e.g., may be used as a sling. The elongated support element 30 illustrated in FIG. 3 A may include a proximal portion 31, a central portion 32, and a distal portion 33. A width of the central portion 32 may be larger than a width of the proximal portion 31 and a width of the distal portion 33. Similarly, the elongated support element 30’ illustrated in FIG. 3B may include a proximal portion 31’, a central portion 32’, and a distal portion 33’. A width of the central portion 32’ may be larger than a width of the proximal portion 31 ’ and a width of the distal portion 33 ’ . The elongated support element 30” illustrated in FIG. 3C may include a proximal portion 31”, a central portion 32”, and a distal portion 33”. In this example, width of the central portion 32” may be similar to, or the same as, a width of the proximal portion 31” and a width of the distal portion 33”. The proximal and distal portions of the elongated support elements 30, 30’, and 30” may include, or may be coupled to, sutures 11 that may be coupled to any suitable anchor such as provided herein (e.g., to clip 10 described with reference to FIGS. 1 A-1B and 2A-2H, or to an anchor such as described with reference to FIGS. 6A-6C, FIGS. 7A-7C, FIGS. 8A-8B, FIGS. 9A-9B, or FIGS. 10A-10B). The elongated support elements 30, 30’, and 30” may have any suitable shapes and/or sizes. In some examples, the width W of the central portion 32, 32’, or 32” is between 3 cm and 5 cm, illustratively about 4 cm. As used herein, the term “about” or “substantially” is intended to mean within 10% of the stated value. In one nonlimiting example, a smaller foreign body (e.g., elongated support element 30, 30’, or 30”) is left behind.

[00110] FIG. 4 schematically illustrates an example support element, which may be configured for placement proximate a patient’s urethra, e.g., may be used as a sling. Elongated support element 40 illustrated in FIG. 4 may correspond to support element 30, 30’, or 30”; that is, support elements 30, 30’, or 30” may be configured in the manner which will now be described with reference to FIG. 4. The elongated support element 40 illustrated in FIG. 4 may include a proximal portion 41 corresponding to proximal portion 31, 31’, or 31”; a central portion 42 corresponding to central portion 32, 32’, or 32”; and a distal portion 43 corresponding to distal portion 33, 33’, or 33”. In some examples, the central portion 42 of support element 40 includes a top surface 45, a bottom surface 46, and a plurality of first openings 47 extending between the top and bottom surfaces 45, 46. In some examples, at least one of the proximal and distal portions 41, 42 of support element 40 include a plurality of second openings 48. In some examples, the first openings 47 are substantially the same size as the second openings 48. In other examples, the first openings 47 are a different size than the second openings 48. Illustratively, first openings 47 may be larger than second openings 48, e.g., at least two times larger in at least one dimension than second openings 48. The first and second openings 47, 48 may have any suitable shape, and may have the same shape as one another or different shapes than one another. Illustratively, in the nonlimiting example illustrated in FIG. 4, first openings

47 are oval and second openings 48 are almond-shaped with pointed comers. In other examples, the first and second openings 47, 48 are substantially circular. In some examples, at least one of the first and second openings 47, 48 are elongated, and in the nonlimiting example illustrated in FIG. 4, both the first and second openings 47, 48 are elongated. In some examples, the first and second openings have substantially the same aspect ratio, while in other examples (such as illustrated in FIG. 4), the first and second openings have different aspect ratios.

[00111] Elongated support element 40, and implementations of elements 30, 30’, and 30” that are configured similarly as support element 40, may be formed in any suitable manner and using any suitable material or combination of materials. For example, support element 40 may be formed using a sheet with hole patterns, instead of only a mesh as is sometimes used in previously known support elements such as slings. The pattern of support element 40 may make the support element more compliant, like a cushion as opposed to a flat sheet. Openings 47 and

48 can promote tissue ingrowth. The pattern of openings 47 and 48 also may be used also may be used to drive the shape of support element 40 when tensioned. In nonlimiting examples, openings 47 and 48 may be laser formed for smoothness. Optionally, the overall shape of support 40 also may be defined, and cut, using a laser.

[00112] Elongated support element 40 may include any suitable synthetic, biodegradable, or cadaveric material or combination of such materials. Illustratively, elongated support element may include a thermoplastic material, foam material, and/or antibiotic material. Additionally, in some examples, at least a portion of the elongated support element 40 includes a material that promotes ingrowth of tissue through at least one of the proximal portion 41, distal portion 43, and central portion 42. For example, the opening surface configuration may be matched to mesh for tissue ingrowth; that is, the openings are the right so that tissue can connect from both sides. Additionally, while openings 47 are illustrated as being approximately the same size and shape as one another in FIG. 4, openings 47 may have a variety of sizes and/or shapes. For example, the size and/or shape of openings 47 may be a gradient across the surface of central portion 42. Additionally, while openings 48 are illustrated as being approximately the same size and shape as one another in FIG. 4, openings 48 may have a variety of sizes and/or shapes. For example, the size and/or shape of openings 48 may be a gradient across the surface of proximal portion 41 and/or across the surface of distal portion 43.

[00113] In some examples, at least one of the proximal and distal portions is connected to a needle, e.g., for use in puncturing the skin. In other examples, at least one of the proximal and distal portions is connected to an electrode including a blunt tip. Such an example may obviate the need to couple the proximal and/or distal portions of the elongated support device to a needle. Instead, the blunt tip may be used to make a tent on the skin, and a foot pedal on an electrical generator coupled to the electrode may be used to apply radio frequency energy to the electrode to create a puncture.

[00114] FIGS. 5A-5E schematically illustrate views of an example support element (e.g., sling) implanted in a patient. Support element 50 illustrated in FIGS. 5A-5E may correspond to any of support elements 30, 30’, 30”, or 40; that is, support elements 30, 30’, 30”, or 40 may be implanted in a patient in the manner which will now be described with reference to FIGS. 5A- 5E. Referring now to the perspective view of FIG. 5 A and the side view of FIG. 5D, support element 50 may be implanted beneath and surrounding bladder 55 proximal to urethra 56, e.g., in a location similar to previously known slings. Support element 50 may be fixed in place using any suitable anchor such as provided herein (e.g., using clip 10 described with reference to FIGS. 1 A-1B and 2A-2H, or using an anchor such as described with reference to FIGS. 6A-6C, FIGS. 7A-7C, FIGS. 8A-8B, FIGS. 9A-9B, or FIGS. 10A-10B). More specifically, support element 50 may include, or may be coupled to, a wire tie or hammock 51 that that anchors through a single incision through the abdominal wall 58 at location 57 shown in FIGS. 5A and 5D. The shape of support element 50 promotes cinching and lifting of bladder 55, and reduces sliding with patient twisting. Combined with a single point of anchoring at location 57, support element 50 requires less force to co-apt the urethra, and may be placed more simply (e.g., in a single step), as compared to tension-free vaginal tape (TVT), transobturator tape (TOT) sling, or Cooper’s Heranova Adjustable Sling (CHAS). FIGS. 5B, 5C, and 5E respectively illustrate a plan view, first side view, and second side view of support element 50 supporting the bladder (bladder not specifically shown). In some examples, support element 50 includes a reducible mesh so the mesh reduces in width, similar to a “finger trap” toy. The reduced width may be easier to pass, leaving less material implanted. Furthermore, manufacturing costs may be reduced with less material and simplified processes. Necked-down sling ends 51 may be used to anchor support element 50 in an appropriate location relative to bladder 55 and urethra 56.

[00115] As noted elsewhere herein, the present elongated support elements (e.g., slings) suitably may be secured in the patient’s body using any suitable anchor such as described above with reference to FIGS. 1 A-1B and 2A-2H, or as now will be described with reference to FIGS. 6A- 6C, FIGS. 7A-7C, FIGS. 8A-8B, FIGS. 9A-9B, or FIGS. 10A-10B. FIGS. 6A-6C illustrate elongated support element 60 (e.g., sling) configured for placement to support a patient’s bladder 55 proximate a patient’s urethra 56 in a manner similar to that described with reference to FIGS. 5A-5E. Support element 60 illustrated in FIGS. 6A-6C may correspond to any of support elements 30, 30’, 30”, 40, or 50; that is, support elements 30, 30’, 30”, 40, or 50 may be anchored in a patient in the manner which will now be described with reference to FIGS. 6A-6C. The elongated support element 60 may include a proximal portion 61, a central portion 62, and a distal portion 63. One or both of the proximal and distal portions 61, 63 include a surface 65 including an adhesive material 66. In some examples, the adhesive material 66 includes Bone Tape which is being developed by the Health Innovation Hub at the University of Toronto. In other examples, the adhesive material includes 2-octyl cyanoacrylate 66. In nonlimiting examples such as illustrated in FIG. 6B, the elongated support element 60 further may include a removable sheath or liner 67 covering the adhesive material 66. Surface 65 and adhesive material 66 of support element 60 may be disposed (taped) at any suitable location in the body to anchor the support element 60 in place. In some examples, surface 65 and adhesive material 66 may be located above pubic bone 20 or may be taped onto the posterior pubic bone or retropubic. In some examples, the surface 65 and adhesive material 66 may be taped fully circumferentially around the pubic bone. Sheath or liner 67 may be used to cover adhesive material 66, and then may be removed when the adhesive material 66 is in place and the adhesive material then adhered to the patient’s bone or other body portion. In some examples, anchoring to bone may reduce sliding of support element 60 on urethra 56. In some examples, texturing may be added to surface 65 and/or to adhesive material 66 for a “barb-effect” that further helps to secure the surface 65 and adhesive material 66 (and therefore support element) in place.

[00116] FIGS. 7A-7C schematically illustrate another example anchor. More specifically, FIGS. 7A-7C illustrate an elongated support element 70 configured for placement proximate a patient’s urethra. Support element 70 illustrated in FIGS. 7A-7C may correspond to any of support elements 30, 30’, 30”, 40, or 50; that is, support elements 30, 30’, 30”, 40, or 50 may be anchored in a patient in the manner which will now be described with reference to FIGS. 7A-7C. The elongated support element 70 illustrated in FIGS. 7A-7C may include a proximal portion 71, a central portion 72, and a distal portion 73 (configured similarly as proximal portion 71 and obscured by proximal portion in FIG. 7A. A first suture 74 may connect the proximal portion 71 to the central portion 72. A second suture (not specifically illustrated, but configured similarly as first suture 74) may connect the distal portion 73 to the central portion 72. Each of the proximal portion 71, central portion 72, and distal portion 73 may include a mesh structure. As illustrated in FIG. 7A, proximal and distal portions 71, 73 may be used as mesh anchors to secure elongated support element 70 so as to support a patient’s bladder 55 proximate a patient’s urethra 56 in a manner similar to that described with reference to FIGS. 5A-5E. In a manner such as illustrated in FIG. 7C, bipolar jaws 78 may be used to compress and weld the patient’s tissue 79 to the mesh of respective proximal and distal portions 71, 73 using heat. Such a mesh-suture- mesh arrangement may minimize or reduce introduction of a foreign body into the patient (via anchoring with mesh). Bipolar jaws 78 may be configured to apply heat in any suitable manner, such as with bipolar radiofrequency energy, to attach anchors (proximal and distal portions 71, 73) to surrounding tissue 79.

[00117] In some examples, at least one of the proximal and distal portions include a barbed surface. In some examples, at least one of the proximal and distal portions include a raised chevron structure. [00118] FIGS. 8A-8B schematically illustrate another example anchor. Anchor 80 illustrated in FIGS. 8A-8B may be used with any suitable elongated support structure (e.g., sling), including but not limited to those described elsewhere herein. Anchor 80 illustrated in FIGS. 8A-8B includes a suture or stitch that anchors to any suitable portion 81 of the patient’s body, such as the abdomen, obturator(s), or Cooper’s ligament. Anchor 80 may be sutured from below (e.g., from within the patient’s abdomen, optionally using a specialized tool or suture driver 82.

[00119] FIGS. 9A-9B schematically illustrate another example anchor. Anchor 90 illustrated in FIGS. 9A-9B may be used with any suitable elongated support structure (e.g., sling), including but not limited to those described elsewhere herein. Anchor 90 illustrated in FIGS. 9A-9B includes a barbed structure that anchors to any suitable portion 81 of the patient’s body, such as the abdomen, obturator(s), or Cooper’s ligament. The anchor 90 may include a body portion 91 and plurality of barbs 92 radially extending from the body portion. The plurality of barbs may have a collapsed configuration (FIG. 9A) in which at least one of the plurality of barbs 92 is separated from the body portion 91 by a first distance, and an expanded configuration (FIG. 9B) in which the at least one of the plurality of barbs 92 is separated from the body portion 91 by a second distance, the second distance being larger than the first distance. In some examples, such as illustrated in FIG. 9B, the plurality of barbs form a star shape when in the expanded configuration. Such a configuration distributes the surface area of the anchor in a relatively low profile.

[00120] FIGS. 10A-10B schematically illustrate another example anchor. Anchor 1001 illustrated in FIGS. 10A-10B may be used with any suitable elongated support structure (e.g., sling), including but not limited to those described elsewhere herein. Anchor 1001 illustrated in FIGS. 10A-10B includes a spiral shaped body portion 1011 that anchors to any suitable portion 81 of the patient’s body, such as the abdomen, obturator(s), or Cooper’s ligament. Such a configuration distributes the surface area of the anchor in a relatively low profile. The spiral shaped body portion 1011 may be considered to have a planar, semi-circular shape. At least a portion of the proximal portion 1012 may be substantially orthogonal to a plane of the planar, semi-circular shape. [00121] From the foregoing, it will be appreciated that the present support elements may be anchored to the patient’s tissue or bone in a variety of suitable ways, and using a variety of suitable structures and tools. FIGS. 11 A-l 1C schematically illustrate operations in an example method for anchoring a support element in a patient. More specifically, FIGS. 11A-11C illustrate an example using a puncture with a suture that is pulled externally and used to anchor an elongated support element. In some regards, the anchoring is similar to that of TOT or TVT. However, rather than using an incision which is more invasive and raises higher risks, the method of FIGS. 11A-11C uses a simpler and safer suture. Any suitable tool may be used to generate the puncture, such as a straight suture needle or hypodermic needle. Optionally, as illustrated in FIGS. 1 IB-11C, a blunt electrode 1101 with an insulated jacket may be used to tent the abdominal tissue 1110. The electrode then may be activated (e.g., using radiofrequency energy) to perforate and/or cauterize tissue 1110 for subsequent advancement of the support element through the abdomen. In some examples, needle 1102 may be extended through the blunt electrode to puncture the abdominal wall 1110.

[00122] FIGS. 12A-12C schematically illustrate operations in an alternative example method for anchoring a support element in a patient. More specifically, FIGS. 12A-12C illustrate an example using a specialized inserter tool 1201 to deploy a hook-shaped micro-anchor 1220 into Cooper’s ligament 1210 in a manner such as illustrated in FIGS. 12A-12B. As illustrated in FIGS. 12A and 12C, inserter tool 1201 includes proximal end 1202 and distal end 1203. The inserter tool 1201 may include a channel 1204 between the tool proximal end 1202 and tool distal end 1203. The channel 1204 may be configured to receive the proximal end of an elongated support element such as described elsewhere herein, illustratively proximal end 31 of elongated support element 30. The inserter tool 1201 may include a blunt tip portion 1205 at the tool distal end 1203. The blunt tip portion may be configured to house anchor 1220. When the anchor 1220 is housed within the blunt tip portion 1205 of the inserter tool 1201, the anchor may be closer to the tool proximal end 1202 than at least a portion of the proximal end (illustratively, 31) of the elongated support element (illustratively, 30). In some examples, the anchor 1220 is or includes a ligament anchor. The physician may palpate the patient’s abdomen during placement of the anchor. For example, the physician may feel for the blunt tip portion 1205 of the inserter tool 1201 relative to Cooper’s ligament, and when the tool is positioned correctly may use the tool to press the anchor 1220 into the ligament, thus securing the elongated support element into the ligament.

[00123] From the foregoing, it will be appreciated that many different methods of treating urinary incontinence in a patient are provided herein. Some examples include making a first incision in the patient’s vaginal wall on a first lateral side of the patient’s urethra, making a second incision in the patient’s vaginal wall on a second lateral side of the patient’s urethra, inserting the proximal portion of the elongated support element of any of the present examples into the first incision; inserting the distal portion of the elongated support element into the second incision; and anchoring the proximal and distal portions of the elongated support element to the patient, for example using the anchors of any of the present examples. Nonlimiting examples of such operations are described with reference to FIGS. 2A-2H.

[00124] In examples such as described with reference to FIGS. 2A-2H, the proximal portion of the elongated support element may be attached to a first anchor, and the distal portion of the elongated support element is attached to a second anchor. Prior to inserting the proximal portion of the elongated support element into the first incision, at least a portion of the elongated support element is provided within an inserter tool such as described with reference to FIGS. 12A-12C. The method may include the step of placing the first anchor in proximity to a pectineal ligament of the patient (that is, Cooper’s ligament). In some examples, the blunt tip portion is configured to emit radio frequency energy to create a puncture in a manner such as described above.

[00125] As an alternative to making multiple incisions in the patient’s vaginal wall, a method of treating urinary incontinence in a patient may include making an incision in the patient’s vaginal wall; and inserting both the proximal and distal portions of the elongated support element of any one of the present examples into the incision. In a manner such as described with reference to FIGS. 5A-5F, the proximal and distal portions of the elongated support element may be attached to a single tissue anchor.

[00126] The following variations apply equally to examples in which the proximal and distal portions of the elongated support element are passed through different incisions than one another, and to examples in which the proximal and distal portions of the elongated support element are passed through the same incision as one another. In some examples, the method may include the step of advancing the proximal and distal portions of the elongated support element towards an abdominal wall of the patient. In some examples, the method may include the step of advancing the proximal and distal portions of the elongated support element through the abdominal wall. In a manner such as described elsewhere herein, each of the proximal and distal portions of the elongated support element optionally may extend through an obturator intemus of the patient. In a manner such as described with reference to FIGS. 7A-7C, the method may include the step of applying heat to at least one of the proximal and distal portions of the elongated support element to anchor the at least one of the proximal and distal ends to the patient, e.g., by applying radiofrequency energy to the at least one of the proximal and distal portions of the elongated support element.

[00127] It will be appreciated that device 100 described with reference to FIGS. 1 A-1B and 2A- 2G is a nonlimiting example of a device that may be used to implant and anchor elongated support elements in a patient. For example, FIG. 13 schematically illustrates components of an example system for treating urinary incontinence. The system 1300 (tool) illustrated in FIG. 13 may include an introducer (pusher) 1310 including a proximal handle 1311 and an elongated member 1312 extending from the handle 1311. System 1300 may provide an ergonomically optimized hand tool for implanting elongated support element 1330 in a manner which will be described in greater detail with reference to FIGS. 14A-14E. Illustratively, in the nonlimiting example illustrated in FIG. 13, the proximal handle 1311 may be overmolded and contoured for comfort and security. The elongated member 1312 may include a straight portion 1313 and a curved portion 1314. The curved portion 1314 may terminate in distal end 1315 which may be located within first tubular sheath 1320 in a manner such as illustrated in FIG. 13.

[00128] The system 1300 may include a first tubular sheath 1320 including an open end 1321, a closed end 1322 terminating in a blunt tip 1323, a sidewall 1324, and a lumen extending from the open end 1321 towards the closed end 1322. The lumen of tubular sheath 1320 may be configured to receive a portion of the elongated member 1312. For example, tubular sheath 1320 may be curved so as to receive curved portion 1314 of elongated member 1312. The system 1300 also may include a second tubular sheath 1320’ including an open end 1321’, a closed end 1322’ terminating in a blunt tip 1323’, a sidewall 1324’, and a lumen extending from the open end 1321’ towards the closed end 1322’. The lumen of tubular sheath 1320’ may be configured to receive a portion of the elongated member 1312. For example, tubular sheath 1320’ may be curved so as to receive curved portion 1314 of elongated member 1312. In a manner such as will be described with reference to FIGS. 14A-14E, the user may use the elongated member 1312 with tubular sheath 1320 disposed thereon to anchor first end 1331 of support element 1330 to the patient, and then may dispose tubular sheath 1320’ onto elongated member 1312 to anchor second end 1332 of support element 1330 to the patient.

[00129] The system 1300 may include an elongated support element 1330 including a first end 1331 and a second end 1332, and configured for removable attachment to the tubular sheath 1320. For example, elongated support element 1330 may include a localized sling with suture tails. Support element 1330 illustrated in FIG. 13 may correspond to any of support elements 30, 30’, 30”, 40, or 50; that is, support elements 30, 30’, 30”, 40, or 50 may be anchored in a patient in the manner which will be described with reference to FIGS. 14A-14E. However, it will be appreciated that system 1300 may be used to anchor any other suitable type of elongated support element (e.g., sling) in the patient. In various examples such as described elsewhere herein, the elongated support element may include a first portion comprising the first end, a second portion comprising the second end, and a third portion between the first and second ends, the third portion having a width greater than either of the first or second portions. The elongated support element optionally may include a synthetic material and/or a biodegradable material.

[00130] System 1300 may include any suitable combination of features to anchor support element 1330 at a suitable location within the patient’s body. Illustratively, the system 1300 further may include a first pledget 1341 attached to the elongated support element 1330 adjacent to the first end 1331 thereof. For example, the first pledget 1341 may include at least one opening 1343 extending through a thickness of the first pledget 1341, the opening configured for receiving the first end 1331 of the elongated support element 1330. Additionally, the system 1300 further may include a second pledget 1342 attached to the elongated support element 1330 adjacent to the second end 1332 thereof. For example, the second pledget 1342 may include at least one opening 1344 extending through a thickness of the first pledget 1341, the opening configured for receiving the second end 1332 of the elongated support element 1330. The pledgets 1341, 1342 may be used to respectively anchor the first and second ends 1331, 1332 in tissue of the patient, e.g., in a manner such as will be described with reference to FIGS. 14A- 14E.

[00131] In some examples, the tubular sheath 1320 may be integrated with the first pledget 1341 and/or first end 1331 (suture tail) of elongated support element 1330. For example, as shown in the inset to FIG. 14C, the tubular sheath 1320 may include a recess 1325 in the sidewall 1324 configured for receiving the first pledget 1341. In some examples, the tubular sheath 1320 includes a living hinge 1326 in the sidewall 1324 for providing access to the recess. Optionally, cover 1327 may cover first pledget 1341. In examples including a living hinge 1326, and the living hinge 1326 may allow cover 1327 to be opened relative to tubular sheath 1320 so that first pledget 1341 may be removed from recess 1325 at an appropriate time. Alternatively, cover 1327 may be adhered to the outer surface of tubular sheath 1320 and may be sufficiently flexible to be removed from tubular sheath 1320 at an appropriate time so that first pledget 1341 may be removed from recess 1325 at an appropriate time; for example, cover 1327 may be or include a peel-away film. Additionally, the tubular sheath 1320’ may be integrated with the second pledget 1342 and/or second end 1332 (suture tail) of elongated support element 1330. For example, the tubular sheath 1320’ may include a recess in the sidewall 1324’ configured for receiving the second pledget 1341’. For example, in a manner similar to that shown in the inset to FIG. 14C, the tubular sheath 1320’ optionally may include a recess in the sidewall 1324’ configured for receiving the second pledget 1342, optionally may include a living hinge 1326 in the sidewall 1324’ for providing access to the recess in a manner similar to that described with reference to first pledget 1341, and/or optionally may include cover 1327. However, it will be appreciated that system 1300 may include any other suitable anchors for anchoring the first and second ends 1331, 1332 in tissue of the patient, e.g., clip 10 described with reference to FIGS. 1A-1B and 2A-2H, or an anchor such as described with reference to FIGS. 6A-6C, FIGS. 7A-7C, FIGS. 8A-8B, FIGS. 9A-9B, or FIGS. 10A-10B, and that tubular sheaths 1320, 1320’ respectively may be suitably configured to deliver such anchors to appropriate locations in the patient’s body.

[00132] FIGS. 14A-14E schematically illustrate operations in an example method for treating urinary incontinence, e g., using system 1300 described with reference to FIG. 13, or any other suitably configured system. The method may include making an incision 1401 in the vaginal wall of a patient, e.g., a single small medial incision. The distal end 1315 of introducer 1310 may be inserted into the patient via the incision 1401 in a manner such as illustrated in FIG. 14A. In a manner such as described with reference to FIG. 13, the first end 1331 of the elongated support element 1330 may be attached to the tubular sheath 1320, and the distal end 1315 of the elongated member of the introducer may be within the lumen of the tubular sheath 1320. Accordingly, inserting introducer 1310 into the incision inserts tubular sheath 1320 into the patient. As illustrated in the inset to FIG. 14A, advancing device 1300 by moving handle 1311 proximally causes the blunt distal tip 1323 of tubular sheath 1320 to perform a blunt dissection of the tissue between the pubic bone 20 and the bladder 55. As illustrated in FIG. 14B, the blunt tip 1323 of the tubular sheath 1320 may be extended towards an abdominal wall 1402 of the patient, e.g., by further advancing the introducer 1310 of device 1300 through incision 1401. In such a manner, the user may extend blunt tip 1323 until it tents abdominal wall 1402, and the user may palpate blunt tip 1323 to confirm its location 1403 at the abdominal wall. As also illustrated in FIG. 14B, the method may include making an incision 1404 in the abdominal wall, e.g., at location 1403 which is confirmed by tenting and palpation.

[00133J As also illustrated in FIG. 14B, the tubular sheath 1320 may be moved through the incision 1404 in the abdominal wall 1402 such that the tubular sheath 1320 is outside of the patient. For example, the tubular sheath 1320 first may be partially moved outside of the patient by advancing introducer 1310 distally using handle 1311. Then, as illustrated in FIG. 14C, the tubular sheath 1320 may be removed from the distal end 1315 of introducer 1310, e.g., by the user sliding the tubular sheath 1320 off of the tool, and fully through the incision to the outside of the patient, using a pulling motion. Moving the tubular sheath 1320 through the incision 1404 to the outside of the patient also moves the proximal end 1331 of elongated support element 1330, as well as first pledget 1341 (in examples including the pledget) or other suitable anchor, to the outside of the patient. As also illustrated in FIG. 14C, the introducer 1310 may be removed from the patient while maintaining the tubular sheath 1320 outside of the patient, for example by retracting handle 1311 distally, while leaving tubular sheath 1320 and pledget 1341 in place outside of the body. The first end 1331 of the elongated support element 1330 then may be removed from the tubular sheath. For example, as also illustrated in FIG. 14C, the cover 1327 may be partially or fully removed from tubular sheath 1320 (e.g., by peeling back a peel-away film, and/or or by using living hinge 1326) to reveal first pledget 1341. First pledget 1341, coupled to the first end 1331 of elongated support element 1330, may be removed from recess 1325. Tubular sheath 1320 then may be discarded.

[00134] As illustrated in FIG. 14D, device 1300 may be loaded with second tubular sheath 1320’ and a similar process repeated. For example, the method may further include placing a distal end 1315 of the elongated member of the introducer 1310 into the lumen 1321’ of second tubular sheath 1320’. As also illustrated in FIG. 14D, the introducer 1310 may be introduced through the incision in the vaginal wall in a manner such as described with reference to FIG. 14A. The blunt tip 1323’ of the second tubular sheath 1320’ then may be advanced towards the abdominal wall of the patient in a manner such as described with reference to FIG. 14B. As illustrated in FIG. 14D, the second tubular sheath 1320’ then may be moved through the incision 1401 in the abdominal wall such that the second tubular sheath 1320’ is outside of the patient, in a manner similar to that described with reference to FIGS. 14B-14C. The introducer 1310 then may be removed from the patient while maintaining the second tubular sheath 1320’ outside of the patient, in a manner similar to that described with reference to FIG. 14C. The second end 1332 of the elongated support element 1330 may be detached from the second tubular sheath 1320’, in a manner such as described with reference to FIG. 14C. As illustrated in FIG. 14E, the first and second pledgets (or other anchors) then may be adjusted from outside the body so as to anchor the elongated support element 1330 in place, e.g., so as to support bladder 55 proximal urethra 56.

[00135] It will be appreciated that the operations of FIGS. 14A-14E may be performed in any suitable order, may omit one or more operations, or may include one or more additional operations. Illustratively, the method optionally further may include attaching the first end 1331 of the elongated support element 1330 to the tubular sheath 1320, and/or may include attaching the second end 1332 of the elongated support element 1330 to the second tubular sheath 1320’. Alternatively, the first end 1331 of the elongated support element 1330 may be attached to the tubular sheath 1320, and/or the second end 1332 of the elongated support element 1330 may be attached to the second tubular sheath 1320’, at an earlier time, and by a different entity than the one who performs the medical procedure, e.g., at manufacture. Additionally, or alternatively, the method further may placing the distal end 1315 of the elongated member of the introducer 1310 within the lumen 1321 of the tubular sheath 1320. Alternatively, the distal end 1315 of the elongated member of the introducer 1310 may be placed within the lumen 1321 of the tubular sheath 1320 at an earlier time, and by a different entity than the one who performs the medical procedure, e.g., at manufacture.

[00136] While preferred embodiments of the invention are described herein, it will be apparent to one skilled in the art that various changes and modifications may be made. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.