Tissue opening closure device

Abstract

The tissue opening closure device may include more than one suture deployed in multiple orientations near the border of the tissue opening. The suture may be pulled through a suture lock to tension the suture and close the tissue opening. The suture lock may be transitioned between a locked configuration and an unlocked configuration in which the tension in the suture may be adjusted.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION

[0001] The disclosed embodiments relate to tissue opening closure devices. [Background technology]

[0002]

[0002] Sutures and suturing techniques can be used to close openings formed in tissue. Summary of the Invention

[0003] In some embodiments, a tissue opening closure device includes a suture lock and a plurality of sutures extending through the suture lock. The suture lock can be configured to maintain a length of the plurality of sutures extending from the suture lock in a first locked configuration and to change a length of the plurality of sutures extending from the suture lock in a second unlocked configuration as the plurality of sutures are pulled through the suture lock. The suture lock can be configured to reversibly move between the first locked configuration and the second unlocked configuration.

[0004] In some embodiments, a tissue opening closure device includes a suture lock and a plurality of sutures, each of which may include a first portion attached to the lock and a second portion passing through an opening formed in the lock, wherein pulling on the second portion of the suture pulls the second portion of the suture through the lock.

[0005]

[0005] In some embodiments, a method of closing an opening formed in tissue includes deploying a plurality of sutures near a boundary of the opening formed in tissue; pulling the plurality of sutures through a suture locking portion to shorten the length of the plurality of sutures, thereby closing the opening; and locking the length of the plurality of sutures with the suture locking portion to maintain the shortened length of the sutures.

[0006]

[0006] It should be understood that the foregoing concepts and additional concepts discussed below may be arranged in any suitable combination, as the disclosure is not limited in this respect. Furthermore, other advantages and novel features of the present disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying figures. [Brief explanation of the drawings]

[0007]

[0007] The accompanying drawings are not intended to be drawn to scale. In the drawings, identical or nearly identical components shown in various figures may be represented by like reference numerals. For clarity, not every component may be numbered in every drawing.

[0008] [Figure 1]

[0008] FIG. 1 is a perspective view of an embodiment of a tissue opening closure device attached to an opening formed in tissue. [Figure 2]

[0009] FIG. 10 is a front view of an embodiment of a tissue opening closure device including a plurality of sutures. [Figure 3]

[0010] 12A-12C are perspective views of an embodiment of a suture lock of a tissue opening closure device. [Figure 4A]

[0011] 12A is a perspective view of an embodiment of a suture lock of a tissue opening closure device in an unlocked configuration. FIG. [Figure 4B]

[0012] 4B is a perspective view of the suture lock of FIG. 4A with portions cut away. [Figure 4C]

[0013] FIG. 4B is a perspective view of the suture lock of FIG. 4A in a locked configuration. [Figure 4D]

[0014] 4D is a perspective view of the suture lock of FIG. 4C with portions broken away in a locked configuration. FIG. [Figure 5A]

[0015] 1 is a perspective view of an embodiment of a tissue opening closure device attached to an opening formed in tissue. [Figure 5B]

[0016] 5B is the tissue opening closure device of FIG. 5A, wherein a plurality of sutures are pulled through the suture lock to close the opening. DETAILED DESCRIPTION OF THE INVENTION

[0009]

[0017] Suturing an opening in tissue, such as a wound, trocar opening, or other opening in a subject's tissue, can involve attaching interrupted sutures to the borders of the tissue opening and tensioning the suture all at once to close the tissue opening. This can place excessive tension on the tissue at each suture site and / or on the suture itself, potentially resulting in tissue damage or suture breakage. Another suturing technique can involve using a running suture to apply a spiral stitch along the length of the tissue opening and tensioning the suture to hold the tissue opening together. This technique can be tedious and time-consuming, requiring frequent stopping and tensioning of the suture throughout the application process to prevent uneven tensioning along the length of the tissue opening.

[0010]

[0018] In light of the above, the inventors have recognized and appreciated the design of a wound closure device that is easier to apply and / or distributes tension more evenly across a tissue opening to prevent tissue damage and suture breakage during closure of the tissue opening. According to some embodiments, a tissue opening closure device may include multiple sutures that can be deployed in multiple directions from a central location (e.g., forming a spider web or bike wheel spoke arrangement) so that the sutures can be attached to the tissue at various locations near the border of the opening formed in the tissue to which the sutures are attached. In some embodiments, the sutures may be attached in a symmetrical pattern and / or evenly spaced around the border of the tissue opening, although the disclosure is not limited thereto and asymmetric and non-uniform spacing near the opening formed in the associated tissue may also be used. Corresponding portions of the multiple sutures may be at a central location with respect to the tissue opening or may be gathered together and tensioned together to bring the tissue opening borders together and close the tissue opening. The use of specific structures to tension the suture is discussed in further detail below.

[0011]

[0019] In some embodiments, the tissue opening closure device can include a suture lock configured to receive lengths of suture therein. In some applications, the suture lock can be positioned at a central location relative to the opening during use. For example, a portion of each suture attached to the tissue opening boundary can be pulled through the suture lock and tensioned to shorten the length of the suture between the tissue opening boundary and the suture lock. As the length of each suture decreases, the corresponding portion of the tissue opening boundary can be pulled inward toward the suture lock and drawn together to close the tissue opening. Depending on the embodiment, the sutures can be tensioned individually or simultaneously to adjust and manage the tension applied to the tissue opening boundary during closure. Once the desired tension is reached, the suture lock may secure and maintain the length of suture that extends from the suture lock to the relevant portion of the tissue opening boundary, thereby preventing the suture from slipping through the suture lock and reopening the tissue opening.

[0012]

[0020] In some embodiments, a suture may be attached to the tissue opening boundary at a first end and pulled through a suture lock at a second end opposite the first end. The suture may be attached to the tissue opening boundary at the first end using various techniques, as described further below, and the suture may remain untensioned or partially tensioned until the next suture is attached to the tissue opening boundary. The second end of the suture, opposite the first end, may be threaded through a cord lock before or after the first end is attached to the tissue opening boundary. The second end of each suture may be pulled through a lock, and each suture may be tensioned individually or simultaneously, as needed, to shorten the length of the suture and approximate the tissue opening boundary. By spacing multiple sutures near the tissue opening boundary, tension may be more evenly distributed near the boundary as the tissue opening is tensioned and closed. Once the suture is properly tensioned to close the tissue opening, the suture locks may engage and secure the suture in a locked configuration.

[0013]

[0021] In some embodiments, the suture lock may include a channel through which the suture is pulled and secured. The suture lock may include multiple attachment sites positioned near the channel boundaries for attaching multiple sutures to the attachment sites. In some embodiments, the attachment sites may correspond to any suitable structure, but may also correspond to one or more through-holes extending from a first surface of the suture lock to a second, opposing surface of the suture lock to which the suture is tied. In some embodiments, the suture lock may include a generally annular portion having larger outer and inner diameters corresponding to the location of the channel through which the suture lock extends, in part or in whole. Other shapes may be used in which one or more suture attachment sites are disposed near the channel and the channel extends through the suture lock, as the present disclosure is not limited thereto. Furthermore, the attachment sites may be positioned near the channel through which the suture may pass, using equal spacing or at various angular ranges about the annulus. One or more sutures may also be attached to each attachment site.

[0014]

[0022] In some embodiments, a first end portion of a suture may be attached to an attachment site on the suture lock, and a second end portion of the suture may be threaded through tissue adjacent the tissue opening boundary, then returned to the suture lock and pulled through the channel. In such embodiments, each suture may extend from a first point on the suture lock to the tissue opening boundary and form a loop that returns through a channel, such as the central channel of the suture lock. Pulling the second end portion of the suture back through the central channel of the suture lock may impart tension to the suture, reducing the length of each loop and closing the tissue opening. The lock may be engaged to secure the suture in a locked configuration. In some embodiments, the suture lock is located at a central location of the tissue opening, and the first ends of multiple sutures may be attached to the suture lock at various angular positions distributed around the lock. The second end portion of the suture may extend radially outward from the suture lock in multiple directions and be attached at various points near the tissue opening boundary (e.g., in a bicycle spoke arrangement) to more evenly distribute the pulling load while tensioning the suture loop.

[0015]

[0023] It should be noted that sutures may comprise any type of flexible fabric, fiber, or other material that can be threaded through tissue, including, but not limited to, mesh strips, ribbons, threads, filaments, or wires. The sutures may be standard-sized sutures (e.g., 2-0, 0, 1) and may have a maximum transverse dimension (e.g., diameter or width) between 0.3 mm and 1 mm, although sutures larger and smaller than these dimensions may also be used as the present disclosure is not limited thereto. In some embodiments, the sutures may have various cross-sectional shapes, including flat, wide cross-sections (e.g., ribbon sutures), square, rectangular, circular, or any other suitable shape. The sutures may be made of various biocompatible materials, including bioabsorbable, non-bioabsorbable, natural, and / or synthetic materials, depending on the application. In some embodiments, the sutures may be monofilament, knitted, woven, nonwoven, or other suitable types of materials, depending on the application. In some embodiments, the suture may have a solid cross-section or a hollow (tubular) cross-section, depending on the application.

[0016]

[0024] In some embodiments, multiple sutures used with the suture locks described herein may include multiple sutures joined at points along their length to form a tether, or attached to a separately formed tether with the individual sutures extending out from the tether. In such embodiments, a first end portion of each of the multiple sutures, opposite the tether end, may be attached to tissue near the tissue opening boundary. The tether ends may be threaded through the suture lock, or the sutures may already extend through the suture lock to the tether, with the tethers simultaneously pulled to apply tension to each suture and pull each suture through the suture lock, shortening the length of each suture. As the end portions of each suture connected to the tissue are pulled together, the tissue opening boundary is closed together. The tether may be pre-threaded through the suture lock, or the first end of each suture may be attached to the tissue opening boundary and then threaded through the suture lock.

[0017]

[0025] The inventors have further recognized and appreciated the design of a reversible suture lock that can be configured to switch between a locked and an unlocked configuration. In the unlocked configuration, the suture may be pulled in one or both directions through the lock to increase or decrease the length of the suture (i.e., increase or decrease tension). In the locked configuration, the suture lock may secure the suture, preventing it from being pulled in one or both directions through the lock. A reversible lock in the locked configuration may be transitioned to the unlocked configuration to allow a user to adjust the length and tension of the suture. For example, a trigger, button, slide, or other structure on the lock may be operated by a user to transition the lock between the locked and unlocked configurations. Once the suture is properly tensioned, the lock may be transitioned back to the locked configuration. The locking portion may be locked and unlocked as many times as desired to reach the desired tension to close the tissue opening. Of course, embodiments are contemplated in which the locking portion is not releasable.

[0018]

[0026] The inventors have further recognized and appreciated various locking mechanism designs for securing multiple sutures to a suture lock. In some embodiments, the suture lock may allow the sutures to be pulled in opposite directions (i.e., increasing or decreasing tension) in the unlocked configuration and may prevent the sutures from being pulled in either direction when in the locked configuration. In one such embodiment, the suture lock may include a locking portion, such as a pin or plate, positioned within the channel of the lock that can increase or decrease the cross-sectional area of ​​the channel. The pin or plate may move in a direction parallel to the cross-sectional area to clamp or unclamp the suture within the channel by selectively increasing or decreasing the cross-sectional area through which the threads pass. In some alternative embodiments, the suture lock may include a press-fit lock or set screw for compressing the sutures together at the lock. In yet another embodiment, the lock may include barbs for engaging and / or piercing the suture. For example, when using larger sutures or sutures with a high aspect ratio, such as flat ribbons, the barbs may be drilled into the suture to secure the suture to the suture lock. Alternatively, when using smaller sutures, the barbs may be pressed into the section of the lock opposite the barb to clamp the suture to the suture lock.

[0019]

[0027] In some embodiments, the suture lock may include a one-way lock that allows the suture to advance through the lock in only one direction. For example, the lock may be configured to allow the suture to be drawn through the lock in a direction that shortens the length of the suture extending from the lock toward the associated tissue, while preventing the suture from being pulled through the suture lock in the opposite direction that would increase the length of the suture. In such embodiments, tension on the suture may be increased but not decreased unless the lock is disengaged. In some embodiments, the suture lock may include a ratchet spring or angled tab that engages the suture to counteract tension applied to the suture and prevent slippage.

[0020]

[0028] Sutures can be attached to the tissue opening boundary using a variety of techniques and arrangements. In some embodiments, individual sutures can be threaded through a section of tissue using a needle, then cut and knotted. The free end portion of the suture can then be threaded through a suture lock. The suture can also include one or more barbs at the first end portion, which can be used to attach the suture to tissue. In some embodiments, the suture can include a loop at one end and a needle at the other end. In such embodiments, the needle can pierce the tissue and thread the loop, creating a lasso-loop stitch. Similarly, sutures can be attached to tissue using a zip-tie arrangement, where one end of the suture pierces the tissue and the other end is pulled through a zip-tie enclosure. Of course, other attachments can be used depending on the desired application, as the present disclosure is not limited in this respect.

[0021]

[0029] In some embodiments, a first end portion of the suture may be attached to the suture lock, and a second end portion may be looped through the tissue opening boundary, threaded back through the suture lock, and pulled through the channel of the suture lock. The tissue opening closure device may be packaged with or without a suture pre-attached to the suture lock. When using a suture lock without a pre-attached suture, the surgeon may attach one or more sutures to attachment sites located near the lock. For example, during tissue opening closure, the surgeon may select how many sutures should be attached to the suture lock and where they should be placed based on the size and shape of the tissue opening. When using a suture lock with a pre-attached suture, any unused sutures may be trimmed from the device once the tissue opening is closed.

[0022]

[0030] In some embodiments, the attachment site may include one or more apertures spaced about the periphery of the suture lock. In some embodiments, the apertures may be positioned about the periphery of a channel, which may be formed in the annular portion of the device, such that the suture extends radially outward from the device when attached to the aperture. Each aperture may have a minimum lateral dimension (e.g., width or diameter) of a size and shape appropriate to receive one or more sutures. For example, the minimum lateral dimension of the aperture may be between 0.15 mm and 1.25 mm, and may be shaped and sized to complement a particular suture. In some embodiments, the aperture may have a dimension sized to allow a needle to thread the suture through the aperture. In some such embodiments, the suture may have a knotted end or other end structure with a lateral dimension larger than the inner diameter of the aperture to prevent the end portion of the suture from passing through or being bound by the aperture. Alternatively, the suture may have a loop on one end and a needle on the opposite end. The looped end may be fed through the opening, and the opposite end (with the needle) may be fed through the loop. When the needle end is pulled, the looped end tightens itself against the suture lock, like a lasso. Alternatively, the suture may be tied to the device at the opening. In some cases, it may be desirable to prevent a knot or other retention structure used to attach the suture to the lock from extending outward from the exterior surface of the device. In such embodiments, one or more recesses may be associated with one or more openings formed in the device. The one or more recesses may be sized and shaped to receive a knot or other structure present on the end portion of the suture to secure the suture to the device.

[0023]

[0031] In embodiments where attachment sites may be positioned near the channel of the suture lock, the attachment sites may be distributed near the device boundary using uniform, non-uniform, symmetrical, and / or asymmetrical spacing. In some embodiments, the number of attachment sites on a suture lock may be 2, 3, 5, 6 or more attachment sites. In some embodiments, the number of attachment sites on a suture lock may be 15, 12, 10, or 9 or less attachment sites. Combinations of the foregoing ranges are contemplated, including numbers between 2 and 15 suture attachment sites. However, both fewer attachment sites than those recited above and greater numbers of attachment sites than those recited above are contemplated, as the disclosure is not limited in this manner.

[0024]

[0032] Zero or more sutures may be attached to the suture lock attachment sites depending on the particular user's needs for closing the tissue opening. The shape and size of the tissue opening may determine the optimal number, spacing, and angle of deployment of the sutures on the suture locks. In some embodiments, the number of sutures deployed from the tissue opening closure device may be 2, 3, 5, 6, or more sutures. In some embodiments, the number of sutures deployed from the tissue opening closure device may be 15, 12, 10, or 9 or fewer sutures. The sutures may be attached to the tissue opening boundary using uniform, non-uniform, symmetrical (bilateral or radial), and / or asymmetrical spacing. In some embodiments, more than one color of suture may be used to identify which sutures are attached to different sections of the tissue opening boundary.

[0025]

[0033] In some embodiments, the channel extending through the suture lock for receiving multiple sutures therethrough can have any suitable maximum lateral dimension (e.g., diameter or width) and / or length for receiving and selectively locking sutures therein. For example, the length of the channel can be between 5 mm or more and 10 mm or less. The maximum lateral dimension of the channel can also range between 1 mm or more and 2 mm or less. In some embodiments, the suture lock can have any desired size and shape, but the maximum outer lateral dimension of the closure device including the suture lock and the channel formed therein for receiving sutures can be between 3 mm or more and 8 mm or less. In some embodiments, the outer maximum lateral dimension of the suture lock can be sized to fit through the inner diameter of trocars used in laparoscopic techniques and procedures. However, while specific dimensions are referred to above and elsewhere herein, it should be understood that the disclosure is not limited in this manner and that both larger and smaller dimensions may be used.

[0026]

[0034] Returning to the drawings, certain non-limiting embodiments will now be described in further detail. It should be understood that the present disclosure is not limited to only the specific embodiments described herein, and that the various systems, components, features, and methods described in connection with these embodiments can be used individually and / or in any desired combination.

[0027]

[0035] FIG. 1 illustrates a schematic of one embodiment of a tissue opening closure device 100 attached to a tissue opening 102. The device may include a suture lock 104 and a plurality of sutures 106 deployed at different angular orientations from the suture lock 104. A first end portion 108 of each suture may be attached to a boundary 110 of the tissue opening 102. As shown in FIG. 1, six sutures 106 are attached to the boundary 110 of the tissue opening, with two groups of three sutures 106 attached to either side of the tissue opening in a symmetrical arrangement. While six sutures are shown in FIG. 1, the disclosure is not limited in this respect, and any number of sutures may be employed in various configurations and angular ranges depending on the size, shape, and location of the tissue opening.

[0028]

[0036] 1, the second end portion 112 of each suture 106 may be threaded through a channel 114 of the suture lock 104. As the second end portion 112 of each suture is pulled through the channel 114, the length of the suture extending between the tissue opening boundary and the suture lock 104 decreases, applying tension to the suture 106 and approximating the tissue opening boundary 110 together, thereby closing the tissue opening. In FIG. 1, the second end portion 112 of each suture 106 has not yet been pulled through the suture lock 104 to apply tension to the suture 106 and the tissue opening boundary 110.

[0029]

[0037] The second end portions 112 may be pulled simultaneously or individually through the suture locks 104 to tension the sutures and bring the tissue opening boundary together. By deploying the sutures in multiple directions near the tissue opening boundary, tension can be more evenly spread among the sutures as the tissue opening is closed. Tension can be adjusted and controlled as desired while closing the tissue opening to avoid excessive tension near the tissue opening and prevent suture breakage and / or tissue damage.

[0030]

[0038] In some embodiments, the suture lock 104 can have a lock configured to secure the suture 106 within the channel 114 when in the locked configuration. In some embodiments, as shown in FIG. 1 , the locking device can be a press-fit or spring-loaded structure, such as a button 116, that can be configured to extend into the channel of the device to selectively clamp the suture within the channel. When in the unlocked configuration, the button 116 does not extend into the channel 114, and the suture 106 can be pulled in either of two directions through the channel 114. However, when in the locked configuration, the button 114 or other suitable locking structure can be pressed into the channel 114, clamping the suture 106 in place within the channel and preventing the suture from being pulled in either direction through the channel. The locking device can be engaged in the locking configuration once the desired tension in each suture is reached and the tissue opening is closed. In the locked position, the suture lock 104 may secure and maintain tension on the suture, thereby holding the tissue opening 102 closed.

[0031]

[0039] In some embodiments, the button 116 may be spring-loaded to bias it into the channel, preventing the suture from being pulled therethrough. Thus, the lock may be biased toward the locked configuration. In such embodiments, pressing the button, or other appropriately configured trigger, may push the button out of the channel, allowing the suture to be pulled through the channel and adjusting the tension. Releasing the button may bias the button back into the channel, securing the suture. While FIG. 1 shows button 114, other locking devices may be used to secure the suture to the suture lock. For example, a ratchet spring or other structure may be used to pull the suture through the lock in one direction, shortening the suture while preventing the suture from slipping out of the suture lock in a second direction.

[0032]

[0040] In some embodiments, the tissue opening closure device may include a suture arrangement 200 in which multiple sutures 202 are combined together to form a tether 204 connected to a proximal portion of each suture, or attached to the tether 204, as shown in FIG. 2 . While only two sutures 202 are shown attached to the tether 204 in FIG. 2 , any number of sutures 202 may be attached to the tether 204. The opposing distal end portion 206 of each suture 202 on the other side of the tether may be attached to the tissue opening boundary, as described above with reference to FIG. 1 . In some embodiments, the tether 204 may be pulled through a suture lock 208 to apply tension to the sutures 202 and close the tissue opening boundary. However, embodiments are also contemplated in which the sutures pass through the suture lock or the tether is not disposed within a channel prior to use. It should also be understood that the tether may be used with any of the locks described herein.

[0033]

[0041] 3 shows a perspective view of one embodiment of a suture lock 300 including one or more barb structures that can be used to lock one or more sutures of the device in place. The lock 300 can include a ring portion 302 and one or more barbs 306 extending from a crossbar 304 in a direction toward an opening 310 in the ring portion 302. The crossbar 304 can be positioned outside the outer boundary of the ring portion 302, and the barbs 306 can be disposed within one or more openings (not shown) in the ring portion 302. In an unlocked configuration, as shown in FIG. 3, the barbs 306 can not extend into the opening 310 of the suture lock 300, allowing one or more sutures 308 to be pulled through the opening 310 to a desired length. The crossbar 304 may then be pushed into the ring portion 302, forcing the barbs 306 into the openings 310, thereby securing the suture in a locked configuration. In some embodiments, the crossbar 304 may be retracted from the openings 310, releasing the suture 308 and allowing the length of the suture to be adjusted.

[0034]

[0042] In some embodiments, the crossbar 304 may fit into a portion of the ring portion 302 to maintain the locked configuration. The suture lock 300 may be used with a variety of suture sizes and cross-sectional shapes, and the barbs 306 may pierce the section of the ring portion 302 opposite the suture and / or crossbar 304 to maintain the locked configuration. In some embodiments, the suture 308 may have a width greater than the width between at least two of the barbs 306, such as the wide, flat suture 308 shown in FIG. 3, and the barbs 306 may secure the suture 308 to the suture lock 300 by piercing the suture 308 as the crossbar 306 is forced into the opening 310. In such embodiments, the barbs 306 may or may not be forced into a section of the ring portion 302. In some embodiments, the suture 308 may include openings (not shown) into which the barbs 306 may fit to secure the suture 308 to the lock 300 .

[0035]

[0043] In other embodiments, the suture 308 may have a width less than the width between the barbs 302, and the barbs 306 may pass on one side of the suture 308 as they are pushed into the section of the ring portion 302 opposite the crossbar 304, which may clamp and secure the suture 308 to the lock 300. In some embodiments, the suture lock 300 may be used with the suture arrangement 200 of FIG. 2, where the tether 204 is pulled through the opening 310 to shorten the length of the suture 202 and the barbs 306 may pierce and / or clamp the tether to the lock 300. In some embodiments, the suture lock 300 may be used with the embodiment shown in FIG. 1. In such embodiments, the button 116 may advance the crossbar 304 and barbs 306 to pierce and / or clamp the suture within the channel 114.

[0036]

[0044] 4A-4D show perspective views of one embodiment of a suture lock 400. The suture lock 400 may include a body 401 with a channel 402 extending therethrough. When used to close a tissue opening, a suture may be threaded through the channel and pulled through the channel to apply tension to the suture.

[0037]

[0045] In some embodiments, the body 401 may include one or more protrusions 404 or other radially extending structures that extend radially outward from a surface of the body 401 in a direction generally perpendicular to the longitudinal axis of the body of the suture lock. For example, as shown in FIGS. 4A-4D , two separate, generally flat, wing-like protrusions extend radially outward from one side of the body. In some embodiments, one or more protrusions may extend wholly or partially around the boundary of the associated body 401. The protrusions 404 may also have an outer diameter or other maximum lateral dimension that is greater than the outer diameter of the body 401. In some embodiments, one or more protrusions may be closer to or at one end portion of the suture lock 400 than at the opposite end portion of the suture lock. The one or more protrusions may also each include one or more suture attachment sites 406 formed therein or connected thereto for attaching a first end of a suture to the suture lock 400. In some embodiments, as shown in FIGS. 4A-4D , the attachment sites may correspond to one or more through-holes 406 extending from a first surface 407 of the protrusion 404 to a second, opposing surface of the protrusion (not shown), such that a suture may be tied to or otherwise connected to the through-hole. In other embodiments, the attachment sites may include other designs, such as knobs or hooks, that may secure the end of a suture to the suture lock 400. In some embodiments, the suture lock 400 may include six through-holes 406, with three through-holes formed in each protrusion extending from the body, and the through-holes may be distributed around the circumference of the associated protrusion. However, more or fewer through-holes arranged in any suitable pattern may be used as the present disclosure is not so limited.

[0038]

[0046] In some embodiments, it may be desirable to position the connection between the suture and the suture lock at a location at least partially cleared from surrounding tissue. For example, the suture lock may include a recess 410 that may be sized and shaped to receive a knot or other connection structure used to attach one or more sutures to a corresponding attachment feature, such as the illustrated through-hole 406. For example, in the illustrated embodiment, the one or more protrusions 404 may be spaced from the adjacent end of the body 401, and the one or more walls 408 may extend from an outer portion of the one or more protrusions 404 toward the adjacent end portion of the body 401 in a direction parallel to the longitudinal axis of the channel 402. The resulting recess 410 may be positioned in the space between the one or more protrusions, the one or more walls, and the exterior surface of the body 401. Depending on the embodiment, the one or more walls may extend to or beyond the end of the adjacent portion of the body.

[0039]

[0047] One or more sutures may be attached to one or more through-holes 406 in the associated projection 404. In some embodiments, the suture may include a knotted end with a diameter larger than the inner diameter of the through-hole 406. Such a suture may be threaded through the insertion side of the through-hole 406 so that the knotted end may be constrained on the insertion side of the through-hole (i.e., within the recess 410). Alternatively, the suture may be knotted onto the through-hole, a structure attached to the suture may form a mechanical interference connection with the through-hole, and / or the suture may be connected to the through-hole or other attachment point on the device in any other suitable manner, as the disclosure is not limited in this manner. Furthermore, the suture may be pre-attached to the suture lock 400 prior to use, or the suture may be attached during use (i.e., during suturing of the tissue opening).

[0040]

[0048] 4A and 4B show the suture lock 400 in an unlocked configuration, while FIGS. 4C and 4D show the suture lock 400 in a locked configuration. In some embodiments, the suture lock 400 can include a button 412 that extends into the channel 402 through a first opening 416 in the body 401. The button 412 can include a latch 414 extending from a first side of the button 412. The latch 414 can be positioned in an opening 420 extending through the body 401 opposite the opening 416. FIGS. 4B and 4D are schematics of the suture lock partially cut away to show a cross-section of the button 412 in the body 401 across the channel 402. In the unlocked configuration ( FIGS. 4A and 4B ), the button 412 can extend out of the body 401 through the opening 416. The latch 414 can be positioned at a first end of the opening 420. Each latch 414 may have a tapered ledge at its end that rests on the underside of the opening 420 to retain the button 412 within the opening 416. The button 412 may have a curved surface 418 between the latches 414 that has the same diameter as the channel 402 when the lock is in the unlocked configuration ( FIGS. 4A and 4B ). In this unlocked configuration, the suture may be pulled through the channel. In the locked configuration ( FIGS. 4C and 4D ), the button 412 may be pushed toward the center of the channel, and the latch 414 may be moved into locking engagement with the opening 420, restraining the lock button 412 in the locked configuration. When the lock button 412 is depressed inward, the lock's inner surface 418, which is curved in the illustrated embodiment but other shapes can be used, may be moved into an inner portion of the channel 402, reducing the area of ​​the channel 402 over which the suture may be placed relative to this position of the channel 402. Thus, the suture can be compressed between the inner surface of the button 418 that extends into the channel and the opposing surface of the channel opposite from the button.

[0041]

[0049] 5A and 5B illustrate a method of closing a tissue opening using the suture lock 400 of FIGS. 4A-4D , according to some embodiments. As shown in FIG. 5A , multiple sutures 500 may be attached to the suture lock 400 and to the boundary 600 of the tissue opening to be closed by the device. The sutures 500 may be attached using the following method, although other methods may be used as the disclosure is not limited thereto. A first end 502 of the suture 500 may be threaded upwardly relative to the orientation shown through a through-hole 406 on the protrusion 404, such that the suture passes from within the recess 410 of the associated opening. In some embodiments, one suture 500 may be attached to each of the six through-holes 406. The associated suture 500 may be pulled through the through-hole 406 until a knot (not shown) at a second end 504 of the suture opposite the first end 502 abuts the inner surface of the through-hole 406 adjacent the recess 410. The knot or other appropriately sized structure on the end portion of the suture may have a larger lateral dimension than the associated through-hole 406 such that the retaining feature is disposed within the recess 410 and held in place by the associated opening.

[0042]

[0050] The first end portion 502 of each suture may be passed through a corresponding portion of tissue adjacent the tissue opening boundary 600 by piercing a first surface of the tissue and exiting the tissue at a second surface. The first surface of the tissue may be the surface facing away from the underlying tissue, proximate the suture lock 400, and may be generally parallel to the plane of the through-hole. The second surface of the tissue may be generally parallel or perpendicular to the first surface, depending on the thickness of the tissue and the shape and size of the tissue opening. As shown in the embodiment of FIGS. 5A and 5B, the second surface may face opposite and be generally parallel to the first surface and be positioned at a greater distance from the suture lock 400 than the first surface. In some embodiments, as shown, three sutures may be attached to either side of the tissue opening boundary 600. The sutures 500 on either side of the tissue opening boundary may have different colors to identify the sutures. The first end portion 502 of each suture may be looped back into the suture lock 400 and threaded through a bottom opening of a channel 402 disposed on the bottom surface of the suture lock 400, which is configured to be directed toward the underlying tissue during use. In this manner, each suture 500 may form a suture loop between the suture lock 400 and the tissue opening boundary 600. As shown in FIG. 5A , the suture may be threaded through the channel 402, but the suture 500 may not yet be pulled to reduce the length of the suture loop and apply tension to the suture 500. The tissue opening may have a diameter 600 before tension is applied to close the tissue opening boundary 600. The button 412 or other suitable lock may be in an unlocked configuration to allow the suture 500 to be pulled through the channel 402 in either direction.

[0043]

[0051] 5B shows the tissue opening closure device after the suture 500 has been pulled through the channel 402 of the suture lock 400, tensioning the suture 500 and reducing the length of the loop. As the loop length is reduced, the tension brings the tissue opening boundary 600 together, reducing the tissue opening diameter 602. As the loop length is reduced and the tissue opening diameter 602 is reduced, the bottom surface of the suture lock 400 may rest on the first surface of the tissue on which the suture lock is disposed and close the tissue opening. A knot or other retention structure connected to the second end portion 504 of the suture may be received in the recess 410 to prevent the knot or other structure from contacting the tissue surface when in the final closed configuration, helping to prevent irritation of the tissue or the tissue opening boundary 600. The suture lock 400 may include notches 422 between the prongs 404 to allow the user to visualize the progress during opening closure.

[0044]

[0052] Once the desired tension and tissue opening diameter 602 is reached, the button 412 may be pressed into the channel 402 in a locked configuration, compressing the suture 500 against the inner surface of the channel 402 and locking the length of the suture, as described above. For example, one or more latches 414 on the press-fit button may be pressed through the opening 420 and engage the outer surface of the channel 402 to maintain the button 412 in the locked configuration. In this manner, the suture lock may maintain the length and tension applied to the suture 500, thereby maintaining the tissue opening in a desired closed configuration.

[0045]

[0053] 5A and 5B, various locking mechanisms may be employed to secure the suture in the channel 402. In some embodiments, the suture lock 400 may include a reversible lock, such as a spring-loaded button biased toward a locked configuration, which allows the suture lock to be switched between locked and unlocked configurations. In this manner, the tension in the suture 500 may be adjusted and readjusted as needed during and after closure of the tissue opening.

[0046]

[0054] While the present teachings have been described in conjunction with various embodiments and examples, it is not intended that the present teachings be limited to such embodiments or examples. On the contrary, the present teachings encompass various alternatives, modifications, and equivalents, as will be appreciated by those skilled in the art. Accordingly, the foregoing description and drawings are by way of example only.

Claims

1. 1. A tissue opening closure device comprising a suture lock, the suture lock is configured to pass a second portion of each suture of the plurality of sutures through a channel within the suture lock when a first portion of each suture of the plurality of sutures is attached to tissue; the suture lock is configured to maintain a length of the plurality of sutures extending out of the suture lock in a first locked configuration, and to change a length of the plurality of sutures extending out of the suture lock in a second unlocked configuration by pulling the plurality of sutures through the channels in the suture lock; the suture lock is configured to reversibly transition between the first locked configuration and the second unlocked configuration; The tissue opening closure device, wherein the suture lock further comprises a plurality of openings positioned around the channel of the suture lock for attaching the plurality of sutures to the suture lock.

2. The tissue opening closure device further comprises the plurality of sutures; the plurality of sutures are connected to a tether; The tissue opening closure device of claim 1 , wherein the tether is configured to be tensioned to simultaneously tension the plurality of sutures.

3. The tissue opening closure device further comprising the plurality of sutures; The tissue opening closure device of claim 1 , wherein each suture of the plurality of sutures is configured to be individually pulled through the suture lock.

4. The tissue opening closure device of claim 1 , wherein the suture lock is configured to allow the plurality of sutures to be pulled through the suture lock in only one direction.

5. The tissue opening closure device of claim 1 , wherein the suture lock includes a button that secures the plurality of sutures when in the locked configuration.

6. The tissue opening closure device of claim 1 , wherein the suture lock includes barbs configured to pierce the plurality of sutures to secure the plurality of sutures when in the locked configuration.

7. The tissue opening closure device of claim 1 , wherein the suture lock is biased into the locked configuration.

8. The tissue opening closure device includes one or more protrusions extending radially outward from a surface of the body of the suture engagement portion; The tissue opening closure device of claim 1 , wherein the plurality of openings are formed in the protrusion.

Images