Systems, devices and methods for treatment of pelvic organ prolapse

Abstract

A magnetic-attractive alignment array is removably attached to a surgically-implantable mesh and configured to align over a surgical manipulator with magnetic-attractive elements, including a Y-shaped woven mesh is used to anchor one or more abdominopelvic structures to the sacrum. Various tools and procedures for performing sacrocolpopexy, sacrohysteropexy, cervicopexy, or other pelvic organ prolapse correction are provided.

Description

SYSTEMS, DEVICES AND METHODS FOR TREATMENT OF PELVIC ORGAN PROLAPSECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit to a) U.S. Provisional Application. Ser. No. 63 / 587,709, filed October 3, 2023, and b) U.S. Provisional Application. Ser. No. 63 / 569,591, filed March 25, 2024. the entire contents of the above applications are hereby incorporated by reference in their entirety.FIELD OF TECHNOLOGY

[0002] This disclosure relates generally to medical devices, and more specifically to sy stems, devices and methods for implantation of vaginal meshes to treat pelvic organ prolapse and for other pelvic reconstruction procedures. Various tools and procedures for performing sacrocolpopexy, sacrohysteropexy or cervicopexy are provided. Some procedures include illumination and visualization tools, as well as suturing and cerclage tools.BACKGROUND

[0003] Pelvic organ prolapse (POP) is a condition where a pelvic organ slips out of a natural position.

[0004] Alternative or additional forms of pelvic organ prolapse are a cystocele or rectocele, where the urinary bladder 107 or the rectum 108, respectively bulge into the vaginal cavity 105. These conditions comprise lower organ prolapse, generally within or below the anatomical area of the abdomen 110, e.g., the pelvic cavity 112.

[0005] Pelvic organ prolapse (POP) is a condition where a pelvic organ slips out of a natural position. Vaginal prolapse is one example of pelvic organ prolapse, and is a condition where the top of a vagina loses tissue support and slips out of position so that it is no longer held deeply within the pelvis. It happens when tissues and muscles in the pelvis overstretch or weaken, commonly due to multiple vaginal childbirth deliveries but also caused by menopause effects on tissue or general weakening throughout life. The body muscles and other tissues near the top of the vagina create a support structure called the pelvic floor. When this structure becomes weakened or traumatized, the lack of support structure allows the vagina to fall out of position from the apex (top) downward, causing the top of the vagina and other nearby organs such as the uterus to collapse downward into the vaginal canal. This can happen with a uterus in place, or after hysterectomy where the uterus has been removed.

[0006] Vaginal prolapse is depicted in FIG. 1A where the apex 101 (top) of the tube-shaped vagina 103, bulges inward (invaginates) into the vagina 103 cavity or vaginal vault 105 formed bythe vaginal wall 102. and sometimes completely out of the vaginal opening 106. Vaginal prolapse occurs within the abdominopelvic region 110 where the apex 101 of the vaginal wall 102 of the vagina (also called the vaginal cavity or vaginal vault) 103 has slipped downward. Other surrounding organs include the urinary bladder 107 and the rectum 108.

[0007] Alternative or additional forms of pelvic organ prolapse are a cystocele or rectocele, where the urinary bladder 107 or the rectum 108, respectively, bulge into the vaginal cavity 105. These conditions comprise low er organ prolapse, generally within or below the anatomical area of the abdomen 110, e.g., the pelvic cavity 112.

[0008] A cystocele occurs when the ligaments and muscles that hold up a patient’s bladder stretch or weaken. The patient may see or feel tissue bulge through their vaginal opening or have difficulty urinating or inserting menstrual products. Sexual intercourse may also be painful. Treatment may include strengthening your pelvic floor muscles or surgery such as placement of permanent mesh as is common during sacrocolpopexy.

[0009] Rectocele may occur when weakened tissues in a patient’s pelvis causes their rectum to sag onto their vaginal wall. If the bulge (prolapse) is small, the patient may not notice symptoms; with a more significant prolapse, their rectum may protrude out of their vagina. This condition may be corrected by surgery such as placement of permanent mesh as is common during sacrocolpopexy.

[0010] The gold standard surgical treatment of post-hysterectomy vaginal vault (tube-shaped structure of the vagina) prolapse is called sacrocolpopexy. A similar procedure can be performed with the uterus in place (sacrohysteropexy) or with the cervix in place after supracervical hysterectomy (sacrocervicopexy). Sacrocolpopexy is often performed laparoscopically through several small abdominal punctures, and robotic laparoscopic sacrocolpopexy has recently been utilized by pelvic reconstructive surgeons to reduce the morbidity’ associated with the more invasive laparotomy sacrocolpopexy through an abdominal incision.

[0011] Sacrocolpopexy involves suspension of the vaginal vault and attachment near the sacrum using an intervening graft material, usually implantable mesh. Various materials have been used in sacrocolpopexy, including natural and synthetic materials, although permanent synthetic mesh is most often described, due to excellent long-term results described in the literature. Of the synthetic materials in use today, the most commonly used is type I, macroporous, monofilament, lightweight polypropylene. This material is well tolerated, easy to handle, and resistant to infection and erosion through tissues in the pelvis, especially the vagina. Most surgeons who perform sacrocolpopexy employ a “Y-shaped” configuration of the mesh, depicted in FIG. IB. This configuration includes two extensions of the mesh that are sutured, one extension each, to the posterior and anterior vaginal walls. During the surgery', schematically depicted in FIG. 1C, thebladder is advanced off the anterior vagina and the rectum is dissected free of the posterior vagina by entrance into the rectovaginal septum. The mesh arms are then placed over the anterior and posterior vagina and sutured in place with multiple interrupted sutures. Once the vaginal sutures have been placed, the surgeon attaches the mesh to an anchor site such as the anterior longitudinal ligament of the sacrum, either at the promontory or lower, in the hollow of the sacrum. Finally, many surgeons choose to bury the mesh under the peritoneum, to prevent the potential development of internal intestinal hernia and subsequent obstruction.

[0012] There have been several vaginal Y-meshes marketed for sacrocolpopexy, including UPSYLON™ mesh (Boston Scientific, Inc.), RESTORELLE™ ultra lightweight mesh (Coloplast, Inc.), and ARTISYN™ mesh (Ethicon, J&J MedTech).

[0013] Dissecting nearby tissues from the vaginal vault, to allow access and suturing of the vault to mesh, is often done by mechanical separating using dissector tips of laparoscopic tools. This dissection can be quite time-consuming, often taking thirty to sixty minutes of the surgical procedure. In order to reduce that time, some surgeons have used hydrodissection in the form of a probe with a forward-jetting fluid port to help with this dissection, and others have used a method where a needle (attached directly to a syringe) is simply inserted through the vaginal wall into nearby tissues and a large volume of fluid is blindly injected.

[0014] An assisting aid often used with sacrocolpopexy and similar procedures is a vaginal manipulator, which is an elongated tool that is inserted into the vagina and extended through the length of the vaginal vault to allow manual positioning of the vaginal fascia tissues during surgery. There have been several such vaginal manipulator designs marketed, including the COLPASSIST™ (Boston Scientific. Inc.), the MERIDIAN™ vaginal positioning system (Coloplast. Inc.), and HOYTE SACRO TIPS™, possibly with Rumi handle (Cooper Surgical Medical Devices, Inc.).

[0015] During the sacrocolpopexy surgical procedure, physical management of the mesh arms can be difficult since they can easily slip out of the desired position before the first four or five sutures can be placed. Furthermore, in some cases the mesh can be sutured in place only for the surgeon to later find that the alignment was off and the mesh needs to be un-sutured and re-sutured in the correct alignment. These possible issues contribute to lengthy procedures, adding another thirty minutes or more to the procedure time, especially during laparoscopic or robotic sacrocolpopexy since they are performed at a distance from the surgeon's hands via very long instruments and an optical scope inserted into the gas-filled abdomen. It is important to allow the mesh to lie in good contact against the endopelvic vaginal fascia so that the mesh does not bunch up or twist while the mesh is being sutured to the vaginal fascia, which is felt to be a risk factor for dyspareunia, infection, mesh exposure, erosion and pain. There is a need for a mesh and / or toolconfiguration that will assist surgeons in the performance of sacrocolpopexy, including directional planning, tissue dissection, mesh placement, alignment and suturing, safely anchoring to tissues of sufficient strength, and peritonealization of the implant.

[0016] There are a variety of mesh designs used today, including standard weight, light weight and ultralight weight meshes. Ultralight meshes can be desirable for flexibility and less impact to the natural tissue feel, while they may in some cases tear during the surgery or perhaps provide less structural support. There is a need for further optimized mesh where tensile characteristics are aligned to the particular dynamics of organ support (such as forw ard-backward tensile strength) as well as treatment or prevention of cystocele and / or rectocele (such as circumferential tensile strength in the regions affected by cystocele and / or rectocele).

[0017] In one embodiment, a surgical mesh system is provided, comprising an implantable mesh body, comprising a first arm, comprising a first central end, a first free end, and a first mesh body therebetween, a second arm, comprising a second central end, a second free end. and a second mesh body therebetween, and a third arm. comprising a third central end, a third free end, and a third mesh body therebetween, and a first plurality of removable magnetic alignment bodies, wherein each of the magnetic alignment bodies of the first plurality of removable magnetic alignment bodies is attached to at least one other magnetic alignment body of the first plurality of removable magnetic alignment bodies by at least one removable interconnect structure that is separate from the first mesh body, second mesh body and a third mesh body, wherein the first plurality removable magnetic alignment bodies are coupled to at least the second and the third arms by at least one releasable coupler. The at least one coupler may comprise a releasable pocket, releasable retention wire, or releasable cuttable securing line. The first plurality of removable magnetic alignment bodies may be coupled by the at least one releasable coupler to the second and third arms but not the first arm. The at least one removable interconnect structure may pass through an opening in the first arm, but none of the first plurality of removable magnetic alignment bodies are in contact with or located on the first arm. The second arm may comprise an inner surface facing toward the third arm and an outer surface facing toward the first arm, and the third arm comprises an inner surface facing toward the second arm and an outer surface facing toward the first arm. The first plurality of removable magnetic alignment bodies may be located on the inner surfaces of the second and third arms. The at least one removable interconnect structure may be located against the inner surfaces of the second and third arms, but not an outer surface of the second or third arm. The at least one removable interconnect structure may be interwoven between the inner surfaces and outer surfaces of the second and third arms. The first plurality of removable magnetic alignment bodies may be located on the outer surfaces of the second and third arms. The at least one removable interconnect structure may be located against the outer surfaces of thesecond and third arms, but not an inner surface of the second or third arm. The at least one removable interconnect structure may be interwoven between the inner surfaces and outer surfaces of the second and third arms. The first plurality of removable magnetic alignment bodies may be located on inner and the outer surfaces of the second and third arms. The at least one removable interconnect structure may be interwoven between the inner surfaces and outer surfaces of the second and third arms. The at least one removable interconnect structure may comprise a single removable interconnect structure serially coupled to each removable magnetic alignment body of the first plurality7of removable magnetic alignment bodies. The at least one removable interconnect structure may comprise a first removable interconnect structure connecting the first plurality of removable magnetic alignment bodies located on the second arm, and a second removable interconnect structure connecting the first plurality of removable magnetic alignment bodies may be located on the third arm. The at least one removable interconnect structure may comprise a third removable interconnect structure connecting the first and the second removable interconnect structures. The at least one removable interconnect structure may comprise a third removable interconnect structure connecting one of the first plurality7of removable magnetic bodies located on the second arm and one of the plurality7of removable magnetic bodies located on the first arm. The first plurality7of removable magnetic alignment bodies may each comprise a non-magnet magnetizable material or comprises a plurality of magnets. One of the first plurality7of removable magnetic alignment bodies may be located at midline between the second and third arms. One of the first plurality of removable magnetic alignment bodies may7be located on or in an opening in the first central end of the first arm. The first arm may comprise a first mesh pattern may be different from a second mesh pattern of the second arm and from a third mesh pattern of the third arm. The second and third mesh patterns may be identical. The second and third arms may be contiguously formed. The first arm may be not contiguously formed with the second arm or the third arm. The first mesh pattern may have a different porosity7than the second and third mesh patterns. The first, second and third arms may each comprise a ribbon shape. The first arm may have a different ribbon width than the second and third arms. The first arm may have a relative width that may be between 10% and 75% of width of the second and third arms. The first arm may have a width in the range from 0.2 cm to 2.5 cm. The first arm may have a width in the range of 1.0 cm to 2.0 cm. The at least one of the first, second and third arms may comprise higher density7edge regions and a lower density inner region therebetween. The higher density edge regions may- have a density in the range of 30-45 g / m2. The lower density inner region may have a density in the range of 17-22 g / m2. The higher density edge regions of the at least one of the first, second and third arms may comprise a percentage width in the range of 10 to 40 percent. The higher density edge regions may comprise a total width percentage in the range of 25% to 70%, or 30%to 50%. The first, second and third arms may each comprise a mesh porosity in the range of 60% to 80%. The higher density edge regions of the at least one of the first, second and third arms may comprise a percentage width in the range of 20 to 70 percent. The higher density edge regions of the at least one of the first, second and third arms may comprise a percentage width in the range of 40 to 60 percent. The first arm may comprise higher density edge regions and a lower density inner region therebetween. The first arm may comprise a first material, and the second and third arms comprise a second material different from the first material. The first arm may have a lower Young's Modulus than the second or third arm. The first, second and third arms may comprise at least one reinforcement structure separate from the at least one releasable coupler and the at least one removable interconnect structure. The system may further comprise an elongate magnetic alignment tool, comprising an elongate body with a proximal handle and a distal alignment region, and a second plurality7of magnetic alignment bodies coupled to the distal alignment region. The second plurality7of magnetic alignment bodies are symmetrically located on the distal alignment region. The second plurality of magnetic alignment bodies comprises a magnet located on a distal tip of the distal alignment region. The e second plurality of magnetic alignment bodies may be located in a single plane through the distal alignment region. The handle region may comprise a curved configuration, and the handle region also lies in the same single plane as the second plurality of magnetic alignment bodies. Either the second and third mesh bodies may be contiguously formed and wherein the second mesh pattern and the third mesh pattern have identical intemodal distances and mesh opening shapes. The system may further comprise elongate strain limiters attached to the mesh body, wherein the elongate strain limiters are only coupled to the mesh body at the free ends of the first, second and third arms. The elongate strain limiters may be branched elongate strain limiters. The branched elongate strain limiters may comprise a first branched end, a second branched end, and an elongate body therebetween. The first branched end and the second branched end may each comprise a plurality7of branched segments, and wherein a number of branched segments in the plurality of branched segments in of the first branched end may be different than a number of branched segments in the plurality of branched segments in of the second branched end. The mesh body comprises an over-and-under weave pattern with a first fiber, in combination with a serpentine weave with a second fiber. The second fiber may be stronger than the first fiber. The second fiber may have a higher tensile strength limit than the first fiber.

[0018] In another embodiment, a method of treating a patient may be provided comprising inserting a magnetic probe into a body cavity of an organ, placing a surgical mesh with a removable magnetic alignment array against an external tissue surface of body cavity7, aligning the magnetic alignment array of the surgical mesh with the magnetic probe to orient the surgical mesh, suturingthe surgical mesh to the external tissue surface of the body cavity, removing the removable magnetic alignment array from the surgical mesh. Inserting a magnetic probe into a body cavity of a body organ may comprise inserting the magnetic probe through an external orifice of the body cavity. Inserting the surgical mesh adjacent to the external tissue surface of the body cavity may be performed via laparoscopic tools. Removing the removable magnetic alignment array from the surgical mesh may comprise withdrawing the magnetic alignment array from an opening of the surgical mesh. The opening of the surgical mesh may be centrally located at a junction of the surgical mesh. The surgical mesh may comprise three elongate arms joined at the junction. The method may further comprise releasing a retention element of the surgical mesh prior to removing the magnetic alignment array. The body cavity may be the vaginal vault.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] FIG. 1A is a schematic sagittal cross-sectional view of an abdomino-pelvic region with vaginal prolapse. FIG. IB is an anterior perspective view of a prior art Y-mesh as used for sacrocolpopexy and an exemplary surgical implantation of the mesh. FIG. 1C is a sagittal cross- sectional view depicting the attachment of the Y -mesh of FIG. IB used to treat the vaginal prolapse depicted in FIG. 1A.

[0020] FIG. 2A is a side view of an exemplary vaginal Y-mesh. FIG. 2B schematically depicts the potential tension forces acting on the Y-mesh of FIG. 2 A.

[0021] FIG. 3 A is a side view of another exemplary' vaginal Y-mesh with alignment structures. FIG. 3B depicts the alignment structure of FIG. 3 A.

[0022] FIG. 4 is a schematic cross-sectional view depicting the use of a vaginal manipulator with the Y -mesh of FIG. 3 A.

[0023] FIG. 5 A is a side perspective view of another exemplary' embodiment of a vaginal Y- mesh. FIGS. 5B and 5C are side and perspective views, respectively, of the mesh of FIG. 5 A engaged to a vaginal mesh model.

[0024] FIGS. 6A and 6B are schematic side views of a mesh device positioned against a vaginal wall.

[0025] FIGS. 7A and 7B are schematic top and side cross-sectional views of an exemplary vaginal probe with a shield and inflatable balloon.

[0026] FIGS. 8A and 8B are schematic top and side cross-sectional views of another exemplary vaginal probe with a wrap-around shield. FIG. 8C depicts the cut pattern for the exemplary shield in FIGS. 8 A and 8B.

[0027] FIG. 9 schematically depicts an exemplary' mesh assembly with an alignment array against a body structure.

[0028] FIG. 10 schematically depicts another exemplary mesh assembly with two alignment arrays.

[0029] FIG. 11 depicts a side view of an exemplary' mesh assembly wi th an alignment array.

[0030] FIG. 12 depicts a side view of an exemplary' vaginal manipulator with light-emitters.

[0031] FIG. 13 is a schematic perspective view of a vaginal manipulator with an imaging tip.

[0032] FIG. 14 schematically depicts a sacrocolpopexy Y-mesh with reinforcements.

[0033] FIGS. 15A to 15H depict various embodiments of suture sites or structures that may be provided on the Y -mesh.

[0034] FIG. 16 schematically depicts a sacrocolpopexy Y-mesh with reinforcements and suture zones and a modified perimeter shape.

[0035] FIG. 17 schematically depict a mesh-free sacrocolpopexy Y-support with tethers and suture zones.

[0036] FIGS. 18A and 18B schematically depicts a ladder-like structure, as well as ladder-like structures in an unattached and attached configuration, respectively, that may be used to provide tension support. FIGS. 18C and 18D are additional examples of ladder-like tension support structures that may be used.

[0037] FIGS. 19A to 19M depict various embodiments of mesh configurations that are usable with the Y-mesh.

[0038] FIGS. 20A to 20E schematically depict a variety' of mesh filament microstructures.

[0039] FIGS. 21 A to 21D schematically depict several fiber configurations for mesh-like constructs with generally serpentine left-to-right segments.

[0040] FIGS. 22A and 22B schematically depict double-lead and triple-lead generally serpentine fiber orientations for mesh-like constructs.

[0041] FIGS. 23 A to 23D schematically depict multi -reinforced mesh-like constructs.

[0042] FIGS. 24A to 24E schematically depict multi-reinforced mesh-like constructs.

[0043] FIG. 25 schematically depicts a multi-reinforced mesh-like construct for use with sacrohysteropexy or sacrocervicopexy.

[0044] FIGS. 26A and 26B schematically depict embodiments for releasably coupling an alignment array to a mesh.

[0045] FIGS. 27 A to 27D schematically illustrate various embodiments of Y-meshes with removable alignment arrays with releasable retention structures.

[0046] FIG. 28A schematically depicts a urinary drainage catheter with inflatable anchor balloon and integrated light source(s). FIG. 28B depict an axial cross-sectional view of the catheter in FIG. 28A. FIG. 28C schematically depicts the urinary' drainage catheter from FIG. 28A as placed within the bladder of a patient.

[0047] FIGS. 29A and 29B depict an exemplary vaginal manipulator or probe with side- extendable hydrodissection needles in the peri-injection and post-injection states, respectively

[0048] FIG. 30 is a perspective side view of a hydrodissection fluid wrapper surrounding a portion of the vaginal vault.

[0049] FIGS. 31A to 31D illustrate a body probe, with one (FIG. 31A). two (FIG. 31B), or four (in FIGS. 31C and 31D) extendable needles, respectively.

[0050] FIG. 32 shows a body probe with two needles supplied by two syringe plungers and two fluid distribution tubing paths.

[0051] FIGS. 33A to 33C illustrate various embodiments of vaginal manipulators that split so that two sides of the manipulator can be driven apart from each other to appose against each opposite side of the vaginal vault.

[0052] FIGS. 34A and 34B show a parallel-bars mechanism by which a vaginal manipulator may open or close its jaws.

[0053] FIG. 35 shows a vaginal manipulator with a channel allowing a side-exiting needle for tissue hydrodissection.

[0054] FIG. 36 shows a vaginal manipulator with a channel allowing a side-exiting needle for tissue hydrodissection and an inflatable balloon.DETAILED DESCRIPTION

[0055] Referring to FIGS. 2A and 2B, one embodiment of an exemplary vaginal Y-mesh 201 comprises an apical (towards the apex) tail mesh segment 203, an anterior mesh segment 205 and a posterior mesh segment 207. The apical tail 203, the anterior portion 205 and the posterior portion 207 are connected at junction or attachment region 209. Each segment 203, 205, 207 comprises an elongate structure with a free end 211, 213, 215, respectively, and a junctional end 217, 219, 221. Y-mesh 201 may be configured to be attached to the vaginal vault via sections or segments 205, 207 in order to hold the vaginal vault in place and prevent prolapse of the organ, via suspension by the apical or tail section 203 to the sacrum The mesh 201 may comprise a uniform mesh pattern throughout each segment 203, 205, 207, as depicted in FIG. 2A, but in other variations, a greater density, or thicker or stronger mesh elements and / or nodes, may be provided in some regions of the mesh 201 to resist tearing at likely anchoring points of the mesh 201 to the anatomy.

[0056] FIG. 2B depicts the selected anchoring points X of the mesh 201. The suture anchoring locations may include six locations for each of the anterior and posterior tails, three along each edge. The sacral anchor is then sutured near the sacrum, such as with two to four suture anchors (four are shown). The first arm 203 sutured to the sacrum while the second arm 205 is sutured tothe anterior / superior surface of the vaginal vault, and the third arm 207 is sutured to the posterior / inferior of the vaginal vault. The first arm 201 is likely to experience longitudinal tension 223, while each of the second and third arms 205, 207 may experience longitudinal tension 225, 227 as well as possibly lateral tension 229, 231 in relation to potential cystocele and / or rectocele.

[0057] Referring back to FIG. 2A. for example, the anchoring arm 203, for example, may comprise an anchoring region 235 at its free end 211, while the anterior and posterior arms 205, 207 may comprise reinforced lateral edge anchoring regions 237, 239 to support attachment to the exterior vaginal walls. Reinforced regions may also resist folding or twisting that may occur during the implantation or attachment procedure.

[0058] On the other hand, the non-anchoring regions or non-reinforced regions of the mesh 201 , may be configured with some elasticity and / or flexibility along its length and / or width to reduce peak tension forces acting on the anchor regions, or to otherwise facilitate redistribution of anchoring forces or tension forces within the mesh 201. The increased flexibility may aid in the delivery of the mesh 201 in limited access procedures, and / or to reduce irritation of surrounding tissues, e g., bowel structures, and therefore may reduce the risk or rate of unintended adhesions between the mesh 201 and other anatomical structures other than the sacrum and vaginal wall structure.

[0059] Referring still to FIG. 2A, in other variations, the middle mesh region 241 of the anchor arm 203 may be configured longitudinal tension filaments or elements to support the longitudinal tension that may be experienced. In the anterior and posterior arms 205, 207, for example, with ty pical suture anchoring locations and some of these primary force directions, proximal regions 243, 245 of the arms 205, 207 closer to the junction 209, respectively, may also be configured to longitudinal tension filaments or elements to support longitudinal tension, while the end regions 257, 249 of the arms 205, 207, closer to the free ends 213, 215, may be configured with both longitudinal and / or transverse tension support elements, per FIG. 2B. The orientation shown (common orientation in most of the figures included here) is of a Y-mesh with the apical tail (the part attached deep within the body, such as near the sacrum) shown at top and anterior and posterior tails at bottom. One or both of the anchoring regions and non-anchoring regions of the mesh 201 may be impregnated or infilled with therapeutic agents such as a corticosteroid or sirolimus, or bioresorbable material, such as PGA, PLGA, or collagen, for example.

[0060] In another embodiment, as shown in FIG. 3A, an alignment array 305 can be temporarily or permanently attached to a mesh (such as a Y-mesh 201 from FIG. 2A) to create an magnetic mesh or mesh assembly 301 , where the alignment array will aid in placing and / or holding the mesh in the desired location before, during and / or after its attachment to natural tissue such as the vaginal vault. The alignment array 305 is shown with a body structure 310. a plurality of magnetic-atractive-elements (MAEs) 315, and removable atachments 320. Although a single alignment body structure 310 provided in FIG. 3 A as carrier of the plurality of MAEs, in other variations, two or more separate body structures may be provided. See, for example, FIGS. 27A or 27C. FIG. 3 A shows an assembly 301 of a vaginal Y-mesh 303 with an alignment array 305. The alignment array 305 is shown with a body structure 310, a plurality of magnetic-atractive-elements (MAEs) 315, and removable attachments 320. MAEs or magnetic alignment elements may be a permanent magnet, a powered electromagnet (in the vaginal manipulator), or magnetically atractable or ferromagnetic metals, such as iron, nickel, cobalt, gadolinium, and alloys containing such ferromagnetic metals, whether in combination with other non-ferromagnetic metals or materials.

[0061] Example materials for the body structure 310 are thermoplastics, such as polyethylene, polypropylene, acetal copolymer, thermoplastic elastomer (TPE), Neoprene, acrylonitrile butadiene sty rene (ABS), polyether block amide (PEBAX®), Ultem® polyetherimide (PEI), Nylon, Nitrile, natural or other synthetic rubbers, or flexible metals such as music wire steel, 302, 316 or 321 stainless steel. Elgiloy, or nickel titanium alloy (NiTi). any of which may be coated with an outer layer such as thermoplastic or paint to prevent corrosion and / or to highlight the visibility of the body structure as a reminder to remove the alignment array at an appropriate time.

[0062] In one exemplary embodiment, the body structure includes or is atached to a long tether or flag (not shown in illustrations) that is highly visible and / or physically ataches to a structure or surgical tool.

[0063] Exemplary magnetic-atractive-elements (MAEs) are permanent magnets such as neodymium alloy (Nd2Fei4B) or ferrite, or electromagnetic coils, or magnet-atracting material (such as steel or magnetic stainless steel; more exemplary ferromagnetic stainless steel {e.g., grade 409, 430 or 439 SS } . Martensitic or Duplex stainless steel1). The MAEs may be embedded within the body structure, atached to a surface of the body structure, or captured by a shaped cavity7which is part of the body structure.

[0064] Alternatively, the body structure 310 itself may sen e as an MAE, such as if composed of 302 stainless steel, without needing additional materials. Zones of greater atraction 316 may be created by varying the width and / or thickness of the body structure 310, as illustrated in inset FIG. 3B. In this particular embodiment, the alignment body 310 may comprise a pre-formed V- shape, or otherwise have one or more pre-formed bends 318. In other variations, however, the alignment body structure 310 may comprise a pre-formed arcuate shape, or a pre-formed linear shape, or a branched shape wherein each individual MAE are connected to a hub of the body structure, rather than connected by the body structure serially. Also, in the particular exampledepicted in FIGS. 3 A and 3B, the anterior and posterior arms 320, 322 of the assembly 301 have the same number of MAEs 315 along their length and along the corresponding sections of the alignment body structure 310, but in other variations, there may be a different number of MAEs in each arm. An MAE 315 is also provided at the midline or bend 318 of the alignment body 310, which may facilitate initial centering of the assembly 301 at the apex of the vaginal vault during the implantation procedure. In other variations, however, no MAE is provided at the midline or bend of the alignment body, or in the magnetic alignment tool or vaginal manipulator described below. In some variations, eliminating of the apical MAE may reduce the risk that the MAEs of the alignment array are inadvertently attached to the MAE located on the tip of the magnetic alignment tool or vaginal manipulator.

[0065] FIG. 4 shows a cross-sectional semi-anatomic view of a handheld vaginal manipulator 401 with a handle element 403 and a vaginal probe 405; the vaginal probe has embedded MAEs 407, and is shown fully inserted into a vaginal cavity to the vaginal apex 409. A vaginal Y-mesh 410 is positioned over the vaginal vault 411, with an anterior portion of the Y-mesh 412 over the anterior portion of the vaginal vault and a posterior portion of the Y-mesh 414 over the posterior portion of the vaginal vault. An alignment array 420 with MAEs 422 is shown temporarily attached to the vaginal Y-mesh by attachments 430. The MAEs 422 in the alignment array 420 are attracted to the MAEs 407 embedded in the vaginal manipulator 401 to hold the Y-mesh in place to facilitate surgical attachment of the Y-mesh to the vaginal vault (not shown). Surgical attachment is typically done by suturing, although other anchoring or even gluing means may be performed. To facilitate the desired positioning, the configuration of MAEs 407 of the manipulator 401, e.g., the spacing between adjacent MAEs 407, are matched to the spacing of the MAEs 422 of the alignment array 420. The MAEs 407 are typically arranged such that the MAEs 407 for the anterior arm of the mesh 410 are 180 degrees opposite of the MAEs 407 for the posterior arm of the mesh 410, while lying in the same vertical or sagittal plane bisecting the manipulator 407. Visual indicia may be provided on the manipulator 401 to indicate this plane, as an indicator of the MAE rotational orientation. In other variations, the curvature of the handle 403 also lies in the same vertical or sagittal plane of the MAEs 407 and may also be used as an indicator of MAE orientation. An MAE 407 may also be provided at the distal tip of the manipulator 401, to correspond to an MAE 422 located at the midline or bend of the alignment array 420, corresponding to the junction region of the mesh 410.

[0066] The probe body 405 may comprise a compressible core, such a polymer foam or an inflatable balloon, or may comprise a rigid material, e.g., metal or plastic, materials which are naturally puncture-resistant.

[0067] The atachments 430 may be, for example, sutures or similar filaments with knots possibly including slip-knots, staples or clips, or a slip-through slot, loops, pocket or tab within the mesh. Alternate exemplary' atachments include one or more wire filaments that are woven between mesh elements to trap the alignment array into position, but can pull free without requiring any tool other than a needle grasper or a dissector. In a further embodiment, an atachment is a combination of a slot, pocket or tab with one or more wire filaments that is woven between mesh elements to trap the alignment array within the slot, pocket or tab.

[0068] FIG. 5 A shows an exemplary assembly 501 of an implantable Y-mesh 503 with an alignment array 505 atached and with an opening or space 507 configured in the Y-mesh 503 near the apex of the Y shape where the alignment array 505 passes through the Y -mesh near the junction 509 of the Y-mesh anterior portion 511, posterior portion 513 and apical tail 515. In this particular embodiment, the opening 507 is located in the apical tail 515.

[0069] FIG. 5B shows a side-view of a Y-mesh 523 and alignment array 525 loaded over a simulated vaginal vault 527 with a vaginal manipulator inside (not visible); magnets embedded within the alignment array (not shown) are atracted to magnets embedded within the manipulator (not shown), holding the mesh tightly to the surface of the vaginal vault.

[0070] FIG. 5c show s an oblique view' of a Y-mesh 543 and alignment array 545 loaded over a simulated vaginal vault 547 with a vaginal manipulator inside (not shown); the alignment array is atached to the Y-mesh with atachment(s) 546.

[0071] FIGS. 6A and 6B are exemplary view's of an implantable mesh 601 in position over a vaginal w all 602. The mesh 601 has divided anchor straps (604 and 605) at two places along the generally U-shaped vaginal vault mesh 606 where the mesh is joined by means (608 and 609) to create a modified Y-shaped mesh, providing a space 607 through which an alignment array can be loaded into position (shown elsewhere in FIGS. 5a-c). FIG. 6A shows a generally sagittal view' of the mesh loaded over a vaginal vault. FIG. 6B show's a collapsed view' with the Y-mesh 601 in a flatened state, not showing the wall thickness of the mesh but in a more simplified diagram to indicate the layering and sewn (for example) atachments 608 and 609.

[0072] An alternative arrangement for atachments is for the alignment array to have multiple MAEs at each intended zone of atraction, with the surgical mesh pinched between a pair of MAEs. The MAEs, in this exemplar}7embodiment, would atach to tabs in the structure of the alignment array that fold over the mesh so that one MAE can be on each side to pinch together and hold the mesh securely until the MAEs and the alignment array are withdrawn from the mesh. To prevent sliding of MAEs along a mesh, ribbed, pin / hole, positive / negative or high-friction surfaces may be employed on the atractive surfaces of mating MAEs.

[0073] The magnetic array is designed to attract an assembly with surgical mesh, (for example, sacrocolpopexy vaginal Y-mesh) that can be loaded onto or is provided attached to an alignment array, with magnetic components with paired geometry. An alignment array may be composed of one or more single magnets, or dual magnets, or groups of dual magnets, or likewise single, dual or groups of dual ferrous metals that can be attracted by magnets. In one example, a curvilinear array of magnetic-attraction elements (MAEs) is located spaced along the vaginal Y-mesh, with as few as two or up to six or more MAEs, aligning the Y-mesh into position over the vaginal vault with vaginal manipulator with MAEs therewithin such that the Y -mesh is held in desired location for suturing the mesh to the vaginal vault.

[0074] With this paired geometry, when the internal probe is placed within a biological structure (such as the vaginal vault) and the alignment array with mesh is placed over the biological structure, the mesh can be easily aligned with the biological structure so that it is evenly-spaced and either lies along the outer surface of the vaginal vault or lies with a predetermined looseness between nodes that allows more freedom of motion for the vaginal vault to shrink or stretch longitudinally or axially within the mesh structure if needed.

[0075] There may be one array of alignment nodes facing generally anterior (towards the front) and a second array of alignment nodes facing generally posterior (towards the back), with respect to the vaginal vault when the probe and / or the mesh is aligned in the intended position. There may be one or more nodes located to align approximately at the apex of the vaginal vault.

[0076] The strength of magnetic attraction should be sufficient to confidently hold the mesh in position before any suture is placed, including moving the vaginal vault by the internal probe including translation, rotation and / or angulation as needed to attain or verify ideal positioning. A practical range of tensile force to hold the MAEs in place is 30 to 150 grams, more preferably 50 to 100 grams. Although discrete MAEs are depicted in several exemplary embodiments herein, in other variations, flexible magnetic strips may be used on the manipulator and / or alignment array.

[0077] Exemplary magnet size for MAEs incorporated as part of the removable alignment array is 2-5mm diameter and 0.5-2.0mm thickness for neodymium magnets. More specifically, an exemplary MAE size is a round button-shaped MAE 3mm diameter x 1mm thickness. An alternate exemplary MAE size is a bar-shaped MAE 2mm x 5mm x 1mm. The complementary MAEs in the alignment array(s) and the manipulator may be selected to generate a contact force in the range of 0.05N to 1.5N, 0.1N to EON, or 0.3N to 0.6N. Actual forces may differ during actual use, due to intervening vaginal wall tissue, which may have a thickness in the range of 0.5 mm to 2 mm.

[0078] The alignment array may be composed of a variety of materials that capture and hold the MAEs at the desired spacing and angle: Thermoplastic polymer (e.g., nylon, vinyl, polyvinyl chloride (PVC), polypropylene, polyethylene terephthalate (PET), heat-shrink tubing, other... );silicone, such as liquid-injected silicone, or similar flexible material such as thermoelastic polymer (TEP); woven fibers, such as a braided mesh tube similar to a Chinese finger-trap (e.g., polypropylene, PET, nickel titanium (NiTi)). Adhesive or thermal bonding with one or more of the example materials.

[0079] In one exemplary embodiment, the alignment array may comprise a construction with one or more magnets or MAEs to one or more thin strips (for example, woven fibers, thermoplastic, or spring steel or stainless steel). Attachment to the thin strip(s) can be done with adhesive, pressure-sensitive adhesive, magnetic attraction, soldering, or the like. In a further exemplary' method, the magnets or MAEs are attached to part of a thin strip that is then folded over to sandwich the magnets or MAEs in between layers of the thin strip.

[0080] One exemplary' method of alignment array construction is to attach one or more magnets or MAEs to a thin strip (for example, woven fibers, thermoplastic, or spring steel or stainless steel) that is later encapsulated in an outer layer (such as by insert molding) or a tube (such as a woven tube). Attachment to the thin strip can be done with adhesive, pressure-sensitive adhesive, magnetic attraction, soldering, or the like. The thin strip or an outer layer may be molded with depressions or pockets into which each magnet can be slipped or snapped into place. Additional processing may further modify the shape, such as heat-forming a plastic strip or woven tube, or constricting by sewing, weaving, crocheting, or embroidering one or more filaments (such as polypropylene). In one embodiment, it is desirable that the alignment array is flexible in one preferred direction, favoring folding in the shape of a very tall and thin taco-shape, preventing or discouraging twisting.

[0081] The alignment array may be colored a hue that is highly-visible, such as yellow, as a visual aid and as a reminder if the array should be removed before completion of a surgical procedure. The alignment array may have printing, such as written instructions (e.g., “Remove after suturing mesh”) or one or more icons that convey a meaning set forth in user instructions. The alignment array, and / or one or more of its alignment nodes may be radiopaque, so that it will be visible under x-ray imaging and can be confirmed to have been removed after a procedure.

[0082] The alignment array may be secured to an implantable mesh in an easily-removable fashion, such as by one or more filaments (such as polypropylene, nylon, PTFE, stainless steel) that can be easily removed such as by pulling to unthread the array from the implantable mesh. A removable filament may be colored a hue that is highly-visible, such as yellow, as a visual aid and as a reminder to remove the filament and alignment array before completion of the surgical procedure.

[0083] A flag feature may be attached to the removable filament and / or to the alignment array as a reminder to remove the filament and alignment array before completion of the surgicalprocedure. A flag feature with filament tether may extend all the way out of the body through a cannula, catheter or tube, as a visual aid and as a reminder to remove the filament and alignment array before completion of the surgical procedure.

[0084] A portion of a securement tether may be attached to the body of the alignment array to facilitate retention (not becoming lost within the abdominal cavity) and removal from the body. In one example, a cut-resistant tether such as braided stainless steel or one or several polymer filaments attaches at one end to the alignment array and at the other end to a flag or anchor outside the body. In a further embodiment, simply pulling the tether is sufficient to pull the alignment array through a cannula (tube structure) without requiring the alignment array to be carefully- placed in alignment with the cannula; in this embodiment, the alignment array and its connection to the tether is smooth, resistant to kinking, and has a tendency to self-direct into the cannula as pulled, such as by smooth bending transitions and tapered edge-free transitions.

[0085] In one exemplar,- method, a vaginal probe is placed within a vaginal vault and pushed or extended forward towards the vaginal apex. The vaginal probe is held in rotational alignment with the vaginal vault so that magnetic attractive elements face in a desired direction (e g., anterior and / or posterior). A vaginal mesh is either provided pre-attached to an alignment array, or the mesh is removably attached to an alignment array by the user, such as by stapling, suturing, clamping, or by slipping at least a portion of the array into a cavity or feature on the mesh that allows engagement of the array to prevent it from accidentally slipping free while also allowing the user to remove the array at a later chosen time. The vaginal mesh is inserted into the body through a tube such as used for a laparoscopic-surgery- port cannula while the mesh is attached to an alignment array. The vaginal mesh is placed over the vaginal vault in approximate alignment along the outer surface of the vaginal vault so the vaginal mesh is approximately co-linear with the central axis of the vaginal vault. An interaction force between magnetic-attracted elements on the alignment array and the vaginal manipulator causes the mesh to be held in place in the desired alignment. While the mesh is held in place by the alignment array, a user attaches the mesh to the wall of the vaginal vault (for example, by sutures, by staples, by self-expanding anchors, by adhesive, or the like). Once the vaginal mesh is sufficiently attached to prevent movement out of the intended position, the alignment array is removed from the mesh (for example, by removing a temporary- suture, clip or other attachment, or by slipping at least a portion of the alignment array- out of a cavity or feature on the mesh) and the alignment array is removed from the body.

[0086] In a further method embodiment, a user counts magnets on an alignment array after removal from the body to ensure no magnets are left within the body. In an alternate further method embodiment, the removed alignment array is placed into a capture package that has indicators that visibly validate that the correct number of magnets have been recovered, such as with cantileveredMAEs built into the capture package with spring-biased indicators that shows no magnets are left unaccounted for.

[0087] In a further exemplary method as described previously, the magnetic-attractive force between the mesh alignment array and the vaginal probe causes an anterior vagina portion of the mesh to be aligned over the anterior portion of the vaginal vault and a posterior vagina portion of the mesh to be aligned over the posterior portion of the vaginal vault.

[0088] In a further exemplary method as described previously, the magnetic-attractive force between the mesh alignment array and the vaginal probe causes an apical vagina portion of the mesh to be aligned over the apex of the vaginal vault. In other variants, however, the MAE in the midline of the alignment array, and the corresponding MAE at the distal tip of the manipulator, is not provided, so complementary MAEs on the alignment array and the manipulator are only provided on the alignment array in regions corresponding to the anterior and posterior arms of the mesh, and at or adjacent to the junction of the Y-mesh.

[0089] In an alternate further exemplary method, the magnetic-attractive force causes an apical vagina portion of the mesh to be aligned above the apex of the vaginal vault, leaving a space near the apex of the vaginal vault so that mesh material does not directly contact the apex of the vaginal vault but instead creates a space betw een the apex of the vaginal vault and the apex portion of the Y-mesh.

[0090] In one example, an alignment array system can be applied to a mesh by temporarily affixing the mesh by7one or more pairs of array nodes that can be magnetically^ attracted to one another, such as by sandwiching the mesh between array node pairs. In this way, the benefit of an alignment array can be applied to a variety of meshes provided by a variety of manufacturers.

[0091] In one exemplary method, a user temporarily attaches a magnetic alignment array to a surgical mesh before inserting the mesh into a patient’s body. The user then uses an alignment probe that magnetically-attracts to the alignment array to place and hold the mesh in a desired position during suturing of the mesh to the patient.

[0092] In one exemplary method, a user temporarily attaches a magnetic alignment array to a surgical mesh after inserting the surgical mesh into a patient’s body. The user then uses an alignment probe that magnetically-attracts to the alignment array to place and hold the mesh in a desired position during suturing of the mesh to the patient.

[0093] In an alternate exemplary method, a user separately introduces into the body a surgical mesh and one or more alignment arrays, and then the mesh is placed into position along the vaginal vault and one or more alignment arrays are placed over the mesh (attracted to MEAs incorporated into a vaginal probe) to temporarily hold it in place while the mesh is permanently attached to thevaginal vault, after which the alignment arrays are removed from their position and removed from the body.

[0094] In a further exemplary' method, for an abdominal surgical procedure (such as hernia repair) where a generally square or rectangular mesh is to be placed, a magnetic alignment array or a spring-force flattening alignment array is temporarily attached to a surgical mesh that is implanted in the body by suturing, adhesive, or other tacking methods while being held by the array, and then the array is removed after all or part of the implantation is complete.

[0095] In one example, an alignment array is permanently secured to a surgical mesh so that magnetic-attracting forces will hold the mesh into position while the mesh is attached to the intended body structure such as by suturing, stapling, anchoring or by adhesive bonding. For permanent implantation, however, it may be strongly desirable that magnetic-attractive features avoid generating significant forces when a patient is later imaged by magnetic resonance imaging (MRI).

[0096] In one example where there is interaction between an alignment array and a surgical probe (such as a vaginal manipulator), the probe may allow the distancing of alignment nodes to be adjustable by the user, such as moving part of or the full array of nodes towards or away from the tip of the probe. A screw-driven alignment assembly can accomplish that motion, for example.

[0097] A removable alignment array may have a grab-pad or handle (for example an open ring) at one or both ends (and / or at the midpoint, and / or along its length) to aid in retrieval and removal through a laparoscopic-surgery' cannula when it’s use has been completed.

[0098] A pusher / puller feature (such as an elongated stick) may affix temporarily onto an alignment array to facilitate loading of the apparatus through a tube such as a laparoscopic-surgery’ cannula. A pusher / puller may then be detached or cut free once the alignment array is in the location for use within the patient (such as within the abdomen).

[0099] An alignment array and surgical mesh may be pre-packaged loaded into a tube for easy insertion through a laparoscope cannula. Alternatively, a user may load the alignment array into a tube for easy insertion. The loading tube may be configured similar to a syringe, with a pusher that pushes the alignment array out of an open end of the loading tube. The loading tube may be quickly dissolvable in body-compatible fluid such as saline.

[0100] In order to facilitate ideal placement of an alignment array without mis-shaping of the mesh or the array, a vaginal mesh may have a design feature to facilitate placement of the alignment array, such as a pass-through hole or space 507 and 607 at or near the apex connection of mesh arms. The pass-through hole may be created by enlarging or creating an opening in the mesh along approximately the centerline of the mesh. Alternatively, the hole or space may be created by attaching a divided mesh anchor strap at two places along the vaginal vault mesh wherea Y-mesh is joined as a Y, as shown in Figures 6A and 6B. The multiple anchor strap atachments may be on opposite sides of, or the same side of, a vaginal vault mesh fold intended to lie at or near the apex of the vaginal vault when surgically atached.

[0101] In some variations, a shield may be used as a puncture-resistant surface covering a compressible core vaginal manipulator, to prevent or reduce the likelihood during the suturing of the mesh to the vaginal wall from accidentally suturing the mesh / wall to the vaginal manipulator. FIGS. 7A and 7B show an insertable portion of a vaginal probe 705 with MAEs 707 and a semirigid shield 708 folded over either side of an inflatable balloon 750.

[0102] FIGS. 8A and 8B show an insertable portion of a vaginal probe 805 with MAEs 807 and a flexible wrap-around shield 808 over a compressible element 850 which is in turn over a rigid support element 803 (shown only in FIG. 8A). FIG. 8B shows details of tabs 810 and slots 812 as part of shield 808.

[0103] FIG. 8C shows an exemplar,' cut patern for a flexible wrap-around shield 808 in flatened configuration, with tabs 810 and slots 812, as well as MAE atachment regions 897 and potential suturing regions 899.

[0104] As previously noted, the alignment array is flexible but may comprise a linear or nonlinear pre-formed shape, e.g., it may be shaped to curve around one side of a ty pical shape vaginal Y-mesh near the apex so that it does not tend to deflect portions of the mesh from the intended final sutured position. FIG. 9 illustrates the curves around the side near the apex. FIG. 9 shows an assembly 1001 of a vaginal Y-mesh 1003 with an alignment array 1005. The alignment array 1005 is shown with a body structure 1010, and a plurality of magnetic-atractive-elements (MAEs) 1015, and removable atachments (not shown). FIG. 9 also shows the alignment array shaped to curve around one side of a typical shape vaginal Y-mesh near the apex so that it does not tend to deflect or wrinkle portions of the mesh from the intended final sutured position.

[0105] A plurality of alignment arrays may be used, such as one alignment array along the anterior portion of a mesh along the anterior portion of the vaginal vault and another alignment array along the posterior portion of a mesh along the posterior portion of the vaginal vault, as illustrated in FIG. 10. The number of MAEs for each alignment array may be as few as one (1) and as many as ten (10) or more, more preferably two (2) or three (3). FIG. 10 shows an assembly 1101 of a vaginal Y-mesh 1103 with two temporarily-atached alignment arrays 1105 and 1106, one on the anterior side and the other on the posterior side, each including a body structure, 1110 and 1111, and a plurality of magnetic-atractive-elements (MAEs) 1115 and 1116. with three MAE for each anterior and posterior arm.

[0106] FIG. 11 shows an assembly 1201 of a stent-like structural wireform alignment array 1205, loaded over a vaginal Y-mesh 1203 that is positioned over a vaginal vault 1211. Thealignment array 1205 is shown with a body structure 1210, and a plurality of magnetic-attractive- elements (MAEs) 121 , and removable attachments, not shown.

[0107] FIG. 12 shows part of the insertable portion of a vaginal manipulator 1301 with lightemitting surfaces 1305 that indicate where magnetic-attractive elements 1315 are embedded near the surface of the vaginal manipulator.

[0108] FIG. 13 show s a semi-orthogonal view' of a vaginal manipulator 1501 with an insertable portion 1503 and a handle portion 1505. The insertable portion has a trans-imaging tip with visible lines of different thicknesses, with thicker lines 1510 and thinner lines 1520 shown.

[0109] A plurality of implantable meshes may be used, such as one mesh used along the anterior portion of the vaginal vault and another mesh used along the posterior portion of the vaginal vault. The two meshes, in this example, may be gathered and attached to each other near the vaginal apex or between the vaginal apex and a sacral or other distal (farther from the vaginal apex) attachment site. Alternatively, the two meshes may be separately attached to a sacral or similar distal attachment site. If a plurality of meshes are used, a single alignment array or a plurality of alignment arrays may be used to assist in holding the meshes in position before and during securement to the vaginal tissue.

[0110] The alignment array may be non-magnetic, with a structural wireform (such as NiTi or stainless steel) or structural plastic attached to a Y-mesh that holds the Y-mesh into a generally tubular-formed structure that can be slipped over the vaginal vault and that will hold a proper position until the mesh can be sutured correctly in place, depicted in FIG. 11. Once the mesh is sutured or otherwise attached to the vaginal vault so that the mesh position will reliably be maintained, the attachment(s) between the alignment array and the mesh can be removed by the user and the alignment array removed from the patient. This concept has an advantage that no specific magnetic-attractive elements need to be included in a vaginal manipulator, and one of a variety of vaginal manipulator shapes may be usable in the procedure.[OHl] One or more embedded lights (such as LED or OLED lights, or light fibers, or bioluminescence or glow -in-the-dark materials) may be incorporated into a surgical probe (such as a vaginal manipulator) so that the light will transilluminate and be visible through the vaginal wall thickness (typically 1.5-3.0mm, more broadly 0.5-5.0mm) so as to give a visual indication of the depth of tissues overlying the probe during tissue dissection, as well as to facilitate visualization of probe alignment or orientation within the body.

[0112] A vaginal probe may have a visible illuminated pattern on the surface of the probe, such as a grid of thicker and / or thinner dark lines against a field of illumination, can provide a measurement indication based on how' clearly the pattern can be discerned from outside the vaginal vault. One example of such alignment is rotational alignment of the probe with the vaginal vaultbefore a mesh and alignment array are loaded into place over the probe within the vaginal vault. Lights may be powered by a battery, such as a button-cell battery, or an external power source as is well-known in the art.

[0113] In one example, a surgical probe employs optically clear materials as a light-pipe to distribute light along a structure or pattern along the surface of the probe. An opaque portion of the probe materials differentiates the lighted portions of the surface from relatively dark portions. One or more LED lights within the structure can provide the illumination to enter the light-pipe matrix. In another example, a thin OLED sticker or film is adhered to the outside of the surgical probe or contained under a clear surface of the surgical probe.

[0114] In an exemplary method, a user places a vaginal probe containing a light source, or light distribution, inside a vaginal vault of a patient and illumination is initiated. The user employs laparoscopic tools to approach the vaginal vault from outside, generally within the abdomen, with a goal of dissecting away surrounding tissues (including the urinary bladder and the rectum) to separate the vaginal vault such as to prepare for mesh implantation as part of a sacrocolpopexy procedure, where it is important not to cut or dissect too deeply and cause an opening into the vaginal vault. During dissection, the user is guided by the directional source and intensity of light coming from the interior surface of the vaginal vault, determining how aggressively or carefully they may cut or dissect as they near the surface of the vaginal vault. In a further method embodiment, the light illumination is highlighted by pulsing or changing between illumination and non-illumination.

[0115] In a further exemplary' method, a user places a vaginal probe with illumination and a pattern of coarse and fine features (such as a gridwork composed of thick lines and thin lines) so that when dissecting laparoscopically from outside the vaginal vault the user can sense the thickness of tissue between their direct view and the interior surface of the vaginal vault by comparing the visible fidelity' of the grid pattern; in this case, with thicker tissues only the thicker lines of the probe will be visible and with thinner tissues the thinner lines will also be visible.

[0116] A surgical probe may be single-use. including the insertable probe and the handle structure, or the surgical probe may have a reusable and steam-sterilizable handle portion (of durable material such as stainless steel or polycarbonate) that connects with a single-use bodyinsertion portion (such as Polyoxymethylene POM-H, HDPE, Nylon, polycarbonate, or the like).

[0117] In one exemplary method, a surgical probe with magnets, transillumination, or both, is a reusable assembly that is covered with a disposable thin transparent sterile sleeve for each procedure.

[0118] One example of embedded lights is to indicate to the user where one or more magnetic- attractive elements are along the surgical probe, to facilitate proper placement of an alignment array over the probe within the body. See FIG. 13, for example.

[0119] One of more embedded lights may be incorporated into an internal probe as an array of indicators suggesting where to locate sutures affixing a mesh to body structures, such as suturing a vaginal mesh to the vaginal vault.

[0120] In one example, suture-location lights may be a different shape or color (or pattern of relative darkness) to rotational alignment lights to distinguish their purpose. In an alternative example, an array of suture-location lights may also serve as rotational alignment lights.

[0121] Needle-guide features

[0122] One or more locations along a mesh alignment array may include shaped features as a needle-guide to facilitate near-but-not-fully-through-thickness penetration of a suture needle within the wall of the vaginal vault (recall that vaginal wall thickness varies considerably; typically 1.5 mm-3.0 mm. more broadly 0.5 mm-5.0 mm). Such shaped feature can take advantage of the known relational geometry between the alignment array shaped feature and the surface of the internal probe. One example of a needle guide is a curved channel that matches the needle curvature and guides the tip of the needle to the desired curved penetration path of the needle through the vaginal vault tissue.

[0123] A method of placing an internal probe with an array of magnetic or ferritic nodes, where the probe is placed through the vaginal opening and directed inside the vaginal vault. The probe is moved to align the probe and array rotationally and axially with the vaginal vault. In one exemplary7alignment, the probe is inserted fully to the apex of the vaginal vault, with one array of alignment nodes facing generally frontally and a second array of alignment nodes facing generally dorsally. Continuing this method, a surgical mesh structure paired with an alignment array is then inserted into the abdomen, such as by laparoscopic techniques. The mesh structure is paired with the alignment array (or the two come pre-assembled, or the two are assembled outside the body) and the assembly is loaded over the vaginal vault with the corresponding alignment nodes and probe nodes paired against each other trapping the thickness of the vaginal vault therebetween. Sutures are placed to affix the mesh to the vaginal vault in multiple locations, which may be guided by lights or physical features of the probe or alignment array. The alignment array is then removed from its attachment with the mesh, and the alignment array is removed by laparoscopic or surgical procedure means. A portion of the mesh (typically the tail end of the Y) can then be sutured or attached to an anchor structure within the body, as is well-known in the surgical art of sacrocolpopexy, such as attachment to or near the sacrum or to a sacral ligament. The probe is then removed.

[0124] Rotational alignment in the previous method may be guided by transillumination of light-emitting features incorporated into or attached to the probe. Alternatively, rotational alignment may be guided by external features or markings that are visible on the portion of the probe that does not enter the vagina, such as a handle or mounting structure; for example, an external probe handle may have a distinguishing feature such as a line that is intended to face patient-anterior (e.g., facing the same direction as the patient’s belly-button).

[0125] Some examples of combinations of features:

[0126] A vaginal manipulator with one or more protruding needles or with passage for one or more protruding needles for tissue hydrodissection, that also has light illumination (with full-body illumination, partial-body illumination, or a lighted ring, lines or grid pattern) such as by fiber optic, LED or OLED light sources, to aid surgical dissection.

[0127] A vaginal manipulator with needles or needle passages for hydrodissection, that also has magnets for interaction with a mesh alignment array.

[0128] A vaginal manipulator with illumination and with magnets.

[0129] A vaginal manipulator with illumination, with needles or needle passages, and with magnets.

[0130] A portion of the implant may have a surface or a textile addition that promotes tissue ingrowth and increases the final anchoring support force. This is well known in the art of mesh, but for a non-mesh tether such as a thick monofilament there can be additional texture added by spun fiber deposition, heat-stamping with a textured die, or overwrapping or braiding with an additional layer or layers of thinner fibers to form a textured surface.

[0131] Variations on surgical mesh design

[0132] Surgical mesh has long been used in pelvic suspension procedures, and a typical Y-mesh is shown in FIG. IB with its typical surgical implantation shown in FIG. 1C. The mesh material is frequently composed of polypropylene monofilament woven into a macro pattern, with small pore sizes between the woven fibers and much larger openings making up the macro porous pattern such as a grid of mostly square openings.

[0133] In one exemplary surgical procedure, sacrocolpopexy, the mesh is wrapped along the wall of the vagina (making up the vaginal vault) with an anterior portion in the front nearer the urinary bladder, a posterior portion in the back nearer the rectum, and an apical tail portion that is anchored deeper within the patient’s body such as near the sacrum at the base of the spine.

[0134] It may be useful to consider the primary force vectors involved in what the mesh is surgically implanted to accomplish.

[0135] The anterior and posterior mesh portions serve to anchor the mesh to hold the vaginal vault, allowing it to be pulled back into a desirable position instead of allowing prolapse where thevaginal vault falls downward. Because the vaginal wall is often thin (often as thin as two millimeters), the mesh is used to bulk up the reduced tensile support of the natural vaginal wall tissue. In regard to the pulling (tensile forces) into position of the vaginal vault, the mostly vertical arrowed lines show the tension supported between the suture anchor locations and the anchor near the sacrum.

[0136] An additional potential factor for many patients is the repair or prevention of cystocele (urinary bladder protruding into the space normally reserved for the vaginal vault) and / or rectocele (rectum protruding into the space normally reserved for the vaginal vault). The mostly horizontal arrowed lines show the circumferential tension supported between the suture anchor locations along the right and left edges of the mesh.

[0137] A typical surgical mesh, such as a mesh used for sacrocolpopexy, has a repeating arrangement of open cells, very often of generally square shape (as indicated in FIG. 44a). These meshes often have the same tensile properties in both directions (e.g., vertical and horizontal). This is not optimized for the true physiologic needs for tissue support in the body, however.

[0138] Once the mesh has been surgically implanted, natural tissue grows into the openings of the mesh and effectively locks the mesh into direct contact with that tissue. This can cause a naturally flexible and stretchy vaginal wall to become much more rigid and no longer allowed to be as compliant (flexible and / or stretchy). Furthermore, the length of the vaginal canal is often shortened as compared with before the implantation, and this can lead to patient discomfort upon sex or other complaints regarding pain or tenderness.

[0139] One concept introduced here is to vary the properties of a mesh-like construct and / or tether to place the tensile support primarily (or only) where needed and allow body tissues to remain more naturally compliant.

[0140] A variety of possible tissue attachment suture zones may be provided, allowing strong contact with the directional force lines, providing a sizeable anchoring location for the surgeon to suture (or otherwise anchor, such as with clips or adhesive) through, and facilitating tissue ingrowth to further increase the attachment to patient tissue.

[0141] As noted previously, in some variations, the intended suture locations of the mesh may not be structurally different or otherwise have a different mesh pattern compared to other regions of the mesh. In other variations, such as that depicted in FIG 14, pre-formed openings 1402, which are larger than the mesh openings 1404 of the main mesh structure 1406. may be provided in the mesh 1400. The perimeter of the openings 1402 may or may not be reinforced, by rings or frames, or via polymer melting, when forming or enlarging the openings 1402. In other variations, retention pockets or retention loops or openings may also be provided in the mesh for releasably retaining the alignment structure. Coupled to each opening 1402 of mesh 1400 are tension linesor support filaments 1408 located in the anterior and posterior arms 1410, 1412 of the mesh 1400 are attached to or terminated at the pre-formed suture openings 1402 of those arms and have a linear orientation that is different from the longitudinal 1414 and transverse 1416 filaments of the mesh pattern of the mesh 1400. The support filaments 1408 converge at a first location or end 1418 of a longitudinal backbone support segment 1422 in the anchor arm 1420. This support segment 1422 may comprise the same support filaments 1708, but may be heat melted, adhered or otherwise bundled together. At the other end of the backbone support 1422, support filaments 1424 may be attached to suture openings 1426 in the anchoring arm 1420 and like the support filaments 1408 of the anterior and posterior arms 1412, 1414, the support filaments 1424 have an orientation that is different from the longitudinal and transverse filaments 1414, 1416 of the mesh pattern 1406 of the mesh 1400, and converge at second location 1428 of the longitudinal backbone support segment 1420. In other variations, the end 1418 of the backbone segment 1422 may be located in the anterior 1410 or posterior 1412 segments, e.g. the tension lines 1408 of each arm 1410. 1412 may converge first in their respective arms 1410, 1412, then converge with the tension lines 1408 of the other arm in the anchor arm 1420. In some variations, the backbone support segment 1422 may comprise tension lines that run uninterrupted from the suture sites or suture openings 1402 of the anterior and posterior arms 1410, 1412 to the suture sites or suture openings 1426 in the anchor arm 1420, e.g. each contiguous tension line comprises a tension line segment 1408 in the anterior or posterior arms 1410, 1412, a backbone segment 1422, and a tension line segment 1424 located in the anchor arm 1420. Because the total number of suture sites or suture openings 1402 in the anterior and posterior arms 1410, 1412 may be different than the total number of suture sites or suture openings 1426 in the anchor arm 1420, some suture openings 1424 in the anchor arm 1420 may have more than one support filament 1424 coupled to it. In other variation, where there are a greater number of suture openings in the anterior and posterior arms 1410, 1412 compared to the anchor arm 1420, some filaments may terminate in the backbone support segment 1422, but are bonded or attached to other filaments. In still other variations, the tension lines may comprise a subset of a multi-filament line of the backbone.

[0142] In other embodiments of a mesh, the suture or tissue attachment sites or openings may comprise a thickened, reinforced opening, or have other geometric configurations to facilitate stable tissue attachment via sutures, tissue anchors, staples, bioadhesive and the like. Non-limiting examples ofthe tissue attachment sites are depicted in FIGS. 15Ato 15H. Each of these exemplary- tissue attachment structures 1500A to 1500H are depicted with a single tension line 1502A to 1502H connecting the body 1504A to 1504H of the suture attachment extension structures 1500A to 1500H, but in other variations, the connector may comprise multiple lines, or a connecting ribbon to provide greater tension support. These tissue attachment structures 1500A to 1500H maybe embedded or integrally formed in the main repeating mesh pattern of the mesh, or may be heat or adhesive bonded to the main repeating mesh pattern of the mesh. In some variations, only the tension lines 1502A to 1502H of the tissue attachment structures 1500A to 1500H are bonded or attached to the mesh, while the tissue attachment body 1504A to 1504H may be a movable flaplike structure of the mesh.

[0143] FIG. 15A depicts a tissue attachment body 1504A that has a similar grid-like structure as the main repeating mesh pattern of the Y-mesh, but may comprise thicker linear elements 1506 A or nodes 1508A in a square region, or comprise a reinforcement coating of the elements 1506A, nodes 1508A or openings 1510A, of the same or different material as the main repeating mesh pattern. In other variations, however, the grid may comprise larger openings or smaller openings than the main repeating mesh pattern. In FIG. 15B, the tissue attachment body 1504B comprises a series of concentric reinforcement circles 1506B that are interconnected via radial elements or struts 1508B. FIG. 15C depicts a tissue attachment body 1504C comprising a single reinforcement aperture or circle 1506C. where the aperture 1506C is larger than the openings of the mesh pattern. FIG. 15D depicts a tissue attachment body 1504D with a fan-shaped series of struts 1506D arranged from their connection to their common tension lines 1502D. FIG. 15E depicts a tissue attachment body 1504E comprising a group of reinforcement apertures or circles 1506E that are arranged such that each reinforcement aperture or circle 1506E abuts the other apertures or circles 1506E, but only one of the aperture or circles 1506E is directly attached to the tension line 1502E. In FIG. 15F, the tissue attachment body 1504F also contains a group of larger reinforcement apertures 1506F, where each reinforcement circle 1506F abuts the other apertures 1506F, but where these larger reinforcement apertures 1506F are surround by a single layer of smaller reinforcement apertures 1508F, wherein each smaller reinforcement apertures 1508F is in direct contact with two other smaller reinforcement apertures 1508F, and one or two of the larger reinforcement apertures 1506F. The smaller apertures 1508F may be the same size or larger than the openings of the mesh pattern. In this particular example, the tension lines 1502F may be characterized as connecting to two adjacent smaller reinforcement apertures 1508F and / or one of the larger reinforcement apertures 1506F. In FIG. 15G, the tissue attachment body 1504G comprises a plurality of smaller apertures of circles 1506G arranged in serial or linear groups 1508G in a radial pattern, with transverse elements or struts 1510G coupling some the apertures 1506G between some the serial or linear groups 1508G. FIG. 15H depicts a tissue attachment body 1504H comprising a rectangular body 1506H with a triangular head or tapered end 1508H that is attached to the tension line 1502H. rectangular body 1506H, like the tissue attachment body 1504A, may have a similar grid-like structure as the main repeating mesh pattern of the Y-mesh, but may comprise thicker linear elements or nodes, or comprise a reinforcement coating of theelements, nodes or openings, of the same or different material as the main repeating mesh pattern. In other variations, however, the grid may comprise larger openings or smaller openings than the main repeating mesh pattern. The tapered head 1508H may comprise longitudinal elements 1510H that taper or angle toward its tension lines 1502H, rather than maintain an orthogonal relationship with the transverse elements of the tissue attachment body 1506H.

[0144] With increased strength along the directional force lines, the shape of the mesh body can be narrowed, especially for the apical tail portion of the implant. This has a benefit of reducing edge contact with the nearby bowel where the tail of the implant crosses from the apex (deepest end) of the vagina to the anchor site near the sacrum. The mesh-like webbing can be completely bioresorbable.

[0145] FIG. 16 shows a schematic representation of a multi-layered mesh 1600, where stronger lines or filaments of support 1602 are show n more directly between tissue attachment suture zones 1604 and anchor suture zones 1606. These support filaments 1602 or lines may comprise a stronger non-elastic but flexible material than the primary mesh material 1608, and may or may not comprise a larger cross-sectional area compared to the filaments or elements of the primary mesh material 1608. The support filaments 1602 may comprise segments that have an orientation that is different than the repeating mesh pattern of the mesh, e.g. different from the orthogonal longitudinal and transverse filaments forming the primary mesh pattern. Because of the ability of the support filaments 1602 to withstand the tension forces acting on the mesh 1600, the anchor portion 1610 of the mesh 1600 may be configured with a narrower width, e.g. a narrow ribbon neck region 1612 and a larger width head region 1614. The ratio between the neck width and head width may be in the range of 1:2 to 1:4, 1: 1.1 to 1:3, 1: 1.5 to 1:2, or 1 : 1.5 to 1:3, for example. In this concept, a mesh-like base layer can have stronger directional force lines of material attached (e.g., woven, crocheted, or adhered) to the base layer are much more directly in line with the force requirements than occurs with standard mesh. The mesh-like base layer may be composed of permanent implant material (e.g., polypropylene, polyester, low density polyethylene (LDPE), ultra high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), polyester, Nylon), of a bioresorbable material (PLA, PGA, PGLA or the like), or of a combination of permanent and bioresorbable materials. The directional force lines may be composed of monofilament, braided cords, braided tapes, braid-like crochet features or the like.

[0146] Thickness of material fibers, such as described above, can be in the range of 0.003" to 0.015” (more preferably in the range of 0.004” to 0.008”) for monofilaments, and in the range of 0.010” to 0.050” (more preferably in the range of 0.013” to 0.026”) for braided constructs. Densities of mesh-like constructs may be in the range of 5 to 150 grams per meter-squared (g / m2), more preferably in the range of 5 to 100 g / m2, more preferably in the range of 10 to 50 g / m2.

[0147] Pore sizes for woven and / or perforated pattems / constructs can be in the range of 0.5 to 3.0 mm. Pore sizes can be more preferably in the range of 1.0 to 2.0 mm. Pores may be symmetric or asymmetric.

[0148] Composite felt-like fabric can be obtained with deposition of material at lower densities along the mesh-like body of the implant material and at greater densities along the directional force lines.

[0149] In one embodiment, as depicted in FIG. 17, the support structure 1700 is depicted without the Y-mesh and with only the anterior arm support structures 1702 shown (the posterior arm support structures would have a similar structure as the anterior support structures). The forces acting on the support structure 1700 is minimized to essentially the combination of directional force lines and tissue-attachment anchors. This embodiment would give support to pull the vaginal vault into position and prevent prolapse, but it may not give support preventing cystocele or rectocele (such support could be added by the surgeon with one or more separate pieces of mesh sutured into place before or after this construct). Although the backbone section 1704 depicted in FIG. 17 comprises braided filaments from the non-braided filaments from each of the attachment structures, in other variations, the backbone section may be monofilament or heat melted, or may comprise a ribbon or tape-like structure. In still other variations, the tension support filaments or elements may comprise a multi-cell or ladder-like structure, as depicted in FIGS. 18A to 18D.

[0150] One embodiment of a tensile element usable for directional force lines is a ladder-like structure with repeated openings along its length, such as shown in FIG. 18A to 18C. It is hypothesized that a ladder-like or lattice-like elongate support structure may have an adjustable length or otherwise have an overall elastic property without the filaments forming the ladder-like or lattice-like structure being elastic itself. In an example method embodiment, a ladder-like structure can be shortened by suturing two open cells (nearly adjacent, or several or many cells apart) together. This is exemplified in FIG. 18 A where open cells 4 and 9 are sutured together and the resulting tensile length is reduced from 12 cells (1-12) to 8 cells (1-4 and 9-12). as depicted in FIG. 18B. The ladder-like structure may comprise a quasilinear repeating series of openings, as depicted in exemplary configurations in FIGS. 18C and 18D. In a further method embodiment, a mesh or tether implant is surgically attached to patient anatomy (such as a vaginal vault) and then the implant is interrogated to determine if there is near-uniform tension as desired or if there are slack areas where the ladder-like structure is too long: if a length of ladder-like structure is found that the user would like to shorten, the user can pass suture through two or more open cells and temporarily tighten the suture to determine if that suture w hen knotted will created the desired reduction in length; the user can then adjust by selecting open cells closer together or farther apartbefore permanently knoting the suture to create the final length of the ladder-like structure. A similar method can be employed to shorten the structure in steps, with two or more suture-knot combinations.

[0151] Typical vaginal vault meshes are composed of nearly orthogonal lines (at right angles to each other), as shown in FIG. 19A. FIGS. 19B to 19M schematically depict alternative circumferential support paterns, and other paterns of openings that can be used create a meshlike construct but that in some cases can allow more compliance in one or more directions. Openings as features depicted in FIGS. 19A to 19M can be created by a woven patern with fiber filaments, by laser- or die-cuting from a thin film, or by a combination of those methods. Specifically, FIG. 19A schematically depicts a typical woven mesh construct of equal -strength w oven multi -filament tensile elements generally criss-crossing at 90-degree angles. In other variations, the mesh may be formed by electrospinning. FIGS. 19B to 19E schematically depict several additional reinforcement paterns that can be added to a more general mesh background. In FIG. 19B, nodes may be connected with transverse elongate elements but may be repeated at other orientations to form the mesh. In FIG. 19C, a serpentine or undulating lines. In FIG. 19D, multiple undulating lines of similar amplitude and frequency may be offset and joined to form the mesh, though in other variations, undulating lines with different amplitude and / or frequency may be used. FIG. 19E depicts multiple discrete oval rings that may be aggregated to form the mesh. FIGS. 19F schematically depicts a typical woven mesh construct of equal-strength woven multifilament tensile elements generally criss-crossing at 90-degree angles, as also shown in FIG. 19A. FIGS. 19G to 19M schematically depict a variety7of paterns that can be (e.g., laser) cut into a thin material sheet or tube structure to create an open pattern suitable for bearing force at a variety of directions while also allowing tissue ingrowth. FIG. 19G depicts a variety- of non-uniform or irregularly shaped openings, while FIG. 19H depicts a grid-like arrangement of openings, but yvherein the struts forming the openings are thicker than in typical grid-like meshes. FIG. 191 depicts a mesh structure comprising non-orthogonally transverse and longitudinal elements. FIG. 19J depicts a mesh material with rounded comer square openings, yvhile FIG. 19K depicts a hexagonal or honeycomb shaped mesh. FIG. 19L depicts a trilobe opening mesh. FIG. 19M schematically depicts a mesh-like cut construct yvith variable pore size, with larger openings as shown at left and smaller openings as shoyvn at right.

[0152] Another embodiment has a variable material makeup in a mesh-like patern, such as where generally horizontal elements are different from generally vertical elements. This is exemplified in FIGS. 20A to 20E, yvhere the different directions can be made of thicker and thinner materials, monofilament and w oven filaments, woven filaments with denser and looser structure, woven filaments with tensile (straight) or springy open cells, permanent or bioresorbable fibers,or any combination of the above. This includes thicker or stronger fibers in FIGS. 20 A, 20C and 20E, and thinner or weaker fibers in FIGS. 20B and 20D. These examples exemplify the variable properties of multi-fiber weaving, with a greater number of fibers, and / or thicker fibers, as woven to form the one subset of filaments, e.g. longitudinal filaments, and a lesser number of fibers, and / or thinner fibers, in the other subset of filaments, e.g. transverse filaments. FIG. 20A depicts a mesh wherein one subset of filaments is thicker than the other. FIG. 20B depicts a mesh w herein one subset of filaments comprises a braided or woven filament, and the other subset is monofilament or otherwise non-braided or non-woven. FIG. 20C depicts a mesh comprising one subset of filaments that is relatively tightly braided while the other is loosely braided. This mesh arrangement may provide greater elongation of the mesh along the orientation of the loosely braided subset of filaments. FIG. 20D illustrates a mesh comprising a thinner braided or w o ven subset of filaments and a thicker braided w oven subset of filaments. FIG. 20E depicts a variation of the mesh in FIG. 20C, wherein a third subset of non-braided or non-woven filament is provided in the same orientation as one of the other subsets, e.g. the loosely braided subset. In some variants, the third subset of non-braided filament may act as a strain limiter for the loosely braided subset of filaments.

[0153] In one concept embodiment, a repeating serpentine pattern (see FIGS. 21A to 21D) of stronger filaments is woven or attached to a weaker, more flexible, or bioresorbable network of lines or generally mesh-like matrix material. The serpentine stronger filaments are intended to provide circumferential (or otherwise tensile) support to prevent cystocele and / or rectocele, while allowing lengthwise compliance of the vaginal vault. In FIG.21A, the serpentine pattern has a uniform amplitude and frequency across the transverse filaments 2104. and comprises parallel filaments 2100 between the filament loops 2102. In contrast to FIG. 2 IB. the serpentine filaments 2110 comprise a non-parallel arrangement between its loops 21 12. The angle from the parallel orientation may be in the range of 1 to 60 degrees, 2 to 30 degrees, 2 to 10 degrees, or 2 to 5 degrees, for example, FIGS. 21C and 21D depict non-parallel serpentine filaments 2120 and 2130 with a relatively greater angle and smaller angle, respectively. In one particular embodiment, the repeating serpentine pattern is composed of braided or woven polypropylene or polyester fibers.

[0154] In an alternate concept embodiment, a repeating serpentine pattern of structural elements provides a generally horizontal support structure such as to resist against cystocele or rectocele. In a further embodiment, the serpentine pattern is attached to. or in close contact with, a matrix which can be generally vertical elements or a matrix of support as described above (such as a matrix of right angles, or various other patterns). In one therapeutic goal, the matrix holds the assembly into apposition with body tissues (such as the vaginal wall) until such time as the repeating serpentine pattern of structural elements can be incorporated or bonded to the body tissues, after w hich pointthe matrix is resorbed by the body and is no longer part of the permanent structure (although the body’s inflammatory reaction before and / or during resorption may remodel the natural tissue to a thicker and / or stronger state than was present before).

[0155] In another concept embodiment, there are doubled, tripled (both depicted in FIGS. 22A and 22B) or further multiplied repeating serpentine structural elements. In the exemplary variant in FIG. 22A each of the serpentine patterns is a mirror image of the other, and offset that is half of its peak-to-peak (or trough-to-trough) distance, while in FIG. 22B, the intermediate serpentine pattern may have a greater filament angle than the other two serpentine patterns, which may or my not be offset mirror images of each other.

[0156] Exemplary concept embodiments including generally serpentine structural pattern of stronger filaments are depicted in FIGS. 23A and 23D and FIGS. 24A and 24E. These figures depict different combinations of the variants features described herein, such as monofilament or braided filaments, but any combination of tethers or filaments may be used (such as braided filaments for permanent filaments and monofilaments for bioresorbable filaments, or thick braided filaments for permanent filaments and relatively thinner or less strong filaments for bioresorbable filaments or matrix material).

[0157] FIG. 23A comprises a Y-mesh 2300 with a braided tension line assembly 2302 with a greater number of branches 2304 to the anchor arm attachment sites 2306. a fewer number of branches 2308 to the proximal arm tissue attachment sites 2310 and to the proximal posterior arm attachment sites (not shown). The anchor arm 2312 comprises a narrow neck region 2314 where the trunk 2316 of the tension line assembly 2302 is located, along with an enlarged head region 2318 where the anchor arm attachment sites 2306 are located. The anterior and posterior arms 2320. 2322 have a generally uniform width along a majority of its length (e.g. at least 60%, 70%, 80% or 90%). A non-parallel serpentine filament pattern 2324 is provided along the length of the anterior and posterior arms 2320, 2322 to support the arms 2320, 2322 generally, in addition to the tissue attachment sites 2326 not directly attached to the tension line assembly 2302. The Y- mesh 2330 in FIG. 23B is similar to FIG.23A except that it has additional anterior / posterior tension branches 2332 going to the anterior / posterior arms tissue attachment sites 2334. The width of the anterior / posterior arms may have less uniformity (e.g. less than 60%, 70% or 80%), including a bulge 2336, in order to o accommodate the additional tension branches 2332.

[0158] FIGS. 23C and 23D schematically illustrate a pattern of generally serpentine filaments that allow less elongation nearer the vaginal vault apex (assisting in tensile suspension of the vagina) and that allow greater axial compliance more distant from the vaginal vault apex, while providing quasi-circumferential support to prevent against cystocele and / or rectocele. The exemplary Y-mesh 3440 in FIG. 23C is similar to the Y-mesh 2330 except that its proximal tissueatachment sites 2342 on the anterior arm 2344 and posterior arm (not shown) are spaced away from the arm edge 2346 compared to the middle tissue atachment sites 2348, so that that no bulge is required to accommodate all of the anterior / posterior branches 2350. In the exemplary mesh 2360 in FIG. 23D, the tension line assembly 2362 comprises a monofilament or non-braided line structure and may comprise a similar material as to the serpentine filament material used in the other Y-meshes 2300, 2330, 2340. In this embodiment, the tension line assembly 2362 comprises a plurality of serpentine lines 2364, 2366 in the proximal arm 2368 and posterior arm (not shown) with lateral serpentine lines 2364 that are shorter and a central larger serpentine line 2366 that extends the general length of the arm 2368. The shorter serpentine lines 2364 may occupy up to 20%. 30%. 40%, 50%, or 60% of the length of the arm 2368. and may comprise a different amplitude and / or frequency compared to the central larger serpentine line 2366.

[0159] FIG. 24A depicts an exemplary' Y-mesh configuration 2400 similar to the Y-mesh 2300 in FIG. 23 A, except wherein the anchor arm tissue attachment sites 2402 are spaced much closer together, to allow an anchor arm 2404 with both a narrow neck 2406 and a narrow head 2408 relative to the width of the anterior and / or posterior arms 2410, 2412. The ratio between the neck and / or head width may be in the range of 1 :2 to 1 :10, 1:1.5 to 1 :8, 1 : 1.5 to 1 :5, or 1:1.5 to 1 :4, with the head width being optionally equal to the neck width or only larger than no more than about 5%, 10%, 15%, 20%, 30%, 40%. 50%. 75% or 100%. FIG. 24B is a U-mesh 2420 has a tension line assembly 2422 that is similar to the tension line assembly 2414 of FIG. 24A, except that the mesh lacks the bioresorbable anchor arm mesh 2416 of FIG. 24 A, and instead solely relies on the tension line assembly 2422 for tissue anchoring and tensioning to the sacrum.

[0160] FIGS. 24C to 24E schematically depict Y-mesh configurations 2430, 2440, 2450 with differing mesh density. FIGS. 24C and 24D depict configurations where a lighter-weight mesh makes up the majority of the Y-mesh structure and added-density (with added-strength) features are aligned with tissue-attachment suturing zones. In FIG. 24C, the Y-mesh 2430 comprises an overall lighter weight or density mesh structure 2432, but with patches of higher- weight or density mesh structures 2434, 2436, 2438 in the anchor arm 2440, junction 2442, and anterior / posterior arms 2444, respectively. These patches 2434, 2436, 2438 may be interconnected via tension lines 2446. In this embodiment, the tension lines 2446 extend separately from the junction patch 2436 to each of the other patches 2434, 2438. FIG. 24D depicts a Y-mesh 2450 that is similar to the Y- mesh of 2430 FIG. 24C except that the junction patch 2452 is larger and that instead of separate tension lines for the anterior / posterior arm patch atachment sites 2454, the tension lines 2456 serially couple the anterior / posterior arm patch atachment sites 2454. FIG. 24E depicts a Y-mesh 2460 with a lighter-weight mesh density 2462 along the central axis of the anterior and posterior portions 2464 of the mesh 2460, with increased-density (with increased-strength) along the sidesor edges 2466 of each of the anterior and posterior portions 2464 of the mesh 2460; the apical tail portion 2468 of the mesh 2460 is shown as narrow, with greater mesh density, and optionally without any lighter density or weight mesh present in the apical tail 2468 or in the junction 2470. One exemplary method of creating a high-density narrow tail 2468 and / or the edges of the anterior and posterior portions 2464 is to include double or triple layers of mesh material in those regions, with a further example being that the total number of filaments of the layered narrow mesh would be equivalent to the total number of filaments in a more typical full-width non-layered tail mesh.

[0161] In another embodiment, as depicted in FIG. 25, a support structure 2500 of high-strength composition 2502 (for example, a braided pattern of filaments or braids) is combined with a generally flat support matrix 2504. where a section of the high-strength composition and the support matrix are wrapped to form a loop 2506 around or through a body structure such as the cervix or uterus and then a portion of the high-strength composition is sutured to a different potion of the high-strength composition to create a permanent attachment of those areas of the high- strength composition. For the example of encircling the cervix, a sacrocervicopexy can be accomplished with the opposite end of the support structure 2500 comprising an apical tail 2508 with a narrow neck 2510 and enlarged head 2512 configured for attachment to or near the sacrum. If the matrix is composed of bioresorbable materials, this concept may have the benefit of allowing natural childbirth through the vaginal canal well after the support structure is implanted, as there would be no permanent complete encirclement preventing the cervical canal from enlarging to allow passage of the infant.

[0162] In other embodiments, a generally mesh-like assembly is composed of two or three layers of mesh, perforated film, crocheted or generally woven filaments or braids, or any combination of these.

[0163] In still other embodiments the mesh may be configured to temporarily keep an apical tail of a mesh or tether out of the surgeon’s way while they affix the mesh / tether to the vaginal vault (before they affix the tail such as near the patient’s sacrum). One method is to temporarily affix the apical tail to the anterior or posterior portion of the implant mesh / tether. such as by a suture with a pull-to-release temporary knot or that is later cut during surgery; for this purpose it is ideal if the temporary suture is a high-visibility color that highlights in the visual field, such as yellow. One method is to have a separate attachable apical tether that can be sutured or clipped or slip- knotted in place; the apex region may for this purpose include a loop, a clip, or a knob-feature that facilitates anchoring to the tether. A single or a variety of anchoring features may be included, with the latter allowing multiple tethers or selectable positioning of the tether.

[0164] Strengthening of ligaments or ligament-like structures

[0165] In one concept embodiment, as illustrated in FIG. 26A to 26C, a ligament of the body is bulked up by sliding over or wrapping a matrix-like flattened structure over the ligament. In a further embodiment, the matrix-like flattened structure is composed of or includes one or more bioresorbable elements such as composed of PLA, PGA, PGLA or the like.

[0166] FIG. 26A depicts a natural ligament in a friable condition. FIG. 26B depicts a resorbable scaffold ligament anchor that may be used to treat the natural ligament depicts in FIG. 26 A. The scaffold may be held in close opposition to the tendon, ligament or other tissue by suture, using multiple knots or a spiral wrapping for example. The anchor may be pushed forward long the ligament until its desired position is reached. Inner gripper teeth may be provided along the length of the anchor, with a radially inward direction, to help facilitate the anchoring. The teeth or projections may be resorbable or permanent. The end of the scaffold may be attached to a tensile organ support, such as the vaginal apex.

[0167] FIG. 26C depicts an alternate embodiment of a resorbably ligament scaffold, comprising an open-cell (e.g. mesh-like) resorbable tap that is wrapped around or against the outer surface of the ligament or tendon.

[0168] Additional Retention and Release Mechanisms for Alignment Arrays

[0169] In other embodiments, as illustrated schematically in FIGS. 27A to 27C, a variety of configurations of the alignment arrays may be provided. FIG. 27A schematically depicts a Y- shaped mesh with a single U-shaped or V-shaped alignment array, releasably coupled to the mesh via retention clips or loops. The alignment array further comprises an engagement structure, such as a hook or a loop at one or both of its ends, to facilitate attachment by laparoscopic tools or manual forceps, to facilitate the pulling and removal of the alignment array after the mesh has been sutured, overcoming the frictional resistance from the retention clips or loops only the mesh has been properly sutured to the tissue. FIG. 27B depicts another embodiment wherein two separate alignment arrays are provided. In some variations, removal of two separate arrays may be easier on each arm may be easier than removal of a single array traversing both arms. FIGS. 27C and 27D depict another variant, wherein instead of retention clips or loops on the mesh, a retention suture or wire is provided to retain the array(s) on the mesh. After suturing is completed, the retention suture or wire is cut or withdrawn first, to remove any mechanical (rather than frictional) interfit between the retention suture or wire to then separate the array from the mesh. Although the embodiments in FIGS. 27C and 27D schematically depict retention sutures or wires from the alignment arrays, in some other variations, the retention sutures or wire may be bonded to the alignment arrays, to lessen the risk that either may be lost in the body cavity during the removal process.

[0170] With many of the embodiments described herein, an important method during surgical implantation is to avoid trapping the removable alignment array and any removable tether materials when suturing the mesh to the patient’s tissues. To facilitate this, the element of color contrast can be used such as by making the alignment array and / or tether materials a bright color that is easy to see in a blood-rich visual field and that shows up in contrast against the material of the mesh so the surgeon can readily see if the alignment array and / or a tether element is trapped underneath mesh or a suture.

[0171] In one concept embodiment, which can be seen in the depiction of FIG. 58b, a surgical mesh is inter-sewn with a high-strength filament such as a much thicker filament or braided filaments of polypropylene, PTFE or Nickel Titanium (NiTi). In this concept embodiment, the inter-sewn high-strength filament remains attached to the mesh after implantation. In a further concept embodiment, the inter-sew n high-strength filament is a bioresorbable filament or w eave.

[0172] In one exemplary method, an apparatus of mesh-like material and / or tethers and / or alignment array(s) similar to concepts described above is surgically implanted during a sacrocolpopexy.

[0173] In one exemplary method, an apparatus of mesh-like material and / or tethers and / or alignment array(s) similar to concepts described above is surgically implanted during a sacrohysteropexy.

[0174] In one exemplary method, an apparatus of mesh-like material and / or tethers and / or alignment array(s) similar to concepts described above is surgically implanted during a sacrocervicopexy.

[0175] In one exemplary method, an apparatus of mesh-like material and / or tethers and / or alignment array(s) similar to concepts described above is surgically implanted during a herniorrhaphy (hernia repair).

[0176] Ultrasound-guided suturing or anchoring:

[0177] In one exemplary method of affixing a tether (e.g., suture and / or anchor) to a body tissue such as ligament and / or bone (e.g., at or near the sacrum, sacrospinus ligament, uterosacral ligament {also called the rectouterine ligament}, sacroiliac ligament, pubocervical ligament, trans verse / cardinal ligament), an elongate member is introduced into the body (e.g., transvaginally, laparoscopically or surgically) and placed into direct contact with an intended tethering location, an integrated ultrasound element (FIGURE) is used to visualize or measure the tissue within the region the tether will be placed, an assessment is made that the tethering location is desirable (e.g., one or more of structurally sound, lacking critical arteries or veins, lacking critical nerves), a tether element (e.g., suture needle, suture filament, clip, staple, screw-type anchor such as a suture anchor (PEEK suture anchor supplier ACUMED), knotless suture anchor, or the like) is advanced throughthe tissue to provide temporary or permanent anchoring of the tether, and the elongate member is withdrawn leaving the tether in place. The tether may be placed through atensile / mesh member to anchor it into position, or the tether may be connected to a tensile / mesh member after anchoring the tether in position.

[0178] In a further exemplary method, a tether-affixing-ultrasound-verification system includes a lumen by which ultrasound gel can be injected into the field near the ultrasound contact with tissue so that any air is displaced by ultrasound gel (FIGURE) in order to optimize the quality of ultrasound imaging and / or ultrasound-based analysis.

[0179] In one exemplar}’ method of puncturing and advancing within a body cavity such as an insufflated abdomen, an elongate member (such as a trocar) is placed into direct contact with the skin of a patient and an integrated ultrasound element is used to visualize or measure the tissue within the region the elongate member will be punctured and advanced (FIGURE), an assessment is made that the puncturing and advancement location is desirable (e.g., one or more of lacking critical arteries or veins, lacking critical nen es, lacking critical organs such as bowel), a puncture element (e.g., trocar, surgical blade) is advanced through the tissue to allow advancement of an elongate member (e.g., trocar, cannula, catheter) safely into the body cavity'.

[0180] Apparatus and methods for producing and using a suture-capture device are well known in the art (for example, the Capio™ suture capture device sold by Boston Scientific, patent US7048749; the Digitex® suture delivery system sold by Coloplast, and the FIXT™ suturing device sold by Bard Medical). In one exemplar}’ embodiment, a suture capturing device incorporates an ultrasound transducer located near the deployment site of the suture needle. Ideally, the ultrasound transducer (and associated image processing) will have a visual field that captures the entirety of the tissue where the suture needle will be directed through in order to place a suture through. In one example, the ultrasound planar field of view is coplanar with the centerline pathway of the suture needle. Alternatively, the ultrasound transducer will have a visual field that captures most of the tissue where the suture needle will be directed through. In one example, the ultrasound plane of view is largely coplanar with the centerline pathway of the suture needle. Alternatively, the ultrasound transducer may have a field of view' or measurement that is at least nearly in alignment with the tissue where the suture needle will be directed through. In one example, an ultrasound transducer may be a small linear array or even a single Doppler-like probe that is nearly or partly in alignment with the tissue where the suture needle will be directed through. In one embodiment, the ultrasound transducer is mounted with spnng bias to allow it to compress against the desired tissue without deforming the tissue enough that would interfere with good needle penetration and passage.

[0181] In a further exemplary embodiment, the plane of the ultrasound field is not coplanar with the plane of the suture-capturing needle passage through tissue, but the two planes intersect along a majority of the region where the suture needle is directed through the tissue. This can be accomplished by the ultrasound transducer cry stal or array of crystals being tilted at an angle and mounted to one side of the body of the suture-capturing device body of the types known in the art that do not include ultrasound means.

[0182] In an alternate embodiment, an ultrasound transducer is integrated into a suture-anchor- delivery system. The field of view of the ultrasound may be coplanar with the axis of where the suture anchor will be implanted, or the field of view of the ultrasound may be inclined to intersect along a portion of the axis of where the suture anchor will be implanted .

[0183] In one embodiment, (FIGURE) an apparatus including ultrasound means with suturepassing means also includes a lumen for delivering ultrasound gel into the region of intended imaging so that the ultrasound gel can be directed substantially into the region of imaging to displace any air bubbles that may otherwise interfere with a clear ultrasound signal or image. In one method embodiment, a user injects ultrasound gel through a lumen of an apparatus comprising suture-passing means and ultrasound means, so that the ultrasound gel substantially fills the area of ultrasound imaging so that air bubbles are displaced and a clear ultrasound signal is obtained or visualized.

[0184] In one embodiment, an ultrasound detector integrated into an anchoring system is a single cry stal. In an alternate embodiment, the ultrasound detector is an array of cry stals. In one embodiment, the ultrasound detector is a Doppler probe that measures blood flow. In one embodiment, the ultrasound detector provides B-mode greyscale imaging. In one embodiment, the ultrasound detector provides color Doppler blood flow overlayed on greyscale imaging. In one embodiment, no visual ultrasound imaging is created but ultrasound data are analyzed by a training engine and an output suggesting whether the proposed anchor site may be adequate or inadequate is communicated to a user. In one embodiment, ultrasound data are analyzed by a training engine and output suggesting what type of tissue or tissues exist, and where they exist, within the region of tissue likely to be transected by the suture needle.

[0185] In one method embodiment, a user places a suture-capture device with integrated ultrasound capability into contact with body tissue at or near an area where a suture is intended to be directed, the user evaluates the ultrasound

[0186] In one method embodiment, 3D navigation technology is used with the ultrasound detector to provide a map of the area contracted with the ultrasound detector as it is moved over the nearby area of a target of interest. In a further embodiment, blood vessels and nerves arehighlighted on a visual map output, and a recommended anchoring location is provided. In a further embodiment, 3D guidance is given to direct the tool into the ideal location to affix an anchor.

[0187] In one exemplary method, the operator would place the suture-capture or anchoring device into contact with tissue at an intended anchor location, visualize via ultrasound to see that the intended location has desirable suturing properties (e.g., strong tissue, lack of bone or calcification within the needle / anchor trajectory, lack of significant blood vessels or nerves within the needle / anchor trajectory or within tissue that will be drawn tight by a suture / anchor), and deploy the needle / anchor through the tissue (either with or without live ultrasound visualization of the needle / anchor passing through tissue), with the overall goal of finding a safe and effective anchor or connection and completing that anchor / connection with the aid of ultrasound guidance.

[0188] Access, identification and dissection of tissues, including hydrodissection

[0189] Instead of being done by the typical and painstaking manual process of using a grasper / dissector / cutter to progressively open up tissue planes, tissue dissection of the vaginal vault from surrounding tissues can be accomplished or facilitated by hydrodissection, which has previously been reported in the art as a manual surgical technique as administered by a simple needle attached to a large syringe. Hydrodissection, simply put, is using injection of fluid to open up a fluid-filled space which in turn causes tissues to split open and create a pocket; this opening dissects the nearby tissues to create the space.

[0190] An exemplary method and apparatus embodiment for ultrasound-guided tumescent (or simply fluid) infiltration to cause hydrodissection of tissue adjacent to the vaginal vault can be accomplished with a long needle and / or port built into a vaginal ultrasound probe, facilitating injection of fluid in-plane (longitudinal or transverse) with ultrasound visualization.

[0191] Another exemplary method and apparatus embodiment for ultrasound-guided hydrodissection is to employ a long needle and / or needle guide that works with a standard vaginal ultrasound probe. To accomplish this, an over-sleeve or partial over-sleeve, or clip-on feature, of the vaginal probe can include a needle guide or an attached needle system that allows puncture of the vaginal vault wall thickness and injection of fluid that occurs within the field of tissue visualized by the vaginal probe

[0192] Hydrodissection can be done without the need for ultrasound visualization if the fluid is injected through a needle placed in a correct position and the volume of injection is appropriate. One exemplary method embodiment of accomplishing this is to use one or more long needle(s) and / or port(s) that works with or is integral to a vaginal manipulator probe (as shown in FIGS. 29A and 29B) for positioning and visualization as used with transvaginal, laparoscopic or open surgery'. FIG. 29A shows a vaginal manipulator or probe with side-extendable hydrodissection needle(s) that can project from the interior surface of the vagina once the probe has smoothly beenslipped into position within the vaginal vault. FIG. 29B depicts the post-injection tissue changes. FIG. 29B shows a vaginal manipulator with side-extendable needles, where a fluid volume is shown extending around the tip of each needle to hydrodissect the tissue surrounding the vaginal vault. Other variants of the hydrodissection vaginal manipulators are depicts in FIGS. 31A to 3 ID. FIGS. 31 A to 3 ID illustrate a body probe, with one (FIG. 31 A), two (FIG. 3 IB), or four (in FIGS. 31C and 3 ID) extendable needles that can protrude from the probe surface to a desired depth of insertion. One and two regions along the length of the body probe are shown (FIGS. 31C and 31D) to have extendable needles. In FIG. 32, the syringe plungers are attached so that one action of pressing on the combined plungers causes a matched displacement for both plungers.

[0193] As an example, a Vaginal manipulator or probe can have side-extendable needle(s) that can project 1-10 mm (more preferably 2-5 mm) from the interior surface of the vagina (as shown FIGS. 29 A, 29B) and allow injection of fluid that distance from the interior surface of the vaginal vault (vaginal wall thickness is typically 1.5-3.0 mm, more broadly 0.5-5.0 mm) so as to create propagating dissection of tissue along approximately an external offset to the interior surface of the vagina so that a dissected thickness of approximately 2-5 mm remains (as shown in FIGS. 29B and 30). FIG. 30 is a schematic perspective view depicting a three-dimensional depiction of hydrodissecting fluid wrapping around a vaginal vault due to injection from side-extendable needles in a vaginal probe, as depicted in FIG. 29B. The fluid wrapper procedures create a partial or complete elongated torus shape of dissected fluid-filled space surrounding the vaginal vault or canal. With this exemplary' apparatus and method embodiment, the probe enters the body in smooth configuration and once in position the needles are exposed outward to penetrate the vaginal wall.

[0194] As a further example concept embodiment, a vaginal manipulator can be configured with a channel allowing direction of a long needle from outside the body to a penetration along the side of the manipulator so that the needle can be made to penetrate through the wall thickness of the vaginal vault (for example, at approximately 2-5mm projection from the surface of the vaginal manipulator) and allow injection of fluid to hydrodissect the perivaginal tissue from around at least a portion of the vaginal vault. FIG. 35 shows a vaginal manipulator with a channel allowing a sideexiting needle for tissue hydrodissection. The vaginal manipulator may have a keyed introduction to a needle channel so that a needle beveled tip are properly angled to make an idealized entry' through the vaginal wall. Likewise, a keyed introduction may ensure that a curved needle properly projects outward into the tissue in one preferred direction. In a further example, an accessory attachment to a vaginal probe can add needle guidance (or a built-in needle) for injection of fluid 2-5mm from the interior surface of the vagina, as depicted in FIG. 36. FIG. 36 shows a vaginal manipulator with a channel allowing a side-exiting needle for tissue hydrodissection and also aninflatable balloon near the opposite side so that inflating the balloon pushes the surface that has the needle-exiting channel to be pushed into contact with the interior surface of the vaginal vault.

[0195] In one exemplar}' method embodiment, a vaginal manipulator is tilted by a user so that within the vaginal vault the side of the manipulator with a needle exit is placed into contact with the vaginal wall so that the needle depth of projection through the vaginal wall can be maximized.

[0196] An apparatus or mechanism can be used to create and ensure close apposition between an internal hydrodissection system and the interior surface of the vaginal vault. In one exemplary hydrodissection concept embodiment, an inflatable balloon can be positioned to act against the opposite side of the vaginal vault so that it forcefully pushes the surface that has needle-extension for hydrodissection to be against the interior surface of the vaginal vault (as shown in FIG. 36).

[0197] In one concept embodiment, two sides of a vaginal manipulator can be driven apart (e.g., separating, diverging, splitting, or the like) from each other to appose against each opposite side of the vaginal vault; this apposition can be a very light touch or a forceful contact. The user can affect this apposition by sliding and / or rotating a mechanism such as a gear set that causes the motion tending to apposition. While a side of the manipulator is in direct contact with the vaginal wall (or nearly direct contact), a needle can project from the surface of the manipulator and inject through the vaginal wall into the tissue surrounding and adjacent the vaginal wall, through which hydrodissection fluid is then injected to separate tissue places and cause propagating hydrodissection. See FIG. 33A to 33C, and FIGS. 34A and 34B. FIGS. 33A to 33C show vaginal manipulators that split so that two sides of the manipulator can be driven apart from each other to appose against each opposite side of the vaginal vault.; needles are shown extending from the end of the manipulator in FIGS. 33B and 33C. FIGS. 34A and 34B show a parallel-bars mechanism by which a vaginal manipulator that splits can be held so the moving surfaces are kept approximately parallel to each other.

[0198] A body probe, such as a vaginal manipulator, may have one, two, three, four or more extendable needles that can protrude from the probe surface to a desired depth of insertion. One, two, or more regions along the length of the body probe may have extendable needles, as shown in FIGS. 31A to 31D.

[0199] Needles for injection of hydrodissection fluid, as generally described here, can be made from stainless steel (such as 18-8 stainless steel, 316 stainless steel, or 304 stainless steel), nickel titanium (NiTi).

[0200] Protruding hydrodissection needles may each connect to a fluid path and a fluid inj ection source such as a syringe. Independent fluid sources have the benefit of injection to multiple locations simultaneously (for example, not randomly more to one region than to another, in the case of a single fluid source split or manifolded into two or more pathways). In one exampleembodiment, two needles are supplied by two syringe plungers and two fluid distribution tubing paths. In a further example embodiment, the syringe plungers are attached so that one action of pressing on the combined plungers causes a matched displacement for both plungers, as depicted in FIG. 32. Alternatively, one of more fluid paths can be combined (e.g., in a manifold) so a fluid injection source drives fluid through a combination of two or more needles.

[0201] Illuminated foley catheter to visualize urinary bladder during anterior vault dissection or other nearby surgery:

[0202] FIGS. 28A and 28B schematically depicts a urinary (e.g., Foley™) catheter with an integrated light source that illuminates for fluid-filled urinary bladder to improve visualization for a surgeon such as during dissection along the anterior vaginal vault during sacrocolpopexy. The urinary catheter may include an anchoring balloon, or be without an anchoring balloon, but the light source should substantially direct light into the interior of the urinary bladder. Example light sources are LEDs (light-emitting diodes), fiber optic transmission from a light source outside the body into or near the interior of the bladder, or luminescent fluid injected into the urinary bladder. FIG. 28C schematically depicts the catheter of FIG. 28 A in situ.

[0203] In one exemplary method, a patient’s urinary bladder is catheterized with a urinary drainage catheter that provides a light source into the urinary7bladder, an anchoring balloon (if present) is inflated to hold the catheter in place, the light source is illuminated, and surgery7(such as tissue dissection along the anterior vaginal vault for a sacrocolpopexy procedure) is done while the surgeon is watching carefully for light to indicate the urinary7bladder and the surgeon uses this light feedback to avoid accidentally cutting into or puncturing into the urinary7bladder.

[0204] In a further exemplary method, the light within the urinary bladder is continuous throughout the procedure. In an alternate further exemplary method, the light within the urinary bladder is discontinuous, such as illuminating for a period of time (such as 1 -4 seconds) and then not illuminating for a period of time (such as 0.5-1 seconds) and then repeating.

[0205] Control of light from an illuminated bladder drainage catheter can be simply turned on by pulling a tab that activates a battery7(such as a button-cell CR2032 battery7), or by activating a switch on the catheter hub, or by a switch or footswitch that activates a remote light source.

[0206] Intensity of light from an illuminated bladder drainage catheter may be adjustable by a user, such as by button presses to select alternate intensities. One exemplary light intensity is to match the light intensity in tissue as produced by the aiming beam of medical lasers and associated fiber optics.

[0207] Other materials and material configurations that may be used in the manufacture and construction of the systems, devices, assemblies and components described herein include:• Polypropylene (common)• Polyester (common)• Low density polyethylene (LDPE)• Ultra high molecular weight polyethylene (UHMWEPE)• Polytetrafluoroethylene (PTFE)• Poly ether ether ketone (PEEK)• Polyester• Nylon• Monofilament• Braided cords or braided tapes• Composite felt fabrics• Two-or-three layers, can be various materials• Macro porous mesh• polylactic acid micro grips (PLA) to aid placement• Cyanoacrylate glue to aid placement

[0208] While the various embodiments described herein has been particularly shown and described with references to examples thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the disclosure. For all of the embodiments described above, the steps of the methods need not be performed sequentially.

Claims

WHAT IS CLAIMED IS:1 . A surgical mesh system, comprising: an implantable mesh body, comprising: a first arm, comprising a first central end, a first free end, and a first mesh body therebetween; a second arm, comprising a second central end, a second free end, and a second mesh body therebetween; and a third arm, comprising a third central end. a third free end; and a third mesh body therebetween; and a first plurality of removable magnetic alignment bodies, wherein each of the magnetic alignment bodies of the first plurality of removable magnetic alignment bodies is attached to at least one other magnetic alignment body of the first plurality of removable magnetic alignment bodies by at least one removable interconnect structure that is separate from the first mesh body, second mesh body and a third mesh body; wherein the first plurality' removable magnetic alignment bodies are coupled to at least the second and the third arms by at least one releasable coupler.

2. The system of claim 1, wherein the at least one coupler comprises a releasable pocket, releasable retention wire, or releasable cuttable securing line.

3. The system of claim 1, wherein the first plurality' of removable magnetic alignment bodies are coupled by the at least one releasable coupler to the second and third arms but not the first arm.

4. The system of claim 3, wherein the at least one removable interconnect structure passes through an opening in the first arm, but none of the first plurality of removable magnetic alignment bodies are in contact with the first arm.

5. The system of claim 1, wherein the second arm comprises an inner surface facing toward the third arm and an outer surface facing toward the first arm, and the third arm comprises an inner surface facing toward the second arm and an outer surface facing toward the first arm.

6. The system of claim 5, wherein the first plurality' of removable magnetic alignment bodies is located on the inner surfaces of the second and third arms.

7. The system of claim 6, wherein the at least one removable interconnect structure is located against the inner surfaces of the second and third arms, but not an outer surface of the second or third arm.

8. The system of claim 6, wherein the at least one removable interconnect structure is interwoven between the inner surfaces and outer surfaces of the second and third arms.

9. The system of claim 5, wherein the first plurality of removable magnetic alignment bodies is located on the outer surfaces of the second and third arms.

10. The system of claim 9, wherein the at least one removable interconnect structure is located against the outer surfaces of the second and third arms, but not an inner surface of the second or third arm.

11. The system of claim 9, wherein the at least one removable interconnect structure is interwoven between the inner surfaces and outer surfaces of the second and third arms.

12. The system of claim 5, wherein the first plurality of removable magnetic alignment bodies are located on inner and the outer surfaces of the second and third arms.

13. The system of claim 12, wherein the at least one removable interconnect structure is interwoven between the inner surfaces and outer surfaces of the second and third arms.

14. The system of claim 1 , wherein the at least one removable interconnect structure comprises a single removable interconnect structure serially coupled to each removable magnetic alignment body of the first plurality of removable magnetic alignment bodies.

15. The system of claim 1, wherein the at least one removable interconnect structure comprises a first removable interconnect structure connecting the first plurality7of removable magnetic alignment bodies located on the second arm, and a second removable interconnect structure connecting the first plurality of removable magnetic alignment bodies located on the third arm.

16. The system of claim 15, wherein the at least one removable interconnect structure comprises a third removable interconnect structure connecting the first and the second removable interconnect structures.

17. The system of claim 15, wherein the at least one removable interconnect structure comprises a third removable interconnect structure connecting one of the first plurality of removable magnetic bodies located on the second arm and one of the plurality7of removable magnetic bodies located on the first arm.

18. The system of claim 1, wherein the first plurality of removable magnetic alignment bodies each comprises anon-magnet magnetizable material or comprises a plurality of magnets.

19. The system of claim 1, wherein one of the first plurality of removable magnetic alignment bodies is located at midline between the second and third arms.

20. The system of claim 13, wherein one of the first plurality of removable magnetic alignment bodies is located on or in an opening in the first central end of the first arm.

21. The system of claim 1, wherein the first arm comprises a first mesh pattern is different from a second mesh pattern of the second arm and from a third mesh pattern of the third arm.

22. The system of claim 21, wherein the second and third mesh patterns are identical.

23. The system of claim 22, wherein the second and third arms are contiguously formed.

24. The system of claim 23, wherein the first arm is not contiguously formed with the second arm or the third arm.

25. The system of claim 21, wherein the first mesh pattern has a different porosity than the second and third mesh patterns.

26. The system of claim 1. wherein the first, second and third arms each comprises a ribbon shape.

27. The system of claim 26, wherein the first arm has a different ribbon width than the second and third arms.

28. The system of claim 27, wherein the first arm has a relative width that is between 10% and 75% of width of the second and third arms.

29. The system of claim 28, wherein the first arm has a width in the range from 0.2 cm to 2.5 cm.

30. The system of claim 29, wherein the first arm has a width in the range of 1.0 cm to 2.0 cm.

31. The system of claim 1. wherein at least one of the first, second and third arms comprises higher density edge regions and a lower density inner region therebetween.

32. The system of claim 31, wherein higher density edge regions have a density in the range of 30-45 g / m2.

33. The system of claim 32, wherein lower density inner region has a density in the range of 17-22 g / m2.

34. The system of claim 31, wherein each of the higher density edge regions of the at least one of the first, second and third arms comprises a percentage width in the range of 10 to 40 percent.

35. The system of claim 34, wherein the higher density edge regions comprise a total width percentage in the range of 25% to 70%, or 30% to 50%.

36. The system of claim 1, wherein the first, second and third arms each comprise a mesh porosity in the range of 60% to 80%.

37. The system of claim 31, wherein the higher density edge regions of the at least one of the first, second and third arms comprises a percentage width in the range of 20% to 70%.

38. The system of claim 31, wherein the higher density edge regions of the at least one of the first, second and third arms comprises a percentage width in the range of 40 to 60 percent.

39. The system of claim 1, wherein the first arm comprises higher density' edge regions and a lower density inner region therebetween.

40. The system of claim 1, wherein the first arm comprises a first material, and the second and third arms comprise a second material different from the first material.

41. The system of claim 40, wherein the first arm has a lower Young's Modulus than the second or third arm.

42. The system of claim 1, wherein the first, second and third arms comprises at least one reinforcement structure separate from the at least one releasable coupler and the at least one removable interconnect structure.

43. The system of claim 1, further comprising an elongate magnetic alignment tool, comprising: an elongate body with a proximal handle and a distal alignment region; anda second plurality of magnetic alignment bodies coupled to the distal alignment region.

44. The system of claim 43, the second plurality of magnetic alignment bodies are symmetrically located on the distal alignment region.

45. The system of claim 44, wherein the second plurality of magnetic alignment bodies comprises a magnet located on a distal tip of the distal alignment region.

46. The system of claim 45, wherein the second plurality of magnetic alignment bodies are located in a single plane through the distal alignment region.

47. The system of claim 46, wherein the handle region comprises a curved configuration, and the handle region also lies in the same single plane as the second plurality of magnetic alignment bodies.

48. The system of claim 1, wherein either the second and third mesh bodies are contiguously formed and wherein the second mesh pattern and the third mesh pattern have identical intemodal distances and mesh opening shapes.

49. The system of claim 1, further comprising elongate strain limiters attached to the mesh body, wherein the elongate strain limiters are only coupled to the mesh body at the free ends of the first, second and third arms.

50. The system of claim 49, wherein the elongate strain limiters are branched elongate strain limiters.

51. The system of claim 50, wherein the branched elongate strain limiters comprises a first branched end, a second branched end, and an elongate body therebetween.

52. The system of claim 51, wherein the first branched end and the second branched end each comprise a plurality of branched segments, and wherein a number of branched segments in the plurality of branched segments in of the first branched end is different than a number of branched segments in the plurality of branched segments in of the second branched end.

53. The system of claim 1, wherein the mesh body comprises an over-and-under weave pattern with a first fiber, in combination with a serpentine weave with a second fiber.

54. The system of claim 53, wherein the second fiber is stronger than the first fiber.

55. The system of claim 53, wherein the second fiber has a higher tensile strength limit than the first fiber.

56. A method of treating a patient, comprising; inserting a magnetic probe into a body cavity of an organ; placing a surgical mesh with a removable magnetic alignment array against an external tissue surface of body cavity; aligning the magnetic alignment array of the surgical mesh with the magnetic probe to orient the surgical mesh; suturing the surgical mesh to the external tissue surface of the body cavity7; removing the removable magnetic alignment array from the surgical mesh.

57. The method of claim 56, wherein inserting a magnetic probe into a body cavity of a body organ comprises inserting the magnetic probe through an external orifice of the body cavity.

58. The method of claim 56, inserting the surgical mesh adjacent to the external tissue surface of the body cavity is performed with laparoscopic tools.

59. The method of claim 56, wherein removing the removable magnetic alignment array from the surgical mesh comprises withdrawing the magnetic alignment array from an opening of the surgical mesh.

60. The method of claim 59, wherein the opening of the surgical mesh is centrally located at a junction of the surgical mesh.

61. The method of claim 59, wherein the surgical mesh comprises three elongate arms joined at the junction.

62. The method of claim 56. further comprising releasing a retention element of the surgical mesh prior to removing the magnetic alignment array.

63. The method of claim 56, wherein the body cavity' is the vaginal vault.

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