Abdominal closure method and device variations

Abstract

To provide abdominal closure reinforcement methods and tissue anchoring devices for reducing the rate of abdominal wall closure dehiscence.SOLUTION: The tissue anchors avoid a permanent footprint of foreign material and preclude materials spanning the interior layer of the abdominal closure where risk to visceral structures exists.SELECTED DRAWING: Figure 11

Description

[Technical field]

[0001] The present invention relates to methods and apparatus for distributing tension across an abdominal wall closure to aid in healing and avoid arytenosis, while simultaneously protecting the intraperitoneal viscera from device-related damage. [Background technology]

[0002] A ventral hernia occurs when there is a defect in the fascia and / or muscle of the anterior abdominal wall. The defect or formation in the abdominal wall most often occurs when a previous fascial incision does not heal adequately (incisional hernia), but may also occur during pregnancy or newly formed lesions.

[0003] Approximately 4 million open abdominal surgeries are performed in the United States, and incisional hernia is a commonly reported postoperative complication that occurs in up to 20% of patients after an attempt at abdominal closure. Figure 1 shows the abdomen A of a patient showing common locations of abdominal wall hernias, e.g., epigastric hernia, ventral hernia, and incisional hernia.

[0004] Treatment techniques for abdominal wall hernias typically fall into three categories: (1) covering the defect with a prosthetic or biological patch (e.g., mesh), (2) closing the defect under some tension and supporting the closure with a prosthetic or biological patch, and (3) separation of abdominal wall elements, in which one or more layers of abdominal wall muscle and fascia are divided and the elements advanced toward the midline to close the defect without a gap in the abdominal wall, usually supported by a patch. All techniques have significant disadvantages, many of which are associated with the use of patches.

[0005] Mesh used to cover abdominal wall defects or support fascial closure is a foreign body with all the inherent risks that foreign bodies pose. The two greatest risks in this situation are infection and erosion of vital structures such as the bowel. Both are devastating events. If an infection occurs, whether acute or delayed, removing the mesh from the tissue that has grown between it can be surgically traumatic, if not impossible. Intestinal erosion can not only cause infection, but can also be life-threatening and reduce quality of life by allowing the bowel contents to leak freely into the abdominal cavity, the mesh, or a hole in the skin (enterocutaneous fistula). Figure 2 shows an example of a mesh 10 that has eroded into the surrounding bowel tissue.

[0006] An additional situation that abdominal surgeons often encounter is the difficulty of closing the abdomen after trauma or extensive abdominal surgery. In such a situation, the intraperitoneal volume increases due to the expansion of abdominal contents, making abdominal wall closure impossible or performed under excessively high tension. However, soft tissues cannot withstand high tension and generally cannot maintain attachment until healing occurs, resulting in abdominal hernias. Surgeons attempt to prevent arytenosis (separation) by using large sutures to hold the abdominal wall in place during the early postoperative phase. Examples are shown in FIG. 3, which shows a retaining suture with backing members 20 placed on either side of incision I, and FIG. 4, which shows a retaining suture 30 directly across the midline of incision I along abdomen A.

[0007] As shown in the schematic detailed cross-sectional view of FIG. 5, the retaining suture 40, by design, typically has segments that extend across the midline of the incision closure both above and below (deep to) the abdominal wall AW. The suture 40 is positioned such that a potential trapping space is created between the suture 40 and the posterior abdominal wall. Vector arrows 44 indicate the net direction of force at the turn point of the suture 40 at the posterior fascia and skin. The segment that is below (deep to) the abdominal wall threatens the underlying intestinal tissue. In addition, the retaining suture 40, like a typical suture, is relatively stiff and sharp, and may cut into tissue leading to incision dehiscence and repair failure. The length of the suture placed on the skin surface may be surrounded by a tubular member 42 to prevent or inhibit erosion into the skin. Summary of the Invention [Problem to be solved by the invention]

[0008] One approach to abdominal obturator arytenosis is to maintain the side-to-side relationship of the abdominal wall fascial edges; (a) avoid longitudinal material deep in the abdominal wall (as opposed to retaining sutures) to prevent device trauma to the underlying bowel and organs; (b) avoid permanent meshes and other materials that are prone to complications even years after surgery; (c) allow for easy placement of tissue anchors; and (d) distribute tension over as many points and as wide an area as is practical. [Means for solving the problem]

[0009] Typically, soft tissue anchors penetrate completely through one or more layers of soft tissue and attach to opposing soft tissues to distribute tension forces across the soft tissues to approximate wound or incision edges or to hold tissues together. Tissue anchors can be used in combination with sutures, and both the anchor and suture are bioabsorbable, so as not to leave permanent foreign body marks that may later cause infection or other complications. Bioabsorbable materials include, but are not limited to, polylactic acid (PLA), polyglycolic acid (PGA), polylactic / glycolic acid (PLGA), polydioxanone (PDO, PDS), polycaprolactone (PCL), and the like.

[0010] In other embodiments, non-bioabsorbable materials may be used in various volumes in combination with the tissue anchors, including, but not limited to, stainless steel, titanium, polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), and other materials that degrade less over time in the body.

[0011] In another embodiment, the tissue anchor may include a first tissue anchor having a distal anchor member coupled to a proximal anchor member by a connecting member. The distal anchor member may be configured with one or more piercing elements, such as teeth, extending away from the platform of the distal anchor member to project toward the proximal anchor member. Similarly, the proximal anchor member may have one or more teeth extending from the platform of the proximal anchor member to project toward the distal anchor member. The connecting member may be pivotally coupled to at least one of the distal and proximal anchor members, such that the anchor members can pivot and angle relative to each other and relative to the connecting member. Alternatively, one or both of the anchor members may be attached to the connecting member at a predetermined fixed angle to facilitate fixation to the underlying tissue.

[0012] In use, the distal anchor member may be positioned against a tissue surface (e.g., along the abdominal wall) near or adjacent a first edge of the wound or incision such that one or more tines extend to penetrate at least partially posteriorly into tissue such as the anterior rectus sheath where the tensile strength of the medial medial abdominal wall is greatest. The connecting member may completely penetrate the skin and / or abdominal wall such that the proximal anchor member is positioned along an opposing tissue thickness such as the posterior rectus sheath above the arcuate line. One or more tines of the proximal tissue anchor may extend forward and pierce at least partially into tissue such that the intervening tissue thickness is sandwiched between the first and second tissue anchors. For purposes of discussion, the relative terms closer to the body core are referred to as "proximal" and "distal" are used as relative terms further from the body core.

[0013] The second tissue anchor may be secured near or adjacent a second edge of the wound or incision directly opposite or staggered opposite the first tissue anchor. Similarly, the second tissue anchor may have a distal anchor member having one or more teeth that project at least partially into the underlying tissue and a proximal anchor member having one or more teeth that project at least partially forwardly into the underlying tissue. The distal and proximal anchor members may be coupled to one another by a connecting member that extends through a thickness of the secured tissue region.

[0014] With the tissue anchors secured to the first and second edges of the wound or incision, each of the distal anchor members may be coupled to one another by a connecting member, such as a suture, which may be secured to each of the tissue anchors, for example, through one or more openings disposed in the device to allow passage of the suture. A suture from one tissue anchor, for example, can be connected to an opposing tissue anchor, such that the assembly of suture and tissue anchor holds the edges in alignment while healing occurs.

[0015] Depending on the length of the wound or incision, any number of pairs of tissue anchors may be applied to the tissue to approximate and / or maintain wound closure, whereby each tissue anchor is applied adjacent to one another along the edges of the wound or incision. The anchors may be placed in opposing pairs across the wound or incision or may be staggered.

[0016] The connecting members passing through the fascia and muscle of the abdominal wall may be angled or hinged relative to the corresponding anchor members to make the inner force of the suture more parallel to the anchor members. This helps reduce the anterior moment arm that tends to place all or most of the force on the anterior rectus sheath rather than the entire abdominal wall (anterior rectus sheath, rectus muscle, and posterior rectus sheath, if present). Additionally, each component of the tissue anchor is made of a fully bioabsorbable material, so that the tissue anchor may be left in place and absorbed by the body over time. Alternatively, a portion of the tissue anchor, such as the posterior anchor member and / or connecting member, may be bioabsorbable and the distal anchor member may not be bioabsorbable. Once the wound or incision has sufficiently healed and adhered, the distal anchor member may be detached from the tissue and removed, while the connecting and proximal anchor members remain in the body to be absorbed.

[0017] Another embodiment includes a first tissue anchor having a rear anchor member with one or more teeth extending distally at least partially into the overlying tissue. One or more posts each defining a lumen may project from the rear anchor member such that each of the posts penetrates an entire thickness of the fascial and / or dermal tissue when the anchor member is deployed against the inner tissue surface. The rear anchor member may extend at an angle relative to the anchor member such that the one or more posts emerge from the tissue at an angle.

[0018] With the second tissue anchor secured to the second edge of the wound or incision directly opposite the first tissue anchor, a flexible connecting member such as a suture can be threaded through each opening and through the corresponding post, threaded along the length of the tissue anchor, and connected to each of the tissue anchors. The suture can be tightened to bring and / or maintain the edges of the wound or incision closer together. The second tissue anchor can also have a rear anchor member with one or more teeth that protrude into the contacted tissue. One or more posts can protrude from the anchor member such that the suture can pass between the openings, through the post, through or along each anchor member, back up the post, and through the corresponding opening.

[0019] A further embodiment of a tissue anchor comprises a first platform with one or more teeth each projecting from the platform. The teeth may extend parallel to one another or one or more teeth may be at different angles to one another. A second platform may be individually attached to each of the teeth of the first platform at various levels or distances such that a tissue region, such as tissue near or adjacent the edge of a wound or incision, may be clamped or secured between the first and second platforms.

[0020] The first platform may have a trapezoidal configuration in variants, but may be formed in a variety of configurations (e.g., circular, oval, triangular, rectangular, rhomboid, etc.). Also, the second platform may be similar or the same shape as the first platform, with the first and second platforms oriented in the same direction. In other embodiments, the first and second platforms may each have a different shape or configuration from one another, provided that the second platform is connectable to the first platform.

[0021] The first edge may further define slots or channels disposed along the edge corresponding to the location of one or more teeth extending from the first platform. Thus, a first slot may be formed along the first edge at a location corresponding to the first tooth, and a second slot may be formed along the first edge at a location corresponding to the second tooth. A third slot may be formed along the first edge at a location corresponding to the third tooth, and a fourth slot may similarly be formed along the first edge at a location corresponding to the fourth tooth. Each slot corresponds to the number of teeth protruding from the first platform.

[0022] In use, one or more teeth of the first platform may be pierced into a tissue area (such as the interior of the abdominal wall) and advanced completely through the tissue thickness (e.g., through the fascia and skin, or at least through the anterior rectus sheath where the tensile strength of the tissue is greatest) until the tissue impinges against the first platform. A second platform may be positioned adjacent to the teeth protruding through the tissue area and then slid into engagement with the first platform by advancing and passing the teeth through corresponding slots. The second platform may engage with the first platform such that the two platforms are maintained parallel to one another. Each tooth may have a preformed area of ​​reduced diameter over which a corresponding slot may selectively engage to maintain a parallel orientation between the platforms. The second platform may be advanced along the teeth until the second platform fully engages the teeth at the end of the slot. The second platform may be positioned on an outer surface of the tissue (such as the outer abdominal wall or the surface of the skin) and positioned along the teeth such that the tissue thickness is sandwiched or securely held between the platforms. Any longitudinal portion of the tines that protrude beyond the second platform can be cut, broken, or otherwise removed so that the tissue anchor maintains a low profile relative to the tissue surface.

[0023] The second tissue anchor is similarly secured adjacent the edge of the wound or incision opposite the first tissue anchor, as described above, such that the first and second tissue anchors are attached or joined together to approximate the edges of the tissue and maintain apposition during healing. The tissue anchors can be secured, for example, by a longitudinal length of suture or other material attached through an opening formed along the second platform. In other embodiments, other longitudinal structures may be used in place of sutures, such as elastic members, springs, coils, ratcheting devices, longitudinal screws, adjustable or fixed staples, or other structures spanning from the first tissue anchor to the second tissue anchor to align and hold the abdominal wall tissue. If the teeth along each of the tissue anchors are angled relative to each other (or angled toward the wound or incision), the force exerted on the tissue by the tissue anchors being close together may be mitigated by the angle of the teeth relative to the first platform reducing the moment arm of the teeth relative to the tissue thickness.

[0024] Additionally, with the tissue anchor secured through the thickness of the tissue, as described herein, the entire tissue anchor may be fabricated from a bioabsorbable material, such that the tissue anchor may be left in place within the body after the tissue has healed, allowing it to degrade and be absorbed over time, eliminating the need to remove the tissue anchor. Alternatively, the first platform and tines may be formed from a bioabsorbable material, and the second platform may be formed from a non-bioabsorbable material, such as a plastic, metal, alloy, etc. Once the tissue area has healed, the second platform may be detached from the tines and then removed from the body, leaving the first platform and tines within the body to degrade and be absorbed.

[0025] Additionally and / or alternatively, the tissue anchors may be secured within the tissue in combination with absorbable or permanent mesh, biological sheets or inserts. One or more teeth may penetrate and pass through the mesh placed on the surface of the tissue. The mesh or biological element may be seated in any plane of the abdominal wall anatomy while secured by the tissue anchors.

[0026] One embodiment of a tissue anchor device may generally comprise a first platform forming one or more anchor members having a longitudinal portion extending from a surface of the first platform, each of the one or more anchor members having a distal piercing end and forming one or more shoulders along the longitudinal portion, and a second platform forming one or more channels extending from an edge of the second platform, the positions of the one or more channels along the edge corresponding to the positions of the one or more anchor members such that each of the one or more anchor members is slidably received along a corresponding channel while the one or more shoulders maintain an orientation of the second platform relative to the first platform.

[0027] One aspect of a method for securing a tissue region may include inserting one or more anchor members, typically extending from a surface of the first platform, through a thickness portion of the first tissue region adjacent the wound or incision, and engaging the second platform with the one or more anchor members of the first platform that protrude beyond the thickness portion of the first tissue region by sliding each of the one or more anchor members along corresponding channels extending from an edge of the second platform while maintaining an orientation of the second platform relative to the first platform, thereby securing the thickness portion of the first tissue region between the first platform and the second platform.

[0028] Another variation of the tissue anchoring assembly generally includes a first platform having one or more piercing members protruding from a first surface configured to contact a first tissue region, and one or more first tubular members extending from the first surface and configured to be disposed through the first tissue region, each of the one or more first tubular members forming a first opening. A second platform has one or more piercing elements extending from a second surface configured to contact a second tissue region. One or more second tubular members extending from the second surface and configured to be disposed through the second tissue region, each of the one or more second tubular members forming a second opening. Additionally, one or more longitudinal portions of a suture may extend between the first and second openings, such that the first and second platforms are configured to cooperatively approximate the first and second tissue regions.

[0029] Another embodiment of a tissue anchor may generally comprise a first platform having one or more piercing elements extending from a first surface configured to contact a first tissue surface, a tubular member extending from the first surface and configured to be positioned through a first tissue region, a distal end of the tubular member forming at least one opening, and a second platform having one or more piercing elements extending from a second surface configured to contact a second tissue surface opposite the first tissue surface.

[0030] Yet another embodiment of a tissue anchor may generally comprise a first platform having one or more piercing elements extending from a first surface configured to contact a first tissue surface, and one or more tubular members extending from the first surface and configured to be disposed through the first tissue surface, wherein each of the one or more tubular members may define a lumen extending therethrough such that each lumen of the one or more tubular members communicates with one another through the first platform, and wherein a proximal end of each of the one or more tubular members may define an opening in communication with a corresponding lumen. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 illustrates a patient's abdomen showing the common locations of ventral hernias. [Diagram 2] FIG. 2 shows an example of a mesh eroded by intestinal tissue. [Diagram 3] FIG. 3 shows an example where a large suture crosses the abdominal closure to hold the tissue in place during the early postoperative period. [Figure 4] FIG. 4 illustrates an embodiment of a retaining suture. [Diagram 5] FIG. 5 is an exemplary cross-sectional side view showing a commonly used method of placement of retaining sutures. [Figure 6] FIG. 6 shows a full thickness tissue anchor with no intraperitoneal portion crossing the closure. [Figure 7] FIG. 7 shows the suture loop passing through two hollow posts and then anchoring across the midline closure in the anterior abdominal wall. [Figure 8A] FIG. 8A illustrates a two-part anchor in which a platform having teeth is positioned on the inside of the abdominal wall and a receiving member having corresponding openings is positioned on the outside of the abdominal wall. [Figure 8B] FIG. 8B illustrates a two-part anchor in which a platform having teeth is positioned on the inside of the abdominal wall and a receiving member having corresponding openings is positioned on the outside of the abdominal wall. [Figure 8C] FIG. 8C illustrates a two-part anchor in which a platform having teeth is positioned on the inside of the abdominal wall and a receiving member having corresponding openings is positioned on the outside of the abdominal wall. [Figure 9] FIG. 9 is a side view of a two-part anchor showing how the teeth are angled relative to its base and receiving member. [Figure 10]FIG. 10 is a top view of an embodiment of a receiving member illustrating the receiving channels and openings. [Figure 11] FIG. 11 illustrates another embodiment in which opposing suture anchors each include a retaining member and a cap or fixation member that are attached to the teeth with one or more sutures (or other fixation elements or biasing members) extending between the anchors. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Soft tissue anchors that penetrate completely through one or more layers of soft tissue and attach to opposing soft tissues can distribute tension forces across the soft tissue to approximate the edges of a wound or incision or to hold the tissues together. In one embodiment, the tissue anchors can be used in combination with sutures, where both the anchors and the sutures are bioabsorbable and do not leave permanent traces of foreign material that may later cause complications such as infection. Bioabsorbable materials include, but are not limited to, polylactic acid (PLA), polyglycolic acid (PGA), polylactic / glycolic acid (PLGA), polydioxanone (PDO, PDS), polycaprolactone (PCL), and the like. Additionally, any number of tissue anchors may be deployed adjacently along the edges of a wound or incision to approximate pairs of tissue anchors at opposing edges of the wound or incision. Additionally and / or alternatively, tissue anchors may be deployed to hold the edges of a wound or incision together until the wound or incision has healed.

[0033] In other embodiments, non-bioabsorbable materials may be used in various volumes in combination with the tissue anchors, including, but not limited to, stainless steel, titanium, polyethylene (PE), polypropylene (PP), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), and other materials that degrade less over time in the body.

[0034] In another variation, the tissue anchors during deployment may include various mechanisms for holding the sutures under tension between two devices, one on each side of the wound or incision, with the devices clamping the abdominal wall between an inner cap and an outer cap. FIG. 6 shows an example of a cross-sectional view of a device having a first tissue anchor with a distal anchor member 50A coupled to a proximal anchor member 54A by a connecting member 58A. The distal anchor member 50A may be configured with one or more piercing elements, such as teeth 52A with piercing distal tips, extending away from the platform of the distal anchor member 50A to project toward the proximal anchor member 54A. Similarly, the proximal anchor member 54A may have one or more teeth 56A extending away from the platform of the proximal anchor member 54A to project toward the distal anchor member 50A. Connecting member 58A may be pivotally coupled to distal anchor member 50A and / or proximal anchor member 54A such that anchor members 50A, 54A can be pivoted and angled relative to each other and to connecting member 58A. Alternatively, one or both of anchor members 50A, 54A may be attached to connecting member 58A at a fixed angle to facilitate fixation to the underlying tissue.

[0035] In either case, during use, the distal anchor member 50A is positioned against a tissue surface (e.g., along the abdominal wall AW) near or adjacent a first edge of the wound or incision I, as shown, such that one or more teeth 52A extend at least partially posteriorly into tissue such as the anterior rectus sheath, where tensile strength is greatest inside the abdominal wall, or extend above the skin surface. The connecting member 58A may extend completely through the skin and / or fascia such that the proximal anchor member 54A is positioned along an opposing tissue thickness, such as the posterior rectus sheath, above the arcuate line. One or more teeth 56A of the proximal tissue anchor 54A may extend at least partially forwardly into tissue to pierce the intervening tissue thickness, such that the intervening tissue thickness is sandwiched between the first and second tissue anchors 50A, 54A.

[0036] The second tissue anchor may be secured near or adjacent to the second edge of the wound or incision I, directly opposite the first tissue anchor, as shown. Similarly, the second tissue anchor may have a distal anchor member 50A having one or more teeth 52B projecting rearwardly at least partially into the underlying tissue, and a proximal anchor member 54B having one or more teeth 56B projecting forwardly at least partially into the underlying tissue. The distal and proximal anchor members 50B, 54B may be coupled to one another by a connecting member 58B extending through the thickness of the secured tissue region.

[0037] With the tissue anchors secured to the first and second edges of the wound or incision I, each of the distal anchor members 50A, 50B may be coupled to one another by a connecting member, such as a suture S, which may be secured to each of the tissue anchors, for example, through one or more openings disposed in the device to allow passage of the suture S. The suture S from one tissue anchor may, for example, be connected to the opposing tissue anchor, such that the assembly of suture S and tissue anchors holds the edges in alignment while healing occurs.

[0038] Depending on the length of the wound or incision I, any number of pairs of tissue anchors may be applied to the tissue to approximate and / or maintain wound closure, whereby each tissue anchor is applied adjacent to one another along the edges of the wound or incision I.

[0039] As described, the connecting members 58A, 58B passing through the fascia and muscle of the abdominal wall AW may be angled or hinged relative to the corresponding anchor members to allow the inner force of the suture S to be more parallel to the anchor members. This may help reduce the anterior moment arm that tends to place all or most of the force on the anterior rectus sheath rather than the entire abdominal wall (anterior rectus sheath, rectus muscle, and posterior rectus sheath, if present). Additionally, each component of the tissue anchor is made of a fully bioabsorbable material, so that the tissue anchor may be left in place and absorbed by the body over time. Alternatively, a portion of the tissue anchor, such as the posterior anchor members 54A, 54B and / or connecting members 58A, 58B, may be bioabsorbable, and the distal anchor members 50A, 50B may be non-bioabsorbable. Once the wound or incision I has sufficiently healed and adhered, the distal anchor members 50A, 50B may be detached from the tissue and removed, leaving connecting members 58A, 58B and proximal anchor members 54A, 54B to be absorbed within the body.

[0040] Another embodiment is shown in the cross-sectional side view of Figure 7, which shows a first tissue anchor having a rear anchor member 70A with one or more teeth 72A extending distally at least partially into the underlying tissue. One or more posts 74A, 78A, each defining a lumen, may protrude from the rear anchor member 70A such that when the anchor member 70A is deployed against the inner tissue surface, each of the posts 74A, 78A penetrates the entire thickness of the fascial and / or dermal tissue. As discussed above, the rear anchor member 70A may have one or more posts 74A, 78A extending at an angle relative to the anchor member 70A such that the posts 74A, 78A emerge from the tissue at an angle, as shown.

[0041] With the second tissue anchor secured to the second edge of the wound or incision I directly opposite the first tissue anchor, a flexible connecting member such as a suture S can be threaded through each opening and through the corresponding post, passing a length of the tissue anchor to connect each of the tissue anchors. The suture S may be tightened to directly approximate or maintain the edges of the wound or incision I together. As shown, the second tissue anchor may also have a rear anchor member 70B having one or more teeth 72B that project into the contacted tissue. One or more posts 74B, 78B may project from anchor member 70B such that the suture S may pass between openings 80A, 80B, through posts 78A, 78B, through or along each anchor member 70A, 70B, back up posts 74A, 74B, and through the respective openings 76A, 76B.

[0042] Turning now to yet another embodiment, shown in perspective views in Figures 8A-8C, the tissue anchor 90 may be comprised of a first platform 94 having one or more piercing elements, such as elongated posts or teeth having piercing tips, each extending from the first platform 94. In one embodiment, the teeth may extend parallel to one another, or one or more teeth may be at different angles to one another. A second platform 102 may be individually attached to each tooth of the first platform 94 at various levels or distances such that a tissue region, such as tissue near or adjacent the edge of a wound or incision, may be clamped or secured between the first and second platforms 92, 102.

[0043] While the first platform 92 can be formed in a variety of configurations (e.g., circular, oval, triangular, rectangular, rhomboid, etc.), the embodiment shown in Figure 8A illustrates a platform 92 having a trapezoidal configuration. The illustrated embodiment may have a first edge 94 (e.g., having a length of 20mm to 50mm) parallel to a second edge 96, a second edge 96 (e.g., having a length of 10mm to 40mm) that is relatively shorter than the first edge 94, and two side edges 98, 100 (e.g., each having a length of 10mm to 50mm) that are angled in opposite directions and are relatively shorter than the first edge 94. The first platform 92 may have one or more teeth protruding from a surface of the platform 92 for attachment to a tissue region. In this example, two teeth 112, 114 are shown projecting from the first platform 92 proximate the apex between the first edge 94 and the corresponding side edge 98 and the apex between the first edge 94 and the corresponding side edge 100, and two further teeth 116, 118 are shown projecting from the first platform 92 similarly proximate the apex between the second edge 96 and the corresponding side edge 98 and the apex between the second edge 96 and the corresponding side edge 100. Each tooth 112, 114, 116, 118 is shown projecting parallel to each other at an angle to the platform 92, as will be described in more detail below. Also, one or more of the teeth may have a length from the first platform ranging from, for example, 5 mm to 50 mm.

[0044] The second platform 102 is shown to have a similar or identical shape to the first platform 92 such that the first and second platforms 92, 102 are oriented in the same direction. In other embodiments, the first and second platforms 92, 102 may each have a different shape or configuration from one another, provided that the second platform 102 is connectable to the first platform 92. In this example where the second platform 102 has the same configuration as the first platform 92, the second platform 102 may similarly have a first edge 104 and a second edge 106 parallel to one another, the second edge 106 being relatively shorter in length than the first edge 104. The two side edges 108, 110 may be angled in opposite directions from one another and are relatively shorter than the first edge 104.

[0045] The first edge 104 may further define slots or channels disposed along the edge 104 corresponding to the location of one or more teeth extending from the first platform 92. Thus, a first slot 120 may be formed along the first edge 104 at a location corresponding to the first tooth 112, and a second slot 122 may be formed along the first edge 104 at a location corresponding to the second tooth 114. A third slot 124 may be formed along the first edge 104 at a location corresponding to the third tooth 116, and a fourth slot 126 may similarly be formed along the first edge 104 at a location corresponding to the fourth tooth 118. As shown, the first and second slots 120, 122 may extend proximally along the second platform 102 toward corresponding side edges 108, 110, and the third and fourth slots 124, 126 may extend proximally along the second platform 102 toward the second edge 106. Additionally, each slot may correspond to a number of teeth protruding from the first platform.

[0046] In use, one or more tines 112, 114, 116, 118 of the first platform 92 may be pierced into a tissue area (such as the interior of the abdominal wall) and advanced completely through the tissue thickness (e.g., through the fascia and skin, or at least through the anterior rectus sheath where the tensile strength of the tissue is greatest) until the tissue impinges against the first platform 92. As shown in FIG. 8B, the second platform 102 may be positioned adjacent to the tines 112, 114, 116, 118 protruding through the tissue area and then slid into engagement with the first platform 92 by advancing the tines 112, 114, 116, 118 through and past the corresponding slots 120, 122, 124, 126. The second platform 102 may be engaged with the first platform 92 such that the two platforms 92, 102 are maintained in a parallel orientation relative to one another. Each tooth 112, 114, 116, 118 may have a predetermined area of ​​reduced diameter that selectively engages a corresponding slot 120, 122, 124, 126, as described in more detail below, to maintain a parallel orientation between the platforms 92, 102. As shown in FIG. 8C, the second platform 102 may be advanced along the teeth until the second platform 102 fully engages the teeth at the end of the slot. The second platform 102 may be positioned on an outer surface of the tissue (such as the outer abdominal wall or surface of the skin) and positioned along the teeth 120, 122, 124, 126 such that a thickness of tissue is sandwiched or securely held between each platform 92, 102. Any longitudinal portion of the teeth that protrude beyond the second platform 102 may be cut, broken, or otherwise removed so that the tissue anchor maintains a low profile relative to the tissue surface.

[0047] The second tissue anchor is similarly secured adjacent the edge of the wound or incision opposite the first tissue anchor, as described above, such that the first and second tissue anchors are attached or joined to one another to approximate the edges of the tissue and maintain the edges in apposition during healing. The tissue anchors may be secured, for example, by longitudinal lengths of suture or other material attached through openings formed along the second platform 102, as described in further detail below. In other embodiments, other longitudinal structures may be used in place of sutures, such as elastic members, springs, coils, ratcheting devices, longitudinal screws, adjustable or fixed staples, or other structures spanning from the first tissue anchor to the second tissue anchor to align and hold the abdominal wall tissue. When the teeth along each of the tissue anchors are positioned at an angle to each other (or toward the wound or incision), the force imparted to the tissue by the tissue anchors being closer together may be mitigated by the angle of the teeth relative to the first platform 92 reducing the moment arm of the teeth relative to the tissue thickness.

[0048] Additionally, with the tissue anchor secured through the thickness of the tissue, as described herein, the entire tissue anchor may be fabricated from a bioabsorbable material, such that the tissue anchor may be left in place within the body after the tissue has healed, allowing it to degrade and be absorbed over time, eliminating the need to remove the tissue anchor. Alternatively, the first platform 92 and tines may be formed from a bioabsorbable material, and the second platform 102 may be formed from a non-bioabsorbable material, such as a plastic, metal, alloy, etc. Once the tissue area has healed, the second platform 102 may be detached from the tines and then removed from the body, leaving the first platform 92 and tines within the body to degrade and be absorbed.

[0049] FIG. 9 is a side view of the first platform 92, teeth, and second platform 102 for illustrative purposes. As discussed above, one or more teeth may be configured with one or more predefined regions of reduced diameter into which a corresponding slot 120, 122, 124, 126 of the second platform 102 may selectively engage. Each tooth may be formed with a region where its outer diameter is a second, smaller diameter. For example, the tooth 112 may be formed with reduced regions 134i, 134ii, 134iii, 134iv, 134v, each separated by a shoulder 130B. Similarly, the tooth 116 may be formed with reduced regions 132i, 132ii, 132iii, 132iv, 132v, each separated by a shoulder 130A, such that each reduced region is formed to be relatively horizontal relative to one another between each tooth. For example, reduced region 132i may be formed to be level with reduced region 134i, reduced region 132ii may be formed to be level with reduced region 134ii, etc. Additionally, a tooth may be formed to have any number of reduced regions 132n, 134n, so long as each reduced region of each tooth is level with respect to one another. This allows the second platform 102 to be advanced to engage the tooth at each reduced region such that the second platform 102 remains parallel to the first platform 92, e.g., such that a first plane 136 formed by the first platform 92 is parallel to a second plane 138 formed by the second platform 102.

[0050] As discussed above, each tooth may be formed to project at an angle relative to the first platform 92. In this example, the teeth 116, 118 may define an angle α between the longitudinal axis 140 of the tooth relative to the plane 136 of the first platform 92, and the teeth 112, 114 may define an angle β between the longitudinal axis 142 of the tooth relative to the plane 136 of the first platform 92. Also, the angle α formed by the teeth 116, 118 may be the same or similar to the angle β formed by the teeth 112, 114 (e.g., in the range of 30 degrees to 90 degrees), but the angles between each tooth may vary from one another rather than being uniform. In addition, the height H defined by the teeth may be in the range of, for example, 5 to 50 mm. The height of each tooth may be uniform or may vary between each tooth as desired. In either case, the portions of the teeth that project beyond the second platform 102 when engaged with each other may be removed to maintain a low profile of the tissue anchor.

[0051] While the first platform 92 is illustrated as having four tines, in other embodiments, the platform 92 may be configured to have less than or more than four tines protruding from the platform 92. Additionally, the first platform 92 may optionally incorporate one or more second tines protruding from the first platform 92 between the tines. These second tines may be configured to be shorter in length than the first tines to partially penetrate tissue (e.g., the posterior rectus sheath) to further anchor the first platform 92 to tissue.

[0052] The tines may have a variety of cross-sectional shapes, such as circular, elliptical, rectangular, etc. Additionally, while the tines have been shown as having elongated piercing tips, they may also be formed in shapes such as conical, parabolic, etc. Additionally, the piercing tips of the tines may also be formed in a variety of configurations, such as cutting, atraumatic, atraumatic, multi-bevel, "pencil" tipped, etc.

[0053] As further shown in FIG. 9, the second platform 102 has a smooth surface for presentation against a tissue surface. Also, in another embodiment, one or more teeth may be formed to protrude from the second platform 102 for at least partially penetrating the underlying tissue. A top view of the second platform 102 is further shown in FIG. 10, showing each of the slots 120, 122, 124, 126 for receiving a corresponding tooth. The slots may extend from the first edge 104 and terminate at respective receiving ends 150, 152, 154, 156 configured to form shoulders for fixedly receiving the teeth. Additionally, the second platform 102 is shown as having one or more openings 158, 160, 162 proximate the first edge 104 for receiving a coupling member, such as a suture for attachment to another tissue anchor to approximate and / or maintain the position of the tissue.

[0054] Additionally and / or alternatively, the tissue anchors may be secured within the tissue in combination with absorbable or permanent mesh, biological sheets or inserts. One or more teeth may pierce and pass through the mesh placed on the surface of the tissue. The mesh or biological element may be seated in any plane of the abdominal wall anatomy while secured by the tissue anchors.

[0055] 11 shows an example of a first tissue anchor 90A attached to a second tissue anchor 90B, where the first tissue anchor 90A may be secured to a first edge proximate the wound or incision and the second tissue anchor 90B may be secured to a second edge proximate the wound or incision and directly opposite the first tissue anchor 90A. The illustrated secured tissue anchors 90A, 90B show an embodiment in which the teeth of each tissue anchor are angled toward one another while the respective second platforms 102A, 102B are joined to one another by sutures 174, 176. In this particular embodiment, the second platforms 102A, 102B may incorporate teeth 172A, 172B for attachment to an underlying tissue surface. Additionally, this embodiment may incorporate an additional fixation platform or cap 170A, 170B that may be positioned (partially or entirely) on each second platform 102A, 102B to engage a reduction along the tooth. This third fixation platform 170A, 170B may additionally anchor the second platform 102A, 102B to the tooth.

[0056] Additionally, various tools can be used to measure tension and ensure that the tissue does not experience pressures greater than about 32 mmHg (about 4.26632 kPa) due to static compressive forces from the tissue anchors (e.g., the first and / or second platform) to prevent tissue necrosis or damage, and thus the static compressive forces can be limited to a level that generally does not cause ischemic damage to the tissue.

[0057] The uses of the above-described devices and methods are not limited to wound closure, but may include any number of additional therapeutic applications. Moreover, such devices and methods may be applied to other treatment sites within the body. Modifications of the above-described assemblies and methods for carrying out the invention, combinations between different variations as may be practiced, and variations of aspects of the invention that are obvious to those skilled in the art are intended to be within the scope of the appended claims.

Claims

1. a first platform defining one or more anchor members having a longitudinal portion extending from a surface of the first platform, each of the one or more anchor members having a distal piercing end and defining one or more shoulders along the longitudinal portion; a second platform forming one or more channels, the positions of the one or more channels corresponding to the positions of the one or more anchor members, thereby receiving each of the one or more anchor members along a corresponding channel while maintaining an orientation of the second platform relative to the first platform by the one or more shoulders; a third platform positionable from a first disengaged position to an engaged position, the third platform being positioned on the second platform and moving along the one or more anchor members into engagement with a reduced portion, whereby the second platform is anchored relative to the one or more anchor members; 1. A tissue anchor device comprising:

2. The apparatus of claim 1 , further comprising a retention platform forming one or more openings corresponding to the locations of the one or more anchor members.

3. The assembly of claim 1 , further comprising one or more fixation elements attachable to a portion of the second platform for fastening to an additional tissue anchor positioned opposite the tissue anchor.

4. The assembly of claim 3 , wherein the one or more fixation elements include a suture or a biasing element having a longitudinal portion.

5. The assembly of claim 1 , wherein the first platform is in the form of a trapezoid having four anchor members.

6. The assembly of claim 1 , wherein each of the one or more anchor members extends parallel to one another from the surface.

7. The assembly of claim 1 , wherein each of the one or more anchor members is angled relative to the first platform.

8. The assembly of claim 1 , wherein the one or more shoulders are formed by a region of reduced diameter along the length of the one or more anchor members.

9. The assembly of claim 1 , wherein the second platform further comprises one or more second anchor members extending from a surface of the platform opposite the surface of the first platform.

10. The assembly of claim 9 , wherein the one or more second anchor members comprise teeth each having a smaller longitudinal portion from the first platform than the one or more anchor members.

11. The assembly of claim 1 , wherein the first platform and the second platform have a parallel orientation to one another.

12. The assembly of claim 1 , wherein each of the one or more anchor members has a uniform height relative to the surface of the first platform.

13. The assembly of claim 1 , wherein a portion of the one or more anchor members that extends beyond the second platform when engaged with the first platform is removable.

14. The assembly of claim 1 , wherein the first platform is configured to be bioabsorbable.

15. The assembly of claim 1 , wherein the second platform is configured to be bioabsorbable.

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