Abdominal closure method and device variations for closing ventral hernias and reducing recurrence

Abstract

Abdominal closure method and device variations for closing ventral hernias and reducing recurrence are described. The tissue anchoring apparatus may generally include a first component having a first platform and a prong projecting from the first platform, wherein the prong includes a distal portion which defines a locking groove, a second component having a second platform which defines an opening sized to receive the prong therethrough, and a locking component which defines a lock opening sized to correspond to the locking groove when the locking component is positioned in a first orientation relative to the locking groove, wherein the locking component is inhibited from translating distally along the prong when the locking component is rotated into a second orientation from the first orientation.

Description

Attorney Docket No.: ABMDZ01700WQABDOMINAL CLOSURE METHOD AND DEVICE VARIATIONS FOR CLOSING VENTRAL HERNIAS AND REDUCING RECURRENCECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Prov. App. 63 / 680,967 filed August 8, 2024, which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates to devices and methods to distribute tension in soft-tissue closure.BACKGROUND OF THE INVENTION

[0003] There are 4 million open abdominal surgical procedures in the US (emedicine.medscape.com / article / 1961789-technique). A commonly documented postoperative complication is incisional hernia resulting from structural failure of healing tissue, which occurs in approximately 9-20% of patients after an abdominal closure, and possibly higher for select risk groups. New technologies and methodologies are desired to reduce the failure rate of abdominal wall closure both primarily and for hernia repair.SUMMARY OF THE INVENTION

[0004] A device may ideally maintain apposition of the abdominal wall edges during healing by: a. broadly distributing suture tension throughout the involved tissues, b. gradually transferring forces from the anchoring device to the healing scar as the device biodegrades, and c. leaving no permanent foreign body.

[0005] One form of the embodiment used for tissue edge apposition includes bioabsorbable components that support tissue closure and optimize healing. For the bioabsorbable components, mechanisms are utilized to form a connection between the posterior (interior of abdominal wall) and anterior (exterior of abdominal wall) elements that are then utilized to distribute the tension of suture passing through one or more of the components. These mechanisms for forming a connection between posterior and anterior elements may include a broad variety of known fastening mechanisms, e.g., threaded features, notches, locking washers, pins or other shapes in grooves, ratchet features,Attorney Docket No.: ABMDZ01700WQ threaded features, etc. used as securement mechanisms. The mechanisms which form the connection may be reinforced or replaced by suture or similar constructs passed through the posterior and anterior components on both sides of the wound. In some cases, there is no securement mechanism other than suture or similar construct. Components for engaging suture tension may include eyelets, hollow posts or other passages, collars, anterior and / or posterior elements, etc. Tension may then be distributed into tissue via one or more tissue interfaces such as tines, a friction surface, the connecting component or components between anterior and posterior elements, fenestrations, the medial edge of any component, etc.

[0006] In one variation of a tissue anchoring assembly, the assembly may generally comprise a first member having one or more first piercing elements extending from a first surface configured for contact against a first tissue region and a second member having one or more openings corresponding to a position of the one or more first piercing elements, and wherein the first member and second member are configured to be secured relative to one another via the one or more first piercing elements. The one or more piercing elements may be hollow, allowing suture or other connecting member to be passed between the first and second members through the lumen of the piercing element(s). The lumen may have one or more lateral openings through the sides of the piercing elements.

[0007] In some variants, the lumen may not extend the full length of the piercing element(s). When this is combined with one or more lateral openings through the sides of the piercing element, it provides a channel for tissue to grow through the piercing element serving to retain the piercing element in the tissue. Similarly, one or more lateral holes through the piercing elements also provide a channel for tissue ingrowth through the piercing element retaining the piercing element in the tissue.

[0008] In another variation of a tissue anchoring assembly, the assembly may generally comprise a first prong defining a lumen at least partially therethrough, the first prong further defining one or more openings at least partially along the first prong and a secondary opening near or at a base of the first prong such that the one or more openings and the secondary opening are in communication via the lumen. The assembly may further include a first member extending from the base of the first prong and configured for contact against a first tissue surface, and a second member configured to move relative to the first prong and further configured for contact against a second tissue surface such that the first member and the second member are maintained relative to one another.Attorney Docket No.: ABMDZ01700WQ

[0009] In one method of approximating tissue via a tissue anchoring assembly, the method may generally comprise attaching a first tissue anchoring assembly to a first region of tissue (e.g., one side of the abdominal wall incision) and a second tissue anchoring assembly to a second region of tissue (e.g., the second side of the abdominal incision), and approximating the first assembly and region of tissue towards the second assembly and region of tissue by passing a suture through the piercing element of one assembly, through the second assembly, and using the suture to secure the two assemblies such that the two regions of tissue (two sides of the abdominal incision) are in contact.

[0010] In another method of approximating tissue via a tissue anchoring assembly, the method may generally comprise piercing a first prong through a tissue region to be approximated such that the first prong extends from a first tissue surface to a second tissue surface of the tissue region, positioning a first member extending from a base of the first prong into contact against the first tissue surface, positioning a second member relative to the first prong and into contact against the second tissue surface opposite to the first tissue surface, and passing a connecting element through a lumen defined at least partially through the first prong and along the second member such that the connecting element passes between the first tissue surface and the second tissue surface.

[0011] In another embodiment, the method may generally comprise a prong(s) extending from the platform of the first member through a tissue region to be approximated to a second tissue region such that the prong(s) extends from a first tissue surface to a second tissue surface of the tissue region. A second member is positioned relative to the prong and in contact against the second tissue surface opposite to the first tissue surface, maintaining the second member on the first prong via a locking mechanism such as a locking disk, washer, clip (such as a C-clip), or bayonet coupler, or other locking feature.

[0012] The embodiment of as described above may include various lengths of the first prong and positioning of the “stop” shoulder on the first prong to allow for different thicknesses of the tissue being apposed.

[0013] The embodiment of may include the positioning of a “stop” shoulder on the first prong that both prevents over compression but also serves as a platform to facilitate accurate placement of a securement mechanism by maintaining the second element at a height aligned such that the second element guides placement of the securement mechanism on the first prong.

[0014] An embodiment wherein one or more detents are present on the second element to assist in positioning and maintaining a third element securement mechanism inAttorney Docket No.: ABMDZ01700WQ the desired position, especially in the rotational axis around the prong. Alternatively, the one or more detents may be present on the third element to assist in positioning and maintaining its position by interacting with the second element. In yet another embodiment, the detents may be present on the first element to assist in maintaining the position of the third element around the prong.

[0015] A device as described in the paragraphs above wherein the third element includes a suture eyelet. This eyelet may be used to prevent third element rotation after deployment and / or to act as an eyelet for suture connecting to an opposing assembly.

[0016] An embodiment of the devices as described above wherein the first and or second elements contain round eyelets. Alternatively, the eyelets may be elongated to facilitate passage of a curved suture needle. In other embodiments, the eyelets may be heart-shaped (bi-lobal) or have other shapes which facilitate suture passage by allowing extended axes of needle / suture passage in multiple dimensions.

[0017] Furthermore, the embodiment may include a posterior component eyelet that is anteriorly displaced relative to the posterior component plate in order to guide the posterior segment of a suture loop away from intra-peritoneal viscera.

[0018] The embodiment may include a method for deploying the assembly that positions the assembly in a desired position such that, for example, the penetrating components are medial to the superior and inferior epigastric vessels as well as main intercostal nerve branches.

[0019] Examples of different embodiments of the tissue anchoring assemblies and materials which may be used with the features described herein are further disclosed in U.S. Pub. 2020 / 0323614 (U.S. Pat. App. 16 / 844,420) filed April 9, 2020 which is incorporated herein by reference in its entirety and for any purpose.

[0020] One variation of the tissue anchoring apparatus may generally comprise a first component having a first platform and a prong projecting from the first platform, wherein the prong includes a distal portion which defines a locking groove, a second component having a second platform which defines an opening sized to receive the prong therethrough, and a locking component which defines a lock opening sized to correspond to the locking groove when the locking component is positioned in a first orientation relative to the locking groove, wherein the locking component is inhibited from translating distally along the prong when the locking component is rotated into a second orientation from the first orientation.Attorney Docket No.: ABMDZ01700WQ

[0021] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise one or more first piercing tines extending from a first surface of the first component.

[0022] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise one or more second piercing tines extending from a second surface of the second component.

[0023] In another aspect of the tissue anchoring apparatus, the second component may define one or more openings along an edge of the second component.

[0024] In another aspect of the tissue anchoring apparatus, the one or more openings may have a heart-shaped configuration.

[0025] In another aspect of the tissue anchoring apparatus, the locking component may define one or more openings along an edge of the locking component.

[0026] In another aspect of the tissue anchoring apparatus, the one or more openings of the locking component may be configured to align with the one or more openings of the second component when the locking component is rotated into the second orientation.

[0027] In another aspect of the tissue anchoring apparatus, the first component may define one or more openings along an edge of the first component.

[0028] In another aspect of the tissue anchoring apparatus, the one or more openings of the first component may be displaced anteriorly relative to a plane defined by the first platform.

[0029] In another aspect of the tissue anchoring apparatus, the one or more openings are configured into a heart-shape.

[0030] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise a connecting element for attaching to at least the second component.

[0031] In another aspect of the tissue anchoring apparatus, the connecting element may attach to the one or more openings of the second component and to the one or more openings of the locking component.

[0032] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise a second tissue anchoring apparatus which is connectable to a first tissue anchoring assembly via the connecting element.

[0033] In another aspect of the tissue anchoring apparatus, the locking component may be rotatable by 90 degrees from the first orientation to the second orientation.Attorney Docket No.: ABMDZ01700WQ

[0034] In another aspect of the tissue anchoring apparatus, the locking groove may comprise a first portion which is aligned with a length of the prong and a second portion connected to the first portion and which is transversely configured relative to the first portion.

[0035] In another aspect of the tissue anchoring apparatus, the locking groove may further comprise one or more detents.

[0036] In another aspect of the tissue anchoring apparatus, the second component may further comprise one or more detents.

[0037] In another aspect of the tissue anchoring apparatus, the prong may further define one or more openings which extend transversely through the prong for encouraging tissue ingrowth.

[0038] Any of the aspects above may be combined in any number of combinations and are intended to be within the scope of this disclosure.

[0039] One variation of the tissue anchoring apparatus may generally comprise a first component having a first platform and a prong projecting from the first platform having one or more openings defined along an edge of the first component wherein the one or more openings is displaced anteriorly relative to a plane defined by the first platform, and a second component having a second platform which defines an opening sized to receive the prong therethrough.

[0040] In another aspect of the tissue anchoring apparatus, a locking component may define a lock opening sized to correspond to a locking groove along the prong when the locking component is positioned in a first orientation relative to the locking groove, wherein the locking component is inhibited from translating distally along the prong when the locking component is rotated into a second orientation from the first orientation.

[0041] In another aspect of the tissue anchoring apparatus, the locking component may be rotatable by 90 degrees from the first orientation to the second orientation.

[0042] In another aspect of the tissue anchoring apparatus, the locking groove may comprise a first portion which is aligned with a length of the prong and a second portion connected to the first portion and which is transversely configured relative to the first portion.

[0043] In another aspect of the tissue anchoring apparatus, the locking groove may further comprise one or more detents.

[0044] In another aspect of the tissue anchoring apparatus, the second component may further comprise one or more detents.Attorney Docket No.: ABMDZ01700WQ

[0045] In another aspect of the tissue anchoring apparatus, one or more first piercing tines may extend from a first surface of the first component.

[0046] In another aspect of the tissue anchoring apparatus, one or more second piercing tines may extend from a second surface of the second component.

[0047] In another aspect of the tissue anchoring apparatus, the second component may define one or more openings along an edge of the second component.

[0048] In another aspect of the tissue anchoring apparatus, the locking component may define one or more openings along an edge of the locking component.

[0049] In another aspect of the tissue anchoring apparatus, the one or more openings of the locking component may be configured to align with the one or more openings of the second component when the locking component is rotated into the second orientation.

[0050] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise a connecting element for attaching to at least the second component.

[0051] In another aspect of the tissue anchoring apparatus, the connecting element may attach to the one or more openings of the second component and to the one or more openings of the locking component.

[0052] In another aspect of the tissue anchoring apparatus, the apparatus may further comprise a second tissue anchoring apparatus which is connectable to a first tissue anchoring assembly via the connecting element.

[0053] In another aspect of the tissue anchoring apparatus, the prong may further define one or more openings which extend transversely through the prong for encouraging tissue ingrowth.

[0054] Any of the aspects above may be combined in any number of combinations and are intended to be within the scope of this disclosure.

[0055] One variation of one method of approximating tissue via a tissue anchoring assembly may generally comprise piercing a prong projecting from a first platform of a first component through a tissue region to be approximated such that the prong passes from a first tissue surface to a second tissue surface of the tissue region, positioning a second component upon the prong such that a second platform is placed into contact against the second tissue surface, and engaging a locking component upon a locking groove defined along a distal portion of the prong by rotating the locking component at least partially about the prong such that the second component is inhibited from translating distally along the prong.Attorney Docket No.: ABMDZ01700WQ

[0056] In another aspect of the method, piercing the prong may further comprise piercing one or more first piercing tines extending from the first platform into the first tissue surface.

[0057] In another aspect of the method, positioning the second component upon the prong may further comprise piercing one or more second piercing tines extending from the second platform into the second tissue surface.

[0058] In another aspect of the method, the second component may define one or more openings along an edge of the second component.

[0059] In another aspect of the method, the one or more openings may have a heartshaped configuration.

[0060] In another aspect of the method, the locking component may define one or more openings along an edge of the locking component.

[0061] In another aspect of the method, positioning the second component may further comprise aligning one or more openings of the locking component with the one or more openings of the second component.

[0062] In another aspect of the method, first component may define one or more openings along an edge of the first component.

[0063] In another aspect of the method, the one or more openings of the first component may be displaced anteriorly relative to a plane defined by the first platform.

[0064] In another aspect of the method, the one or more openings may be configured into a heart-shape.

[0065] In another aspect of the method, the method may further comprise securing a connecting element to at least the second component.

[0066] In another aspect of the method, the method may further comprise connecting a second tissue anchoring apparatus to a first tissue anchoring assembly via the connecting element.

[0067] In another aspect of the method, engaging the locking component may comprise rotating the locking component by 90 degrees from a first orientation to a second orientation.

[0068] In another aspect of the method, the locking groove may further comprise one or more detents.

[0069] In another aspect of the method, the prong may further define one or more openings which extend transversely through the prong for encouraging tissue ingrowth.Attorney Docket No.: ABMDZ01700WQBRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1A shows a perspective view of an anchor (100) with a single prong (104) and two tines (112) having barbs (116).

[0071] Figure IB shows a perspective view of an anchor with first (100) and second (120) members with a single prong (104), and one or more tines (112), where the second member can slide along the prong. The second member has a groove (124) for accommodating a connecting element.

[0072] Figure 2A show a perspective view of an anchor with first (100) and second (120) members with a single prong (104), and one or more tines (112), where the second member has fingers (140) which engage with features (142) on the prong and resist movement of the second member along the prong. Figures 2B and 2C show perspective views of the anchor with first and second members illustrating the suture trough (124) defined upon the surface and extending from the edge of the second member in alignment with the opening (108) along the single prong.

[0073] Figures 3A and 3B show cross-sectional side views of an anchor with first (100) and second (120) members illustrating how a suture length (152) or other connecting element may be positioned along the suture trough (124) to extend through the single prong (104) and out along an opening (110) defined along the base (102) of the single prong.

[0074] Figure 4 shows a cross-sectional view of an anchor such as in Figure 3 used with a similar anchor to approximate tissue (160) in conjunction with a suture (152).

[0075] Figure 5 shows a perspective view of an anchor with first (100) and second (120) members with a single prong (104), and one or more tines (112) without barbs, where the second member has fingers (140) which engage with features (142) on the prong and resist movement of the second member along the prong. The base (102) of the first member is shown having fenestrations (170) and the base (122) of the second member is shown having an additional (third) eyelet (126) in the area of the suture trough (124).

[0076] Figure 6 shows a perspective view of an anchor with first (100) and second (120) members with a single prong (104), and one or more tines (112) without barbs, where the second member has fingers (140) which engage with features (142) on the prong and resist movement of the second member along the prong. The base (102) of the first member is shown having fenestrations (170) and four tines (112) while the second member has eyelets (126).

[0077] Figure 7 shows a perspective view of an alternate design an anchor similar to Figure 6.Attorney Docket No.: ABMDZ01700WQ

[0078] Figure 8 shows a perspective view of an anchor design consisting of a posterior first member (100) with barbed (116) tines (112), a tri-lobe post (104), and bosses (182) to limit the travel, limiting approximation of the anterior second member (120) towards the posterior first member (100) as it slides on the posterior member post (104).

[0079] Figure 9 shows a cross-sectional view of an anchor where the anterior member (120) has a projection (190) which fits within the slot (108) on the post (104) of the posterior member (100).

[0080] Figure 10 shows a cross-section view of an anchor where the post (104) of the posterior member (100) and the hole (128) of the anterior member (120) are tri-lobed.

[0081] Figure 11 A shows a perspective view of an anchor with a penta-lobe post (104), bosses (182) to limit the travel of the second member (120) along the post of the first member (100), tines (112) with barbs (116) on both the first and second members, a reinforcing ring (180) protruding above the surface of the second member around the post hole (128), a protrusion (190) on the hole of the second member which is aligned in the slot (108) on the post of the first member, and concave edge elements (130) on the second member to guide the placement of additional connecting elements which do not directly interact with the first or second members.

[0082] Figure 11B shows a cross-sectional view (through the prong, perpendicular to the platforms) of the anchor of Figure 11 A.

[0083] Figure 11C shows a cross-sectional view (through the platform of the second member, perpendicular to the axis of the prong) of the anchor of Figure 11 A.

[0084] Figure 12 shows a pair of anchors as shown in Figures 11 A, 11B, and 11C with a connecting element (152) securing the two anterior members (120) relative to the posterior members (100) and the two anchors relative to each other. Not shown is the tissue between the members. The suture path demonstrates curved or radiused surfaces to minimize sharp bends in the suture which may cause high focal stress on the suture leading to possible failure of the suture.

[0085] Figure 13A shows a perspective view of an unassembled anchor having three components. The first component (200) having a round prong (202) that has truncated sides near the tip (206), cross holes (208) in the prong, an eyelet (216) displaced toward the second component, and tines (212). The second component (220) having tines (224), three eyelets (226, 228), and detents (230) for the third component. The third, locking component (240) having an eyelet (244) and an oblong hole (246) for interfacing with the notches (204) on the prong. The eyelet (244) may be configured into any numberAttorney Docket No.: ABMDZ01700WQ of shapes for accommodating the passage of a connecting element such as a suture through the eyelet (244). For example, the eyelet (244) may be configured into an oval, elliptical, or circular configuration or it may be configured as a heart-shaped opening which may allow for the passage of suture at any angle relative to the eyelet opening.

[0086] Figure 13B shows the anchor of Figure 13A partially assembled.

[0087] Figure 13C shows a cross-sectional view of the anchor of Figure 13B with the locking component (240) not engaged with the notches (204) on the prong (202). This view also shows the prong being hollow (218) for part of the length.

[0088] Figure 13D shows the anchor of Figure 13A fully assembled.

[0089] Figure 13E shows a cross-sectional view of the anchor of Figure 13D with the locking component (240) engaged with the notches (204) on the prong (202). This view also shows the prong being hollow (218) for part of the length.

[0090] Figure 14A shows a perspective view of an unassembled anchor having three components. The first component (260) having a round prong (262) that has tracks (264) for a bayonet-style locking mechanism, a “stop” shoulder (268) that limits the translation of the second component towards the platform of the first component, an eyelet (276) displaced toward the second component, and tines (272). The second component (280) having tines (284), and three eyelets (286, 288). The third, locking component (300) having an eyelet (304) and pins (308) for interfacing with the tracks on the prong.

[0091] Figure 14B shows a side view of the first component of Figure 14A.

[0092] Figure 14C shows a cross-sectional view of the anchor of Figure 14A with the second component and third component slid onto the prong of the first component with the third component not rotated into the locked position.

[0093] Figure 14D shows a cross-sectional view of the anchor of Figure 14A with the second component and third component slid onto the prong of the first component with the third component rotated into the locked position.

[0094] Figure 15A shows a perspective view of an unassembled anchor having three components. The first component (320) having a round prong (322) that has truncated sides along the entire length, cross holes (328) in the prong, an eyelet (336) displaced toward the second component, and tines (332). The second component (340) having tines (344), detents (350) on the anterior component for the locking component, and three eyelets (346, 348). The third, locking component (360) having an eyelet (364) and an oblong hole (370) for interfacing with the notches on the prong (324).Attorney Docket No.: ABMDZ01700WQ

[0095] Figure 15B shows the anchor of Figure 15A with the second component slid onto the prong of the first component with the third component not yet assembled.

[0096] Figure 15C shows a perspective view of the anchor of Figure 15 A with the third component slid onto the prong of the first component above the second component but with the third component not rotated into the locked position.

[0097] Figure 15D shows a top view of the anchor as in Figure 15C with the locking component not engaged with the notches on the prong.

[0098] Figure 15E shows a perspective view the anchor of Figure 15A fully assembled with the third component rotated into the locked position.

[0099] Figure 15F shows a top view of the anchor as in Figure 15E with the locking component engaged with the notches on the prong.

[0100] Figure 16A shows a perspective view of an unassembled anchor having three components. The first component (380) having a round prong (382) that has truncated sides along the entire length, multiple notches (384) for assembling the anchor at different heights, a “stop” shoulder (388) that limits the translation of the second component towards the platform (390) of the first component, an eyelet (396), and tines (392). The second component having tines (404), three anterior eyelets (406, 408), and detents (410) on the anterior component for the locking component. The third, locking component (420) having an eyelet (424) and an oblong hole (430) for interfacing with the notches on the prong.

[0101] Figure 16B shows a front view of the assembled anchor of Figure 16A with the second and third components at the lowest notch on the prong.

[0102] Figure 16C shows a front view of the assembled anchor of Figure 16A with the second and third components at the middle notch on the prong.

[0103] Figure 16D shows a front view of the assembled anchor of Figure 16A with the second and third components at the highest notch on the prong.

[0104] Figure 16E shows a cross-sectional view of the assembled anchors of Figure 16D.

[0105] Figure 17 shows perspective view of an assembled anchor similar to the anchor of Figure 15 with the third component (460) not having an integrated eyelet.

[0106] Figure 18A shows a series of assembled anchors similar to those shown in Figure 13 in the tissues of the abdominal wall with the sharp tips of the prongs truncated and with a connecting element (530) such as suture run through the eyelets of the anchors.Attorney Docket No.: ABMDZ01700WQThe assembled anchors having three separate components (500, 510, 520). This view is of the outer (anterior) wall of the abdomen.

[0107] Figure 18B shows the series of assembled anchors of Figure 18A from the inside of the abdomen.

[0108] Figure 18C shows a cross-sectional view of the assembled anchors of Figure 18A and 18B.

[0109] Figure 19A shows a side view of an assembled anchor with a prong extending from a first member with a dovetail shape that mates with a prong extending from a second member having the inverse dovetail shape.

[0110] Figure 19B shows a cross-sectional view of the assembled anchor of Figure 19A.DETAILED DESCRIPTION OF THE INVENTION

[0111] A tissue anchor is described that attaches to soft tissue edges (or near the edges) and allows for the application of distributed tensile force across said soft tissues.

[0112] The embodiments for the soft tissue anchor described may be made partially or entirely from bioabsorbable (bioresorbable) materials. Bioabsorbable materials may include, but are not limited to, polylactic acid (PLA), polyglycolic acid (PGA), lactic / glycolic acid copolymers (PLGA), polydioxanone (PDO, PDS), trimethylene carbonate (TMC), and polycaprolactone (PCL). Also included in this bioresorbable materials are the various co-polymers of these materials such as PLA-co-TMC or PLGA- co-PDO.

[0113] Alternatively, the devices may be made partially or entirely from materials that are not bioabsorbable. Non-bioabsorbable materials could include stainless steel, titanium, polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), or other materials which do not significantly degrade in the body.

[0114] The various embodiments may have antibiotics, active pharmaceuticals, and / or antimicrobials as a surface coating or incorporated into the material.

[0115] The prongs and tines described below may have any of a variety of geometries. These include, but are not limited to, cylindrical shaped, oval, rectilinear, conic, parabolic, or other shapes. The tips of the prongs and tines (104, 114, 206, 212, 224, 266, 272, 284, 326, 332, 344, 386, 392, 404, 448, 444) can also take multiple forms such a cutting, atraumatic, traumatic, multi-bevel, ‘pencil’ tip, etc. The prong (202, 262, 322,Attorney Docket No.: ABMDZ01700WQ382) may have a protrusion (“stop” shoulder) (268, 388) which may project radially from the surface of the prong at a distance or may be defined by a change in the diameter or cross-section of the prong that limits the extent to which the second member can glide along the post towards the first member. In addition, the tines and prongs may be barbed or have other features which tend to resist any tendency of the tine to pull out of the tissue. The prong(s) may be hollow or partially hollow, forming a lumen (218, 524) along at least part of the length of prong. The lumen may serve as a passageway for engaging suture; it may serve to reduce polymer volume; and / or it may create a passage for tissue ingrowth - thereby improving long-term stabilization of the device and / or obliterating a potential passageway from intra- to extra-peritoneal. In addition, the prong may have one or more openings along the length of the prong which allows a connecting element such as suture which is passed through the lumen of a prong to exit at desired point(s) or along a desired region of the prong.

[0116] The prong may have one or more cross holes (208, 328, 526) which serve to reduce polymer volume and / or provide a passage for tissue ingrowth, thereby improving long-term stabilization of the device and / or obliterating a potential passageway from intra- to extra-peritoneal. These cross holes may also be combined with a lumen (218, 524) as described above with the lumen extending partially or completely through the tissue.

[0117] The prong may have a locking groove to accept a securement element for maintaining orientation in any axis between the first and second element. This locking groove can be a flat groove (204, 324, 284) which interacts with the securement element or the locking groove may define a cam surface or track (264) for one or more pins (308) to follow, similar to a ‘bayonet lock’. This design can be reversed to have the track on the securement element and the pins on the prong.

[0118] In one embodiment (perspective view of Figure 1 A), an anchor (100) having a base or platform (102, 210, 270, 330, 390) has one or more prongs (104, 202, 262, 322, 382) which penetrate through the abdominal wall, typically from either an intra- or pre- peritoneal position and including the posterior rectus sheath (where present), the muscles, and anterior rectus sheath (fascia) where tensile strength is greatest, and / or tines (112, 212, 272, 332, 392, 444) to further distribute tension within desired tissue regions. The anchor may comprise a base defining one or more openings therethrough with one or more prongs that may project away from the base either in a normal direction or angled relative to a plane defined by the base. The prong(s) may also define a first diameter or thickness, preferably less than 5 mm to obviate the need for fascial closure should a device beAttorney Docket No.: ABMDZ01700WQ repositioned or undergoes early dislodgement, and may also define any number of cross- sectional shapes, including round, oval, triangular, square, or other polygon whether regular or not. Additionally, the prongs may extend at a distance of, e.g., 7 to 25 mm (although longer lengths may be needed for unusually thick abdominal walls), to help ensure that the prongs can extend through the entire thickness of the abdominal wall to which the anchor is to be secured. Excess portions of the lengths may be removed as described in further detail herein. One or more of the prongs may be hollow, presenting a lumen (150) of sufficient length such that all or substantially all of the prong length in the tissue is hollow. The lumen is such a diameter that one or more pieces of a surgical suture may be passed through the lumen (lumen preferably 0.5mm diameter or larger). The lumen may also have a non-circular shape. One section of the wall of such prong may have one or more openings (108) such that the prong may be truncated after insertion into the tissue and allow the suture to exit the lumen without being elevated above the level of the surrounding tissue by the wall of the prong. One or more tines shorter than the prong(s) may be arranged on the base and configured such that they pass completely or partially through the tissues of the abdominal wall. The tines and / or prongs may have undercuts or barbs (116) which would tend to resist the device disengaging from the tissues.

[0119] The prong may have a region for accepting a securement component such as a ratchet, locking washer, bayonet coupling component, etc. For a locking washer, the prong may form or contain a region (204, 324, 384) wherein part of the circumference is squared-off to allow placement of a quarter-turn locking washer. For a bayonet coupling component, the prong may contain a region with grooves (264) to accept the coupling protrusions (308) of the locking component. Additionally, grooves may facilitate a ratchet coupler. Threads may accept a nut-type of locking mechanism. Other locking mechanisms (pins, heating of the polymer to create a locking- “head”, mechanical deformation, etc.) may be utilized.

[0120] A prong(s) may also be positioned over the base to provide a stable securement relative to the tissue to which they are attached. The examples shown illustrate one prong (104, 202, 262, 322, 382) extending from the base (102, 210, 270, 330, 390, 442) but other variations may utilize greater numbers of prongs which may be positioned at alternate locations of the base. The prongs may have undercuts or barbs which would tend to resist the device disengaging from the tissues.

[0121] Tines (112, 212, 272, 332, 392, 444) may also be incorporated to extend from the base such that they each define a second diameter or thickness, e.g., 1 to 6 mm,Attorney Docket No.: ABMDZ01700WQ and may also define any number of cross-sectional shapes, as described hereinabove for prongs. Additionally, the tines may extend at a relatively shorter distance of, e.g., 1 to 8 mm, than the prongs to help ensure further engagement with the tissue but may not extend through the entire thickness of the tissue. Furthermore, the tines may be positioned at multiple positions on the base around the prong or around and in-between the prongs if more than one prong is present. The tines may have undercuts or barbs (116) which would tend to resist the device disengaging from the tissues.

[0122] While the one or more tines (112, 212, 272, 332, 392, 444) may be used to pierce partially into the tissue and help secure a position of the base, the one or more tines may be optionally omitted entirely from the base (102, 210, 270, 330, 390, 442).Alternatively, other variations may include a base having the one or more tines, each configured with a length commensurate with a length of the prong such that the one or more tines extend entirely through the tissue thickness. The lengths of the one or more tines extending from the tissue surface may be left unaltered or they may be optionally truncated so that the one or more tines are reduced in length so as to remain flush with the tissue surface.

[0123] The variations of the tines being omitted entirely or varied in length, for example, extending entirely through the tissue thickness, may be combined in any combination with any of the different embodiments described herein.

[0124] To protect the viscera, the anchors are typically installed with the prongs passed from the inside of the abdomen towards the outside. This safety measure does not restrict the anchors to only that usage and an alternative is to pass the prong from the outside of the abdomen towards the inside.

[0125] The anchor may be composed of two members, the first (100) as shown in Figure 1A paired with a second member (120) configured to be used in conjunction with the first member in order two sandwich a region of tissue between the two members with the prong(s) (104) of the first member passing through the tissue and through hole(s) (128) on the second member such that the second member can be moved along the prong(s) of the first member. The first member may also have one or more eyelets configured on the platform to allow for a connecting element such as suture to be passed through the eyelet(s). Where an eyelet is present on the first member, it may be anterior displaced such that a suture running from one assembly to a second assembly within the abdomen is likely to lie flush against the posterior abdominal wall. The second member may include a base (122) which may optionally have one or more tines (112) configured on the surface of theAttorney Docket No.: ABMDZ01700WQ base which is in contact with tissue. The tine(s) preferably have a tip (114) configured to penetrate tissue and may optionally have one or more barbs (116) arranged along the length of the tine(s). The second member may also have one or more eyelets (126) configured on the platform to allow for a connecting element such as suture to be passed through the eyelet(s). The platform of the second member may also have a depression such as a groove or trench (124) along the surface of the platform which is configured to extend from a periphery of the platform to the hole (128) such that the groove or trench (124) allows the connecting element to lie in close proximity to the surface of the tissue. The groove or trench (124) may also prevent the connecting element from sliding over the surface of the platform. The groove may be positioned such that it aligns from a location at or near the hole for the prong in the platform towards an edge of the platform. In the case where the prong has hole(s) (108) in the side to allow the connecting element to exit along the length of the prong lumen, the groove in the second platform is ideally aligned with the hole in the prong.

[0126] With a matching anchor on the opposite side of the wound or incision, a connecting element, which may be a flexible and biocompatible element such as a suture (152, 530), can be passed through the lumens and / or eyelets, connecting the suture anchors on each side of the incision to one another, thus holding the edges of the abdominal wall in apposition during healing. The associated internal base of the anchor in the abdomen may have a thinner section, a trough, or an anteriorly displaced eyelet relative to the plate that allows suture passing on the internal surface of the abdominal wall to rest on, within, or only minimally proud of the posterior surface of the abdominal wall, thereby minimizing the risks to the viscera.

[0127] In another embodiment, the components may be reversed such that the base or platform may be inserted from the exterior with prongs through the wall.

[0128] In one embodiment, two prongs (556, 566) may be directed towards each other from opposite sides of the abdominal wall (anterior and posterior) such that they conjoin within tissue either through a dovetail-type engagement or other interlocking shapes. These interlocking shapes may be composed of one or more elements from each side. The interlocking shapes may include ratchet features that secure the two components relative to each other rotationally (around the axis of the prongs) or longitudinally (along the length of the prongs).

[0129] Anchors similar to the previous embodiments may be coupled or secured to a second member (120, 220, 280, 340, 400, 450, 500) having a base or platform (122, 222,Attorney Docket No.: ABMDZ01700WQ282, 342, 402, 452) (as shown in the perspective views of Figure 2), preferably superficial to the anterior rectus sheath (fascia). In such embodiments the anchor may comprise a base (first member) (102) with one or more prongs (104) that are placed from the interior of the abdominal wall to its external surface, with the prongs extending through the thickness of the wall and a base or platform (second member) (122) on the exterior of the wall which clips, snaps, screws, or is otherwise attached to the prong(s) from the first member (100). The variation shown in Figure 2 illustrates how the second member (120) may also comprise a base defining one or more openings (128) and one or more tines (112) which extend from the base of the second member in the same manner as tines (112) of the first member (100). In some embodiments, the second member is able to slide on the prong(s) of the first member. In such a case, a suture or other connecting (securement) element can be used to hold the first member and second member in position such that the prong(s) does not slide out of the receiving structures of the second member. It is also desirable in some embodiments to arrange one or more structures which limit the sliding of the first and second member relative to each other. Features such as snaps (190) near the distal tips of the prong(s) can assist maintaining the second member on the prong of the first member prior to suture placement or prevent the second member from sliding off the first member. Bosses or other features such as the tines may be arranged and dimensioned on one or both of the platforms or on the post(s) to limit how closely together the platforms may slide. In the embodiment shown in Figure 8, protrusions (182, 268, 388) are arranged at one or more locations around the prong of a first member, limiting how close the platform of the second member can be to the platform of the first member.

[0130] Alternatively, a third element (240, 300, 360, 420, 460, 510) may be utilized to secure the second element relative to the first. The third element may consist of a locking-washer, bayonet coupling mechanism, screw-on nut, pin, etc. A locking washer may include an eyelet (244, 304, 364, 424, 512) that may match an eyelet (226, 286, 346, 406, 502) on the second element such that a suture is passed through both, thus reducing the risk of the locking washer becoming disengaged from rotational dislodgment. The eyelet may be heart-shaped to facilitate suture-needle placement from an angle away from the post of the first element.

[0131] In an embodiment with a locking washer, the travel of the locking washer along the prong of the first element may be limited by a change in profile of the prong of the first element, “stop” shoulders on the prong of the first element that limit the travel of the second element along the prong and thereby limit the travel of the third element, or byAttorney Docket No.: ABMDZ01700WQ using an instrument to deploy the third element which limits the travel relative to the first element.

[0132] An embodiment whereby the locking features as described above are integrated into the second element can also be realized when the first and or second elements do not have secondary piercing features (tines). Then the first and second elements can be rotated relative to each other to engage the locking features.

[0133] As similarly described with respect to the one or more tines (112) extending from the base (first member) (102), the one or more tines (112) extending from the second member (120) may be used to pierce into the tissue and help secure it. In one variation, the one or more tines may be optionally omitted entirely from the second member.Alternatively, other variations may include a second member having the one or more tines each configured with a length commensurate with a length of the prong such that the one or more tines extend entirely through the tissue thickness. The lengths of the one or more tines extending from the tissue surface may be left unaltered or they may be optionally truncated so that the one or more tines are reduced in length so as to remain flush with the tissue surface.

[0134] The variations of the tines (112) being omitted entirely or varied in length from the second member (120) may be combined in any combination with any of the different embodiments of the one or more tines (112) extending from the base (first member) (102) and are intended to be within the scope of this description. For example, the first member (100) and / or second member (120) in one variation may both omit the tines entirely. In another variation, the first member may include the one or more tines while the second member may omit the tines entirely or vice versa. In yet another variation, the first member and second member may each include the respective one or more tines each with uniform lengths or each having different lengths from either or both of the first and second members.

[0135] One or more of the openings (128) or receiving channels of the second member may further correspond to the positioning of the prong(s) (104) extending from the first member (100). In this manner, the second member (120) may be positioned so that the prong(s) from the first member extends through the corresponding opening(s) defined in the second member while allowing for the first member and the second member to maintain an orientation relative to one another while sandwiching the tissue thickness between each of the members. The orientation may be in any axis such as anterior- posterior, planar along the tissue surfaces, rotational, etc. The one or more tines (112) ofAttorney Docket No.: ABMDZ01700WQ the second member may be oriented to point towards the first member, as shown, to further secure the tissue between each of the members.

[0136] With a corresponding matching anchor assembly on the opposite side of the wound or incision, a connecting element (152), e.g., wire, suture, etc. can then be passed through the lumens (150) and / or eyelets and connect the suture anchors on each side of the incision to one another, thus holding the edges of tissue in apposition during healing and / or reinforcing an additional tissue repair at the incision. In addition, suture can act to hold the bases of both the first and second members in contact with the tissue. In another embodiment, the components may be reversed such that the base or platform may be inserted from the exterior with prong(s) through the wall. The bases of the anchors may have a thinner section(s), trough(s) (110,124), or an anteriorly displaced (relative to the plate) posterior eyelet(s) that allows suture passing along a surface of the abdominal wall to rest on, within, or minimally proud of the face of the abdominal wall. Any eyelet may have a heart-shaped orifice or otherwise non-round shape to facilitate suture-needle passage from a variety of angles.

[0137] In several embodiments (Figures 2 to 8), the anchor comprises a first member (100) (also referred to as a posterior plate or base), with one or more prongs (104) extending perpendicularly from the plate (102), as previously described, that are placed from the interior of the abdominal wall with the prongs extending through the thickness of the abdominal wall towards the external surface and a second member (120) (also referred to as an anterior plate or base), on the exterior of the abdominal wall, preferably subcutaneously. The second member may have integrated features such as one or more flexible finger(s) (140) that engage with one or more notch(es) (142) or similar geometry on the prongs from the plate of the first member. The flexible fingers may be configured as cantilevered members which are biased into contact against the prong surface to allow the second member to slide down the prongs towards the first member but may or may not have a different force resisting sliding off (away from the plate) due to engagement of the fingers against the notches when urged in the opposite direction. The fingers or pawls may be arranged on one or more sides of the prongs. In Figures 2A-2C, flexible fingers are shown which act on multiple sides of the prongs. Specifically, a posterior member has a prong or prongs with ridges or rings provided on all or part of each prong. In the example of fingers on the second member (Figures 2A, 2B, and 2C), the fingers (140) engage the notch (142) on the prong to hinder separation from the prong. The example shown has four fingers but the number of fingers can be varied based on the diameter of the prong, theAttorney Docket No.: ABMDZ01700WQ force to resist motion relative to the prong, or limitation of manufacturing methods. Similarly, the thickness, length, and width of the fingers can be varied to achieve desired forces and accommodate the materials and methods of construction. In some embodiments the fingers and notches may be configured such that they can only be engaged in one rotational orientation around the prong or such that after engagement of the fingers to the notches, the ability of the second member to rotate around the axis of the prong is similarly limited. In Figure 2 A this is achieved with one or more longitudinal ribs (144) interrupting the circumferential notches (142) around the prong.

[0138] Alternative to multiple circumferential notches, a single groove may be positioned on the prong to receive a locking washer. The circumference of the prong may be partially amputated along all or part of the prong’s length to allow for a quarter- turn locking washer mechanism. Similarly, another embodiment may include grooves in the post to accept protrusions in a bayonet coupling element, a ratchet element, or threaded grooves to accept a screw-on nut shaped device.

[0139] Figures 2A, 2B, and 2C show perspective views of the anchor with the first and second members to illustrate a connecting channel (124) such as a groove or trough for receiving the connecting element such as a suture, where the connecting channel is defined upon the surface of the second member (120) and extending from the edge of the platform (122) of the second member in alignment with the opening (108) along the single prong. In addition, the first member illustrates a groove or slit (110) on the plate that allows the connecting element to lie flush or sub-flush with the tissue surface.

[0140] Figures 13A, 13B, 13C, 13D, 13E, 15A, 15B, 15C, 15E, 17, 18B, and 18C show an anteriorly displaced posterior eyelet. In Figures 13A, 13B, 13C, 13D, 13E, 15A, 15B, 15C, 15E this is combined with a heart-shaped orifice (346).

[0141] Figures 3A and 3B show cross-sectional side views of the anchor with the first and second members illustrating how a suture length (152) may be positioned to lie within the channel of the second member (120) along the platform (124) of second member to extend through one or more openings (108) or channels in communication with the lumen (150) defined at least partially through a length of the single prong (104). As shown, the suture may extend through the lumen and out along a secondary opening (110) defined along the base of the single prong or along the first member. With the first and second members secured to, for example, the internal and external surfaces of the tissue, the suture may reside and slide, if needed, along the connecting channel of the second member, within the lumen, and along the opening of the single prong without directlyAttorney Docket No.: ABMDZ01700WQ imparting medial force on the tissue so that tearing of the suture through the tissue is reduced.

[0142] As shown in Figure 4, with a matching anchor on the opposite side of the wound or incision, a suture (152) can then be passed through the lumens (150) and connect the suture anchor assemblies on each side of the incision to one another, thus holding the edges of tissue (160) in apposition during healing and / or reinforcing an additional tissue repair at the incision. In addition, the suture can act to hold the bases ( 102, 122) of both the first and second members (100,120) in contact with the tissue, thus lessening the strength required in, for example, flexible fingers to hold the members in position relative to each other. In another embodiment, the components may be reversed such that the base or platform may be inserted from the exterior with prongs through the wall. The bases of the anchors may have a thinner section(s) (110,124) or troughs that allows the suture passing within the surface of the abdominal wall to rest on, within, or only minimally proud of the surface of the abdominal wall.

[0143] Similar to the other embodiments described, a first member (100) having one or more posts (104) with a lumen(s) and optionally one or more tines (112) and a slot (110) through the base for the connecting element to lay on the surface or slightly in the surface can be combined with a second member (120) with one or more holes (128) corresponding to the one or more posts of the first members and further optionally having one or more tines (112). In this embodiment, the second member has a reinforcing ring (180) around the post hole(s) which may be raised. Such ring(s) may optionally have projection(s) (190) which fit into slot(s) (108) on the post(s). Additionally, in some cases it is desirable to radius the base of the post(s) and the surfaces of the ring(s) and projection(s) so that the connecting element (152), such as suture, has a smooth path without sharp corners or small radii which would otherwise cause a localized stress concentration in the connecting element(s) and potentially lead to premature failure of the connecting elements. Both the first and / or second-member bases may have one or more edge contours (130) to indicate to the user where to place additional suture or other reinforcing elements that, while not passing through the described plates, are located in some proximity to the members to help maintain the wound edges in apposition.

[0144] Figures 13A, 13B, 13C, 13D, 13E, 15A, 15B, 15C, 15D, 15E, 16A, 16B, 16C, 16D, 16E, 17, 18A, 18B, and 18C demonstrate a third element (240, 360, 420, 460, 510) for securement of the second element on the first element in the form of a locking-Attorney Docket No.: ABMDZ01700WQ washer. The post-circumference is partially or completely amputated on the sides to facilitate a quarter-turn lock.

[0145] Detents (protrusions) (230, 350, 410) are present on the second element which engage with depressions or holes, such as on the heart-shaped eyelet (244, 406) or oblong hole for the prong (370, 430, 464) on the third element to reduce the risk of rotational dislodgement. Alternatively, the protrusions may be arranged on the third element to interact with depressions or holes on the second element in a similar manner. In another embodiment, the protrusion / depression features may interact between the prong of the first element and the third element.

[0146] Figures 5, 6, and 7 show a variety of embodiments demonstrating different configurations that are possible. These include adding fenestrations (170) to the first or second member to reduce mass, tailor the strength, or encourage tissue ingrowth. The number and shapes of the tines (112) on both members can also be tailored to change the area of device which penetrates the tissue and thereby distributes the forces acting on the anchor across a larger or smaller area of tissue contact. In contradistinction to Figures 1 and 2, which include barbs (116) on some or all of the tines of both members, Figures 4, 5, and 6 show tines with no barbs. The number and locations of eyelets (126) on the members can also be changed to allow for more or fewer engagement points for suture to interact with the anchors. The shape and sizes of the members can also encompass a range including circular, semi-circular, triangular, quadrilateral, or any desired shape to enable the desired device performance elements including numbers of eyelets, tines, fenestrations and ratchet fingers. Any of the first members (or similar shapes) can be combined with any of the second members (or similar shapes).

[0147] In each of these embodiments described, the first member (100) may alternatively be referred to as a posterior plate or base due to its relative positioning within the body and the second member (120) may alternatively be referred to as an anterior plate or base also due to its relative positioning within the body and relative to its position with respect to the posterior plate or base. The reverse may also be described.

[0148] Any of the anchors described above may be bioabsorbable, thus avoiding a permanent footprint of foreign material that can later lead to complications such as infection.

[0149] One or more holes (126) may be placed in either or both members of the device to allow for suture passage, as shown in anterior plates (122) in the various embodiments herein. The suture from one anchor can connect to an anchor on theAttorney Docket No.: ABMDZ01700WQ contralateral side such that each of the anchors is interconnected to the other. The suture and anchor complex may hold the abdominal wall edges in apposition while healing occurs and / or reinforcing an additional tissue repair at the incision. The suture holes may be provided on the anterior, posterior, or multiple members of the anchor.

[0150] In many embodiments described, the prong(s) (104) extending from the first member (100) may be cut, broken, or melted above the second member (120) after assembly to limit excessive length of prongs protruding above the second member into or through subcutaneous tissues superficial to the abdominal wall.

[0151] The prong may be partially or completely hollowed (218, 524) to allow suture passage, to reduce polymer volume, and / or to facilitate tissue ingrowth. Cross-holes (208, 328, 526) may be included to further reduce polymer and facilitate tissue ingrowth separately or in combination with a hollow prong.

[0152] In several of the embodiments described, such as in the case of only one prong (104) extending from a first member (100) through a second member (120), it is advantageous to include features to control the rotational angle of the second member around the axis of the prong of the first member. These features may include one or more projections (190) from one of the members arranged to fit into a slot (108) of the other member. Alternatively, the same functionality may be achieved by using a non-round, non-uniform profile on the prong and the mating hole in the second member.

[0153] Figure 10 shows a tri-lobe prong (104) which mates with a tri-lobe hole (128) in the second member (120). This prong is hollow for the majority of its length with a slot (108) extending from the base of the tip (106) to a fixed distance above the platform (102). The “stop” shoulders (172) on the sides of the prong may be configured such that the distance between plates is to be longer than the tines (112) of both platforms, or alternatively, the tines from one platform may be configured to pass alongside the opposite platform or through a hole in the opposite platform. The hole (128) of the second member is slightly larger than the prong and the “stop” shoulders on the prong extend from the sides of the prong in an overlapping dimension such that when the second member slides along the prong, the rim of the hole comes into contact with the surface of the “stop” shoulders and limits further motion of the second member towards the platform (102) of the first member (100). The height of the “stop” shoulders on the prong of the first member is configured such that the base of the slot (108) in the wall of the prong does not extend above the rim of the hole in the second member. In some cases, it may be desirable to eliminate the “stop” shoulders on the prong and instead to utilize the tines contacting theAttorney Docket No.: ABMDZ01700WQ opposing platform(s) to limit the translation of the second member along the prong of the first member. A similar height of the tines relative to the slot position on the prong, as described for the “stop” shoulder position, is possible.

[0154] In embodiments with only one prong, it is desirable to limit the rotation of the second member around the axis of the prong of the first member. One embodiment which achieves this goal includes a round prong (104), a round hole (128) in the second member configured to pass along the prong, and a tongue-like projection (190) from the inner edge of the hole that engages with the slot (108) of the prong. This embodiment is shown in Figure 9 which is a cross-sectional view through the platform of the second member. The projection interacts with the slot to limit rotation of the second member around the longitudinal axis of the prong. The surfaces of the projection of the second member can be configured to provide a radiused or otherwise smooth surface to any connecting element passed through the lumen of the anchor and over this projection.

[0155] In other embodiments it is desirable to use a non-circular prong (104) on the first member (100) and a similarly shaped hole (128) in the second member (120) to limit rotation of the second member around the longitudinal axis of the first member. This embodiment is shown in Figure 10 which is a cross-sectional view through the platform of the second member. In this case, the prong is tri-lobal.

[0156] One embodiment combining a number of the features described in previous examples is shown in Figures HA (perspective view), 11B (cross-sectional view through the prong perpendicular to the platforms), and 11C (cross-sectional view through the platform of the second member perpendicular to the prong axis). The first member (100) consists of a platform (102) with one hollow prong extending from the platform. The prong is penta-lobal in cross section with a slot (108) extending from near the tip (106) to a short distance above the platform. Two small “stop” shoulders (172) are arranged on the sides of the prong. Two shorter tines (112) with barbs (116) are arranged on the platform. Additionally, the platform has two fenestrations (170) and a slot (110) which allows a suture to rest against the surface of the tissue that the anchor is in rather than being suspended from the surface by the platform. A second member (120) may define a hole (128) in the second platform (122) with the hole having a similar penta-lobal shape as the prong. A projection (190) from the rim of the hole extends into the slot of the prong. The hole also has a raised rim (180) to increase strength. Similarly, to the first member, the second member also has multiple barbed tines (four) (112). Rather than eyelets for additional suture engagement, two semi-circular notches (130) are arranged on one edge ofAttorney Docket No.: ABMDZ01700WQ the second member to provide a visual guide for placing sutures which do not directly engage with the anchor.

[0157] The first member (100) of one anchor can be inserted into tissue so that the prong (104) and tines (112) penetrate into the first surface of a region of tissue with the distal end protruding beyond the opposite surface of the tissue. The second member (120) can then be pushed down over the exposed prong such that the tines (112) of the second member penetrate the second surface of the tissue. A second anchor can be inserted in a similar fashion into another region of tissue separate from the first anchor by an incision or gap. The two regions of tissue can then be approximated toward each other by placing a connecting member (152) through the lumens (150) of both anchors and / or through the holes (128) of the second members. Such a connecting member can then be used to approximate the two regions of tissue toward each other. Multiple such pairs of anchors can be used together to approximate a larger region of tissue.

[0158] Figure 12 shows a pair of anchors as shown in Figures 11A, 11B, and 11C with a connecting element (152) securing the two anterior members (120) relative to the posterior members (100) and the two anchors relative to each other. Not shown is the tissue between the members. The suture path demonstrates curved or radiused surfaces to minimize sharp bends in the suture which may cause high focal stress on the suture leading to possible failure of the suture.

[0159] In the various embodiments described with a round prong, a multifaceted prong may be utilized and achieve the same effect. In the various embodiments describing a prong with two flat truncated sides, the number of truncated sides can be as few as one or more than two.

[0160] Figure 13A shows a perspective view of an unassembled anchor having three components. The first component (200) having a round prong (202) that has truncated sides near the tip (206), cross holes (208) in the prong, an eyelet (216) displaced toward the second component, and tines (212). Although the prong (202) may have a round or circular cross-sectional area, the prong in this and other embodiments shown herein may be configured to have other shapes (e.g., elliptical, triangular, rectangular, square, pentagonal, hexagonal, etc.). The second component (220) having tines (224) which extend from the second component (220) and project towards the first component (200), a receiving opening (234) through which the prong (202) may be inserted, three eyelets (226, 228), and detents (230) for the third component. Alternatively, the second component (220) may be configured to have two eyelets or more than three eyelets in this and otherAttorney Docket No.: ABMDZ01700WQ embodiments shown herein depending upon the configuration. The third, locking component (240) having at least one eyelet (244) and a hole (246) which may correspond in shape to the prong (202) and for interfacing with notches (204) on the prong.

[0161] Figure 13B shows the anchor of Figure 13A partially assembled in which the second component (220) may be engaged with the first component (200) by inserting the prong (202) into a sliding engagement through the receiving opening (234). The first component (200) and second component (220) may be aligned relative to one another such that each of the platforms are oriented into alignment with one another. The locking component (240) may also be placed upon the assembly by inserting the prong (202) into hole (246). A distal portion of the prong (202) may be shaped to have a non-uniform crosssection and the hole (246) may be configured to have a similar cross-sectional opening so that the locking component (240) may be received upon the prong (202) in a first orientation relative to the second component (220). The example shown illustrates how the locking component (240) may be initially placed upon the prong (202) so that its major axis LI (defined as an axis bisecting locking component (240) through the eyelet (244) and hole (246)) is parallel with the major axis L2 (defined as an axis extending through the elongate direction of second component (220)) of second component (220). Although the axes LI, L2 are shown parallel relative to one another, other variations may have the axes oriented in other angles relative to one another.

[0162] Figure 13C shows a cross-sectional view of the anchor of Figure 13B with the locking component (240) not engaged with the notches (204) on the prong (202). This view also shows the prong being hollow (218) for part of the length.

[0163] Figure 13D shows the anchor of Figure 13A fully assembled in which locking component (240) may be rotated about the prong (202) so that major axis LI of locking component (240) is reoriented to be transverse (or at a second angle) relative to major axis L2 of second component (220). The locking component (240) may be rotated about the notches (204) so that opening (246) becomes locked into a securement engagement about prong (202) so that locking component (240) is inhibited from sliding off the prong (202) and is maintained in its position thereby preventing the second component (220) from sliding off the prong (202). In securing the locking component (240), it may be rotated in a clockwise direction relative to the second component (220) as viewed from a top-down perspective until the locking component (240) engages the detent(s) (230). For example, the locking component (240) may be rotated up to 90 degrees or more although in other variations, the angle of rotation may be less than 90 degrees. InAttorney Docket No.: ABMDZ01700WQ order to disengage the locking component (240) and second component (220), the locking component (240) may be rotated in the opposite direction (e.g., counter-clockwise). The locking component (240) may be advanced upon the prong (202) initially facing the opposite direction in which case the locking component (240) may be rotated in a counterclockwise direction relative to the second component (220) as viewed from a top-down perspective until the locking component (240) engages the detent(s) (230).

[0164] Figure 13E shows a cross-sectional view of the anchor of Figure 13D with the locking component (240) engaged with the notches (204) on the prong (202). This view also shows the prong being hollow (218) for part of the length.

[0165] Figure 14A shows a perspective view of an unassembled anchor having three components. The first component (260) having a round prong (262) that has tracks (264) for a bayonet-style locking mechanism, a “stop” shoulder (268) that limits the translation of the second component towards the platform of the first component, an eyelet (276) displaced toward the second component, and tines (272). The tracks (264) in this variation may include a first receiving section which is longitudinally aligned with the length of the prong (262). A second receiving section may extend from the first receiving section and curve into a circumferential direction which is transversely oriented relative to the first section so that as the locking component (300) is advanced over the prong (262), a keyed projection or pin (308) projecting within the opening (306) of the locking component (300) may follow the first receiving section as the locking component (300) is initially advanced along the prong (262) and then rotated along the second receiving section to then lock or engage the locking component (300) to the prong (262). As described hereinabove, the prong (262) of this embodiment as well as other embodiments described, may be configured in any number of other cross-sectional profile shapes. The second component (280) having tines (284), and three eyelets (286, 288). The third, locking component (300) having an eyelet (304) and projections such as pins (308) for interfacing with the tracks on the prong.

[0166] Figure 14B shows a side view of the first component of Figure 14A.

[0167] Figure 14C shows a cross-sectional view of the anchor of Figure 14A with the second component and third component slid onto the prong of the first component with the third component not rotated into the locked position.

[0168] Figure 14D shows an angled cross-sectional view of the anchor of Figure 14A with the second component and third component slid onto the prong of the first component with the third component rotated into the locked position.Attorney Docket No.: ABMDZ01700WQ

[0169] Figure 15A shows a perspective view of an unassembled anchor having three components. The first component (320) having a round prong (322) that has truncated sides along the entire length, cross holes (328) in the prong, an eyelet (336) displaced toward the second component, and tines (332). The second component (340) having tines (344), detents (350) on the anterior component for the locking component, and three eyelets (346, 348). The third, locking component (360) having an eyelet (364) and an oblong hole (370) for interfacing with the notch on the prong (324).

[0170] Figure 15B shows the anchor of Figure 15A partially assembled.

[0171] Figure 15C shows a top view of the anchor of Figure 15B with the locking component not engaged with the notches or detents on the prong.

[0172] Figure 15D shows the anchor of Figure 15A fully assembled.

[0173] Figure 15E shows a top view of the anchor of Figure 15D with the locking component engaged with the notches on the prong.

[0174] Figure 16A shows a perspective view of an unassembled anchor having three components. The first component (380) having a round prong (382) that has truncated sides along the entire length, multiple notches (384) for assembling the anchor at different heights, a “stop” shoulder (388) that limits the translation of the second component towards the platform (390) of the first component, an eyelet (396), and tines (392). The second component having tines (404), three anterior eyelets (406, 408), and detents (410) on the anterior component for the locking component. The third, locking component (420) having an eyelet (424) and an oblong hole (430) for interfacing with the notches on the prong. The notches on the prong are similar to the singular notch shown in Figure 15. The two or more notches are distributed such that the lowest notch corresponds with the thinnest tissue anticipated to be anchored and the highest notch corresponds with the thickest tissue anticipated to be anchored. A sufficient un-notched section of prong needs to be between each notch to assure the prong can hold the third component in the notch below.

[0175] Figure 16B shows a front view of the assembled anchor of Figure 16A with the second and third components at the lowest notch on the prong.

[0176] Figure 16C shows a front view of the assembled anchor of Figure 16A with the second and third components at the middle notch on the prong.

[0177] Figure 16D shows a front view of the assembled anchor of Figure 16A with the second and third components at the highest notch on the prong.Attorney Docket No.: ABMDZ01700WQ

[0178] Figure 16E shows a cross-sectional view of the assembled anchors of Figure 16D.

[0179] Figure 17 shows perspective view of an assembled anchor similar to the anchor of Figure 15 with the third component (460) not having an integrated eyelet.

[0180] Figure 18A shows a series of assembled anchors similar to those shown in Figure 13 (although any of the anchor variations described may be used) in the tissues of the abdominal wall with the sharp tips of the prongs truncated and with a connecting element (530) such as suture running through the eyelets of the anchors. The assembled anchors having three separate components (500, 510, 520). This view is of the outer (anterior) wall of the abdomen. With the anchor openings oriented to face along the opening or edge of the wound, a single connecting element (530) may be passed through each of the anchors in a single continuous, running connecting element or suture. Alternatively, individual pairs of anchors positioned opposite to one another across the wound may be coupled to one another forming multiple interrupted suture connections in order to close the wound edges.

[0181] Figure 18B shows the series of assembled anchors of Figure 18A from the inside of the abdomen illustrating how the connecting element (530) may pass through each anchor and connect to the opposite anchor along the interior tissue surface.

[0182] Figure 18C shows a cross-sectional view of the assembled anchors of Figure 18A and 18B with a connecting element (e.g., suture) running through the eyelets. In this example, the connecting element is shown passing through the eyelet (512) of the locking component (510), the eyelet (502) of the second component (510), and through the eyelet (522) of the first component (520) for coupling with the corresponding eyelets of an opposing anchor for approximating a wound edge positioned between the anchors. The connecting element may, of course, be passed through all three eyelets of an anchor or through fewer than three eyelets. Additionally, the connecting element is shown as being positioned a distance away from the main body of the prong and component body although the connecting element may be positioned a closer distance to the prong as well. Because the connecting element is passed through an interior surface of the eyelets as well as the upper surface of the eyelet (502) and (512) and the lower surface of the eyelet (522), the connecting element is prevented directly from contacting against the upper tissue surface and lower tissue surface in proximity to the eyelets which may help to prevent cutting or extrusion of the connecting element through the tissue itself.Attorney Docket No.: ABMDZ01700WQ

[0183] Furthermore, the second component (500) may be further prevented from sliding towards the first component (520) by the presence of the tissue sandwiched between. The third locking component (510) may be seen secured against the prong of the first component (520) so that the second component (500) is further inhibited or prevented from sliding proximally off of the prong.

[0184] Figure 19A shows a side view of an assembled anchor with a prong extending from a first member with a dovetail shape that mates with a prong extending from a second member having the inverse dovetail shape.

[0185] Figure 19B shows a top view of the assembled anchor of Figure 19A illustrating how the two separate prong members may interlock with one another in a sliding engagement. Such an embodiment enables the first component (550) and second component (562) to slide relative to another while maintaining an engaged translation.

[0186] Many of the embodiments shown use a quarter-turn (e.g., 90 degree rotation) for the locking engagement. However, securement is not limited to such quarterturn embodiments. Rather, any amount of rotation could be used such as 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, or 180 degrees or any range of degrees between any of the values shown.

[0187] In the various anchor embodiments utilizing a connecting element (152, 530), such as suture, to apply a force which holds two opposing regions of tissue in position relative to each other or to bring two opposing regions of tissue together, there is a tensile force in the connecting element which acts parallel, or nearly parallel, to the tissue surfaces in the segments where the connecting element is arranged parallel to the tissue surfaces. This tensile force converts to an axial force along the direction of the prong. The resultant axial tension provides a force that tends to bring the first member and second member closer to each other. This force may cause a deeper engagement of tines within the tissue , or instead of modifying the texture of the tissue contacting surfaces, the friction force between the anchor surfaces and the tissue surfaces can also be enhanced through use of an adhesive. Some examples of adhesives which are biocompatible and could serve this purpose include but are not limited to fibrin glue, collagen adhesive, gelatine-resorcinol- formaldeyde (GRF), urethane prepolymer adhesives, and cyanoacrylate.

[0188] The anchor assemblies are ideally deployed from an applier instrument. The instrument may include physical limitations to device placement. In one embodiment, the applier is advanced parallel to the tissue plane on both the deep and superficial surface ofAttorney Docket No.: ABMDZ01700WQ the tissue until a purposely determined limit is reached wherein an applier component abuts the tissue plane edge. Ideally, the limitation prevents penetrating components of the anchor assembly from passing through tissue more than 3 cm from the midline, thus avoiding passage of penetrating components near the superior or inferior epigastric arteries as well as main branches of intercostal nerves. The limitation of placement beyond 3 cm from the midline with or without the combination of atraumatic tips for all penetrating components of the anchor assembly increases the safety profile of device in abdominal wall surgery.

[0189] It is specifically contemplated that any of the features described with respect to a particular embodiment may be combined with the features of any other embodiment such that any number of combinations are permissible.

[0190] The applications of the devices and methods discussed above are not limited to wound closure but may include any number of further treatment applications. Moreover, such devices and methods may be applied to other treatment sites within the body.Modification of the above-described assemblies and methods for carrying out the invention, combinations between different variations as practicable, and variations of aspects of the invention that are obvious to those of skill in the art are intended to be within the scope of the claims.

Claims

Attorney Docket No.: ABMDZ01700WQCLAIMSWhat is claimed is:

1. A tissue anchoring apparatus, comprising: a first component having a first platform and a prong projecting from the first platform, wherein the prong includes a distal portion which defines a locking groove; a second component having a second platform which defines an opening sized to receive the prong therethrough; and a locking component which defines a lock opening sized to correspond to the locking groove when the locking component is positioned in a first orientation relative to the locking groove, wherein the locking component is inhibited from translating distally along the prong when the locking component is rotated into a second orientation from the first orientation.

2. The apparatus of claim 1 further comprising one or more first piercing tines extending from a first surface of the first component.

3. The apparatus of claim 1 further comprising one or more second piercing tines extending from a second surface of the second component.

4. The apparatus of claim 1 wherein the second component defines one or more openings along an edge of the second component.

5. The apparatus of claim 4 wherein the one or more openings has a heart-shaped configuration.

6. The apparatus of claim 4 wherein the locking component defines one or more openings along an edge of the locking component.

7. The apparatus of claim 6 wherein the one or more openings of the locking component are configured to align with the one or more openings of the second component when the locking component is rotated into the second orientation.

8. The apparatus of claim 1 wherein the first component defines one or moreAttorney Docket No.: ABMDZ01700WQ openings along an edge of the first component.

9. The apparatus of claim 8 wherein the one or more openings of the first component are displaced anteriorly relative to a plane defined by the first platform.

10. The apparatus of claim 8 wherein the one or more openings are configured into a heart-shape.

11. The apparatus of claim 1 further comprising a connecting element for attaching to at least the second component.

12. The apparatus of claim 11 wherein the connecting element attaches to the one or more openings of the second component and to the one or more openings of the locking component.

13. The apparatus of claim 11 further comprising a second tissue anchoring apparatus which is connectable to a first tissue anchoring assembly via the connecting element.

14. The apparatus of claim 1 wherein the locking component is rotatable by 90 degrees from the first orientation to the second orientation.

15. The apparatus of claim 1 wherein the locking groove comprises a first portion which is aligned with a length of the prong and a second portion connected to the first portion and which is transversely configured relative to the first portion.

16. The apparatus of claim 1 wherein the locking groove further comprises one or more detents.

17. The apparatus of claim 1 wherein the second component further comprises one or more detents.

18. The apparatus of claim 1 wherein the prong further defines one or more openings which extend transversely through the prong for encouraging tissue ingrowth.Attorney Docket No.: ABMDZ01700WQ19. A tissue anchoring apparatus, comprising: a first component having a first platform and a prong projecting from the first platform having one or more openings defined along an edge of the first component wherein the one or more openings is displaced anteriorly relative to a plane defined by the first platform; and a second component having a second platform which defines an opening sized to receive the prong therethrough.

20. The apparatus of claim 19 further comprising a locking component which defines a lock opening sized to correspond to a locking groove along the prong when the locking component is positioned in a first orientation relative to the locking groove, wherein the locking component is inhibited from translating distally along the prong when the locking component is rotated into a second orientation from the first orientation.

21. The apparatus of claim 20 wherein the locking component is rotatable by 90 degrees from the first orientation to the second orientation.

22. The apparatus of claim 20 wherein the locking groove comprises a first portion which is aligned with a length of the prong and a second portion connected to the first portion and which is transversely configured relative to the first portion.

23. The apparatus of claim 20 wherein the locking groove further comprises one or more detents.

24. The apparatus of claim 20 wherein the second component further comprises one or more detents.

25. The apparatus of claim 19 further comprising one or more first piercing tines extending from a first surface of the first component.

26. The apparatus of claim 19 further comprising one or more second piercing tines extending from a second surface of the second component.Attorney Docket No.: ABMDZ01700WQ27. The apparatus of claim 20 wherein the second component defines one or more openings along an edge of the second component.

28. The apparatus of claim 27 wherein the locking component defines one or more openings along an edge of the locking component.

29. The apparatus of claim 28 wherein the one or more openings of the locking component are configured to align with the one or more openings of the second component when the locking component is rotated into the second orientation.

30. The apparatus of claim 20 further comprising a connecting element for attaching to at least the second component.

31. The apparatus of claim 30 wherein the connecting element attaches to the one or more openings of the second component and to the one or more openings of the locking component.

32. The apparatus of claim 30 further comprising a second tissue anchoring apparatus which is connectable to a first tissue anchoring assembly via the connecting element.

33. The apparatus of claim 19 wherein the prong further defines one or more openings which extend transversely through the prong for encouraging tissue ingrowth.

34. A method of approximating tissue via a tissue anchoring assembly, comprising: piercing a prong projecting from a first platform of a first component through a tissue region to be approximated such that the prong passes from a first tissue surface to a second tissue surface of the tissue region; positioning a second component upon the prong such that a second platform is placed into contact against the second tissue surface; and engaging a locking component upon a locking groove defined along a distal portion of the prong by rotating the locking component at least partially about the prong such that the second component is inhibited from translating distally along the prong.Attorney Docket No.: ABMDZ01700WQ35. The method of claim 34 wherein piercing the prong further comprises piercing one or more first piercing tines extending from the first platform into the first tissue surface.

36. The method of claim 34 wherein positioning the second component upon the prong further comprises piercing one or more second piercing tines extending from the second platform into the second tissue surface.

37. The method of claim 34 wherein the second component defines one or more openings along an edge of the second component.

38. The method of claim 37 wherein the one or more openings has a heart-shaped configuration.

39. The method of claim 37 wherein the locking component defines one or more openings along an edge of the locking component.

40. The method of claim 39 wherein positioning the second component further comprises aligning one or more openings of the locking component with the one or more openings of the second component.

41. The method of claim 34 wherein the first component defines one or more openings along an edge of the first component.

42. The method of claim 41 wherein the one or more openings of the first component are displaced anteriorly relative to a plane defined by the first platform.

43. The method of claim 41 wherein the one or more openings are configured into a heart-shape.

44. The method of claim 34 further comprising securing a connecting element to at least the second component.

45. The method of claim 44 further comprising connecting a second tissue anchoring apparatus to a first tissue anchoring assembly via the connecting element.Attorney Docket No.: ABMDZ01700WQ46. The method of claim 34 wherein engaging the locking component comprises rotating the locking component by 90 degrees from a first orientation to a second orientation.

47. The method of claim 34 wherein the locking groove further comprises one or more detents.

48. The method of claim 34 wherein the second component further comprises one or more detents.

49. The method of claim 34 wherein the prong further defines one or more openings which extend transversely through the prong for encouraging tissue ingrowth.

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