Systems and methods for treating stress urinary incontinence

Abstract

The present disclosure provides an improved method and device for creating a hammock effect to stabilize the urethra without abdominal or vaginal incisions and without the use of surgical mesh. Furthermore, this implementation leaves no permanent material in the body. The simplicity of this procedure and method allows for outpatient treatment and avoids the risks and drawbacks associated with the introduction of permanent mesh.

Description

[Technical Field]

[0001] This application is related to U.S. Provisional Patent Application No. 63 / 045,918, filed June 30, 2020. The above-referenced patent application is incorporated by reference herein in its entirety for any purpose.

[0002] Between 15 and 60% of women experience stress urinary incontinence (SUI) during their lifetime. Urinary leakage occurs when laughing, coughing, sneezing, lifting, or exercising. The current standard surgical treatment for stress urinary incontinence (SUI) is vaginal sling surgery using polypropylene mesh. This procedure is the most effective of all SUI procedures and can improve quality of life. However, in recent years, polypropylene mesh has come under scrutiny due to the risk of infection and erosion, and its use has largely been abandoned for the surgical treatment of pelvic organ prolapse. While vaginal mesh continues to be used in the treatment of SUI, concerns about the long-term safety of this technique are growing, and numerous product liability lawsuits related to this issue are currently ongoing. A few countries, such as Scotland, have banned all pelvic mesh procedures, including the use of mesh slings for SUI. The most common sling alternative is the Burch procedure, which involves placing sutures along the urethra via a laparotomy incision or laparoscopy. Open surgery has high morbidity and long hospital stays, and laparoscopic placement is technically very difficult. Figure 1 shows the differences between the Burch technique and the autologous sling technique.

[0003] In the Burch procedure (Figure 1), sutures are tied to Cooper's (iliac) ligaments to suspend the anterior vaginal wall at the level of the bladder neck. As shown, two sutures are placed on either side of the anterior vaginal wall, one at the bladder neck and one at the gluteus medius muscle. These paired sutures are then tied to Cooper's (iliac) ligaments, thereby suspending the anterior vaginal wall and creating a hammock effect for the urethra. This results in improved urethral stability and prevents urine leakage during coughing or vigorous activity.

[0004] Figure 1B shows the autologous sling technique. In this technique, a harvested piece of rectal fascia is placed transvaginally at the level of the proximal urethra. The piece is secured to the superior rectal fascia (rectus abdominis fascia) with permanent sutures. This creates a sling beneath the urethra near the bladder neck, which helps elevate and stabilize the bladder neck and urethra.

[0005] In the past, needle procedures involved passing permanent sutures through the vagina and rectal fascia to create a stable hammock under the urethra. However, because these procedures required vaginal and abdominal incisions, they fell into disuse with the advent of simpler sling procedures. However, these needle procedures remain highly effective for treating SUI. One such technique is the Pereira technique. In this technique, a loop of suture or other material is inserted through the paraurethral tissue near the bladder neck and attached to the abdominal fascia to elevate the neck. A needle is used to pass the needle from the vagina to the abdominal wall. These needles may first pass through the vagina, then pass under the pubic bone and through the skin, or vice versa. Figure 2 shows how a needle passes through the vagina (where the urethra and bladder join) next to the urethra near the bladder neck. The needle also passes behind the pubic bone and penetrates the rectal fascia and skin. It is understood that there is room in the art for improvement over the above technique. Summary of the Invention

[0006] The advantages of the present disclosure will be set forth in and will become apparent from the following description. Additional advantages of the present disclosure will be realized and attained by the specific methods and systems particularly described in the written description, claims and accompanying drawings.

[0007] According to some implementations, the present disclosure provides methods and devices for treating stress urinary incontinence (SUI).

[0008] According to some implementations, a stress urinary incontinence (SUI) treatment system is provided that includes a housing with at least one actuator, an extension shaft extending distally from the actuator, a tissue anchor disposed at the distal end of the extension shaft, a tether coupled to the tissue anchor, and an actuator disposed within the housing that releases the tissue anchor after it is positioned within the tissue, wherein the extension shaft is removable after the tissue anchor is released, leaving behind the tissue anchor and tether.

[0009] In some implementations, the system further includes at least one pull wire coupled to the actuator and the tissue anchor, where pulling the at least one pull wire with the actuator separates the tissue anchor from the extension shaft. The system may further include at least one push rod coupled to an additional actuator, where the at least one push rod is configured to advance distally to redirect the tissue anchor after it is separated from the extension shaft. The extension shaft may define at least one lumen along its length. The pull wire and push wire each traverse at least a portion of the extension shaft from the housing to the tissue anchor. In some embodiments, the tissue anchor forms a leading end of the system and may comprise a tissue-cutting end. In some implementations, a tether may pass through an opening defined in the anchor. First and second ends of the tether may be coupled to the housing.

[0010] According to further implementations, the system further includes a vaginal anchor coupled to the tether. The vaginal anchor is configured to couple to the tether after tension is applied to the tether after the tissue anchor is implanted. The vaginal anchor may include at least one stop for coupling to the tether. In some implementations, the vaginal anchor may include two housing elements coupled to each other. The two housing elements may be fastened to the tether when coupled to each other. In some implementations, the two housing elements may be coupled at multiple locations.

[0011] In some implementations, the fascial anchor may be disposed within the shaft prior to deployment. If desired, the tissue anchor may form at least one of an X-shape, a star-shape, a disk-shape, and an extended shape after deployment. At least one of the fascial anchor, vaginal anchor, and tether may be at least partially formed of a bioabsorbable material. For example, the bioabsorbable material may be PDS. The vaginal anchor may be defined by a smooth, oval surface.

[0012] According to a further aspect, the present disclosure further provides an implementation of a method for treating stress urinary incontinence (SUI).

[0013] In some implementations, the method includes delivering a tether from a location within the vagina along a first path laterally offset from the urethra to a location near the rectus abdominis muscle, deploying a fascial anchor attached to a first end of the tether anterior to the rectus abdominis muscle, coupling a vaginal anchor to a second end of the tether within the vaginal canal, and applying tension to the tether to elevate the vaginal anchor and lift the anterior wall of the vaginal canal.

[0014] If desired, in some implementations, delivering the tether includes introducing an elongated shaft along a path. The fascial anchor may be coupled to the elongated shaft before being deployed. The elongated shaft may pass through the vaginal opening, through the vaginal wall along a path, and through the rectus abdominis muscle. The fascial anchor may be deployed after at least a portion of the elongated shaft has crossed the rectus abdominis muscle. The method may further include removing the elongated shaft through the vaginal canal and loading the vaginal anchor onto the tether during the coupling step. The method may further include delivering a second tether along a second path near the first path. At least one of the first and second paths may pass near the mid-urethra. The other of the first and second paths may pass near the bladder neck. In some embodiments, the first tether may be coupled to a first vaginal anchor within the vaginal canal, and the second tether may be coupled to a second vaginal anchor within the vaginal canal.

[0015] In some implementations, the method further includes adjusting the relative position of the vaginal anchor and the tether after surgery. The adjusting step can include unlocking the tether and loosening the vaginal anchor. In some implementations, the adjusting step can include unlocking the tether and tightening the vaginal anchor.

[0016] In some implementations, the present disclosure provides a method for treating stress urinary incontinence (SUI) that includes delivering a tether along a first pathway from a location within the vagina to a location near the obturator internus muscle, deploying an anchor coupled to a first end region of the tether within the obturator internus muscle, coupling a vaginal anchor to a second end of the tether within the vaginal canal, and applying tension to the tether to elevate the vaginal anchor and lift the anterior wall of the vaginal canal.

[0017] In some embodiments, the anchor may comprise at least one barb integral with the suture, hi other embodiments, the anchor may comprise at least one deployable anchor coupled to a first end of a tether.

[0018] The present disclosure further provides a method for treating stress urinary incontinence (SUI), comprising delivering a barbed tether from a location within the vagina to a location near the rectus abdominis muscle along a first path that is laterally offset from the urethra; deploying at least some barbs of the barbed tether attached to a first end region of the tether within the rectus abdominis muscle; coupling a vaginal anchor to a second end of the tether within the vaginal canal; and applying tension to the tether to elevate the vaginal anchor and lift the anterior wall of the vaginal canal.

[0019] In further accordance with the present disclosure, any of the systems described herein may further comprise a matrix material that induces scarring in the surgical area. The matrix material may be coupled to the tether. The matrix material may be at least partially formed from a bioabsorbable material. The bioabsorbable material may include at least one of polydioxanone (PDS), polylactic acid, poly-D-lactic acid, and poly-L-lactic acid. The matrix material may be integrally formed with the tether.

[0020] In further accordance with the present disclosure, any of the methods described herein may further include delivering a matrix material along the first pathway to induce scarring in the surgical area. The matrix material may be coupled to a tether and pulled into the first pathway by being coupled to the tether. The matrix material may be introduced in a step separate from the step of introducing the tether.

[0021] It is understood that the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed embodiments. The accompanying drawings, which are incorporated in and constitute a part of the specification, are included to explain and provide a further understanding of the disclosed systems and methods. Together with the description, the drawings explain the principles of the present disclosure.

[0022] The accompanying drawings illustrate various exemplary, non-limiting, inventive aspects, embodiments, and features (“for example” or “examples”) according to the present disclosure. [Brief explanation of the drawings]

[0023] [Figure 1A] FIG. 1A shows an example of the Burch procedure, as known in the art. [Figure 1B] FIG. 1B shows an example of an autologous sling procedure known in the art. [Figure 2] FIG. 2 illustrates the Pereira procedure as known in the art. [Figure 3A] FIG. 3A is an example of a needle path for delivering and deploying an anchor that lies approximately in the sagittal plane according to the present disclosure. [Figure 3B] FIG. 3B is an example of anchor and suture placement along an oblique anatomical viewing angle relative to an anatomical cross-plane according to the present disclosure. [Figure 4] FIG. 4 is a schematic diagram of an example vaginal anchor according to the present disclosure. [Figure 5] FIG. 5 schematically illustrates a further example of a vaginal anchor according to the present disclosure. [Figure 6]6A and 6B are isometric views of a further implementation of a vaginal anchor fully secured to a pair of sutures in accordance with the present disclosure. [Figure 7] 7A and 7B are exploded isometric views of the vaginal anchor of FIGS. 6A and 6B illustrating certain internal members of the vaginal anchor. [Figure 8A] FIG. 8A is an isometric view of the vaginal anchor of FIGS. 6A and 6B in a partially anchored configuration. [Figure 8B] FIG. 8B is a partial isometric view of the vaginal anchor in the partially anchored configuration of FIG. 8A. [Figure 9A] FIG. 9A is an isometric view of a pair of sutures with vaginal anchors in a partially fixed configuration as illustrated in FIG. 8B. [Figure 9B] FIG. 9B is an isometric view of a pair of sutures with the vaginal anchors in a fully secured position as shown in FIGS. 6A and 6B. [Figure 10A] FIG. 10A is a partial isometric view of the vaginal anchor of FIGS. 6A and 6B. [Figure 10B] FIG. 10B is a partial view of the vaginal anchor shown in FIG. 10A. [Figure 11] 11A and 11B are cross-sectional views showing the inner members of both sides of the vaginal anchor of FIGS. 6A and 6B. [Figure 12A] FIG. 12A is an isometric cross-sectional view of the partially secured vaginal anchor of FIGS. 6A and 6B. [Figure 12B] FIG. 12B is an isometric cross-sectional view of the vaginal anchor of FIGS. 6A and 6B fully secured. [Figure 13A] FIG. 13A is an isometric cross-sectional view of the inner member of the vaginal anchor of FIGS. 6A and 6B holding the suture in place in a fully anchored configuration. [Figure 13B] FIG. 13B is a further isometric cross-sectional view of the inner member of the vaginal anchor of FIGS. 6A and 6B holding the suture in place in a fully anchored configuration. [Figure 14] FIG. 14 is an upper isometric view of various embodiments of a delivery system according to the present disclosure. [Figure 15]15 is a bottom isometric view of each embodiment of the delivery system illustrated in FIG. 14 according to the present disclosure. [Figure 16] FIG. 16 is an enlarged view of a nearby portion of the delivery system of FIG. [Figure 17] FIG. 17 is an exploded view of the delivery system of FIG. [Figure 18] 18 is an enlarged exploded view of FIG. 17 illustrating an aspect of the handle portion of the delivery system of FIG. 14. FIG. [Figure 19] 19A-19C show top, near, and bottom isometric views of a first portion of the housing of the delivery system of FIG. [Figure 20] 20A and 20B show top and bottom isometric views of a second portion of the housing of the delivery system of FIG. [Figure 21] 21A and 21B are upper and lower isometric views of a portion of the retention block of the delivery system of FIG. [Figure 22] 22 is a partial isometric exploded view of a portion of the delivery system of FIG. 14 illustrating aspects of the system's retaining block and delivery system guide alignment plate. [Figure 23] 23 is a partial isometric exploded view of a portion of the delivery system of FIG. 14 illustrating aspects of the system's retaining block and delivery system guide alignment plate. [Figure 24] 24 is a partial isometric exploded view of a portion of the delivery system of FIG. 14 illustrating aspects of the system's retaining block and delivery system guide alignment plate. [Figure 25] 25A and 25B are large isometric views of the distal portion of the system of FIG. 14 illustrating aspects of the fascial anchor of the system. [Figure 26] 26A and 26B are large isometric views of the distal portion of the system of FIG. 14 illustrating aspects of the fascial anchor of the system. [Figure 27] 27A-27C are various isometric views of the distal portion of the delivery system of FIG. 14 coupled to the fascial anchor of the system of FIG. [Figure 28]28A-28C are various isometric views of the fascial anchor of the system of FIG. [Figure 29] 29A and 29B are isometric views of the fascia anchor and distal end member of the delivery system of FIG. [Figure 30] 30 is an isometric view of the distal portion of the delivery system of FIG. 14 with components of the system omitted to illustrate the relative positions of the holding rod and push rod that encourage deployment of the fascial anchor. [Figure 31] 31 is an enlarged view of the distal end portion of the handle portion of the delivery system of FIG. 14. FIG. [Figure 32] 32 is an enlarged isometric view of the proximal end portion of the handle portion of the delivery system of FIG. 14. FIG. [Figure 33] 33 is an enlarged isometric view of the proximal end portion of the handle portion of the delivery system of FIG. 14. FIG. [Figure 34] 34 is an enlarged isometric view of the proximal end portion of the handle portion of the delivery system of FIG. 14. FIG. [Figure 35] 35 is an enlarged isometric view of the proximal end portion of the handle portion of the delivery system of FIG. 14. FIG. [Figure 36] FIG. 36 is an isometric view of the fascial anchor of FIG. 14 showing the relative positions of the sutures passing therethrough. [Figure 37] FIG. 37 is an isometric view of the fascial anchor of FIG. 14 showing the relative positions of the sutures passing therethrough. [Figure 38] FIG. 38 is an isometric view of portions of the system of FIG. [Figure 39] FIG. 39 is an isometric view of portions of the system of FIG. [Figure 40] 40A-40C are various isometric views of further implementations of vaginal anchors in accordance with the present disclosure. [Figure 41] 41A-41C are various isometric views of further implementations of vaginal anchors in accordance with the present disclosure. [Figure 42] 42A-42C are various isometric views of further implementations of vaginal anchors in accordance with the present disclosure. [Figure 43]43A-43C are various isometric views of further implementations of vaginal anchors in accordance with the present disclosure. [Figure 44] 44A and 44B are various isometric views of further implementations of vaginal anchors in accordance with the present disclosure. [Figure 45] FIG. 45 is a representative illustration of an implementation using a scar-forming matrix material to promote the formation of scar tissue, which helps ensure the long-term benefits of the procedures described herein. DETAILED DESCRIPTION OF THE INVENTION

[0024] The objects and advantages of the embodiments of the present disclosure will be set forth in and become apparent from the following description. Additional advantages of the embodiments of the present disclosure will be realized and attained by the methods and systems particularly pointed out in the description, claims, and accompanying drawings set forth herein.

[0025] In some implementations, the present disclosure provides improved methods and devices for creating a hammock effect to stabilize the urethra without abdominal or vaginal incisions and without the use of surgical mesh. Furthermore, this implementation leaves no permanent material in the body. The simplicity of this procedure and method allows for outpatient treatment, avoiding the risks and drawbacks associated with the introduction of permanent mesh. Furthermore, in some implementations, the system and method allow for adjustment of the system in an outpatient setting if it is determined to be too tight or too loose when initially implanted. This allows for easy recovery from traditional mesh sling procedures. If the mesh sling is too tight, the mesh must be removed through major surgery. If the mesh sling is too loose, it cannot be easily adjusted and is less effective.

[0026] In some implementations, the provided system includes a small-diameter (e.g., 1-2 mm) needle coupled to a first end of a thread (suture, tether, etc.) and incorporating a folded fascial anchor therein for anchoring to the fascia. If desired, the suture may include a barbed suture or a suture with a barbed portion directed through the fascia, where the barbs can prevent the suture from backing out. The anchor may be used in combination with partially or fully barbed sutures, such as, but not limited to, molded barbed sutures. In some embodiments, the thread, suture, and / or anchor may be made from an absorbable material, such as polydioxanone (PDS). PDS is a slowly absorbable material that typically dissolves completely within six months of implantation. In some implementations, the device may also include a vaginal anchor coupled to a second end of the thread for engaging the vaginal wall. The vaginal anchor may include one or more smooth surfaces to minimize its physical profile within the vaginal canal. The vaginal anchor may also be made from a bioabsorbable material such as PDS.

[0027] In some implementations, referring to Figures 3A and 3B, an example procedure begins by placing a urinary catheter, such as a conventional Foley-type catheter, into the urethra and bladder and inflating its distal end to hold it in place (not shown). The bladder is drained through the urinary catheter. Alternatively, a catheter such as that described in U.S. Patent Application No. 63 / 012,056, filed April 17, 2020, which is incorporated herein by reference in its entirety, may be used instead. The catheter of the '056 application (or a different catheter) may be further modified (or specially configured) to include an additional light source, such as an LED light, at a location corresponding to the mid-urethra, approximately 2 cm from the bladder neck, since the female urethra is approximately 4 cm long. A second light source, such as an LED, may be included in the mid-urethral catheter, and a light-conducting medium may be used to guide light from the light source in the urinary catheter, located just past the bladder neck, downward to approximately 2 cm from the bladder neck. For example, if the catheter includes an opaque coating over a light-transmitting layer (e.g., inner tube), the opaque coating may be peeled back, or otherwise absent from, the mid-urethra, so that, for example, an endoscope (not shown) within the peritoneal or pelvic cavity can be used to shine a light through the catheter visible inside the patient, outside the urethra, and show the surgeon where they can place the needle laterally to the mid-urethra and deliver the necessary sutures. Illumination of the mid-urethra guides the surgeon to the correct location for placement and prevents the surgeon from placing the needle too close to the urethra. After placement of the urinary catheter, a local anesthetic (e.g., 0.5% marcaine) is used to locally numb the body.

[0028] Next, delivery system 10, including a hollow applicator needle (e.g., 1-2 mm) defining a lumen along its length, may be inserted, preferably under direct endoscopic vision, through the vagina, next to the urethra on each side, for placement of each of the four sutures 30. It is understood that fewer or more sutures 30 may be used. For placement of each suture 30, the needle is directed behind the pubic bone and then through the rectal fascia, as shown in FIG. 3A. The rectal fascia is thick and tough, allowing the surgeon to feel a discernible "pinch" as the needle passes through. Once the needle passes through the rectal fascia, the surgeon then advances fascia anchor 20 through the lumen of the needle and expands the anchor 20 and / or performs one or more manipulative steps to expand the fascia anchor 20. Once deployed, fascia anchor 20 may have, for example, an X-shape, a star-shape, a barbed shape, a disc-shape, or other shapes, further implementations of which are described below. The fascia anchors 20, thread or suture 30, and vaginal anchor 40 are each preferably, but not necessarily, made from an absorbable material. After each of the four fascia anchors 20 has been placed, the hollow delivery needle is withdrawn, leaving the thread or suture 30 extending into the vaginal canal. After all four sutures have been delivered, two punctures will be created through the anterior vaginal wall on either side of the urethra, one positioned generally parallel to the bladder neck and the other positioned generally parallel to the mid-urethra.

[0029] Each of the threads or sutures 30 on either side of the urethra may then be threaded through a vaginal anchor 40, which may be made from PDS or other bioabsorbable material. The sutures 30 are then placed under tension, and the vaginal anchor 40 is gently pushed upward. The sutures 30 are then secured in place and tied together, or crimped, captured, or otherwise secured in place to secure the vaginal anchor in place.

[0030] Preferably, the vaginal anchors 40 are oval and smooth-walled to minimize patient discomfort and the anchor's profile. If absorbable PDS anchors and sutures are used, the anchors and sutures are expected to dissolve in approximately six months. During that time, the elevated bladder neck is expected to scar in place, maintaining the effects of the surgery over the long term. Figure 3B further illustrates the relative placement of the vaginal anchors 40 (behind the anterior vaginal wall) and the placement of four sutures through the rectus abdominis muscle. Instead of the rectus abdominis muscle, the sutures 30 and / or anchors 40 may alternatively be routed through the obturator internus muscle or through one or more locations or a combination of locations.

[0031] However, after surgery, it may be desirable to adjust the fixation of the vaginal anchor. For example, the suspension may be too tight. This may manifest, for example, as the patient having difficulty emptying their bladder. In this instance, it is possible to adjust the placement by unlocking the sutures 30 (e.g., by untying the knots or removing the locks holding them in place), slightly loosening the vaginal anchors 40, and resecuring the sutures 30. On the other hand, if the patient still experiences urinary leakage, for example, the suspension may be too loose. In this case, the sutures 30 may be untied, the vaginal anchors may be lifted, and the distance between the fascial anchors 20 and the vaginal anchors 40 may be reduced, and then the sutures 30 may be resecured. The patient will typically notice either condition occurring within a few days, long before the repair has scarred into place.

[0032] Although the suture can be untied, loosened, or retied, in further implementations, the free end of the suture may be held in place within an anchor having an engaged and disengaged position, for example, by a clamping force or a friction lock. The vaginal anchor may be unlocked to allow the suture to pass through it, and then locked to prevent the suture from moving. The suture may traverse a tortuous path, for example, as it traverses through the lock. The anchor can appropriately engage or disengage the suture by depressing an actuator or friction lock built into the suture path, or by flipping a mechanical switch that locks the suture in place in a first position and allows the suture to slide within the vaginal anchor in a second position. In the case of a friction lock, the suture path may include a wedge-shaped lock, which may include teeth or undulations, for example, that jams the suture into place when fully inserted and slides into a keyed slot that allows the suture to move freely or under detectable physical resistance when partially retracted. If barbed sutures are used, the barbs may be oriented to prevent the vaginal anchor from loosening, and the unlocking mechanism may comprise a tubular member or other device that advances over the barbs and collapses them to allow the vaginal anchor to be adjusted.

[0033] FIG. 4 shows a schematic diagram of one example of a vaginal anchor 40 according to the present disclosure. The anchor 40 may be enclosed in an atraumatic, low-profile trough-like body 42 and may include first and second suture entry ports for receiving sutures 30 (S1 and S2) at the top of the anchor, and a suture exit port that may be directed toward the entrance of the vagina and may include a mechanical lock, such as a wedge lock, received by interference engagement within the lock body. The wedge body of the lock 46 may be disengaged, for example, by a suitably configured hand tool (not shown). Suture S1, positioned further into the vagina than suture S2, is guided around smooth protrusions 44 and through an opening in the wedge-shaped body out of the vaginal anchor. Suture S2 enters through the top of the lock and is guided in the opposite direction to the entry port into the vagina, where it loops around an additional protrusion that allows for a 180-degree rotation, and exits the lock body through a third protrusion over which the suture slides. It is understood that the locking mechanism of the anchor may be configured in multiple ways. However, it is preferred that the sutures enter the top of the vaginal anchor and exit through the bottom or end of the anchor. In another embodiment, one or both sutures may exit through a lateral side of the vaginal anchor, if desired. It is understood that the vaginal anchor may be configured to receive one tether or more than two tethers, if desired.

[0034] 5 shows a schematic diagram illustrating a further embodiment of a vaginal anchor according to the present disclosure. As shown, a suture 30 is provided having oppositely facing barbs 32 that are guided through the fascia, the barbs preventing the suture from backing out. A second portion of the suture has oppositely facing barbs for threading through the vaginal anchor. The barbs may be collapsed by a tubular instrument or hollow needle advanced over the suture, thereby loosening the anchor. The anchor can be tightened by simply advancing the anchor over the barbs of the barbed suture.

[0035] 6A and 6B are isometric views of a further implementation of a vaginal anchor in a fully secured position to a pair of sutures in accordance with the present disclosure. Figures 7A and 7B are exploded isometric views of the vaginal anchor of Figures 6A and 6B illustrating certain internal members of the vaginal anchor.

[0036] As shown, anchor 140 is comprised of two interlocking portions 142, 144 that cooperate to form a generally continuous outer surface that is oval in side view and generally circular in end view. It is understood that anchor 140 may be modified to any general shape and still operate in the manner described herein. Interlocking portion 144 of the anchor defines a pair of openings 146 through its side wall, which allow one or more sutures to be threaded therethrough to secure it in place. FIG. 6A illustrates anchor 140 with the two interlocking portions 142, 144 fully locked in place, with barbs 141 on each side of interlocking portion 142 received in corresponding ones of a pair of barb-receiving openings 143 defined through the side wall of interlocking portion 144. The openings 143 for receiving the barbs 141 of the housing member 142 do not need to be provided, but may be useful to allow an instrument such as forceps (not shown) to push the barbs 141 radially inward when a doctor or surgeon desires to release the anchor 140 from the suture 130.

[0037] 7A and 7B, housing member 144 includes a pair of generally parallel plates 145 spaced apart to define a cavity 145a therebetween, with suture 130 passing between the plates 145 and through an opening 146 in sidewall 144a of member 144. Plates 145 are generally tongue-shaped, with each plate 145 received in a corresponding cavity 142a (FIG. 12B) in housing member 142. Housing member 142 includes two outwardly extending arms having barbs 141 thereon that slide into the corresponding cavities or in tracks 141a in housing member 144. Housing member 142 further defines an outer protrusion 147 that is slidably received in cavity 145a of housing member 144 and urges against suture 130 to hold suture 130 in place within housing member 144.

[0038] FIG. 8A is an isometric view of the vaginal anchor of FIGS. 6A and 6B in a partially locked position. FIG. 8B is a partial isometric view of the vaginal anchor of FIG. 8A in a partially locked position. In this configuration, anchor 140 can slide along suture 130 with some resistance as the physician or surgeon adjusts the tension on tether 130 during surgery. Once the physician or surgeon is confident that anchor 140 is correctly positioned, it may be snapped into place. As can be seen in FIG. 8B, the interior of anchor member 144 defines multiple bearing surfaces 149a, b, c against which curved end surfaces 147a of corresponding protrusions 147 press suture 130 when anchor 140 is in a fully locked position. FIGS. 10A and 10B are additional views (isometric and isometric cross-sectional views, respectively) of member 144 showing the relative positions of the inner members.

[0039] Figure 9A is an isometric view of a pair of sutures with the vaginal anchors in a partially anchored configuration as shown in Figure 8B. Figure 9B is an isometric view of a pair of sutures with the vaginal anchors in a fully anchored configuration as shown in Figures 6A and 6B. As can be seen, in the fully anchored configuration shown in Figure 9B, the suture 130 traverses a much more tortuous path than in the partially anchored state of Figure 9A.

[0040] Figures 11A and 11B are cross-sectional views showing the inner members of either side of the vaginal anchor of Figures 6A and 6B. As shown, this cross-sectional view is orthogonal to the cross-sectional view of, for example, Figure 8B. For member 142, cavities 142a that receive protrusions 145 and cavities 145a that receive protrusions 147 are clearly shown in the cross-sectional view. Also shown are barbs 141 on the deflectable cantilever arms that extend axially away from the outer edges of member 142, and cavities 141a that receive arms carrying barbs 141 in member 144. Also shown is catch or cavity 146a that receives barb 141 when the anchor is in the intermediate or partially locked configuration of Figures 8A and 8B.

[0041] Figure 12A is an isometric cross-sectional view of the vaginal anchor of Figures 6A and 6B in a partially secured position. As can be seen, in this position, barbs 141 are received by cavities 14a of member 144. Suture 130 is shown in cross-section. Figure 12B is an isometric cross-sectional view of the vaginal anchor of Figures 6A and 6B in a fully secured position. In this configuration, the suture is fully captured and held in place between surfaces 149c and 147a, and barbs 141 are held in place against surface 143a, which partially defines opening 143.

[0042] Figure 13A is an isometric cross-sectional view of the inner member of the vaginal anchor of Figures 6A and 6B holding the suture in place in the fully anchored configuration. As can be seen in this view, suture 130 is pressed against surfaces 149a, 149b, and 149c by curved surface 147a when anchor 140 is in the fully anchored state. Figure 13B is a further isometric cross-sectional view of member 142 of the vaginal anchor of Figures 6A and 6B rotated 90 degrees about the central longitudinal axis of anchor 140, showing the inner member holding the suture in place in the fully anchored configuration, and particularly showing barbs 141 and protrusions 147 and their relative positions with respect to suture 130.

[0043] 14 is an upper isometric view of an embodiment of a delivery system 100 in accordance with the present disclosure. It is understood that the illustration and description of the system 100 and its aspects are merely exemplary and are not intended to be limiting in any way.

[0044] Generally, system 100 includes a housing 110 that includes a handle or actuator handle for actuating a pull or push rod that moves hollow shaft 112 to a distal portion that includes fascial anchor 120. Additionally, vaginal anchor 140 is shown in a relative position, and further implementations of vaginal anchor 240 are described in detail below with reference to Figures 40-44B.

[0045] A length of suture material 130, e.g., a length of suture, extends from the proximal end of device 130, held in place by, e.g., a cleat, clamp, or removable tape 162, along the exterior surface of hollow shaft 112, through body portion 122 of fascia anchor 20 located at the distal end of device 100, and back along shaft 112 near handle 110, with both free ends of the suture held in place by, e.g., retainers or tape 162. Device 100 is used to advance the anchor and shaft 112 through the upper vaginal wall, as described above, through the patient's tissue, and through the fascia until distal portion 120 of the anchor passes through the fascia. At this point, suture 130 is pulled through the path defined through the tissue by device 100, and the anchor may be placed across and / or within the patient's fascia holding the anchor in place. Shaft 112 and the push rod therein are removed, leaving behind the anchor and the suture that marks the vagina. A vaginal anchor (e.g., 140, 240) is then threaded over the free end of the suture, tensioned, and secured in place, generally as described above.

[0046] More specifically, as shown, system 100 comprises a housing or handle 110 having three removable adhesive panels (e.g., adhesive tapes): a first tape 162 holds the free end of suture 130 to the underside of the housing; a second tape 164 holds actuator handles 114a, b coupled to a push rod (described in more detail below) in place relative to the housing; and a third tape 166 holds actuators 115a, b coupled to a retractable wire or rod in place relative to the housing. Tubular member 112 extends proximally within handle or housing 110 within a passage 110c defined within handle or housing 110. The tubular member extends distally and terminates within fascia anchor assembly 120. FIG. 15 is a bottom isometric view of the embodiment of FIG. 14.

[0047] Figure 16 is an enlarged view of the vicinity of the delivery system of Figure 14, viewed from below the housing 110. Wires or rods 126, 128 can be seen extending from the actuators 114, 115 into the passageway 110c defined in the housing and further into the tubular member 112 towards the distal end of the system 100.

[0048] Figure 17 is an exploded view of the delivery system of Figure 14. In various views based on the exploded view of Figure 17, certain hardware (such as screws) is shown. However, it is understood that the threaded fasteners used to hold the handle or housing 110 together are only one possible arrangement according to the present disclosure. As shown, in this example, the handle is comprised of two housing members 110a, 110b coupled to a tubular member 112 that terminates in two wires 126, 128 coupled to a proximal portion of the anchor assembly 120. Also shown are the suture loop 130, tapes 162, 164, 166, and anchor 240 that pass through the distal portion 122 of the anchor assembly 120 and are described in detail below.

[0049] Figure 18 is an enlarged view of the exploded view of Figure 17 illustrating an embodiment of the handle portion of the delivery system of Figure 14. As shown in this embodiment, an actuator block 114 is provided, formed from a single or two sections 114a, 114b, that captures the proximal end of a wire 128. Also shown is a portion 115b of a lower actuator block 115 that couples to the proximal end of a wire 126. As can be seen, each wire 126, 128 passes through a lumen defined along the entire length of the tubular member 112. A retainer plate 117b is received in a groove defined in a housing member, described below. The plate may be attached to the tubular member 112 (e.g., by adhesive, etc.).

[0050] With continued reference to FIG. 18, a top view of the upper portion 110a of the housing 110 is shown. As shown, the housing may be elongated, if desired, and may include a proximal gripping portion 110g. Additionally, the housing member 110 defines a channel or groove 113a therein, characterized by a main channel that begins at the proximal end of the device and extends distally. The channel further includes one or more undercuts 113u that form guide tracks along the main channel and receive corresponding tabs 114j on the upper actuator block 114. FIGS. 19A-19C show top, near, and bottom isometric views of the first portion 110a of the housing 110 of the delivery system 100 of FIG. 14. As can be seen, the housing member 110a defines a divided longitudinal portion of the elongated axial path 110c along which it receives a proximal region of the tubular member 112, which is secured to a plate 117b that, in turn, receives a slot 117a defined in the underside of the housing member 110a. FIG. 19B illustrates that path 110c terminates at its proximal end at the distal end of channel 113a.

[0051] Figures 20A and 20B show top and bottom isometric views of the second portion 110b of the housing of the delivery system of Figure 14. Housing member 110b is essentially a mirror image of member 110a and defines a corresponding second portion of channel 110a that receives plate 117b and slot 117c that in turn holds and positions tubular member 112. A similar channel 113b with lateral guide rails or undercuts 113v is defined in the underside of housing member 110b.

[0052] 21A and 21B are top and bottom isometric views of portion 114a of retention block 114 of the delivery system of FIG. 14. The block defines a groove 114c on its underside that bends partway through to hold the proximal end of wire 128 in place. One or more mounting bosses 114d (or pegs glued into recesses) may be provided that are received by corresponding sockets in block 114b. FIGS. 22-24 are partial isometric exploded views of a portion of the delivery system of FIG. 14, illustrating aspects of the system's retention block and delivery system guide alignment plate. FIG. 22 more clearly shows the routing of wires 126 and 128 through each actuator block or handle 114, 115 to tubular member 112. In use, each actuator block is pulled proximally or pushed distally to pull or push each wire 126, 128, actuating distal anchor assembly 120 and deploying the fascia anchor when it is in position. Figure 23 shows a bottom exploded view, with wire 136 received in a channel defined in the underside of block 115b. Figure 24 shows an exploded view of block or actuator handle 114 with members 114a, 114b separated. Each block 114, 115 sandwiches a respective wire 128, 126 in its center, and a wire-receiving groove may be formed in one or both of the centers of each block.

[0053] 25A-26B are enlarged isometric views of the distal portion of the system of FIG. 14 illustrating the fascia anchor aspect of the system. The anchor assembly 120 is formed of two sections: a first proximal section 124 attached to the distal end of a tubular member and a second distal section 122 removably attached to the proximal section 124 by a puller wire 126. The puller wire 126 passes through both sections, holding the sections in place as it advances through tissue. Additionally, the sections 124, 122 are held together by a keyed arrangement, such that when the push rod or pull rod 126 is in place, the sections 122, 124 cannot be separated axially, laterally, or rotationally. When the puller rod is withdrawn proximally, the sections 124, 122 can be separated, leaving the section 122 in the patient after passing through the fascia, with the trailing tether 130 passing through an opening in the section 122. FIG. 25B shows the relative placement of a tether or suture 130 passing through member 122, with puller wire 126 holding members 122, 124 together.

[0054] 26A and 26B illustrate members 122, 124 with tether or suture 130 removed for illustrative purposes. Distal anchor member 122, which is removable from the system, defines an opening 122a on its lateral side through which suture 130 can pass. If desired, channel 112 e may be defined along either side of anchor portion 122 near opening 122b to allow the suture to be at least partially received in channel 122e with low friction when the assembled device 100 is introduced into tissue.

[0055] 27A-27C are various isometric views of the proximal portion 124 of the anchor assembly 120 that couples to the distal removable portion 122 of the anchor assembly. The member 124 has a proximal end that begins with a crescent-shaped sleeve 124f that is received by the lumen of the tubular member 112 and coupled to the lumen by any suitable method (adhesive, welding, etc.). The body of the member 124 is generally cylindrical and elongated, with a scalloped portion or recess 124r between its ends, and a rounded or knuckled distal end 124b. A first set of elongated axial passages 126b, 126a may be defined through the portion 124 that accommodates a puller wire or tube 126 that holds the members 122, 124 together during delivery. These passages allow the puller wire or tube 126 to extend completely through the member 124 and into the member 122. Additionally, a second passageway 128a may be defined axially through an adjacent portion of member 124 and laterally offset from passageway 128b. Passageway 128a receives a push tube or push rod 128 therein to push against a portion of anchor portion 122 and assist in rotating anchor portion 122 into an orientation that is not aligned with the axial direction of device 100 along an orientation oblique or perpendicular to the direction of suture travel so that the anchor provides adequate resistance to tension forces applied to suture 130.

[0056] 28A-28C are various isometric views of fascial anchor 122 of the system of FIG. 14. Anchor 122 is the portion of the system that is left in place and delivered to a point within or beyond the fascia to provide an anchor for tether 130. Anchor 122 includes a pointed distal end 122d for gently cutting tissue as it is advanced by delivery system 100. Passages 126c, 126d receive wire 126 therein. The knuckled distal end of member 124 is received within recess 122b of distal anchor 122. Thus, when assembled, wire 126 passes through passages 126a, 126b of member 124 and passages 126c, 126d of member 122, forming a rigid interlock between members 122, 124. Additionally, anchor 122 defines a push surface or push rod receiving surface 128c upon which wire 128 is advanced distally as anchor cavity 122b pivots around the rounded, fist-shaped distal end of member 124. Thus, in use, delivery system 100 delivers the anchor into or across the fascia as generally described above. However, at this point, anchor 122 is still longitudinally aligned with delivery system 100, which could result in the anchor being withdrawn when tension is applied to the suture. Thus, once the anchor is in position, wire 126 is withdrawn by removing tape 166 (or other retainer) and advancing block 115, to which it is attached, proximally. This causes wire 126 to exit distal anchor 122 and release from the mechanism, except for tension applied to tether or suture 130 passing through opening 122a in member 122. While tensioning the tether, the push rod or push tube is pushed distally by removing tape 164 from housing 110, allowing block 114 attached to the proximal end of wire tube or rod 128 to advance distally through opening 128a and onto surface 128c. The off-axis force exerted by the distal end of rod 128 on surface 128c creates a leverage or moment about a rotational axis defined by the coordinated movement of the inner curved surface of cavity 122b around the rounded distal surface of member 124.By continuing to push with push rod, tube, or wire 128 while maintaining tension on tether 130 to hold members 122, 124 in contact, the proximal end of anchor 122 will swing distally and the distal end 122d of the anchor will swing proximally until the anchor is positioned obliquely, possibly perpendicular or orthogonal, to the longitudinal axis of delivery system 100. After this occurs, device 100 can be withdrawn from the patient, leaving anchor 122 in place, with suture 130 passing through the fascia and the passage defined by the insertion of device 100, and both trailing ends of the suture extending through the vaginal wall and out of the patient's vagina. At this point, suture 130 passes through opening 122a in anchor 122. A vaginal anchor, such as 140 or 240, can then be introduced into suture end 130 using the suture end as a guide rail. Tension may then be applied to the suture 130 to lift the vaginal wall, securing the vaginal lock in place. If desired or necessary, the vaginal lock can be released and the tension adjusted to ensure that urine leakage is minimal or has stopped.

[0057] Figures 29A and 29B are isometric views of the fascia anchor and distal member of the delivery system of Figure 14. From this view, it can be seen how the rounded distal end 124b of member 124 fits into recess 122b of member 122. Figure 30 is an isometric view of the distal portion of the delivery system of Figure 14 with system members omitted to illustrate the relative positions of retaining rod 126 and pushing rod 128 that urge fascia anchor 122 into position.

[0058] Figure 31 is an enlarged view of the distal portion of the handle portion of the delivery system of Figure 14, illustrating the relative placement of the tape or retainer 162 for holding the suture 130 in place as shown. Figures 32-35 are enlarged isometric views of the proximal portion of the handle portion 110 of the delivery system of Figure 14. For illustrative purposes only, this view shows the actuator block 115 coupled to the pull wire 126 both in the track and outside the track. If desired, additional actuator blocks may be included (e.g., two for each channel 113a, 113b) to provide a means for pulling or pushing additional actuator wires or rods. Figures 36 and 37 are isometric views of the fascia anchor of Figure 14, showing the relative positions of the sutures threaded therethrough. As can be seen, in this orientation, the long axis of the anchor 122, once rotated, is perpendicular or nearly perpendicular to the suture 130, maximizing pullout resistance. Figures 38 and 39 are isometric views of a portion of the system of Figure 14 showing the relative position of retaining plate 117b around tubular member 122. Figure 39 illustrates tubular member 122 as terminating in member 124.

[0059] 40-44B show various isometric views of a further implementation of a vaginal anchor 240 in accordance with the present disclosure. The anchor 240 is oval-shaped and defined by an atraumatic outer surface without sharp edges. As shown, the anchor 240 comprises an upper portion 242 and a lower portion or cap 244. The upper portion 242 and the lower portion 244 together define a housing. The upper portion 242 defines two openings therein for accommodating the passage of sutures 242a. As shown in FIGS. 42-44, the upper portion 242 of the lock, which rests against the vaginal wall after implantation, includes a central boss 245 on either side of which are located locking cleats. Each locking cleat includes a plate offset from the surface of the upper portion 242, which defines a gap between the plate and the surface. Each gap includes one or more ribs or ridges 249 that hold the suture 130 in place through an interference fit. In use, tether 130 is tensioned and then wrapped around each cleat, and then cover 244 is coupled to upper portion 242 to retain the trailing suture within the anchor. Upper portion 242 of anchor 240 includes one or more barbs 241 disposed on cantilevered arms that are received by respective openings 246 in lower portion 244. As with the other anchors described herein, after installation, cover 242 can be removed and the tension in tether 130 can be adjusted by untying the tether from each cleat, thereby adjusting the tether tension and allowing the tether to be resecured around the cleat.

[0060] According to a further aspect, the system may be configured to encourage the formation of scar tissue to maintain the new shape created by the surgery. For example, one or more of the fascial anchor, tether(s), and vaginal anchor may include a surface or projections that encourage the formation of scar tissue. For purposes of illustration and not limitation, a representative implementation of such an arrangement is shown in FIG. 45, in which a matrix material 300 having a spiral, helix, lattice, matrix, and / or projection morphology, etc., is attached to the tether 130. When attached to or integrally molded with the tether, the matrix material 300 may be drawn into the tissue along with the fascial anchor and tether 130. Alternatively, such a matrix material may be introduced in a separate operation from the tether 130. The matrix material 300 may or may not be absorbable, as desired. Enhanced scarring along the tether passing through the tissue can improve the strength of the tissue structure caused by the surgery. The matrix material may be natural and / or synthetic. The tether and / or matrix material may be formed from absorbable or non-absorbable materials in separate or the same operation. In some implementations, the material may include PDS as described herein and / or variations of polylactic acid, such as PLA, PDLA (poly-D-lactic acid), or PLLA (poly-L-lactic acid), of various molecular weights and densities. For example, the suture material and matrix material may be formed in the same molding and / or extrusion operation. In other implementations, the matrix material 300 may be made from animal skin, such as fish skin. The matrix material preferably extends from a location near the fascial anchor 122 for a distance of about 2 to about 5 cm, but not the entire length of the vaginal anchor. Preferably, the matrix material 300 forms a mass of material in the region of the tether 130, inducing the formation of scar tissue to hold the urethra in place after surgery.

[0061] The methods and apparatus provided by the present disclosure, as described above and shown in the drawings, provide methods and systems for medical diagnosis and treatment with the superior properties described herein. It is understood that the disclosed systems, or portions thereof, may be used for other applications. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments of the present disclosure described herein without departing from the spirit or scope of the present disclosure. Therefore, it is intended that the present disclosure cover such modifications and variations as come within the scope of the appended claims and their equivalents.

Claims

1. A system for treating stress urinary incontinence (SUI), The housing comprises at least one actuator located within the housing, An extension shaft that extends proximally within the housing and distally beyond the distal end of the housing, A tissue anchor assembly disposed at the distal end of the extension shaft, comprising two parts, a proximal portion and a distal portion, wherein the distal portion is removably attached to the proximal portion and the distal portion can be left in the tissue, A tether is positioned to penetrate the distal portion of the tissue anchor assembly and extends along the extension shaft toward the housing, At least one actuator disposed within the housing, the actuator being coupled to a pull wire that passes through the extension shaft and the proximal portion of the tissue anchor assembly and extends into the distal portion of the tissue anchor assembly, the actuator being configured such that, after the distal portion of the tissue anchor assembly is positioned in the tissue, the actuator is activated to pull the pull wire proximally and retract it from the distal portion of the tissue anchor assembly, thereby separating the distal portion of the tissue anchor assembly from the extension shaft and the proximal portion of the tissue anchor assembly, Equipped with, The extension shaft and the proximal portion of the tissue anchor assembly are removable from the tissue after the distal portion of the tissue anchor assembly is released and the distal portion of the tissue anchor assembly and the tether remain in the tissue. system.

2. The system according to claim 1, wherein the tissue anchor assembly forms the leading end of the system and has a tissue cutting end.

3. The system of claim 1, wherein the tether passes through an opening defined in the tissue anchor assembly.

4. The system of claim 3, wherein the first and second ends of the tether are coupled to the housing.

5. The vaginal anchor is further connected to the tether, The vaginal anchor is configured to connect to the tether after the tissue anchor assembly has been embedded in the tissue and tension has been applied to the tether. The system according to claim 1.

6. The system of claim 5, wherein the vaginal anchor comprises at least one cleat for coupling with the tether.

7. The system according to claim 5, wherein the vaginal anchor comprises two housing members that are connected to each other.

8. The system of claim 7, wherein the two housing members are secured to the tether when joined together.

9. The system according to claim 8, wherein the two housing members are joined at multiple positions.

10. The system according to claim 1, wherein the tissue anchor assembly is a fascial anchor, and the fascial anchor is positioned within the extension shaft before being deployed.

11. The system according to claim 5, wherein the vaginal anchor is an oval-shaped anchor with a smooth surface.

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